VACCINE BIOPROCESSING & MANUFACTURING CONFERENCE
Tuesday 29th March Plenary sessions are shared across all conferences
Bioprocessing & Manufacturing, 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 11:26
Bioprocessing & Manufacturing, Wednesday 30 March 2016
Chair’s opening remarks
Dr Christopher Yallop, Chief Operations and Scientific Officer, Batavia Biosciences
Key attributes necessary to generate well characterized adjuvant formulations
- Designing the best delivery systems for vaccine adjuvants, ensuring effective co-delivery
- Optimal utilization of alternative candidates, Alum, emulsions, liposomes and nanoparticles
- Defining assays to allow clinical progression of candidates
Dr Derek O'Hagan, Global Head of Vaccine Chemistry and Formulation Research, GSK Vaccines
Development and manufacturing challenges for a new stabilized pre-fusion RSV vaccine
- Challenges for stable cell line development for expression of the RSV vaccine
- Understanding the quality attributes of the pre-fusion vaccine
Mr Richard Schwartz, Chief of Vaccine Production Program, Vaccine Research Center of N.I.A.I.D. of N.I.H.
How process parameters impact your final vaccine formulation and stability
- Variations in manufacturing process parameters may influence your drug product stability.
- Understanding this impact is important to prevent surprises in stability studies.
- Process – product relationship is also an essential part of process validation.
Ms Renske Hesselink, Senior Scientist of Formulation Development, Janssen Infectious Diseases and Vaccines
10:40
Networking coffee break
Optimizing and developing new or novel formulations: Ensuring stability and scalability
- Biologic, chemical, and physical characterization of vaccines
- Dosage form development based on particle engineering for oral, parenteral, nasal, and pulmonary delivery
- Enteric capsules for oral delivery and rapid pre-clinical development
- Scale-up and technology transfer
Mr David Lyon, Senior Vice President of Research, Bend Research
Improving the pace and efficiency of viral vaccine development
- Viral Vaccines represent a high proportion of currently-produced vaccine doses globally
- New viral vaccine development has historically relied on infectivity- or antibody-based quantitation methods that are time-consuming, technically demanding, and somewhat imprecise
- New technologies, such as the Virocyt Virus Counter, address all of these difficulties and will allow more rapid and efficient development of new viral vaccine manufacturing processes
- Additional benefits will be seen in improving existing viral vaccine manufacturing and the development of viral vectors for gene therapy
Dr Daniel Vellom, Senior Director Global Technology Innovation, Sanofi Pasteur
Manufacturing and development challenges for conjugate vaccines
- End-to-end strategies for development, scale up and seamless transfer of multivalent vaccines
- Case studies of vaccine transfers and lessons learned
Mr Bo Arve, Executive Director, Pfizer Vaccine Research
Basav Ghosh, Sr. Director, Pfizer
13:10
Networking Lunch
Intranasal vaccination for elicitation of mucosal immunity
- Enabling vaccines for both respiratory & sexually transmitted infections
- Elicitation of efficacious and balanced immune responses
- Homing immunity to the port of entry: A new paradigm of protection
- Breaking the vicious cycle of infection by preventing carriage, shedding, and transmission of the associated pathogen
Dr Ali L. Fattom, Senior Vice President of Vaccine Research and Development, NanoBio Corporation
Microneedle patches: Innovation in vaccine delivery
- Design and fabrication of microneedle patches
- Improved immune responses to skin vaccination using microneedle patches
- Future uses of microneedle technology in wider vaccine development
Prof Mark Prausnitz, Regents’ Professor, Georgia Institute of Technology
Intradermal delivery of vaccines: Potential benefits and current challenges
- Review of the rationale and current state of intradermal injections
- Addressing the technology offerings for intradermal injection and trials designs to achieved for actionable results
Dr Diane Doughty, Lead Scientist, MedImmune
Advantages and progress with oral vaccines – advantages of plant-based vaccines over their traditional methods
- Manufacturing does not require expensive purification equipment, while transporting and storing them doesn’t require a costly “cold chain” of refrigeration
- Illustrating results of oral booster vaccine that produces systemic and mucosal immunity against different serotypes of polio
- Elimination of OPV boosters to avoid recombination with non-polio enteroviruses associated with acute flaccid paralysis
