Pre-congress Workshops, April 6

MATERNAL IMMUNITY
10:00

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.
ANIMAL HEALTH
10:00

WORKSHOP B (FULL DAY): ANIMAL HEALTH

AM: SCIENTIFIC ADVANCEMENTS IN THE COMPANION ANIMAL CANCER VACCINE SPACEBridging the gap between human and animal cancer: translational studies of a polyvalent cancer preventative vaccineOvercoming current limitations in selecting immunogenic neoantigensPersonalized autologous cancer vaccine for cats & dogsDevelopment of an animal health vaccine using gene-based checkpoint inhibitorsThe safety of an adjuvanted autologous cancer vaccine platform in canine cancer patientsFrom treating veterinary cancers to launching a first-in-human clinical trial
MARKET ACCESS
10:00

WORKSHOP C (FULL DAY): MARKET ACCESS

Workshop: 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.10:10am Panel Discussion: Older Adult Immunization Uptake: Understanding Barriers and DriversModerator: Richard Hughes IV, JD, MPH, Principal, Avalere HealthVaccine Preventable Disease in the Medicare Population Vaccine Uptake and Cost-Sharing in the Medicare PopulationRole of Quality in Driving Vaccine Uptake11:30am Panel Discussion: The Vaccine Pipeline and the Role of Real-World EvidenceVaccine Pipeline The Evolving Role of the Real-World EvidenceCapturing the Full Value of Vaccines Novel Candidates and the Role of the ACIPresident and GH&V BU Head, Vaccines, Pfizer
C. difficile
10:00

WORKSHOP D (MORNING ONLY): TACKLE C. difficile

The Centers for Disease Control (CDC) has named C. difficile infections an urgent public health threat and the leading hospital-acquired infection in the U.S. With an enormous human toll, and significant health care costs, there is a clear need to treat this infection. Currently no drug or biological product has not been approved by the FDA for C. difficile infections. Join us in this workshop as we hear from experts on their promising approaches to tackle the infection.Workshop Leader: Kevin Killeen, Chief Scientific Officer, MatrivaxVACCINE EFFORTTHERAPIES-Antibiotics: Merck’s DIFICID® (fidaxomicin)-Immunotherapy:-Microbiome:-Fecal Microbiota Transplant
BIODEFENCE
10:00

WORKSHOP E (FULL DAY): BIODEFENCE

The role of vaccines in preventing outbreaks, through natural causes or biothreatsIt 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. NIAID’s gap filling preclinical services for vaccine developmentExpanding the utility of biodefense vaccinesUpdate on the broadly neutralizing influenza monoclonal antibody used for the DARPA-funded Pandemic Preparedness Platform (P3) initiativeA disruptive, transportable mRNA vaccine manufacturing platform that can rapidly combat multiple diseases
ADJUVANTS
10:00

WORKSHOP F (FULL DAY): ADJUVANTS

Discovering and identifying optimal use of adjuvantsPrecision adjuvants: Developing adjuvantation systems tailored to target populationsSystem biology around the effect of adjuvants during vaccinationIdentification of immune signatures of novel adjuvant formulations using machine learningImpacts of Formulation and Delivery on Vaccine Safety and ImmunogenicityCombination adjuvants and the molecular mechanism – synergies and antagonistic behaviorsProgramming Multifaceted and Durable Pulmonary T Cell Immunity to Subunit Vaccines
VACCINE QUALITY
10:00

WORKSHOP G (FULL DAY): ANALYTICAL METHODS TO SUPPORT VACCINE QUALITY

Analytical 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 QClabs 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 leader opening remarks: Dr Maura C. Kibbey, Senior Scientific Fellow, Education & Training, Global Biologics, USPUse of NMR assays for characterization of polysaccharide-based vaccines Opportunities and challenges of in vitro potency development for FSME Immun release and stability testingA regulatory perspective on NGS for adventitious virus detection in biologics Strategies and Examples for vaccine development and lifecycle management
ANTIMICROBIAL RESISTANCE
10:00

