in this issue breathing for life exposome blueprint ... · “providers need to suggest patient...
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Connect with ATS #ATS2017
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Washington, DCMay 19-24, 2017
Sunday, May 21, 2017
IN THIS ISSUE BREATHING FOR LIFE PAGE 4 CF’s CHANGING FACE PAGE 8 EXPOSOME BLUEPRINT PAGE 24
Investing in early childhood education for socially and economically disadvantaged children makes sense. Every dollar invested in early childhood development returns
between $7 and $13 annually in improved physical and mental health, more education, higher income, and reduced crime over the succeeding decades.
“What is socially fair is also economically efficient,” says James Heckman, PhD, Henry Schultz Distinguished Professor of Econom-ics at the University of Chicago and winner of the Nobel Prize in Economics in 2000. “Even if you discount the social element, there is an op-portunity, based solely on economic grounds, to intervene early to build healthier, more productive lives.”
Prof. Heckman discussed the research evidence supporting early childhood interven-tion Saturday during his Opening Ceremony address, “Developmental Origins of Health and Well-Being.” Interventions as simple as teach-ing new mothers in low-income neighborhoods for one hour every two weeks how to be better parents produces demonstrable benefits into their children’s adult years.
Success in life and in society is determined
Early childhood social intervention directly impacts health and success
see OPENING CEREMONY page 38
KEYNOTE SERIES
TodaySpeakers to examine
infectious disease control,
effect of short telomeres
The ATS Keynote Series high-lights state-of-the-art lectures on a variety of topics to show-case major discoveries in pul-
monary, critical care, and sleep medicine. Two sessions are presented from 8:15 to 9 a.m. each day during the conference, when no other programming is scheduled.
Sunday’s speakers will examine the challenges of controlling infectious dis-ease and the effect of short telomeres on lung aging.
AIDS to Zika: The Perpetual Challenge of Emerging and Re-Emerging Infectious Diseases (K1)Salon A-C (South Building, Street Level),Walter E. Washington Convention Center
Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (NIAID), will discuss the challenges that public health offi-cials face in controlling transmittable diseases.
Since his appointment as NIAID director in 1984, Dr. Fauci has overseen an exten-sive research portfolio devoted to prevent-ing, diagnosing, and treating infectious and immune-mediated diseases. He has published a paper, “Ending the HIV/AIDS Pandemic: An Achievable Goal,” which outlines the scientific community’s progress in controlling HIV and treating patients living with the disease.
Telomeres and Telomerase in Pulmonary Fibrosis and Emphysema (K2)Salon G-I (South Building, Street Level)Walter E. Washington Convention CenterMary Armanios, MD, associate professor of
Patients should not be the passive victims of their diseases and condi-tions. Instead, they should act as the quarterbacks of their treatment
teams to improve their outcomes. That was the message delivered by six health care profession-als to dozens of patients and their families at Saturday’s Public Advisory Roundtable (PAR)Meet-the-Experts session.
The experts at The Role of Patients in Ad-vancing Treatments and Cures explained the role of research, how clinical trials are devel-oped, and how patients can—and should—be
more involved. That involvement is a two-way street, says Kathleen Lindell, PhD, RN, a research assistant professor at the University of Pittsburgh.
“Providers need to suggest patient involve-ment, but you need to ask them,” she says, adding, “It’s OK to ask questions.”
Patients in the audience, their families, and their friends were receptive to the message. Many already are proactive in their treatments, which is why they attended the PAR event.
Jennifer Miner, Chantilly, Virginia, has two teenaged sons with cystic fibrosis and asthma. Her oldest son has participated in clinical trials.
“I want to learn what other clinical tri-als are out there, and what else can be done
from a patient advocacy perspective,” she says. “I’m just trying to figure out how best to treat them…what else could be done to help keep them healthy.
“My older son was diagnosed at 18 months, and we had an amniocentesis for my younger son, so we knew before he was born. That made a huge difference because that 18 months did so much damage to my 15-year-old’s lungs, but his brother has only been hospitalized for it one time.”
Another attendee, Carol Harrison, New York, has been diagnosed with sarcoidosis of the kidney in the last year. “I drove here because I am just reaching out for more information about the disease. This is a start to networking and finding out more,” she says.
Anthony S. Fauci, MD
see KEYNOTE SERIES page 37
PAR Encourages Patients to Take Charge
See Patients Perspective on page 38
James Heckman, PhD: ‘The early years are very important times and places for lifetime success.’
Changing Lifetime Outcomes
to expanding healthcare
options for individuals living
with cardiovascular and
pulmonary diseases.
Gilead is committed
© 2016 Gilead Sciences, Inc. All rights reserved. UNBP2550 10/16 Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc.
ATS Daily Bulletin • ATS 2017 International Conference • Sunday, May 21, 2017 3
Editors of the Journal of the American Medical Association and the New England Journal of Medicine will discuss recently published papers
with the authors.The papers are of significant importance to
the fields of pulmonary and critical care medi-cine. Attendees will have the opportunity to ask questions of the editors and authors. These discussions are intended to provide insight into the papers, the selection process, and how the
research applies directly to the fields.Jeffrey Drazen, MD, NEJM editor-in-chief,
will be the co-chair of both sessions. He is the Distinguished Parker B. Francis Professor of Medicine at Harvard Medical School, senior physician at Brigham and Women’s Hospital,
and professor of physiol-ogy at the Harvard School of Public Health.
George O’Connor, MD, MS, JAMA associ-ate editor, will co-chair the morning session, and Phil B. Fontan-arosa, MD, MBA, JAMA executive editor, will co-chair the afternoon session. Dr. O’Connor is professor of medi-
cine at Boston University School of Medicine. Dr. Fontanarosa is an adjunct professor of emergency medicine and preventive medicine at Northwestern University Feinberg School of Medicine.
JAMA and NEJM
Discussion on the Edge: Reports of Recently Published Pulmonary Research (A2)
9:15-11:15 a.m. Sunday
Room 207 A-B (South Building, Level 2)Walter E. Washington Convention Center
NEJM and JAMA
Discussion on the Edge: Reports of Recently Published Critical Care Research (A84)
2:15-4:15 p.m. Sunday
Room 207 A-B (South Building, Level 2)Walter E. Washington Convention Center
JAMA, NEJM Editors to Discuss Papers
Welcome!By Zea Borok, MD International Conference Committee Chair
On behalf of the ATS Interna-tional Conference Commit-tee, I am pleased to welcome you to ATS 2017. It is won-
derful to be meeting in Washington, DC, the city that 113 years ago hosted the first conference of the American Sanatorium Association, which became the American Thoracic Society in 1960.
The ATS founders could scarcely have imagined the advances in preventing and treating tuberculosis that have occurred over the past century, let alone the discov-eries in pulmonary, critical care, and sleep
medicine that will be shared during this con-ference. However, the Society’s founders would recognize one similarity of ATS 2017 with their first conference: An un-derlying belief that when clinicians and scientists
share ideas and exchange information, the path to better treatments is shortened, and patients’ hopes are raised.
At ATS 2017, you will find sessions led by world experts and master clinicians in pulmonary, critical care, and sleep medi-cine and research; trainees presenting their research or a case study for the first time; and members of the multidisciplinary team that defines health care today engaged in discussions about how they can integrate their work to restore the health of adult and pediatric patients. Furthermore, at ATS 2017, you will find presenters whose careers lie outside of respiratory medicine, or even medicine itself.
We have taken advantage of our Washington, DC, location to invite the participation of government officials. Our program will be enriched by presenta-tions from a U.S. senator and from leaders of the National Institutes of Health, the Environmental Protection Agency, and the Smithsonian Museum, among many others who work in government. Our meeting also coincides with the American Col-lege of Radiology’s annual meeting, and together, we will hold a joint symposium Tuesday afternoon on thoracic imaging and radiographic metrics in the quantifica-tion of lung disease.
In a conference this big—500 sessions, 800 speakers, 6,700 abstracts and case re-ports, and over 200 exhibitors—it is impos-sible to touch on even a fraction of the many highlights. In today’s ATS Daily Bulletin and those that will follow, you can read previews of many sessions that will take place during ATS 2017. And, of course, all of the sessions are listed in the Final Program and within the International Conference app.
We on the International Conference Committee are proud of the sessions we have programmed this year and welcome your feedback so that this conference can continue to grow and meet the needs of all those concerned with advancing pulmo-nary, critical care, and sleep medicine. Enjoy the conference!
Zea Borok, MD
ATS Unveils InitiativesHealth care, science advocacy at the heart of Society’s mission
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ATS Daily Bulletin
The ATS continues its efforts to impact health care and policies domestically and around the globe. The ATS president and president-
elect outlined those efforts in addresses Sat-urday evening during the ATS 2017 Opening Ceremony.
Proposed changes in U.S. health care and environmental policy are contentious topics on Capitol Hill, and ATS President David Gozal, MD, MBA, made it clear during his address that the ATS does not agree with some of Presi-dent Donald Trump’s positions.
“Here in the United States, since the end of the second World War, a powerful partnership in medical research has emerged involving academic institutions, industry, and govern-ment,” Dr. Gozal says. “Together, we have made truly remarkable progress in many key areas of pulmonary, critical care, and sleep medicine. That partnership is facing significant chal-lenges, some would say a crisis. And that’s why it is so fortunate we are having this conference here in Washington.”
To counter the president’s proposals, the ATS is redoubling its advocacy tactics. It is holding a rally on Capitol Hill and sending members to visit their congressional representatives—both on Tuesday.
“When it comes to public policy advocacy, whether in the United States or internationally, our priorities have not changed—including fund-ing for medical research, access to health care, clean air, and tobacco control,” Dr. Gozal says.
Dr. Gozal also discussed some of the Society’s other priorities, including attracting more early career professionals to pulmonary, critical care, and sleep medicine with targeted programs. The new ATS Emerging Leaders Program was launched during the conference and aims to cultivate a pipeline of leaders who can serve the global community, their own institutions, and the ATS. Other efforts include the Best of ATS Video Lecture Series—a series of peer-reviewed educational videos—and continued support from the ATS Foundation Research Program to fund young researchers.
“So why do we spend so much time and ef-fort cultivating the next generation of research-
ers and clinicians? Why is advocacy such a high priority?” Dr. Gozal asks. “The answer is really quite simple and straightforward. We do it for our patients. We do it to make their lives better, and in so doing make the world better, too.”
The ATS is expanding its general education efforts. It has added new editors for the Ameri-can Journal of Respiratory Cell and Molecular Biology and Annals of the American Thoracic Society, and it has started a new clinical guide-line implementation program.
“This pilot program will work closely with select hospitals to determine how our guidelines can be best implemented to improve patient care,” Dr. Gozal says. “We also are starting a new Pulmonary Function Testing Laboratory accredi-tation program to ensure that PFT labs meet the same high standards as other medical labs.”
ATS President-Elect Marc Moss, MD, ex-plained the efforts of the Society to expand its global footprint.
The Global Scholars Program, which seeks to help address the shortage of advanced training programs in respiratory, critical care, and sleep medicine in middle- and low- income coun-tries, offers 25 webinars on a range of topics.
The MECOR 2.0 program offers a hybrid course emphasizing out-of-class preparation that enables a greater focus on individual students in the classroom. Finally, the ATS is co-sponsoring a South American conference from July 13-15 in Sao Paulo, Brazil. It will focus on acute respiratory failure and mechani-cal ventilation.
“Taken together, these initiatives demon-strate the ATS commitment to broadening our scientific and clinical reach throughout the world,” Dr. Moss says. “In the years to come, you will see ATS investing more resources in these types of activities. They are an essential component in the overall drive to improve lung health globally.”
ATS President David Gozal, MD, MBA: ‘A powerful partnership in medical research has emerged involving academic institutions, industry, and government.’
ATS Daily Bulletin • ATS 2017 International Conference • Sunday, May 21, 20174
Exhibitors Showcase Clinical Trial Experience, Products
Clinical trial investigators can learn about research opportunities at ATS 2017 by visiting exhibitors currently involved in trials. Nine
exhibitors are featured in the Exhibit Hall and in the Clinical Trials Awareness Area. The area is in Concourse B of the Walter E. Washington Convention Center.
FibroGen, Inc., Booth 2, is a biotechnol-ogy company focused on development and commercialization of therapeutic agents, including pamrevlumab (FG-3019). It is an investigational anti-fibrotic therapeutic anti-body that inhibits the activity of connective tissue growth factor. It is being evaluated in a randomized placebo-controlled phase 2 trial in idiopathic pulmonary fibrosis.
Novartis Pharma AG, Booth 8, offers a diversified portfolio that features innovative
medicines, eye care, and cost-saving generic pharmaceuticals. Novartis employs 118,000 full-time-equivalent associates, and its prod-ucts are sold in more than 150 countries.
PAREXEL, Booth 1147, is a central review core lab for clinical trials. It offers multiple solutions to standardize central imaging and pathology endpoint assessments in respiratory and pulmonology diseases. It has managed more than 1,300 trials requiring centralized collection and review of data, and it is a lead-ing provider of IPF imaging, having supported the majority of IPF imaging trials and two Breakthrough Therapy Approval trials.
Pulmonx Corp., Booth 949, has conducted two multicenter, multinational randomized controlled trials of its Zephyr endobronchial valves for the treatment of emphysema. The TRANSFORM and IMPACT studies evaluated
a total of 190 patients with homogeneous em-physema and absence of collateral ventilation. The Global Initiative for Chronic Obstructive Lung Disease recently included endobron-chial valves in its recommendations for the treatment of patients with emphysema. The company expects to submit its valves for FDA approval in 2018.
Reata Pharmaceuticals, Booth 9, is a clini-cal stage biopharmaceutical company that develops novel therapeutics by targeting mo-lecular pathways involved in the regulation of cellular metabolism and inflammation. Reata’s two most advanced clinical candi-dates are bardoxolone methyl and omavelox-olone, which target an important transcrip-tion factor, Nrf2, to restore mitochondrial function, reduce oxidative stress, and resolve inflammation.
Santhera Pharmaceuticals, Booth 3, focuses on the development of treatments for mitochondrial, neuromuscular, and neuro-ophthalmological diseases that currently lack treatment options. Its leading drug in development is idebenone, which is in phase 3 development for Duchenne muscular dystro-phy. The study has demonstrated that the drug slows the decrease in respiratory muscle func-tion over time, resulting in less respiratory-related symptoms in boys with DMD.
Spyryx Biosciences, Booth 6, is develop-ing SPX-101, a peptide nebulized with an in-vestigational eFlow nebulizer for the manage-ment of cystic fibrosis. SPX-101 is a mimetic of the SPLUNC1 protein and represents a novel mechanism of action in the search for correction of the pulmonary manifestations of CF.
Temple University Health Systems Inc., Booth 1309, emphasizes patient-centered care, research and education focused on pulmonary disease. Temple has one of the most active centers for pulmonary care in the nation with thousands of patient visits and procedures performed each year.
Bellerophon Therapeutics, Booth 7, is a clinical-stage biotherapeutics company focused on developing innovative therapies at the intersection of drugs and devices that address significant unmet medical needs in the treatment of cardiopulmonary diseases. It is currently developing three product candidates under its INOpulse program, a proprietary pulsatile nitric oxide delivery device. The first candidate is for the treat-ment of pulmonary arterial hypertension, which is enrolling patients in phase 3 clini-cal trials.
ATS Foundation Recognizes Work of David Center
On Saturday, David Center, MD, was recognized for his long service as a clinician, investigator, and teacher as he received the Breathing for
Life Award at the Ninth Annual ATS Founda-tion Research Program Benefit at the Marriott Marquis Washington.
The Breathing for Life Award is the highest honor given by the Foundation for philanthropy, scientific achievement, and commitment to mentorship. The Foundation Benefit attracts international leaders from across the pulmonary, critical care, and sleep fields of medicine and supports research grants for young investigators.
Dr. Center is the Gordon and Ruth Snider Professor of Pulmonary Medicine and associ-ate provost for translational research at Boston University, where he has served as chief of
pulmonary medicine for 30 years. Dr. Center led the training of generations of physicians and scientists, many of whom are now themselves leaders in pulmonary medicine.
A renowned researcher, Dr. Center recognizes the impact of early career research awards and the vital role of ATS Foundation Research Pro-gram grants. He and William Cruikshank, MD, identified a T lymphocyte-specific chemotactic factor, now known as IL-16. Their work helped open doors for other researchers interested in allergic diseases, asthma, HIV, and cancer.
“I’m truly honored to receive the Breathing for Life Award and to help support the ATS Foundation Research Program,” Dr. Center said. “Research grants from this program not only provide financial support, they also build the confidence and recognition that comes from having been selected in a stiff competition.”
Since the program began more than a decade ago, the Research Program has awarded $16 million in grants to 210 investigators who have gone on to secure $215 million in federal fund-ing. Dean Schraufnagel, MD, the chair of the ATS Foundation, knows the value of the ATS Foundation funding more research.
“A lot of people do a lot of good things for the ATS. But ATS also does a lot of good things for people, including helping members build their careers,” Dr. Schraufnagel said. “People give because they are interested in better health and
better life for their patients and for everybody.”In 2017, the ATS Foundation will fund more
than 20 awards, including unrestricted research awards in pulmonary, critical care, and sleep medicine; research partner awards; and awards for outstanding alumni from the Methods in Epidemiologic, Clinical, and Operations Re-search program. Applications for the 2017-2018 Research Program grant cycle are being ac-cepted. Letters of intent are due by June 6, 2017. Visit thoracic.org/go/researchgrants for details.
The ATS Foundation thanks Genentech for
support at the Sapphire Level; AstraZeneca LP at the Gold Level; Freeman Decorating Services, Inc., Gilead Sciences, Inc., Insmed Incorporated, Sunovion Pharmaceuticals, Inc., and Teva Respi-ratory at the Silver Level; and Boston Scientific Corporation, Inc., Circassia Pharmaceuticals, Merck, and Vertex Pharmaceuticals Inc. at the Bronze Level.
For the most up-to-date list of generous dona-tions from individuals, medical institutions, and corporate supporters of the ATS Foundation, visit foundation.thoracic.org/benefit.
Exhibit Hall HoursSUNDAY10:30 a.m.-3:30 p.m.Unopposed Hours 1:15-2:15 p.m.
MONDAY10:30 a.m.-3:30 p.m.Unopposed Hours 1:15-2:15 p.m.
TUESDAY10:30 a.m. to 3:30 p.m.Unopposed Hours 1:15-2:15 p.m.Toast to Innovation 1:15-2:15 p.m.
BREATHING FOR LIFE AWARD RECIPIENTS
Sally Wenzel, MD (2016)Marvin Schwarz, MD (2015)William Busse, MD (2014)Gerard Turino, MD (2013)Talmadge King, Jr., MD (2012)Louis Libby, MD (2011)Sen. Mike Crapo (R-Idaho) (2010)ATS PAR (2009)
David Center, MD, (right) and ATS Foundation Chair Dean Schraufnagel, MD, hold the Breathing for Life Award.
Join us for a non-CME educational program
sponsored by Insmed Incorporated open to all ATS 2017
International Conference attendees
Join us for a dinner program that will explore approaches to managing NTM in the community setting using case discussions to highlight considerations around screening, diagnosis, treatment, and ongoing monitoring.
The program will conclude with a question-and-answer session with the expert faculty panel.
Preregistration is recommended but not required.
An industry-organized symposium at the ATS 2017 International Conference.
To register, visit
www.insmedsymposiumregistration.com
or call 215-944-9442.
FACULTYChairAnne E. O’Donnell, MDGeorgetown University Hospital Washington, DC
Shannon Kasperbauer, MDNational Jewish HealthDenver, CO
Patrick Flume, MDMedical University of South Carolina Charleston, SC
NP-US-00264
Sunday, May 21, 2017 / 6:30 – 9:30 PM EST
Grand Hyatt Washington1000 H Street NW, Washington, DC 20001
Independence Ballroom F-I
DIAGNOSING AND MANAGING NTM IN THE COMMUNITY SETTING
370 Newsletter Ad-FINAL.indd 1 4/13/17 9:46 AM
ATS Daily Bulletin • ATS 2017 International Conference • Sunday, May 21, 20176
Indoor Air PollutionHousehold air pollution expedites decline in respiratory health
Household air pollution from burn-ing biomass is a known problem in developing nations, where food often is prepared over these fires.
However, North America also has indoor pollution problems, particularly in homes near highways, with improperly ventilated gas
fireplaces, or where wood is burned for heat. Speakers will examine health issues related to pollution during a Sunday symposium.
Presentations will track the causes of pollu-tion and how the causes are being addressed around the world. Speakers will examine the
latest research on the toxic effects of pollut-ants on lung cells and the development of interventions.
“The session represents a combined effort of a lot of assemblies with a common interest in the environmental effects on lung health. It ranges from very basic mechanisms of disease to clinical and epidemiological aspects,” says Gregory Downey, MD, a session moderator.
“What many people don’t understand is that even in North America there is a significant component of indoor air pollution that contrib-utes to lung diseases. In rural America, people
keep their houses heated with wood stoves or gas fireplaces that are improperly vented. These contribute significantly to obstructive lung dis-ease,” says Dr. Downey, professor and executive vice president of academic affairs at National Jewish Health, Denver.
The session will start with an overview of household air pollution, and each presentation will build on information from the previous presentation.
“Inflammatory Lung Diseases in Vulnerable Populations Exposed to HAP” will explain the epidemiology of HAP and present clinical observations. It also will trace the effects of par-ticulate matter and gaseous byproducts from stoves on inflammatory disease that can lead to obstructive lung disease.
“Household Air Pollution Exposure Occurs in Developed Countries as Well!” will present data from a study of Caucasian, Hispanic, and Native American populations in the Southwest United States. Those populations are exposed to allergens and dust contained in pollutants.
“Studying Biologic Mechanisms of HAP-Induced Diseases” will analyze the effect of various pollutants on cells in culture, especially epithelial cells. Animal dung often is burned for fuel, and the resulting pollutants vary among animals and affect the levels of toxicity.
“The Role of Biomass Smoke in Respira-tory Infections” will explore how exposure to biomass fuels makes people more susceptible to bacterial and viral respiratory tract infections. Those infections can contribute to an expedited decline in lung function.
“Translational Approaches to Understand the Effects of Biomass Smoke” will include an analysis of the chemical components of smoke from different environments and the effect of those components in small animal models.
“Does Exposure to Household Air Pollution Increase Cardiovascular Morbidity and Mortal-ity?” will present a big-picture view of how indoor air pollution affects respiratory health. This will include the effect of gasoline and die-sel fuel from highways on neighboring homes.
Speakers also will discuss the development
of treatments and proactive efforts to prevent pollution. Many developing nations and global agencies are giving people better stoves and helping them improve ventilation in their homes. Education about proper ventilation is becoming more common in North America, Dr. Downey says.
