TIME (Eastern)
7:30 AM
On-site registration open / Exhibit Area Open (Breakfast available)
‍
8:30 - 8:45 AM
Welcome

Speakers:
Giles Platford, President, Plasma-Derived Therapies Business Unit - Takeda

Anita Brikman, President & CEO - PPTA

8:45 - 9:30 AM
Keynote Speech:  Elevating Research, Science, and Innovation Through Regulatory Excellence

Speaker: Namandjé N. Bumpus, Ph.D., Founding Principal, Bumpus Advising LLC; Former FDA Principal Deputy Commissioner

9:30 - 10:15 AM
Session 1: Essential, Exported, Exempt? Trade Tensions and Potential Implications for Plasma Proteins
Experts will provide key insights into the Trump Administration's trade policies and the impact they have on plasma, PDTs and the wider pharmaceutical industry.

Moderator: Julia Fabens, Senior Director, Global Plasma & International Affairs - PPTA

Speaker: Bob Rossilli, Chief Commercial Officer, Global Business & US GM - Kedrion BioPharma

10:15 - 10:45 AM
Networking Break in Exhibit Area Sponsored by Marketing Research Bureau
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10:45 - 11:45 AM
Session 2: Leveraging Real-World Evidence for Regulatory Evaluation of Source Plasma Donor Health and Biologics
Explore how ongoing research is driving advancements in plasma donor safety and PDTs. This session will highlight how real-world data is being used to generate real-world evidence to support global efforts in donor health and safety research and PDT development.

Moderator: Toby  Simon, M.D., Senior Medical  Consultant - PPTA

Speakers:
Dr. Yun Lu, Deputy Division Director - FDA/CBER/Office of  Biostatistics and Pharmacovigilance (OBPV)/Division of Analytics and  Benefit-Risk Assessment (DABRA)

Dr. Mark  G. Thompson, Consultant

Michael  "Chris" Runken, PharmD - Grifols
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11:45 AM - 1:15 PM
Networking Lunch in Exhibit Area

1:15 - 2:15 PM
Session 3: On the Front Lines: State Policy and Its Impact on Plasma Collection
In the U.S., states governments have wide latitude to regulate plasma collection through licensure, staff training requirements, user fees, and other policies. Learn more about how PPTA is working with its members in several states to harmonize state law and ensure widespread availability of plasma for fractionation.

Moderator: Daniel Seaton, Director, Public Affairs and State Advocacy - PPTA

Speakers:
Peter Martinez, Managing Partner - Martinez Strategic Alliances
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Nathan Schaefer, Senior Vice President of Public Policy & Access - National Bleeding Disorders Foundation        

Vlasta Hakes, Senior Director, Corporate Affairs - Grifols

2:15 - 3:30 PM
Session 4: Innovation: Developments in Testing and Manufacturing
We will look at the evolution of various safety strategies, testing practices and manufacturing technologies that are a vital aspect of our industry to maintain safety and quality of our finished products.

Moderator: Dr. James R. Knowles, Senior Director, Global Regulatory Policy - PPTA

Speakers:
Dr. Thomas R. Kreil, Vice President, Global Pathogen Safety - Takeda    

John Curling (virtual), Independent Consultant - JCC AB

Dr. Sara Del Carlo, QA Manager & Qualified Person - Kedrion

Dr. Marion Lanteri, VP Scientific Affairs - Creative Testing Solutions

3:30 - 4:00 PM
Networking Break in Exhibit Area Sponsored by Onbe

4:00 - 5:00 PM
Session 5: Health Policy in the 119th Congress
While President Trump has dominated the headlines with his trade and international positions, Congress has been toiling away on several key health policy priorities, including PBM reforms, changes to hospital payment, Medicaid reforms, and other important policy. Get the latest on these developments and learn how they could affect your business.

Moderator: Leigh Ann Caldwell, Chief Washington Correspondent - Puck News

Speakers: 
Leigh Ann Fairley, Health Legislative Assistant - Office of Congressman Gus Bilirakis (R-FL-12)    
‍
Dillon Cooke, Legislative Director - Office of Representative Scott Peters (D-CA)      

Eric Gascho, Representing GBS/CIDP Foundation International; Vice President - CRD Associates

5:00 PM
Announcement of the Otto Schwarz Award Winner

5:00 - 7:00 PM
Networking Reception in the Exhibit Area

TIME (Eastern)
07:15 AM
On-site registration open / Exhibit Area Open (Breakfast available)
‍
8:15 - 8:30 AM
Day Two Welcoming Remarks

Speaker: Joshua Penrod, Senior Vice  President, Global Plasma and Technical Advocacy - PPTA

Global Plasma Board of Directors Chairman's Message

Speaker: Jerome  Parnell III  Vice Chairman and Founder - ImmunoTek Bio Centers

8:30 - 9:15 AM
Keynote Speech: Markets in Substances of Human Origin: Societal Benefits, Public Perceptions, and Regulatory Challenges

Speaker: Dr. Mario Macis, Professor of Economics - Johns Hopkins Carey Business School

9:15 - 10:30 AM
Session 6: Driving Awareness & Action for Anti-D
This thought-provoking discussion focuses on the collection and use of anti-D plasma, a critical component in preventing hemolytic disease of the fetus and newborn. This session will feature medical experts, patients, and donors sharing insights on the challenges and opportunities surrounding anti-D plasma collection globally. The presentation will provide an overview of current practices and offer suggestions for how to navigate this evolving and complex landscape.

Moderator: Anita Brikman, President & CEO - PPTA

Speakers: 
Katie Shanahan, Director of Development - Allo Hope Foundation

Steve Mitzelfelt, U.S.  Regulatory Affairs Director - Kamada Plasma LLC

Steven L. Spitalnik, M.D., Professor - Columbia University; Co-Director of the Laboratory of Transfusion Biology; Executive Vice Chair for Laboratory Medicine - Columbia University Irving Medical Center

Ben Pritchard, Anti-D Donor    

Christine Pickard, Donor & Patient; Nurse Practitioner

10:30 - 11:00 AM
Networking Break in Exhibit Area Sponsored by Abbott

11:00 AM - 12:00 PM
Session 7: AI in our Industry
Join me along with experts, industry members, and government representatives for an engaging discussion on AI in Our Industry where we will explore emerging trends, challenges, and opportunities of adopting AI.

Speakers:
Vic  Boddie II, Ph.D., Independent Regulatory Affairs & Policy Lead

Thomas Szatkowski, Head of DD&T Delivery - Takeda    

Dr. Jan Hartmann, SVP, Chief Medical  Officer - Haemonetics  

Valerie J. Parker, Assistant  Research Director, Regulatory and RWD/E - Duke-Margolis Institute for Health  Policy
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12:00 PM
Closing Announcements

12:00 - 1:00 PM
Networking Lunch in Exhibit Area Sponsored by ADMA Biologics