program...regional program baltimore, md november 2, 019 asfa 2019 regional meeting speakers and...

REGIONAL MEETING

PROGRAM

THE JOHNS HOPKINS HOSPITAL IN BALTIMORE, MARYLANDBALTIMORE, MD | NOVEMBER 22, 2019

REGIONAL PROGRAM

BALTIMORE, MD | NOVEMBER 22, 2019

WELCOME FROM THE ASFA PRESIDENTOn behalf of the Board of Directors and myself, I would like to extend a warm welcome to the 6th Regional Meeting of the American Society for Apheresis at The Johns Hopkins Hospi-tal in Baltimore, Maryland. I would like to take this opportunity to thank the Regional Meeting Organizing Committee, led by Parvez Lokhandwala, MD, PhD, for their hard work in planning a fantastic program for you.

The meeting program offers a full day of exciting education-al and networking opportunities in apheresis medicine that will appeal to all apheresis prac titioners. We are pleased to introduce a new session this year, Session 4: Vascular Ac-cess New Approaches, which will highlight three 15-minute presentations about novel approaches to improving apher-esis venous access, including Powerflow, ultrasound guided PIV access, and single needle platforms for apheresis. Fol-lowing these presentations, there will be case studies pre-sented to the group for discussion.

I encourage you to take advantage of networking opportuni-ties at the meeting. Please seek out members of the Regional Meeting Organizing Committee, other ASFA members, and the ASFA Registration Desk to find out about the benefits of ASFA membership, and how you can become more involved in the society.

I must also men tion the expertise and tireless effort provided by the ASFA Head Office staff. Finally, I want to extend our thanks to our exhibitors and our hosts at The Johns Hopkins Hospital who helped make this Regional Meeting possible. I hope you en joy the 6th ASFA Regional Meeting and look forward to future regional meetings.

Sincerely,

YanYun Wu, MD, PhD, QIA

President, American Society for Apheresis

WELCOME FROM THE ASFA REGIONAL MEETING ORGANIZING COMMITTEEOn behalf of the ASFA Regional Meeting Organizing Commit-tee, we warmly welcome you to Johns Hopkins Hospital for the ASFA Regional Meeting. The Organizing Committee has put together a one-day program of didactic and interactive sessions intended to appeal to all apheresis practitioners. We are very excited about this educational and networking op-portunity. We look forward to your participation!

We thank the Johns Hopkins Hospital, and the Department of Pathology of Johns Hopkins University School of Medicine, for allowing us to use their facilities for this meeting.

Sincerely,

Parvez M. Lokhandwala, MD, PhD

2019 Regional Meeting Organizing Committee Chair Medical Director, Apheresis ServiceDepartment of Pathology, Johns Hopkins University School of Medicine

REGIONAL MEETING

THE JOHNS HOPKINS HOSPITAL IN BALTIMORE, MARYLANDwww.apheresis.org

GENERAL INFORMATION

TARGET AUDIENCE

The target audience for this program is physicians, scientists and allied health professionals working in apheresis, includ-ing but not limited to pathology, hematology, immunology, ne-phrology, pediatrics and rheumatology.

LEARNING OBJECTIVES

After participating in this CME activity, participants should be able to:

• Describe the general practice of apheresis medicine and its role in the treatment of diseases in a variety of organ systems

• Describe the emerging field of personal cellular therapy and the importance of good manufacturing practices in the manufacturing of these products

• Describe current knowledge of cellular therapy• Assess the limitations, advantages and technical

aspects of new apheresis instruments along with best practices on the use of central venous catheters for apheresis procedures in children and adults

ACCREDITATION AND DESIGNATION OF CREDIT

Please complete the online evaluation and credit request that will be sent to you via email post-conference to obtain your respective credit certificates.

CONTINUING MEDICAL EDUCATION CREDIT INFORMATION

This activity has been planned and implemented in accor-dance with the accreditation requirements of the Washington State Medical Association through the joint providership of Providence Health Care and the American Society for Apher-esis. Providence Health Care is accredited by the WSMA to provide continuing medical education for physicians.