“Several of the speakers will talk about how, based on the knowledge of signaling pathways that lung cells are exposed to, there are specific pharmacological interventions,” he says. “There are medications to try to limit the damage.”
Catching Fire: The Global Health Issue of Household Air Pollution (A91)
2:15-4:15 p.m. Sunday
Room 145 A-B (Middle
Building, Street Level),
Walter E. Washington
Convention Center
Translating evidence-based care into sustainable clinical practice can take years of concerted effort. Using implementation science
methods can help reduce the lag time between those two steps that transform the treatment of patients.
“Implementation science is the scientific study of methods and strategies to promote the translation of evidence produced by research into clinical practice—examining how and why adoption occurs or fails,” says Deena Costa, PhD, RN, one of the moderators of Monday’s imple-mentation symposium. “Implementation could be considered the final step that turns the evidence developed by successful research into improved clinical practice and improved patient outcomes.”
Symposium presentations will build on recent research statements on implementation
science from the ATS and the Sleep Research Society, says Dr. Costa, an assistant professor at the University of Michigan School of Nurs-ing in the Department of Systems, Popula-tions, and Leadership.
Health care professionals recognize the gap between the publication of new evidence and the broad adoption of evidence into clinical practice. As pressure mounts to provide high-quality, evidence-based care, both research-ers and clinicians can benefit from a deeper understanding of how implementation science can reduce that lag.
“The real strength of this session is the ability to hear concrete examples of implementation science in action across different settings,” Dr. Costa says. “We will discuss current uses of implementation science in complex care deliv-ery in the ICU, pulmonary rehabilitation, lung cancer and tuberculosis screening, and CPAP adherence—providing practical approaches to how implementation science can shorten the gap between theory, research, and practice. And we will talk about both funding sources and the practicalities of changing behavior.”
A major barrier to implementing change is the need to change behavior, she says. Imple-mentation science provides tailored strategies to help change the processes of individual clini-cians, patients, institutions, and other stake-holders. Helping stakeholders change behavior to incorporate new evidence is the hard part.
“Figuring out how to implement new best
practices usually starts with a barrier-facilita-tor elicitation,” Dr. Costa says. “You partner with the key stakeholders and identify what prevents adoption of a particular care practice in that setting and what can best support adoption of that care practice, beginning the change process.”
The key to successful implementation is creating a viable partnership among research-ers, clinicians, and other stakeholders.
“You can provide the evidence for the intervention, some potential implementation strategies, and how best to evaluate the implementation intervention, but clinicians provide invaluable insight and feedback as to how it may need to be tailored for their particular setting. Regardless of your practice setting, implementation of evidence-based practice is something you will confront,” Dr. Costa says. “This session offers opportunities and practical skills, including tips on funding options for this work, for both clinicians and researchers alike.”
Implementation Science in Pulmonary, Critical Care, Sleep and Pediatric Medicine: How Soon is Now? (B91)
2:15-4:15 p.m. Monday
Salon A-C (South
Building, Street Level),
Walter E. Washington
Convention Center
Deena Costa,
PhD, RN
Time LapseImplementation science reduces lag between new science and clinical practice
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ATS Daily Bulletin • ATS 2017 International Conference • Sunday, May 21, 20178
Wearable technology, data col-lection, and reporting devices worn by patients on the go is the next frontier in clinical
research and treatment. A host of new devices and communications technologies are poised to transform the ways researchers, clinicians, and patients collect and use data to improve patient care and outcomes.
“There has been an explosion in our ability to collect data in real-world situations and use it to help patients improve their health,” says Ted Reiss, MD, MBE, head of clinical research
and development for the Inflammation and Immunology Division of Celgene Corp. “These technologies come in all different shapes and sizes, from reminders on your cell phone to tracking activity and recording clinical input that help monitor asthma, COPD, or other chronic respiratory diseases.”
Dr. Reiss also is the chair of the ATS Drug, Device, Discovery, and Development Committee, which is
sponsoring two sessions on wearable technology. The first, “The Promise and Reality of Wearable Health Technology,” will explore the types of devices and technologies that are moving into more common use. The current generation of wearable technology is finding applications in smoking cessation, sleep medicine, pulmonary rehab, COPD, and other pulmonary diseases. Look for further developments in the use of wearable technologies to reach vulnerable popu-lations and promote pulmonary health equity.
Other wearable technologies are being developed for diabetes, arthritis, cardiovascular disease, and a variety of chronic conditions, Dr. Reiss notes.
A second session, “The Importance of Technology Implementation in Respiratory
Care and Public Health,” will examine the practical side of implementing
new technology in patient care. Speakers will pres-
ent practical insights on how to optimize
the integration of respiratory care innovations, human factors in technol-ogy adoption,
the impact of human and orga-
nizational behavior on implementation, and the
utility of real-world data in COPD.“The key to successful implementation is
patient centricity,” Dr. Reiss says. “Imple-mentation is really the last step in research
translation—taking the innovation and mak-ing it effective in the real world. We not only have to envision and develop new tech-nology, we have to follow through and implement it to the benefit of patients and to the health care system.”
One of the most important consider-ations in developing wearable technology is to engage patients. It is not enough to collect data or send reminders that are clini-cally useful; it must also be data and reminders that patients see as helpful.
“Think about technology from the patient’s point of view,” Dr. Reiss says. “What reminders at the patient level or feedback from health care providers help patients monitor their therapy more fully and take more responsibility and advantage of those therapies? People are starting to use them, but they need to be improved and used more broadly in the health care system.”
From Drawing Board to PatientWearable health technology races forward and into the future
The Promise and Reality of Wearable Health Technology (A12)
9:15-11:15 a.m.
Sunday
Room 152A-B, (Middle
Building, Street Level),
Walter E. Washington
Convention Center
The Importance of Technology Implementation in Respiratory Care and Public Health (B12)
9:15-11:15 a.m.
Monday
Room 202 B (South
Building, Level 2),
Walter E. Washington
Convention Center
Ted Reiss, MD, MBE
Exhibit Hall Hours
SUNDAY10:30 a.m.-3:30 p.m.Unopposed Hours 1:15-2:15 p.m.
MONDAY10:30 a.m.-3:30 p.m.Unopposed Hours 1:15-2:15 p.m.
TUESDAY10:30 a.m. to 3:30 p.m.Unopposed Hours 1:15-2:15 p.m.Toast to Innovation 1:15-2:15 p.m.
The Changing Face of Cystic FibrosisCF patient advocate, researchers to showcase advances
Cystic Fibrosis didn’t even have a name until 1936. That was when Dorothy Hansine Andersen, MD, recognized the disparate symp-
toms of CF as a single syndrome and eventually gave it a name.
“In Dorothy Andersen’s day, newborns with CF didn’t live longer than months or a few years,” says Scott H. Randell, PhD, associate professor of cell biology and physiology, and principal investigator at the Univer-sity of North Carolina Mar-isco Lung Institute. “Now the mean age of survival is 40 in the United States. And it is still improving. There have been significant changes in the CF timeline since her era.”
Dr. Randell and Stephanie D. Davis, MD, professor of pediatrics at Indiana University School of Medicine, are co-moderators of a ses-sion on what is new in CF treatment.
“This session is intended to update caregiv-ers and researchers about the incredible story of advances in CF and help them stay up to date in the latest developments from basic and clinical science and animal models to the treat-
ment pipeline,” Dr. Randell says. “We will begin with an explosive look at CF from the patient perspective by Emily Kramer-Golinkoff, one of the most amazing people you will ever meet in the CF community.”
Ms. Kramer-Golinkoff founded Emily’s Entourage, one of the most visible patient advocacy groups in CF. She has raised more than $2 million for research focused on less common forms of CF and was named a Champion of Change for Precision Medicine by the White House in 2015.
At the heart of the pulmonary manifestations of CF is a mael-strom of mucus, which is begin-ning to be understood and tamed even in the youngest newborns with CF. Many advances in CF began with a veritable Noah’s ark of animal models. The CF mouse was the first animal model, Dr. Randell says, followed by the CF pig, ferret, rat, and rabbit.
“None of them exactly recapitulate the hu-man disease, but each does to a different ex-tent in different organ systems,” he explains. “The CF mouse doesn’t get the lung disease but does get the intestinal disease. The CF pig
gets both while the CF ferret gets CF diabetes. Every model gives us a different piece of the CF puzzle.”
Although CF is caused by a mutation in a single gene, more than 1,800 mutations to the
cystic fibrosis transmembrane conductance gene have been identified. The development of CFTR modulators allows clini-cians to target the genetic defect responsible for the disease rather than targeting effects of the defect, such as thick, sticky mucus in the lungs. There are only two CFTR modulators approved by the FDA for use in the United States, Dr. Randell says, but many others are in development.
“This one session will give you a searing patient perspective of CF, an update on cutting-edge science, agents in the clinical pipeline, and progress toward a permanent cure,” he says. “Dorothy Andersen would recognize the disease our patients have, but she would be astounded by the progress we have made in treating it.”
It’s Not Dorothy Andersen’s CF Anymore (A92) is supported by an educational grant from Vertex Pharmaceuticals, Inc.
Scott H. Randell, PhD
It’s Not Dorothy Andersen’s CF Anymore (A92)
2:15-4:15 p.m. Sunday
Ballroom B (South
Building, Level 3),
Walter E. Washington
Convention Center
ATS Daily Bulletin • ATS 2017 International Conference • Sunday, May 21, 2017 9
N ew to the ATS International Conference
are Guru Bars, which are designed to
offer participants quick-burst learning
opportunities. Each Guru Bar seats only 25 par-
ticipants to create a dynamic, intimate group with
lots of interaction.
These small-group learning opportunities are
led by industry experts and organized by catego-
ries of interest:
• Guru Bar 1: Education/Awareness/Prevention
• Guru Bar 2: Diagnosis
• Guru Bar 3: Treatment
• Guru Bar 4: Adherence/Compliance
This learning experience is built around Burst
Sessions. A Burst Session is a 10-minute
outline of a problem statement, mitigating
factors, the host’s perspective/solution, and
a challenge or question posed to attendees,
who discuss it for the remaining 5-10 minutes.
Guru Bars run every 30 minutes from
11 a.m. to 2 p.m. Sunday through Tuesday,
just to the left of Industry Theater 2, Booth
1661, in the Exhibit Hall.
SUNDAYGURU BAR 1
Education/Awareness/Prevention11-11:30 a.m.Alpha1-Antitrypsin Deficiency: The Major Known Genetic Risk Factor for COPDOverview and interactive discussion of
Alpha1-antitrypsin deficiency including epide-
miology, genetics, diagnostic guidelines, and
appropriate medical interventions.
Company: Grifols USA, LLC
Noon-12:30 p.m.Clinically Refractory Hypotension: A Case Study ApproachA case study of CRH: current epidemiology,
treatments, and its associated outcomes.
Speaker: Terry Dettling, BSN, JD,
MPH, medical science liaison, La Jolla
Pharmaceutical Company
Company: La Jolla Pharmaceutical Company
GURU BAR 2 Diagnosis11:30 a.m.-NoonUncovering a Genetic Cause of COPD: Alpha1-Antitrypsin DeficiencyAlpha-1 Antitrypsin Deficiency is a genetic
cause of COPD that is severely underdiag-
nosed with as many as 90 percent of the
individuals living with the condition. Learn
more about the mechanism of the disease,
how to determine which patients may be
at risk, and about genetic testing used to
diagnose this condition.
Company: Grifols USA, LLC
1:30-2 p.m.Lung Cancer Diagnosis: Current Challenges in Pulmonary Nodule Management Clinicians face numerous challenges in the
management of patients with pulmonary
nodules, and existing diagnostic tools often
present more questions than answers. During
this interactive, case-based Guru Bar, you will
hear from experts in the field regarding the
need for new biomarkers and their potential
future role in clinical practice.
Speakers: J. Scott Ferguson, MD, associate
professor pulmonary and critical care
Department of Medicine, University of
Wisconsin-Madison, Madison, Wisconsin;
Nichole T. Tanner, MD, MSCR, associate
professor of medicine, co-director lung
screening program, Division of Pulmonary,
Critical Care, Allergy and Sleep Medicine,
Medical University of South Carolina, Charleston,
South Carolina
Company: OncoCyte Corporation
GURU BAR 3 Treatment11-11:30 a.m.Topic: Asthma/COPDCompany: Boehringer Ingelheim Pharmaceuticals, Inc.
Noon-12:30 p.m.Nasal High Flow: What Really Matters?Join this interactive Guru Bar where we will outline the challenges associated with traditional oxygen therapy, review the findings from recent clinical stud-ies, and debate your implementation of Nasal High Flow for patients across the continuum of care.Speaker: Chris Hutchinson, product manager,
Fisher & Paykel HealthcareCompany: Fisher & Paykel Healthcare Ltd.
GURU BAR 4 Adherence/Compliance11:30 a.m.-NoonPAMS: Patient Adherence Management SystemAdjusting to PAP therapy is a behavioral change that can be challenging for OSA patients. PAMS delivers a dedicated sleep coaching service that provides a consistent approach to post-setup PAP patient follow-up.Speaker: Tony RossCompany: Philips Home Healthcare Solutions
btg-im.com
* In accordance with the AdvaMed Code on Interactions with Healthcare Professionals, attendance at this promotional program is limited to healthcare professionals. As such, attendance by guests or spouses is not permitted. Certain federal and/or state laws as well as policies of your institution may limit your ability to accept the modest meal provided during this educational program.
Victor F. Tapson, MD FCCP, FRCPCedars-Sinai Medical Center, Los Angeles, CA
US FDA CLEARED INDICATIONS: The EkoSonic® Endovascular System is indicated for the ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism; the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature; and the infusion of solutions into the pulmonary arteries. Instructions for Use, including warnings, precautions, potential complications, and contraindications can be found atwww.ekoscorp.com. Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. EKOS and EkoSonic are registered trademarks of EKOS Corporation, a BTG International group company. BTG and the BTG roundel logo are registered trademarks of BTG International Ltd.
EKOS is a registered trademark of EKOS Corporation, a BTG International group company. ‘Imagine where we can go’ is a trademark of BTG International, Ltd. BTG and the BTG roundel logo are registered trademarks of BTG International Ltd in US, EU, and certain other territories and trademarks of BTG International Ltd elsewhere. © 2017 BTG International Ltd. NA-EKO-2017-0413.
You are Invited to Revolutionize yourInterventional Options for PE at ATS 2017
Tuesday, May 23, 201711:30 am (lunch provided)*Theater 2, The ATS Exhibit Hall
Walter E. Washington Convention Center Washington DC
Hosted by EKOS Corporation BTG Booth #1209
This is an Industry Theater Presentation at the ATS 2017 International ConferenceThis presentation is sponsored by EKOS Corporation, a BTG International group company, and
is open to all ATS 2017 International Conference attendees.
EKOS Corporation 11911 North Creek Parkway S, Bothell, WA 98011 USA
Copyright © 2017 EKOS Corporation, All rights reserved.
Revolutionary Pulmonary Embolism InterventionJoin EKOS® to learn how a low-dose, short treatment-time
procedure can transform your interventional options for PE
Guru Bars Offer Quick Bursts of Education for Small Groups
ATS Daily Bulletin • ATS 2017 International Conference • Sunday, May 21, 201710
Breathe Easy
thoracic.org/about/ats-podcasts
New Technology at ATS 2017A
TS is leveraging new technologies to improve your experience at the International Conference. These include new functionalities on
the conference app, use of beacon technology to facilitate attendee traffic flows and session attendance, and a web-based audience response system that will make sessions more interactive.
CONFERENCE MOBILE APPFor information at your fingertips, download the conference mobile app, supported by Gilead Sciences, Inc., from the App Store or Google Play. With this tool, you can build your itiner-ary, learn about special events, browse sessions and speakers, map your trip to the Exhibit Hall, and receive important updates.
In addition, two new features will make the app a must-have networking tool. The first is Connect, which helps you find other attend-ees and share your contact information. Its functions include identifying and messaging other attendees, as well as taking notes and compiling contact information of those you connect with.
The second feature is called Contact Scan-ning and is also found on the home page (you may need to scroll down to see it on your device). Easily exchange contact information by scanning a colleague’s registration badge.
Once scanned, their contact information will appear on your screen and can be stored on your device, saving you time and allowing you to continue the conversation long after the conference.
Together, these and other capabilities make the ATS 2017 conference app a must-have tool. Visit the App Store or Google Play to download it today, or go to conference.app.thoracic.org.
AUDIENCE RESPONSEIn Washington, DC, the ATS is implementing new Audience Response System technology that helps presenters and attendees interact. It also translates feedback into charts and graphs that can display results in real time. However, unlike the system used previously, which consisted of small electronic keypads, this year the ARS system will be web-based. When you are in the session room, you will be able to participate by typing a simple URL into your browser on your laptop, tablet, or mobile device. Alternatively, you can access the ARS through the conference app by selecting a link in the session program.
This is a pilot program that will involve 47 sessions. All session rooms engaging this ARS system will have Wi-Fi, which will also allow attendees to browse the web and check
email. We hope to expand the use of this technology at ATS 2018 in San Diego.
BEACON TECHNOLOGYWhat’s in your badge? A tiny computer chip that will make your life easier dur-ing ATS 2017.
Beacon technology will be used to scan badges to capture attendance at select sessions. This technology will help ATS ensure that everyone has the optimum conference experience. No more waiting in line to attend a popular session while your badge gets manually scanned. Sensors will automatically scan the blue disc affixed to your registration badge.
This technology will give us a better understanding of attendee traffic flows, help us plan future conferences, and allow us to provide the best possible learning experience.
Should you have any questions, please contact ATS staff or the onsite team from Panvista, our service provider.
TURNING RESEARCHINTO RECOVERY — FASTER. THAT’S THE DIFFERENCEBETWEEN PRACTICING MEDICINE AND LEADING IT.At Houston Methodist, we focus on innovative research that directly benefi ts our patients. Through more than 700 clinical studies across the Houston Methodist system and many national studies we exclusively offer in Texas, we are discovering new technologies and treatments for some of medicine’s toughest challenges, and getting them to our patients — faster.
Visit houstonmethodist.org/lung-center and explore all the ways we’re leading medicine.
ATS Daily Bulletin • ATS 2017 International Conference • Sunday, May 21, 201712
Q You have a unique background, personally and professionally,
which is truly global in nature. How has that experience been useful to you in the ATS leadership?A: ATS is clearly a global society and is proud of its multicultural diversity, which enriches every aspect of our Society activities. We have members originating from nearly every country in the world, and the fact that they see the ATS as a professional home speaks loudly about the unique value and content that the ATS offers. I look at myself as a global citizen and have been fortunate to live, learn, and thrive in many countries throughout my life. This multicultural background and the acquisition
of several polyglot skills on the way have been uniquely helpful during my tenure on the ATS leadership team. Being able to engage and com-municate with the leaders and members of the many sister societies around the world in their national language, while being keenly aware of their customs and traditions, have undoubt-edly fostered the trust and mutual respect that is fundamental for collaboration and progress toward achieving our mission.
Q You have expressed concern about the misperception that ATS is for
academic physicians when, in fact, it has significant resources for community clini-cians. What are the most important ways
ATS President David Gozal, MD, MBA, looks
back at his tenure in ATS leadership, in which he
has used his previous experience traveling the
world to expand the impact of ATS.
you believe ATS supports clinicians, what-ever their practice setting?A: The ATS is a very heterogeneous society that aims to serve in its best capacity the needs of all constituencies. As such, we need to first remember that even if a large proportion of our members are academic physicians, many more see themselves as clinical educators who strive to enrich the field with evidence-based medical practice. The ATS book of assets is therefore replete with a vast array of ever-evolving educational activities geared toward providing the members with the best and most forward-looking clinical practice models. This constant enrichment process is paramount for any practitioner, irrespective of their practice setting. As such, the unique wealth of educational opportunities and the fact that the ATS represents not only how clinical practice is performed today but also how it will look tomorrow should be an extraordinary impetus for many community clinicians to join and be a valued and contributing part of our Society.
Q You’ve called attention to the fact that the millennial generation learns
differently from previous generations. How will the ATS International Confer-ence change to take advantage of new ways of learning?A: Over the last several decades, the emer-gence of novel technologies and a myriad of changes in many aspects of our personal and professional lives have also modified the way we learn. We have gone from top-down rigid educational models to personalized learning. The ATS is a member-driven orga-nization and therefore these changes have permeated every aspect of our activities. Rather than responding passively to mem-ber-driven requests, we are now embarking on an ambitious set of initiatives aimed at introducing state-of-the-art technologies that will reflect not only the global trends of educational aspirations but also will permit a more personalized learning opportunity for each of our members and for conference attendees.
Q You are the driving force behind the South American Critical Care
Conference that will take place in July in Sao Paulo. How does this initiative play into the larger ATS global mission and will ATS become involved in similar confer-ences in other parts of the world?A: As a global society, the ATS needs to have a global footprint and provide value to its inter-national members. The South American Con-ference is one of many ATS activities designed
to fulfill potential education gaps and serve our entire membership. However, it is impor-tant to emphasize that the ATS views such activities as collaborative enhancers, and as such has sought and will continue to seek lo-cal or regional partners to better leverage the unique portfolio of ATS educational, research, and professional opportunities. Together, we hope that such efforts will culminate in a much more expansive and collaborative global ATS footprint.
Q Since the worldwide recession of 2007-2009 has receded, funding for
the clinician-scientist has been slowly improving. Are there still reasons to be concerned? What role is ATS taking to help boost research funding to the greatest extent possible?A: I am afraid that the survival of scientists in general, and of the clinician-scientist in particular, is being threatened more than ever by irresponsible and shortsighted decisions in Washington. The decades-long roller coaster of federal funding along with many parallel changes in health care policies have gener-ated a terrible void in the future outlook of respiratory science. In addition to our intense advocacy efforts in Washington, the ATS will continue to allocate every possible available dollar to the funding of meritorious junior investigators to promote and sustain their highly vulnerable careers. Therefore, the more attendees we have at the International Confer-ence and the more engagement and contribu-tions are made to the ATS Foundation, the more grants will be available to support the next generation. This is a time when we all need to dig deep and contribute in any way we can.
Q Many countries, including the U.S., appear to be reacting against global-
ization. Do you believe that medicine and science, which seem to progress fastest when artificial boundaries are erased, can buck this trend?A: I want to believe that the globalization of medicine and science is an irreversible process, and that no short-sighted national political trends will reverse such a long-await-ed and precious reality. However, we need to be vigilant and protect the unique values of humanism embedded in a global scientific and medical community. To this end, the ATS needs to lead such efforts and partner with every national, regional, and international like-minded association to preserve and foster the universal principles of our mission: to help the world breathe.
QA& ATS Stays in Step With the Times
VISIT orenitram.comFOR ADDITIONAL DOSING, SAFETY,
AND EFFICACY INFORMATION
FOR PULMONARY ARTERIAL HYPERTENSION (WHO GROUP 1) TO IMPROVE EXERCISE CAPACITY
© 2017 United Therapeutics Corporation.All rights reserved. US/ORE/0130 Printed in USA.
