2022 International Plasma Protein Congress
14-15 June | Berlin

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On 14-15 June 2022, at the International Plasma Protein Congress, policymakers, stakeholders, patient groups and industry came together to discuss the need to increase plasma collection in Europe to facilitate patient access to plasma-derived medicinal products (PDMPs). This year, the congress took place in Berlin and was opened by the German Minister of Health who discussed German plasma collection and PDMP ecosystem.

On day 1, we looked into how plasma collection is organised in many and partnerships between national authorities and the private sector to increase plasma collection in a country. We also explored how forthcoming changes to EU legislation could help Europe reduce its dependency on third countries for plasma.

On day 2, we looked into the value that PDMPs bring to patients and society and the clinical need for PDMPs and how patient access can be optimised. We discussed how within regulatory policy, there are many opportunities to improve availability of plasma and access to PMDP; for example, with a mutual recognition agreement on GMP inspections for PDMPs and plasma.

And finally, given that safety of PDMPs, next to donor safety, is in the core of our mission, we had an expert panel discuss the latest developments in pathogen safety and pathogen reduction in PDMPs, such as SARS-COV-2 and vCJD.

With the imminent revision of EU legislation such as the Blood Directive and General Pharmaceutical legislation and given the EU’s path towards strategic autonomy around critical medicines, we have a historic opportunity to increase availability of plasma and patient access to PDMPs.

Thank you for attending the 2022 International Plasma Protein Congress (IPPC)!
We hope to see you at next year's IPPC to be held 20-21 June in Lisbon, Portugal.

Quick links:

Meeting Programme*

Day One - Tuesday, 14 June 2022

Time (CET) 

07:00-17:30 On-site registration open
08:30-09:00

Opening - Revising EU Legislation: A One-Off Opportunity to Increase Plasma Collection?



Welcome
Maarten Van Baelen, Executive Director, Head of Europe - PPTA

Opening speech
Karl Lauterbach, Minister of Health - Germany

09:00-10:45 SESSION 1 : Paving the Way in Europe Plasma Collection in Germany - Tried and Tested: A success story?
CHAIR: Stephan Walsemann - Scinomed GmbH
Germany has a well-functioning plasma collection system based on the co-existence and cooperation of all plasma collection stakeholders (ARGE Plasmapherese). Nevertheless, even well-functioning systems need regular updates to meet current and future needs.

Historic Overview - Presentation
Rainer Moog, Member of the Board - ARGE Plasmapherese

Pros and Cons Panel Discussion - Industry perspective
Svenja Barckhausen, Member of the Board - Haema AG

Pros and Cons Panel Discussion - Patient Perspective
Gerd Klock, dsai-regional group leader from Frankfurt/Mainz

Pro and Cons Panel Discussion - Donor Perspective
Michael Fuhr, Plasma donor

Pros and Cons Panel Discussion - Industry perspective
Stephan Proske, Director Sales & Marketing Western Europe - Kedrion Biopharma

10:45 -11:30 Networking Break

An opportunity for attendees to network with meeting participants, speakers, and sponsors.

Sponsored by Haemonetics Logo RED

11:30-13:00 SESSION 2: Plasma collection models: Public and Private Sectors: Coexistence, partnership or silo - Seeking the optimum model
CHAIR: Alexa Wetzel, Director, Lead for European Plasma - PPTA
There are different blood and plasma collection systems worldwide. There is no one-size-fits-all model. Every country has its own health system structure. There is no single solution to ensure stable and safe access to plasma-derived medicinal products for patients. This is why in this session we are presenting different collection models, providing examples within the framework of either a public or a public-private coexistence structure.

