7:30 am Registration Opens

Future Directions & Adapting to COVID-19

8:00 am Advancing Pfizer’s mRNA Strategy

Synopsis

David Morrissey, Head of Pfizer’s RNA Incubator, discusses the company’s strategy for advancing its leadership in mRNA and related technology platforms

8:30 am Breakfast Panel: What does the Future Landscape of Vaccinology Look Like? How Can we Further Leverage mRNA Technology in Vaccinology & How Can Pharma & Biotech Prepare to Expand?

  • Afam Okoye Research Associate Professor, VGTI-Vaccine & Gene Therapy Institute, OHSU
  • Denis Vargo Vice President, Head of Drug Safety & Pharmacovigilance, Akebia Therapeutics
  • Emma Thompson Professor of Infectious Diseases, Centre for Virus Research, University of Glasgow
  • Kay Hunsberger Director of Infrastructure for Biological Clinical Manufacturing,, Merck
  • Joshua DiNapoli Global Project Head, mRNA Platform Development, Sanofi Pasteur

Synopsis

  • Could self-amplifying RNA be a more potent version of mRNA?
  • Could mRNA be used to develop vaccines that target numerous strains of a virus family, like coronaviruses and influenza, and act as a first-line defence against future pandemics?
  • What are the challenges of developing, manufacturing, and scaling up these new modalities? How can we meet these challenges?

9:15 am Overcoming Challenges in Genetic Vaccine Development – Manufacturing and Testing

  • James Cody Senior Manager, Business Development, Biologics Solutions, Charles River Labs

Synopsis

  • Overview of hurdles for genetic vaccine development
  • Focus on key challenges involved manufacturing and testing of DNA and viral vector vaccines
  • How CRL’s end-to-end support can help product developers avoid and overcome these challenges

9:45 am Speed Networking

Synopsis

Foster new relationships and form new connections with your piers from the vaccines community in quick rounds of networking.

10:15 am Morning Refreshment Break

10:45 am A Framework to Analyze the Pandemic Potential of Pathogens: COVID-19 & Future Directions

  • Amesh Adalja Senior Scholar , John Hopkins Centre for Health Security

Synopsis

  • How will the integration of data form new technologies impact human resilience to GCBR-level threats?
  • How can we incentivize R&D for emerging pathogens, and which pathogens with pandemic potential should we be already looking to equip ourselves against?
  • What are the biggest learning’s from the COVID-19 pandemic, and how can we best prepare for the next?

11:15 am SARS-CoV-2 Genetic Variation and Vaccine Effectiveness

  • Emma Thompson Professor of Infectious Diseases, Centre for Virus Research, University of Glasgow

Synopsis

  • Tracking of the SARS-CoV-2 variant through high-throughput genomic sequencing was used in the UK as an “early warning system”
  • Linked datasets have helped to associate vaccine effectiveness with genetic variation
  • Phenotypic changes in new variants cannot always initially be predicted through sequencing

11:45 am Pre-Clinical and Clinical Development of a Next-Generation mRNA COVID-19 Vaccine

Synopsis

  • Preliminary preclinical results for second generation vaccines designed with improved anti-viral immunogenicity exhibited cross neutralizationagainst alpha, beta, gamma and delta circulating viral variants in mice and non-human primates
  • Rhesus macaque immunogenicity studies showed high neutralizing antibody titers after two prime injections 28 days apart
  • A further increase in neutralizing antibody titers were observed with a boost injection 120 days after the second prime injection

12:15 pm Increasing Productivity of IVT Reaction Using At-Line Monitoring by HPLC Chromatography

  • Rok Sekirnik Head Process Development mRNA/ pDNA, BIA Separations

12:45 pm Lunch & Speed Networking

Advancing Next-Generation Vaccine Process, Pre-Clinical, & Clinical Development

1:45 pm Optimizing DNA Vaccines Against Emerging Infectious Diseases

  • Ami Patel Research Assistant Professor, The WISTAR Institute

Synopsis

  • Understanding DNA vaccine design and insight into mechanism of action
  • Demonstrating DNA vaccine preclinical studies
  • immunogenicity and protection in animal models
  • Understanding what constitutes next generation DNA vaccines and future outlook

2:15 pm Next Generation Self-Replicating RNA Vectors to Enable New Approaches to Immunotherapy Synopsis

Synopsis

  • Next generation synthetic srRNA vectors can lower dose by orders of magnitude compared to current srRNA designs
  • Developing new srRNA products requires independent optimization of vectors, gene inserts, and delivery
  • Improved srRNA bioactivity enable new approaches for strategies in vaccine development

2:45 pm Clinical Updates of mRNA-1345, Moderna’s Prophylactic Vaccine for RSV

  • Grace Chen Senior Director, Clinical Development, Moderna

Synopsis

  • Learn how an mRNA vaccine against RSV encoding a pre-fusion F glycoprotein, can lead to a superior neutralizing antibody response compared to the post-fusion state
  • Phase 1 data to show promising results of RSV prevention in older adults

3:15 pm Scalable Manufacturing Platform for RNA-LNP Vaccine Development

  • Jason Coleman Clinical Application Scientist Lead, Precision Nano Systems

Synopsis

  • COVID-19 mRNA vaccines, while an extraordinary accomplishment, have revealed that rapid development and scale-up, as well as access to innovative technologies, are needed to keep up with emerging variants and to usher in a new wave of genomic medicines
  • Challenges associated with addressing a global pandemic include the need for a scalable, quick and localized manufacturing platform as well as the need for a higher potency vaccine
  • In this presentation, we will share insights into a cutting-edge technology to enable scalable manufacturing for RNA-LNPs and the use of this technology for the development of a high potency saRNA-LNP COVID vaccine

3:45 pm Afternoon Refreshments & Poster Session

4:15 pm A Novel Two-Component VLP Technology for the Development of Vaccines Against Respiratory Viruses

Synopsis

  • Vaccine technology covering an RSV/hMPV bivalent vaccine as well as a SARS2 candidate which is in Ph1 testing now in Australia
  • Advantages of computational protein design to better inform antigen formulation and to achieve higher efficacy rates

4:45 pm Replicating RNA as a Platform for Active or Passive Immunization Against Emerging Infectious

Synopsis

  • Vaccine development activities for active immunization against COVID-19
  • Enabling intramuscular administration of RNA-encoded antibodies for passive immunization strategies

5:15 pm Unravelling Viral & Non-viral Delivery Approaches for Next Generation RNA Therapeutics

  • Anna Blakney Assistant Professor , University of British Columbia

Synopsis

  • Understanding the stability and quality differences between viral and non-viral delivery strategies
  • Understanding biological mechanism of non-viral delivery strategies to improve targeted delivery
  • Choosing the most appropriate delivery system for different types of RNA

5:45 pm Therapeutic HBV Vaccine to Target Internal Viral Proteins: Clinical Development

Synopsis

  • Methods Vaccines are delivered by chimpanzee adenovirus vectors (AdC) of serotype 6 (AdC6) and 7 (AdC7) used in prime only or prime-boost regimens
  • Results show that the vaccines are immunogenic in mice and induce potent CD8⁺ T cell responses that recognize multiple epitopes

6:15 pm Chair’s Closing Remarks & End of Day 1