The inaugural West Coast meeting for the Clinical Supplies Support Group (CSSG, www.jeiven.com/ clinical_supplies_support_group.htm) was held in San Diego on June 8, 2007. CSSG has been hosting meetings on the pharma-rich East Coast to support companies in clinical supplies project management efforts for nearly a decade. The meetings routinely focus on creating a clinical supply plan, securing contract manufacturers, preparing budgets, qualifying timelines, working with analytical laboratories, etc., and are highly interactive. This first West Coast meeting opened to a larger than expected crowd of predominantly biopharmaceutical and clinical supply professionals.
The meeting was arranged and coordinated by Jeiven Pharmaceutical Consulting, Inc. (Scotch Plains, NJ, www.jeiven.com), which specializes in providing guidance to drug and clinical development to the pharmaceutical and device industries. As per tradition, the meeting was kicked off by a networking reception the night before, where presenters and attendees were encouraged to meet in preparation for the upcoming session.
The day-long seminar featured highly qualified and engaging speakers such as Rob Pizzie, senior director of Schering Plough Global Clinical Supply, Antonia Daniel, associate director of clinical supply at Eisai Medical Research, Inc., and Steven Jacobs, president of Bilcare, Inc., and formerly in key clinical supply positions at J&J and McNeil. The discussion topics included subjects, such as “Change Management in the Regulated Environment,” which focused on methods to ensure improved project management and decreased clinical supplies cycle times and “Communication and Teamwork in Clinical Supplies,” which highlighted means to develop and improve partnerships, inside and outside of clinical supplies units, and to improve planning, milestone achievement, and on-time delivery. An interactive workshop session allowed attendees to apply principles featured in the earlier sessions in specific applications.
Althea Technologies, Inc. (San Diego, CA, www.altheatech.com), the sponsor of the inaugural meeting, provided transportation to its San Diego cGMP contract manufacturing facilities, an overview of facilities design, clinical manufacturing support activities, and a brief tour of the aseptic fill and finish areas for vials and syringe filling of parenteral products.
The attendees selected the topics and potential speakers for the next West Coast session with a focus on the clinical supply issues, approaches, and case studies from the biotech company perspective. Details on upcoming CSSG meetings can be found at www.jeiven.com.