CBI Newsletter / Spring 2008
Highlights Research Updates Events- 2008 CBI Stakeholders’ Summit
- Strategy and Policy Council to Meet in October
- CBI’s Prof. Anthony Sinskey to Facilitate Panel Discussion at the 2008 STeLA Leadership Forum
Publications
- Finkelstein, Stan and Peter Temin. Reasonable Rx: Solving the Drug Price Crisis. Upper Saddle River, New Jersey: FT Press, February 2008.
- Allen, Thomas J. and Rory P. O'Shea. Building Technology Transfer within Research Universities: An Entrepreneurial Approach. New York, New York: Cambridge University Press, forthcoming 2008.
Education
Member Opportunites- Professional Education
- Participate in a Study to Determine Best Practices in University / Industry Collaboration
Highlights
|
CBI Hosts Event with CDC Director In her keynote address, Dr. Gerberding presented an engaging look at the imbalances in our current healthcare system and spoke of its tendency towards treating disease rather than focusing on health protection. Noting how the United States is spending a growing percentage of its gross domestic product on health with little return on its investment, Dr. Gerberding advocated a value-based health system which would focus on health protection and prevention, access, measured results, and preparedness. Such a paradigm shift would necessitate new performance metrics which truly reflect the complexity of health promotion, new information management systems to track and monitor trends, and new incentives for engaging both patients and healthcare providers. “We need to think about the person in terms of their whole environment and milieu,” Dr. Gerberding asserted. Only then could the United States achieve a “healthiest nation status.”
|
 |
CBI Welcome First Distinguished Fellow: Peter Farina, PhD Peter Farina, PhD, is the first appointee to the newly established CBI Distinguished Fellow post. Farina retired this year following a distinguished 28 year career at Boehringer Ingelheim Pharmaceuticals, Inc, where most recently he was Senior Vice President for Development in North America. “I’m really pleased to be working with CBI,” Farina said. “I’m helping to advise CBI on its mission and issues that come before us, particularly from my perspective in 30 years in the Pharma world. I think CBI is really on the right path, bringing together biotech and Pharma, the FDA and other government bodies, and academic experts to tackle important problems. It’s the right mix of groups and people, and the right leadership.” As CBI’s first Distinguished Fellow, Farina is a member of the Strategy & Policy Council, and will co-chair a newly established Steering Committee for the Council. “We are happy to have Peter Farina as part of the CBI team,” said Executive Director Gigi Hirsch, MD. “He brings a unique, and important, perspective to our mission, and his experience in drug development, delivery and as a scientist is invaluable to our work.” As Senior Vice President at Boehringer Ingelheim, Farina was responsible for establishing and overseeing an interdisciplinary group of seven departments, encompassing more than 400 scientists and staff. His team was most recently responsible for the pre-clinical development of Aptivus (tipranavir), an HIV drug, and Atrovent HFA (ipatropium bromide), used to treat COPD. “One of the greatest challenges in the CBI model is to give everyone a voice, while making sure that there is not a predominant one, creating a process of openness and teamwork,” Farina said. “From an industry perspective, I think the issues we’re dealing with go beyond any one company. The dialogue we’re engaged in for safety surveillance, stratified medicine and biomanufacturing, for instance, is one where we can learn much more collectively than any individual company can alone.” Besides working with CBI, Farina’s retirement from industry has allowed him to pursue new life goals and accomplishments. “My attention has been focused on issues that are much more global,” he said. He is founder, along with Dr. Denice Spero, of Developing WorldCures, a non-profit venture aimed at the discovery and development of therapeutics for neglected diseases in developing countries. “We have assembled an excellent team of pharma-experienced scientists and executives to work with institutions such as Yale, MIT and others to help treat diseases that have not received the attention they deserve,” he said. “Right now we are considering a new approach to diarrheal disease management and potentially a rabies diagnostic. It’s a tremendous challenge and one that offers new opportunities for my life’s priorities. My goal with Developing World Cures and at CBI is to help create better health care both in the U.S. and the developing world.”
|
Research Updates
Biomanufacturing
On May 14th, CBI and the MIT Center for Integrated Photonic Systems (CIPS) are co-hosting a biophotonics session at the CIPS Annual Conference. This session will explore the application of optical systems for monitoring and improving our understanding of biological processes, as well as cover topics such as spectroscopy and imaging and how these techniques are being used as analytical tools for biotechnology and pharmaceutical applications.
