Workshop:

The Future Directions in Regulatory Science with

Focus on Regulatory Intelligence Gathering and

Education – How to stay current on trends and events

Thursday 21 April 2016

Biopeople, University of Copenhagen

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Invitation to Workshop:

WHAT: Workshop on the Future Directions in Regulatory Science with Focus on Regulatory

Intelligence Gathering and Education – How to stay current on trends and events

WHEN: Thursday 21 April 2016, 8:30-15:30

WHERE: Biopeople, Faculty of Health and Medical Sciences, University of Copenhagen,

Auditorium 3, Universitetsparken 2, DK-2100 Copenhagen, Denmark

Biopeople and the Copenhagen Centre for Regulatory Science is hosting this workshop in

collaboration with the International Center for Regulatory Science, University of Southern

California (USC), School of Pharmacy, USA, to share knowledge between academic and

industrial professionals in regulatory science. USC is bringing a group of five faculty and 14

senior experienced doctoral students from the US pharmaceutical and medical device

industry. The workshop will include presentations from both the US perspective and the

European perspective on regulatory intelligence gathering and education, and it will include

interactive discussions on the subject matter. The workshop will also provide the opportunity

for the Danish participants to meet and greet with the US Colleagues. Topics that will be

discussed include Benefit-Risk Assessment and Management, Quality Issues and Metrics

(Manufacturing), data integrity and sharing, and as for Education and Training, the

Multifaceted Approaches to Stakeholders, Skill sets and Harmonization.

The workshop participants are invited to the following Danish Beer Reception 15:30-17:00

hosted by USC International Center for Regulatory Science.

Biopeople contact: Dr. Per Spindler, pesp@biopeople.ku.dk

International Center for Regulatory Science contact: Dr. Nancy Pire-Smerkanich,

piresmer@usc.edu; and Dr. Michael Jamieson, mjamieso@usc.edu

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Program:

8:30-9:00 Registration and coffee

9:00-9:30 Opening Remarks

• Dr. Per Spindler, Biopeople, University of Copenhagen, Denmark

• Dr. Nancy Smerkanich, International Center for Regulatory Science, School of Pharmacy at the

University of Southern California, USA

• Dr. Christine Erikstrup Hallgreen, The Copenhagen Centre for Regulatory Science, University of

Copenhagen, Denmark

9:30-12:00 Benefit Risk Framework, Quality and Data Integrity / Session chair: Dr. Per Spindler

9:30-10:30 Status and challenges in Europe

• Ms. Merete Schmiegelow, Novo Nordisk A/S, Denmark

• Prof. Marie L De Bruin, Utrecht University, Netherland

• Prof. Timo Minssen, University of Copenhagen, Denmark

10:30-11:30 Status and challenges in the US - International Center for Regulatory Science, School of

Pharmacy at the University of Southern California, USA

• Dr. Nancy Smerkanich

• Dr. Frances Richmond

• Dr. Michael Jamieson

11:30-12:00 Q&A and Morning panel discussion

12:00-13:00 Lunch

13:00-15:30 Training and Education, Patient Training and Engagement / Session chair: Dr.

Michael Jamieson

13:00-13:25 European perspectives on education

• Prof. Ole Jannik Bjerrum, University of Copenhagen, Denmark

13:25-13:50 Possibilities and challenges in patient engagement

• Dr. Birgitte Bruun, Post doc at the Department of Anthropology, University of Copenhagen

13:50-14:15 European perspectives on patient training and engagement

• Dr. Niels Westergaard, Biopeople, University of Copenhagen, Denmark

14:15-15:00 US Perspectives

• Dr. Frances Richmond, International Center for Regulatory Science, School of Pharmacy at the

University of Southern California, USA

15:00-15:30 Q&A and Afternoon panel discussion

15:30 -17:00 Reception hosted by USC International Center for Regulatory Science at

Biopeople’s premises

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BIOS OF WORKSHOP FACULTY:

University of Southern California, International Center for Regulatory Science:

Frances Richmond, PhD, is currently Director of Regulatory Science Programs and Professor of

Clinical Pharmacy in the Titus Family Department of Clinical Pharmacy and Pharmaceutical Economics

and Policy in the School of Pharmacy. She comes to USC from Queen’s University, where she was

Professor and Director of the Medical Research Council in Sensory-Motor Neuroscience. Dr.

Richmond’s research interests have included both basic and applied studies of movement systems.

