Annual Industry-FDA Statistics Workshop 1997
co-sponsored by the ASA Biopharmaceutical Section and the FDA Statistical Association

SUMMARY

Christy Chuang-Stein

The Biopharmaceutical Section held its fall workshop on October 27 and 28 (1997) in Hyatt Bethesda, Washington DC. The workshop, with a theme on FDA and Industry - Working Together to Expedite the Development of New Pharmaceutical Products, attracted approximately 200 registrants. The workshop opened with a critical examination of the future challenge of the statistics profession in new drug development as well as a historical review of the charge of the biometrics units at the FDA. Following the opening session, the workshop examined the various components of the drug development process both from the industry's and the FDA's perspectives. The latter covered activities such as discovery, early clinical trials, planning the confirmatory activities, the assembly of an NDA, clinical trials inspection and QA/QC consideration, the use of Advisory Committees to advise the FDA on its final decision on an application as well as pharmaceutical companies' preparing for the Advisory Committee meetings. In addition to issues related to the development of drugs, the workshop also examined challenges in the development of biological pharmaceuticals and the evaluation of medical devices. The workshop attenders also heard from an industry presenter on the advances and challenges in protein-based therapeutics. The workshop closed with a panel discussion during which communication between the FDA and the industry was identified as the key to a successful partnership and much discussion was devoted to how communication could be improved.

The workshop aimed to create a congenial environment to foster exchange between the FDA and the industry statisticians. During the two-day workshop, exchange was earnest. Furthermore, communication at the grass-root level was identified as a priority for future workshops of this nature. In this regard, the workshop achieved its goal of serving as the beginning to an open dialogue between the FDA and the industry statisticians which, hopefully, will continue and flourish in the many years to come.

Workshop participants received copies of the presentation materials. For individuals who did not attend the workshop but would like to obtain a copy of the workshop materials (bound together as a booklet), we have limited copies that can be purchased at $25 apiece. Please direct your request to Ms. Tracey Dowden at the Meetings Department of the ASA (Tel: (703) 684-1221 x147; e-mail: tracey@amstat.org). Requests will be processed on a first-come first-serve basis.

Please watch for announcement of future Biopharmaceutical workshops at the section's Web-site, in the AMSTAT News, and in the Section's publication Biopharmaceutical Report. For those who couldn't join us at this workshop, we hope to see you in our future workshops.

In addition, please share your thoughts on future workshop topics with Bob Small at (919) 286-8917, e-mail: small003@mc.duke.edu