MIT'S PROGRAM ON THE PHARMACEUTICAL INDUSTRY

Annual Report of Research and Educational Programs
1996

5. Leadership Structure, Participation, and Collaborative Activities

Key to POPI's success has been our ability to bring together discipline-based faculty from three MIT schools to participate in multidisciplinary research and teaching focused on the pharmaceutical industry. Our efforts are strengthened by a leadership structure that has proven highly effective. We have three co-directors from different disciplines, as well as an advisory board that draws from several of our important constituencies.

LEADERSHIP STRUCTURE

Co-Directors. POPI is led by three co-directors: Dr. Thomas J. Allen, Dr. Charles L. Cooney, and Dr. Stan N. Finkelstein. Each director has extensive experience with multidisciplinary research and teaching. Our co-directors are supported by a part-time financial manager and a full-time administrative assistant. Day-to-day management responsibility for the Program is held by Dr. Finkelstein.

Advisory committee. POPI's principal advisory committee includes nine distinguished members: senior executives from pharmaceutical firms; senior executives from other firms that serve as part of the industry's infrastructure; a divisional director at the Food and Drug Administration; and senior members of the MIT faculty. One of these faculty members is the winner of the 1993 Nobel Prize in Medicine and chairs the biology department; the other is director of MIT's International Motor Vehicle Program. A complete list of Advisory Committee members is included as Appendix F.

PARTICIPATION

One key to our success thus far has been POPI's ability to attract high-quality MIT faculty and students (both graduate and undergraduate) to participate in our research projects and classroom activities. Faculty have participated from nearly all of the disciplines essential for our research projects. Most have been senior faculty, but as our visibility and respect has grown we continue to attract more junior faculty.

From our founding, support for our work from other constituencies has also been key to our success. POPI has received six years of continuous and generous support from the Alfred P. Sloan Foundation as one of its centers for the study of industry. We have also enjoyed the support of the industry itself: several firms-including Aetna Health Plans, Amgen, Genentech, Genzyme, IMS, Lilly, Merck, Pfizer, and Upjohn-provide direct financial support to projects and/or large amounts of data for our researchers.

CONSORTIA

Consortium for the Advancement of Manufacturing in Pharmaceuticals (CAMP). POPI and MIT have undertaken a major manufacturing technology initiative in collaboration with the Department of Pharmaceutical Engineering at Purdue University, key individuals at a leading engineering/design firm, and several pharmaceutical companies. This initiative involves the conceptualization and development of a consortium of industry and academic leaders-the Consortium for the Advancement of Manufacturing in Pharmaceuticals-to examine possibilities for the migration of technologies, the development of new technologies, and the creation of new intellectual property that can help the pharmaceutical industry achieve several manufacturing-related goals. As the CAMP mission statement indicates, this consortium has as its objective to "improve healthcare delivery by lowering product cost and decreasing new product time-to-patient." The MIT component of CAMP falls under the POPI umbrella.

Pharmaceutical firms have generally not considered manufacturing technologies as means to meet the challenges faced by the industry, relying almost exclusively on mergers and acquisitions, product innovation, and pricing policies. In the view of CAMP's founders, this has resulted in a fragmented approach, and only technology-driven solutions can produce the speed and agility firms need to meet the demands of an evolving marketplace and regulatory world.

CAMP offers a unique approach to addressing new manufacturing technologies from process development to validation and into production, "in the interest of shattering tacitly imposed limitations," as its statement of purpose affirms. The consortium's approach is to identify and qualify manufacturing technologies that would benefit the industry; utilize the resources and expertise of members to develop these technologies, concluding with beta testing; and obtain FDA acceptance for the use of these technologies in a pharmaceutical manufacturing application.

Consortium on Health and Productivity (CHAP). Established within the Harvard-MIT Division of Health Sciences and Technology, CHAP's mission is to "stimulate and conduct multidisciplinary research on the relationships among the occurrence of illness and an individual's productivity of performance at work." Faculty and graduate students are being drawn from among clinicians, economists, social scientists, and management scientists with specific expertise or interest in this areas.

Over time, CHAP will develop a broad research program on issues related to health and productivity. Specific studies will include analyses of carefully collected retrospective data as well as original designs for prospective interventions carried out at employer sites. Already, a number of industrial firms and government agencies have expressed interest in serving as possible worksites for the research.

Please send comments and suggestions to popi-www@mit.edu