CMC Strategy Forum January 27, 2008 Renaissance Mayflower Hotel Washington, DC USA Sponsored by CASSS PARALLEL SESSIONS: Extractables and Leachables: Challenges and Strategies in Biopharmaceutical Development Current Practices for Assessing the Comparability and Stability of Gene Therapy Products

HOTEL RESERVATION DEADLINE HAS BEEN EXTENDED TO JANUARY 14, 2008

CMC Strategy Forum Mission Statement
The purpose of the CMC Strategy Forum is to provide a venue for biotechnology/biological product discussion.  The meetings focus on relevant CMC issues throughout the lifecycle of a product and thereby foster collaborative technical and regulatory interactions.  The Forum strives to share information with the regulatory agencies to assist them in merging good scientific and regulatory practices.  Outcomes of the Forum meetings are published in an appropriate peer-reviewed journal.  It is envisioned that these outcomes will help assure that biopharmaceutical products manufactured in a regulated environment will continue to be safe and efficacious.

Workshop Format
To provide adequate opportunity for regulatory agency and industry involvement, one two-day Forum will be conducted annually and will be held in Bethesda, Maryland at Lister Hill Auditorium on the NIH Campus. A one-day Forum(s) will be held in conjunction with the WCBP annual meeting. In addition, as of 2007, an annual CMC Forum Europe will be held on the European continent following a similar format to the existing US forums, and will be aimed at fostering global interactions and harmonization. Each meeting will focus on CMC related issues such as product characterization, comparability, specifications, etc. The format of each meeting will consist of case studies and presentations by industry and/or regulatory agency experts to introduce the topic and the key issues of concern. Breakout sessions will then be conducted to allow for additional discussion on the technical and regulatory details of the topics. It is envisioned that the final outcome of the workshop discussions will be the development of a document to be submitted to the appropriate regulatory agency designees for their consideration in developing and/or clarifying good regulatory practice guidelines for biotechnology derived products.