2021 PDA Innovations in Vaccines Conference

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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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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

Standard Pricing

Standard Member Price

$800

GovernmentMember Only

$435

Health AuthorityMember Only

$435

Early Career ProfessionalMember Only

$475

StudentMember Only

$265

AcademicMember Only

$435

Non-Member

$915

See Qualifying Criteria for Member Types.

GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

Day 1

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

 

Day 2

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

 

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