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Pre-Conference Short Courses



Pre-Conference SHORT COURSES* 

Monday, August 15, 2011
2:00 -5:00pm


SC1: Vaccine Business Opportunities 

By 2012, vaccines are expected to generate over $30 billion, yet new, more complex vaccines challenge capacity, requiring innovative strategies. While global demand for vaccines increases, pharmaceutical and biotech companies are searching for ways to secure partnerships that will help to advance their vaccine programs. This course will cover opportunities in the vaccine industry, effective partnerships and collaborations, and future value and perspectives.

1:00-2:00 pm Short Course Registration

2:00 Opening Remarks

2:05 Examination of Global Opportunities in the Vaccine Industry

Clement LewinClement Lewin, M.B.A. Ph.D., Head, Strategic Immunization Planning, Novartis Vaccines and Diagnostics -  Biography 

By preventing infectious diseases vaccines represent one of the most important public health interventions. The last decade has seen the introduction of new vaccines targeted at infants, adolescents and adults as well as expanded use of existing vaccines. Despite some challenges particularly in mature markets, there is significant potential for vaccines going forward. The opportunities for growth in immunization include the following: geographic expansion, improvements in safety and efficacy of existing vaccines, new antigens for existing immunization platforms and the emergence of new immunization platforms targeted at specific populations such as pregnant women.

2:55 Identifying, Valuing and Managing Partnerships with Large Players in the Vaccine Industry

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

Currently the number of large players in the vaccine industry worldwide is limited to less than a dozen. Small companies seeking partnerships with these players need to consider the positioning of their assett or technology and potential partnership in the context of the overall culutre, strategy and business of the large players. To value an assett, both players need to seek agreement on some basic marketplace and policy assumptions that the small company should be fully educated on. Finally signing the deal is only the first step for both parties in successfully gaining value from any partnership.

3:45 Refreshment Break

4:00 Successful Translational Project Management: Experiences of a Recent Collaboration between Private and Public Sectors

Bernd EiseleBernd Eisele, M.D., CEO, Vaccine Project Management GmbH - Biography 

This talk will describe how VPM develops its 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 to follow for a successful collaboration and present a case study on value creating translational project management. The benefits to both parties will be assessed and information on handling IP, royalties and terms will be given.

4:50 Q&A

5:00 End of Course

 

SC2: Supply Chain Management for Vaccines 

Sponsored by
Pall_LifeSciences
Effectively managing the supply chain is essential for developing vaccines, as any weak link can result in significant impairment to the quality of the drug, profitability and reputation of the manufacturer. Supply chain complexity requires an in depth understanding of multiple factors, players, and regulatory issues.

Instructor:


Patricia SeymourPatricia Seymour, Senior Consultant, Bioprocess Technology Consultants, Inc. - Biography




 

 

 

1:00-2:00 pm Short Course Registration

2:00 pm Opening Remarks

2:05 Part I

During this first session, we will cover the recent changes that regulatory authorities, primarily the FDA and EMA, are proposing to ensure improved security of global pharmaceutical supply chain, including:

  • The recently published draft revisions to both Chapters 5 and 7 of the EU GMP Guide, titled "Production" and "Outsourced Activities" respectively, and Annex 11
  • Proposed US legislation and FDA initiatives, including guidance on standardized numerical identifier (SNI)
  • The regulators are focusing more intensely on the suppliers used throughout the supply chain, so we will cover the industry best practices for how to identify, select, audit and manage a CMO to close Part I.

3:45 Refreshment Break

4:00 Part II

Following the break we will cover the logistics aspects of the supply chain by reviewing the different cold chain management strategies that vaccine developers use through-out their supply chains. We will also review the initiatives recently launched to improve visibility and security through-out the supply chain:

  • EDQM'strack-and-trace pilot study for pharmaceuticals, with the intention of developing a serial number system that will provide point-of-dispensing verification of medicine packages
  • FDA' Predictive Risk-based Evaluation for Dynamic Import ComplianceTargeting (PREDICT) information system to target its oversight of imports to more risky food and drug products.
  • US Customs and Border Protection (CBP) agency's Customs-Trade Partnership Against Terrorism (C-TPAT) program, which offers priority processing forproducts from companies with secure supply chains.

4:50 Q&A

5:00 End of Course



*Separate registration required 


 



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