NEW WORKSHOP ANNOUNCED

Get up to speed on the Coronavirus outbreak, COVID-19 :
An unprecedented quick and coordinated response

 

 

The WHO:  “This outbreak is a test of solidarity - political, financial and scientific. We need to come together to fight a common enemy that does not respect borders, ensure that we have the resources necessary to bring this outbreak to an end and bring our best science to the forefront to find shared answers to shared problems. Research is an integral part of the outbreak response.”

 

Come together and join us to identify the urgent priorities for research , to mobilize, coordinate and align funding to enable the research needed to tackle this crisis and stop the outbreak, and commit with our experts how you can learn mechanisms for continuing scientific interactions and collaborations , now and beyond the congress.

 

 

 

Outline: 9am – 4pm

 

2:00 Workshop leader opening remarks
Dr Philip Krause , Deputy Director, OVRR, CBER, FDA
2:05 SARS-CoV-2:  Going Viral
Dr Gregory A. Poland , Director of Mayo Vaccine Research Group, Mayo Clinic
2:25 Coronaviruses in Livestock: Vaccines and International Transport of Virus
Dr Mark Kehrli , Center Director, National Animal Disease Center
What existing treatments and vaccine development platforms show promise to control the rate of infection and spread?
  • How long will it be until we have a vaccine?
  • Research and development for candidate vaccines and varying approaches
2:50 Protein-based vaccines:
Dr Peter Hotez , Dean, Professor, Co-Head of Pediatric Tropical Medicine, Baylor College of Medicine & Co-Director, Texas Children’s Hospital Center for Vaccine Development
3:00 DNA vaccines:
Dr Jacqueline Shea , COO, Inovio
3:15 RNA vaccines:
Dr Juan Andres , CTO, Moderna
3:30 Oral vaccine platform & mucosal immunity:
Dr Sean Tucker , CSO and VP Research, Vaxart Inc. 
3:45 Adjuvant platforms:
Reserved for GSK Vaccines - TBC
4:00 Vaccine platforms and funding:
Senior representative , CEPI 
4:15 – 5:00 All speakers to join panel and Q&As with workshop participants: The race is on: Perspectives from industry, academia, global governing bodies and funders – strategic and collaborative opportunities

 

 

 

 

Pre-congress workshops

Pre-Workshops - 9AM START

WORKSHOP A (MORNING ONLY): MATERNAL IMMUNITY

Maternal immunization has the potential to protect mothers, their fetuses and infants from several vaccine preventable diseases. The routinely recommended vaccines for pregnant women, are influenza and tetanus, however there are several new vaccines being developed to be specifically administered during pregnancy. This workshop will provide up to date key information on both current and new targets.Worshop moderator: Dr Saad Omer, Director, Yale Institute for Global Health, Professor of Medicine, Yale School of MedicineMaternal immunization: current development and vaccine pipeline Developing a six valent polysaccharide CRM197 conjugate vaccine for the prevention of infant GBS invasive disease by maternal immunizationVaccine Prevention of Maternal Cytomegalovirus Infection Conducting clinical trials in pregnant women and emerging infectious diseasesSafety of vaccines during pregnancy: Lessons from the Centers for Disease Control and Prevention

WORKSHOP E (FULL DAY): MARKET ACCESS

The 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.Workshop leader: Richard Hughes IV, JD, MPH, Principal, Avalere Health
  • Panel Discussion: Older Adult Immunization Uptake: Understanding Barriers and Drivers
    • Vaccine Preventable Disease in the Medicare Population
    • Vaccine Uptake and Cost-Sharing in the Medicare Population
    • Role of Quality in Driving Vaccine Uptake
  • Panel Discussion: The Vaccine Pipeline and the Role of Real-World Evidence
    • Vaccine Pipeline
    • The Evolving Role of the Real-World Evidence
    • Novel Candidates and the Role of the ACIP

