Time (EST|CET) 

Welcome to the 2021 GPS / Q&A with PPTA President & CEO 

Welcoming remarks and a live Q&A featuring PPTA President & CEO, Amy Efantis and PPTA Counsel & Kelley Drye Partner, Paul Rosenthal, JD.

Moderator: Paul Rosenthal, JD, Partner - Kelley Drye & Warren LLP
Speaker: Amy C. Efantis, President & CEO - PPTA

Defy the Odds: An update on PPTA’s Campaign to Increase Plasma Donations 

A conversation featuring PPTA staff and representatives from MikeWorldWide (MWW) that will focus on PPTA’s current campaign, “Defy the Odds,” including its goals, scope, and current successes.

Sponsored by

Moderator: Mathew Gulick, Senior Director, Global Communications - PPTA
Speakers:

• Michelle Corrigan Rios, MBA, Executive Vice President & Managing Director of Washington DC - MWW
  
• Parker Ray, Chief Digital Strategist - MWW
  
• Shelley Noeldechen, Senior Vice President and Integrated Creative Director - MWW

An opportunity for attendees to network with meeting participants, speakers, and sponsors, with rewards for the most interaction!

Sponsored by

Communication Campaigns to Raise Awareness of the Need for Plasma Donations 

This interactive session will discuss several public and private initiatives to raise awareness of plasma and the need for plasma donations. This includes global patient perspectives via discussions about awareness campaigns launched by patient advocacy groups and insights from the public and private sector.

Sponsored by

Moderator: Brian Maguire, Independent Journalist - Producer - EBX Media
Speakers:

• Lisa Butler, Executive Director - GBS|CIDP Foundation International
• Martine Pergent, President - International Patient Organisation for Primary Immunodeficiencies (IPOPI)
  
• Matthias Gessner, PhD, Chair of the European Plasma Alliance and Senior Director - BioLife European Operations, Takeda
  
• Aurora Masip Treig, Director of Communication and Donation - Banc de Sang i Teixits (Catalan Blood and Tissue Bank)

An opportunity for attendees to network with meeting participants, speakers, and sponsors, with rewards for the most interaction!

Sponsored by

Developing the WHO Guidance on Access to Plasma and PDMPs in Low- and Middle-Income Countries 

A roundtable discussion on the significance of the WHO guidance on access to plasma and PDMPs to address the clinical need for plasma, followed by a live Q&A session.

Sponsored by

Moderator: Dominika Misztela, PhD, Senior Director, Regulatory Policy Europe - PPTA
Speakers:

• Jan M. Bult, Owner & Managing Director - JMB Consultancy BV
  
• Jay S. Epstein, MD, Medical Officer - US Department of Health and Human Services
  
• Thierry Burnouf, PhD, Vice-Dean, College of Biomedical Engineering - Taipei Medical University
  
• Yuyun Maryuningsih, PhD, Team Lead for Blood and other Products of Human Origin - Health Products Policy and Standards Department, World Health Organization
  

Time (EST|CET) 

Welcoming and introductory remarks from PPTA’s Executive Director, Europe, and a Keynote Address from Dr. Andrzej Ryś, Director of Health Systems, Medical Products, and Innovation at DG SANTE in the European Commission.

Moderator: Maarten Van Baelen, MBA, Executive Director Europe - PPTA
Keynote Speaker: Andrzej Ryś, MD Director, Health Systems, Medical Products, and Innovation - Directorate General, Health and Food Safety (DG SANTE), European Commission

The Hilfenhaus Award recognizes individuals who have made outstanding contributions to patient access to safe plasma protein therapies. Presented by PPTA’s Executive Director, Europe, and Chair of the European Board of Directors.

Moderator: Maarten Van Baelen, MBA, Executive Director Europe - PPTA
Presenter: Oliver Schmitt, Chair of the PPTA EU Board of Directors and General Manager, Italy - CSL Behring

Experts discuss recent positive developments in countries seeking to increase the availability of plasma.

Sponsored by

Moderator: Gerardo Fortuna, Health Editor - EURACTIV.com
Speakers:

• Peter Cleary, Principal - Santis Health
  
• Gerry Gogarty, MBA, Plasma Programme Director - The National Health Service (England) Blood & Transplant (NHSBT)
  
• Radosław Sierpiński, MD, PhD, MBA, President of the Medical Research Agency (ABM) Poland and High Representative of the Prime Minister for the Development of the Biotechnology Sector and Poland's Independence in Blood Products
  

An opportunity for attendees to network with meeting participants, speakers, and sponsors, with rewards for the most interaction!