Important Safety InformationCONTRAINDICATIONS• Orenitram is contraindicated in patients with severe hepatic impairment
(Child Pugh Class C)WARNINGS AND PRECAUTIONS• Abrupt discontinuation or sudden large reductions in dosage of Orenitram may result
in worsening of PAH symptoms• Orenitram inhibits platelet aggregation and increases the risk of bleeding• The Orenitram tablet shell does not dissolve. In patients with diverticulosis, Orenitram
tablets can lodge in a diverticulumDRUG INTERACTIONS / SPECIFIC POPULATIONS• Concomitant administration of Orenitram with diuretics, antihypertensive agents, or other
vasodilators increases the risk of symptomatic hypotension• Orenitram inhibits platelet aggregation; there is an increased risk of bleeding, particularly
among patients receiving anticoagulants• Co-administration of Orenitram and the CYP2C8 enzyme inhibitor gemfi brozil increases
exposure to treprostinil; therefore, Orenitram dosage reduction may be necessary inthese patients
• Pregnancy Category C. Animal reproductive studies with Orenitram have shown anadverse effect on the fetus. There are no adequate and well-controlled studies in humans
• It is not known whether treprostinil is excreted in human milk or absorbed systemicallyafter ingestion. Because many drugs are excreted in human milk, choose Orenitram orbreastfeeding
• Safety and effectiveness in patients under 18 years of age have not been established• There is a marked increase in the systemic exposure to treprostinil in hepatically
impaired patientsADVERSE REACTIONS• In the 12-week placebo-controlled monotherapy study, adverse reactions that occurred
at rates at least 5% higher on Orenitram than on placebo included headache, diarrhea,nausea, flushing, pain in jaw, pain in extremity, hypokalemia, and abdominal discomfort
INDICATIONOrenitram is a prostacyclin vasodilator indicated for treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. The study that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (75%) or PAH associated with connective tissue disease (19%). When used as the sole vasodilator, the effect of Orenitram on exercise is about 10% of the deficit, and the effect, if any, on a background of another vasodilator is probably less than this.
OREISIhcpJAN16
Please see the Brief Summary of the Full Prescribing Information for Orenitram on the following page.For additional information about Orenitram,visit www.orenitram.com or call1-877-UNITHER (1-877-864-8437).
FOR pulmonary arterial hypertension
Choose the only prostacyclin analogue in a tablet
As PAH needs change,
ORENITRAM ADAPTS
• Initiate treatment with 0.125 mg TID (~8 hrs apart) or 0.25 mg BID (~12 hrs apart), then titrate up ordown every 3 to 4 days as needed
• In the pivotal trial, dose was titrated based on clinical response and tolerability. If not tolerated, titrateslower or decrease dose by 0.25 mg. Avoid abrupt discontinuation
FOR PULMONARY ARTERIAL HYPERTENSION (WHO GROUP 1) TO IMPROVE EXERCISE CAPACITY
Important Safety InformationCONTRAINDICATIONS
FOR pulmonary arterial hypertension
Choose the o
• Initiate treatment with 0.125 mg TID (~8 hrs apart) or 0.25 mg BID (~12 hrs apart), then titrate up or down every 3 to 4 days as needed
• In the pivotal trial, dose was titrated based on clinical response and tolerability. If not tolerated, titrate slower or decrease dose by 0.25 mg. Avoid abrupt discontinuation
START EARLYat FC II or FC III
TITRATEas dosing needs change
MONITORfor clinical response
and tolerability
BID=2 times daily; FC=functional class; PAH=pulmonary arterial hypertension; TID=3 times daily; WHO=World Health Organization.
head tobooth #813for more
info
8048_4_DailyBulletin_AdResize_M1.indd 1 4/7/17 12:42 PM
Follow #ATS2017 for the latest updates
during the ATS 2017International Conference
Facebook: American Thoracic SocietyTwitter: @atscommunityInstagram: atscommunitySnapchat: atscommunityLinkedIn: American Thoracic Society
Find Dr. Thor!Dr. Thor, a “stuffed lung” will be hidden at spots around ATS 2017. Take a photo with it and post it to Instagram with the hashtag #ATSEarlyCareer. You could win a prize!
VISIT orenitram.comFOR ADDITIONAL DOSING, SAFETY,
AND EFFICACY INFORMATION
FOR PULMONARY ARTERIAL HYPERTENSION (WHO GROUP 1) TO IMPROVE EXERCISE CAPACITY
© 2017 United Therapeutics Corporation.All rights reserved. US/ORE/0130 Printed in USA.
Important Safety InformationCONTRAINDICATIONS• Orenitram is contraindicated in patients with severe hepatic impairment
(Child Pugh Class C)WARNINGS AND PRECAUTIONS• Abrupt discontinuation or sudden large reductions in dosage of Orenitram may result
in worsening of PAH symptoms• Orenitram inhibits platelet aggregation and increases the risk of bleeding• The Orenitram tablet shell does not dissolve. In patients with diverticulosis, Orenitram
tablets can lodge in a diverticulumDRUG INTERACTIONS / SPECIFIC POPULATIONS• Concomitant administration of Orenitram with diuretics, antihypertensive agents, or other
vasodilators increases the risk of symptomatic hypotension• Orenitram inhibits platelet aggregation; there is an increased risk of bleeding, particularly
among patients receiving anticoagulants• Co-administration of Orenitram and the CYP2C8 enzyme inhibitor gemfi brozil increases
exposure to treprostinil; therefore, Orenitram dosage reduction may be necessary inthese patients
• Pregnancy Category C. Animal reproductive studies with Orenitram have shown anadverse effect on the fetus. There are no adequate and well-controlled studies in humans
• It is not known whether treprostinil is excreted in human milk or absorbed systemicallyafter ingestion. Because many drugs are excreted in human milk, choose Orenitram orbreastfeeding
• Safety and effectiveness in patients under 18 years of age have not been established• There is a marked increase in the systemic exposure to treprostinil in hepatically
impaired patientsADVERSE REACTIONS• In the 12-week placebo-controlled monotherapy study, adverse reactions that occurred
at rates at least 5% higher on Orenitram than on placebo included headache, diarrhea,nausea, flushing, pain in jaw, pain in extremity, hypokalemia, and abdominal discomfort
INDICATIONOrenitram is a prostacyclin vasodilator indicated for treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. The study that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (75%) or PAH associated with connective tissue disease (19%). When used as the sole vasodilator, the effect of Orenitram on exercise is about 10% of the deficit, and the effect, if any, on a background of another vasodilator is probably less than this.
OREISIhcpJAN16
Please see the Brief Summary of the Full Prescribing Information for Orenitram on the following page.For additional information about Orenitram,visit www.orenitram.com or call1-877-UNITHER (1-877-864-8437).
FOR pulmonary arterial hypertension
Choose the only prostacyclin analogue in a tablet
As PAH needs change,
ORENITRAM ADAPTS
• Initiate treatment with 0.125 mg TID (~8 hrs apart) or 0.25 mg BID (~12 hrs apart), then titrate up ordown every 3 to 4 days as needed
• In the pivotal trial, dose was titrated based on clinical response and tolerability. If not tolerated, titrateslower or decrease dose by 0.25 mg. Avoid abrupt discontinuation
FOR PULMONARY ARTERIAL HYPERTENSION (WHO GROUP 1) TO IMPROVE EXERCISE CAPACITY
Important Safety InformationCONTRAINDICATIONS
FOR pulmonary arterial hypertension
Choose the o
• Initiate treatment with 0.125 mg TID (~8 hrs apart) or 0.25 mg BID (~12 hrs apart), then titrate up or down every 3 to 4 days as needed
• In the pivotal trial, dose was titrated based on clinical response and tolerability. If not tolerated, titrate slower or decrease dose by 0.25 mg. Avoid abrupt discontinuation
START EARLYat FC II or FC III
TITRATEas dosing needs change
MONITORfor clinical response
and tolerability
BID=2 times daily; FC=functional class; PAH=pulmonary arterial hypertension; TID=3 times daily; WHO=World Health Organization.
head tobooth #813for more
info
8048_4_DailyBulletin_AdResize_M1.indd 1 4/7/17 12:42 PM
BRIEF SUMMARYThe following is a brief summary of the full prescribing information for Orenitram® (treprostinil) Extended-Release Tablets. Please review the full prescribing information before prescribing Orenitram.
INDICATIONS AND USAGEOrenitram is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. The study that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (75%) or PAH associated with connective tissue disease (19%). When used as the sole vasodilator, the effect of Orenitram on exercise is about 10% of the deficit, and the effect, if any, on a background of another vasodilator is probably less than this.
CONTRAINDICATIONSSevere hepatic impairment (Child Pugh Class C).
WARNINGS AND PRECAUTIONSWorsening PAH Symptoms upon Abrupt Withdrawal—Abrupt discontinuation or sudden large reductions in dosage of Orenitram may result in worsening of PAH symptoms.
Risk of Bleeding—Orenitram inhibits platelet aggregation and increases the risk of bleeding.
Use in Patients with Blind-end Pouches—The tablet shell does not dissolve. In patients with diverticulosis, Orenitram tablets can lodge in a diverticulum.
ADVERSE REACTIONSClinical Trials Experience—Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In a 12-week placebo- controlled monotherapy study (Study 1; WHO Group 1; functional class II-III), the most commonly reported adverse reactions that occurred in patients receiving Orenitram included: headache, diarrhea, nausea and flushing. Table 1 lists the adverse reactions that occurred at a rate on Orenitram at least 5% higher than on placebo. Orenitram patients in Table 1 for Study 1 (N = 151) had access to 0.25 mg tablets at randomization. Approximately 91% of such patients experienced an adverse reaction, but only 4% discontinued therapy for an adverse reaction (compared to 3% receiving placebo). The overall discontinuation rate for any reason was 17% for active and 14% for placebo.
Orenitram was studied in a long-term, open-label extension study in which 824 patients were dosed for a mean duration of approximately 2 years. About 70% of patients continued treatment with Orenitram for at least a year. The mean dose was 4.2 mg BID at one year. The adverse reactions were similar to those observed in the placebo-controlled trials.
The safety of Orenitram was also evaluated in an open-label study transitioning patients from Remodulin. The safety profile during this study was similar to that observed in the three pivotal studies.
Post-Marketing Experience—The following adverse reactions have been identified during post approval use of Orenitram: dizziness, dyspepsia, vomiting, myalgia, and arthralgia. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
DRUG INTERACTIONSAntihypertensive Agents or Other Vasodilators—Concomitant administration of Orenitram with diuretics, antihypertensive agents or other vasodilators increases the risk of symptomatic hypotension.
Anticoagulants—Treprostinil inhibits platelet aggregation; there is increased risk of bleeding, particularly among patients receiving anticoagulants.
Effect of CYP2C8 Inhibitors—Co-administration of Orenitram and the CYP2C8 enzyme inhibitor gemfibrozil in healthy adult volunteers increases exposure to treprostinil. Reduce the starting dose of Orenitram to 0.125 mg BID and use 0.125 mg BID increments every 3 to 4 days.
Effect of Other Drugs on Orenitram—Based on human pharmacokinetic studies, no dose adjustment of Orenitram is recommended when co-administered with either fluconazole, rifampin, sildenafil, bosentan or esomeprazole.
Warfarin—A drug interaction study was carried out with Remodulin co-administered with warfarin (25 mg/day) in healthy volunteers. There was no clinically significant effect of either medication on the pharmacokinetics of treprostinil. Additionally, treprostinil did not affect the pharmacokinetics or pharmacodynamics of warfarin. The pharmacokinetics of R- and S-warfarin and the international normalized ratio (INR) in healthy subjects given a single 25 mg dose of warfarin were unaffected by continuous subcutaneous infusion of treprostinil at an infusion rate of 10 ng/kg/min.
USE IN SPECIFIC POPULATIONS Pregnancy—Pregnancy Category C. Animal reproductive studies with treprostinil diolamine have shown an adverse effect on the fetus. There are no adequate and well-controlled studies in humans.
Labor and Delivery—The effect of Orenitram on labor and delivery in humans is unknown. No treprostinil treatment-related effects on labor and delivery were seen in animal studies.
Nursing Mothers—It is not known whether treprostinil is excreted in human milk or absorbed systemically after ingestion. Because many drugs are excreted in human milk, choose Orenitram or breastfeeding.
Pediatric Use—Safety and effectiveness in pediatric patients have not been established.
Geriatric Use—Clinical studies of Orenitram did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic or cardiac function, and of concomitant disease or other drug therapy.
Patients with Hepatic Impairment—Plasma clearance of treprostinil is reduced in patients with hepatic insufficiency. Patients with hepatic insufficiency may therefore be at increased risk of dose-dependent adverse reactions because of an increase in systemic exposure. Titrate slowly in patients with hepatic insufficiency, because such patients will likely be exposed to greater systemic concentrations relative to patients with normal hepatic function. In patients with mild hepatic impairment (Child Pugh Class A) start at 0.125 mg BID with 0.125 mg BID dose increments every 3 to 4 days. Avoid use of Orenitram in patients with moderate hepatic impairment (Child Pugh Class B). Orenitram is contraindicated in patients with severe hepatic impairment (Child Pugh Class C).
Patients with Renal Impairment—No dose adjustments are required in patients with renal impairment. Orenitram is not removed by dialysis.
OVERDOSAGESigns and symptoms of overdose with Orenitram during clinical trials reflect its dose-limiting pharmacologic effects and include severe headache, nausea, vomiting, diarrhea, and hypotension. Treat supportively.
Table 1. Adverse Reactions with Rates at Least 5% Higher on Orenitram Monotherapy than on Placebo
Treatment (%)
Reaction Orenitram (N=151) Placebo (N=77)
Headache 63% 19%
Diarrhea 30% 16%
Nausea 30% 18%
Flushing 15% 6%
Pain in jaw 11% 4%
Pain in extremity 14% 8%
Hypokalemia 9% 3%
Abdominal discomfort 6% 0%
United Therapeutics Corporation, Research Triangle Park, NC 27709Rx onlyJanuary 2017www.orenitram.com OREBShcpJAN17
ATS Daily Bulletin • ATS 2017 International Conference • Sunday, May 21, 2017 15
BRIEF SUMMARYThe following is a brief summary of the full prescribing information for Orenitram® (treprostinil) Extended-Release Tablets. Please review the full prescribing information before prescribing Orenitram.
INDICATIONS AND USAGEOrenitram is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. The study that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (75%) or PAH associated with connective tissue disease (19%). When used as the sole vasodilator, the effect of Orenitram on exercise is about 10% of the deficit, and the effect, if any, on a background of another vasodilator is probably less than this.
CONTRAINDICATIONSSevere hepatic impairment (Child Pugh Class C).
WARNINGS AND PRECAUTIONSWorsening PAH Symptoms upon Abrupt Withdrawal—Abrupt discontinuation or sudden large reductions in dosage of Orenitram may result in worsening of PAH symptoms.
Risk of Bleeding—Orenitram inhibits platelet aggregation and increases the risk of bleeding.
Use in Patients with Blind-end Pouches—The tablet shell does not dissolve. In patients with diverticulosis, Orenitram tablets can lodge in a diverticulum.
ADVERSE REACTIONSClinical Trials Experience—Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In a 12-week placebo- controlled monotherapy study (Study 1; WHO Group 1; functional class II-III), the most commonly reported adverse reactions that occurred in patients receiving Orenitram included: headache, diarrhea, nausea and flushing. Table 1 lists the adverse reactions that occurred at a rate on Orenitram at least 5% higher than on placebo. Orenitram patients in Table 1 for Study 1 (N = 151) had access to 0.25 mg tablets at randomization. Approximately 91% of such patients experienced an adverse reaction, but only 4% discontinued therapy for an adverse reaction (compared to 3% receiving placebo). The overall discontinuation rate for any reason was 17% for active and 14% for placebo.
Orenitram was studied in a long-term, open-label extension study in which 824 patients were dosed for a mean duration of approximately 2 years. About 70% of patients continued treatment with Orenitram for at least a year. The mean dose was 4.2 mg BID at one year. The adverse reactions were similar to those observed in the placebo-controlled trials.
The safety of Orenitram was also evaluated in an open-label study transitioning patients from Remodulin. The safety profile during this study was similar to that observed in the three pivotal studies.
Post-Marketing Experience—The following adverse reactions have been identified during post approval use of Orenitram: dizziness, dyspepsia, vomiting, myalgia, and arthralgia. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
DRUG INTERACTIONSAntihypertensive Agents or Other Vasodilators—Concomitant administration of Orenitram with diuretics, antihypertensive agents or other vasodilators increases the risk of symptomatic hypotension.
Anticoagulants—Treprostinil inhibits platelet aggregation; there is increased risk of bleeding, particularly among patients receiving anticoagulants.
Effect of CYP2C8 Inhibitors—Co-administration of Orenitram and the CYP2C8 enzyme inhibitor gemfibrozil in healthy adult volunteers increases exposure to treprostinil. Reduce the starting dose of Orenitram to 0.125 mg BID and use 0.125 mg BID increments every 3 to 4 days.
Effect of Other Drugs on Orenitram—Based on human pharmacokinetic studies, no dose adjustment of Orenitram is recommended when co-administered with either fluconazole, rifampin, sildenafil, bosentan or esomeprazole.
Warfarin—A drug interaction study was carried out with Remodulin co-administered with warfarin (25 mg/day) in healthy volunteers. There was no clinically significant effect of either medication on the pharmacokinetics of treprostinil. Additionally, treprostinil did not affect the pharmacokinetics or pharmacodynamics of warfarin. The pharmacokinetics of R- and S-warfarin and the international normalized ratio (INR) in healthy subjects given a single 25 mg dose of warfarin were unaffected by continuous subcutaneous infusion of treprostinil at an infusion rate of 10 ng/kg/min.
USE IN SPECIFIC POPULATIONS Pregnancy—Pregnancy Category C. Animal reproductive studies with treprostinil diolamine have shown an adverse effect on the fetus. There are no adequate and well-controlled studies in humans.
Labor and Delivery—The effect of Orenitram on labor and delivery in humans is unknown. No treprostinil treatment-related effects on labor and delivery were seen in animal studies.
Nursing Mothers—It is not known whether treprostinil is excreted in human milk or absorbed systemically after ingestion. Because many drugs are excreted in human milk, choose Orenitram or breastfeeding.
Pediatric Use—Safety and effectiveness in pediatric patients have not been established.
Geriatric Use—Clinical studies of Orenitram did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic or cardiac function, and of concomitant disease or other drug therapy.
Patients with Hepatic Impairment—Plasma clearance of treprostinil is reduced in patients with hepatic insufficiency. Patients with hepatic insufficiency may therefore be at increased risk of dose-dependent adverse reactions because of an increase in systemic exposure. Titrate slowly in patients with hepatic insufficiency, because such patients will likely be exposed to greater systemic concentrations relative to patients with normal hepatic function. In patients with mild hepatic impairment (Child Pugh Class A) start at 0.125 mg BID with 0.125 mg BID dose increments every 3 to 4 days. Avoid use of Orenitram in patients with moderate hepatic impairment (Child Pugh Class B). Orenitram is contraindicated in patients with severe hepatic impairment (Child Pugh Class C).
Patients with Renal Impairment—No dose adjustments are required in patients with renal impairment. Orenitram is not removed by dialysis.
OVERDOSAGESigns and symptoms of overdose with Orenitram during clinical trials reflect its dose-limiting pharmacologic effects and include severe headache, nausea, vomiting, diarrhea, and hypotension. Treat supportively.
Table 1. Adverse Reactions with Rates at Least 5% Higher on Orenitram Monotherapy than on Placebo
Treatment (%)
Reaction Orenitram (N=151) Placebo (N=77)
Headache 63% 19%
Diarrhea 30% 16%
Nausea 30% 18%
Flushing 15% 6%
Pain in jaw 11% 4%
Pain in extremity 14% 8%
Hypokalemia 9% 3%
Abdominal discomfort 6% 0%
United Therapeutics Corporation, Research Triangle Park, NC 27709Rx onlyJanuary 2017www.orenitram.com OREBShcpJAN17
An Industry Theater presentation at the ATS 2017 International Conference. This program is sponsored by GSK and is open to all ATS 2017 International Conference attendees.
©2017 GSK group of companies. All rights reserved. Printed in USA. 818589R0 April 2017
This program is not sponsored or programmed by ATS. Due to government regulations, GSK is prohibited from providing meals and food items to healthcare professionals licensed or practicing in the states of Minnesota and Vermont. In addition, many employers (eg, hospitals, teaching institutions, the federal government, state and local governments) place restrictions on what their employees may accept from outside parties as a condition of employment. GSK respects these restrictions and asks that you limit your participation to those activities permitted by your employer. GSK will collect and report healthcare professional information concerning meals and other transfers of value pursuant to the Federal Sunshine Act and state laws. Invited healthcare professionals cannot bring guests. International attendees may have restrictions depending on their countries’ rules and regulations.
1:15 PM to 2:00 PMMonday, May 22, 2017
Industry Theater 2The ATS 2017 Exhibit Hall
GSK invites you to an overview of the clinical development program for NUCALA, which will include the effi cacy and safety profi le. At the end of this program you will be able to identify the appropriate patients for NUCALA.
Treatment Strategy With NUCALA® (mepolizumab)
Mark Forshag, MD, MHA - US Medical Expert, GSK
Four to be Recognized During Sunday Awards Session
Four renowned physicians and researchers will be honored during Sunday’s Awards Session, featur-ing the Amberson Lecture and the
presentation of the Trudeau Medal and two Distinguished Achievement Awards.
AMBERSON LECTURERPresenting the Amberson Lecture will be Peter D. Paré, MD, who will present “The
Smoking Gun: Genetics and Genomics Reveals Causal Pathways for COPD.” He is an emeritus professor of medicine and pathology in the Faculty of Medicine at the University of British Columbia.
Dr. Paré was president of the Canadian Thoracic Society. For five years, he was chairman of the Canadian Thoracic Society’s National Grant review committee. He received the Jacob Churg Distinguished Researcher award and was a Michael Smith Distinguished Scholar at the Michael Smith Foundation for Health Research. He has received large grants from national and international agencies, includ-ing the Canadian Institutes of Health, the U.S. National Institutes of Health, and
AllerGen, the National Center of Excellence for allergic disease.
EDWARD LIVINGSTON TRUDEAU MEDALSharon I.S. Rounds, MD, will receive the Edward Livingston Trudeau Medal. She is a
professor of medicine and a professor of pathology and laboratory medicine at the Alpert Medical School of Brown University. Dr. Rounds also is a staff pulmonary/critical care physician at the Providence VA Medical Center and pre-viously served as its chief of
the medical service.Dr. Rounds has demonstrated commitment
and tangible support for research training of women and underrepresented minorities in pulmonary, critical care, and sleep medicine. She has received numerous awards for teach-ing and mentoring, including the Elizabeth A. Rich, MD, Award from the American Thoracic Society Membership Committee and the Pulmonary Circulation Assembly Leadership Award.