Providence Health Care designates this live activity for a maxi-mum of 7.5 AMA PRA Category 1 Credit(s) ™. Physicians should claim only the credit commensurate with the extent of their par-ticipation in the activity.

This activity meets the criteria for up to 7.50 hours of Category I CME credit to satisfy the relicensing requirements of the Washington State Medical Quality Assurance Commission.

CEUCEUs have been approved by ASFA along with the California Board of Registered Nursing. A maximum of 7.50 CEUs can be earned through this educational activity (ASFA Provider Number CEP 14122). Completion of the online evaluation sur-vey is required for all conference delegates which, upon com-pletion, will allow you to receive your CEU credits. This survey must be completed within one month after the meeting in or-der to receive your credits. Electronic CEU certificates will be e-mailed within 4-6 weeks following the meeting.

CMLEThis continuing medical laboratory education activity is recog-nized by the American Society for Clinical Pathology (ASCP) as meeting the criteria for a maximum number of 7.50 CMLE credits. ASCP CMLE credit hours are acceptable to meet the continuing education requirement for the ASCP Board of Registry Certification Maintenance Program. (ASFA Provider Number 261-12-11). Completion of the online evaluation survey is required for all conference delegates which, upon comple-tion, will allow you to receive your CMLE credits. This survey must be completed within one month after the meeting in or-der to receive your credits. Electronic CMLE certificates will be e-mailed within 4-6 weeks following the meeting.

REGIONAL PROGRAM


ASFA 2019 REGIONAL MEETING SPEAKERS AND FACILITATORS

SPEAKERSJoseph Schwartz, MD, MPH, Columbia University, New York, NYJohn Tisdale, MD, National Institute of Health Medical Center, Chevy Chase, MDCourtney E. Lawrence, MD, MS, Johns Hopkins Hospital, Baltimore, MDParvez M. Lokhandwala, MD, PhD, Johns Hopkins Hospital, Baltimore, MDRobert A. Brodsky, MD, Johns Hopkins Hospital, Baltimore, MDLaura Connelly Smith, MBBCh, DM, Seattle Cancer Care Alliance, Seattle, WAWalter Linz, MD, MBA, BaylorScott and White Health, Temple, TXJeffrey L. Winters, MD, Mayo Clinic College of Medicine, Rochester, MN Don L. Siegel, MD, PhD, University of Pennsylvania, Philadelphia, PAAndrew Fesnak, MD, University of Pennsylvania, Philadelphia, PAVictor Lemas, PhD, Johns Hopkins Hospital, Baltimore, MDJill Adamski, MD, PhD, Mayo Clinic Hospital, Phoenix, AZSonja Vozniak, RN, BSN, Johns Hopkins Hospital, Baltimore, MD

FACILITATORSJill Adamski, MD, PhD, Mayo Clinic Hospital, Phoenix, AZParvez M. Lokhandwala, MD, PhD, Johns Hopkins Hospital, Baltimore, MDAaron Tobian, MD, PhD, Johns Hopkins Hospital, Baltimore, MDMargaret Hannan, BS, MSM/OL, CQA, Blood Bank of Delmarva, Newark, DEJeffrey L. Winters, MD, Mayo Clinic College of Medicine, Rochester, MN Alicia Garcia, RN, HP(ASCP), Canventa Life Sciences, Emeryville, CAKamille West, MD, National Institute of Health Medical Center, Chevy Chase, MDLaura Connelly Smith, MBBCh, DM, Seattle Cancer Care Alliance, Seattle, WASonja Vozniak, RN, BSN, Johns Hopkins Hospital, Baltimore, MD