Sponsored by

An examination of the methodology and results of a recent study of donor adverse events, as well as some thoughts about what comes next.

Sponsored by

Moderator: Janet Hershman, MD, Medical Director - BioLife/Takeda
Speakers:

• George Schreiber, ScD, MS, Director, Epidemiology - PPTA
  
• Toby L. Simon, MD, Senior Medical Director - CSL Plasma
  

An opportunity for attendees to network with meeting participants, speakers, and sponsors, with rewards for the most interaction!

Sponsored by

The revision of the European Union Blood, Tissues and Cells (BTC) Legislation brings an opportunity to strengthen this legal framework to encourage new approaches that will increase the collection of plasma across Europe, needed for the manufacturing of plasma-derived medicinal products.

Sponsored by

Moderator: Eduardo Pisani, CEO, Health Policy Advisor - All.Can International asbl
Speakers:

• Stefaan Van der Spiegel, MD, MBA, Head of Sector, Substances of Human Origin - Directorate-General Health, European Commission
• Pierre Tiberghien, MD, PhD, President - European Blood Alliance (EBA)
  
• Leni von Bonsdorff, PhD, EMBA, Executive Director - International Plasma and Fractionation Association (IPFA)
  
• Alice Simonetti, PhD, Member of the Executive Council - Secretary of the European Continental Committee - International Federation of Blood Donor Organizations (IFBDO/FIODS)
  
• Johan Prevot, BA, Executive Director - International Patient Organisation for Primary Immunodeficiencies (IPOPI)
  
• Maarten Van Baelen, MBA, Executive Director Europe - PPTA

Time (EST|CET) 

Welcoming remarks from PPTA’s Vice President, Global Regulatory Policy and a Keynote Address from Nobel Prize laureate Harvey J. Alter, MD.

Moderator: Mary Gustafson, Vice President, Global Regulatory Policy - PPTA
Keynote Speaker: Harvey J. Alter, MD, Nobel Prize Laureate and Distinguished Scholar - National Institutes of Health

The Otto Schwarz Award recognizes leadership in the plasma protein therapeutics industry and related scientific fields. Presented by PPTA’s President & CEO and Chair of the Global Board of Directors.

Moderator: Amy C. Efantis, President & CEO - PPTA
Presenter: Karen Etchberger, PhD, Chair of the PPTA Global Board of Directors and Head I&T Operational Excellence - CSL Behring

Experts with regional expertise will discuss patient access to care in Latin America.

Sponsored by

Moderator: Sonia Balboni, MIA, CQA, Director, Source and Standards - PPTA
Speakers:

• Antonio Condino-Neto, MD, PhD, Professor of Immunology and Experimental Medicine - Institute of Biomedical Sciences, University of São Paulo
  
• Matthew Hotchko, PhD, MBA, President & CEO - Marketing Research Bureau
  
• Miguel Izquierdo, Regional Manager – Central America and Caribbean - World Federation of Hemophilia

This session will provide an overview of pathogen safety issues such as SARS-CoV-2 and variant CJD, how science has informed recent key regulatory decisions and why vigilance remains paramount for the plasma industry.

Sponsored by

Moderator: Dominika Misztela, PhD, Senior Director, Regulatory Policy Europe - PPTA
Speakers:

• Thomas R. Kreil, PhD, Vice President - Global Pathogen Safety - Takeda
• Richard Knight, BA, BSc Open, BM BCh, FRCP(E), Emeritus Professor of Clinical Neurology - University of Edinburgh, Scotland
  
• Martyn Paddick, Head of Product Development - Bio Products Laboratory Ltd
  

This panel will discuss the therapeutic value of Ig and their appropriate use in Europe and the US, and examine obstacles to access, as well as potential solutions, with a particular focus on issues highlighted by the COVID-19 pandemic.

Sponsored by

Moderator: Larisa Cervenakova, MD, PhD, Medical Director - PPTA
Speakers:

• Mel Berger, MD, PhD, Independent Consultant & Berger Consulting, LLC
  
• Jacqueline Kerr, PhD, Clinical Assessor - Paul-Ehrlich-Institut
  
• Dorothy Scott, MD, Supervisory Medical Officer and Chief of the Plasma Derivatives Branch (PDB), Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies - U.S. Food & Drug Administration
  

Closing remarks and the announcement of the GPS Participation Winners from PPTA’s Coordinator of Global Regulatory Policy, Michelle Mason.

Speaker: Michelle Mason, Coordinator, Global Regulatory Policy & QSEAL Administrator - PPTA