Her research interests include mechanisms of endothelial cell injury, effects of post-trans-
lational processing on small GTPase function, pulmonary vascular disease in COPD, and effects of cigarette smoking on pulmonary circulation.
DISTINGUISHED ACHIEVEMENT AWARDSJack Gauldie, PhD, DSc, and Steven D. Shap-iro, MD, will receive Distinguished Achieve-
ment Awards.Dr. Gauldie is Dis-
tinguished Univer-sity Professor at McMaster University, in Hamilton, Ontario, Canada, where he has conducted his research in immunology, inflam-mation, and respiratory diseases for the past 45 years, and was chair of the Department of Pathology from 1989 to 2004.
He is recognized in-ternationally in cytokine biology and the molecu-lar regulation of chronic inflammation and immu-nity. He made several key
discoveries that defined molecular aspects of the host response to injury and infection. One
discovery was IL-6 as the major regulator of the body’s acute phase inflammatory response, linking the acute host response to adaptive immune responses.
Dr. Shapiro is executive vice president of the University of Pittsburgh Medical Center, president of its Health Services Division, which includes 40 hospitals and 4,000 physicians. In addition, he is the chief medical and scientific officer for the integrated delivery and finance system. As such, he leads a group that uses analytics and machine learning to merge population health and precision medicine, developing new models of care that will fun-damentally improve patient health.
Dr. Shapiro remains active clinically and in the laboratory. His main research goal has been to understand the pathogenesis of COPD. He cloned and knocked out macro-phage elastase (MMP-12) to demonstrate that MMP-12-deficient mice are completely protected from the development of cigarette smoke-induced emphysema.
Awards Session (G2)
4:30-5:45 p.m. Sunday
Hall E (Middle Build-
ing, Level 2), Walter E.
Washington Convention
Center
Peter D. Paré, MD
Sharon I.S. Rounds, MD
Jack Gauldie, PhD, DSc
Steven D. Shapiro, MD
TREATING SYMPTOMATIC SARCOIDOSIS: AN INTERACTIVE CASE DISCUSSION
COME JOIN USAT AN INDUSTRY-ORGANIZED SYMPOSIUM AT THE ATS 2017 INTERNATIONAL CONFERENCE
Sunday, May 21, 2017Embassy Suites Washington, DC Convention Center
Registration:6:30 pm - 7:00 pm
Dinner and Program: 7:00 pm - 9:00 pm
Capital BallroomLower Lobby900 10th St NWWashington, DC
Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt. ARDUS/01-13/0417/0020 04/17
TREATING SYMPTOMATIC SARCOIDOSIS: AN INTERACTIVE CASE DISCUSSION
SUNDAY, MAY 21, 2017Registration:6:30 pm - 7:00 pm
Dinner and Program: 7:00 pm - 9:00 pm
Embassy Suites Washington, DC Convention Center
Sarcoidosis is a chronic inflammatory granulomatous disease that typically affects the lungs, but frequently includes extrapulmonary manifestations. This dinner program will address the significant unmet need in the treatment of symptomatic sarcoidosis, introduce the melanocortin receptor system, and feature an interactive discussion around symptomatic sarcoidosis patient cases. Supported and presented by Mallinckrodt Pharmaceuticals.
ROBERT P. BAUGHMAN, MDUniversity of Cincinnati
Medical Center
ALVIN L. BOWLES, MD Henry Ford Hospital
DAVID CHU, MD Metropolitan Eye Research and
Surgery Institute
Dinner will be provided. This is a non-CME educational program sponsored by Mallinckrodt Pharmaceuticals open to all ATS 2017 International Conference attendees from the United States.
COME JOIN US AT AN INDUSTRY-ORGANIZED SYMPOSIUM AT THE ATS 2017 INTERNATIONAL CONFERENCE
Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt. ARDUS/01-13/0417/0020 04/17
TREATING SYMPTOMATIC SARCOIDOSIS: AN INTERACTIVE CASE DISCUSSION
COME JOIN USAT AN INDUSTRY-ORGANIZED SYMPOSIUM AT THE ATS 2017 INTERNATIONAL CONFERENCE
Sunday, May 21, 2017Embassy Suites Washington, DC Convention Center
Registration:6:30 pm - 7:00 pm
Dinner and Program: 7:00 pm - 9:00 pm
Capital BallroomLower Lobby900 10th St NWWashington, DC
Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt. ARDUS/01-13/0417/0020 04/17
TREATING SYMPTOMATIC SARCOIDOSIS: AN INTERACTIVE CASE DISCUSSION
SUNDAY, MAY 21, 2017Registration:6:30 pm - 7:00 pm
Dinner and Program: 7:00 pm - 9:00 pm
Embassy Suites Washington, DC Convention Center
Sarcoidosis is a chronic inflammatory granulomatous disease that typically affects the lungs, but frequently includes extrapulmonary manifestations. This dinner program will address the significant unmet need in the treatment of symptomatic sarcoidosis, introduce the melanocortin receptor system, and feature an interactive discussion around symptomatic sarcoidosis patient cases. Supported and presented by Mallinckrodt Pharmaceuticals.
ROBERT P. BAUGHMAN, MDUniversity of Cincinnati
Medical Center
ALVIN L. BOWLES, MD Henry Ford Hospital
DAVID CHU, MD Metropolitan Eye Research and
Surgery Institute
Dinner will be provided. This is a non-CME educational program sponsored by Mallinckrodt Pharmaceuticals open to all ATS 2017 International Conference attendees from the United States.
COME JOIN US AT AN INDUSTRY-ORGANIZED SYMPOSIUM AT THE ATS 2017 INTERNATIONAL CONFERENCE
Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt. ARDUS/01-13/0417/0020 04/17
ATS Daily Bulletin • ATS 2017 International Conference • Sunday, May 21, 201718
Two popular forums that celebrate diversity and the role of women in pulmonary, critical care, and sleep medicine will take place Sunday
and Monday. A plated lunch will be served at both events.
Sunday’s ATS Diversity Forum will feature speaker Eliseo J. Pérez-Stable, MD, director of the National Institute on Minority Health and Health Disparities at the National Institutes of Health since 2015. Dr. Pérez-Stable has worked
to improve the health of racial and ethnic mi-norities and underserved populations, as well as cross-cultural communication skills among health care professionals.
During the luncheon, Minority Trainee Development Scholarships, which recognize trainees who are members of underrepresented minority groups, will be presented.
The featured speaker at Monday’s ATS Women’s Forum will be Redonda Miller, MD, MBA, the first female president of Johns Hopkins Hospital.
Dr. Miller has a long history at Johns Hop-kins Health System, serving as its senior vice president of medical affairs. She also was vice president of medical affairs for Johns Hopkins Hospital and an assistant professor of medi-cine at the Johns Hopkins University School of Medicine, where she focused her work on
medical education and women’s health. She became president at Johns Hopkins Hospital last July.
During the Women’s Forum, the 2017 Elizabeth A. Rich, MD Award will be presented to a fe-male ATS member who has made significant achievements in the practice or science of pulmonary, critical care, or sleep medicine; is a recognized leader in her field;
and serves as a mentor to junior colleagues. This year’s recipient, Zea Borok, MD, chief of pulmonary and critical care medicine at the Keck School of Medicine of USC, will address the audience. Men are welcome to attend the luncheon.
Yolanda Mageto, MD, MPH, ATS Member-ship Committee chair, will host both forums.
Registration is required to attend, although there may be seats available on the day of the event. There is no fee or tickets necessary to attend either event, but conference badges are required for admission.
ATS Diversity Forum
11:45 a.m. to 1:15 p.m. Sunday
Renaissance Washington Downtown, Grand Ballroom North (Ballroom Level)
Women’s Forum
11:45 a.m. to 1:15 p.m. Monday
Renaissance Washington Downtown, Grand Ballroom North (Ballroom Level)
www.atsjournals.com/ootb
A podcast that takes you out of the pages of the Blue Journal
and into the minds of the most brilliant researchers in respiratory, critical care, and sleep medicine.
Register at: www.PILOTforPulmonary.org/IPF17
IPF TUESDAY, MAY 236:00 PM
Sponsored by
A non-CME educational program sponsored by The France Foundation and supported by a Grant from Genentech open to all ATS 2017 International Conference attendees
Renaissance Washington DC HotelOnly a 5-minute walk from the convention center!
Wrap up your ATS experience with a pre-meeting social event!
ARE YOU THERE YET?THINGS YOU NEEDTO KNOW ABOUT 5 IPF IN 2017
A MECC-Organized Symposium at the ATS 2017 International Conference
Expert FacultyKEVIN R. FLAHERTY, MD, MS
FERNANDO J. MARTINEZ, MD, MSDAVID J. LEDERER, MD, MS
03.ats pilot daily news ad.qxp_Layout 1 4/13/17 2:42 PM Page 1
Forums Focus on Diversity, Role of Women in Medicine
COI Disclosure Reminder
The ATS requires that all faculty members speaking at CME-accredited International Conference sessions prepare
and show conflict of interest disclosure slides at the beginning of their presenta-tions. (This is in addition to completing a preconference disclosure questionnaire.) COI slides ensure that the ATS complies with Accreditation Council for Continu-ing Medical Education requirements for disclosure to learners.
Instructions and PowerPoint disclosure slide templates can be downloaded at con-ference.thoracic.org/speakers. Moderators and presenters can retrieve their 2016 conference disclosures by logging into thoracic.coi-smart.com/login.php.
Session chairs/moderators are reminded to look for the COI documentation form on the podium at their sessions. They must complete the form by the end of each session they moderate for the ATS to meet ACCME requirements for written attesta-tion that disclosure slides were shown and of any other disclosures made orally.
Contact the ATS conflict of interest office at conference.thoracic.org/speakers for more information.
Register on-site or online at: www.PAHsymposium.comThis promotional program is sponsored by Actelion Pharmaceuticals US, Inc.
Dinner will not be provided to physicians and other healthcare professionals licensed in Vermont or other states where gifts and meals are prohibited. Dinner provided to physicians will be subject to reporting under Federal law. We regret that spouses and other guests may not be accommodated.
An Industry-Organized Symposium at the ATS 2017 International Conference. A non-CME educational program sponsored by Actelion Pharmaceuticals US, Inc. open to all ATS 2017 International Conference attendees.
PAH Combination Therapy:
Targeting Multiple Pathways to
Optimize Treatment
You are invited to an evening symposium
Sunday, May 21, 20176:30 pm – 7:00 pm Registration
and Dinner7:00 pm – 8:30 pm Symposium
Washington Marriott at Metro Center
Grand Ballroom (Ballroom Level)775 12th Street NWWashington, DC
© 2017 Actelion Pharmaceuticals US, Inc. All rights reserved. ACT-01511 0517
Washington Marriott at
Metro Center
AGENDA AND FACULTYWelcome and IntroductionsVALLERIE MCLAUGHLIN, MD, Program ChairUniversity of Michigan Health SystemAnn Arbor, Michigan
Overview of Pulmonary Arterial Hypertension (PAH)
VALLERIE MCLAUGHLIN, MD, Program Chair
Targeting the Endothelin Pathway for the Treatment of PAH
NICK KIM, MDUniversity of California, San DiegoLa Jolla, California
Targeting the Prostacyclin Pathway for the Treatment of PAH
RONALD OUDIZ, MDLos Angeles Biomedical Research Institute at Harbor-UCLA
Medical CenterTorrance, California
Panel DiscussionALL FACULTY
Concluding RemarksVALLERIE MCLAUGHLIN, MD, Program Chair
Pipeline (17-0310) ATS 2017 Daily Bulletin Ad.indd 1 4/11/17 2:59 PM
Register on-site or online at: www.PAHsymposium.comThis promotional program is sponsored by Actelion Pharmaceuticals US, Inc.
Dinner will not be provided to physicians and other healthcare professionals licensed in Vermont or other states where gifts and meals are prohibited. Dinner provided to physicians will be subject to reporting under Federal law. We regret that spouses and other guests may not be accommodated.
An Industry-Organized Symposium at the ATS 2017 International Conference. A non-CME educational program sponsored by Actelion Pharmaceuticals US, Inc. open to all ATS 2017 International Conference attendees.
PAH Combination Therapy:
Targeting Multiple Pathways to
Optimize Treatment
You are invited to an evening symposium
Sunday, May 21, 20176:30 pm – 7:00 pm Registration
and Dinner7:00 pm – 8:30 pm Symposium
Washington Marriott at Metro Center
Grand Ballroom (Ballroom Level)775 12th Street NWWashington, DC
© 2017 Actelion Pharmaceuticals US, Inc. All rights reserved. ACT-01511 0517
Washington Marriott at
Metro Center
AGENDA AND FACULTYWelcome and IntroductionsVALLERIE MCLAUGHLIN, MD, Program ChairUniversity of Michigan Health SystemAnn Arbor, Michigan
Overview of Pulmonary Arterial Hypertension (PAH)
VALLERIE MCLAUGHLIN, MD, Program Chair
Targeting the Endothelin Pathway for the Treatment of PAH
NICK KIM, MDUniversity of California, San DiegoLa Jolla, California
Targeting the Prostacyclin Pathway for the Treatment of PAH
RONALD OUDIZ, MDLos Angeles Biomedical Research Institute at Harbor-UCLA
Medical CenterTorrance, California
Panel DiscussionALL FACULTY
Concluding RemarksVALLERIE MCLAUGHLIN, MD, Program Chair
Pipeline (17-0310) ATS 2017 Daily Bulletin Ad.indd 1 4/11/17 2:59 PM
Copyright ©2017, Boehringer Ingelheim Pharmaceuticals, Inc. All rights reserved. (03/17) PC-02710
THE BEST SEAT IN DC
IS ALL YOURSJOIN US FOR A
NON-CME/CNE SYMPOSIUMSponsored by
Boehringer Ingelheim Pharmaceuticals, Inc.
Sunday, May 21, 20176:30 p.m. - 9:30 p.m.
Grand Hyatt, Constitution Ballroom C-EWashington, DC
ADMISSION IS COMPLIMENTARY AND WILL BE ON A FIRST-COME, FIRST-SERVED BASIS. DINNER WILL BE PROVIDED.
An Industry-Organized Symposium at The American Thoracic Society (ATS) 2017 International Conference. All ATS 2017 International Conference attendees are invited to this non-CME/CNE educational program
sponsored by Boehringer Ingelheim Pharmaceuticals, Inc.
Attendance is limited to healthcare professionals only.
Aspects of this program may be reportable under the Physician Payments Sunshine Act.CME, continuing medical education; CNE, continuing nursing education.
VISIT BOOTH #725
This ad to run May 21PREPARED BY FCB
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Product: NINT Trim: 21.75”w x 15”h Producer: Genet Micael x3810
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4C ATS Daily Bulletin
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10723081_ATS_Daily_Bulletin_M3FR.indd 2 3/27/17 1:56 PM
Copyright ©2017, Boehringer Ingelheim Pharmaceuticals, Inc. All rights reserved. (03/17) PC-02710
THE BEST SEAT IN DC
IS ALL YOURSJOIN US FOR A
NON-CME/CNE SYMPOSIUMSponsored by
Boehringer Ingelheim Pharmaceuticals, Inc.
Sunday, May 21, 20176:30 p.m. - 9:30 p.m.
Grand Hyatt, Constitution Ballroom C-EWashington, DC
ADMISSION IS COMPLIMENTARY AND WILL BE ON A FIRST-COME, FIRST-SERVED BASIS. DINNER WILL BE PROVIDED.
An Industry-Organized Symposium at The American Thoracic Society (ATS) 2017 International Conference. All ATS 2017 International Conference attendees are invited to this non-CME/CNE educational program
sponsored by Boehringer Ingelheim Pharmaceuticals, Inc.
Attendance is limited to healthcare professionals only.
Aspects of this program may be reportable under the Physician Payments Sunshine Act.CME, continuing medical education; CNE, continuing nursing education.
VISIT BOOTH #725
This ad to run May 21PREPARED BY FCB
Job #: 10723081Releasing as: Other Production: Barbara Grant x3946
Colors: 4C AD: Serena Juan x2844
Client: BI Live: 21.5”w x 14”h AE: Kelsey Fenton x7837
Product: NINT Trim: 21.75”w x 15”h Producer: Genet Micael x3810
Client Code: PC-02710 Bleed: 21.75”w x 15.25”h QC: L. Powell
Date: March 27, 2017 1:54 PM Note: Digital Artist: CL, BB, VA
Proof: M3FRAdd’l Info:
Fonts: Co Text, Gotham, Minion Pro, Helvetica Neue LT Std
M1 Spellcheck: Meredith Massey
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Path: PrePress:BI_Pfizer:NINTEDANIB:10723081:_PACKAGED:10723081_ATS_Daily_Bulletin:10723081_ATS_Daily_Bulletin_M3FR
4C ATS Daily Bulletin
S:21.5”S:14”
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10723081_ATS_Daily_Bulletin_M3FR.indd 2 3/27/17 1:56 PM
ATS Daily Bulletin • ATS 2017 International Conference • Sunday, May 21, 201722
The ATS encourages ATS 2017 attendees to participate in any of several Non-CME Symposia Sunday and Tuesday. Please see the Tuesday
issue of the ATS Daily Bulletin for a list of Tuesday Non-CME Symposia.
SUNDAY6:30-9:30 p.m.Washington Marriott at Metro Center, Junior Ballroom (Second Floor)The 2017 GOLD Update: Incorporating the New Treatment Recommendations Into Clinical Practice(Open to U.S. attendees only) GOLD recently released an updated strategy for management of COPD based on expert opinion and current data. Experts will review the 2017 update and discuss implications of GOLD recommendations on clinical practice, with a focus on the refined ABCD assessment tool and treatment algorithm. Panelists and at-tendees will interactively examine patient cases, demonstrating applicability of GOLD treat-ment recommendations in real-world settings. Speakers: Fernando J. Martinez, MD, MS, chief, Division of Pulmonary and Critical Care Medicine, New York-Presbyterian Hospital/Weill Cornell Medical Center; Claus Vogelmeier, Dr. Med., professor of medicine and head of the Department for Pulmonary Medicine, Philipps-University of Marburg, Germany; Christine Jenkins, MD, clinical professor and head of respiratory discipline, University of Sydney, Sydney, NSW, Australia; Gerard Criner, MD, chair and professor, Thoracic Medicine and Surgery, Temple UniversityCompany: Boehringer Ingelheim Pharmaceuticals, Inc.
6:30-9:30 p.m.Renaissance Washington, DC, DuPont Circle, City Center Ballroom (Lower Lobby Level)Biologics and Immune Therapies in an Office Setting—Optimizing Treatment and Outcomes Through Patient-Centered CareThis complimentary dinner symposium will outline the merits of establishing allergy and immunology office-based administration of therapies and the steps required. Three expert faculty will facilitate an interactive discussion of injectable and infused therapies in the pulm-onology, allergy, and immunology settings and their roles in treatment. Additionally, patient-centered benefits of office-based administration and operational strategies for establishing an in-office infusion practice will also be high-lighted throughout the symposium via collab-orative panel and audience discussions.Speakers: Gregory Bensch, MD, Allergy Immunology and Asthma Group, Stockton, California; Bradley E. Chipps, MD, medical director, Capital Allergy & Respiratory Disease Center, Sacramento, CA; Josh Jacobs, MD, Allergy & Asthma Medical Group of the Bay Area, Berkeley, CaliforniaCompany: Academy for Continued Healthcare Learning (supported by an educational grant from Teva Pharmaceuticals)
6:30-9:30 p.m.Grand Hyatt Washington, Independence Ballroom B-E (Independence Level 5B)Chronic Use of Oral Corticosteroids In Asthma: Will Biologics End This?(Open to international attendees only)Patients with severe asthma are frequently prescribed oral corticosteroids, despite the evidence that prolonged use of OCS is associ-ated with potentially serious adverse events. This Novartis-sponsored symposium will focus on alternative treatments, such as biologics, which can reduce the reliance on OCS in severe
allergic asthma patients. How a phenotype-driven approach to treatment may aid in the prevention of the chronic use of OCS in severe asthma will also be discussed. Please note that this symposium is for non-U.S. HCPs only.Speakers: Roland Buhl, MD, PhD, professor, Johannes Gutenberg University of Mainz; Guy Brusselle, MD, PhD, professor, Department of Respiratory Medicine, Ghent University Hospital; Ulrich Hans Wahn, MD, FRCP, professor, Charité-Universitätsmedizin Berlin; Jean Bousquet, MD, PhD, professorCompany: Novartis Pharma AG
6:30-9:30 p.m.Westin Washington DC City Center, National Ballroom (Ballroom Level)Clinically Refractory Hypotension: (CRH) Evolution of Shock ManagementThe goal of this program is to provide an overview of different forms of shock, current management strategies, and outcomes associ-ated with hypotension. It will focus on a subset of patients who remain refractory despite adequate fluid resuscitation and high dose vasopressors. Management strategies and current therapeutic outcomes will also be discussed.Company: La Jolla Pharmaceutical Company
6:30-9:30 p.m.Grand Hyatt Washington, Constitution Ballroom C-E (Constitution Level 3B)Clinicians’ Review: A Case-Based Look at Diagnosing and Treating Patients With IPFDuring this branded symposium, relevant case studies will be delivered from the per-spective of pulmonologists experienced in the diagnosis and management of patients with IPF. The treatment of these patients will also be discussed. Interactive Q&A and audience response system will be utilized throughout the program.Speakers: Lucas Ryan Pitts, MD, assistant professor, Pulmonary and Critical Care
Medicine, University of Kansas Medical Center; Paul W. Noble, MD, chair, Department of Medicine, director, Women’s Guild Lung Institute, Cedars-Sinai Medical Center; Nina Patel, MD, assistant professor of medicine, co-director, Columbia University Interstitial Lung Disease Program, Division of Pulmonary, Allergy & Critical Care, Columbia UniversityCompany: Boehringer Ingelheim Pharmaceuticals, Inc.