WORKSHOP H (FULL DAY): ANTI MICROBIAL 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? Insight and progress from international healthcare agencies; How can regulatory and access policies can be used to strengthen utilization of vaccines in our international action plans to address AMR?Stewardship & social behavior change in the USAMR transfer between human and animal healthWhy do we think this is possible? Update on vaccine technology that is enabling better vaccinesPipeline updates from biotech and industry – alternatives from antibiotics-vaccines and anti-infectives-Interplay with viruses and their impact on AMR-AntibodiesProgress made towards TB, Staph, COPD, E.coliHow to develop a bacterial vaccine with limited biological information
1:00

Networking Lunch Break

ANIMAL HEALTH
2:00

WORKSHOP B (CONTINUED) : ANIMAL HEALTH

PM: SHORTENING THE INNOVATION PIPELINE FOR ANIMAL HEALTH PRODUCTSWorkshop Collaboration with STAR-IDAZ IRC - Speakers TBCWorkshop Leader: Alex Morrow, Chair of The International Research Consortium, STAR-IDAZ IRC Introduction to the research road maps: Vaccines, therapeutics, diagnosticsAlex Morrow, Chair of The International Research Consortium, STAR-IDAZ IRC
  • What are the opportunities for collaboration and co-funding with other agencies around the world which would allow sharing of expertise and resources internationally?
  • What do we as research funders and programme managers need to do, to ensure that the research community and industry work better together to shorten the innovation pipeline?
  • How can we get the research institutes engaging with the animal health companies at an earlier stage?
  • How can we guarantee that the funding activities of public funders are addressing the underpinning needs of the more strategic/applied end of the innovation pipeline?
Dr Cyril Gay, Senior National Program Leader, Office of National Programs, USDADr. Lorenzo Terzi, Minister Counselor, Delegation of the European Union to the United States of AmericaScott Brown, Vice President, External Innovation, Veterinary Medicine R&D ZoetisLisa J Becton, Director, Swine Health Information and Research, National Pork Board
MARKET ACCESS
2:00

WORKSHOP C (CONTINUED): MARKET ACCESS

2.00pm Should there be risk-based immunization recommendations for older adults due to immunosenescence?Dr Bradford Gessner, Vice President, Global Medical Lead for Pneumococcal Vaccines, Pfizer2.30pm Understanding decision making from ACIP and other recommending bodiesSAGE: Prof. Kathy Neuzil, Director, Center for Vaccine Development and Global Health (CVD), University of Maryland School of MedicineInvited: ACIP – Dr Helen Keipp Talbot, Associate Professor of Medicine, Department of Medicine, Division of Infectious Diseases, Vanderbilt University Medical Center3.30pm Addressing the link between influenza season and antimicrobial resistance in respiratory pathogens in the BD Insights Research National DatabaseVikas Gupta, Director, Clinical Strategy, BD Insights Research3.45pm WHO’s Market information for access to vaccines initiative (MI4A)Tania Cernuschi, Technical Officer, Vaccine Pricing, Supply- Procurement, World Health Organization4.15pm Market access in Low Income and LMICS
VACCINE TECHNOLOGY
2:00

WORKSHOP I (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.Development of the first human vaccine created solely by artificial intelligenceDr Nikolai Petrovsky, Chairman, Vaxine PtyOptimizing High Parameter Caytometry for Large Cohort AnalysisDr Mario Roederer, Chief of Immune Technology, NIHApplications of structural bioinformatics in vaccine design Dr Gwo-Yu Chuang, Co-Head and Staff Scientist of the Structural Bioinformatics Core Section, NIHStructural based antigen design in industryMatthew Bottomley, Function Head, Vaccine Design and Characterization, GSK
ANTIBODIES AND BIOLOGICS
2:00

WORKSHOP J (AFTERNOON ONLY): ANTIBODIES AND BIOLOGICS CANCER – Engineered

Cancer treatments have been advancing on a variety of fronts in the last decade. Antibodies engineering has led to the successful use of antibodies, which had encouraged more interest in the development of more and better drugs based on these proteins. Join this session to find out more about the latest advancements in cancer antibodies, covering monoclonal, bispecific and multi-specific antibodiesSignaling antibodies in cancer therapyAntibody engineering – title TBCDr Jamie Spangler, Assistant Professor, Johns Hopkins UniversityMAbs Influence of the bispecific antibody IgG subclass on T cell redirectionDevelopment of antibody circuits to redirect immunity against cancer
BIODEFENCE
2:00