WORKSHOP F (FULL DAY): 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: Matthew Hepburn, Joint Product Lead, Enabling Biotechnologies Joint Program Executive Office, CBRN Defense
  • Biodefense and Pandemic Preparedness:Two sides of the same coin?
  • NIAID’s gap filling preclinical services for vaccine development
  • Expanding the utility of biodefense vaccines
  • Update on the broadly neutralizing influenza monoclonal antibody used for the DARPA-funded Pandemic Preparedness Platform (P3) initiative
  • A disruptive, transportable mRNA vaccine manufacturing platform that can rapidly combat multiple diseases
  • Accelerating into and through Phase 1 in an emergency
  • Rapid response – from discovery to clinical trials
  • NIAID’s international clinical trials efforts

WORKSHOP G (FULL DAY): ADJUVANTS

Discovering and identifying optimal use of adjuvantsWorkshop leader: Dr Wolfgang Leitner, Chief, Innate Immunity Section, Basic Immunology Branch, NIAID, NIH
  • Precision adjuvants: Developing adjuvantation systems tailored to target populations
  • Impacts of Formulation and Delivery on Vaccine Safety and Immunogenicity
  • Identification of immune signatures of novel adjuvant formulations using machine learning
  • Programming Multifaceted and Durable Pulmonary T Cell Immunity using combination adjuvants
  • Perspectives of vaccine adjuvant discovery and development, and funding opportunities for adjuvant research
  • Optimal approaches for clinical evaluation of Small Molecule Immune Potentiators
  • Next Generation Saponin Adjuvants for Improved Vaccines
  • Adjuvants that specifically drive immune responses required for challenging vaccines -TB
  • Influenza: Identification of new adjuvants inducing potent and durable humoral immune responses
  • Speaker Q&As and panel

WORKSHOP H (FULL DAY): VACCINE QUALITY

IMPLEMENTING IMPROVED ANALYTICAL METHODS TO SUPPORT VACCINE QUALITYAnalytical methods that ensure identity, purity, and potency of vaccines have continued to improve but are primarily used for characterization rather than release testing. USP Biologics will gather stakeholders to learn about novel methods and to discuss opportunities to advance these methods in both pharmaceutical QC labs as well as global control laboratories. The workshop will include talks as well as an expert panel to debate these topics and address questions from the audience.Workshop leaders: Dr Maura C. Kibbey, Senior Scientific Fellow, Education & Training, Global Biologics, USP & Dr Earl Zablackis, Director-Principle Scientist, Sanofi Pasteur
  • USP Welcome and Strategies to Support Quality of Vaccines
  • Strategies and Examples for vaccine development and lifecycle management
  • The overall control strategy as tool to develop and advance new vaccine platforms
  • Potency testing for vaccines- challenges and opportunities from development to commercial lifecycle
  • Opportunities and challenges of in vitro potency development for FSME Immun release and stability testing
  • Industry perspective on implementing novel analytical technologies for viral vector based vaccines
  • Molecular size, from distribution coefficient to multiple measured characteristics using light scattering-not as easy as you would think
  • Use of NMR assays for characterization of polysaccharide-based vaccines
  • A regulatory perspective on NGS for adventitious virus detection in biologics
  • Panel with all speakers

WORKSHOP I (FULL DAY): ANTIMICROBIAL RESISTANCE

Harmonizing national and international priorities – what is the role of public health and government in implementation AMR efforts? Collaborative strategies from industry to halting the AMR crisis – do we have a consistent message?Workshop leader: Dr George Siber, Adjunct Professor of Medicine, Johns Hopkins Medical School & Director and Co-founder, Affinivax
  • Vaccines as Another Strategy to Reduce Antibiotic Resistance in Healthcare Settings
  • Gaps in veterinary vaccines to address AMR
  • Why do we think this is possible? Update on vaccine technology that is enabling better vaccines
Pipeline updates from biotech and industry – alternatives from antibiotics
  • Bacterial Vaccine Polypeptides
  • Vaccine efforts in Acinetobacter baumannii
  • Update on the development of a Klebsiella and Pseudomonas vaccine
  • How do we assess the value and multi-attributes vaccines has on preventing AMR?
  • Understanding the impact of vaccines on AMR: what we know and what we need to know
  • Panel with all speakers