ASFA 2019 REGIONAL MEETING ORGANIZING COMMITTEE

CHAIRParvez M. Lokhandwala, MD, PhD, Johns Hopkins Hospital, Baltimore, MD

PLANNING MEMBERSAaron Tobian, MD, PhD, Johns Hopkins Hospital, Baltimore, MDDavid Oh, MD, Hoxworth Blood Center, Cincinnati, OHJoseph Schwartz, MD, MPH, Columbia University, New York, NYKamille West, MD, National Institute of Health Medical Center, Chevy Chase, MDMargaret Hannan, BS, MSM/OL, CQA, Blood Bank of Delmarva, Newark, DESonja Vozniak, RN, BSN, Johns Hopkins Hospital, Baltimore, MDWalter Linz, MD, MBA, BaylorScott and White Health, Temple, TX

EDUCATIONAL GRANTS

American Society for Apheresis wishes to recognize and thank the following companies for their ongoing support through educational grants:

• Mallinckrodt Pharmaceuticals• Terumo BCT


REGIONAL MEETING

PROGRAM SCHEDULE

MORNING SESSION6:00am – 7:00am Exhibitor Setup

7:00am – 8:00am Breakfast and Registration

8:00am – 8:05am WELCOME REMARKS FROM ASFASpeaker: Joseph Schwartz, MD, MPH, ASFA Immediate Past-President

8:05am – 8:10am WELCOME REMARKS FROM JOHNS HOPKINS HOSPITALSpeakers: Parvez M. Lokhandwala, MD, PhD, Aaron Tobian, MD, PhD, & Sonja Vozniak, RN, BSN

Session 1: Sickle Cell Disease – Red Cell Exchange & BeyondModerator: Aaron Tobian, MD, PhD

8:10am – 8:40am KEYNOTE LECTURE: TOWARDS CURATIVE THERAPIES FOR SICKLE CELL DISEASESpeaker: John Tisdale, MD

8:40am – 9:05am FINDING THE RIGHT TARGETS IN RED CELL EXCHANGESpeaker: Courtney Lawrence, MD, MS

9:05am – 9:30am DEPLETION-EXCHANGE & PLASMA-TO-RED CELL EXCHANGESpeaker: Parvez M. Lokhandwala, MD, PhD

9:30am – 9:55am BMT FOR SCD – WHAT ARE THE OPTIONS? IS HAPLOIDENTICAL THE ANSWER?Speaker: Robert A. Brodsky, MD

9:55am – 10:15am LIFE AS A THALASSEMIA MAJOR PATIENTSpeaker: Mr. Khaled Alhegelan

10:15am – 10:45am Break

Session 2: Hot Topics in Apheresis Moderator: Joseph Schwartz, MD, MPH

10:45am – 11:10am THE ASFA GUIDELINES 2019 – WHAT IS NEW?Speaker: Laura Connelly-Smith, MBBCh, DM

11:10am – 11:35amTELEMEDICINE AND THERAPEUTIC APHERESIS: INTRODUCTION AND PRACTICE IMPLICATIONS

Speaker: Walter Linz, MD, MBA

11:35am – 12:00pm THE ROLE OF PLASMA EXCHANGE IN VASCULITISSpeaker: Jeffrey L. Winters, MD

12:00pm – 1:00pm Lunch


REGIONAL PROGRAM

AFTERNOON SESSION

1:00pm – 2:00pm

ROUND TABLE DISCUSSION Moderator: Walter Linz, MD, MBA

1. TPE – Jill Adamski, MD, PhD

2. Procedural Targets (FCR and HCTs) for RBCX Procedures – Parvez M. Lokhandwala, MD, PhD

3. Blood for RBCX Patients – Regular vs Rh/Kell Matching, vs Extended Phenotypic Matching – Aaron Tobian, MD, PhD

4. Donor Apheresis – Margaret Hannan, BS, MSM/OL, CQA

5. LDL-Apheresis – Jeffrey L. Winters, MD

6. Pediatric Apheresis – Alicia Garcia, RN, HP(ASCP)

7. Autologous Stem Cell Collections with SCD Patients – Kamille West, MD (NIH)

8. ECP – Laura Connelly-Smith, MBBCh, DM

9. Cellular Collections in Small Children – Sonja Vozniak, RN, BSN

2:00pm – 2:30pm Break

2:30pm – 3:30pm Exhibitor Move-Out

Session 3: Cellular TherapyModerator: Jill Adamski, MD, PhD

2:30pm – 2:55pm MNC COLLECTION FOR CAR-T CELLS: HOW IT ALL STARTED Speaker: Don L. Siegel, MD, PhD