6:30-9:30 p.m.Grand Hyatt Washington, Independence Ballroom F-I (Independence Level 5B)Diagnosing and Managing NTM in the Community SettingNon-tuberculous mycobacterial pulmonary disease is a chronic and debilitating infection. Diagnosis can be challenging as the signs and symptoms of NTM pulmonary disease are non-specific and similar to existing structural lung diseases of NTM patients, such as bronchi-ectasis and COPD. Additionally, the deci-sion to treat is multifactorial and requires an individualized and patient-centered approach. This symposium will explore the approaches of managing NTM in the community setting, us-ing case discussions to highlight considerations for identifying patients at risk for NTM, diag-nosing NTM, initiating treatment, and ongoing monitoring of patient responses to treatment.Chair: Anne O’Donnell, MD, chief, Pulmonary, Critical Care and Sleep Medicine, Georgetown University HospitalSpeakers: Shannon Kasperbauer, MD, assistant professor, Division of Mycobacterial and Respiratory Infections, National Jewish Health; Patrick Flume, MD, Powers-Huggins Endowed Chair for Cystic Fibrosis, professor of medicine and pediatrics, Medical University of South CarolinaCompany: Insmed
Non-CME Symposia Offer Learning Opportunities
ATS Daily Bulletin • ATS 2017 International Conference • Sunday, May 21, 2017 23
ENTELLIGENCE PROGRAM FAST FACTSYear established: 2005Review cycles completed: 11Awards distributed: 55Funding: Over $4.5 Million
Awardees (2005–2016)Scientifi c congress presentations: >65Peer-reviewed manuscripts: >60
Established in 2005, the ENTELLIGENCE Young Investigator Program has provided funding to promising young investigators to encourage and promote quality medical care and enhance patients’ lives through research in pulmonary vascular diseases.
Award winners receive a research grant of up to $100,000 to fund a 1-year mentored project
The next grant cycle opens on September 14, 2017
For more information, please visit our updated website: www.ENTELLIGENCEMD.org
The ENTELLIGENCE™ Young Investigator Program is supported through an educational grant from Actelion Pharmaceuticals US, Inc.
CELEBRATING OUR 12TH YEAR!
Visit ENTELLIGENCEMD.org
YOUNG INVESTIGATOR PROGRAM
2016 Winners
6:30-9:30 p.m.Grand Hyatt Washington, Independence Ballroom A (Independence Level 5B)IPF Hackathon: Disrupting and Evolving the Management of IPF(Open to U.S. attendees only) Engage in collaborative discussions with a team of expert pulmonologists while investi-gating and discussing challenges in the man-agement of IPF. In this interactive symposium, actively participate in timed, small group discussions designed to address and solve key issues around:• Barriers to treating IPF patients upon
diagnosis• Better preparing patients to live with an IPF
diagnosis• Providing IPF patients with the tools and
resources needed to commit to a shared physician-patient partnership
Speakers: Steven Nathan, MD, Inova Fairfax Hospital, Falls Church, Virginia; Robert Sussman, MD, Overlook Medical Center, Summit, New Jersey; Rajeev Saggar, MD, University of Arizona—College of Medicine, Tuscon, Arizona Company: Genentech, A Member of the Roche Group
6:30-9:30 p.m.Washington Marriott at Metro Center, Grand Ballroom A-D (Ballroom Level)PAH Combination Therapy: Targeting Multiple Pathways to Optimize TreatmentThe management of pulmonary arterial hyper-tension continues to evolve, with combination therapy that targets multiple pathways now at the forefront of our treatment strategies. This interactive symposium will feature a panel of experts who will discuss treatment options for patients with PAH.
Dinner will be provided. (Dinner will not be provided to physicians and other health care professionals licensed in Vermont or other states where gifts and meals are prohibited.)Speakers: Vallerie McLaughlin, MD, program chair, University of Michigan Health System, Ann Arbor, Michigan; Nick Kim, MD, University of California, San Diego, La Jolla, California; Ronald Oudiz, MD, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CaliforniaCompany: Actelion Pharmaceuticals U.S., Inc.
6:30-9:30 p.m.Grand Hyatt Washington, Constitution Ballroom A-B (Constitution Level 3B)Redefining Severe Uncontrolled Asthma: A Fresh Look at a Complex DiseaseYou are cordially invited to an AstraZeneca sponsored non-CME dinner program on severe uncontrolled asthma. This faculty led
symposium will examine asthma heterogene-ity and the burden of disease from the pheno-type/endotype perspective to demonstrate the importance of relating observable characteris-tics to disease mechanisms in clinical settings. The presentation will include a detailed discus-sion of eosinophils as an emerging mechanism of disease and review current evidence linking eosinophilic activity to many of the character-istic features of severe uncontrolled asthma.Speakers: Nicola Hanania, MD, MS, associate professor of medicine, director, Airways Clinical Research Center, Baylor College of Medicine; Jonathan A. Bernstein, MD, professor of clinical medicine, University of Cincinnati, Department of Internal Medicine, Division of Immunology/Allergy Section; Thomas B. Casale, MD, professor of medicine and pediatrics, University of South Florida Morsani College of Medicine; Michael Wechsler, MD, MMSc, professor of medicine, co-director
National Jewish Cohen Family Asthma Institute, National Jewish HealthCompany: AstraZeneca
6:30-9:30 p.m.Embassy Suites DC Convention Center, Capital Ballroom (Lower Lobby)Treating Symptomatic Sarcoidosis: An Interactive Case Discussion(Open to U.S. attendees only) Sarcoidosis is a chronic inflammatory granulo-matous disease that typically affects the lungs, but frequently includes extrapulmonary mani-festations. This dinner program will address the significant unmet need in the treatment of symptomatic sarcoidosis, introduce the melanocortin receptor system, and feature an interactive discussion around symptomatic sar-coidosis patient cases. Supported and presented by Mallinckrodt Pharmaceuticals, Inc.Company: Mallinckrodt Pharmaceuticals, Inc.
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ATS Daily Bulletin • ATS 2017 International Conference • Sunday, May 21, 201724
The ATS International Conference features a variety of centers that offer networking and learning op-portunities specifically for clinicians,
researchers, early career professionals, and in-ternational attendees. These centers all provide avenues to build connections that can lead to joint research projects, referrals, jobs, grants, and published papers.
CLINICIANS CENTERThe Clinicians Center provides a comfortable setting to relax, network, and learn in Hall D (Middle Building, Level 2) of the Walter E. Washington Convention. It is open from 7 a.m. to 5 p.m., Sunday through Tuesday, and from 7 a.m. to 1 p.m., Wednesday.
Clinicians Center activities kick off with a reception for nurses from 11 a.m. to 12:30 p.m., Sunday. The 2017 Outstanding Clinician Award recipient, Jack H. Hasson, MD, will be recognized during a reception from 4 to 5 p.m., Monday. Educational programs on tap are:• ATS Coding and Billing Practices—
The Basics 1 to 2 p.m., Sunday• Organizing and Operating a Pediatric
Bronchoscopy Program 11:30 a.m. to 12:30 p.m., Monday
• ATS Coding and Billing Practices—
Advanced 1 to 2 p.m., Monday• Results of an ATS Pulmonologist Survey
Regarding Knowledge, Attitudes, and
Practices With Inhalation Devices for
COPD 1 to 2 p.m., Tuesday
Educational Session Demonstrations include:• Tracheostomy Troubleshooting 11:30 a.m.
to noon, Sunday
• Mechanical Ventilation: Case Studies Noon to 1 p.m., Sunday
• Difficult Airways Management 1 to 2 p.m., Sunday
• EBUS Transbronchial Needle Aspiration—
Improving Your Yield 11:30 a.m. to 12:30 p.m., Monday
• Advanced Topics in Pediatric Bronchos-
copy 12:30 to 2 p.m., Monday• Early Mobility in the ICU: Evidence and
Demonstrations 11:30 a.m. to 1:30 p.m., Tuesday
• Home Care Technologies 12:30 to 2 p.m., Tuesday
SCIENCE AND INNOVATION CENTERThe Science and Innovation Center provides a forum for scientists and researchers to meet, network, learn, and relax. It is open from 7 a.m. to 5 p.m., Sunday through Tuesday, and from 7 a.m. to 1 p.m., Wednesday. It is located in Hall D (Middle Building, Level 2) of the Walter E. Washington Convention Center.
Breakfast will be served at 7 a.m. each day, and light refreshments will be provided at noon.
If you need to brush up on the basics of a topic before attending a symposium, you can attend an SIC 101 series presentation. The schedule is:• 3D Lung Organoids 101: 7:15 to 8 a.m.,
Sunday• Genomics 101: 7:15 to 8 a.m., Monday
Four special events will be presented at the SIC:• Rising Stars of Research 1:15 to 3 p.m., Sun-
day, will feature basic and translational science researchers at the assistant professor or early associate professor levels making 15-minute presentations of their work, with time for Q&A.
• Early Career Professionals Coffee Corner
7:15 to 8 a.m., Tuesday, will provide an opportunity for mentors and mentees to meet.
• Complementing NIH Funding:
Philanthropic Organizations and
Department of Defense 11:15 a.m. to noon, Tuesday, will focus on seeking funding from a range of sources.
• The SIC Abstract Awards 1:15 to 3 p.m., Tuesday, will recognize the best scientific abstracts submitted to ATS 2017 by early career professionals.
CENTER FOR CAREER DEVELOPMENTThe Center for Career Development is a profes-sional networking and career development forum for early career professionals, includ-ing graduate and medical students, medical residents, clinical and postdoctoral fellows, and junior faculty. It is open from 7 a.m. to 5 p.m., Sunday through Tuesday, with a complimentary breakfast at 7 a.m. and a Professional Network-ing Hour from 3:30 to 4:30 p.m. each day. The CCD, located in Hall D (Middle Building, Level 2) of the Walter E. Washington Convention Center, will have information about the Early Career Researchers Group, Career Development Workshops, and Faculty Development Work-shops. The center also will provide networking opportunities, such as the Trainee Educators ATS Camaraderie Hour (TEACH) Medical Education Fellow Mixer, on Sunday.
Education sessions schedule:• ATS 101: 11 a.m. to noon, Sunday• How to Write a Paper: noon to 1 p.m., Sunday• How to Create a Podcast and Web-Based
Videos for Medical Education: 4 to 5 p.m., Sunday
• How to Get Involved in Government and
Advocacy: 11 a.m. to noon, Monday• Early Career Group: How to Be a Success-
ful and Effective Peer Reviewer: noon to 1 p.m., Monday
• How to Write a Specific Aims Page:
1 to 2 p.m., Monday • Best Practices in Billing and Coding for
Senior PCCM Fellows: 4 to 5 p.m., Monday• How to Teach Effectively at the Bedside:
11 a.m. to noon, Tuesday• Global Health Session—LMIC Practice
and Opportunities: noon to 1 p.m., Tuesday • How to Access ATS Grants: 1 to 2 p.m.,
Tuesday • How to Develop an Effective Training Plan:
4 to 5 p.m., Tuesday
INTERNATIONAL PARTICIPANTS CENTERThe International Participants Center is de-signed to enhance the conference experience for participants from outside North America, as well as provide opportunities to learn about ATS international activities. It is open from 10 a.m. to 4 p.m., Sunday through Tuesday, and is located in Hall D (Middle Building, Level 2) of the Walter E. Washington Conven-tion Center.
The Center Plan will present Grant Writ-ing for Investigators from Low- and Middle-Income Countries Discussion from noon to 1 p.m., Monday. The session is open to MECOR program graduates.
This year’s International Trainee/MECOR Scholarship awardees will be recognized from 4:15 to 6:30 p.m., Tuesday. The event is open to all international attendees, current and former International Trainee/MECOR award recipients, and their colleagues.
The Exposome BlueprintThe exposome encompasses human environmental exposures, revealing insights into lung function
Researchers and clinicians have long recognized that environmental exposures affect lung function and dysfunction. But lung cancer,
interstitial lung disease, asthma, or other chronic condi-tions are seldom the result of a single exposure. Suscepti-bility to lung disease is the cumulative effect of a lifetime of exposures from in utero through child-hood and into the adult years.
“The concept of the exposome is that the environment produces cumulative
changes in DNA, RNA, proteins, lipids, and metabolites in lung tissues, cells, and fluids,” says Andrew Halayko, PhD, professor of
physiology and pathophysiology, and internal medicine at the University of Manitoba Max Rady College of Medicine in Winnipeg. “It is the collective change that ultimately manifests as the disease state we are interested in.”
Dr. Halayko developed the exposome symposium with Jane E. Bourke, PhD, senior lecturer in phar-macology and head of the Respiratory Pharmacol-ogy Group at Monash University in Melbourne, Australia. The session is part of the Basic Science Core program on environmental exposure and lung disease. There are two related exposome sessions as part of the program. DOHAD: Developmental Origins of Health and Disease and the Circle of Life for Lung Disease (A5) will examine the prenatal and neonatal exposome. Gene-Environmental Interaction in Interstitial Lung Disease (B88) will explore the exposome in interstitial lung disease.
The exposome includes complex and integrated molecular and cellular networks defined by environmental exposures that can underpin chronic disease. Dr. Halayko says that although cigarette smoke and air pollution are familiar exposures, less obvious exposures that impact health can include diet, infection, socioeconomic status, stress, and ac-cess to health care as well as their cumulative or age-specific effects.
Defining an exposome includes using novel data collection and analysis techniques that al-low researchers to amass enormous data sets. These data sets can identify associations and links between environmental exposures and physical changes at the molecular and cellular levels. Big data is opening windows into the ways molecular circuits adapt and mis-adapt to exposures of diesel exhaust and allergens in asthma. Metabolic profiles of lipid media-tors can inform environmental responses in chronic lung disease while environmental toxin transcriptomes may allow early detec-tion and prevention of lung cancer.
The Exposome Concept: Understanding Impact on Lung Health and Disease (A85)
2:15-4:15 p.m. Sunday
Independence Ballroom
Salon E-H (Level M4),
Marriott Marquis
Washington
During the session, speakers will explain how researchers use data sets to track clues about how exposures associate with molecu-lar signatures to affect pathophysiology, Dr. Halayko says.
“This insight from our speakers will un-doubtedly provide fuel for other investigators to tap into this rich approach to research,” he says. “The exposome concept and the data tools that are part of it are helping us identify interactions between molecules that relate to environmental exposures and create research questions that we couldn’t even imagine before. The exposome is the next level in asking better, more informed questions to understand chronic disease, its causes, and responses to treatment.”
The concept of the exposome is
that the environment produces
cumulative changes in DNA, RNA,
proteins, lipids, and metabolites in
lung tissues, cells, and fluids.
Andrew Halayko, PhD
Andrew Halayko,
PhD
Personalize Your ATS 2017 Experience
IPF HACKATHON: DISRUPTING AND EVOLVING THE MANAGEMENT OF IDIOPATHIC PULMONARY FIBROSIS
Join Us for a Dinner Symposium
IndicationEsbriet® (pirfenidone) is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).Select Important Safety InformationElevated liver enzymes: Increases in ALT and AST >3× ULN have been reported in patients treated with Esbriet. In some cases these have been associated with concomitant elevations in bilirubin. Patients treated with Esbriet had a higher incidence of elevations in ALT or AST than placebo patients (3.7% vs 0.8%, respectively). No cases of liver transplant or death due to liver failure that were related to Esbriet have been reported. However, the combination of transaminase elevations and elevated bilirubin without evidence of obstruction is generally recognized as an important predictor of severe liver injury that could lead to death or the need for liver transplants in some patients. Conduct liver function tests (ALT, AST, and bilirubin) prior to initiating Esbriet, then monthly for the first 6 months and every 3 months thereafter. Dosage modifications or interruption may be necessary.Photosensitivity reaction or rash: Patients treated with Esbriet had a higher incidence of photosensitivity reactions (9%) compared with patients treated with placebo (1%). Patients should avoid or minimize exposure to sunlight (including sunlamps), use a sunblock (SPF 50 or higher), and wear clothing that protects against sun exposure. Patients should avoid concomitant medications that cause photosensitivity. Dosage reduction or discontinuation may be necessary.Gastrointestinal disorders: Gastrointestinal events of nausea, diarrhea, dyspepsia, vomiting, gastroesophageal reflux disease, and abdominal pain were more frequently reported in patients treated with Esbriet. Dosage reduction or interruption for gastrointestinal events was required in 18.5% of patients in the 2403 mg/day group, as compared to 5.8% of patients in the placebo group; 2.2% of patients in the Esbriet 2403 mg/day group discontinued treatment due to a gastrointestinal event, as compared to 1.0% in the placebo group. The most common (>2%) gastrointestinal events that led to dosage reduction or interruption were nausea, diarrhea, vomiting, and dyspepsia. Dosage modifications may be necessary in some cases.Adverse reactions: The most common adverse reactions (≥10%) are nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dyspepsia, dizziness, vomiting, anorexia, gastroesophageal reflux disease, sinusitis, insomnia, weight decreased, and arthralgia.Drug interactions: Concomitant administration with strong inhibitors of CYP1A2 (eg, fluvoxamine) significantly increases systemic exposure of Esbriet and is not recommended. Discontinue prior to administration of Esbriet. If strong CYP1A2 inhibitors cannot be avoided, dosage reductions of Esbriet are recommended. Monitor for adverse reactions and consider discontinuation of Esbriet as needed. Concomitant administration of Esbriet and ciprofloxacin (a moderate inhibitor of CYP1A2) moderately increases exposure to Esbriet. If ciprofloxacin at the dosage of 750 mg twice daily cannot be avoided, dosage reductions are recommended. Monitor patients closely when ciprofloxacin is used.Agents that are moderate or strong inhibitors of both CYP1A2 and CYP isoenzymes involved in the metabolism of Esbriet should be avoided during treatment.The concomitant use of a CYP1A2 inducer may decrease the exposure of Esbriet, and may lead to loss of efficacy. Concomitant use of strong CYP1A2 inducers should be avoided.Specific populations: Esbriet should be used with caution in patients with mild to moderate (Child Pugh Class A and B) hepatic impairment. Monitor for adverse reactions and consider dosage modification or discontinuation of Esbriet as needed. The safety, efficacy, and pharmacokinetics of Esbriet have not been studied in patients with severe hepatic impairment. Esbriet is not recommended for use in patients with severe (Child Pugh Class C) hepatic impairment.Esbriet should be used with caution in patients with mild (CLcr 50–80 mL/min), moderate (CLcr 30–50 mL/min), or severe (CLcr less than 30 mL/min) renal impairment. Monitor for adverse reactions and consider dosage modification or discontinuation of Esbriet as needed. The safety, efficacy, and pharmacokinetics of Esbriet have not been studied in patients with end-stage renal disease requiring dialysis. Use of Esbriet in patients with end-stage renal diseases requiring dialysis is not recommended. Smoking causes decreased exposure to Esbriet, which may alter the efficacy profile of Esbriet. Instruct patients to stop smoking prior to treatment with Esbriet and to avoid smoking when using Esbriet.You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.Please see full Prescribing Information for additional Important Safety Information.An Industry-Organized Symposium at the ATS 2017 International Conference.A non-CME educational program sponsored by Genentech. Due to regulatory restrictions, this program is only available to attendees from the United States.Minnesota, Vermont, and Federal Entities have restrictions on receiving in-kind benefits (e.g., meals, valet parking) at company-sponsored events. You are accountable for understanding such restrictions and complying with them. If you are licensed in or affiliated with any of these states or federal agencies, Genentech policies may restrict you from consuming any portion of the Genentech-sponsored meal at this program or from receiving any other in-kind benefit from Genentech (e.g., valet parking) in connection with the program.
© 2017 Genentech USA, Inc. All rights reserved. ESB/020317/0013a
ROBERT SUSSMAN, MDOverlook Medical Center
Summit, NJ
6:30 p.m. to 9:00 p.m. SUNDAY, MAY 21, 2017
Engage in collaborative discussions with a team of expert pulmonologists while investigating and discussing challenges in the management of IPF. In this interactive symposium, actively participate in timed, small group discussions designed to address and solve key issues.
GRAND HYATT WASHINGTON, INDEPENDENCE BALLROOM A 1000 H Street NW, Washington, DC 20001
FEATURED SPEAKERS INCLUDE:
STEVEN NATHAN, MDInova Fairfax Hospital
Fairfax, VA
RAJEEV SAGGAR, MDUniversity of Arizona College of Medicine
Tucson, AZ
ATS Daily Bulletin • ATS 2017 International Conference • Sunday, May 21, 201726
Lunch and Learn at Industry Theaters, Mini Theater
The learning continues at ATS 2017 through lunch with Industry The-aters and Mini Industry Theaters on Sunday, Monday, and Tuesday in
the Exhibit Hall. Enjoy a complimentary boxed lunch provided by the ATS (while quantities last) as you listen to the latest clinical updates from supporting companies related to pulmo-nary, critical care, or sleep medicine.The theater locations are:Industry Theater 1: Booth 160Industry Theater 2: Booth 1661Mini Theater: Booth 663
SUNDAYIndustry Theater 111:30 a.m.-12:15 p.m.Advancing the Treatment of IPF: A Patient Journey(Open to U.S. attendees only) Please join our expert pulmonologist for an engaging case-based presentation about the treatment and management of IPF. Attendees will gain an increased understanding of IPF, treatment with an FDA-approved IPF specific therapy, and suggestions for managing patients during their journey with IPF.The program will review:• Treatment upon diagnosis• Setting treatment goals and expectations
with IPF patients • Managing IPF patients on an FDA-
approved IPF specific therapySpeaker: Daniel Dilling, MD, Loyola University Hospital Maywood, Illinois Company: Genentech, A Member of the Roche Group
1:15-2 p.m.COPD Treatment Strategy for 2017(Open to international attendees only)The GOLD report provides clinicians with an evidence-based reference tool to effectively manage the diagnosis and treatment of COPD. In the 2017 edition, the pivotal treatment goals of alleviating symptoms and reducing exacerbation risk remains unchanged. However, the updated guidelines now give physicians more clarity on those patients initially suited for treatment with bronchodilators and those who may require
additional therapy. This industry theater will focus on the importance of LAMA+LABA in maximizing bronchodilation and the benefits of escalation to triple therapy, with the addition of an ICS, for patients with persistent exacerbations. These GOLD recommendations provide physicians with the options to use a more personalized treatment approach.Speakers: Christopher Cooper, BSc, MB, BS, MD(Lond), MD (ECFMG), MS, professor, Global Respiratory Franchise, GSK, US; Dave Singh, BA (Hons), MB, B.Chir, MA, (Hon), MRCP, MD, professor, University of Manchester, Manchester, UK; Neil Barnes, BA, Hons, MA, LRCP, MRCS, MBBS, professor, Global Respiratory Franchise, GSK, UK.Company: GSK GlaxoSmithKline
Industry Theater 211:30 a.m.-12:15 p.m.Progressing the COPD Treatment Strategy: A Central Role for Dual Bronchodilation(Open to international attendees only)During this Novartis-supported Industry Theater, a faculty of world-renowned experts will summarize recent developments in COPD management, focusing on the updated position of dual bronchodilation in treatment recom-mendations. The practicalities of implement-ing new recommendations in clinical practice will be explored, with emphasis on assessing benefit/risk when determining appropriate treatment.Speakers: Ken Chapman, MD, professor of medicine, University of Toronto, Canada; Marc Miravitlles, MD, pulmonologist, Vall d’Hebron University Hospital, Barcelona; Dave Singh, MD, professor of clinical pharmacology and respiratory medicine, University Hospital of South ManchesterCompany: Novartis Pharma AG
1:15-2 p.m.Is ICS Really the Answer to Reducing the Risk of Exacerbations?Gary T. Ferguson, MD, and Antonio An-zueto, MD, will present clinical data on how COPD maintenance therapies reduce the risk of exacerbations and debate the effectiveness of LAMA/LABAs versus ICS-containing
therapies. They also will discuss how recent data has led to updated GOLD treatment recommendations favoring LAMA/LABA as a preferred treatment option for most patients with COPD, and the implications for clinical practice. Speakers: Gary T. Ferguson, MD, director, Pulmonary Research Institute of Southeast Michigan; Antonio Anzueto, MD, professor in the Department of Pulmonary Diseases and Critical Care Medicine, University of Texas Health Science Center at San Antonio Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Mini Theater11:30 a.m.-NoonClinical and Practical Consideration for Prostacyclin Analogue Use Across a PAH Continuum of Care(Open to U.S. attendees only) Through the course of your patient’s journey with PAH, they may be treated with a pros-tacyclin analogue, which may be available in multiple routes of administration—oral, inhaled, subcutaneous, and intravenous. This session will cover why these therapies may be important for treating your patients with this progressive disease. Speaker: Ronald J. Oudiz, MD, professor of medicine at the David Geffen School of Medicine at UCLA, director, Liu Center for Pulmonary Hypertension at LA Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CaliforniaCompany: United Therapeutics Corporation
1:30-2 p.m.Know Your Patient Goals: Understanding the Goal-Oriented Approach in PAH (WHO Group 1)When discussing PAH treatment options, what goals do you set for your adult PAH (WHO Group 1) patients? A PAH expert will present and discuss cases targeting the NO-sGC-cGMP pathway and review a goal-oriented approach in PAH.Speaker: Chad E. Miller, MD, program director, Pulmonary Vascular Disease, Piedmont HealthcareCompany: Bayer
Expand Your ExpertiseTap in to the educational infor-mation and career-enhancing opportunities available through the American Thoracic Society
by stopping by the ATS Center. The ATS Center can be found in the Exhibit Hall at the Walter E. Washington Convention Cen-ter, Hall A (South Building, Lower Level).