She is conducting animal and clinical trials of implantable devices and consults on regulatory aspects

of medical product development. She is currently directing Program of certificate, Master’s and

Doctorate programs in Regulatory Science at the University of Southern California. Her current

interests are focused on the regulatory and clinical management of new product development in

biomedical areas.

Michael Jamieson, DRSc, is currently the Associate Director of the International Center for

Regulatory Science and an Assistant Professor, Clinical Pharmacy. Dr. Jamieson joined the faculty of

the University of Southern California (USC) School of Pharmacy in 2008 after spending twenty five

years in the pharmaceutical, biologics and medical device industry. He has been teaching in the

Regulatory Science Program at USC since its inception in 2000, first as a guest lecturer from 2000 to

2007 and then as the Associate Director of the Regulatory Sciences Programs from 2008-2010. He is

currently the Associate Director of the International Center for Regulatory Sciences and an Assistant

Professor in the Titus Family Department of Clinical Pharmacy and Pharmaceutical Economics and

Policy. Dr. Jamieson received his Master's from the University of Southern California in 2008 and was

in the first graduating class of the Doctorate of Regulatory Sciences in 2011. Dr. Jamieson's research

interests include the regulatory support of university based researchers and the development of a

new model for conducting joint research projects between industry/not for profits and universities.

The title of his doctoral dissertation was "The Role of Universities in the Development of Medical

Products: A Survey of Industry Views" which looked at what the medical products industry in the US

industry sees as the impediments to working with universities on joint research projects and the

development of new products and how best to improve the current model. Dr. Jamieson is also the

Co-Founder/ Director of Clinical and Regulatory Affairs for Artenga Inc., a university spin off that has

developed a drug delivery system which improves the efficacy of chemotherapy drugs and provides a

platform to deliver larger sized molecules across the blood brain barrier.

Nancy Smerkanich, DRSc is an Educational Liaison at the International Center for Regulatory Science,

School of Pharmacy at the University of Southern California (USC). Dr. Smerkanich recently

completed her doctorate in Regulatory Science on the topic of Benefit-Risk Frameworks. She

continues to provide regulatory guidance to her academic and industry peers. In her role at USC, she

brings many years of practical regulatory knowledge and experience to academia. As the former

(Executive) Vice President of Global Regulatory Affairs at Octagon Research Solutions, and a senior

Consultant in Regulatory Affairs at Accenture, Ms. Smerkanich was responsible for advising sponsors

on regulatory filing strategy and submission development. With over 30 years of experience, Ms.

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Smerkanich has participated in all regulatory aspects of drug development,

having served as Regulatory Liaison, US Agent, and Global Regulatory Lead across all therapeutic

areas.

Daryl L. Davies, PhD, is Director of the Alcohol and Brain Research Laboratories and Associate

Professor of Clinical Pharmacy at the Titus Family Department of Clinical Pharmacy and

Pharmaceutical Economics & Policy at USC School of Pharmacy. Dr. Davies is also the Director of the

Master of Science, Management of Drug Development program. Dr. Davies earned his Bachelor and

Master Degrees in Biology at California State University, Dominguez Hills. His PhD training was

completed (1996) in the Department of Molecular Pharmacology and Toxicology at USC School of

Pharmacy. Dr. Davies dissertation focused on identification of critical targets (sites) of ethanol

(alcohol) action in the CNS and how alcohol alters brain function. Alcohol is the number one drug of

abuse in the United States with over 17 million persons adversely affected by alcohol. Currently the

sites and mechanism(s) of alcohol action are poorly understood. To address this issue, Dr. Davies’

laboratory focuses on identifying molecular sites (targets) of alcohol action in the CNS with the goal

of identifying specific targets at which therapeutically relevant pharmacological agents can be

directed to reduce social problems, loss of lives and tremendous economic costs resulting from the

misuse and abuse of alcohol. To accomplish this goal, Dr. Davies’ group utilizes molecular,

electrophysiological, biochemical, pharmacological, computational and behavioral techniques in their

alcohol investigations. The certificate program in Pre-Clinical Development was originally conceived,

in part, on Dr. Davies interest in regulatory issues that are related to drug discovery/drug

development and how these processes relate to each other in a successful drug development

program.

