Tuesday 29th March Plenary sessions are shared across all conferences


Influenza and Respiratory, Tuesday 29 March 2016

Dr Gregory A. Poland

Chair’s opening remarks

Dr Gregory A. Poland, Director of Mayo Vaccine Research Group, Mayo Clinic and Foundation
Dr Gregory A. Poland

Vaccinomics and vaccinology 3.0 – The way forward

  • Vaccinomics, adversomics and the immune response network theory: Individualized vaccinology in the 21st century
  • New understandings of how vaccines stimulate immune responses, new biomarkers for vaccine response, and facilitate the understanding of what genetic and other factors might be responsible for rare side effects due to vaccines
  • Integrating increasingly complex high throughput data into descriptive and predictive equations for immune responses to vaccines
Dr Gregory A. Poland, Director of Mayo Vaccine Research Group, Mayo Clinic and Foundation
Dr. Leonard Friedland

Vaccine adjuvant science: Understanding modern vaccines

  • Novel adjuvant systems under investigation by GSK and safety considerations
  • Learning and challenges in combining adjuvants including pre-clinical and clinical experience
  • Experience and considerations for use in special populations
  • Potential application of adjuvants to future vaccines (experience with adjuvanted investigational zoster vaccine), and adjuvant communication to healthcare providers and patients
Dr. Leonard Friedland, VP, Scientific Affairs and Public Health Vaccines, North America, GSK
Dr Peter Hotez

Developing a new generation of neglected disease vaccines

  • New human hookworm and schistosomiasis vaccines now in clinical trials and earlier stage vaccines for Chagas disease, leishmaniasis
  • Building vaccine development capacity in critical areas threatened by poverty and conflict, including ISIS held territories with the White House and State Department US Science Envoy
Dr Peter Hotez, President of the Sabin Vaccine Institute and Dean of National School of Tropical Medicine, Baylor College of Medicine

Networking Coffee Break



Vaccinating the anti-vaxxers
Dr Adrian Wildfire, Project Director - Infectious Diseases & Viral Challenge Unit, SGS Life Sciences

The need for a vaccine development fund 
Prof Stanley A. Plotkin, Emeritus Professor, University of Pennsylvania & Executive Advisor, Sanofi Pasteur
Dr Gregory A. Poland, Director of Mayo Vaccine Research Group, Mayo Clinic

How can the pharma/CRO industry better collaborate with the site networks?
Lynlee Burton, Director of Project Delivery – Vaccines, PRA Health Sciences

Practical issues around inclusion/exclusion criteria and protocol design with their impact on time-lines, data collection, and quality of subjects
Prof William B. Smith, Founder, President, and Principal Investigator NOCCR/VRG

Overcoming hurdles in technology transfer & IP
Dr Mukul Ranjan, Senior Advisor for Innovation and Technology Transfer, National Institute of Allergy and Infectious Diseases

Considerations for global clinical vaccine studies
Dr Cynthia Dukes, VP Global Project Management, Vaccines, Infectious Diseases, Women’s Health and Primary Care, ICON Clinical Research

New approaches to accessing patient populations: Adults in G8 markets, middle income countries and helping Gavi-funded governments reach the fifth child
Tara Azimi, Expert Associate Principal, McKinsey & Company
Aliza Apple, Engagement Manager, McKinsey & Company

Designing effective processes to enable scalability of vaccine products
Dr Joseph G. Joyce, Director, Vaccine Process Development, Merck Research Laboratories

A Transition to Targeted or “Smart” Vaccines: How Understanding Commensal Colonization Can Lead to Selective Vaccination
Dr Blaine Pfeifer, Associate Professor, Chemical and Biological Engineering Department, State University of New York at Buffalo

The issue of virally-induced cancers: Barriers to awareness
Dr Lopa Mishra, Director, Center for Translational Research Department of Surgery and GWU Cancer Center, George Washington University

