EMERGING & RE-EMERGING DISEASES CONFERENCE
Tuesday 29th March Plenary sessions are shared across all conferences
Emerging and Re-emerging, Tuesday 29 March 2016
09:00
Chair’s opening remarks
Dr Gregory A. Poland, Director of Mayo Vaccine Research Group, Mayo Clinic and Foundation
09:10
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
09:40
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
10:10
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
10:40
Networking Coffee Break
11:40
ROUNDTABLES
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
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
12:40
Networking Lunch
14:10
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
14:50
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
15:30
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
16:00
Networking coffee break
16:30
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
17:00
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
17:30
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
-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.
18:00
Chair’s closing remarks and close of congress day 1
Dr Gregory A. Poland, Director of Mayo Vaccine Research Group, Mayo Clinic and Foundation
18:10
Pre-Awards Networking Drinks Reception
19:30
Gala Dinner & ViE Awards Ceremony
last published: 24/Mar/16 11:25
Emerging and Re-emerging, Wednesday 30 March 2016
Chair’s opening remarks
Dr Jerome Kim, Director-General, International Vaccine Institute
Panel: Breaking News: Prospects for a Zika virus vaccine
- What do we know about the pathogenesis of Zika virus infection?
- What can we expect to learn as a larger number of individuals becomes infected?
- What is the quickest path to a safe and effective vaccine?
- What is the response of the FDA, and other regulatory authorities, to the Zika vaccine development?
- Will a live virus vaccine be safe enough to vaccinate pregnant women?
- How will governmental agencies and NGO respond to the Zika threat?
- What financial assistance can be expected from the US Federal government?
- What can we expect to learn as a larger number of individuals becomes infected?
- What is the quickest path to a safe and effective vaccine?
- What is the response of the FDA, and other regulatory authorities, to the Zika vaccine development?
- Will a live virus vaccine be safe enough to vaccinate pregnant women?
- How will governmental agencies and NGO respond to the Zika threat?
- What financial assistance can be expected from the US Federal government?
Dr Wellington Sun, Director Division of Vaccines and Related Products Applications CBER, U.S. Food and Drug Administration
Dr Rick Bright, Director of the Influenza Division and Emerging Infectious Disease, HHS/OS/ASPR/BARDA
Dr Nicholas Jackson, Vice President, Head of Global Research, Sanofi Pasteur
Dr Peter Hotez, President of the Sabin Vaccine Institute and Dean of National School of Tropical Medicine, Baylor College of Medicine
Dr Elliot Parks, President & CEO, Hawaii Biotech
Update and path forward on rVSV Ebola vaccine development
- Data on clinical efficacy, safety, tolerability and immuncogenicity
- Current epidermiological findings and implications for future vaccine use
Dr swati gupta, exec director, Merck
10:40
Networking coffee break
Synthetic DNA vaccine provides robust protection from disease in NHP and appears immune potent in Camels: MERS-CoV
- Preventing the pandemic potential of MERS-CoV: Updates on research and clinical development
- Generating potentially protective antibodies in blood drawn from camels
- The potential to overcome important production and deployment limitations
Prof David Weiner, WW Smith Endowed Chair in Cancer Research, Director Wistar Vaccine Center, EVP of The Wistar Institute, Professor Emeritus, University of Pennsylvania School of Medicine
Why do we need to bring back a vaccine for Lyme disease?
- Potential vaccine strategies and targets
- Lessons learned from LYMErix
- Progress towards a second generation Lyme disease vaccine
Prof Stanley A. Plotkin, Emeritus Professor, University of Pennsylvania & Executive Advisor, Sanofi Pasteur
12:35 Presentation of Valneva’s Lyme vaccine candidate VLA 15
- Target Product Profile and results to date (pre-clinical)
- Product development strategy and expected route to marketing approval
- Potential market entry & expected benefits
Thomas Lingelbach, President & CEO, Valneva
1:00 Discussions
- Lessons learned from LYMErix
- Progress towards a second generation Lyme disease vaccine
Prof Stanley A. Plotkin, Emeritus Professor, University of Pennsylvania & Executive Advisor, Sanofi Pasteur
12:35 Presentation of Valneva’s Lyme vaccine candidate VLA 15
- Target Product Profile and results to date (pre-clinical)
- Product development strategy and expected route to marketing approval
- Potential market entry & expected benefits
Thomas Lingelbach, President & CEO, Valneva
1:00 Discussions
Prof Stanley Plotkin, Emeritus Professor, University of Pennsylvania School of Medicine
Mr Thomas Lingelbach, President and Chief Executive Officer, Valneva SE
13:10
Networking Lunch
Developing a prophylactic vaccine against chikungunya – First-in-man results
- Assessing the vaccine’s safety and tolerability profile
- Future plans for trials and large scale production
Dr Erich Tauber, Chief Executive Officer and Founder, Themis Bioscience
Technologies to facilitate a rapid vaccine response to newly emerging pathogens
- Identification of protective antigens
- Novel adjuvants to increase potency and breadth
- Rapid response to newly emerging pathogens
Dr Jeffrey Ulmer, Head, Preclinical R&D US, GSK Vaccines
Making dengue the next vaccine-preventable disease
- Phase III efficacy results and clinical platform
- Sanofi’s vision and engagement plan for successfully executing the vaccine to dengue stricken areas: Exploring unique collaborations
Dr Nicholas Jackson, Vice President, Head of Global Research, Sanofi Pasteur
16:10
Networking coffee break
Identifying the mechanism in how the Dengue virus infection elicits highly polarized T cells for vaccine development
- Illustrating how the human CD8+ T-Cell responses against the 4 Dengue virus serotypes are associated with distinct patterns of protein targets
- CD8+ T cell responses induced by a live attenuated tetravalent dengue vaccine are directed against highly conserved epitopes
Dr Daniela Weiskopf, Instructor, Division of Vaccine Discovery, La Jolla Institute for Allergy and Immunology
Vaccine progression and developments against Malaria
- A review of the current candidates including RTS,S is the most advanced malaria vaccine candidate in development globally
- How can we prevent the parasite from infecting, maturing and multiplying in the host
- Practical considerations when making a vaccine for malaria stricken areas
- Will we always need to use other control methods such as bed nets?