Plasma collection in Hungary
Miklos Szolnoky - Biotest

Plasma collection in Egypt
Ahmed Serag - GRIFOLS Egypt Plasma Derivatives

Plasma collection in Ukraine
Oksana Muliarchuk - Biopharma Plasma

Plasma collection in the United Kingdom
Gerard Gogarty - NHS Blood and Transplant

13:00-14:15 Networking Lunch
An opportunity for attendees to network with meeting participants, speakers, and sponsors.
14:15-15:45 SESSION 3: EU Pharma Strategy - Open strategic autonomy: Could the EU approach to starting materials boost plasma collection in Europe?
CHAIR: Leo Cendrowicz - The Independent – i – The Brussels Times
The EU Pharma strategy calls for strategic autonomy on starting materials for medicines in the EU and a reduction in dependency on third countries. The EU has a reliance of 38% (around 5.15 million liters) on the US. In this session, we will discuss how increasing plasma collection in the EU contributes to the EU's goals of that open strategic autonomy, how it improves patient access to PDMPs, and how the private sector is committed to collecting more plasma in Europe.

Stefaan van der Spiegel, Team Leader - Substances of human origin, DG Health & Food Safety – European Commission

Matthew Hotchko, President - The Marketing Research Bureau

Karmin Saadat, GMP Inspector - Austrian Agency for Health and Food Safety (AGES)

Martine Pergent, President - IPOPI

David Bell, Chief Corporate Development Officer & Legal Counsel – Grifols

15:45-16:15 Networking Break

An opportunity for attendees to network with meeting participants, speakers, and sponsors.

Sponsored by Haemonetics Logo RED

16:15-17:30 SESSION 4: EU Pharma Strategy - Europe's industrial policy Progressing From Plasma to Product Establishing Successful Fractionation Plants: Lessons from the Past and Present
CHAIR: Leo Cendrowicz - The Independent – i – The Brussels Times
With a total of 37 plants, Europe has currently one of the strongest plasma fractionation plant footprints in the world. However, there remain European countries that do not at present have their own fractionation plants, but who plan to set them up. Through utilising their own plasma resources, the aim is to control the manufacture of PDMPs in their own country. Setting up a fractionation plant is, however, very complex, expensive and time-consuming. This interactive session strives to discuss aspects of how to be successful and how to avoid failure, amidst the myriad challenges to the availability of sufficient plasma in the EU, not least due to the pandemic.

Patrick Robert, Consultant - The Marketing Research Bureau

Radosław Sierpiński, President of Medical Research Agency, Prime Minister's High Representative for Development of Biotechnology - Poland

Sinisa Varga - Former Minister of Health of Croatia

Ruud Zoethout, Representative of Prothya Biosolutions, The Netherlands

Adrian Goretzki, President - Healthcare Education Institute, Poland

17:30-17:45 End of the day closure - Hilfenhaus Award
Presented by Oliver Schmitt, Chair - PPTA EU Advisory Committee; General Manager - CSL Behring
17:45-19:15 Networking Reception

An opportunity for attendees to network with meeting participants, speakers, and sponsors.

Sponsored by

Day Two - Wednesday, 15 June 2022

Time (CET) 

08:00-12:00 On-site registration open
09:00 - 09:30

Opening



Welcome
Ainhoa Mendizabal, VP DACH-H Affairs Office – Grifols

Keynote address
Andreas Glück, Member of the European Parliament - Renew Europe, Germany

09:30 - 10.45 SESSION 5 : EU Pharma Strategy - A Vision Beyond the legislation Improving the Access Pathway for Plasma Protein Therapies
CHAIR: Tomasz Kluszczyński Partner - Vintura
One of the EU’s Pharmaceutical Strategy key objectives is to ensure access to critical medicines for patients, including plasma-derived medicinal products (PDMPs). These medicines are unique biological therapies derived from human plasma and are used to treat patients (300,000 in Europe) with rare, often genetic, life-threatening conditions. Immunoglobulin (IG) therapies, which are used to treat dysfunctional immune systems, represent a lead product category amongst PDMPs. Patients are, however, facing access challenges and a debate on prioritisation and optimising the use of IG has already begun. Restricting patient access would lead to lower socio-economic benefits and is not the solution to an ever-growing clinical need. This session provides a timely opportunity to reflect on how to take up this debate. Healthcare professionals, authorities, together with patients and industry representatives, will share their analyses of the current situation and propose solutions about how to enhance patient access to PDMPs. We will discuss these challenges and opportunities in the context of the EU Pharmaceutical Strategy, which highlights the importance of access to medicines and the goal to reach an EU Open Strategic Autonomy for starting materials for medicines, such as plasma.

