Cambridge Healthtech Institute’s Inaugural
Regulatory Compliance in Drug-Diagnostics Co-Development
Navigating Regulatory Reefs
Part of the Fourth Annual Next Generation Dx Summit
August 21-22 

Targeted and tailored therapies and companion diagnostics are the two pillars of personalized medicine. The acceptance of the concept of personalized medicine was recently fueled by the latest success stories (Xalkori and Zelboraf) as well as the increasing demand from insurance companies for evidence of efficacy to support reimbursement decisions. Despite the strong FDA endorsement of personalized medicine, regulatory approval of therapeutic and companion diagnostics is a complicated process that requires precise knowledge and experience. The inaugural Regulatory Compliance in Drug-Diagnostics Co-Development conference is designed to help all parties involved in the process of drug-diagnostics co-development to learn how to navigate the regulatory reefs and bring their product to the market in the most effective and timely manner.

Topics may include:     

  • CMS’s CLIA regulations
  • Validation process for prognostics and predictive biomarkers
  • Integration of Rx and Dx development plans
  • Approval processes outside the US (EMA guidance, Japanese and Canadian considerations)
  • Diagnostic Bridging Studies
  • Coordinated NDA/PMA submissions
  • Coordinated BLA/PMA submissions
  • Solutions for successful pharma–diagnostics regulatory affairs collaboration
  • FDA inspections: What to expect
  • Draft FDA Guidance – In Vitro Companion Diagnostic Devices
  • Draft FDA Guidance – Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies
  • Historical examples of drug-diagnostics co-development
  • LDTs as companion tests

Scientists who wish to present their knowledge and expertise to their colleagues are asked to click here to submit an abstract.  Remember to specify the conference that you are interested in and please 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 submit a speaking proposal for review. 
Deadline for submission is February 17, 2012 

We welcome your comments, suggestions and speaker referrals as we shape the 2012 program.

For more details on the conference, please contact:
Marina Filshtinsky
Conference Producer
Cambridge Healthtech Institute
T: (+1) 781-972-5496
E: mfilshtinsky@healthtech.com 

For exhibit & sponsorship opportunities, please contact:Joe Vacca
Manager, Business Development
Cambridge Healthtech Institute
T: (+1) 781-972-5431
E: jvacca@healthtech.com