Day 3, September 30th

round tables


Analytical Issues Impacting Quality in Vaccine Development
Nathaniel Hentz

Nathaniel Hentz, Scientific Market Development Director, Artel

Choke points in vaccine study start up -- An investigator’s view
Nathan Segall

Nathan Segall, Medical Director, Clinical Research Atlanta

De-Risking Vaccine Clinical Trials in Lower Resource Settings
Christopher Woods

Christopher Woods, Professor And Chief Infectious Diseases Division, Duke University

Developing more effective vaccines for emerging/re-emerging pandemic threats
Dr James Cummings

Dr James Cummings, President, ICON Government & Public Health Solutions

How to ensure your trial crosses the finish line - Trial design, operational roll-out, recruitment, retention and data collection
New quantitative analytical technology replacing antiquated plaque and TCID50 assays
Dr Gray Heppner

Dr Gray Heppner, Chief Medical Officer And Managing Partner, Crozet BioPharma LLC

Pediatric vaccine trials – Recruitment and retention
Pros and cons of using animal models for evaluating HIV vaccines
The promise of nanovaccines and the question of safety
Vaccine, Vaccination, and Immunization Law
Bioprocess & Manufacture

Introduction to Bioprocessing & Manufacturing Channel

Panel discussion

Vaccine safety in LMICs, outbreaks or emergencies

Viral Associated Cancers

Broadly Protective and Pandemic Influenza Vaccines Updates

Vaccine Safety

Introduction to Vaccine Safety Channel

Vaccine Safety

The Safety Platform for Emergency Vaccines (SPEAC) Project

  • The Brighton Collaboration was created in 2000 with the goal of building trust in the safety of vaccines via rigorous science.
  • The Coalition for Epidemic Preparedness Innovations (CEPI) and the Brighton Collaboration launched the Safety Platform for Emergency vACcines (SPEAC) Project on May 28, 2020.
  • SPEAC aims to support the emerging CEPI portfolio by creating practical solutions for harmonized safety assessment of CEPI vaccines by working:
    • To enhance vaccine safety assessment across CEPI development programs.
    • To harmonize vaccine safety monitoring during CEPI preclinical and clinical trials.
    • To provide a continuous improvement framework for the SPEAC program.
Cancer & Immunotherapy

Introduction to Cancer & Immunotherapy Channel


Chair’s opening remarks

Bioprocess & Manufacture

Chair's opening remarks

Bioprocess & Manufacture

Interactive panel: Unique rapid production opportunities and challenges that face nucleic acid-based vaccine manufacture and delivery

  • Why and where will it make a difference?
  • How is it different to DNA vaccines?
  • What are the unique challenges and advantages of RNA vaccine?
  • How will RNA vaccines help in an outbreak like SARS-CoV-2? Can the scale-up/volume be big enough?
  • Does the speed and dosage have an effect on the overall quality of the vaccine?
Frederic Krohn, Director Business Development, CureVac
Immune Profiling

Real use of next generation approaches into new vaccines: Role of human mABs for discovery, therapy, and vaccine acceleration

-Exploring new non-traditional vaccine technologies and progression from passive immunity-Using mAbs to accelerate vaccine development by anticipating some of the key biological and regulatory questions


Vaccine Safety

The Ebola vaccine story; where are we now?

  • Wrapping up the DRC outbreak
  • The licensure process and unique pathway to regulatory approval
  • Policy & ethical considerations
  • Innovations, challenges and lessons learned throughout development
  • Implications for development of future emerging /re-emerging disease vaccines

Exhibition Hall & Partnering

Vaccine Safety Case Studies & Surveillance

Immune Profiling Techniques for Better Vaccine Design

Immune Profiling Technologies for Better Vaccine Design

Checkpoints & Combinations

Vaccine Development & Manufacturing 2.0

Vaccine Safety

Panel: Unravelling dengue vaccine safety concerns: To what extend could they have been predicted?

  • Use of controlled human infection models
  • Need for complete assessment of viremia induced by the vaccine
  • The importance of balanced infectivity in live attenuated vaccines and balanced efficacy across age groups and sero-status
  • Surveillance:
    • Need for improved surveillance systems where dengue vaccine is introduced
    • How long should active surveillance continue?
    • Collection of blood samples – baseline & routinely scheduled collections
Cancer & Immunotherapy

Update on approaches to the development of clinical combination therapies

  • What are the fundamental principles of combination science?
  • Huge amounts of data have been generated from combination studies, how do you analyze these?
Cancer & Immunotherapy

Panel: Targeted approaches to combinations, what’s working?

  • What strategies can we use to identify the best combinations?
    • Using immunology as a guide?
    • Combinations of any active compound?
  • What are the major mechanisms we need to focus on?
  • How successful have targeted combinations been so far?
    • IO-IO/ IO-Non-IO combos / Targeting the TME / Angiogenesis inhibitors / Standard of care agents
  • What are the best biomarkers for combination studies?
  • What major challenges remain?
Bioprocess & Manufacture

Proprietary microbial platform to make therapeutic antibodies for treating Priority Pathogens and other diseases: Faster, cheaper, better

Casey J Lippmeier, Vice President Of Innovation, Conagen, Inc.

Exhibition Hall & Partnering

last published: 28/Sep/20 15:15 GMT