Lieven Annemans, Professor health Economy - UGent

César Hernández García, Head of Department, Department of Medicines for Human Use - Spanish Agency for Medicines and Health Products (AEMPS)

Martin van Hagen, Head of Clinical Immunology, Internal Medicine/Immunology - University Medical Center Rotterdam

Mark Stettner, Senior Consultant, Neurologist and Associate professor - Department of Neurology, University of Essen

Jean Philippe Plançon, President - EPODIN

Roberto Tana, Global Marketing Director | International Contract Manufacturing Director - Kedrion Biopharma

10:45 -11:30 Networking Break

An opportunity for attendees to network with meeting participants, speakers, and sponsors.

Sponsored by Haemonetics Logo RED

11:30 - 12:45 SESSION 6: EU files: The Uniqueness of Plasma - An Essential Differentiation from Blood from a Policy Perspective
CHAIR: Faraz Kermani, Head Global Communications - PPTA
In view of the ongoing revision of the EU general pharmaceutical legislation and blood Directive, this session aims to highlight how having clear definitions and differentiating between blood for transfusion and plasma for manufacturing could enhance access to PDMPs for patients. Using specific examples from the relevant regulatory provisions in the EU Blood Directive and the general EU pharmaceutical legislation, this session will highlight how specific provisions in the EU legislation would reduce regulatory uncertainty, make more plasma available for manufacturing of plasma-derived medicinal products (PDMPs), ultimately benefitting patients in the EU.

ECJ decision and how legal definitions are outlined in other legal frameworks
Bita Bakhschai, Specialist lawyer for medical law, Commercial Lawyer - Univ. Bayreuth

Global co-operation and EMA/network initiatives on the supply
Tom Brusselmans, Scientific Administrator - European Medicines Agency, Quality and Safety of Medicines Department, Inspections Office

Industry perspective, current hurdles and need for a global collaboration
Jens Rehbein Director, Plasma Lead, Global Regulatory Affairs - CSL Behring

Stefaan van der Spiegel, Team Leader - Substances of Human Origin, DG Health & Food Safety – European Commission

Patient perspective, the importance of differentiation to increase patient access
Leire Solis, Senior Manager, Health Policy and Advocacy - IPOPI

12:45 - 14:00 Networking Lunch
An opportunity for attendees to network with meeting participants, speakers, and sponsors.
14:00- 15:20 SESSION 7: Improving Pathogen Safety - Key Highlights and Developments
CHAIR: Dominika Misztela, Senior Director Lead for European Regulatory & Quality - PPTA
This expert session will address the importance of constant pathogen safety vigilance for the plasma industry and highlight key regulatory decision making and challenges, showcasing UK plasma as an example.

Mission and role of Arbeitskreis Blut: Pathogen Safety of Blood Components
Ruth Offergeld, Chair - Arbeitskreis Blut

Emerging viruses, and consequences for the safety and efficacy of plasma products
Thomas R. Kreil, Chair - PPTA Global Pathogen Safety Committee; Associate Professor of Virology, Vice President - Takeda

Anti-SARS-COV-2 antibodies in IG preparations and therapeutic implications
Eleonora Widmer, Executive Director, Global Pathogen Safety R&D

The curious case of UK plasma
David McIntosh, Chair - UK Plasma Action

15:20- 15:30 Closure of IPPC 2022

*Subject to change 

Sponsors & Exhibitors

Thank you 2022 IPPC Sponsors!



Supporting Organisations

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PPTA Contacts
Hotel and Congress inquiries:
Melanie Conrads or +32.2.724.0188
Registration inquiries:
Charon Smith or +1.443.433.1114
Sponsorship and Exhibit inquiries:
Michelle Mason or +1.443.433.1106

Additional Information (COVID-19 Regulations)


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