WORKSHOP E (CONTINUED): BIODEFENCE

Accelerating into and through Phase 1 in an emergencyLTC Melinda Hamer, Chief, Clinical Trials Center, Walter Reed Army institute for Research Rapid response – from discovery to clinical trialsDr Chris Earnhart, Joint Product Lead, PRISM - Platforms for Rapid Integrated Solutions for Medical Countermeasures, Medical Countermeasure Systems, U.S. Army Dr. Amy Jenkins, Program Manager, Biological Technologies Office (BTO), DARPA – invited NIAID’s international clinical trials effortsElizabeth Higgs, Global Health Science Advisor, Division of Clinical Research, NIAID/ NIHBiotech perspective on outbreak clinical trialsWendy Holman, CEO, Ridgeback Therapeutics – invited
ADJUVANTS
2:00

WORKSHOP F (CONTINUED): ADJUVANTS

Perspectives of vaccine adjuvant discovery and development, and funding opportunities for adjuvant researchDr Wolfgang Leitner, Chief, Innate Immunity Section, Basic Immunology Branch, NIAID, NIHOptimal approaches for clinical evaluation of Small Molecule Immune PotentiatorsDr Derek O'Hagan, Senior Advisor in R&D, GSK VaccineAdjuvants that specifically drive immune responses required for challenging vaccines -TBDr Jay Evans, President and CEO, Inimmune Corporation & Director, Center for Translational Medicine, University of Montana Next Generation Saponin Adjuvants for Improved VaccinesTyler Martin, MD, Chairman, President & CEO, Adjuvance Technologies, Inc.Influenza: Identification of new adjuvants inducing potent and durable humoral immune responsesDr Norbert Pardi, Research Assistant Professor of Medicine, Research Associate, Perelman School of Medicine, University of Pennsylvania
VACCINE QUALITY
2:00

WORKSHOP G (CONTINUED): ANALYTICAL METHODS TO SUPPORT VACCINE QUALITY

Potency testing during development- in vivo & in vitro testing. Scope, challenges and illustrative case studiesDr Xianzhi Zhou, Bioassay Manager, GSK Vaccines Analytical strategy evolution during lifecycleDr Samantha Hawgood, Head of Analytical Modernisation & Harmonisation, Global Analytical Science & TechnologyMolecular size, from distribution coefficient to multiple measured characteristics using light scattering-not as easy as you would thinkDr Earl Zablackis, Director-Principle Scientist, Sanofi PasteurIndustry perspective on implementing novel analytical technologies for viral vector based vaccinesDr Mark van Oojj, Scientific Director, PER.C6 technical lead/ Head of Platform innovation and implementation, JanssenThe overall control strategy as tool to develop and advance new vaccine platformsDr Marta Isabel da Conceição Carreira Germano, Scientific Director, Group Head of Product Characterization, JanssenPanel with all speakersModerated by Dr Dirk Redlich, Vice President, Strategy & Operations Leader, Integrated Operations Head, Infectious Diseases and Vaccines Therapeutic Area, Janssen
ANTIMICROBIAL RESISTANCE
2:00

WORKSHOP H (CONTINUED): ANTI MICROBIAL RESISTANCE

Call to action: How the innovative vaccines industry is contributing to fight against AMRHow do we assess the value and multi-attributes vaccines has on preventing AMR?Dr Julia Spencer, Associate Vice President, Global Vaccine Public Policy, Merck, IFPMADr Bruce Gellin, MD, MPH, President, Global Immunization, Sabin Vaccine InstitutePanel with all speakers
VACCINE INVESTMENT
2:00

WORKSHOP K (AFTERNOON ONLY): INVESTING IN VACCINE BIOTECH

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. Join this workshop to hear from case studies from biotechs, big pharma and non-profit organizations with significant sources of capital.Topics include:
  • Vaccine Biotechs: Systemic challenges in raising capital
  • Big Pharma requirements: What makes you tentative? How do you create a business case for acquiring company?
  • Non-profit organizations: who evaluates companies at Gates & BARDA?
Moderator: Dr Timothy Cooke, Biotechnology Industry Representative, US NVPODr Stephen Hoffman, CEO, SanariaAdditional speakers TBC
5:00

Chair Closing Remarks & End of Workshops

last published: 22/Jan/20 10:05 GMT