New Cells for New Vaccines IV - Changing the Vaccine Landscape: Recombinant Systems

Day 1, Monday, October 12

08:00-08:45 Keynote: Recombinant Protein Vaccines: Past, Present, and Future

John W. Boslego (PATH)

Session 1 - Improved and New Technologies


Session Co- Chair – Stephen Streatfield, Fraunhofer USA CMB

 

08:45-09:15 Plenary Talk: Agile Vaccine platforms for countering rapidly-emerging and anthropogenic pathogens
Michael Callahan, Director, Biodefense and Mass Casualty Care, CIMIT, Massachusetts General Hospital, Harvard Medical School


09:15-09:35 A rapid and inexpensive fungal production platform for producing influenza vaccine antigens
Debbie Higgins, Director - Vaccine Research & Development, Neugenesis Corp.


09:35-09:55 Use of the Pseudomonas fluorescens-based Pfēnex Expression Technology™ platform to rapidly produce antigens for vaccine development
Charles Squires, Pfēnex Expression Technology


09:55-10:20 BREAK

Session Co- Chair – Christine Farrance, Fraunhofer USA CMB

10:25-10:45 Embryonic stem cells for the industrial manufacture of Vaccines

Majid Mehtali, Vivalis, France

10:45-11:00 Robert Erwin, iBioPharma

11:00-11:25 FluBlok update and novel H1N1 produced using baculovirus-insect cell system

Jason Hollister, Scientist, Protein Sciences

11:25-11:45 cDNA to 3 Million Doses of Vaccine in under 3 Months: The Accelerated Manufacture of Pharmaceuticals Initiative”

Geoffrey Hodge, Xcellerex

11:45-12:05 Portable, Self-Contained,Biopharmaceutical Manufacturing

Barry Holtz, Holtz BioPharma Consulting

12:15-13:30 BREAK

Session 2 - Establishing target profiles 1: Molecular Characterization

Session Chair – Tudor Arvinte, Therapeomic, Switzerland

13:30-14:00 Plenary Talk: Towards the cause of TGN1412-induced adverse effects

Ulrich Kalinke, Twincore, Germany

14:00-14:20 Alan Shaw, VaxInnate

14:20-14:40 Biochemical Characterization of Insect cell Produced Influenza Virus-Like Particle (VLP) Vaccines

Steven Pincus, Novavax

14:40-15:00 Molecular Characterization of Plant-Produced HA Molecules

Vidadi Yusibov, Fraunhofer USA CMB

15:00-15:30 BREAK

Session 3 - Establishing target profiles 2: Biological Properties

Session Chair – Gale Smith, Novavax

15:30-16:00 Plenary Talk: Alternate Antibody Formats for Passive Immune-Interventions in Infectious Diseases
Ezio Bonvini, MacroGenics

16:00-16:20 Alan Shaw, VaxInnate

 

16:20-16:40 Immunogenicity of Plant-Produced Subunit HA-based Influenza Vaccines

Jessica Chichester, Senior Scientist, Fraunhofer USA CMB.

16:40-17:00 The Development of Recombinant Influenza Pandemic A (H1N1) 2009 and Seasonal Virus-Like Particle (VLP)Vaccines

Gale Smith, Novavax

17:00-17:20 Novel Enzyme Replacement Therapy for Gaucher Disease

Yoseph Shaaltiel, Protalix Biotherapeutics, Israel

18:30-20:00 CONFERENCE DINNER

DAY 2, Tuesday, October 13

Session 4 - Formulation 1: Target stability

Session Chair – Darrick Carter, IDRI

 

08:00-08:30 Plenary Talk: Importance of Formulation for the Success of Biopharmaceuticals

Tudor Arvinte. Ph.D., Prof., CEO, Therapeomic Inc.

