2017 Plasma Protein Forum Highlights

Following welcoming remarks from Jan M. Bult, PPTA President & CEO, the 2017 Plasma Protein Forum kicked off with a message from Mr. David Bell, Chairman of the PPTA Global Board of Directors. Mr. Bell noted the importance of educating patients, legislators, regulators, and the public on how safety & efficacy standards, donor compensation, and adequate reimbursement is necessary to ensure access to care for all who need it.

He called for everyone to help set the record straight against misperceptions about the plasma industry.

The theme of this year’s forum is evolution, as the PPTA marks its 25th Anniversary. Day One featured three sessions on the evolution in hemophilia therapies, viral safety, and the treatment of immune deficiencies.

The panel on hemophilia therapies began with a presentation from Glenn Pierce, M.D. on how treatments have changed over the past 60+ years and how those changes have affected the lives of patients in terms of health outcomes and quality of life. Professor Edward Tuddenham, M.D gave a synopsis of the progress and current status of gene therapies. Although this field has seen many groundbreaking and life-changing discoveries, many parts of the world still do not have access to therapies. Val Bias, CEO of the National Hemophilia Foundation shared the patient perspective and underscored how patient groups have played an important role in the evolution of how patients receive therapies. The speakers foresee the future of hemophilia care will include expanding access to care, raising treatment standards to improve patient outcomes, and innovative therapies that will ultimately lead to a cure.

Jay Epstein, M.D., kicked off the viral safety session with a history of regulatory oversight related to the plasma protein industry, much of which was shaped by the emergence of transmissible pathogens. A presentation from Jerry Holmberg, Ph.D. detailed how test development for pathogens has advanced over the past 30 years, and the future of testing blood and plasma is in multiplex assays. Similarly, there have been tremendous enhancements in manufacturing processes to eliminate pathogens, underscored by the remarks from Thomas Kreil, Ph.D.; going forward the industry will apply its plasma learnings to the processes for advanced therapy medicinal products. The cooperative efforts of industry, regulators, and patients have resulted in many improvements, however vigilance remains extremely important to ensure a safe environment for both patients and donors.

The final panel of Day One began with a historic overview of immune globulins and its uses from Mel Berger, M.D. Advances in understanding diseases have driven the evolution of therapies, and will continue to do so as more individuals are diagnosed with immune deficiencies and global access to care expands. Similar to the hemophilia community, endeavors by patient groups such as the Immune Deficiency Foundation shaped how patients access therapies. Marcia Boyle, IDF President & Founder, gave an overview of the organization’s activities and achievements since its 1980 creation, as well current and future endeavors. Day One wrapped up with a presentation from Professor Jennifer Puck, M.D., who gave a comprehensive overview of the development of the newborn screening test for Severe Combined Immunodeficiency and stressed the importance of best treatment protocols for diagnosed patients.

2017 Award Recipients

On Tuesday June 13, Chairman of the Global Board of Directors, David Bell, PPTA President & CEO Jan M. Bult, and North America Board member Bill Zabel presented five Lifetime Achievement Awards to individuals who have made substantial contributions in the field of plasma protein therapies. Their work embodies PPTA’s mission: to promote the availability of and access to safe and effective plasma protein therapeutics for all patients in the world. Each of these individuals has left an indelible mark on the lives of patients who rely on plasma protein therapies, and PPTA is delighted to recognize their contributions.

The recipients of the awards are:

  • John Bacich
  • Jay Epstein
  • Victor Grifols Roura
  • Bernard Horowitz
  • John Walsh

We were pleased to be joined by Ms. Linda Walsh, daughter of John Walsh, who accepted the award which posthumously honors her father’s contributions.

Day Two

PPTA’s Vice President of Source & International Affairs Joshua Penrod opened day two of the 2017 Plasma Protein Forum. He announced Mr. Roger Brinser as the newly elected Chairman of the Source Board of Directors. The Chairman gave an update on the state of the source plasma industry, noting that plasma collection is expanding both in the United States and in Europe, and Source committees are actively working on issues surrounding plasma vigilance, regulatory, and expansion projects.

Day Two featured panels on the evolution of source plasma collection and a discussion of current challenges facing the plasma industry. The panel on Source plasma collection began with a presentation from Göte Carlebjörk on how collection has changed since the inception of PPTA 25 years ago. He underlined how many of the changes have been patient-driven. Charles Auger spoke to how innovations such as computer systems, automated plasmapheresis, and advanced testing streamlined the plasma collection process, improving the experience for both centers and donors. Mr. Auger also introduced a new perspective on the relation between donors and plasma centers. The session concluded with a detailed overview of how plasma logistics have evolved from Michael Deem. Improvements in domestic & international transport, freezer storage, tracking systems, and technology have increased efficiency and substantially reduced losses in the plasma supply chain.

The final session of the 2017 Plasma Protein Forum featured PPTA experts who discussed current challenges facing the plasma industry. Jan M. Bult, PPTA President and CEO, discussed the need to collect more plasma in different parts of the world. Although many countries have increased plasma collection efficiency, distinct challenges remain worldwide, particularly in India and China. Mr. Bult pointed out the importance of increasing plasma collection in the rest of the world to globally improve access to safe and effective plasma protein therapies for patients. Larisa Cervenakova M.D., PPTA Medical Director, gave a presentation on Creutzfeldt - Jakob disease (CJD). She summarized the types of CJD and the industry’s recent statement on plasma protein product safety in response to two cases of sporadic CJD reported in the UK. George Schreiber, ScD, PPTA Director of Epidemiology, addressed source plasma safety. His talk highlighted industry efforts with respect to donor, manufacturing pool, and the fractionation process quality which result in safe, high quality plasma products. Dr. Schreiber presented compelling data on the impact of IQPP & QSEAL standards on reducing the risk of pathogen safety.

PPTA sincerely thanks our Sponsors & Exhibitors; Save the Date for the 2018 Plasma Protein Forum, June 12 – 13, at the Washington Marriott Georgetown in Washington, D.C.