Animal, Vegetable, or Mineral: 20 Questions to a Winning CMC Strategy
Speaker: Stephen F. Tuck, Ph.D. – Co-Founder, Solutio Partners
Date/Time: Thursday, Dec. 18th, 8:00-10:00 AM, presentation begins at 8:30 sharp
Place: Genentech, 475 East Grand Ave, SSF, CA 94080, Building 42-1D
RSVP: http://NCBPPMDec2014Breakfast.eventzilla.net (Admission is free, but registration is required by 9:00 am 12/16)
Speaker Bio:
Stephen is a strategic drug development expert who cofounded Solutio Partners in 2007, a firm that provides drug development and regulatory consultation and contract services to emerging biopharma companies. He has extensive experience leading CMC, manufacturing, and product development programs and setting global CMC regulatory strategy for a range of novel medicinal products that includes Fluad? at Chiron and Heplisav?at Dynavax. He earned a Ph.D in chemistry from Imperial College London and completed post-doctoral training at Johns Hopkins University School of Medicine in Pharmacology and Therapeutics and at UCSF in Pharmaceutical Chemistry. Stephen’s career in biotech has spanned over 20 years in both public and private biopharmaceutical companies.
As a consultant, he has contributed to a diverse range of projects. Recently he has provided his CMC regulatory expertise to lead submissions to US and European authorities and has contributed to the design and execution of CMC programs for first-in-human as well as established molecules for cancer, asthma, and infectious diseases.
Stephen is unique among technical leaders. He brings not only strategic vision but also pragmatism and operational excellence to companies. This marriage of big-picture thinking and technical execution has earned him a reputation as an innovative problem solver who can streamline products through development while minimizing risk and expense.
Abstract:
Chemistry, Manufacturing, and Controls (CMC) is one leg of the development triangle that is critical to moving your drug into the clinic, keeping it there, and, if you are fortunate, submitting an NDA or BLA. In recent years, the second most common reason for FDA issuance of a complete response letter is a major deficiency in the CMC package. Building a robust CMC program requires the ability to adjust the CMC strategy to be appropriate for each successive stage of development from Discovery through NDA or BLA and navigating the inevitable speed bumps that arise. Thus, a thoughtful and nimble CMC approach paves a time- and cost-efficient route to the IND or marketing application. Using some examples of the challenges and opportunities that can occur, Stephen will discuss how to tailor CMC strategies and build a solid CMC regulatory package. The starting point is always good science. He will convince you that the process is the same as used in the parlor, radio and TV game known as “20 Questions” in which no more than 20 questions must be asked to distinguish between 220, or 1,048,576, objects.
*2 PDUs awarded for PMP re-certification
RSVP: http://NCBPPMDec2014Breakfast.eventzilla.net (Admission is free, but registration is required by 9:00 am 12/16)
Speaker Bio:
As a consultant, he has contributed to a diverse range of projects. Recently he has provided his CMC regulatory expertise to lead submissions to US and European authorities and has contributed to the design and execution of CMC programs for first-in-human as well as established molecules for cancer, asthma, and infectious diseases.
Stephen is unique among technical leaders. He brings not only strategic vision but also pragmatism and operational excellence to companies. This marriage of big-picture thinking and technical execution has earned him a reputation as an innovative problem solver who can streamline products through development while minimizing risk and expense.
Abstract:
Chemistry, Manufacturing, and Controls (CMC) is one leg of the development triangle that is critical to moving your drug into the clinic, keeping it there, and, if you are fortunate, submitting an NDA or BLA. In recent years, the second most common reason for FDA issuance of a complete response letter is a major deficiency in the CMC package. Building a robust CMC program requires the ability to adjust the CMC strategy to be appropriate for each successive stage of development from Discovery through NDA or BLA and navigating the inevitable speed bumps that arise. Thus, a thoughtful and nimble CMC approach paves a time- and cost-efficient route to the IND or marketing application. Using some examples of the challenges and opportunities that can occur, Stephen will discuss how to tailor CMC strategies and build a solid CMC regulatory package. The starting point is always good science. He will convince you that the process is the same as used in the parlor, radio and TV game known as “20 Questions” in which no more than 20 questions must be asked to distinguish between 220, or 1,048,576, objects.*2 PDUs awarded for PMP re-certification