- Scale up for manufacturing and cGMP industrial production of plants producing vaccine antigens
Dr Henry Daniell, Professor, University of Pennsylvania
16:10
Networking coffee break
Flexible high containment vaccine manufacturing
Dr Thomas Page, Assistant Vice President of Engineering, Fujifilm Diosynth Biotech
Challenges and considerations in developing nucleic based vaccine drug products
- Formulating for delivery
- Conformation and stability
- Refined analytical methods
Dr Murali Bilikallahalli, Asso Dir, Medimmune L.L.C (A.Z.N)
Bioreactor needs for the developing world: Vaccine self-sufficiency and pandemic outbreaks
- Linearly scalable breaking oxygen scale up limitation
- Only packed bed bioreactor in the world using same cell culture method (Tide based) from seed preparation to large scale production with automated and closed cell harvesting
- Only packed bed bioreactor in the world using same cell culture method (Tide based) from seed preparation to large scale production with automated and closed cell harvesting
XiangLiang Lin, Founder, President & CEO, VacciXcell, Esco Global
PRINT® molding technology changing the paradigm in vaccine development and production
· Developing vaccine formulations containing incompatible components
· Formulating poorly soluble drug substances or adjuvants
· Changing vaccine schedules with pulsatile antigen release
· Dry collection to eliminate the need for lyophilzation
· Alternative administration routes such as inhaled delivery
· Versatile technology with broad potential to influence vaccines formulation
· Formulating poorly soluble drug substances or adjuvants
· Changing vaccine schedules with pulsatile antigen release
· Dry collection to eliminate the need for lyophilzation
· Alternative administration routes such as inhaled delivery
· Versatile technology with broad potential to influence vaccines formulation
Dr Michele Stone, Executive Director of Vaccine, Liquidia Technologies
How variations in vaccine process affects regulation and life cycle management
- Driving global regulatory convergence for post approval changes in regulations
- Facilitating global standards and risk mitigation strategies that protect patient safety and drive global regulatory convergence
Dr Andrew Robertson, Director, Global Regulatory Policy and Affairs, Merck and Company
Chair’s closing remarks and close of congress day 2
Dr Daniel Vellom, Senior Director Global Technology Innovation, Sanofi Pasteur
last published: 24/Mar/16 11:26
Bioprocessing & Manufacturing, Thursday 31 March 2016
Chair’s opening remarks
Dr Daniel Vellom, Senior Director Global Technology Innovation, Sanofi Pasteur
Challenges in the development and scale-up of an attenuated live virus vaccine candidate for human cytomegalovirus infection
- Application of a novel genetic inactivation strategy
- Challenges in adapting an adherent cell substrate to micro-carrier based production systems
- Challenges in developing downstream unit operations for a fully aseptic process
Dr Joseph Joyce, Director, Vaccine Process Development, Merck
Case study Q&A: Manufacturing live attenuated vaccines – Has it gotten any easier?
- Why are live attenuated viruses manufactured so much less – have we come any closer to maintaining quality and consistency?
- What steps do manufacturers and FDA take to assess the quality of viral vaccines during the production process?
- Will the industry just rely on other vaccine types out of ease of production?
Dr Scot Shoemaker, Senior Director, Takeda
Dr Joseph Joyce, Director, Vaccine Process Development, Merck
10:40
Networking coffee break
Novel pathways to robust and cost-effective vaccine manufacturing
- Holistic approach that integrates new tested strategies for cost efficient manufacturing of vaccines
- Linking innovations in cell line development, upstream and downstream provides high productivity processes
- Single-use affinity membrane purification platform enables simplified process architecture, robustness and high yield and enhance competitive advantage
Dr Renaud Jacquemart, Principal Scientist, Natrix Separations
12.0 Designing closed, single-use processes for vaccine formulations
• Adjuvanted processing: protein adsorption, heterogeneity, PAT
• Sterile filtration design and compliance
• Particulates evaluation in the process train of consumables
• Sampling limitations and disasters
• Sterile filtration design and compliance
• Particulates evaluation in the process train of consumables
• Sampling limitations and disasters
Kirsten Strahlendorf, Senior Scientist - BioProcess R&D Formulation and Stability Platform, Sanofi Pasteur
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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