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Attend a comprehensive program lead by top scientists in industry and the FDA presenting big pharma and biotech approaches to the challenges of cost effective, commercially viable vaccine production. Presentations focus on vaccine production from a variety of novel sources, process development, optimization and validation, and also measures to control product quality. The scale-up session will include the handling of a rapid response to seasonal flu and potential pandemics. The event will also focus on analytical studies to ensure product quality at all stages of development together with industry and regulatory perspectives on handling manufacturing process change.

WORKING WITH REGULATORY AUTHORITIES

Opening Keynote Presentation:
Regulatory Authority Perspective on Handling Vaccine Production, Manufacturing and Process Change

Norman Baylor, Ph.D., Director, Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, FDA

Industry Perspective on Handling the Complex and Sometimes Undefined Regulatory Requirements

Michael L. Dekleva, Director, Worldwide Regulatory Affairs, Merck, Inc.

SCALE-UP AND RAPID RESPONSE TO PANDEMICS

Scale-Up of an Intensified Process for Rad35 Adenovirus Production Using the PER.C6 Cell Substrate

Alfred Luitjens, Senior Scientist, New Technology, Crucell

Technical Challenges and Solutions for Development, Manufacturing Scale-Up and Management of Seasonal Strain Changes for Recombinant Influenza Vaccine

Albert Price, Ph.D., Technical Director, Influenza, Protein Sciences Corporation

Case Study on Scale-Up of Production from Bench to Commercialization

Rinaldo Zurbriggen, Ph.D., Senior Program Manager, Lonza AG (Formerly CSO of Pevion Biotech)

Staying Live: Scale-Up of an Attenuated Respiratory Syncytial Virus (RSV) Vaccine

Mark W. Thompson, R.Ph., Ph.D., Director, Vaccine Process Biochemistry, Vaccine Development, MedImmune, Inc.

PROCESS DEVELOPMENT AND OPTIMIZATION FOR VACCINE MANUFACTURE

Gaining Control and Determining Specifications of the Process

Speaker to be Announced

Designing and Validating a Manufacturing Process

Trevor Deeks, Ph.D., Senior Director, Manufacturing Support Group, Contract Manufacturing Group, Emergent BioSolutions, Inc.

Advances in Purification Technology

Speaker to be Announced

Manufacturing a Sterile, Autologous Colon Tumor Derived Vaccine for a Patient-Specific Immunotherapeutic Treatment

Michael Hanna, Ph.D., Chairman and CEO, Vaccinogen, Inc.

Managing Aggregation of VLP and Viral Vaccines

Speaker to be Announced

Measures to Reduce Cost of Goods in Vaccine Manufacturing Particularly in Implementing Change

Speaker to be Announced

Production of Influenza Vaccines Using a Fungal Production Platform

Debbie Higgins, Ph.D., Vice President, Vaccine Development, Neugenesis Corporation

Spray Drying in Vaccine Manufacturing for Improved Stability

Tom Jin, M.D., Scientist, Principal Investigator, Technique Operations & Manufacturing, Aeras Global TB Vaccine Foundation

QUALITY ISSUES & COMPARABILITY

Quality by Design for Maintaining Quality and Potency of the Product and for Risk Analysis

Speaker to be Announced

Change Control Assays to Ensure Consistent Antigen and Product Characteristics

Speaker to be Announced

After the License Approval - What Can Analytics Do?

Robert D. Sitrin, Ph.D., Executive Director, GVTE-Bioanalytics, Merck Manufacturing Division

Characterization of the Product to Satisfy the Regulatory Authorities

Jonathan Liu, D.V.M., Ph.D., Director, R&D, Vaccine Development, MedImmune, Inc.