From surrogate markers to predictive biomarkers of vaccine efficacy: How realistic is to enhance the blood markers beyond serum antibody?
Dr Ali Harandi, Associate Professor, Lab head, University of Gothenburg

Challenges and Opportunities in Conducting Clinical Trials in West Africa

Dr David Hoover, Senior Medicial Advisor, Clinical RM
Dr Kevin J. Gilligan, Senior Scientific Advisor, Clinical RM

Zika virus: Challenges for medical countermeasure development
Dr Robert Malone, CEO and Consultant, RW Malone MD, LLC
Pre-clinical biomarkers of safety and efficacy in vaccine design and development
Dr Michael Vajdy, Co-Founder, President and Chief Scientific Officer, Epito Genesis Inc
Adjuvants and technology advancements driving vaccine R&D
Dr Michel De Wilde, Former Senior Vice President R&D of Sanofi Pasteur & Owner, MDW Consultant LLC


Networking Lunch

Dr Heather Sings

An interactive point-count point discussion: Polysaccharide vs conjugate pneumococcal vaccine

  • Policy recommendations for pneumococcal vaccination around the world
  • Amount of disease caused by vaccine serotypes
  • Indirect protection in adults from pediatric use of PCV13
  • Vaccine effectiveness and other immunologic considerations
  • Carriage, duration of protection and cost effectiveness
Dr Heather Sings, Senior Director and Medical Lead, Pneumococcal Vaccines, Pfizer
Dr Melvin Kohn, Medical Director for Adult Vaccines, Merck Vaccines
Dr Laura York

An interactive joint presentation on the FDA approved meningococcal B vaccines

  • The science behind different approaches
  • Discussing the different approaches in getting FDA approval
  • Predictions of effectiveness in additional strains
Dr Laura York, VP, Global Meningococcal Vaccines, Medical Development and Scientific/Clinical Affairs, Pfizer
Dr Rino Rappuoli, Chief Scientist, GSK Vaccines
Dr Wellington Sun

Regulating vaccines at the FDA: Development and licensure of Ebola vaccines

  • What have we learnt from the Ebola crisis?
  • How quickly can we work together to help speed up the process of licensure?
  • How will we respond to the next threat?
Dr Wellington Sun, Director Division of Vaccines and Related Products Applications CBER, U.S. Food and Drug Administration

Networking coffee break

James Mansi

A century of vaccine development & innovation: Ensuring novel influenza vaccines are available to meet the needs of diverse patients groups

  • Vaccines developed for the young, the old, and everyone in between
  • Moving from traditional needle and syringe to innovative needle-free delivery systems
  • Transition from traditional trivalent flu vaccines to quadrivalent, cell culture based, and adjuvanted vaccines
James Mansi, Global Head, Medical Affairs, Novartis Influenza Vaccines
Dr Gary Nabel

What is the vision for a HIV vaccine? Has it changed in the last decade?

  • Update on the clinical trials and their progress
  • Has the sense of urgency for a HIV vaccine lost its momentum with effective preventative methods that can stop/limit transmission
  • Could HIV eliminate itself eventually?
  • The vision for a vaccine to replace all preventative methods 
Dr Gary Nabel, Senior Vice President and Chief Scientific Officer, Sanofi Inc
Rahul Singhvi

The future sustainability of vaccines - What pressure does the industry suffer from that could prevent access to vaccine?