Gerald Loeb, MD received a B.A. (’69) and M.D. (’72) from Johns Hopkins University and did one year

of surgical residency at the University of Arizona before joining the Laboratory of Neural Control at

the National Institutes of Health (1973-1988). He was Professor of Physiology and Biomedical

Engineering at Queen’s University in Kingston, Canada (1988-1999) and is now Professor of

Biomedical Engineering and Director of the Medical Device Development Facility at the University of

Southern California (http://mddf.usc.edu). He has published over 250 journal articles and is an

inventor on 58 issued US patents. Dr. Loeb was one of the original developers of the cochlear implant

to restore hearing to the deaf and was Chief Scientist for Advanced Bionics Corp. (1994-1999),

manufacturers of the Clarion cochlear implant. That experience taught him how to go from

understanding the science to developing the technology to building the business model. Most of Dr.

Loeb’s current research is directed toward sensorimotor control of limbs – human arms, prosthetic

replacements and industrial robots – based on his prior physiological research into the properties

and natural activities of muscles, motoneurons, sensors and spinal reflexes. While participating in a

DARPA project on prosthetic arms, his research team at USC developed the first tactile sensor with

properties similar to a human fingertip. He and his students formed SynTouch

(www.SynTouchLLC.com) in 2008 to commercialize the BioTac® and Machine Touch® systems that

can identify materials based on their texture better than humans can. SynTouch was designated a

Technology Pioneer for 2014 by the World Economic Forum. Dr. Loeb has a long-standing interest in

minimally invasive electronic implants. He was one of the inventors of the Biochip RFID capsules now

commonly implanted in pets. That technology led his team to develop BION® injectable

neuromuscular stimulators, whose safety and efficacy were demonstrated in several pilot clinical

trials. When commercialization of this technology stalled in the US, he formed a joint venture with a

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leading medical device company in China. Dr. Loeb’s team at USC recently

developed a rechargeable cardiac pacemaker that is small enough to inject into a fetus while still in

the mother’s womb (now being tested in fetal sheep). Similar technology is being developed for a

pediatric and adult version that would avoid the complications associated with surgically implanted

endocardial pacemakers. Another spin-off company is in the discussion phase.

Sunita Babbar, MS, DABT, is currently Senior Director of Nonclinical Research and Development at

Revance Therapeutics, Inc. based in Newark, California. She has been over 18 years of experience in

small and large molecule nonclinical and clinical drug development. She has an extensive background

in toxicology/pharmacology/DMPK studies supporting screening, lead optimization, pre-clinical

development and clinical trials to meet US and EU regulatory requirements. Her expertise include:

non-clinical study design (general toxicology, safety pharmacology, reproductive toxicology,

carcinogenicity, genotoxicity and PK/ADME) and execution, data interpretation and reporting;

understanding of GLP regulations, FDA and ICH guidelines and experience in writing regulatory

documents such as NDAs, MAAs (leading to successful approvals in the US and the European Union)

INDs, IBs, Annual reports, White papers/Risk assessments, product labeling, clinical protocols and

interactions with the FDA; preparation for Advisory Committee meeting; expert placement and

monitoring of CROs, budget negotiation and project management; manage interactions with

corporate partners, review safety data for potential candidates for in-licensing and trouble-shoot

possible safety issues. Sunita was born in India and holds a Bachelor of Pharmacy degree from India.

She came to the US as a graduate student (Master of Science) in Pharmacology at School of

Pharmacy, Idaho State University. She is also a Board certified toxicologist.

Victor J. Gangi, MS, is Associate Vice President, Global Regulatory CMC Biologics, Genzyme/Sanofi.

With over 23 years of experience in the biopharmaceutical industry, Victor has managed teams and

developed effective strategies for successful product development and lifecycle maintenance of

global product portfolios for biologics, drugs, vaccines and medical devices. In addition to a practical

knowledge of all types of pharmaceutical product manufacturing processes, he has experience in

various drug delivery devices including syringes, autoinjectors and scaffolds (implants). Victor earned

a B.S. in Microbiology and an M.S. in Biology from the University of Massachusetts. Victor joined

Genzyme, a Sanofi company in 2012 as Sr. Director Regulatory Affairs CMC, leading the RA Site CMC

function for the Genzyme Biologics facilities in addition to regulatory management of the Genzyme

Biosurgery commercial and development product portfolio. He then transitioned to lead the Global

RA CMC function for the majority of the Genzyme commercial and development portfolio of biologic

products, as well as leading the regulatory aspects of the Consent Decree activities. Victor was

formerly the Director of Regulatory Affairs CMC at Wyeth Biopharma (Pfizer) responsible for leading

the function of registration and maintenance of biopharmaceutical, vaccine and device products.

