Pre-congress Workshop Day

Panel discussion
10:00

HALF DAY WORKSHOP A1: VACCINE TECHNOLOGY

New emerging tools in immunology have become a much-anticipated field over the years with increasingly more preclinical and clinical staged developments. This workshop focuses on recent advances and their application in providing protection against infectious diseases to improve immunogenicity of vaccines and understanding the immune response.
  • HIV Adaptive Immunity
    • What have we learned from the adaptive immunity response to better our knowledge of HIV and vaccine design
​​​​​​​
  • Structural Vaccinology​​​​​​​
  • Reverse Vaccinology
    • Understanding the immune response during disease and vaccinology
  • Systems Biology in vaccinology
    • How is this being integrated for rational vaccine designs
  • Computational and Bioinformatics tools
    • ​​​​​​​Applications to vaccines development and clinical efficacy
  • Artificial intelligence use in vaccines
    • Biomarker identification using Artificial Intelligence to predict vaccine response
  • Discussion with all the speakers
Panel discussion
10:00

HALF DAY WORKSHOP F: MICROBIOME

The influence of the microbiome in vaccine response The importance of considering the wholemicrobiome—taking into account viruses, bacteria, fungi, and parasites, as potential modulators of immune responses, inflammation and drivers of heterogeneity invaccineresponses—is becoming increasingly evident. Join this workshop to learn more about how we can use this information to create better vaccinesWorkshop Leader: Mollie Roth, Executive Director, The Microbiome Coalition
  • The role of the microbiome in modulating the inflammatory response
  • When prevention is possible
  • Rational selection of bacteria cocktails
  • What is the right intervention stage? Developing combination strategies
  • HIV infection: Contribution of gut microbiota on immune response and vaccine effectiveness
  • Insight from industry leading pharma vaccine companies
Panel discussion
10:00

WORKSHOP B: PASSIVE IMMUNITY FOR INFECTIOUS DISEASES

Anti-Infective ImmunotherapiesShould there really be a distinction between passive and active immunization when responding to diseases and infections therapeutically? Join this workshop to understand how anti-infective immunotherapies are increasingly combined and the role of both passive and active immunization in future.
  • Scientific rationale & landscape of antibodies in preclinical and clinical development for infectious diseases
  • Anti-fungal Immunotherapy – Candida vaccine
  • ​​Anti-fungal immunotherapy – Cryptococcus Neoformans vaccine
  • RSV and bacterial (Sa and Pa) prophylactic monoclonals in development
  • Development and testing of a human IgG1 monoclonal antibody to the broadly conserved microbial surface polysaccharide, PNAG
  • ​​​​​​​Bacterial mAbs and vaccine approaches
  • MAbs against viruses
  • Designing and Engineering antibodies to mutable protein targets
  • Regulatory Strategy and guidance on developing anti-infective immunotherapies​​​​​​​
Panel discussion
10:00

WORKSHOP C: MARKET ACCESS

Market access & regulatory challenges in vaccinesThe market access landscape for vaccines is more complex than most. Various obstacles are creating a disproportionate move away from investing in preventative interventions and vaccines. Learn how get optimal value for our vaccines and avoid the pit falls when launching a new vaccine.
  • Burden of disease and the future of vaccines in development
  • Accurately capturing the full benefits of vaccines
  • Balancing regulatory requirements, individual benefits, and public health impact in vaccine evaluations and labeling
  • HTA assessments around the world: What are the key attributes that drive decisions?
  • PAHOs approach to procurement – could other regions learn from this?
  • Value based contracting and managed entry agreements – Making sure uncertainties at launch do not hinder market access
  • Market Access life-cycle management
  • Group discussion and Q&A with audience
Panel discussion
10:00

WORKSHOP D: BIODEFENCE

The role of vaccines in preventing outbreaks, through natural causes or biothreats It only takes natural outbreaks and bioterrorism attacks like the Ebola and anthrax to highlight the danger and fragile balance we live in. To ensure global and international security, important decisions need to be made in stockpiling and prioritizing research efforts, however there is a lack of vaccine manufacturers producing these countermeasure treatments. Participate in this workshop to understand the rationale for developers to produce these lower commercial interest vaccines, and the challenges/opportunities associated in working with the government. Workshop leader: Col Matthew Hepburn, Program Manager, DARPA
  • Government strategy in pre-preparedness
  • Strategy for civilian population response, post outbreak
  • Challenges and outlook of vaccine development during unknown outbreaks
  • Platforms suitable for rapid response and emergency outbreaks
  • The importance of a One Health approach to biodefense and biosecurity
  • Regulatory consideration for the development and licensure of vaccines to prevent emerging infectious disease outbreaks and biothreats
Julie Ake, Lieutenant Colonel, Walter Reed Army Institute Of Research
Panel discussion
10:00

WORKSHOP E: ADJUVANTS

Trials and tribulations of integrating adjuvants into your vaccine. What’s the value of current and new adjuvants?
  • Value of current adjuvants & research gaps
  • Adjuvant technology and its impact on vaccine development
  • Precision adjuvants: Developing adjuvantation systems tailored to target populations
  • New adjuvants and overcoming formulation challenges
  • Designing and building the next generation of vaccine adjuvants
  • Controlling vaccine kinetics with adjuvants for enhanced immunity
  • Lessons learned from approved adjuvanted vaccines
  • Perspectives of vaccine adjuvant discovery and development, and funding opportunities for adjuvant research
Elizabeth Sutkowski, Chief Of Regulatory Review Branch 3, FDA
Panel discussion
13:30

HALF DAY WORKSHOP G: ONCOVIRUSES

This workshop will focus on the epidemiology, background medical need, advances in the research & development of therapeutic and prophylactic vaccines for HPV and EBV and challenges and considerations for each approach.HPV
  • Explanations for the high potency of HPV prophylactic vaccines – Could we move from 3 to 1 dose regimens?
  • An Immunotherapeutic approach for HPV associated dysplasia
  • Clinical progress of alternative therapeutic HPV vaccines
  • HPV Discussion & Q&A with Audience
EBV
  • Updates in early clinical development efforts to develop vaccine against Epstein Barr Virus
  • Rational design of a prophylactic Epstein-Barr Virus vaccine targeting infection of B cells and epithelial cells
  • Progress of therapeutic vaccines against EBV associated cancers
  • EBV Discussion & Q&A with Audience
Panel discussion
13:30

HALF DAY WORKSHOP H: BIOPROCESSING

Approaches to establishing clinically relevant specifications for vaccine bioprocessing Workshop leaders: Dr Basav Ghosh, Senior Director, Manufacturing Sciences and Technology, Pfizer &Dr Bo Arve, Executive Director, BioPharmaceutical Sciences, PfizerAn analytical perspective on patient-centric specificationsUnderstand what quality attributes may influence clinical outcomes, both efficacy and safety, and how to established a link between product attributes and clinical data. Considerations for batch selection for clinical trials and their potential impact on clinical experience. Specification setting approaches and their connection to manufacturing experience, process and analytical variability and lot selection. A regulatory/process perspectiveUnderstand regulatory considerations and perspectives on how to approach specification setting and clinical experience. Understand the difference between clinical relevance and clinical experience.Clinical perspective on traditional vaccines (bacterial and viral)Case studies for microbial and viral vaccines. Approaches and considerations for novel technologiesConsiderations for developing novel approaches for new medicines and vaccines for meeting critical unmet medical needs.
Anuja Rastogi, Clinical Associate, Food And Drug Administration
last published: 18/Jan/19 09:26 GMT

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