2:55pm – 3:20pm CHALLENGES WITH MNC COLLECTIONS FOR CAR-TSpeaker: Andrew Fesnak, MD

3:20pm – 3:45pmTHE CELLULAR THERAPY LABORATORY PERSPECTIVE – WHAT DOES THE APHERESIS PRACTITIONER NEED TO KNOW

Speaker: Victor Lemas, PhD

Session 4: Vascular Access: New Approaches and Q&AModerators: Alicia Garcia, RN, HP(ASCP) & Margaret Hannan, BS, MSM/OL, CQA

4:00pm – 4:15pm APHERESIS IV PORT: IMPLEMENTATION AND PERFORMANCESpeaker: Jill Adamski MD, PhD

4:15pm - 4:30pm ULTRASOUND-GUIDED PERIPHERAL VENOUS ACCESSSpeaker: Sonja Vozniak, RN, BSN

4:30pm – 4:45pm SINGLE-NEEDLE ADAPTORSSpeaker: Parvez M. Lokhandwala, MD, PhD

4:45pm – 5:00pm VASCULAR ACCESS NEW APPROACHES Q&A

5:00pm – 5:15pm SUMMARY & CLOSING REMARKSSpeakers: Parvez M. Lokhandwala, MD, PhD; Aaron Tobian, MD, PhD; & Sonja Vozniak, RN, BSN


REGIONAL MEETING

SPEAKER PRESENTATION SUMMARIES KEYNOTE LECTURE: TOWARDS CURATIVE THERAPIES FOR SICKLE CELL DISEASEJohn Tisdale, MD

Dr. Tisdale will summarize current efforts to cure sickle cell disease using hematopoietic stem cells either from family donors or from patients after their genetic manipulation.

FINDING THE RIGHT TARGETS IN RED CELL EXCHANGECourtney Lawrence, MD, MS

Trial data has focused on the impact of chronic transfusion therapy on primary and secondary stroke prevention in patients with sickle cell disease. The role of regular transfusions in preventing other debilitating sickle cell complications is an increasing area of interest. Little evidence exists to support specific transfusion parameters for these patients, particularly when using an automated red cell exchange modality. We will discuss how patient comorbidities influence goals of transfusion and how transfusion strategies can be adjusted to achieve optimal clinical outcomes while minimizing procedural burden on both patients and the donor blood supply.

DEPLETION-EXCHANGE & PLASMA-TO-RED CELL EXCHANGEParvez M. Lokhandwala, MD, PhD

Speaker will talk about the two modifications to conventional red cell exchange procedures. Depletion-Exchange is a modified red cell exchange procedure, which improves efficiency of exchanges and can result in reduced blood utilization, or increased interval between the procedures. Speaker will talk about the indications and limitations of depletion exchange procedures. Plasma-to-red cell exchange procedure is a uniquely modified procedure that allows one to remove plasma while simultaneously replacing with red cells. This procedure allows for rapid euvolemic transfusions of red cells to patients that are volume intolerant. Dr. Lokhandwala will summarize 7-years of experience in performing these procedures at Hopkins.

BMT FOR SCD – WHAT ARE THE OPTIONS? IS HAPLOIDENTICAL THE ANSWER?Robert A. Brodsky, MD

This session will discuss curative treatment options for sickle cell disease. Presentation will discuss advantages and disadvantages of bone marrow transplantation, gene therapy and genome editing.

