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2021Vaccines-1988x680a

2021 PDA Innovations in Vaccines Conference

Jun 08 - Jun 09, 2021
Eastern Standard Time | Online
  • Virtual
  • Conference
  • The Americas
  • Online

Overview

On behalf of the Program Planning Committee and PDA, we would like to invite you to the 2021 PDA Innovations in Vaccines Conference on 08-09 June 2021. The agenda will focus on the theme of “Manufacturing. Technology. Supply.” This conference will provide a platform to present and discuss new developments in Vaccines & Cold Chain.

On day one we plan to focus on the vaccine landscape, control strategies & host a panel discussion focused on challenges in cold chain. On day two we plan to discuss PDA Vaccine activities, Supply Chain & host a regulatory panel discussion.

We anticipate a strong agenda of knowledgeable experts in this field along with an exciting virtual exhibition of the latest commercial inspection technology and services. If you are interested in exhibiting please contact David Hall.

We look forward to seeing you online for the 2021 PDA Innovations in Vaccines Conference!

Program Planning Committee

Cristiana Campa, GSK Vaccines
Jane Halpern,
Consultant
Nina Heinz,
DHL (co-chair)
Sabrina Restrepo,
Merck (co-chair)

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Agenda

  • Day 1
  • Day 2
  • Tuesday, 08 June

    09:00 – 10:10 | Plenary 1: How COVID Changed the Vaccine Landscape
    Moderator: Sabrina Restrepo, Director, Merck & Co.

    The urgent response driven by the COVID-19 pandemic brought the need for speed in the vaccine development space as well as the sense for collaboration among all the relevant stakeholders. In addition, forced us to: open the barriers to new technologies, or accelerate development by leveraging prior knowledge and/or existing platforms; educate more the general public about vaccines so herd immunity can be achieved faster; worked together as a village (suppliers, drug manufacturers, governments, regulatory agencies, patients) to enable production at higher levels for a worldwide coverage; and lastly, teach us more lessons to better prepare us for next pandemic. This session will present some of those lessons learned during this pandemic.

    09:00 - 09:10 | Welcome from the Program Planning Committee Co-Chair

    09:10 - 09:30 | Lessons Learned
    Andrea Gruber
    , Head Special Cargo, IATA

    09:30 - 09:50 | Cross Company Learnings and Discussion with Vaccines
    Thierry Gastineau
    , Global Head Quality Advocacy, Culture & Innovation, Sanofi

    09:50 - 10:10 | Q&A Panel Discussion


    10:10 – 10:40 | Break & Extended Q&A

    10:40 – 11:40 | Plenary 2: Control Strategies
    Moderator: Cristiana Campa, Technical R&D Advisor and Fellow, GSK Vaccines

    This session will provide insights on advanced control strategies for vaccines development and lifecycle, taking into account product, process and analytical considerations. In this context, reflections on how to enable accelerated development will be discussed, including risk- based strategies and technical innovations. Examples will include use of prior knowledge, tech transfer, testing and stability strategies, considering novel and established vaccine platforms, with learnings from COVID-19 health emergency.

    10:40 - 11:00 | Quality by Digital Design to Support Rapid RNA Vaccine Production Against Emerging Infectious Diseases
    Zoltan Kis, PhD, Research Associate, Imperial College London

    11:00 - 11:20 | Enabling Accelerated Development - Patient Centric Specifications and Stability
    Julia O’Neill, Distinguished Fellow, Moderna Inc.

    11:20 - 11:40 | Q&A Panel Discussion


    11:40 – 12:30 | Break & Extended Q&A

    12:30 – 13:30 | Plenary 3: Panel Discussion - Supply/Cold Chain Challenges
    Moderator: Nina Heinz, Global Head of GXP Compliance, Temperature Management Solutions, DHL Global Forwarding

    This session will discuss the supply and cold chain challenges as they relate to vaccine distribution and administration.

    Panel

    • Rafik Bishara, RHB Technical Advising, LLC
    • Ruud van der Geer, MSD
    • Ben VanderPlas, Sonoco
    • Paul Wolsencroft, Seqirus

     

  • Wednesday, 09 June

    09:00 – 10:10 | Plenary 4: PDA Vaccine Activities
    Moderator: Jane Halpern, Consultant

    The PDA Vaccine Task Force and PDA Vaccine Interest Group have multiple activities planned for 2021 and beyond. These includes publications as well as webinars and meetings on topics of interest for both novel vaccines and more traditional products. This session will provide an overview of current activities and areas for volunteering from interested members.