On March 21st, the BioMAN Sensors Working Group held a presentation session and group discussion entitled, “Future Vision for Bioprocessing.” Presenters included: Charles Cooney (MIT Robert T. Haslam Prof of Chemical Engineering, Faculty Director of Deshpande Center of Technological Innovation); Ingrid Maes (Sr. Consultant Innovative Technologies, Siemens); Stephen V. Hammond (Director of the Process Analytics Support Group, Pfizer); and David Radspinner (Director of Marketing & Application Support at Thermo Fisher Scientific). Keith Webber, (Deputy Director of CDER, FDA), gave summary comments. Presenters, Presentation Topics, and Schedule
On January 28th, CBI, together with NIH, FDA, and NIST, organized the special session entitled “A 10-year Vision of Biotechnology Manufacturing” at the annual meeting of the Vision of Biotechnology Manufacturing” at the International Forum for Process Analytical Chemistry (IFPAC) annual meeting. The session detailed challenges facing the industry over the next 10 years and outlined approaches to solving critical scientific and technical hurdles. Session Summary (PDF) Article in BioPharma International (External Link)
Biomanufacturing Program Contact: Stacy Springs (ssprings@mit.edu)
Safety Surveillance
Discussions within the Safety Surveillance program have indicated a need to look more broadly at issues and strategies for Drug Safety. Enter Futures for Drug Safety 2020 – CBI’s scenario-based strategy development initiative to identify key activity sets for advancing drug safety into 2020. The initiative is broad-based examining all aspects of patient-focused drug safety and employs a working group drawn from academia, industry, and the government. The group met on April 8th to begin the process which will identify key drivers of change in drug safety, a set of future scenarios, and ultimately a series of future oriented strategic imperatives for action by CBI and its partners in late 2008/2009. Currently, the Strategic Advisory Group for Drug Safety 2020 includes: Burt Adelman (MIT/CBI), Vikram Dev (AstraZeneca), Peter Farina (MIT), Tim Garnett (Eli Lilly), Gigi Hirsch (MIT/CBI), Scott Korn (Merck), Robert Laubacher (MIT), Lawrence Lesko (FDA), Michael McGinnis (NAS), Gary Neil (Johnson & Johnson), Brad Perkins (CDC), Richard Platt (HMS/HPHC), Wayne Rosenkranz (AstraZeneca), and Tony Sinksey (MIT). The next working sessions for the Strategic Advisory Group are scheduled for June 27th, September 24th, and October 23rd / 24th. For more information, contact Gigi Hirsch at ghirsch@mit.edu.
On March 13th, CBI hosted a workshop in its Safe Haven environment focused on translating knowledge from other industries to drug safety surveillance. The workshop sought to provide MIT faculty and healthcare experts from industry, providers and government an opportunity to work together to assess the current state of the system and identify research methodologies and tools from other fields which might enhance safety surveillance of pharmaceuticals. Workshop Summary (PDF)
Stratified Medicine
Industry interactions have continued to grow with discussions and interviews with 11 firms including five therapeutics developers and six diagnostics companies as well as interactions with the FDA. Over the coming quarter investment analysts and other stakeholder groups will be included in the process.
In March, the stratified medicine team expanded to six investigators with the support of the ongoing grant from the Merck Research Foundation. The team has been augmented with graduate students Brian Newkirk and Sameer Sabir from the Harvard/MIT Biomedical Enterprise Program (BEP), David Chan a physician from the Brigham & Women’s Hospital (a Harvard affiliated teaching hospital) who is also joining the MIT Economics Department Ph.D. program and Jeong Choi studying Mathematics and Management at MIT.
On April 13th, CBI’s Mark Trusheim was an invited speaker at the American Association of Cancer Researcher’s Annual Meeting in San Diego where he presented “Stratified Medicine: Strategic and Economic Implications of Combining Drugs and Clinical Biomarkers”. The special panel entitled “Targeted Therapy for Personalized Cancer Care: Matching the Economics to Evolving Science” also included, Kapil Dhingra Vice President Oncology, Hoffmann La-Roche Inc. & Steve Shak the Chief Medical Officer of Genomic Health.