-How will the industry look in 10 years? Understanding the industry dynamics and factors that will give you a competive advantage
-Addressing the obstacles poised in market access and manufacturing
-How to treat the vaccine industry differently to the pharmaceutical industry as a whole, using value based pricing as an example
Rahul Singhvi, Chief Operating Officer, Takeda Vaccines, Inc.
Dr Gregory A. Poland

Chair’s closing remarks and close of congress day 1

Dr Gregory A. Poland, Director of Mayo Vaccine Research Group, Mayo Clinic and Foundation

Pre-Awards Networking Drinks Reception


Gala Dinner & ViE Awards Ceremony

last published: 24/Mar/16 11:25



Influenza and Respiratory, Wednesday 30 March 2016

Dr George Siber
Influenza and Respiratory

Chair’s opening remarks

Dr George Siber, CSO of ClearPath Vaccines & Scientific Advisory Board of Genocea, ClearPath Vaccines
Mr Louis Fries
Influenza and Respiratory

The RSV nanoparticle vaccine, progress towards infant and elder protection

  • Finding the path to developing a successful human RSV vaccine
  • How this vaccine will reduce the consequences of disease caused by RSV in children, adults and pregnant women
Mr Louis Fries, CMO, Novavax
Dr Steve Projan
Influenza and Respiratory

Bringing a next-gen mAb RSV treatment to the market

  • Presenting phase I safety trials to investigate the candidate in healthy preterm infants
Dr Steve Projan, Senior Vice President of Innovative Medicines, Research and Development and Head of Infectious Diseases and Vaccines, MedImmune Inc
Dr Jerald Sadoff
Influenza and Respiratory

Providing RSV protection to pre-infants, elderly and maternal patients

Dr Jerald Sadoff, Senior Advisor CEO, Janssen Infectious Diseases and Vaccines

Networking coffee break

Dr Kees Leenhouts
Influenza and Respiratory

RSV prefusion F-type subunit vaccines for different target populations

​• Characteristics of a prefusion-type F antigen
• Relevance of mucosal immunity
• Intramuscular and intranasal applications
Dr Kees Leenhouts, Chief Scientific Officer, Mucosis
Assoc. Prof Asuncion Mejias
Influenza and Respiratory

Gaps in knowledge of RSV epidemiology and pathogenesis – The importance for vaccine development

Assoc. Prof Asuncion Mejias, Assoc. Prof of Pediatrics, Division of Infectious Diseases at Ohio State University College of Medicine & Principal Investigator, The Research Institute at Nationwide Children's Hospital
Ms Deborah Higgins
Influenza and Respiratory

RSV vaccines for maternal immunization

  • Where are we in maternal immunization in vaccine development? Providing a clinical overview
  • The RSV case definition and endpoint guidance developed to date
  • Additional studies and information required beyond vaccine licensure to achieve WHO prequalification to allow the vaccine to be made available to the developing world
Ms Deborah Higgins, Director - RSV Vaccine Project, P.A.T.H.
Dr Peter Kwong
Influenza and Respiratory

Structure-based design of a second generation pre-fusion RSV F vaccine

  • Development of an RSV F vaccine with improved stability and immunogenicity
  • Example of structure-based optimization
  • General paradigm for structure-based vaccine design
Dr Peter Kwong, Chief, Structural Biology Section, NIH

Networking Lunch

Dr Ruben Donis
Influenza and Respiratory

Advanced development of more effective universal influenza vaccines

  • Making sure proposals are mature enough and hit government criteria for support
  • Request for Proposal (RFP) to develop, manufacture, and evaluate more effective influenza vaccine candidates toward US licensure 
Dr Ruben Donis, Chief of the Molecular Virology and Vaccines, U.S. Dept. of Health
Dr Peter Palese
Influenza and Respiratory

Presenting a universal influenza virus vaccine approach

Dr Peter Palese, PROFESSOR and CHAIR Microbiology, Mount Sinai School of Medicine
Dr Pamuk Bilsel
Influenza and Respiratory

The promise of prevention: Developing a novel universal vaccine virus, M2SR, based on deletion of a portion of the M2 gene

  • Allowing single replication of the vaccine virus that achieves long-lasting, cross-protective immunity against multiple viral subtypes
  • Encoding viral antigens from any influenza strain; e.g. insertion of the HA and neuraminidase antigens (NA) from the H1N1pdm
  • Entering human trials in 2016
Dr Pamuk Bilsel, Vice President Research and Development, FluGen Inc
Dr Sean Tucker
Influenza and Respiratory

