Tuesday 29th March Plenary sessions are shared across all conferences


Clinical Development and Trials, 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 11:26



Clinical Development and Trials, Wednesday 30 March 2016

Dr Peter R. Paradiso
Clinical Development and Trials

Chair’s opening remarks

Dr Peter R. Paradiso, Former Vice President, New Business And Scientific Affairs, Pfizer Vaccines
Prof Stanley Plotkin
Clinical Development and Trials

Correlates of protection: The ability to establish what they are and what they can test

  • For some vaccines, we have no true correlates, but only useful surrogates, for an unknown protective response
  • The need to evaluate the constistency of vaccine production; the suseptibilities of individuals and populations after vaccinations; the validation of vaccines for which efficacy trials are not ethical, as when a prior-generation vaccine is already licensed, and the licensure of combination vaccines
Prof Stanley Plotkin, Emeritus Professor, University of Pennsylvania School of Medicine
Dr William Warren
Clinical Development and Trials

Developing predictive models to accurately assess human immune responses

  • Is it possible to develop a representative human translational immune model?
  • How to implement a science-based fast to fail/fast to succeed decisional process?
  • Can we do better than the animal model?
  • Will a few donors be representative of 1000’s of subjects?
Dr William Warren, Vice President, Sanofi Pasteur
Dr Andreas Meinke
Clinical Development and Trials

Pseudomonas aeruginosa / Clostridium difficile – Are prophylactic vaccinations against hospital acquired infections the right strategies?

Dr Andreas Meinke, VP Preclinical & Translational Research, Valneva Austria GmbH

Networking coffee break

Dr nathalie GARCON
Clinical Development and Trials

Future of adjuvants – what is needed? Better strategy for a rational design

  • The need to take a step back in order to clearly define your biomarkers
  • Knowing what you need to trigger to get the right responses for your vaccine
Lynlee Burton
Clinical Development and Trials

Vaccines studies – Operationalize before you finalize

  • Important operational questions to ask before your protocol is final
  • How to incorporate feedback from an experienced site
  • Re-think how/when the operations team and sites are trained
  • How sites can plan for optimal enrollment
Lynlee Burton, Director of Project Delivery - Vaccines, PRA Health Sciences
Dr Jeffrey Rosen, Medical Director and Founder, Clinical Research of South Florida
Adrian Wildfire
Clinical Development and Trials

A consideration of H1N1 2009pdm and new variant H3N2 2013 for viral challenge trials

  • THe use of live virus in viral challenge models to give early predictors of vaccine efficacy is becoming accepted by regulatory authorities as a valid bridge between animal modeling, first-in-human (FIH) and early phase field trials
  • Providing further information to those wishing to manufacture viral challenge agents to cGMP viruses
Adrian Wildfire, Project Director - Infectious Diseases & Viral Infection Unit, SGS Life Science Services

Networking Lunch

Dr Matthew Memoli
Clinical Development and Trials

The healthy human challenge model and endpoints for influenza: A path to accelerated vaccine evaluation

Dr Matthew Memoli, Director, Clinical Studies Unit, Laboratory of Infectious Diseases, NIAID - NIH
Dr Patricia Pietrobon
Clinical Development and Trials

Where are we in developing a vaccine against on C.diff?

Dr Patricia Pietrobon, Associate Vice President, R&D, Cdiff Program Leader, Sanofi Pasteur
Andrea Hulse
Clinical Development and Trials

Regulatory considerations for designing efficacy studies and trials for novel vaccines

Andrea Hulse, Chief, Clinical Review Branch II, Division of Vaccines, Center for Biologics Evaluation and Research F.D.A.

Networking coffee break

Dr Jerald Sadoff
Clinical Development and Trials

Encouraging results from pre-clinical and clinical studies for a HIV vaccine

  • Preventing the reoccurrence of the “dark days”
  • Evidence of protection against the simian immunodeficiency virus
  • Using a prime-boost strategy to produce antibodies and enhance the immune response over time
  • Summary of current clinical trials and their different approaches
Dr Jerald Sadoff, Senior Advisor CEO, Janssen Infectious Diseases and Vaccines
Dr Seth Hetherington
Clinical Development and Trials

Positive top-line Phase II data for genital herpes immunotherapy

  • Presenting highly statistically significant 55% reduction in viral shedding rate with best dose
Dr Seth Hetherington, Chief Medical Officer, Genocea Biosciences
Dr Tong Ming Fu
Clinical Development and Trials

A replication defective CMV vaccine for prevention of congenital CMV

  • Unmet need for a CMV vaccine to prevent congenital CMV infection; desired profiles of a protective immunity against maternal-fetal transmission
  • Design of a CMV vaccine capable of eliciting both arms of adaptive immunity; immunogenicity evaluation in NHP.
Dr Tong Ming Fu, Senior Investigator, Merck and Company
Hui (David) Shao
Clinical Development and Trials

A novel PIKA vaccine adjuvant in vaccine and beyond

  • Status of current vaccine adjuvant development
  • PIKA Adjuvant Chemistry and Biology
  • Preclinical and Clinical Results of PIKA adjuvant vaccine 
Hui (David) Shao, Chief Financial Officer, Yisheng Biopharma
Clinical Development and Trials

Chair’s closing remarks and close of congress day 2

last published: 24/Mar/16 11:26



Clinical Development and Trials, Thursday 31 March 2016


Networking coffee break


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