Stratified Medicine Program Contact: Mark Trusheim (trusheim@MIT.EDU)
Events
| 2008 CBI Stakeholders’ Summit The next CBI Stakeholders’ Summit will take place on October 23 & 24 at the Royal Sonesta Hotel in Cambridge. Open exclusively to CBI members and invited guests, the Stakeholders’ Summit is a unique opportunity to:
Please mark your calendars; and if you would like membership information contact Cheryl Mottley at mottley@mit.edu or (617) 253-0257. Strategy and Policy Council to Meet in October
CBI’s Prof. Anthony Sinskey to Facilitate Panel Discussion at the 2008 STeLA Leadership Forum “Prof. Sinskey’s experience with the pharmaceutical industry from biological, governmental, and political perspectives makes him the ideal facilitator for this panel,” states Conference Chair Brianne Holmbeck ’08. STeLA’s 2008 Leadership Forum will be held at MIT from August 2 through August 9, 2008. Focusing this year on the theme “global public health”, the forum will bring together students from Harvard and MIT, Tokyo and Keio Universities in Japan, and Peking and Tsinghua Universities from China. Established in 2007 and based on MIT’s campus, STeLA is an intellectual network of advanced undergraduate and graduate students from prestigious international universities committed to cultivating multicultural and interdisciplinary perspectives of leadership amongst the next generation of scientists, engineers, entrepreneurs, and policymakers.
|
Publications
- Finkelstein, Stan and Peter Temin. Reasonable Rx: Solving the Drug Price Crisis. Upper Saddle River, New Jersey: FT Press, February 2008.
Drug prices are soaring. Today, millions of Americans can’t afford their medicines. Insurance rates are skyrocketing. Public programs like Medicare D are failing to solve these problems. We desperately need new medicines, but drug research costs more every year. Fewer truly innovative medicines make it to market – and, of those that do, too few target the work’s most urgent health needs. A crisis is upon us – but most conventional solutions will simply make matters worse.
In this book, two leading MIT experts on the pharmaceutical industry propose a radical new solution: one that preserves the advantages of free markets while controlling costs and refocusing drug development where it will do the most good. Their carefully considered plan distributes the financial risks of research across society and restores science and human needs to the center of the drug development process.
Reasonable Rx offers the first real solution that goes beyond sterile ideology and political posturing. It will transform the debate about drug prices and accessibility – and not a moment too soon.
- Allen, Thomas J. and Rory P. O'Shea. Building Technology Transfer within Research Universities: An Entrepreneurial Approach. New York, New York: Cambridge University Press, forthcoming 2008.
The increasing challenge of competing in a global economic context is forcing regions to reconsider and often revise their approach to economic development. With knowledge now the fundamental basis of competitive advantage, regional economic development agencies are looking for ways to create and develop new and innovative, technology-based start-ups. One of the key technology transfer mechanisms that has attracted attention in recent years is the emergence of university spinoffs. University spinoffs are a highly successful sub-set of all start-up firms because they generate jobs for highly skilled graduates and demonstrate strong economic effects for regional communities. With knowledge and innovation recognized as a third production factor besides labor and capital, universities are increasingly looking for ways to play a greater role in regional economic development.
Technology Transfer is an important driver in innovation and the creation of sustainable growth. According to the Association of University Technology Managers’ (AUTM) Annual Report (2004), the United States federal government agencies now provide more than $27.7 billion annually to university researchers to conduct scientific research. This continuing investment expands human knowledge and helps to educate the next generation of science and technology leaders. Furthermore, this research can also have a big impact on the “discovery of innovation” element of the technology transfer process (Murray, 2006). Mansfield has also highlighted the central role of university innovation in US productivity growth. In a random sample of 76 major American firms in seven manufacturing industries, Mansfield (1991) investigated the extent to which technological innovations are based on recent academic research. According to the author, one-tenth of the new products and processes commercialized during 1975-1985 could not have been developed without academic research. These results were also confirmed in a follow up study conducted in 1986–1994 (Mansfield, 1998). According to the AUTM, university spinoffs have created over 140,000 jobs and $16.5 billion in value-added activities for the US economy (Shane, 2004).
Education
Special Thanks to Industry Participants of “Case Studies in Drug Discovery and Development” Course and Call for Future Guest Speakers
|
Member Opportunities
Professional Education
CBI members are now eligible for a 10% discount off MIT’s Professional Education “Biotechnology / Pharmaceutical” courses. Enter code “biocbi1008” in the field for promotional codes at the top of the course application form. View Available Courses
Participate in a Study to Determine Best Practices in University / Industry Collaboration
Directed by Prof. E.M. Greitzer (MIT Dept. of Aeronautics and Astronautics) and Dr. W.A. Lucas (Executive Director of Cambridge-MIT Institute Partnership Program). More Information