At ATS Center, you may:• Access patient information fact sheets at
our computer kiosks. Choose from more than 100 titles in English, Spanish, and Portuguese. Learn about Lung Disease Week at the ATS.
• Test your knowledge on pulmonary, critical care, sleep, or pediatric medicine when you visit the Take the Challenge kiosk. See how you stack up against others.
• Enhance your education. Learn about ATS education products, including MOC and CME opportunities; many are free to ATS members.
• Learn about grant opportunities through the ATS Foundation Research Program and other programs.
• Rediscover our three medical jour-nals and the journal apps for iOS and Android.
• Purchase gift items, including a pewter lung key chain, conference T-shirt, fleece jacket, 4-in-1 pen/stylus with pointer and laser light, robot puzzle cube, and more.
• Obtain a copy of Highlights for Clini-cians, peruse Guidelines Pocket Cards, and pick up copies of the Clinical Year in Review, Nursing Year in Review, and Pediatric Year in Review.
• Pick up the Road Map for Early Career Professionals to learn about conference sessions most advantageous for your career.
• Check out our interactive world map to learn about the number of ATS mem-bers, ATS 2017 attendees, and ATS jour-nal submissions from your country, as well as such educational activities as the Global Scholars Program and MECOR that may be available.When you join the American Thoracic
Society or renew your membership at the ATS Center (or the Membership Booth next to Conference Registration), you will receive a free gift pack. Plus, your ATS membership will guarantee you reduced prices on ATS products and services, in-cluding a discount on ATS 2018 San Diego registration fees.
ATS Center Is Info Central
NUCALA—the fi rst subcutaneous anti-interleukin 5 (IL-5) targeted therapy for severe asthma with an eosinophilic phenotype
Please see additional Important Safety Information for NUCALA throughout.
Please see Brief Summary of Prescribing Information for NUCALA on the pages following this advertisement.
IndicationNUCALA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older with an eosinophilic phenotype. NUCALA is not indicated for treatment of other eosinophilic conditions.NUCALA is not indicated for the relief of acute bronchospasm or status asthmaticus.
Important Safety InformationCONTRAINDICATIONS NUCALA should not be administered to patients with a history of hypersensitivity to mepolizumab or excipients in the formulation.
Visit NUCALAHCP.com for additional information
VISIT US AT BOOTH
#937
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1.74
NUCALA added to SOC*(n=194)
REDUCTION (P<0.001)
Placebo added to SOC* (n=191)
53% 50%
61%
Important Safety Information (cont’d)WARNINGS AND PRECAUTIONS Hypersensitivity ReactionsHypersensitivity reactions (eg, anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred following administration of NUCALA. These reactions generally occur within hours of administration but in some instances can have a delayed onset (ie, days). In the event of a hypersensitivity reaction, NUCALA should be discontinued.Acute Asthma Symptoms or Deteriorating DiseaseNUCALA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.Opportunistic Infections: Herpes ZosterIn controlled clinical trials, 2 serious adverse reactions of herpes zoster occurred in subjects treated with NUCALA compared to none in placebo. Consider varicella vaccination, if medically appropriate, prior to starting therapy with NUCALA. Reduction of Corticosteroid DosageDo not discontinue systemic or inhaled corticosteroids (ICS) abruptly upon initiation of therapy with NUCALA. Decreases in corticosteroid doses, if appropriate, should be gradual and under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.Parasitic (Helminth) InfectionIt is unknown if NUCALA will infl uence a patient’s response against parasites. Treat patients with pre-existing helminth infections before initiating therapy with NUCALA. If patients become infected while receiving treatment with NUCALA and do not respond to anti-helminth treatment, discontinue treatment with NUCALA until infection resolves.
REDUCTION IN EXACERBATIONS RESULTING IN HOSPITALIZATION AND/OR EMERGENCY DEPARTMENT (ED) VISITS VS PLACEBO(NUCALA: 0.08/year, placebo: 0.20/year; P=0.015)1,2
NUCALA signifi cantly reduced exacerbations
Exacerbation frequency at Week 32 in the MENSA study1
Study description MENSA (Trial 2)1 Design: 32-week study comparing treatment with NUCALA or placebo in 576 patients with severe asthma with an eosinophilic phenotype (identifi ed by blood eosinophil counts ≥150 cells/µL at initiation of treatment or ≥300 cells/µL in the past 12 months).Primary endpoint: Frequency of exacerbations.Secondary endpoint: Included frequency of exacerbations requiring hospitalizations and/or ED visits.Exacerbation defi nition: Exacerbations of asthma were defi ned as the worsening of asthma that required use of oral/systemic corticosteroids and/or hospitalization and/or ED visits; for patients on maintenance oral/systemic corticosteroids, exacerbations were defi ned as requiring at least double the existing maintenance dose for at least 3 days.
*SOC=standard of care (regular treatment with high-dose inhaled corticosteroids [ICS] and at least 1 other controller with or without oral corticosteroids [OCS]).
MORE THAN HALF OF PATIENTS HAD AT LEAST A 50% REDUCTION IN DAILY OCS DOSE AT WEEKS 20 TO 24†
54% of patients treated with NUCALA achieved at least a 50% reduction in the daily prednisone dose compared with 33% of patients treated with placebo (compared with the baseline dose) (95% CI for difference: 4%, 37%)†
NUCALA signifi cantly reduced OCS dose while maintaining asthma control
Additionally...
Study description SIRIUS (Trial 3)3
Design: 24-week study comparing treatment with NUCALA or placebo in 135 patients with severe asthma with an eosinophilic phenotype (identifi ed by blood eosinophil counts ≥150 cells/µL at initiation of treatment or ≥300 cells/µL in the past 12 months) who required at least 5 mg to 35 mg of prednisone equivalent per day in addition to regular use of high-dose ICS plus an additional controller.Primary endpoint: Percent reduction in daily OCS dose (Weeks 20 to 24) while maintaining asthma control.
‡ Results are descriptive only; statistical signifi cance cannot be inferred.2
† Performed as a sensitivity analysis to the primary endpoint; results considered exploratory.2
Patients treated with NUCALA achieved greater reductions in daily OCS dose, while maintaining asthma control, compared with patients receiving placebo (P=0.008)3
23% OF PATIENTS TREATED WITH NUCALA HAD A 90% TO 100% REDUCTION IN THEIR OCS DOSE compared with 11% in the placebo group2‡
36% of patients in the group receiving NUCALA vs 56% in the placebo group were classifi ed as having no improvement for OCS dose2,3‡
Please see additional Important Safety Information for NUCALA throughout.
Please see Brief Summary of Prescribing Information for NUCALA on the pages following this advertisement.
NUCALA is a registered trademark of GSK group of companies.
©2017 GSK group of companies. All rights reserved. Printed in USA. 819103R0 April 2017
Please visit NUCALAHCP.COM
References: 1. Ortega HG, Liu MC, Pavord ID, et al; for the MENSA Investigators. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198-1207. 2. Data on fi le, GSK. 3. Bel EH, Wenzel SE, Thompson PJ, et al; for the SIRIUS Investigators. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014;371(13):1189-1197.
Important Safety Information (cont’d)ADVERSE REACTIONSThe most common adverse reactions (≥3% and more common than placebo) reported in the fi rst 24 weeks of 2 clinical trials with NUCALA (and placebo) were: headache, 19% (18%); injection site reaction, 8% (3%); back pain, 5% (4%); fatigue, 5% (4%); infl uenza, 3% (2%); urinary tract infection, 3% (2%); abdominal pain upper, 3% (2%); pruritus, 3% (2%); eczema, 3% (<1%); and muscle spasm, 3% (<1%).Systemic Reactions, including Hypersensitivity Reactions: In 3 clinical trials, 3% of subjects who received NUCALA experienced systemic (allergic and nonallergic) reactions, compared to 5% in the placebo group. Systemic allergic/hypersensitivity reactions were reported by 1% of subjects who received NUCALA, compared to 2% of subjects in the placebo group. Manifestations included rash, pruritus, headache, and myalgia. Systemic nonallergic reactions were reported by 2% of subjects who received NUCALA and 3% of subjects in the placebo group. Manifestations included rash, fl ushing, and myalgia. A majority of the systemic reactions were experienced on the day of dosing.Injection site reactions (eg, pain, erythema, swelling, itching, burning sensation) occurred at a rate of 8% in subjects treated with NUCALA, compared with 3% in subjects treated with placebo.
USE IN SPECIFIC POPULATIONSA pregnancy exposure registry monitors pregnancy outcomes in women exposed to NUCALA during pregnancy. Healthcare providers can enroll patients or encourage patients to enroll themselves by calling 1-877-311-8972 or visiting www.mothertobaby.org/asthma.The data on pregnancy exposures from the clinical trials are insuffi cient to inform on drug-associated risk. Monoclonal antibodies, such as mepolizumab, are progressively transported across the placenta in a linear fashion as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimesters of pregnancy.
S:21.25”
S:14.5”
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Rat
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0.5
1.0
1.5
2.0
0.83
1.74
NUCALA added to SOC*(n=194)
REDUCTION (P<0.001)
Placebo added to SOC* (n=191)
53% 50%
61%
Important Safety Information (cont’d)WARNINGS AND PRECAUTIONS Hypersensitivity ReactionsHypersensitivity reactions (eg, anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred following administration of NUCALA. These reactions generally occur within hours of administration but in some instances can have a delayed onset (ie, days). In the event of a hypersensitivity reaction, NUCALA should be discontinued.Acute Asthma Symptoms or Deteriorating DiseaseNUCALA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.Opportunistic Infections: Herpes ZosterIn controlled clinical trials, 2 serious adverse reactions of herpes zoster occurred in subjects treated with NUCALA compared to none in placebo. Consider varicella vaccination, if medically appropriate, prior to starting therapy with NUCALA. Reduction of Corticosteroid DosageDo not discontinue systemic or inhaled corticosteroids (ICS) abruptly upon initiation of therapy with NUCALA. Decreases in corticosteroid doses, if appropriate, should be gradual and under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.Parasitic (Helminth) InfectionIt is unknown if NUCALA will infl uence a patient’s response against parasites. Treat patients with pre-existing helminth infections before initiating therapy with NUCALA. If patients become infected while receiving treatment with NUCALA and do not respond to anti-helminth treatment, discontinue treatment with NUCALA until infection resolves.
REDUCTION IN EXACERBATIONS RESULTING IN HOSPITALIZATION AND/OR EMERGENCY DEPARTMENT (ED) VISITS VS PLACEBO(NUCALA: 0.08/year, placebo: 0.20/year; P=0.015)1,2
NUCALA signifi cantly reduced exacerbations
Exacerbation frequency at Week 32 in the MENSA study1
Study description MENSA (Trial 2)1 Design: 32-week study comparing treatment with NUCALA or placebo in 576 patients with severe asthma with an eosinophilic phenotype (identifi ed by blood eosinophil counts ≥150 cells/µL at initiation of treatment or ≥300 cells/µL in the past 12 months).Primary endpoint: Frequency of exacerbations.Secondary endpoint: Included frequency of exacerbations requiring hospitalizations and/or ED visits.Exacerbation defi nition: Exacerbations of asthma were defi ned as the worsening of asthma that required use of oral/systemic corticosteroids and/or hospitalization and/or ED visits; for patients on maintenance oral/systemic corticosteroids, exacerbations were defi ned as requiring at least double the existing maintenance dose for at least 3 days.
*SOC=standard of care (regular treatment with high-dose inhaled corticosteroids [ICS] and at least 1 other controller with or without oral corticosteroids [OCS]).
MORE THAN HALF OF PATIENTS HAD AT LEAST A 50% REDUCTION IN DAILY OCS DOSE AT WEEKS 20 TO 24†
54% of patients treated with NUCALA achieved at least a 50% reduction in the daily prednisone dose compared with 33% of patients treated with placebo (compared with the baseline dose) (95% CI for difference: 4%, 37%)†
NUCALA signifi cantly reduced OCS dose while maintaining asthma control
Additionally...
Study description SIRIUS (Trial 3)3
Design: 24-week study comparing treatment with NUCALA or placebo in 135 patients with severe asthma with an eosinophilic phenotype (identifi ed by blood eosinophil counts ≥150 cells/µL at initiation of treatment or ≥300 cells/µL in the past 12 months) who required at least 5 mg to 35 mg of prednisone equivalent per day in addition to regular use of high-dose ICS plus an additional controller.Primary endpoint: Percent reduction in daily OCS dose (Weeks 20 to 24) while maintaining asthma control.
‡ Results are descriptive only; statistical signifi cance cannot be inferred.2
† Performed as a sensitivity analysis to the primary endpoint; results considered exploratory.2
Patients treated with NUCALA achieved greater reductions in daily OCS dose, while maintaining asthma control, compared with patients receiving placebo (P=0.008)3
23% OF PATIENTS TREATED WITH NUCALA HAD A 90% TO 100% REDUCTION IN THEIR OCS DOSE compared with 11% in the placebo group2‡
36% of patients in the group receiving NUCALA vs 56% in the placebo group were classifi ed as having no improvement for OCS dose2,3‡
Please see additional Important Safety Information for NUCALA throughout.
Please see Brief Summary of Prescribing Information for NUCALA on the pages following this advertisement.
NUCALA is a registered trademark of GSK group of companies.
©2017 GSK group of companies. All rights reserved. Printed in USA. 819103R0 April 2017
Please visit NUCALAHCP.COM
References: 1. Ortega HG, Liu MC, Pavord ID, et al; for the MENSA Investigators. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198-1207. 2. Data on fi le, GSK. 3. Bel EH, Wenzel SE, Thompson PJ, et al; for the SIRIUS Investigators. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014;371(13):1189-1197.
Important Safety Information (cont’d)ADVERSE REACTIONSThe most common adverse reactions (≥3% and more common than placebo) reported in the fi rst 24 weeks of 2 clinical trials with NUCALA (and placebo) were: headache, 19% (18%); injection site reaction, 8% (3%); back pain, 5% (4%); fatigue, 5% (4%); infl uenza, 3% (2%); urinary tract infection, 3% (2%); abdominal pain upper, 3% (2%); pruritus, 3% (2%); eczema, 3% (<1%); and muscle spasm, 3% (<1%).Systemic Reactions, including Hypersensitivity Reactions: In 3 clinical trials, 3% of subjects who received NUCALA experienced systemic (allergic and nonallergic) reactions, compared to 5% in the placebo group. Systemic allergic/hypersensitivity reactions were reported by 1% of subjects who received NUCALA, compared to 2% of subjects in the placebo group. Manifestations included rash, pruritus, headache, and myalgia. Systemic nonallergic reactions were reported by 2% of subjects who received NUCALA and 3% of subjects in the placebo group. Manifestations included rash, fl ushing, and myalgia. A majority of the systemic reactions were experienced on the day of dosing.Injection site reactions (eg, pain, erythema, swelling, itching, burning sensation) occurred at a rate of 8% in subjects treated with NUCALA, compared with 3% in subjects treated with placebo.
USE IN SPECIFIC POPULATIONSA pregnancy exposure registry monitors pregnancy outcomes in women exposed to NUCALA during pregnancy. Healthcare providers can enroll patients or encourage patients to enroll themselves by calling 1-877-311-8972 or visiting www.mothertobaby.org/asthma.The data on pregnancy exposures from the clinical trials are insuffi cient to inform on drug-associated risk. Monoclonal antibodies, such as mepolizumab, are progressively transported across the placenta in a linear fashion as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimesters of pregnancy.
S:21.25”S:14.5”
T:21.75”T:15”
B:22”B:15.25”
BRIEF SUMMARY NUCALA® mepolizumab
The following is a brief summary only; see full prescribing information for complete product information.
1 INDICATIONS AND USAGENUCALA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. [See Clinical Studies (14) of full prescribing information.]Limitations of Use• NUCALA is not indicated for treatment of other eosinophilic conditions.• NUCALA is not indicated for the relief of acute bronchospasm or status asthmaticus.
4 CONTRAINDICATIONSNUCALA should not be administered to patients with a history of hypersensitivity to mepolizumab or excipients in the formulation.
5 WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity ReactionsHypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred following administration of NUCALA. These reactions generally occur within hours of administration, but in some instances can have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, NUCALA should be discontinued [see Contraindications (4)].5.2 Acute Asthma Symptoms or Deteriorating DiseaseNUCALA should not be used to treat acute asthma symptoms or acute exacerbations. Do not use NUCALA to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with NUCALA.
5.3 Opportunistic Infections: Herpes ZosterIn controlled clinical trials, 2 serious adverse reactions of herpes zoster occurred in subjects treated with NUCALA compared with none in placebo [see Adverse Reactions (6.1)]. Consider varicella vaccination if medically appropriate prior to starting therapy with NUCALA.
5.4 Reduction of Corticosteroid DosageDo not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with NUCALA. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy
5.5 Parasitic (Helminth) InfectionEosinophils may be involved in the immunological response to some helminth infections. Patients with known parasitic infections were excluded from participation in clinical trials. It is unknown if NUCALA will influence a patient’s response against parasitic infections. Treat patients with pre-existing helminth infections before initiating therapy with NUCALA. If patients become infected while receiving treatment with NUCALA and do not respond to anti-helminth treatment, discontinue treatment with NUCALA until infection resolves.
6 ADVERSE REACTIONSThe following adverse reactions are described in greater detail in other sections:• Hypersensitivity reactions [see Warnings and Precautions (5.1)]• Opportunistic infections: herpes zoster [see Warnings and Precautions (5.3)]6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
A total of 1,327 subjects with asthma were evaluated in 3 randomized, placebo-controlled, multicenter trials of 24 to 52 weeks’ duration (Trials 1, 2, and 3). Of these, 1,192 had a history of 2 or more exacerbations in the year prior to enrollment despite regular use of high-dose inhaled corticosteroids plus an additional controller(s) (Trials 1 and 2), and 135 subjects required daily oral corticosteroids in addition to regular use of high-dose inhaled corticosteroids plus an additional controller(s) to maintain asthma control (Trial 3). All subjects had markers of eosinophilic airway inflammation [see Clinical Studies (14) of full prescribing information]. Of the subjects enrolled, 59% were female, 85% were white, and subjects ranged in age from 12 to 82 years. Mepolizumab was administered subcutaneously or intravenously once every 4 weeks; 263 subjects received NUCALA (mepolizumab 100 mg subcutaneous [SC]) for at least 24 weeks. Serious adverse events that occurred in more than 1 subject and in a greater percentage of subjects treated with NUCALA (n = 263) than placebo (n = 257) included 1 event, herpes zoster (2 subjects vs. 0 subjects, respectively). Approximately 2% of subjects receiving NUCALA withdrew from clinical trials due to adverse events compared with 3% of subjects receiving placebo.
The incidence of adverse reactions in the first 24 weeks of treatment in the 2 confirmatory efficacy and safety trials (Trials 2 and 3) with NUCALA is shown in Table 1.
Table 1. Adverse Reactions with NUCALA with Greater than or Equal to 3% Incidence and More Common than Placebo in Subjects with Asthma (Trials 2 and 3)
Adverse Reaction
NUCALA (Mepolizumab 100 mg
Subcutaneous)(n = 263)
%
Placebo (n = 257)
%Headache Injection site reaction Back pain Fatigue Influenza Urinary tract infection Abdominal pain upper Pruritus Eczema Muscle spasms
19855333333
183442222
<1<1
52-Week TrialAdverse reactions from Trial 1 with 52 weeks of treatment with mepolizumab 75 mg intravenous (IV) (n = 153) or placebo (n = 155) and with greater than or equal to 3% incidence and more common than placebo and not shown in Table 1 were: abdominal pain, allergic rhinitis, asthenia, bronchitis, cystitis, dizziness, dyspnea, ear infection, gastroenteritis, lower respiratory tract infection, musculoskeletal pain, nasal congestion, nasopharyngitis, nausea, pharyngitis, pyrexia, rash, toothache, viral infection, viral respiratory tract infection, and vomiting. In addition, 3 cases of herpes zoster occurred in subjects treated with mepolizumab 75 mg IV, compared with 2 subjects in the placebo group.
Systemic Reactions, including Hypersensitivity ReactionsIn Trials 1, 2, and 3 described above, the percentage of subjects who experienced systemic (allergic and non-allergic) reactions was 5% in the placebo group and 3% in the group receiving NUCALA. Systemic allergic/hypersensitivity reactions were reported by 2% of subjects in the placebo group and 1% of subjects in the group receiving NUCALA. The most commonly reported manifestations of systemic allergic/hypersensitivity reactions reported in the group receiving NUCALA included rash, pruritus, headache, and myalgia. Systemic non-allergic reactions were reported by 2% of subjects in the group receiving NUCALA and 3% of subjects in the placebo group. The most commonly reported manifestations of systemic non-allergic reactions reported in the group receiving NUCALA included rash, flushing, and myalgia. A majority of the systemic reactions in subjects receiving NUCALA (5/7) were experienced on the day of dosing.
