BioInsights - Spotlights

VACCINE INSIGHTS

Spotlights 2023

Preclinical research & next-generation vaccine platforms

January

Preclinical research & next-generation vaccine platforms

Isis Kanevsky

Isis Kanevsky, Senior Director Bacterial Vaccines at Pfizer

Promising new vaccines and approaches in preclinical development
Scientific, regulatory, and manufacturing challenges of new and emerging platforms
Progress toward vaccines for challenging diseases
Beyond antibody response: harnessing cytotoxic T cells and trained immunity
New technology and approaches in cancer vaccines

Raw materials & supply chain

February

Raw materials & supply chain

Regulatory agency expectations for raw and starting materials
Improved demand forecasting and inventory management of raw materials and critical consumables
Increasing consistency, scalability, and standardization - and reducing costs
Managing complex international supply chains
Unique challenges for LMIC

RNA vaccines Part 1: Exploring future potential

March

RNA vaccines Part 1: Exploring future potential

Sudha Chivukula

Sudha Chivukula, Head of Discovery Biology, mRNA Center of Excellence at Sanofi

Emerging applications for RNA vaccines
Business and finance
Exploring the potential for rapid response vaccine production
Next-generation RNA vaccines – circular RNA, self-amplifying RNA

Advances in vaccine manufacturing Part 1: Upstream advances and intensifying production

April

Advances in vaccine manufacturing Part 1: Upstream advances and intensifying production

Upstream bioprocessing
Emerging production systems e.g., yeast and BICS
Intensifying vaccine production
Disruptive technologies for vaccine manufacturing

Pandemic preparedness: getting ready for the next “Disease X”

May

Pandemic preparedness: getting ready for the next “Disease X”

Tackling new SARS-CoV-2 variants and novel coronaviruses
Rapid response vaccine development & manufacture
Moving from product to platform in regulatory evaluation
Veterinary vaccines & One Health
Broadly protective & multivalent vaccines
The importance of equity in global countermeasures
Developing better early-warning systems

Advances in formulation & administration

June

Advances in formulation & administration

Ana Jaklenec

Ana Jaklenec, Research Scientist & Co-Principal Investigator, Langer Lab at David H Koch Institute Professor MIT

Advances in alternative administration routes, including transdermal, intranasal, inhaled, and oral
Deepening our understanding of adjuvant mechanisms and predicting the adjuvants of the future
Tailoring adjuvants to specific populations
Eliminating cold chain with lyophilization or liquid stabilization

Clinical development

July

Clinical development

Jacqueline Miller

Jacqueline Miller, Senior Vice President, Therapeutic Area Head, Infectious Diseases at Moderna

Challenges facing vaccine clinical trials
Improving communication between CROs, sites, and developers.
Improving the efficiency of clinical trials via better clinical trial design
Creating a global network of clinical trial sites
Human challenge trials
Decentralized trials

Understanding immune responses

August

Understanding immune responses

Wayne Koff

Wayne Koff, President and CEO, Human Immunome Project, and Adjunct Professor of Epidemiology

Understanding immune responses to better predict immunogenicity of candidate vaccines at all ages
Omics as an emerging tool for understanding early immune responses and optimizing regimes
Correlates of protection: can they be used to license forthcoming vaccines?
Immune responses in infants/elderly/pregnant

CMC & analytics

September

CMC & analytics

Accelerating vaccine lot release without compromising quality
Meeting evolving regulatory guidance at all stages of development
Best practice in assay development - from immunogenicity to exposure and safety
Moving from preclinical and early clinical to GMP production
Extracting actionable information from large analytical data sets
New and emerging analytical technologies, including advances in process analytical technology (PAT), to reduce time to market

RNA vaccines Part 2: Addressing ongoing challenges

October

RNA vaccines Part 2: Addressing ongoing challenges

Tackling stability, immunogenicity, and cost of materials
Overcoming challenges in mRNA process development and manufacturing
Improving delivery with modified LNPs or polymer-based delivery systems
Regulatory considerations

Advances in vaccine manufacturing Part 2: Downstream bottlenecks and increasing manufacturing capacity

November

Advances in vaccine manufacturing Part 2: Downstream bottlenecks and increasing manufacturing capacity

Downstream bioprocessing & fill/finish
Technological and policy innovations to boost vaccine manufacturing capacity worldwide
Localized and flexible vaccine manufacturing approaches to allow more efficient and equitable distribution
Speeding up technology transfer in LMIC

Tools of tomorrow

December

Tools of tomorrow

Enabling tools and emerging vaccine platforms likely to make a splash in 2024.