WORKSHOP C (MORNING ONLY): INVESTING IN VACCINES

The enthusiasm for investing in biologics, including vaccines, has grown significantly over the last decade with the advent of novel platform technologies and new therapeutic modalities but raising capital remains a challenge.
  • What is the average cost and time to develop a new vaccine? (CEPI)
  • How have biotechs raised money when they don’t have access to these funds? How was it done? How hard was it? (Sanaria)
    • Successful case studies of biotechs who have raised capital through venture investments (Icosavax)
  • Funding needs and research and development gaps for achieving vaccine research and development preparedness targets (?)
  • Promoting private investment in vaccine development (Adjuvant Capital)
12:00

Networking Lunch Break - Workshops resume at 1pm

WORKSHOP E (CONTINUED): MARKET ACCESS

WORKSHOP J (AFTERNOON ONLY): VACCINE TECHNOLOGY

Breakthrough vaccine technologiesNew technologies in vaccinology 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.Workshop leader: Michel De Wilde, Former Senior Vice President R&D of Sanofi Pasteur & Owner, MDW Consultant LLC
  • Technologies that are transforming vaccinology
  • Applications of structural bioinformatics in vaccine design
  • Development of the first human vaccine created solely by artificial intelligence
  • Optimizing high parameter cytometry for large cohort analysis
  • Structural based antigen design in industry

WORKSHOP F (CONTINUED): 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: Matthew Hepburn, Joint Product Lead, Enabling Biotechnologies Joint Program Executive Office, CBRN Defense
  • Biodefense and Pandemic Preparedness:Two sides of the same coin?
  • NIAID’s gap filling preclinical services for vaccine development
  • Expanding the utility of biodefense vaccines
  • Update on the broadly neutralizing influenza monoclonal antibody used for the DARPA-funded Pandemic Preparedness Platform (P3) initiative
  • A disruptive, transportable mRNA vaccine manufacturing platform that can rapidly combat multiple diseases
  • Accelerating into and through Phase 1 in an emergency
  • Rapid response – from discovery to clinical trials
  • NIAID’s international clinical trials efforts

WORKSHOP G (CONTINUED): ADJUVANTS

Discovering and identifying optimal use of adjuvantsWorkshop leader: Dr Wolfgang Leitner, Chief, Innate Immunity Section, Basic Immunology Branch, NIAID, NIH
  • Precision adjuvants: Developing adjuvantation systems tailored to target populations
  • Impacts of Formulation and Delivery on Vaccine Safety and Immunogenicity
  • Identification of immune signatures of novel adjuvant formulations using machine learning
  • Programming Multifaceted and Durable Pulmonary T Cell Immunity using combination adjuvants
  • Perspectives of vaccine adjuvant discovery and development, and funding opportunities for adjuvant research
  • Optimal approaches for clinical evaluation of Small Molecule Immune Potentiators
  • Influenza: Identification of new adjuvants inducing potent and durable humoral immune responses
  • Adjuvants that specifically drive immune responses required for challenging vaccines -TB
  • Next Generation Saponin Adjuvants for Improved Vaccines
  • Speaker Q&As and panel