Prior to Wyeth he was Associate Director of Regulatory CMC at Biogen Idec. Victor started his career

at the Food and Drug Administration where he held the positions of Biotechnology Specialist

Investigator in the New England District and Microbiologist in the FDA regional laboratory.

John Hartigan has been improving product quality and ensuring compliance to laws and standards

since 1989. He is a Quality & Regulatory professional whose many years of experience and multi-

disciplinary skills include a strong background in GXP operations, quality management systems, new

product development, and compliance activities for chemical, manufacturing, and software

processes in the biomedical industry. Mr. Hartigan holds a Master’s in Regulatory Science from Johns

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Hopkins University as well as an MBA from the University of Colorado with a

concentration in finance and electives in healthcare administration. He also holds a BS in Chemistry

from Sonoma State University and numerous certifications including: Certified Quality Engineer

(ASQ), Certified Software Quality Engineer (ASQ), Lead Auditor, ISO 9001:2008 with Emphasis on ISO

13485:2003 (BSI), and a Biomedical Regulatory Affairs certificate from the University of Washington.

Mr. Hartigan joined Philips Healthcare in 2009 and currently works as a Global Compliance Manager

within the Imaging Systems Quality and Regulatory group. His primary focus includes ongoing quality

initiatives and compliance oversight of Philips Healthcare Imaging Systems business units, worldwide.

The tenets of Mr. Hartigan’s business philosophy and success are founded on sincerity, respect for

others, and diplomatic resolve. His approach to achieving excellence in business relies on the

following strategic management techniques which include: competitive analysis and strategy,

building and managing core competencies, financial analysis, measuring performance, global

strategy, and building a learning organization. Mr. Hartigan maintains a strong commitment to health

and the biomedical industry. He is a member of the American Society for Quality (ASQ), the

Regulatory Affairs Professionals Society (RAPS), as well as the Organization of Regulatory and Clinical

Affairs (ORCA). His passions include family, fitness, and outdoor activities.

Michelle Mc Guinness is the Head, Compliance Strategy & Analytics, Janssen – Pharmaceutical

Companies of J&J. Previously she was at Veloxis where she brought 15+ years of experience in

regulatory, quality and compliance roles within the pharmaceutical industry. Prior to joining Veloxis,

Ms. Mc Guinness held the position of Senior Director of Regulatory Conformance at Mylan, where

she established the global regulatory conformance function and team, deployed global processes and

systems, and drove strategic regulatory, quality and compliance projects. Prior to joining Mylan, Ms.

Mc Guinness held various positions of increasing responsibility at PA Consulting, Accenture (formerly

Octagon Research Solutions), Sanofi, Liquent (a Paraxel company) and Ranbaxy Pharmaceuticals Inc.

Ms. Mc Guinness has participated in a number of joint industry-agency initiatives. She was awarded

the FDA Commissioner’s Special Citation for her contribution the development of the HL7 Structured

Product Labeling standard & FDA guidance. Ms. Mc Guinness holds an MSc in Quality

Assurance/Regulatory Affairs from the Temple University School of Pharmacy. She holds a BA in

Biology-Biotechnology from Kean University and is RAC-US certified. Ms. Mc Guinness is passionate

about supporting the rare diseases and orphan indication communities. She volunteers as a director

of the Southeastern PA Chapter of Huntington’s Disease Society of America (HDSA) and is a scientific

advisor for the CADASIL Association.

Nami Migita, MBA, MS, RAC is a Senior Manager, Regulatory Affairs, APAC at Thoratec Corporation,

the world leader in mechanical circulatory support with the broadest product portfolio to treat the

full range of clinical needs for patients suffering from advanced heart failure. She is based in

Pleasanton, CA and responsible for various regulatory affairs projects for the Asia-Pacific region. Ms.

Migita has over 18 years of experience in the global medical device and biopharmaceutical industries

based in Japan and the United States. She has performed leadership roles in marketing, project

management, and international regulatory affairs at various medical devices/biopharmaceuticals

companies, including AbbVie, Stryker, and Tyco Healthcare (now Medtronic). She also held the

position of Senior Vice President at Pacific Bridge Medical that exclusively services the medical

device, pharmaceutical, and in vitro diagnostics industries. Ms. Migita obtained a Bachelor of Arts

degree in Humanities at Wako University (Japan), a Master of Business Administration degree at

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Emory University, and a Master of Science degree in Bioscience Regulatory

Affairs from the Johns Hopkins University.

