2016 Plasma Protein Forum Highlights

Dr. Shari Ling, Deputy Chief Medical Officer, Centers for Medicare and Medicaid Services (CMS), delivered the Keynote opening up the 2016 PPF. Dr. Ling's remarks highlighted CMS's movement towards value based purchasing and quality based payment programs.

PPTA's Chairman of the Global Board of Directors, Mr. David Bell, delivered the Chairman's Message. Mr. Bell emphasized the importance of and dedication to safety and quality standards for plasma collection and plasma protein therapies. His call to action was to keep a focus on quality, supply, access, and best in class safety.

Professor Dr. Herold J. Metselaar delivered a talk on the role of the liver in plasma protein deficiencies. Professor Metselaar used the story of one patient with Haemophila B with HCV infection and showed how plasma protein therapies, hepatitis C treatment and a liver transplant resulted in a total cure. He then shared insights on the future of liver transplants.

The panel on Traceability under the Drug Supply Chain Security Act examined how plasma protein therapies are traced through the entire supply chain. The panel covered everything from law and regulatory issues to the design of enterprise resource planning systems, to wholesale distribution, to the specifics of packaging requirements.

Dr. Thomas Kreil presented the industry experience and evolution in pathogen safety issues. Though product safety is as high as it has ever been, the pathogen safety experts remain focused on new developments to ensure that patients will get safe therapies.

Mr. Jan M. Bult, PPTA’s President and CEO, presented Mr. Joe Rosen with a special industry recognition award for his four decades of dedication to the industry. In his remarks, Mr. Rosen asked that we remember that safety is central to this business, respect your regulators, appreciate your donors, keep pursuing access to all markets, update IQPP and QSEAL, be vigilant for emerging viruses, continue to invest in R&D, and, finally, respect one another.

The Patient Access: The A-PLUS Perspective panel examined key issues from the patient point of view. The panelists from a number of different organizations talked about newborn screenIng for severe combined immunodeficiency and efforts to get all 50 states to screen newborns and several issues that could have a negative impact on patient access to plasma protein therapies including preferred drug lists, federal regulation on patient premium assistance, and the proposed Medicare Part B Prescription Drug Model rule change. Also discussed were DME competitive bidding, specialty drug tiers, questions around biosimilars, and a change to the Medicaid pharmacy reimbursement methodology. Panelists noted that a common issue is that the patient voice is not being considered in these matters.

PPTA President and CEO Jan M. Bult and PPTA’s Chairman of the Global Board of Directors, Mr. David Bell, presented the Dr. Otto Schwarz award to Dr. Thomas Kreil.

PPTA’s Chairman of the Source Board of Directors, Mr. Shinji Wada, kicked off day two of the Plasma Protein Forum with an update on the state of the source plasma industry. Mr. Wada spoke to the unique environment in which the source plasma industry operates. He stated that PPTA’s Source priorities are donor health and safety, enhancement of the IQPP standards, increasing industry transparency and public awareness of the industry, increasing awareness of donor contributions, expanding and solidifying European activities, and continuing to assure the availability of high quality plasma.

The Evolving Technologies in Plasma Collection panel addressed opportunities presented by the development and application of new technologies. There was an overview of the NDDR and CDCS, their evolution, and their importance in ensuring donor health and in ensuring the safety and quality of source plasma. Also talked about was the use and utility of information technology for managing donor health, allowing source plasma collectors to monitor donor health and to improve the donation process for all. Finally, there was a presentation on the use of social media for engaging with stakeholders in the plasma collection industry. Social media also provides an opportunity to become a credible source of information, be proactive in conversations, and build a brand.

The panel on International Dynamics examined the complicated environment faced by the plasma protein industry in China, Canada, and an update on Transatlantic Trade and Investment Partnership (TTIP) negotiations. The discussion on China noted challenges such as Article 49 that prohibits the importation of plasma or plasma products, a lack of accurate knowledge about Chinese rare diseases and patients, uneven health care infrastructure, and political barriers to advocacy. Also presented was an overview of the TTIP with a focus on the potential opportunities for the plasma protein industry including mutual recognition of inspections, regulatory convergence, and global sufficiency for source plasma. Finally, challenges faced by the source plasma collection industry in Canada were examined, specifically the issue of compensated plasma donation. The robust and effective safety initiatives in place were noted as was the impeccable safety record of the industry for the last few decades. The industry is working to counter inaccurate information and bring the debate back to facts to ensure access to safe and effective therapies for Canadians.

 Winners of the Dr. Otto Schwarz Award
  2016 Dr. Thomas R. Kreil
  2015 Herbert Dichtelmüller
  2014 Professor Reinhard Burger
  2013 Larry Guiheen
  2012 Steve Pettaway