High titre neutralizing antibodies to influenza after oral tablet immunization: A phase 1, randomized, placebo-controlled trial

  • An oral tablet alternative made in cell culture
  • Assessing the safety and immunogenicity of an oral tablet vaccine against influenza A H1N1 in healthy adults
Dr Sean Tucker, CSO and VP Research, Vaxart

Networking coffee break

Dr Nicolas Noulin
Influenza and Respiratory

The gold standard for human challenge studies in respiratory vaccines

  • A superior alternative to early stage, field-based trials, enabling respiratory vaccine development to accelerate
  • Reducing the cost of bringing anti-viral drugs, diagnostics and vaccines to market.
  • Permitting the development of new diagnostics and companion biomarkers
Dr Nicolas Noulin, Principal Virologist, hVIVO
Dr Ted Ross
Influenza and Respiratory

Broadly protective and universal influenza vaccines: enhancing the standard of care

  • Design and characterization of a COBRA HA vaccine for H1N1 influenza viruses
  • Eliciting a broad antibody response against H5N1 isolates from different clades
  • Reporting the development and characterization of a COBRA-based vaccine for both seasonal and pandemic H1N1 influenza isolates
Dr Ted Ross, Director, Vaccines & Infectious Diseases, University of Georgia
Dr Tim Alefantis, Director, Pre to Early Development Project Leader - R&D Global Projects, Sanofi Pasteur Inc
Dr Kristin Bedard
Influenza and Respiratory

Developing novel innate immune agonists to adjuvant influenza vaccines

  • Developing an immunomodulator that activates IRF-3 and induces innate immune signaling to drive an antigen-specific protective immune response against viral infections
  • Inducing Th2 and immunoregulatory cytokines
  • KIN adjuvant systems are dose sparing for influenza vaccines
Dr Kristin Bedard, Director and Head of Virology, Kineta Inc
Dr Andrei Egorov
Influenza and Respiratory

Panel: Advances and prospects for universal and broadly cross-reactive vaccines: Are we getting any closer?

  • Why is the general efficacy of flu vaccines not that effective?
  • How to predict future strains when manufacturing in advance?
  • Can a universal and highly immunogenic vaccine at low doses be achieved?
Panelists to be announced shortly
Dr Andrei Egorov, CSO, Vacthera BioTech GmbH
Dr Francesco Berlanda Scorza, Scientific Director of Influenza Vaccine Project, P.A.T.H.
Dr Peter Palese, PROFESSOR and CHAIR Microbiology, Mount Sinai School of Medicine
Dr Tim Alefantis, Director, Pre to Early Development Project Leader - R&D Global Projects, Sanofi Pasteur Inc
Dr George Siber
Influenza and Respiratory

Chair’s closing remarks and close of congress day 2

Dr George Siber, CSO of ClearPath Vaccines & Scientific Advisory Board of Genocea, ClearPath Vaccines
last published: 24/Mar/16 11:26



Influenza and Respiratory, Thursday 31 March 2016

Dr George Siber
Influenza and Respiratory

Chair’s opening remarks

Dr George Siber, CSO of ClearPath Vaccines & Scientific Advisory Board of Genocea, ClearPath Vaccines
Dr Ann Ginsberg
Influenza and Respiratory

TB vaccine candidates in clinical development around the world

  • Discussing the range of different TB vaccine clinical trials taking place and their progress
  • Potential for modernizing and harmonizing BCG manufacture to address current supply and variability issues
Dr Ann Ginsberg, Chief Medical Officer, Aeras
Dr Cecilia Lindestam Arlehamn
Influenza and Respiratory

Understanding the immunobiology of TB for development of vaccines and diagnostics