Penny Ng, MBA, MS, RAC is currently working as the Director in the Regulatory Affairs department at

Celgene Corporation, focusing on biologic and small molecules development in the hematology &

oncology areas. After obtaining her microbiology undergraduate degree from University of Toronto,

she worked at Connaught Laboratories (currently Sanofi Pasteur) in the Quality and Control, and

Research departments. Curious to understand the overall picture of biopharmaceutical product

development, she transferred to regulatory affairs in 1997. In 2000, Penny earned an MBA, majoring

in Finance from the Schulich School of Business, York University (Ontario, Canada) and received the

Regulatory Affairs Certificate from the Regulatory Affairs Professional Society. In 2010, she

completed a MS in Regulatory Affairs from San Diego State University, with a thesis on pediatric drug

development with a special focus on oncology. Over the last 18 years, she worked on CMC

submissions, IND/IDE/clinical trial applications, health authorities meetings (pre-IND to pre-sNDA,

Scientific Advice), pre-marketing applications (including Breakthrough Therapy Designation Request,

Fast-Track Designation Request, Proposed Pediatric Study Request, etc.), marketing applications,

post-marketing activities, and regulatory strategies for small molecules, biologics and combination

product in a global setting that spans the US, EU, Canada and APAC countries. She currently resides in

Lawrence Kansas with her husband and daughter. In her spare time, she loves to cook, play the

piano, paint, create imperfect but still beautiful pottery, and travel the world with family.

Raina Olexa, MS, RAC holds a Master of Science degree in Bioscience Regulatory Affairs from Johns

Hopkins University and Bachelor of Science degree in Biobehavioral Health, with a specialization in

Neuroscience, from Pennsylvania State University. Ms. Olexa has worked in the medical research and

pharmaceutical fields for over 15 years, gaining experience in pre-clinical, clinical and commercial

manufacturing aspects of the drug development lifecycle. At Drexel University College of Medicine,

Ms. Olexa conducted research to assess recovery of function in animal models of spinal cord injury.

From this pre-clinical position she moved into clinical and commercial drug manufacturing, working

in vaccine operations at Merck and biologic drug operations at Bristol Myers Squibb. After gaining

significant GMP experience, Ms. Olexa transitioned into clinical research supporting international

Phase I-IV clinical trials. She has held senior level quality assurance positions at Kendle International,

Optum and Quintiles, ensuring that clinical trials are conducted ethically and in accordance with

global regulations. Ms. Olexa serves as an adjunct professor for the graduate Regulatory Affairs

program at Northeastern University and the undergraduate Clinical Research program at University

of North Carolina, Wilmington. She is also the founder of Lakeside Regulatory, a non-profit

organization dedicated to empowering the public to engage in the regulatory process.

Darin Oppenheimer, MS is a Regulatory Affairs Director at Baxter Healthcare. Based in the Chicago

Area, Darin is involved in many facets of the Product Development Lifecycle including regulatory

submissions, due diligence, and active participation on industry trade organizations and standards

committees. Darin leads a team of regulatory professionals focusing on electromechanical devices

and software. His prior background as a Research and Development Scientist focused on

pharmaceuticals and medical device diagnostic applications for biomarker and drug discovery.

Darin’s undergraduate degree is in Molecular Biology from the University of Tampa. He also holds

two Masters Degrees from Johns Hopkins University in Biotechnology and Regulatory Science as well

as a graduate Certificate in Biotechnology Enterprise.

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Katherine St. Martin is a United States Military Academy graduate. She served

as an active duty Army intelligence officer in Germany including several developments to Baghdad,

Iraq. Upon honorable discharge as a Captain, she transitioned into a corporate regulatory

environment with Boston Scientific Cardiac Rhythm Management. While working as a Senior

Regulatory Specialist on class III medical devices, she pursued a Masters in Bioscience for Regulatory

Affairs from Johns Hopkins University. Her most recent regulatory experience is with Be the Match

operated by the National Marrow Donor Program (NMDP). NMDP is a growing non-profit

organization of over 1,000 employees, representing multiple stem cell product lines and extensive

product development prospective and observational research. The NMDP holds several

congressional contracts to facilitate unrelated stem cell donation for terminally ill cancer patients

and manages proprietary DNA-matching algorithms that search worldwide bio-repositories for the

best potential transplant matches. As the Regulatory Compliance Project Manager for NMDP, she

advises executive staff on the regulatory impact of biologic drug product development and business

process improvement related to both manufacturing and clinical trials.

