The rising importance of generic drugs, evolving requirements in the ever-more global supply chain, and supplier-management strategies in biologics manufacturing are some key topics to be addressed next month during DCAT Week.
The Drug, Chemical, and Associated Technologies Association (DCAT) announced its education programs for DCAT Week, which will be held Mar. 15–18 in New York City. DCAT is a business-development association whose membership is comprised of companies that manufacture, distribute, or provide services to the pharmaceutical, chemical, nutritional, and related industries. The educational programs at the 2010 installment of DCAT Week reflect several key changing dynamics of the pharmaceutical industry.
One such consideration is the increased penetration of generic drugs in the pharmaceutical industry. On Mar. 15, DCAT will hold a program on the integration of the business models between innovator-drug and generic-drug companies. On Mar. 16, the association will examine the impact of mergers and acquisitions in the generic-drug industry. Also, on Mar. 16, the association will provide a pharmaceutical chemical outlook with analysis from the market research and consulting firms Life Science Analytics and Datamonitor.
The elongation of the pharmaceutical supply chain and the evolving commercial and regulatory requirements between pharmaceutical companies and their suppliers will be examined in several sessions. One session will review how the US Food and Drug Administration, the International Pharmaceutical Excipients Council, and the pharmaceutical industry are addressing the issue of excipient equivalence. Another session will examine a recent initiative by several major pharmaceutical companies called the Qualified Trusted Importer Program, an approach in the border-management process. Also, Hilde Boone, the new liaison of the European Medicines Agency to FDA, will participate in a lunchtime forum. This particular forum is open only to DCAT member companies.
DCAT also added a Biologics Forum to its slate of programs during DCAT Week to reflect the growing business development needs of its members. “Many of our current members, especially those within the Big Pharma segment such as Merck, GlaxoSmithKline, and Pfizer, have been involved in the biologics/biomanufacturing business for a long time, but those business divisions are not integrated into the DCAT organization like their small-molecule/chemical divisions,” says Joe Principe, DCAT president and vice-president of global business development at Piramal Healthcare (Mumbai, India). “We want to expand our reach within our pharma and commercial member companies to include areas involved in the biologics/biomanufacturing area. In addition, we want to add more facets to our programming to attract nonmember companies that would derive value from DCAT programming and networking opportunities.”
DCAT will hold a Biologics Forum on Mar. 17 to examine approaches for designing and implementing a successful supplier-management program in biologics manufacturing given the specialized economic, regulatory, and technical issues involved with biologic-based manufacturing. Scheduled speakers include: Richard Crowley, senior vice-president of biopharmaceutical operations of ImClone Systems, a wholly owned subsidiary of Eli Lilly (Indianapolis, IN); Nigel Darby, vice-president of biotechnologies at GE Healthcare Life Sciences (Uppsala, Sweden); Jim Skrine, executive director and site head of quality at Amgen (Thousand Oaks, CA); Karen King, president of the biologics division at DSM (Heerlen, The Netherlands); and Michael Howaldt, vice-president of biotech operations at the biopharma business unit at Boehringer Ingelheim (Ingelheim, Germany). The session will be moderated by Marc Lampron, senior director of procurement at Genentech (South San Francisco, CA).
The Biologics Forum is part of a larger effort by DCAT to broaden its membership to include more participation from the biotechnology side of its member companies and other prospective members. During DCAT Week, a steering committee of both DCAT members and nonmembers will meet to discuss how the organization can better serve this sector. “Many of our member companies have biologics and biotechnology business units,” explains Principe. “Those individuals are starting to attend more activities, including DCAT Week, so they obviously see the benefits DCAT provides, and we need to follow through with more business-development opportunities.”
The biotechnology segment is one segment within the DCAT executive committee. The executive committee consists of four officers (president, senior vice-president, finance officer, and vice-president) and five segment vice-presidents: chemical, biotechnology, pharmaceutical, associated technologies, and nutrition and health. The executive committee also consists of the three immediate past presidents of DCAT.
Full details of the educational programs at DCAT Week may be found here.