  • Immunological consequences of intragenus conservation of Mycobacterium tuberculosis T-cell epitopes
  • Impairment of immunity to Candida and Mycobacterium in humans with bi-allelic RORC
  • Immunodominant antigens and epitopes defined using approaches targeting TB proteins by genome-wide discovery approaches
Dr Cecilia Lindestam Arlehamn, Instructor, Division of Vaccine Discovery, La Jolla Institute for Allergy and Immunology
Dr Jens Gertow
Influenza and Respiratory

FluoroSpot/ELISpot in Influenza vaccine development

  • Measure T-cell and B-cell responses at the single cell level
  • Virus cross-reactivity in Influenza
  • Ferret IFN-gamma ELISpot
Dr Jens Gertow, Senior Scientist, Mabtech
Influenza and Respiratory

High density display of antigens on the surface of bacterial OMVs elicits protective responses

  • Developing unique vaccine platform based on Gram-negative bacteria and derived Outer Membrane Vesicles (OMVs)
  • Simultaneously expressing different antigens per bacterium or derived membrane vesicle, allowing broadly protecting vaccines that induce immunity to multiple pathogens or pathogen variants
  • Compatibility via nasal or oral administration routes

Networking coffee break

Dr Elizabeth Trainor Schoenfeld
Influenza and Respiratory

Development of a baboon model of pertussis for vaccine development

  • Understanding critical questions about pertussis pathogenesis and host responses to aid development of next-generation pertussis vaccines
Dr Elizabeth Trainor Schoenfeld, Fellow, Division of Bacterial, Parasitic and Allergenic Products, Center for Biologics Evaluation and Research, F.D.A
Dr Giuseppe Ciaramella
Influenza and Respiratory

The ability of modified mRNA to express viral antigens in vivo and to induce robust immune responses

  • Using mRNA to express antibodies that bind to viral and other targets
  • Illustrating preclinical infectious disease models, together with the inherent, rapid turn-around time in creating novel mRNA constructs,
  • A versatile new platform to create a broad array of vaccines and passive immunity therapies including influenza
Dr Giuseppe Ciaramella, Chief Scientific Officer, Valera

Networking Lunch

Dr Gregory A. Poland

Chair’s opening remarks

Dr Gregory A. Poland, Director of Mayo Vaccine Research Group, Mayo Clinic and Foundation
Dr Thomas Breuer

ABCs of Supply and Demand: Creating the Future

-    Appreciating the intricacies of the vaccine industry: Roles and structure of the Industry, R&D and manufacturing cycles    
-    Industry future: Health solutions and business challenges
-    How we achieve business sustainability and meet global vaccine needs
-    Measuring and recognizing the full economic and social value of vaccines
-    What the industry, partners and governments need to do
Dr Thomas Breuer, Senior Vice President, Chief Medical Officer, G.S.K. Vaccines
Dr Carol J. Baker

Do we need a new strategy for maternal immunization?

  • Are vaccines that benefit the baby more than the mother acceptable?
  • Have we progressed in our understanding of maternal and neonatal vaccine immunology?
  • Where are we with development of vaccines that affect maternal and infant health (e.g., group B Streptococcus, respiratory syncytial virus, pertussis and influenza)?
Dr Carol J. Baker, Head of Infectious Disease Professor of Pediatrics, Baylor College of Medicine
Dr Jerome Kim

A MERS vaccine: Doing research and vaccine development preemptively

  • For-profit vaccine companies will find it difficult to make vaccines that are not used except in an emergency
  • Governments can and do fund the production of vaccines that are not commercially viable but bear the risks of discovery and the burden of development
  • MERS is not the herald of an impending epidemic apocalypse but public health, and the vaccines necessary to maintain it, is not free or easy
Dr Jerome Kim, Director-General, International Vaccine Institute
Dr Gregory A. Poland

Chair’s closing remarks and close of congress

Dr Gregory A. Poland, Director of Mayo Vaccine Research Group, Mayo Clinic and Foundation
last published: 24/Mar/16 11:26