Plasma Protein Forum Program

PPTA Forum LOGO 2016 01

Thank you for attending the
2016 Plasma Protein Forum!

Plan to attend the 2017 Plasma Protein Forum, to be held
June 13-14 in Washington, D.C. at the Washington Marriott Georgetown.

 

 

DAY ONE:    JUNE 14, 2016

7:00 am – 7:30 pm Registration and Exhibit Hall Open
7:00 am – 8:30 am Sponsored breakfast by Roche DiagnosticsExhibit Hall
8:30 am – 8:35 am
WELCOME Julie Birkofer, Senior Vice President, North America & Global Health Policy, PPTA
8:35 am – 9:00 am KEYNOTE ADDRESS
Speaker:
  • Dr. Shari Ling, Deputy Chief Medical Officer, Centers for Medicare and Medicaid Services (CMS)
9:00 am –  9:15 am CHAIRMAN'S MESSAGE David Bell, Executive Vice President and General Counsel, Grifols Inc.
9:15 am – 10:00 am
THE ROLE OF THE LIVER IN PLASMA PROTEIN DEFICIENCIES
Professor Dr. Herold J. Metselaar, Erasmus University Hospital, Netherlands
Professor Dr. Metselaar brings a wealth of experience in internal medicine with special interest in liver diseases. He is the head of the liver transplant program in Rotterdam and recently his team surpassed the 1,000 LTx milestone. He is well known for his passion for patient care.
10:00 am – 10:30 am BREAK
10:30 am – 12:00 pm TRACEABILITY UNDER THE DRUG SUPPLY CHAIN SECURITY ACT
Moderator: Mary Clare Kimber, Senior Manager, Regulatory Policy, PPTA
Maintaining the legitimacy and quality of drugs throughout the supply chain is a global priority. In the U.S., the Drug Supply Chain and Security Act (DSCSA) was enacted in 2013. Implementation of the law ensures identification, verification, and tracing of drugs from manufacturer to patient. Various requirements are being phased in within the ten-year implementation time frame. Today's panel will explore the requirements of the law and implementation progress by the FDA and those affected by the requirements.

Speakers:
  • Dr. Linda Silvers, DVM, MPH, Special Assistant for Manufacturing and Policy, FDA, CBER, Office of Compliance and Biologics Quality
  • Rajagopalan Subramanyam, MBA, PMP, Global Serialization Solution Program Manager; Global Process Lead, Order-to-Cash, CSL Behring
  • Juergen Idinger, Project Manager Product Integrity, Engineering Packaging, Baxalta (now part of Shire)
  • Julie Kuhn, Vice President, Supply Chain Integrity, H.D. Smith

12:00 pm – 1:30 pm LUNCH - On Your Own
1:30 pm – 2:00 pm
PATHOGEN SAFETY: WHAT DOES THAT MEAN?
Moderator: Jan M. Bult, President & CEO, PPTA
A discussion about past viruses and an overview of the work of the Pathogen Safety Steering Committee (PSSC) and its members, including publications and groundbreaking work on prion removal, West Nile Virus, as well as the most current, ZIKA.

Speaker:
  • Dr. Thomas R. Kreil, Senior Director Global Pathogen Safety, Baxalta Inc.(now part of Shire)
2:00 pm – 2:30 pm SPECIAL INDUSTRY RECOGNITION Moderator: Jan M. Bult, President & CEO, PPTA
2:30 pm – 3:00 pm NETWORKING BREAK
 
Please join our Exhibitors in the Exhibit Hall for an old fashioned ice cream social!
3:00 pm – 4:30 pm PATIENT ACCESS: THE A-PLUS PERSPECTIVE Moderator: Bill Speir, PPTA Senior Director, State Affairs
Changing markets and the impact. Advocating for patient access.

Speakers:
  • Katie Verb, Director, Policy & Government Relations, Hemophilia Federation of America
  • Johanna Gray, Senior Vice President, Cavarocchi Ruscio Dennis Associates
  • Larry LaMotte, Vice President, Public Policy, Immune Deficiency Foundation
  • Jim Romano, Director, Government Relations and Advocacy, Patient Services Inc.
4:30 pm – 5:00 pm CLOSING ANNOUNCEMENTS/ADJOURNMENT
5:00 pm – 7:00 pm AWARD RECEPTION     Sponsored by:  Fresenius Kabi
5:30 pm Presentation of the Dr. Otto Schwarz Award                                                           

 

DAY TWO:    JUNE 15, 2016

7:30 am – 1:00 pm Registration and Exhibit Hall Open
7:30 am – 8:30 am Sponsored breakfast by Roche DiagnosticsExhibit Hall
8:30 am – 8:35 am
WELCOME
Joshua Penrod, Vice President, Source & International Affairs, PPTA
8:35 am – 9:00 am SOURCE MESSAGES
Speaker:
  • Shinji Wada, Chairman, PPTA Source Board of Directors; President & CEO, Grifols
9:00 am –  10:30 am

EVOLVING TECHNOLOGIES IN PLASMA COLLECTION
Moderator: Sonia Balboni, Senior Manager, Source & Standards, PPTA

Advances in technology are providing opportunities for companies big and small. New developments have transformed all aspects of the industry, including donor selection, recruitment, and health management. In particular, innovations in information technology systems have opened doors for plasma collection organizations, regardless of their size.

Speakers:

  • Mike Taormina, Senior Manager, Plasma Systems, Biotest
  • Roger Brinser, Chair, PPTA Regulatory Affairs Steering Committee; Director, Regulatory Affairs, BioLife Plasma Services LP
  • Vlasta Hakes, Director, Public Affairs, Grifols
10:30 am – 11:00 am BREAK
11:00 am – 12:30 pm
INTERNATIONAL DYNAMICS
Moderator: John Delacourt, Vice President, Legal Affairs & Global Operations, PPTA
Plasma industry activities in a networked and global setting is growing increasingly important in a world filled with globalized trade. Issues involving new markets include new patient populations, new regulatory policies, different governmental and reimbursement systems, and, of course, new opportunities for industry. In other cases, plasma is becoming newly recognized and, as such, is encountering opportunities for greater outreach and education. In this panel, speakers will discuss some of the dynamics involved in Asia, trade agreements, and current challenges even in countries where the plasma industry has been active for many years, such as Canada.

Speakers:
  • Joshua Penrod, PPTA Vice President, Source & International Affairs
  • Bill Bees, Vice President, Plasma Technology, ProMetic Plasma Resources
  • Jennifer McCadney, Special Counsel, Kelley Drye & Warren
12:30 pm               
CLOSING ANNOUNCEMENTS/ADJOURNMENT  


[Program is subject to change]