THE ASFA GUIDELINES 2019 – WHAT IS NEW?Laura Connelly-Smith, MBBCh, DM

For over 30 years, the American Society for Apheresis (ASFA) has published practice guidelines on the use of therapeutic apheresis in the Journal of Clinical Apheresis (JCA) Special Issue. These guidelines are periodically reviewed with the addition of new indications, retirement of some former indications and the provision of updated recommendations for current indications based on new published literature. During the last 12 years, updated guidelines have been published every 3 years to provide a reflection of current evidence-based apheresis practice. Recently, the eighth special issue was published. Significant updates and changes to the last edition are discussed here today.

TELEMEDICINE AND THERAPEUTIC APHERESIS: INTRODUCTION AND PRACTICE IMPLICATIONSWalter Linz, MD, MBA

At the macro level, health outcome risk sharing, regulatory mandates and general revenue pressure have encouraged healthcare organizations to consolidate and seek operational efficiencies. Simultaneously, information and telecommunication technology are faster, less expensive and evermore readily available given numerous technical advances. The need for healthcare efficiency tethered to better outcomes and the potential opportunity of use of these advanced telecommunication and information technologies has energized development of working telemedicine models that seek to eliminate the cost associated with distance and medical staffing models allowing immediate access to specialist care and complex services. Tele-stroke, Tele-ICU and Tele-radiology are recognized successful applications. As the technologies and pressures are ubiquitous, Apheresis medicine practitioners also have an opportunity to develop practice models that can make apheresis practice more readily available and of greater value to the organizations


REGIONAL PROGRAMand patients they serve. This presentation is intended to introduce Telemedicine concepts and review implications for evolving apheresis practice models.

THE ROLE OF PLASMA EXCHANGE IN VASCULITISJeffrey L. Winters, MD

Vasculitis is a term that is used to describe a broad group of disorders characterized by vascular inflammation. In many of these disorders, this is the result of the deposition of antibodies and immune complexes within vessel walls of arteries and veins of varying sizes. The vessels involved vary depending upon the disease. Signs and symptoms, while due to a common pathology, can be pleomorphic depending upon the organ(s) involved. This session will describe the pathophysiology, signs and symptoms, and role of plasma exchange in the treatment of these disorders. Those entities described in the ASFA guidelines will be discussed in this session with special attention to ANCA-associated vasculitides (microscopic polyangiitis, granulomatosis with polyangiitis, eosinophilic granulomatosis with polyangiitis, and renal limited vasculitis) and possible changes in practice looming on the horizon related to the PEXIVAS trial. Available published data from the PEXIVAS trial will be reviewed.

MNC COLLECTION FOR CAR-T CELLS: HOW IT ALL STARTEDDon L. Siegel, MD, PhD

Our understanding of basic principles governing how cells of the immune system interact combined with novel gene transfer approaches applied in the laboratory have led to exciting new strategies for enhancing natural cell functions in order to create personalized cell-based therapies for cancer and other disorders. In particular, the ability to turn a patient’s T lymphocytes into chimeric antigen receptor-expressing T cells (CAR-Ts) has led to the creation of “serial killer cells” that are engineered to destroy that patient’s malignancy in a rapid, decisive, and durable manner. For these new therapeutic approaches to be at all possible, mononuclear cell collections performed by apheresis is critical in order to provide patient “raw material” for drug manufacture. This presentation will review the chronology of many of the steps that took place that eventually led to the approval by the FDA of the first genetically modified cell therapy in the United States.

CHALLENGES WITH MNC COLLECTIONS FOR CAR-T Andrew Fesnak, MD

This presentation aims to provide the audience with insight into how patient and collection variability impacts downstream CAR-T cell manufacturing. We will begin by discussing the basic elements of the autologous engineered T cell manufacturing cycle. Then we will review the mechanisms of apheresis cell separation with a special focus on elements that could differ from patient to patient. We will then discuss pre-collection and collection parameters that may impact circulating cell frequency. We will review Penn’s experience in patient to patient and collection to collection variability. Finally, we will describe how variability impacts downstream manufacturing and what potential mitigation strategies may effectively standardize these processes.