Dr Christian Ockenhouse, Director, Medical and Clinical Operations, PATH
Panel on Malaria: Do we need this first generation vaccine or should we be developing a second generation vaccine?
- As all current malaria vaccines were designed with the old paradigm, is it necessary to develop second generation vaccines?
- Defining the purpose of a vaccine, should it eliminate completely or still need to be used with traditional preventative methods?
- Are vaccines that need continual boosts realistic in the developing regions where malaria is most prevalent
Dr Christian Ockenhouse, Director, Medical and Clinical Operations, PATH
Dr Stephen Hoffman, Chief Executive and Scientific Officer, Sanaria Inc
Dr Jerald Sadoff, Senior Advisor CEO, Janssen Infectious Diseases and Vaccines
Chair’s closing remarks and close of congress day 2
last published: 24/Mar/16 11:26
Emerging and Re-emerging, Thursday 31 March 2016
Chair’s opening remarks
Dr Jerome Kim, Director-General, International Vaccine Institute
Identification of host genes and proteins that affect the replication of emerging and re-emerging viruses - Developing enhanced vaccine cell lines
- Introducing a platform-enabling technology that can screen the genome to find host genes/pathways that resist viral replication
- Validating and knocking out genes in replication without changing the performance of the cell line
- Identifying druggable targets through gene editing, repurposed drugs and understanding the associated microRNAs
Dr Ralph Tripp, PI, University of Georgia
Advancing new vaccines against pandemic influenza in developing countries
- With the support of BARDA, PATH is working with governments and vaccine manufacturers to strengthen their influenza vaccine manufacturing capacity and improve their ability to respond to emerging pandemic influenza viruses, focuding on influenza A/H5N1 and A/H7N9
- Identifyinh best technologies and models for technical and clinical development of high quality and potent vaccines
- Reviewing the work carried out within this project to discuss lessons learned that can guide future activities
Dr Francesco Berlanda Scorza, Scientific Director of Influenza Vaccine Project, P.A.T.H.
Creating a vaccine against B.pseudomallei using a glyco-engineering vaccine strategy
- Illustrating major advancement in this field as well as introducing glyco-tools used for the design and production of vaccines
- Demonstrating safety, stability, potential and scalability
Dr Natalia Bednarska, PhD, London School of Hygiene and Tropical Medicine
10:40
Networking coffee break
Developing a promising new bacterial vaccine against enterotoxigenic Escherichia coli (ETEC)
- The potential to curtail the number and severity of food-borne illnesses due to ETEC
- Decreasing the risk of post-infectious irritable bowel syndrome
- Launching full-scale clinical development of a multivalent adhesin-based ETEC vaccine
Dr Ramiro L Gutierrez, Head, Enteric Diseases Department Deputy Dir., Infectious Diseases Directorate Chair, Institutional Review Board, Naval Medical Research center
Progress and clinical efficacy with new oral vaccines against Cholera and Typhoid
- Increasing cholera incidence especially in sub-Saharan Africa and Asia, developing regions in the Caribbean and South America have been particularly vulnerable to outbreaks
- Successfully meeting primary endpoints in phIII clinical trials to prevent spread and further outbreaks
Dr Lisa Danzig, Vice President, Clinical Development and Medical Affairs, PaxVax
12:30
Networking Lunch
13:30
Chair’s opening remarks
Dr Gregory A. Poland, Director of Mayo Vaccine Research Group, Mayo Clinic and Foundation
13:40
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
- 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
14:10
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
14:40
A MERS vaccine: Doing research and vaccine development preemptively
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Dr Jerome Kim, Director-General, International Vaccine Institute
15:10
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
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