Short Courses

Monday, August 16, 2010*

1:00pm Pre-Conference Short Course Registration


2:00 Chairman’s Remarks
Melissa Malhame M.B.A., Senior Director, Dynavax Technologies Corp

2:05 Examination of Global Opportunities in the Vaccine Industry

C.S. LewinC.S. Lewin, M.B.A., Ph.D., Head, Strategic Immunization Planning, Novartis Vaccines and Diagnostics

The past two decades have seen significant progress on immunization due in part to a favorable policy environment and partnerships between stakeholders in the public and private sectors. R&D efforts are focused on traditional targets for immunization and also new areas. Vaccines targeted at man-made or emerging natural threats represent development opportunities. Governments and the vaccine industry have invested accordingly. Vaccine development is becoming increasingly more complex but despite this challenge it is anticipated that over the next decade new vaccines will be introduced and the burden of vaccine-preventable infectious diseases will decline. Biography 

2:40 Positioning your Product to take Advantage of Business Opportunities in the Vaccine Market

Alan R. ShawAlan R. Shaw, Ph.D., Chairman, CSO, VaxInnate Corporation

Taking a vaccine candidate from concept through implementation is a long process with many checkpoints and pitfalls. Questions to consider include the following: is there a public health need for your vaccine and if you make it, will it get used; can you construct a clinical trial that proves it works; can you convince the FDA that it is safe; how do you get the vaccine community on board; how and where will you manufacture your vaccine; do you have a consistent process; do you have a test-release strategy that is robust and informative; what are inspectors most likely to question? Biography

3:15 Refreshment Break

3:45 Experiences of a Recent Collaboration between Private and Public Sectors

Bernd Eisele, M.D., CEO, Vaccine Project Management, GmbH

The talk will report on how we have developed products in a fast and cost-efficient way together with a consortium of well-experienced partners that belong both to academia and the private sector. It will examine the steps followed for a successful collaboration and present a case study. The benefits to both parties will be assessed, and information on handling IP, royalties and terms will be given.

4:20 Critical Skills for Effective Alliance Management

Melissa MalhameMelissa Malhame, M.B.A., Senior Director, Dynavax Technologies Corp.

Collaborations between small and large vaccine developers provide the potential for utilizing the core competencies and experiences of each player toward a successful product development. Defining “success” and aligning both the scientific and business priorities and levels of risk tolerance for each partner are critical for creating and maintaining successful partnerships. From the perspective of a small player, maximizing the value of collaborations across your portfolio of projects should involve a myriad of approaches, each tailored to the strengths of potential collaborators. Biography

4:55 Discussion

5:30 End of Short Course


2:00 Chairperson’s Opening Remarks
Trevor Deeks, Ph.D., Senior Director, Manufacturing Operations and Engineering, Contract Manufacturing Group, Emergent BioSolutions Inc.

2:05 Industry Case Study on Comparison between Disposables and Conventional Methods

Harold Ross, Consultant and Former Vice President, Process Development & Manufacturing, KBI Biopharma, Inc.

Disposable technologies typically provide flexibility, and reduce capital costs, water utilization, validation time and cost, and equipment footprint. KBI Biopharma has embraced single-use technologies for cell culture based biologics at its multi-product facility. In addition, KBI has developed a proprietary next-generation single-use cell handling technology, kSep®, to fill the gap in the disposable centrifugation area. Challenges and advantages will be discussed.

2:35 Application of Single Use Systems in Dedicated and Multi-Product Vaccine Plants: Implications for Plant Utilization, COGS and Validation

Roman Necina, Ph.D., Site Director Vienna, Intercell, A.G.

At Intercell Biomedical Ltd. Scotland, Intercell’s novel JE vaccine is manufactured in a dedicated plant, whereas at IC USA, the needle-free vaccine patch against Travelers’ Diarrhea (Phase III) and Pandemic Influenza (Phase II) are manufactured in a multi-product plant. In Scotland, single use systems allow best possible utilization of plant capacities for routine, commercial manufacturing. At IC USA, single use systems allow flexible capacity utilization with different products. Application of those systems impacts the design of manufacturing plants as well as the cleaning and process validation approach. Biography

3:05 How Single Use Systems Lend Themselves to Management of Multi-Product Facilities

Howard L. Levine, Ph.D., President, BioProcess Technology Consultants, Inc.

While single-use capsule filters have been used in biomanufacturing for decades, other downstream unit operations, such as chromatography and tangential flow filtration, have been slower to evolve scalable disposable-format technologies. This presentation will provide a review of the driving forces for adoption of single-use technologies as well as an overview of recent advances in disposable-format technologies for downstream processing.

3:35 Refreshment Break

4:00 Implementation of Single-Use Technology in Vaccine Formulation ApplicationsSponsored by
Pall Life Sciences

Donna Riedman, Scientific Services Project Manager, Pall Life Sciences

In this presentation we will address critical applications of single use technology focusing on the challenges, and provide examples including timelines. We will give a brief overview of some key components for formulation & mixing applications, and include validation aspects with especial reference to particulate testing.

4:30 Application of Single Use Systems for Pandemic Preparedness

H. James White, P.E., Executive Director, Engineering & Technical Services, Technical and Quality Operations, Novavax, Inc.

The onset of the H1N1 influenza pandemic brought to light many gaps in global preparedness. The use of single-use systems can reduce the time it takes to build production capacity and get the product to market. This presentation will highlight strategies and benefits related to the use of single-use systems and the potential for use of a regional facility concept in response to a pandemic, as well as challenges in using relatively new technologies in delivering product on a global scale. Biography

5:00 Application of disposable membrane capsules in the manufacture of plasmid DNA for pre-clinical studies

Henry HebelHenry L. Hebel, COO, VGXI Inc.

Two commercially available anion exchange membrane products were compared at process scale regarding DNA binding capacity, contaminant removal and form separation. One had a binding capacity ten-fold that of typical resins. These membrane capsules provide simple, convenient, and economical alternatives to traditional ion exchange chromatography. Their flexibility allows minimized product turn-around time, an essential feature for the manufacture of variable DNA vaccines at large scale for quick response to pandemic threats. Biography

5:30 End of Short Course


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