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Challenges in Pre-Clinical Development - Top 5 Challenges in Vaccines & Immunotherapeutics


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Cambridge Healthtech Institute’s Third Annual Challenges in Pre-Clinical & Clinical Development conference will focus on the 5 challenges facing vaccine and immunotherapy developers in 2010. Development professionals from across the country and around the world will meet to address challenges to move beyond “one size fits all” vaccine development. Regulatory requirements, advancements in pre-clinical animal models, and novel methods for determining immune response will be addressed.   Expert speakers will provide examples of new and improved markers for immunogenicity and the movement toward standardization to better improve lab-to-lab correlations. Strategies for managing risk and evaluating analytical methods for post-marketing surveillance will be discussed by emerging leaders in the field.  Learn new opportunities in funding, including venture capitalism and strategic collaboration.  Ample opportunities to network, discuss advancements in disease–specific projects, and learn about the latest technologies available from multiple vendors will be available.  

  • Challenge 1: Selecting the Best Pre-Clinical Animal Models
  • Challenge 2: Identifying Biomarkers for Immune Response
  • Challenge 3: Standardizing Immunogenicity Testing
  • Challenge 4: Navigating Changing Regulatory Requirements
  • Challenge 5: Analyzing Post-Marketing Surveillance and Epidemiology

Topics to Include, but not limited to:

  • Effective methods for measuring immune response
  • Role of genetic host factors in safety and efficacy
  • Novel biomarkers for immune response
  • Identifying non-responsive patients using biomarkers
  • Risk management strategy
  • Post-marketing surveillance: new methods for signal detection
  • Prophylactic vaccine development from the lab to the clinic
  • Therapeutic vaccine development from the lab to the clinic
  • Selection of pre-clinical animal models for clinical success
  • Assessing concomitant vaccine safety and efficacy
  • Pre-clinical development of cellular immunotherapeutics
  • Case studies for the use of isolated cells vs. genetically engineered
  • Standardization of immunogenicity tests

Pre-Clinical and Clinical Development professionals who wish to present their knowledge and expertise to their colleagues are asked to submit an abstract.  Please remember to specify the conference that you are interested in and to provide your full contact information.

All proposals are subject to review by the Scientific Advisory Committee to ensure the highest quality of the conference program.

If you are interested in presenting, please click here to submit a speaking proposal for review. 
Deadline for submission is February 19, 2010

For more details on the conference, please contact:
Kate Skaare
Conference Producer
Cambridge Healthtech Institute
Phone: 781-972-5406
Email: kskaare@healthtech.com 

For partnering & sponsorship information, please contact:
Suzanne Carroll
Manager, Business Development
Cambridge Healthtech Institute
Phone: 781-972-5452
Email: scarroll@healthtech.com 

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