Curtis Truesdale, MS, MSE, RAC is currently the Regulatory Affairs Franchise Head for Prostate Health

at Boston Scientific Urology and Pelvic Health (formerly American Medical Systems). He is based in

Minneapolis MN. Prior to his current role, he served as Director of Regulatory Affairs for the

Americas at Mölnlycke Health Care, a health care technology company headquartered in Gothenburg

Sweden. Other previous experience consists of a variety of regulatory affairs roles at companies

within the medical device industry, including Guidant Vascular Intervention (now Abbott Vascular),

Stryker Spine and CareFusion. He is also a former Review Scientist and Engineer at the FDA Center for

Devices and Radiological Health, Office of Device Evaluation. His combined FDA and industry

experience offers him a unique perspective on the commercialization of health care products. Curtis

is board certified by the Regulatory Affairs Professionals Society. He holds a Master of Science in

Bioscience Regulatory Affairs from Johns Hopkins University, Baltimore MD; a Master of Science in

Engineering, with a Biomedical Engineering concentration from The Catholic University of America,

Washington DC; and a Bachelor of Science in Electrical Engineering from North Carolina A&T State

University, Greensboro NC. He has also completed graduate coursework in the biomedical sciences

at Saint Louis University School of Medicine, St Louis MO.

James Turner, MS, RAC is a Regulatory Affairs Manager at GE Healthcare in Waukesha, WI. He

received his BS in Forensic Science from Michigan State University and MS in Quality Assurance/

Regulatory Affairs from Temple University. His 15+ years of experience is in various Quality and

Regulatory roles and spans the Pharmaceutical and Medical Device industries with his most recent

role focused on creating internal processes and procedures to meet the new Unique Device

Identification regulations and to help communication and implement the new UDI requirements

across the business. He has experience in quality investigations, quality system implementation,

acquisition due diligence and integration, R&D to production technology transfers, medical device

premarket authorizations, advertising, promotion & labeling approvals, and the development of new

processes and supporting IT solutions in an effort to meet new requirements or to simplify existing

practices. Mr. Turner is a member of the Regulatory Affairs Professional Society, served two terms on

the Regulatory Affairs Certification Board and is currently a member of the RAPS Annual Conference

Planning Committee. He enjoys spending time outside of work with his wife and young son, and can

often be found at the ice rink either officiating high school ice hockey or playing in a recreational ice

hockey league.

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Jennifer Wiley, M.S., RAC, is currently Associate Director of Regulatory Affairs

at Alder BioPharmaceuticals, Inc., based in Bothell, WA. She has over 10 years of regulatory

experience in the biopharmaceutical industry. In her current role she is responsible for developing

and implementing global regulatory development strategies for oncology and neurology monoclonal

antibody products manufactured in a yeast expression system. Jennifer earned a B.A. in Chemistry

from Smith College and a M.S. in Epidemiology from the University of Washington.

National Faculty:

Marie L De Bruin is an assistant professor at the division of Pharmacoepidemiology & Clinical

Pharmacology, Utrecht University (Netherlands). She was trained as a pharmacist and

epidemiologist. Her research focuses on pharmacoepidemiology in the drug regulatory setting and

pharmacovigilance. The main clinical areas are cardiovascular diseases and cancer. Dr. De Bruin is the

Scientific coordinator of the CARING (Cancer Risk and INsulin analoGues) consortium (EU-FP7 grant

282526) and PI on behalf of the UU two public private Escher projects 'Improving the EU system for

marketing authorization: Reviewing regulatory deficiencies and inefficiencies' and

'Pharmacovigilance of Biologics: Addressing the challenges of product and batch traceability in ADR

reporting'. She is the deputy team leader in the European Commission funded 'Study on the

regulation of advanced therapies in selected jurisdictions (20147306 RfS Chafea/2014/Health/24). As

liaison officer Marie L De Bruin coordinates the research collaboration between the dept. of

pharmacovigilance of the Medicines Evaluation Board and the division of Pharmacoepidemiology &

Clinical Pharmacology. She is a member of the steering group of the European Network of Centers for

Pharmacoepidemiology and Pharmacovigilance (ENCePP) and a board member of the Netherlands

Epidemiology Society. She was appointed by the European Commission as an independent scientific

expert of the Pharmacovigilance Risk Assessment Committee (PRAC) that meets monthly at the

European Medicines Agency in London.

