It’s hard to believe an entire week has gone by since the conclusion of the 2013 ISPE Annual Meeting. The event was incredibly powerful, bringing together over 1,600 industry and regulatory attendees to discuss some of pharma’s biggest challenges and opportunities.
Here’s a look at some of the highlights from this year’s event:
Featuring talks from FDA CDER Director Janet Woodcock and Baxter’s Julie Kim, the 2013 Annual Meeting plenary session had many attendees buzzing. Dr. Woodcock announced a reorganization of the FDA that is slated to take place next year, including the creation of the Office of Pharmaceutical Quality (OPQ), and discussed her vision of a pharmaceutical industry that is focused on quality and requires minimal regulatory insight. She stated that consistent high quality, as proven by metrics that ISPE is working with FDA to develop, will lead to pharma companies being given increased freedom to operate.
Julie Kim’s speech underlined the importance of investing in manufacturing and related her case to the ultimate end goal of patient health. While discussing Baxter’s billion-dollar manufacturing facility in Covington, Georgia, Ms. Kim discussed the facility’s potential to help patients suffering from Alzheimer’s disease and primary immunodeficiency disorders.
The plenary session also featured the announcement of ISPE’s Facility of the Year Awards Program 2013 Overall Winner. Novartis took home the prize for its United States Flu Cell Culture Facility, a public-private partnership which introduced an innovative new cell culture process for manufacturing flu vaccines.
“Too Many Good Sessions to Choose From!”
The 2013 ISPE Annual Meeting featured over 50 sessions, more than any other ISPE Annual Meeting to-date. Often, delegates could be heard discussing the fact that there were “too many good sessions to choose from,” and asking if certain presentations would be offered again at future ISPE events. Among the most popular sessions were the Quality Metrics session on Monday afternoon and the Quality Metrics breakfast the following morning, where delegates gathered to hear the ISPE Quality Metrics Working Group, featuring Cindy Salamon from Bristol-Myers Squibb and the FDA’s Russ Wesdyk, discuss ideas for acceptable metrics related to batch failure rates, OOS/lab failure rates and other new ideas.
The ISPE Research Initiative session was also packed, as ISPE released the results of the industry’s first-ever patient survey related to experiences with clinical trials. ISPE also shared an update on its drug shortages initiative, which was recently cited in the FDA’s Strategic Plan for Preventing and Mitigating Drug Shortages. The session featured a panel discussion of ISPE and FDA’s joint efforts to mitigate drug shortages and outlined ISPE’s plans to bring together stakeholders to discuss drug shortages throughout 2014.
Another standout session was Tuesday’s Breakthrough Therapies talk. Just days before the start of the Annual Meeting, the FDA announced the first breakthrough designation, which was conferred on Genentech’s Gazyva, a medication for chronic lymphocytic leukemia. Delegates were treated to first-hand observations from a member of the Genentech team responsible for Gazyva in the Breakthrough Therapies session, along with insights from the FDA and other key stakeholders involved in this important topic.
One of the Industry’s Most Significant Events
After attending the ISPE Annual Meeting for the first time this year, Life Science Leader editor Rob Wright published a piece entitled, “Why Pharma Execs, Not Just Engineers, Should Attend ISPE.” In it, he talks about the industry-leading sessions he sat in on, and his takeaway observations on why pharma leaders should make the ISPE Annual Meeting a priority. Aside from the full slate of solution-focused education opportunities and hot topic discussions, the Annual Meeting also featured a host of important networking opportunities, a big-picture view of the Society’s achievements and forward-looking plans and formal recognition for Members who’ve made substantial contributions to ISPE. The 2013 ISPE Annual Meeting lived up to its billing as “one of the industry’s most significant events,” by bringing together top-level speakers, thought leaders and regulators for a powerful four days of discussion to move the industry forward.
Planning is already underway for the 2014 Annual Meeting; if you are interested in participating as a speaker, you may submit your content proposal anytime between now and 31 December 2013.