THE CELLULAR THERAPY LABORATORY PERSPECTIVE – WHAT DOES THE APHERESIS PRACTITIONER NEED TO KNOW Victor Lemas, PhD

Successful collection, processing and shipping of apheresis products for CAR-T manufacture relies on the coordinated efforts of the apheresis and laboratory teams. This session will focus on practical logistics between the groups, beginning with site qualifications. What training or documentation can you expect a sponsor or company to provide? How extensive is the sponsor’s site qualification audit? Workflow topics such as scheduling, labeling and product testing, will be discussed along with approaches for handling products that are de-identified prior to shipment. Efficient communication between the collection, laboratory and clinical teams helps to ensure that each patient has the opportunity for treatment using this novel immunotherapy.


REGIONAL MEETING

APHERESIS IV PORT: IMPLEMENTATION AND PERFORMANCE Jill Adamski, MD, PhD

Patients requiring chronic apheresis treatments usually do not have sufficient peripheral venous access to support long term therapy. Historically, central venous tunneled catheters, septum-bearing subcutaneous ports and fistulas were used to obtain required blood flow rates for apheresis procedures. In 2017, the FDA approved the first intravascular device specifically designed for apheresis therapy, the PowerFlow Implantable Apheresis IV Port. This device can be used for all apheresis therapies due to its capacity for high flow rates, >100 ml/min. The unique design of this port poses some challenges for implementation and training. However, with good communication and planning, the PowerFlow can be safely integrated into the apheresis practice.

ULTRASOUND-GUIDED PERIPHERAL VENOUS ACCESSSonja Vozniak, RN, BSN

Our apheresis center’s performance improvement goal is to decrease the use of ventral venous catheters in TPE and RBCX patients. In order to accomplish this goal we purchased an ultrasound. I will discuss our experience implementing the use of ultrasound guided IV access and the many lessons we have learned.

SINGLE-NEEDLE ADAPTORSParvez M. Lokhandwala, MD, PhD

Speaker will talk about using a Y-shaped adapter that allows an apheresis operator to convert a conventional double-needle procedure to a single-needle procedure. Advantages and disadvantages of using this single-needle adapter for TPE and RBCX procedures will be discussed.


REGIONAL PROGRAM

NOTES:


REGIONAL MEETING

ASFA MEMBERSHIP ASFA membership is available to all professionals who are actively involved in apheresis medicine. As a member of ASFA, you are part of a network of professionals in the field of apheresis. ASFA members are encouraged to actively participate in the leadership of the Society by joining ASFA Committees that are working to advance apheresis-re-lated education, research, and advocacy initiatives.

MEMBERSHIP BENEFITS:

• Electronic Subscription to the Journal of Clinical Apheresis. Members will receive six (6) issues of the journal in electronic format. Members save up to $421

• Free Registration for Educational Webinars. Members save up to $525• Reduced Rates for the ASFA Annual Meeting. Members save up to $230• Reduced Rates for Educational Resources and Materials. Members save up to 40% on ASFA publications• TOTAL POTENTIAL SAVINGS OF UP TO $1176

ADDITIONAL BENEFITS:

• Subscription to the member-only ASFA Newsletter• Access to the member-only Facility Directory• Access to the member-only ASFA Discussion Forum• Subscription to the ASFA Newsflash• Option to participate in ASFA Committees• Option to participate in the ASFA Journal Club

Please note that ASFA membership runs from January 1 to December 31.

REGISTER NOW: WWW.APHERESIS.ORG/JOIN_ASFA

MEMBERSHIP REFERRAL PROGRAM

ASFA relies on its members to advance the Society’s mission. Growing the ASFA membership helps advance apher-esis medicine for patients, donors and practitioners through education, evidence-based practice, research and advocacy.

• REFER ONE NEW MEMBER AND RECEIVE 50% OFF YOUR NEXT RENEWAL. • REFER TWO OR MORE NEW MEMBERS AND YOUR NEXT RENEWAL IS FREE!

Login at www.apheresis.org. Under the heading My Profile, click on Refer a Friend to start sending out referrals. ASFA will review your referrals and provide a discounted renewal invoice by November 30th.

START REFERRING TODAY!

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