Injection Site ReactionsInjection site reactions (e.g., pain, erythema, swelling, itching, burning sensation) occurred at a rate of 8% in subjects treated with NUCALA compared with 3% in subjects treated with placebo.
Long-term SafetyNine hundred ninety-eight (998) subjects have received NUCALA in ongoing open-label extension studies, during which additional cases of herpes zoster have been reported. The overall adverse event profile was similar to the asthma trials described above.
6.2 ImmunogenicityOverall, 15/260 (6%) subjects treated with NUCALA developed anti-mepolizumab antibodies. The reported frequency may underestimate the actual frequency due to lower assay sensitivity in the presence of high drug concentration. Neutralizing antibodies were detected in 1 subject receiving mepolizumab. Anti-mepolizumab antibodies slightly increased (approximately 20%) the clearance of mepolizumab. There was no evidence of a correlation between anti-mepolizumab antibody titers and change in eosinophil level. The clinical relevance of the presence of anti-mepolizumab antibodies is not known.
The data reflect the percentage of patients whose test results were positive for antibodies to mepolizumab in specific assays. The observed incidence of antibody positivity in an assay is highly dependent on several factors, including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.
6.3 Postmarketing ExperienceIn addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of NUCALA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to NUCALA or a combination of these factors.
Immune System DisordersHypersensitivity reactions, including anaphylaxis.
7 DRUG INTERACTIONSFormal drug interaction trials have not been performed with NUCALA.
8 USE IN SPECIFIC POPULATIONS8.1 PregnancyPregnancy Exposure RegistryThere is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to NUCALA during pregnancy. Healthcare providers can enroll patients or encourage patients to enroll themselves by calling 1-877-311-8972 or visiting www.mothertobaby.org/asthma.
Risk SummaryThe data on pregnancy exposure from the clinical trials are insufficient to inform on drug- associated risk. Monoclonal antibodies, such as mepolizumab, are transported across the placenta in a linear fashion as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimesters of pregnancy. In a prenatal and postnatal development study conducted in cynomolgus monkeys, there was no evidence of fetal harm with IV administration of mepolizumab throughout pregnancy at doses that produced exposures up to approximately 30 times the exposure at the maximum recommended human dose (MRHD) of 100 mg SC [see Data].In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical ConsiderationsDisease-Associated Maternal and/or Embryofetal Risk: In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control.
DataAnimal Data: In a prenatal and postnatal development study, pregnant cynomolgus monkeys received mepolizumab from gestation days 20 to 140 at doses that produced exposures up to approximately 30 times that achieved with the MRHD (on an AUC basis with maternal IV doses up to 100 mg/kg once every 4 weeks). Mepolizumab did not elicit adverse effects on fetal or neonatal growth (including immune function) up to 9 months after birth. Examinations for internal or skeletal malformations were not performed. Mepolizumab crossed the placenta in cynomolgus monkeys. Concentrations of mepolizumab were approximately 2.4 times higher in infants than in mothers up to day 178 postpartum. Levels of mepolizumab in milk were less than or equal to 0.5% of maternal serum concentration.
In a fertility, early embryonic, and embryofetal development study, pregnant CD-1 mice received an analogous antibody, which inhibits the activity of murine IL-5, at an IV dose of 50 mg/kg once per week throughout gestation. The analogous antibody was not teratogenic in mice. Embryofetal development of IL-5–deficient mice has been reported to be generally unaffected relative to wild-type mice.
8.2 LactationRisk SummaryThere is no information regarding the presence of mepolizumab in human milk, the effects on the breastfed infant, or the effects on milk production. However, mepolizumab is a humanized monoclonal antibody (IgG1 kappa), and immunoglobulin G (IgG) is present in human milk in small amounts. Mepolizumab was present in the milk of cynomolgus monkeys postpartum following dosing during pregnancy [see Use in Specific Populations (8.1)]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NUCALA and any potential adverse effects on the breastfed infant from mepolizumab or from the underlying maternal condition.
8.4 Pediatric UseThe safety and efficacy in pediatric patients younger than 12 years have not been established. A total of 28 adolescents aged 12 to 17 years with asthma were enrolled in the phase 3 studies. Of these, 25 were enrolled in the 32-week exacerbation trial (Trial 2) and had a mean age of 14.8 years. Subjects had a history of 2 or more exacerbations in the previous year despite regular use of high-dose inhaled corticosteroids plus an additional controller(s) with or without oral corticosteroids and had blood eosinophils of greater than or equal to 150 cells/mcL at screening or greater than or equal to 300 cells/ mcL within 12 months prior to enrollment. [See Clinical Studies (14) of full prescribing information.] Subjects had a reduction in the rate of exacerbations that trended in favor of mepolizumab. Of the 19 adolescents who received mepolizumab, 9 received NUCALA and the mean apparent clearance in these subjects was 35% less than that of adults. The adverse event profile in adolescents was generally similar to the overall population in the phase 3 studies [see Adverse Reactions (6.1)].8.5 Geriatric UseClinical trials of NUCALA did not include sufficient numbers of subjects aged 65 years and older that received NUCALA (n = 38) to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Based on available data, no adjustment of the dosage of NUCALA in geriatric patients is necessary, but greater sensitivity in some older individuals cannot be ruled out.
10 OVERDOSAGESingle doses of up to 1,500 mg have been administered intravenously to subjects in a clinical trial with eosinophilic disease without evidence of dose-related toxicities.
There is no specific treatment for an overdose with mepolizumab. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of FertilityLong-term animal studies have not been performed to evaluate the carcinogenic potential of mepolizumab. Published literature using animal models suggests that IL-5 and eosinophils are part of an early inflammatory reaction at the site of tumorigenesis and can promote tumor rejection. However, other reports indicate that eosinophil infiltration into tumors can promote tumor growth. Therefore, the malignancy risk in humans from an antibody to IL-5 such as mepolizumab is unknown.
Male and female fertility were unaffected based upon no adverse histopathological findings in the reproductive organs from cynomolgus monkeys treated with mepolizumab for 6 months at IV doses up to 100 mg/kg once every 4 weeks (approximately 70 times the MRHD on an AUC basis). Mating and reproductive performance were unaffected in male and female CD-1 mice treated with an analogous antibody, which inhibits the activity of murine IL-5, at an IV dose of 50 mg/kg once per week.
17. PATIENT COUNSELING INFORMATIONSee FDA-Approved Patient Labeling. Hypersensitivity ReactionsInform patients that hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred after administration of NUCALA. Instruct patients to contact their physicians if such reactions occur.
Not for Acute Symptoms or Deteriorating DiseaseInform patients that NUCALA does not treat acute asthma symptoms or acute exacerbations. Inform patients to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with NUCALA.
Opportunistic Infections: Herpes ZosterInform patients that herpes zoster infections have occurred in patients receiving NUCALA and where medically appropriate, inform patients varicella vaccination should be considered before starting treatment with NUCALA.
Reduction of Corticosteroid DosageInform patients to not discontinue systemic or inhaled corticosteroids except under the direct supervision of a physician. Inform patients that reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Pregnancy Exposure RegistryInform women there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to NUCALA during pregnancy and that they can enroll in the Pregnancy Exposure Registry by calling 1-877-311-8972 or by visiting www.mothertobaby.org/asthma [see Use in Specific Populations (8.1)]. NUCALA is a registered trademark of GSK group of companies.
Manufactured byGlaxoSmithKline LLCPhiladelphia, PA 19112U.S. License No. 1727
Distributed by
GlaxoSmithKline Research Triangle Park, NC 27709
©2017 GSK group of companies. All rights reserved.Revised 2/2017 NCL:2BRS
©2017 GSK group of companies. All rights reserved. Printed in USA. 819103R0 April 2017
S:10.375”S:14.5”
T:10.875”T:15”
B:11.125”B:15.25”
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ATS Daily Bulletin • ATS 2017 International Conference • Sunday, May 21, 201732
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Use the 5WsWho: Include your chapter, committee, assembly, or section in photos of yourself, mentors, and others.
What: Show off your ATS swag (ATS pens, key chains, mugs, and jackets).
Where: Take photos in public spaces of the Walter E. Washington Convention Center and hotels, such as lobbies, corri-dors, and atria; at receptions, dinners, and anywhere ATS attendees gather; at the ATS
selfie station; and out and about at Wash-ington, DC, landmarks. (Photography is not permitted in the Exhibit Hall.)
When: Avoid the midday sun when natural light is the most harsh. Opt for early morning, late afternoon, and early evening photo opps.
Why: Photos are fun to share, and your colleagues will feel connected.
Twitter Essentials for NewbiesGo easy on the hashtags. Hashtags are a must-have, but use them in moderation, lim-iting yourself to about two per tweet. Include the official conference hashtag, #ATS2017 so attendees can see, share, and engage with your tweets.
Less is more: Stop short of the 140-character limit to allow for easy sharing and reposting (e.g., RT @atscommunity).
Diversity is key: Follow the 60-30-10 rule with 60 percent retweets to promote other posts, 30 percent for conversation and responses, and 10 percent for your updates, announcements, and events. Remember: You are joining the conversation, not taking it over.
Grow Your Group’s Social NetworksActive members of ATS chapters,
committees, assemblies, or sections can use this primer to build their social media presence.
Moderation: Don’t overwhelm your followers. A basic guideline for social me-dia frequency is about one Facebook post per day, or five to seven posts per week. For Twitter, a general rule is three to five tweets per day.
Practice makes perfect: Inspiration for posts takes time and effort. Get into the habit of regularly searching, sourcing, and posting compelling content.
Speak with images: Photos uploaded to Facebook generate five times the interac-tion and engagement compared to posts without photos. Twitter is the same, with tweeted photos getting twice the interac-tion.
Stay fit: Social networks are mobile, so view your posts on mobile devices to make sure they appear correctly. Use link short-eners, such as bit.ly, to add more informa-tion and keywords to your updates.
Test content variations. Do certain pictures perform better than others? Is there an optimal time of day, or day of the week to post? As you adjust what you post and how often, you’ll soon go from social media novice to pro.
Use #ATS2017 to track events, see photos, share experiences
Maximize your ATS 2017 experi-ence by sharing your thoughts and experiences on social media. Also watch for your colleagues’
posts and blogs. If you want to be part of the conversation on
Twitter, Instagram, and Facebook, use the main hashtag for the conference, #ATS2017. (See “Ramp Up Your Social Media Posts” on this page for tips.)
ATS will regularly post to its five top social media platforms (Facebook, LinkedIn, Twitter, Snapchat, and Instagram), including posts targeted at early career professionals. A social media station has been set up at the Center for Career Development, a networking area for early career professionals. The station will stream all ATS 2017 early career professional social media posts.
FACEBOOK AND LINKEDINBy following the ATS on Facebook (facebook.com/americanthoracic) and LinkedIn (linkedin.com/company/american-thoracic-society_2?trk=company_name), you can stay up to speed on activities and colleagues.
On both platforms, the ATS will have posts each morning describing what will be happening that day. Other posts will include a photo of the day, a photo album each evening, and blog posts.
Early career professionals can also follow ATS 2017 on another Facebook page (facebook.com/atsearlycareer), which will post daily education sessions and workshops of interest.
Two Center for Career Development work-shops will be featured on Facebook Live. The workshops are:
• How to Create Podcasts and Web-Based Videos for Medical Education: 4-5 p.m., Sunday
• How to Get Involved in Government and Advocacy: 11 a.m.-noon, Monday.
TWITTER ATS will post on Twitter (twitter.com/atscom-munity) throughout the day, including pro-gram alerts and photos.
There is also a Twitter account for early ca-reer professionals (twitter.com/atsearlycareer).
Early career professionals will be Live Tweet-ing throughout the conference. Join the con-versation by following #ATSEarlyCareer. Also follow this Twitter account for updates, room changes, and other important information for early career professionals at ATS 2017.
INSTAGRAM Images will be posted throughout the day, and a selfie station has been set up in the Exhibit Hall (instagram.com/atscommunity). Take your picture with DC backdrops and cool props. You’ll have a choice of the White House or Capitol building for a backdrop, white coats to dress up in, and clever signs to hold.
For early career professionals (instagram.com/atsearlycareer) there will be a fun activity involv-ing Dr. Thor, a “stuffed lung” that will be hidden at spots around ATS 2017. Attendees are encour-aged to find the lung and take a photo with it in the location they found it. At the end of the conference, ATS will present a prize to the person who posts the most photos with the stuffed lung and uses the hashtag #ATSEarlyCareer.
SNAPCHATBehind-the-scenes images and videos will be posted throughout the day on the ATS Snapchat Story (snapchat.com/add/atscommunity). They will also be featuring a countdown to ATS 2017 in the days leading to the conference! An ATS 2017 geofilter will also be available to Snapchat users. Enable the location feature on electronic devices and “swipe right” on the Snapchat screen to use the official ATS 2017 geofilter to provide the perfect background im-age for your posts!
Through these social media channels, the ATS hopes to offer a fun way for ATS Inter-national Conference attendees to interact virtually, in addition to the many thousands of personal encounters attendees have each day during the conference.
Bloggers Add Color, Insight
Four physicians and a patient advocate attending the ATS International Conference will share their experiences through blogs.
They will post their thoughts on the ATS Community on Facebook. The bloggers are:• Ann Wu, MD, MPH, is an asthma
researcher and physician whose regular blog is Asth.ma. She is an asthma researcher at Harvard Medical School and Harvard Pilgrim Health Care Institute, a pediatrician at Children’s Hospital Boston, and mom of a 12-year-old with asthma.
• Nitin Seam, MD, is director of training and simulation at the National Institutes of Health Clinical Center Critical Care Medicine Department and a clinical as-sociate professor of medicine at George Washington University. Dr. Seam has an educational interest in the appropriate use of innovative technologies in medi-cal education. He is the digital media editor of the American Journal of Respi-ratory and Critical Care Medicine.
• Jess Mandel, MD, 2015-17 chair appointee of the ATS International Conference Committee, is an associate dean for undergraduate medical education and professor of medicine at the University of California, San Diego, School of Medicine. He has blogged about the conference in the past and wants to share updates about ATS 2017.
• Kevin S. Gipson, MD, is a clinical fellow in pediatrics at Massachusetts General Hospital who will focus on information for early career professionals.
• Susan Wisliceny is a member of the ATS Public Advisory Roundtable and a patient advocate for non-tuberculous mycobacteria. She also is executive director for NTM Info & Research, Inc.
Get Social at ATS 2017
ATS Daily Bulletin • ATS 2017 International Conference • Sunday, May 21, 2017 33
Assemblies and Sections Host Member Events
One of the best ways to get involved in the ATS is to participate in your assembly and/or section activities.
The Society’s assemblies and sections will hold their annual membership meetings Sunday and Monday at various Washington, DC, locations. All ATS 2017 attendees are encouraged to attend these meetings. (See the schedule below for specific times and locations of assembly membership meetings, receptions, section meetings, and assembly dinners.)
ASSEMBLY MEMBERSHIP MEETINGS
The Assembly Membership Meetings provide updates on assembly activities from each as-sembly’s leadership. These meetings give mem-bers the opportunity to provide input on future direction and get involved in assembly and networking activities. Voting results for the as-sembly’s future leaders also will be announced.These meetings will all be held from 5 to 7 p.m. Monday, with the exception of the Assembly on Behavioral Science and Health Services Re-search and the Assembly on Pediatrics, which will meet from 6:30 to 8:30 p.m. Sunday.
SUNDAY6:30-8:30 p.m.Behavioral Science and Health Services ResearchChair: Christopher H. Goss, MD, MScRenaissance Washington Downtown, Grand Ballroom South (Ballroom Level)
PediatricsChair: James F. Chmiel, MD, MPHRenaissance Washington Downtown, Grand Ballroom Central (Ballroom Level)
MONDAY5-7 p.m.Allergy, Immunology, and InflammationChair: Mitchell A. Olman, MA, MDGrand Hyatt Washington, Independence Ballroom B-E (Independence Level 5B)
Clinical ProblemsChair: Sanjay Sethi, MDGrand Hyatt Washington, Constitution Ballroom C (Constitution Level 3B)
Critical CareChair: Carolyn S. Calfee, MDRenaissance Washington Downtown, Grand Ballroom South (Ballroom Level)
Environmental, Occupational, and Population HealthChair: Jack R. Harkema, DVM, PhDRenaissance Washington Downtown, Ballroom East (Ballroom Level)
Microbiology, Tuberculosis, and Pulmonary InfectionsChair: Kevin P. Fennelly, MD, MPHGrand Hyatt Washington, Declaration A-B (Declaration Level 1B)
NursingChair: Eileen G. Collins, PhDRenaissance Washington Downtown, Renaissance Ballroom West B (Ballroom Level)
Pulmonary CirculationChair: Troy Stevens, PhDRenaissance Washington Downtown, Grand Ballroom North (Ballroom Level)
Pulmonary RehabilitationChair: Carolyn L. Rochester, MDRenaissance Washington Downtown, Renaissance Ballroom West A (Ballroom Level)
Respiratory Cell and Molecular BiologyChair: Irina Petrache, MDGrand Hyatt Washington, Independence Ballroom F-I (Independence Level 5B)
Respiratory Structure and FunctionChair: Blanca Camoretti-Mercado, PhDGrand Hyatt Washington, Independence Ballroom A (Independence Level 5B)
Sleep and Respiratory NeurobiologyChair: Susheel P. Patil, MD, PhDGrand Hyatt Washington, Constitution Ballroom B (Constitution Level 3B)
Thoracic OncologyChair: Michael K. Gould, MD, MSRenaissance Washington Downtown, Congressional Hall A (Ballroom Level)
SECTION MEETINGS
SUNDAY6:30-8:30 p.m.Section on Genetics and GenomicsCo-Chairs: Craig P. Hersh, MD, MPH, and Blanca E. Himes, PhDRenaissance Washington Downtown, Renaissance Ballroom West A-B (Ballroom Level)
TUESDAY4:30-6:30 p.m.Section on Medical EducationCo-Chairs: Alison S. Clay, MD, and Jennifer McCallister, MDRenaissance Washington Downtown, Congressional Hall B (Ballroom Level)
Section on Terrorism and Inhalation DisastersCo-Chairs: Sadis Matalon, PhD, ScD (Hon.), and Carl White, MDRenaissance Washington Downtown, Meeting Room 4 (Meeting Room Level)
ASSEMBLY DINNER
MONDAY7-10 p.m.PediatricsRenaissance Washington Downtown, Grand Ballroom Central (Ballroom Level)
ASSEMBLY RECEPTIONS
MONDAY7-10 p.m.Allergy, Immunology and Inflammation and Respiratory Cell and Molecular BiologyGrand Hyatt Washington, Constitution Ballroom A (Constitution Level 3B)
Critical CareRenaissance Washington Downtown, Congressional Hall B (Ballroom Level)
Microbiology, Tuberculosis and Pulmonary InfectionsGrand Hyatt Washington, Penn Quarter A-B (Declaration Level 1B)
Respiratory Structure and FunctionGrand Hyatt Washington, Independence Ballroom A (Independence Level 5B)
Sleep and Respiratory NeurobiologyGrand Hyatt Washington, Wilson—Arlington (Constitution Level 3B)
Thoracic OncologyRenaissance Washington Downtown, Mount Vernon Square A (Meeting Room Level)
CONFERENCE SESSION WEBCASTS
Registrants who have paid for the full conference will receive 12 months of free access to on-demand online viewing of webcasts of selected 2017 International Conference presentations reflecting the diverse topic areas of the conference, including major symposia in clinical, basic, translational, and behavioral science, and all Year in Review sessions.
Free access will be available several weeks post-conference through the ATS Store at http://store.thoracic.org/. An informational email including login credentials to the ATS Store will be sent to all eligible registrants.
On-demand webcasts, audio (MP3s), and syllabus PDFs of the 2017 postgraduate courses can be purchased through the ATS Store at http://store.thoracic.org/ or the ATS Store Best of ATS Education Products booth onsite in Washington, DC.
Please visit the Best of ATS booth, located in the Walter E. Washington Convention Center, L Street Bridge (Level 2), to take advantage of discounted onsite pricing.
12 MONTHS OF FREE ON-DEMAND ONLINE ACCESS TO THE ATS 2017 INTERNATIONAL CONFERENCE SESSION WEBCASTS AS A BENEFIT OF YOUR REGISTRATION.*
ATS STORE BEST OF ATS EDUCATION PRODUCTS
ATS MEMBERS ENJOY A 20% DISCOUNT ON ALL PURCHASES!
Over the course of the International Conference, the ATS records an expansive amount of educational
material presented during the postgraduate courses, scientific symposia, core curriculum sessions, and
workshops that comprise the major part of attendee education at the conference. This yearly compilation
of live education is what the ATS captures and proudly presents in the Best of the ATS Conference
collection. Presentations are offered and sold as individual sessions or select track packages with most
available in your choice of on-demand webcast, or downloadable audio files.
FREE ACCESS TO
PLEASE VISIT THE ATS STORE’S BEST OF ATS EDUCATION PRODUCTS BOOTH IN WALTER E. WASHINGTON CONVENTION CENTER, L STREET BRIDGE (LEVEL 2)
SATURDAY, MAY 20 8:30 a.m. – 5:00 p.m.SUNDAY, MAY 21– TUESDAY, MAY 23 7:00 a.m. – 5:00 p.m.WEDNESDAY, MAY 24 7:00 a.m. – 1:00 p.m.
Free access is limited to PAID Conference registrants in the following registration categories: Full Members, Affiliate Members, In-Training Members, Senior/Emeritus Members, Non Members, and In-Training Non Members who are registered for the full conference. One day ONLY registrants and other attendees are welcome to pre-order our educational products onsite at the ATS Store Best of ATS Education Products Booth at discounted pricing.
*
Postgraduate Course syllabus flash drives
sold here!
ATS Daily Bulletin • ATS 2017 International Conference • Sunday, May 21, 201734
Attend the Building Education to Advance Research Cage competi-tion this afternoon to hear the top three finalists selected by the
DDDD Committee defend their submitted research proposals in competition for a $5,000 grand prize.
The early career investigators will pitch their innovative research propos-als to a panel of translational science experts representing aca-demia, industry, and governmen-tal sectors, and compete for the grand prize be-
fore a live audience. The presenters of the two runner-up proposals will each receive $2,500.
As the judges are deliberating, last year’s BEAR Cage winner, Jake Brenner, MD, PhD, will present an update on his project, “Pulmo-nary Endothelial-Targeted Liposomes for the Treatment of ARDS” and share his experience as a BEAR Cage mentee.