08:30-08:50 The Human Hookworm Initiative (HHVI): Methodology applied for targeted stability of vaccine candidates

Maria Elena Bottazzi, the Human Hookworm Vaccine Initiative, George Washington University

08:50-09:10 Systematic formulation of vaccines

Russ Middaugh, University of Kansas

09:10-09:30 Phil Krause, FDA Office of Vaccines

09:30-10:00 BREAK

Session 5 - Formulation 2: Adjuvants

Session Chair – Lars Haaheim

 

10:10-10:40 Plenary Talk: Rational Design of Adjuvants

Nick Valiante, Novartis

10:40-11:00 Developing Next Generation Adjuvants: Pathogens show the way

Prakash Sambhara, CDC

11:00-11:20 The GSK Adjuvant experience

Ozzie Berger, GlaxoSmithKline Biologicals

11:20-11:40 Matrix-M adjuvant – a safe and efficacious ISCOM technology based adjuvant

Karin Lövgren Bengtsson, Isconova, Sweden

11:45-13:00 LUNCH


Session 6 - Formulation 3: Delivery Systems, Storage and Distribution

Session Chair –James Baker, NanoBio

13:00-13:30 Plenary Talk: Optimizing Adjuvant Formulations for Prophylactic and Therapeutic Vaccines

Steven G. Reed, IDRI (Infectious Disease Research Institute)

13:30-13:50 Nanoemulsions as Vaccine Adjuvants

James Baker, NanoBio

13:50-14:10 Alexander von Gabain, Intercell AG, Austria

14:10-14:30 A Broadly Applicable Stabilisation Technology for Vaccines and Biopharmaceuticals

Jeff Drew, CSO, Stabilitech, U.K.

14:30-14:50 Delivery Systems & Adjuvants for DNA and Protein-based Vaccine

Alain Rolland, Executive Vice President, Product Development, Vical

15:00-15:20 BREAK


Session 7 - Accelerating Time to Proof of Concept

Session Chair – John Petricciani, IABS

15:20-15:40 Plenary Talk: The 3R’s & Safe Vaccines

Rebecca Sheets, NIAID

15:40-16:00 Human ex vivo systems to predict immuno-modulatory potential of new drugs

Armin Braun, Head of Immunology, Fraunhofer ITEM, Germany

16:00-16:20 In Vitro Biomimetic Models Reflecting Human Immunophysiology

William Warren, VaxDesign

16:20-16:40 Feasibility Study on Production of Rabies Virus Vaccines in AGE1 Designer Cell Lines of Human and Duck Origin

Volker Sandig, ProBioGen, Germany

 

17:00-18:30 Poster Viewing, Wine and Cheese Reception

18:30 EVENING FREE

Day 3, Wednesday, October 14

Session 8 - VLPs - Late breaking information

Session Chair – John Schiller, Laboratory of Cellular Oncology, Division of Principal Sciences, National Cancer Institute, NIH

08:00-08:30 Plenary Talk: Overview of VLP Platforms and their Immunogenicity

John Schiller

08:30-08:50 A VLP-based Phage Display System for Vaccine Discovery

Bryce Chackerian, Assistant Professor, Molecular Genetics and Microbiology, University of New Mexico

08:50-09:10 Self-Assembling Polypeptide Nanoparticles (SAPN) - A New Platform Used to Make a Vaccine Against Malaria

Dave Lanar, Walter Reed Army Institute of Research

09:10-09:30 VLP-based Malaria Transmission Blocking Vaccines

Vidadi Yusibov, Fraunhofer USA CMB

09:30-09:50 Rinaldo Zurbriggen


09:50-10:20 BREAK

Session 9 - Regulatory Issues and the Current Global Situation Expanding Markets, Emerging Challenges

Session Chair - William Egan, Vice President, PharmaNet Consulting

10:20-10:30 Introductory Remarks: William Egan

10:30-10:50 A Regulatory Update on Cell Substrate Issues

Arifa Khan, FDA

10:50-11:10 The role of BARDA in the advanced development and procurement of vaccines

Arthur Elliott, BARDA (Biomedical Advanced Research and Development Authority)

11:10-11:30 Pandemic Influenza Vaccine Production: Challenges Facing the New Platforms

Ruben Donis, Chief, Molecular Virology and Vaccines, CDC CCID/NCIRD

11:30-12:00 Panel Discussion moderated by William Egan

Ruben Donis Arthur Elliot

Arifa Khan Phil Krause

Andrew Lewis

12:00 Adjourn

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