Merete Schmiegelow, MSc Ph., Senior Director, Regulatory Policies and Intelligence, at Novo Nordisk

A/S and Honorary Industrial Ambassador in Regulatory Science at University of Copenhagen. Dr.

Schmiegelow has been with Novo Nordisk A/S since 1984 and she follows regulatory trends in EU, US,

ICH and WHO make company positions within areas of responsibilities, and influence the regulatory

environment within these regions including impacting legislation and guidelines in especially EU.

Responsible for Regulatory policies and Intelligence EU, USA, ICH and WHO covering drug

development as well as Life Cycle Management (LCM). Dr. Schmiegelow represents Novo Nordisk A/S

in various EU Trade Associations.

Timo Minssen is Associate Professor, Centre for Information and Innovation Law at University of

Copenhagen. His research concentrates on Intellectual Property-, Competition & Regulatory Law with

a special focus on (emerging) technologies in the pharma, life science & biotech sectors. His studies

comprise a broad variety of legal issues that become relevant during the lifecycle of related products

and processes - from the regulation of research and incentives for innovation to technology transfer

and commercialization. He is a frequent lecturer on a variety of topics with many invited

presentations at international IP expert symposia, major law firms, the Universities of Oxford &

Cambridge, Harvard Law School, MIT, and at the European Medicines Agency etc.. He has written 2

books and published more than 40 articles and book chapters in leading international publications,

such as Nature Biotech, PLoS-Computational Biology, Biotech. J., BLR, Person. Med., IIC, EIPR, ECLR,

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JIPLP, GRUR Int., Chi.-Kent J. Intell. Prop., IPQ, QMJIP, ERT, NIR & EUConst.LR.

He is also a regular contributor on Harvard Law School's "Bill of Health" blog and co-heads the

Copenhagen Biotech & Pharma Forum (CBPF).

Ole Jannik Bjerrum is Professor Emeritus in Experimental Pharmacology at University of

Copenhagen. His primary field of research is pharmacotherapies and prophylaxes of neuropathic

pain, animal pain models for monitoring of pain relieving effect of new compounds, the development

of in silico models for simulation of pharmacodynamics effects in pain treatment, faster drug

development through micro dosing and faster and improved registration of adverse drug reactions.

Prof. Bjerrum is involved in training programs such as pharmacology and toxicology for pharmacy and

pharmaceutical sciences students, Master of Industrial Drug Development and European Master of

Safety Sciences of Medicines (Innovative Medicines Initiative and EU). Prof. Bjerrum has been

instrumental in the establishment of European research policy for the pharmaceutical industry and

biotech including "New Safe Medicines Faster" and the Innovative Medicines Initiative.

Sukhwinder Singh Jossan, M.Sc. Pharm., PhD in Pharmacology, Associate Vice President, Global

Regulatory Affairs, Development Projects, Ferring Pharmaceuticals A/S. Dr. Sukhwinder has an

extensive research background with among others 25 original publications, as well as several

overview publications and abstracts. His background includes more than five years as a Research

Scientist with the Medical Pharmacology University of Uppsala in Sweden and several years with the

Swedish Medical Products Agency. He joined Ferring in 2001 as Director of Regulatory Intelligence

and has since had different positions within Regulatory Affairs. As of 2010 he has been Associate Vice

President within Global Regulatory Affairs with responsibility for development projects for all

therapeutic areas within Ferring. Ferring Pharmaceuticals is a research-driven, specialty

biopharmaceutical group active in global markets. The company identifies, develops and markets

innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology

and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its

products in 110 countries.

Niels Westergaard, PhD, Dr Pharm, is Manager at Biopeople, Denmark’s Life Science Cluster at

University of Copenhagen. Past affiliations include department Head at Novo Nordisk A/S, director of

Biology and member of the Management Group at Combio A/S, Senior Scientific Officer, Corporate

Licensing and Business Development at LEO Pharma A/S, and Program Director Metabolic and

Infectious Diseases at Santaris Pharma (now Roche). Dr. Westergaard is actively involved with patient

training and patient engagement activities in IMI projects such as the EUPATI.