Early career investigators who are ATS members were encouraged to submit innova-tive clinical or translational science research proposals to the ATS BEAR Cage competi-tion, hosted by the ATS Drug Device Discov-ery and Development Committee, prior to the conference. Applications were received from around the world, representing the ATS pillars of pulmonary, critical care, and sleep medicine. The committee invited the investigators with the top selected proposals
Researchers Pitch Proposals in BEAR CageEarly career investigators compete for funding
BEAR Cage
2-4 p.m., Sunday
Center for Career
Development
Walter E. Washington
Convention Center,
Hall D (Middle Building,
Level 2)
Last year’s BEAR cage winner Jake Brenner, MD, PhD (right).
to present Sunday, in a setting that facilitates discussion and leads to collaboration, men-torship, and improvement of the proposals. The 2017 finalists are:
“Chest CT at Chest X-Ray Radiation Dose”Marcus Y. Chen, MDNational Heart, Lung, and Blood Institute
“Communicating With Mechanically Ventilated Patients”Prema R. Menon, MD, PhDUniversity of Vermont Medical Center
“Unmasking Resistance: Impact of Low-Frequency Drug Resistance on Molecular Diagnosis of Drug-Resis-tant Tuberculosis” Sanghyuk Shin, PhDUCLA Fielding School of Public Health
Launched in 2015, this unique program supports innovation in translational research and provides mentorship to junior profes-sionals with novel ideas.
The American Board of Internal Medicine and the American Board of Pediatrics have changed how MOC points can be awarded. MOC
points are now equivalent to the number of CME credits. ATS 2017 attendees can still earn at least as many MOC points as in past years.
The ATS Education and the International Conference committees have collaborated on a plan in which 22 symposia, as well as adult and pediatric core curriculum symposia, are eligible for MOC.
ATS 2017 attendees are able to earn 46.5 ABIM MOC points—up from 30 points in 2016—and 10 ABP MOC points—the same number as in 2016. The symposia will cover adult pulmonary, critical care, and sleep medi-cine as well as pediatric pulmonary symposia. The Adult and Pediatric Symposia eligible for MOC at the conference can be found at con-ference.thoracic.org/program/moc.php.
HOW TO EARN MOC POINTS AT ATS 2017• During ATS 2017: Attend any and all of the
MOC sessions you are interested in. These sessions will be highlighted in the Final Program and on the ATS 2017 mobile app, as well as convention center signage.
• After ATS 2017: Take the post-session test. All of the tests will be available at the end of the International Conference. Attendees can take the tests at no cost through July 31, 2017. If you take the pre-test, you will receive notification that the post-test is online. Please note: Audience response during a session does not count as the post-test.
The ABIM and ABP require internists and subspecialists who were certified during or after 1990 to continually participate in MOC activities. In January 2014, ABIM modified its MOC program. Physicians must earn 100 MOC points every five years to maintain their certifications. They also must earn some points in an MOC activity every two years to meet the new requirements. The ABP had previously implemented similar requirements and timing for pediatric subspecialists.
CME AND NURSING CEATS is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. This live activity has been planned and implemented in accordance with the essential areas and policies of the ACCME and are free from the control of commercial interests. The ATS designates this activity for a maximum of 45 AMA PRA Category 1 Credits™. The designation of AMA PRA Cat-egory 1 Credit(s)™ per session is listed in the session pages. Physicians should only claim the credit commensurate with the extent of their participation in the activity.
ATS partners with National Jewish Health® to provide Nursing Contact Hours for selected sessions. Provider approved by the California Board of Registered Nursing, Provider Number CEP 12724.
Pediatric Clinical Core Curriculum 1 is supported by an educational grant from Teva Pharmaceuticals.
Earn MOC Points, CME Credits
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ATS Daily Bulletin • ATS 2017 International Conference • Sunday, May 21, 201736
NIH Theater to Focus on Government Programs, Funding
The ATS International Conference is introducing the NIH Theater, presenting government-focused ses-sions that are a great educational op-
portunity for attendees looking for insight from the National Institutes of Health. Choose from a variety of topics that focus on global health care and how to obtain government funding for research and clinical trials. These hour-long programs are offered from 10:30 a.m. to 3:30 p.m. on Sunday, Monday, and Tuesday at Booth 1503.
SUNDAY10:30 a.m.-12:30 p.m.Grant Writing and Peer Review 101Understand what happens to your applica-tion upon submission, and hear from NIH staff involved in peer review on how review-ers approach applications. Join an interactive session on grant writing with a mock study section using scientists who have served on NIH study sections. Attendees will gain an increased understanding of the peer review process.
• 10:30-10:45 a.m.: Introduction: The NIH Grant Competition Imperative, Michael Twery, Division of Lung Disease, NHLBI
• 10:45-11:15 a.m.: NIH Peer Review, Ghenima Dirami, Center for Scientific Review
• 11:15-11:45 a.m.: Grant Writing, Natalia Komissarova, Center for Scientific Review
• 11:45 a.m.-12:15 p.m.: Mock Review Panel, Bradley Nuss, CSR; Faculty Panel: TBD, three academics
• 12:15-12:30 p.m.: Specific Aims and “The
Elevator Pitch” (interactive, audience partici-pation), Michael Twery (moderator), NIH Panel: all of the above
12:30-1:30 p.m.Training and Funding Opportunities for Minorities Underrepresented in the SciencesLearn how to use NIH funding opportunities to create a career path as a mentor of, or as an, under-represented minority. There are funding opportunities at all stages of education, which can foster a career in the sciences.• 12:30-12:35 p.m.: Introduction• 12:35-12:50 p.m.: Career Development
Opportunities, at NHLBI for Diverse Ap-plicants, Xenia Tigno, NHLBI
• 12:50-1 p.m.: The PRIDE Program at NHLBI, Sonia Arteaga, NHLBI
• 1-1:15 p.m.: NIGMS and NIH Diversity Consortium Programs to Foster a Diverse Biomedical Workforce, Alison Gammie, NIGMS
• 1:15-1:30 p.m.: Q&A Moderator
1:30-2:30 p.m.Global HealthJoin NIH experts involved in oversight of NIH global health programs to learn about oppor-tunities, procedures, and special issues around support for research in non-U.S. settings. Learn about the World RePORT. • 1:30-1:35 p.m.: Brief Overview on the
Burden of Disease in the World, Tony Punturieri, NHLBI
• 1:35-1:48 p.m.: NIH Grants/Contract policy in global health, with few examples of cur-rent funded grants and what are the arrange-ments (i.e., U.S. award with subcontracts, other mechanisms of cooperation, etc.) that support them, Erik Stemmy, NIAID
• 1:48-2 p.m.: Special Issues/Intriguing Research Areas Internationally, Focusing on Low and Middle Income Countries, Flora Katz, FIC
• 2-2:30 p.m.: Q&A With Attendees, Panel of above
2:30-3:30 p.m.Update on New NIH Policies on Clinical TrialsIn September 2016, NIH announced a suite of initiatives aimed at improving the stewardship of NIH-supported clinical trials. This session will highlight some salient elements of those ini-tiatives, including requirements that multi-site trials utilize a single IRB, that all applications for clinical trial funding be submitted in response to a clinical trial-specific FOA, and that clinical trials register with ClinicalTrials.gov (per NIH policy, as well as FDAAA). Experts from NIH will address each of these topics, providing the history, reasoning, and expectations associated with each.• 2:30-2:50 p.m.: Origins of the Clinical Trial
Stewardship Reform Initiatives, Michael Lauer, Office of Extramural Research
• 2:50-3:10 p.m.: Requirements for a Single IRB for Multisite Trials, Sherry Mills, Office of Extramural Programs
• 3:10-3:30 p.m.: ClinicalTrials.gov Registra-tion and Reporting Requirements, Rebecca Williams, National Library of Medicine
Affiliated with the University of Pittsburgh School of Medicine, UPMC is ranked among the nation’s best hospitals by U.S. News & World Report.
UPMC’s Acute Lung Injury Center of Excellence is dedicated to investigating life-threatening
complications of inflammatory disorders, including pneumonia. Our recent focus involves the use of
cutting-edge initiatives to reverse lung injury associated with pneumonia, based on fundamentally
new discoveries of mechanisms of the disease in critically ill patients. Our researchers are actively
pursuing multiple strategies, including identification of biomarkers for at-risk patients with
pneumonia, use of stem cell replacement strategies, and the development of novel
immunomodulatory drug therapies. To learn more about our breakthroughs in treating inflammatory
conditions of the lungs, visit UPMCPhysicianResources.com/Pulmonology.
Our experts are challenging conventional treatments for inflammatory conditions of the lungs.
Rama Mallampalli, MD Bill B. Chen, PhD
ATS Daily Bulletin • ATS 2017 International Conference • Sunday, May 21, 2017 37
ATS CENTERWhy visit the ATS Center in the Exhibit Hall?
SHOP THE ATS CENTER
1. INFORMATION FOR YOUR PATIENTS: Access patient information fact sheets at our computer kiosks: choose from more than 100 titles in English, Spanish, Portuguese, Arabic, Italian, Turkish or Serbian.
2. GIFT ITEMS: Purchase gift items including a conference T-shirt, pewter lung key chain, ATS hat, 4-in-1 pen with stylus, pointer and laser light, or a robot puzzle cube.
3. Receive a FREE GIFT PACK when you join ATS or renew your membership while in Washington, DC!
4. TEST YOUR KNOWLEDGE on pulmonary, critical care or sleep medicine at the Take the Challenge kiosk. You could win a prize!
5. Rediscover our three SCIENTIFIC JOURNALS and the journal apps for iOS and Android.
The Exhibit Hall is located in the Walter E. Washington Convention Center, Halls A-B (South Building, Lower Level).The ATS Center is booth #1161.
ATS CENTERWhy visit the ATS Center in the Exhibit Hall?
SHOP THE ATS CENTER
1. INFORMATION FOR YOUR PATIENTS: Access patient information fact sheets at our computer kiosks: choose from more than 100 titles in English, Spanish, Portuguese, Arabic, Italian, Turkish or Serbian.
2. GIFT ITEMS: Purchase gift items including a conference T-shirt, pewter lung key chain, ATS hat, 4-in-1 pen with stylus, pointer and laser light, or a robot puzzle cube.
3. Receive a FREE GIFT PACK when you join ATS or renew your membership while in Washington, DC!
4. TEST YOUR KNOWLEDGE on pulmonary, critical care or sleep medicine at the Take the Challenge kiosk. You could win a prize!
5. Rediscover our three SCIENTIFIC JOURNALS and the journal apps for iOS and Android.
The Exhibit Hall is located in the Walter E. Washington Convention Center, Halls A-B (South Building, Lower Level).The ATS Center is booth #1161.
,
,
oncology and pathology at Johns Hopkins School of Medicine, will discuss her exten-sive research in the genetics of inherited syndromes of telomere shortening.
Dr. Armanios has worked at the Johns Hopkins McKusick-Nathans Institute of Genetic Medicine with an interest in defining the genetics and biol-ogy of disease caused by genome instability.
Her research team has discovered that, in most cases, short telomeres manifest in adults who have premature lung aging, and mutations in telomerase genes are the most common identifiable cause of idiopathic pulmonary fibrosis and emphysema.
MondayPatient Safety
Latest CF Research
TuesdayManaging TB
How Precision Medicine Affects Lung Cancer Trials
WednesdayA Geological Perspective on Climate Change
The Effects of Low Oxygen Levels on Illnesses
KEYNOTE SERIES LINEUP
Mary Armanios, MD
KEYNOTE SERIES Continued from page 1What’s Next for CTD-ILD?
Seeking better diagnosis and management options for patients beyond immunosuppression
Immunosuppression is the standard treat-ment for patients with connective tissue disease associated with interstitial lung disease. However, different approaches
toward diagnosis and management are on the horizon. Those developing approaches will be explained using case studies during a Monday symposium.
“There are nuances to treating and managing these challenging patients that can be important. Consideration for novel therapies, including clinical trial participation, and lung transplantation should be part of the discussion,” says the session moderator, Joyce Lee, MD. “These patients
have challenging clinical scenarios. “This session is an opportunity to touch on
what is being done from a research perspec-tive in trying to help us better diagnose and manage our patients with connective tissue disease-ILD.”
During the session, a case will be presented, and a multidisciplinary panel of a clinician, radiologist, and pathologist will discuss diag-nosis and treatment. Mixed in will be lectures on a topic related to the case discussed.
“It is an opportunity for people to observe this multidisciplinary approach that often is
done in larger centers,” says Dr. Lee, an assis-tant professor of medicine at the University of Colorado Denver and director of its interstitial lung disease program.
“Second, it focuses on cases that we see in the clinical realm and uses those cases to highlight the conundrums that come up in terms of diagnosis and management, and how research that is ongoing will hopefully help us answer some of these questions down the line,” she says.
Case 1 and the talk that follows will examine the role of histopathologic phenotypes, which may be important in managing idiopathic interstitial pneumonias.
“The talk will cover the relevance of histo-pathologic phenotypes of autoimmune forms
of ILD and emerging therapies to consider in this group of diseases,” Dr. Lee says.
Case 2 and a related presentation will ex-plore interstitial pneumonia with autoimmune features. The speaker will discuss a recent workgroup statement on IPAF management.
“It was not de-veloped for clinical purposes, but it may help us better study these groups of pa-tients and figure out what this means in terms of the disease entity, its pathobiol-ogy, and its natural history,” Dr. Lee says.
Case 3 and its re-lated talk will evalu-ate treatment and management options beyond conventional immunosuppression.
“The presentation will touch on some novel therapies that are being tried,” Dr. Lee says. “It will discuss the data and share the pros and cons of lung transplantation and why it is often difficult in this patient population.”
The symposium will end with a panel discus-sion in which audience members will be able to ask questions beyond the option emphasized in each case.
A Multidisciplinary, Case-Based Approach to Hot Topics in CTD-ILD (B83) is supported by an educational grant from Gilead Sciences, Inc.
A Multidisciplinary, Case-Based Approach to Hot Topics in CTD-ILD (B83)
2:15-4:15 p.m. Monday
Ballroom C (South
Building, Level 3),
Walter E. Washington
Convention Center
Joyce Lee, MD
It is an opportunity for people
to observe this multidisciplinary
approach that often is done in
larger centers.
Joyce Lee, MD
The ATS Center is booth 1161
Halls A-B (South Building, Lower Level)
Walter E. Washington Convention Center
My ATS
“When I joined ATS
as a trainee member,
I gained access to the
clinicians and scientists
working to actively
shape our field. This af-
forded me a mentorship
network that stretched
far beyond my home
institution and helped to place my academic
interests in the context of the broader com-
munity.”Andrew Admon, MD, MPH
“I am a member of ATS
because it allows me
to meet people from all
over the country, and the
world, who share my in-
terest in improving medi-
cal care by improving the
medical education we
provide.”Rosemary Adamson, MBBS
“As an early career
professional, I found
ATS provided a forum
to present my work,
interact with lead-
ers in my field, and
identify mentors who
helped guide my career
development. Over the
years, the relationships that began through my
ATS membership have led to leadership op-
portunities, research collaborations, and lasting
friendships.”Jeffrey Horowitz, MD
“Rarely does one size fit
all, but the ATS comes
close. Exchanging ideas
about basic, translation-
al, or clinical research
with world experts is
intellectually stimulating,
and learning the latest
information about medi-
cal education and clinical practice round out
what ATS offers.
“Whether you live in the clinical or research
realm, ATS is constantly looking for new ways
to meet the needs of its members.Yolanda N. Mageto, MD, MPH
You can join ATS or renew your membership at the Membership Booth next to ATS 2017
Registration, or at the ATS Center, Booth 1161, in the Exhibit Hall.
We asked members of the American Thoracic Society what they most valued about belonging to the Society. Here are their answers.
ATS Daily Bulletin • ATS 2017 International Conference • Sunday, May 21, 201738
Getting an Early Start on Learning
Thousands of health care profes-sionals see the ATS International Conference as an opportunity to expand their knowledge. Several
hundred of them arrived early to jump-start their learning with programs for early career professionals.
The Resident Boot Camp, the Student Schol-ars Program, and the ATS Fellows Track Sym-posium teach fellows, residents, and students nuances of pulmonary, critical care, and sleep medicine or introduce them to the fields.
The Resident Boot Camp has grown to teach 160 fellows “things they didn’t learn in resi-dency that they need to know for their first day of fellowship,” says Boot Camp Chair Brendan Clark, MD, of the University of Colorado, Denver.
The Boot Camp assembled a faculty of 110 health care professionals to share their knowl-edge in hands-on workshops and interactive lectures and discussions Friday and Saturday.
“They have fun, meet new people, and learn new things,” Dr. Clark says. “They should walk out of this weekend really excited to start that first day of fellowship instead of being scared.”
Residents about to embark on fellowships said they were excited with the opportunity.
“The hands-on expertise of the tutors and learning to do things the right way the first time is good,” says Francis Christian, MD, who will soon start a fellowship at the University of Oklahoma. “In different institutions, people do things different ways. It is good to see what other people are doing nationally.”
The Fellows Track Symposium attracted more than 200 fellows from around the world for 15 lectures and two breakout sessions on Friday and Saturday. The Student Scholars
Program is designed to introduce students to pulmonary, critical care, or sleep medicine so they might enter the field.
Jared Mereness, MS, a graduate student at the University of Rochester, says of the Student Scholars Program, “This is the one big meeting for our lab every year. This is the perfect space for what we do.”
Resident Boot Camp is supported by an educational grant from Olympus Corporation of the Americas. The RBC also received in-kind support from Ambu, AstraZeneca LP, BD, Boehringer Ingelheim Pharmaceuticals, Inc., CareFusion, Clement Clarke, Cook Medical,
LLC, ERBE USA, Inc., FUJIFILM SonoSite, Inc., Getinge, GlaxoSmithKline, Hill-Rom, MicroDi-rect, Monaghan Medical Corporation, Olympus Corporation of the Americas, Philips Respironics, ResMed, Smiths Medical, Teleflex, Teva Pharma-ceuticals, Verathon, and Vyaire Medical, Inc.
The Fellows Track Symposium is supported by educational grants from Actelion Pharma-ceuticals US, Inc., AstraZeneca LP, Boehringer Ingelheim Pharmaceuticals, Inc., FUJIFILM SonoSite, Inc., Genentech, GlaxoSmithKline, and Sunovion Pharmaceuticals, Inc.,. The FTS also received in-kind support from FUJIFILM SonoSite, Inc.
largely by one’s capabilities or traits, Prof. Heckman says. Cognitive capacities such as attention span and self-control are part of the picture. So are social and emotional skills and biological traits.
“Success in life has a heritability com-ponent,” he says. “But the role of heritabil-ity has been exaggerated both in popular notions and in public policy. DNA itself means nothing. It is how it is expressed that counts. And that expression is heavily influenced by environment, especially the family environment.”
Childhood cognitive scores can be predicted by maternal education levels and similar socioeconomic factors. So can adult education, income, health status, risk behaviors such as tobacco and drug use, in-volvement in criminal activities, and related measures.
Early childhood intervention doesn’t just improve lifetime outcomes for children. Helping children changes their own family dynamic for the better. Children who benefit from early intervention pass those socioeco-nomic gains on to their own offspring.
“The early years are very important times and places for lifetime success,” Prof. Heck-man says. “Public policy should act on those opportunities. Targeting early disadvantage is good public policy.”
OPENING CEREMONY Continued from page 1
ATS Recognizes Three Physician-Scientists
Three physicians were recognized Saturday during the Opening Ceremony for their contributions to pulmonary, critical care, and sleep
medicine. In addition, a Presidential Award was presented.
PUBLIC SERVICE AWARDMichelle Cloutier, MD, emeritus professor at the Departments of Pediatrics and Medicine at UConn Health in Connecticut, received the Public Service Award. She is founding di-rector of the Asthma Center
at Connecticut Children’s Medical Center and developed the Easy Breathing asthma manage-ment program for primary care physicians.
The award honors contributions to public health related to improvement of indoor and outdoor air quality, eradication of tobacco usage, prevention of lung disease, improved management of communicable respiratory diseases or improvement in the ethical delivery, and access to health care in areas related to lung diseases, sleep disorders, or critical care.
WORLD LUNG HEALTH AWARDSurendra K. Sharma, MD, PhD, head of the Department of Internal Medicine at All India
Institute of Medical Sci-ences, New Delhi, received the World Lung Health Award. He is a leader in the development of sleep apnea and tuberculosis treatment guidelines for India and tuberculosis guidelines for the World
Health Organization. The award recognizes contributions to im-
proving world lung health in the area of trans-lational or implementation research, delivery of health care, continuing education or care of patients with lung disease, or related political advocacy with a special emphasis on efforts that have the potential to eliminate gender, racial, ethnic, or economic health disparities worldwide.
JO RAE WRIGHT AWARD FOR OUTSTANDING SERVICE
Hallie Prescott, MD, MSc, an assistant professor at the University of Michigan and a staff physician at the VA Ann Arbor Health-care System, received the Jo Rae Wright Award for Outstanding Service. Her research work has focused
on sepsis survivorship. Dr. Wright was the first PhD scientist to head the ATS, an outstanding researcher, and an extraordinary educator.
The award is given in her memory and rec-ognizes a rising generation of individuals who have the potential to be scientific leaders.
PRESIDENTIAL AWARDA Presidential Award was presented to Dan Costa, ScD, and his colleagues at the U.S. Environmental Protection Agency’s Air, Climate, and Energy Re-
search Program in recognition of career-long achievements.
Dr. Costa has played an essential role coor-dinating EPA’s science policy with the scientific expertise of the ATS and the research commu-nity at large. The EPA research program that he leads has supported seminal research that has furthered the understanding of the links between air pollution and health. The science supported by Dr. Costa’s program, combined with EPA’s authority under the Clean Air Act, has led to vast improvements in our nation’s air quality.
More recently, his program has supported research on the health effects of climate change and the potential health co-benefits of taking immediate action on climate change.
Nicole ReedReston, Virginia“I have pulmonary hyper-tension. I am treated at NIH, so I’ve had excellent communication there, but with my family physician, that was more difficult. They had no idea what
was wrong, and I felt I was unheard, that my symptoms were written off as ‘It’s all in your head, you’re getting older, you’re out of shape.’ I never got the evaluations that would have discovered this earlier.”
Mary KitklowskiBaltimore, Maryland“I am a primary ciliary dyskinesia patient. There could be a little sensitivity at times. I have an asthma component to it, and the first pulmonologist I went to had me do a pulmonary
function test. I had to exhale for 12 seconds, and I kept coughing. The nurse said I was hav-ing trouble, and he said, ‘She’s obviously not trying hard enough.’”
Terrance WigginsAlexandria, Virginia“I lost a close family member to sarcoidosis. I don’t know that there were challenges, but in my uncle’s situation, it pro-gressed quickly. He was in the process of waiting
for a transplant, but the process was long and tedious, and maybe there could have been some changes there.”
Patient Perspectives
What challenges have you had in communicating with your health care professional?
Michelle Cloutier, MD
Dan Costa, ScD
Hallie Prescott, MD, MSc
Surendra K. Sharma, MD, PhD
Residents practice endotracheal intubation and other procedures during Saturday’s Resident Boot Camp.
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