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 MWWPR that will focus on PPTA’s current campaign, “Defy the Odds,” including its goals, scope, and current successes.

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

• Michelle Corrigan Rios, Executive Vice President, Corporate Communications and Managing Director, Washington DC - MikeWorldWide
  
• Parker Ray, Chief Digital Strategist - MikeWorldWide
  
• Shelley Noeldechen, Senior Vice President and Integrated Creative Director - MikeWorldWide

Communication Campaigns to Raise Awareness of the Need for Plasma Donations 

This interactive session will discuss public and private initiatives to raise awareness of plasma and the need for plasma donations, featuring U.S. and EU patient perspectives about awareness campaigns, as well as a the perspective of an EU public authority.

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

• Lisa Butler, Executive Director - GBS|CIDP Foundation International
• Martine Pergent, Chair - International Patient Organisation for Primary Immunodeficiencies

Additional Speaker(s) to be Announced

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.

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

• Jan M. Bult, Owner & Managing Director - JMB Consultancy BV
  
• Jay S. Epstein, MD, Medical Officer - Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services
  
• Thierry Burnouf, PhD, Distinguished Professor - Taipei Medical University
  
• Yuyun Maryuningsih, MD, Team Lead - Blood and Other Products of Human Origin, World Health Organization

Time (EST|CET) 

Welcoming and introductory remarks from PPTA’s Executive Director, Europe, and a Keynote Address from the Director-General – Directorate-General Health and Food Safety (SANTE), Sandra Gallina (to be confirmed).

Moderator: Maarten Van Baelen, Executive Director, Europe - PPTA
Keynote Speaker: Sandra Gallina (Invited), Director-General – Directorate-General Health and Food Safety (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, Executive Director, Europe - PPTA
Presenter: Oliver Schmitt, General Manager - CSL Behring, Italy

Sponsored by

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

Moderator: Gerardo Fortuna, Agrifood & Health Editor - Euractiv
Speakers:

• Peter Cleary, Principal - Santis Health, Canada
  
• Gerry Gogarty, Plasma Programme Director - The National Health Service (NHS) England
  
• Radosław Sierpiński, President - Medical Research Agency (ABM) Poland

Sponsored by

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

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

Moderator: Janet Hershman, MD, Head of BioLife Medical Affairs - Takeda
Speakers:

• George Schreiber, ScD, Director, Epidemiology - PPTA
  
• Toby L. Simon, MD, Senior Medical Director, Plasma and Plasma Safety - CSL Plasma
  
• Mark Becker, MD, Corporate Medical Director - Grifols

Sponsored by

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

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.

Moderator: Eduardo Pisani, Chief Executive Officer/Ex Officio Member of the Board of Directors - All.Can International
Speakers:

• Stefaan van der Spiegel, Head of Sector - Health Innovation and Substances of Human Origin, DG SANTE - European Commission
  
• Pierre Tiberghien, Executive Director - European Blood Alliance (EBA)
  
• Leni von Bonsdorff, PhD, Executive Director - International Plasma and Fractionation Association (IPFA)
  
• Alice Simonetti, Executive Board Member - International Federation of Blood Donor Organizations (IFBDO/FIODS)
  
• Johan Prevot, Executive Director - International Patient Organisation for Primary Immunodeficiencies
  
• Maarten Van Baelen, 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 Senior Scholar - National Institutes of Health, Bethesda, MD

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, Senior Vice President, Alliance Management for Digital Technology - CSL Behring

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

Moderator: Sonia Balboni, Director, Source & Standards - PPTA
Speakers:

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

Sponsored by

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.

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

• Thomas Kreil, PhD, Vice President - Global Pathogen Safety - Takeda
• Richard Knight, MD, Professor - University of Edinburgh Centre for Clinical Brain Sciences and an Honorary Consultant Clinical Neurologist in the Department of Clinical Neurosciences, Lothian University Hospitals Trust, Edinburgh, Scotland
  

Additional Speaker(s) to be Announced

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.

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

• Mel Berger, MD, PhD, Adjunct Professor, Pediatrics and Pathology & Case Western Reserve University & Berger Consulting, LLC
  
• Jacqueline Kerr, PhD, Clinical Assessor - Paul-Ehrlich-Institut
  
• Dorothy Scott, MD, Supervisory Medical Officer and Principal Investigator - 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