Christine Erikstrup Hallgreen is Assistant Professor at the Copenhagen Centre for Regulatory Science

at University of Copenhagen.

Birgitte Bruun, PhD, is a post doc at the Department of Anthropology, University of Copenhagen,

where she works on an interdisciplinary research project on life with statins in Denmark. A focus in

her sub-project is processes of generating knowledge about medication and its possible side effects,

involving both researchers from different disciplines and statin users themselves. Birgitte holds an

MA in anthropology from the University of Copenhagen and a PhD from the London School of

Hygiene and Tropical Medicine. Her PhD thesis analyzes lay engagement in transnational medical

research in Zambia.

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Per Spindler, DVM, Executive MBA, MSc (Applied Toxicology), ERT, is Director

of Biopeople, Denmark’s Life Science Cluster at University of Copenhagen. Dr. Spindler has

professional international experience within safety sciences, regulatory sciences and affairs, project

management R&D and leadership in medicinal products, health & life sciences. Experiences include

Novo Nordisk, H. Lundbeck, the scientific committees of the European Medicines Agency, ICH, and

others. Dr. Spindler currently leads Denmark’s Life Science Cluster, Biopeople, which was the first Life

Science cluster in Europe that was awarded the Gold Label of the European Cluster Management

Excellence in recognition of excellent management performance. Dr. Spindler is a member of the

Scientific Advisory Board of the Copenhagen Centre for Regulatory Science (CORS), Board Member of

the DIA, and Chair of the European Cluster Excellence Expert Group (CEEG) of the European

Secretariat for Cluster Analysis (ESCA).

deltagerliste 21 april 2015 – workshop regulatory science

Aleksandra Bartosik University of Copenhagen Anna B. Almarsdottir University of Copenhagen Astrid E. Esparza Novo Nordisk Birgitte Bruun University of Copenhagen Birthe B. Holm Rare Diseases Denmark Budhesh Dhamija Novo Nordisk Camilla Bertelsen Novo Nordisk Christine E. Hallgreen University of Copenhagen Curtis D. Truesdale Boston Scientific Darin S. Oppenheimer Baxter Healthcare Daryl Davies USC School of Pharmacy Ella Loginova Jobseeker Emma Cheesman Leo Pharma Flemming Madsen University of Copenhagen Frances J. Richmond International Center for Regulatory Science Gerald E. Loeb USC Viterbi School of Engineering Gitte Borup Copenhagen Centre for Regulatory Science Ida Brorson Private James T. Turner Jr GE Healthcare Jannik Nielsen Novo Nordisk Jennifer R. Wiley Alder BioPharmaceuticals Jette Claville Biopeople John P. Hartigan Philips Heathcare Julie Siboni Novo Nordisk Katherine E. St. Martin National Marrow Donor Program Katrine Rasmussen Ferring Pharmaceuticals Kaur Damandeep Rambøll Laila Syed Ferring Pharmaceuticals Lukas Berchlukl Novo Nordisk Maiken G. Kongstad Novo Nordisk Marcus Schartau Novo Nordisk Marie L. de Bruin Utrecht University Merete Schmiegelow Novo Nordisk Mette Simonsen Novo Nordisk Michael Jamieson USC School of Pharmacy Michelle A. McGuinness Janssen Mingye Zhang Copenhagen University Nami Migita Thoratec Corporation Nancy Pire-Smerkanich USC School of Pharmacy Niels Westergaard Biopeople Nina Christiansen Leo Pharma

Nina Jordan Novo Nordisk Ole J. Bjerrum University of Copenhagen Patryk Hes University of Warsaw Per Spindler Biopeople, Denmark Life Science Cluster Pernille Jansen Novo Nordisk Pernille Warrer Novo Nordisk Pia N. Andersen ALK Raina Olexa Quality Assurance Stefan O. Hamad Jakob & Partners Stense Vestergaard University of Copenhagen Sunita Babbar Revance Therapeutics Susanne Kaae University of Copenhagen Susanne Kaae University of Copenhagen Susanne H. Rasmussen Novo Nordisk Susanne L. Rasmussen Novo Nordisk Sven Frokjaer University of Copenhagen Svetlana Petersen S & P Petersen Timo Minssen University of Copenhagen Torbjörn Callréus Danish Medicines Agency Vibeke Bjerregård Novo Nordisk Victor J. Gangi Genzyme Wai P. P. Ng Celgene Corporation