    09:00 - 09:20 | Vaccines IG Update
    Jane Halpern
    , Consultant

    09:20 - 09:40 | Current PDA Vaccine Initiatives and Volunteer Opportunities
    Stephan Krause, PhD,
    Director, Product Quality, AstraZeneca

    09:40 - 10:00 | Q&A Panel Discussion

    10:10 – 10:40 | Break & Extended Q&A

    10:40 – 11:40 | Plenary 5: Supply Chain for Temperature Sensitive Products
    Moderator: Nina Heinz, Global Head of GXP Compliance, Temperature Management Solutions, DHL Global Forwarding

    The Covid-19 pandemic has brought to the forefront many of the challenges encountered in the transportation of temperature sensitive vaccine shipments across the globe. This includes managing multiple supply chain partners, airfreight capacity restrictions, changing government regulations, new ultra-low temperature ranges and may other factors.
    What have we learned over the course of the past 12-24 months and how can we benefit from these lessons to continuously drive improvement in vaccines logistics? The speakers will share their experience bringing in different perspectives on how elements such as speed, reliability, transparency, collaboration and security have been key elements of success.

    10:30 - 10:50 | Where to Reduce E2E Distribution Costs?
    Fabian de Paoli
    , CCM28

    10:50 - 11:10 | Supply Chain for Temperature Sensitive Products
    Richard Peck,
    AstraZeneca

    11:10 - 11:30 | Q&A Panel Discussion

    11:40 – 12:30 | Break & Extended Q&A

    12:30 – 13:30 | Plenary 6: Panel Discussion - The Regulatory Lessons from COVID-19
    Moderator: Sabrina Restrepo, Director, Merck & Co.

    Industry and National Health Authorities will talk about the regulatory lessons learned during this pandemic regarding post-approval changes, harmonization, reliance/recognition and COVAX efforts that have enabled an accelerated approval of the emergency use for several vaccine candidates, as well as the challenges ahead for pursuing licensure of these vaccines. In addition, perspectives about how to further enable vaccine modernization in the future based on COVID lessons would be discussed.

    Panel

    • Cristiana Campa, GSK Vaccines
    • Matthew Downham, PhD, CEPI
    • Robin Levis, PhD, U.S. FDA
    • Mic McGoldrick, Merck & Co.
    • Heidi Meyer, PEI
    • Wim van Molle, Sciensano

     

Highlighted Speakers

Cristiana Campa
Cristiana Campa
GSK Vaccines
Thierry TG Gastineau
Thierry TG Gastineau
Sanofi Pasteur
Andrea C. Gruber
Andrea C. Gruber
International Air Transport Association (IATA)
Jane L. Halpern
Jane L. Halpern
Self-Employed
Nina Heinz
Nina Heinz
DHL Global Forwarding
Julia C. O'Neill
Julia C. O'Neill
Moderna, Inc.
Sabrina Restrepo
Sabrina Restrepo
Merck & Co., Inc.
Ben VanderPlas
Ben VanderPlas
Sonoco ThermoSafe

Learning Objectives

At the completion of this meeting, participants will be able to:

  • Discuss lessons learned in vaccine development due to the pandemic to apply in future instances
  • Identify how to enable accelerated development, including risk- based strategies and technical innovations
  • Articulate the importance of vaccine logistics through perspectives about the challenges encountered in the transportation of temperature sensitive vaccine shipments

Registration Fees

Register Now
Early Registration
Registration Type Price by 30 April 2021
Member $650
Non-member $765
Govern./Health Authority/Academic Member $350
Govern./Health Authority/Academic Non-member $400
Student Member $140
Student Non-member $155
Young Professional Member $399
Regular Registration
Registration Type Price After 30 April 2021
Member $800
Non-member $915
Govern./Health Authority/Academic Member $435
Govern./Health Authority/Academic Non-member $475
Student Member $265
Student Non-member $275
Young Professional Member $475

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Tel: +1 (301) 656-5900 ext. 115
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