WORKSHOP H (CONTINUED): VACCINE QUALITY

IMPLEMENTING IMPROVED ANALYTICAL METHODS TO SUPPORT VACCINE QUALITYAnalytical methods that ensure identity, purity, and potency of vaccines have continued to improve but are primarily used for characterization rather than release testing. USP Biologics will gather stakeholders to learn about novel methods and to discuss opportunities to advance these methods in both pharmaceutical QC labs as well as global control laboratories. The workshop will include talks as well as an expert panel to debate these topics and address questions from the audience.Workshop leaders: Dr Maura C. Kibbey, Senior Scientific Fellow, Education & Training, Global Biologics, USP & Dr Earl Zablackis, Director-Principle Scientist, Sanofi Pasteur
  • USP Welcome and Strategies to Support Quality of Vaccines
  • Strategies and Examples for vaccine development and lifecycle management
  • The overall control strategy as tool to develop and advance new vaccine platforms
  • Potency testing for vaccines- challenges and opportunities from development to commercial lifecycle
  • Opportunities and challenges of in vitro potency development for FSME Immun release and stability testing
  • Industry perspective on implementing novel analytical technologies for viral vector based vaccines
  • Molecular size, from distribution coefficient to multiple measured characteristics using light scattering-not as easy as you would think
  • Use of NMR assays for characterization of polysaccharide-based vaccines
  • A regulatory perspective on NGS for adventitious virus detection in biologics
  • Panel with all speakers

WORKSHOP I (CONTINUED): ANTIMICROBIAL RESISTANCE

Harmonizing national and international priorities – what is the role of public health and government in implementation AMR efforts? Collaborative strategies from industry to halting the AMR crisis – do we have a consistent message?Workshop leader: Dr George Siber, Adjunct Professor of Medicine, Johns Hopkins Medical School & Director and Co-founder, Affinivax
  • Vaccines as Another Strategy to Reduce Antibiotic Resistance in Healthcare Settings
  • Gaps in veterinary vaccines to address AMR
  • Why do we think this is possible? Update on vaccine technology that is enabling better vaccines
Pipeline updates from biotech and industry – alternatives from antibiotics
  • Bacterial Vaccine Polypeptides
  • Vaccine efforts in Acinetobacter baumannii
  • Update on the development of a Klebsiella and Pseudomonas vaccine
  • How do we assess the value and multi-attributes vaccines has on preventing AMR?
  • Understanding the impact of vaccines on AMR: what we know and what we need to know
  • Panel with all speakers

WORKSHOP K (AFTERNOON ONLY): COVID-19

Get up to speed on the Coronavirus outbreak: An unprecedented quick and coordinated response The WHO: “This outbreak is a test of solidarity -- political, financial and scientific. We need to come together to fight a common enemy that does not respect borders, ensure that we have the resources necessary to bring this outbreak to an end and bring our best science to the forefront to find shared answers to shared problems. Research is an integral part of the outbreak response.”Come together and join us to identify the urgent priorities for research, to mobilize, coordinate and align funding to enable the research needed to tackle this crisis and stop the outbreak, and commit with our experts how you can learn mechanisms for continuing scientific interactions and collaborations, now and beyond the congress. Workshop leader: Dr Philip Krause, Deputy Director, OVRR, CBER, FDA
  • SARS-CoV-2:Going Viral
  • Coronaviruses in Livestock: Vaccines and International Transport of Virus
    • What existing treatments and vaccine development platforms show promise to control the rate of infection and spread?
      • How long will it be until we have a vaccine?
      • Research and development for candidate vaccines and varying approaches
  • Protein-based vaccines
  • DNA vaccines
  • RNA vaccines
  • Oral vaccine platform & mucosal immunity
  • Adjuvant platforms
  • Vaccine platforms and funding
  • All speakers to join panel and Q&As with workshop participants: The race is on: Perspectives from industry, academia, global governing bodies and funders – strategic and collaborative opportunities
16:00

Chair Closing Remarks & End of Workshops - Offical opening of congress and plenary sessions

AFTERNOON OPENING PLENARY

16:30

Chair’s welcoming remarks

Prof Ab Osterhaus
16:40

What have we learnt from the various coronavirus outbreaks? SARS-CoV-1, MERS-CoV-2, SARS-CoV-2… What next?

  • Intervention strategies
  • Early detection
  • Epidemiology
Panel discussion
17:10

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
18:40

Chair’s Closing Remarks

18:50

Pre-Awards Networking Drinks Reception (@ Reinassance Hotel) followed by the ViE awards and Gala Dinner

last published: 23/Sep/20 15:55 GMT