2021 Global Plasma Summit (GPS): November 16 – 18

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Thank you for attending the 20201 Global Plasma Summit, held November 16-18, 2021! The Global Plasma Summit is a worldwide virtual event featuring industry leaders, patient advocates, and public officials, all of whom gathered to provide the latest updates and information about the plasma protein therapeutics industry and its unique role in the broader pharmaceutical sector.

Panel discussions and presentations focused on the ongoing need for plasma donation – particularly considering the declines that have occurred because of the ongoing pandemic – and how PPTA and its membership are utilizing their collective voices to advocate for increased donations to meet growing clinical need. Case studies explored how several countries are respectively working to increase plasma availability, and a moderated discussion focused on activities underway to ensure the revised EU Blood Directive meets the needs of plasma donors and patients who rely on plasma-derived therapies.

Meeting Program

Day One - Tuesday, November 16 - Awareness 

Time (EST|CET) 

08:00 – 08:30 | 14:00 – 14:30 

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

08:30 – 09:30 | 14:30 – 15:30 

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 QualTex Full Color Logo Sub Line

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
09:30 – 10:00 | 15:30 – 16:00  Networking Session 

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

Sponsored by FK Claim 4c

10:00 – 11:00 | 16:00 – 17:00

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 FK Claim 4c

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)
11:00 – 11:30 | 17:00 – 17:30  Networking Session 

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

Sponsored by FK Claim 4c

11:30 – 12:30 | 17:30 – 18:30

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 QualTex Full Color Logo Sub Line

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
Day Two - Wednesday, November 17 - Availability

Time (EST|CET) 

08:00 – 08:15 | 14:00 – 14:15  Welcome & Keynote Address 

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 Ry
ś, MD Director, Health Systems, Medical Products, and Innovation - Directorate General, Health and Food Safety (DG SANTE), European Commission

08:15 – 08:30 | 14:15 – 14:30 Presentation of the 2021 Hilfenhaus Award 

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

08:30 – 09:30 | 14:30 – 15:30  Increasing Plasma Availability: The Case Studies of Canada, England, and Poland 

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

Sponsored by Haemonetics Logo RED 1

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
09:30 – 10:00 | 15:30 – 16:00  Networking Session 

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

Sponsored by Haemonetics Logo RED 1

10:00 – 11:00 | 16:00 – 17:00  Donor Adverse Events Study: Protocol and Findings

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 Haemonetics Logo RED 1

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
11:00 – 11:30 | 17:00 – 17:30  Networking Session 

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

Sponsored by Haemonetics Logo RED 1

11:30 – 12:30 | 17:30 – 18:30  Strengthening the EU Blood Directive: Meeting the Needs of Plasma Donors and Patients Using Plasma-Derived Medicines 

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 Haemonetics Logo RED 1

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
Day Three - Thursday, November 18 - Access 

Time (EST|CET) 

08:00 – 08:20 | 14:00 – 14:20 Welcome & Keynote Address

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

08:20 – 08:30 | 14:20 – 14:30  Presentation of the 2021 Dr. Otto Schwarz Award 

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

08:30 – 09:30 | 14:30 – 15:30  Latin America: Plasma Protein Therapies to Meet Patients' Needs 

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

Sponsored by JM Logo Horizontal JPEG

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
09:30 – 10:00 | 15:30 – 16:00  Networking Session
An opportunity for attendees to network with meeting participants, speakers, and sponsors, with rewards for the most interaction!
10:00 – 11:00 | 16:00 – 17:00  Pathogen Safety: Not Losing the Focus 

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 AsahiKASEI BIOPROCESS

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
11:00 – 11:30 | 17:00 – 17:30  Networking Session
An opportunity for attendees to network with meeting participants, speakers, and sponsors, with rewards for the most interaction!
11:30 – 12:30 | 17:30 – 18:30  Challenges to Access to Immunoglobulin Therapies in the Pandemic Environment

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 Paysign Horz 4C

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
12:30 – 12:35 | 18:30 – 18:35 Closing Remarks

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


Please contact Michelle Mason with any questions

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Thank you 2021 GPS Sponsors & Exhibitors!

PROGRAM SESSION SPONSORS
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AsahiKASEI BIOPROCESS
FK Claim 4c
Haemonetics Logo RED 1
JM Logo Horizontal JPEG
Paysign Horz 4C
QualTex Full Color Logo Sub Line
RENOLIT logo
Roche logo
NETWORKING SESSION SPONSORS
FK Claim 4c
Haemonetics Logo RED 1
VIRTUAL BOOTH SPONSORS
Labtech Horiztonal
Headspring 1
IDF 2020

For more information about becoming a sponsor or exhibitor, contact:
Michelle Mason.

This detailed video takes viewers through all of the steps a first-time plasma donor would experience during the process of donating lifesaving plasma.

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Learn more about the need for plasma donors, plasma donation, and how you can save and improve lives. Find a Donation Center.

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"How Is Your Day?" is an initiative to raise awareness of the unique nature of plasma protein therapies and the value they provide to patients. It aims to inform and educate decision makers and the general public worldwide.

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