News-Events
CBI e-Newsletter/CBI Report
Collaborative Innovation > Transformational Impact
Winter 2008 - Vol 3, Issue 1
In This Issue
- New Leadership Team, Structure at CBI
- An Exciting Year Begins
- CBI Research Aids Students, Industry, and Our Mission
- CBI Calendar
- CBI Research Highlights
- Recent CBI Publications
New Leadership Team, Structure Set for CBI - Hirsch Named Executive Director, Sinskey Faculty Director
It's official! MIT has officially approved a new leadership team and structure for the Center. Gigi Hirsch, M.D., was named Executive Director of CBI, and Anthony Sinskey, Sc.D., Professor of Microbiology and Health Sciences Technology will be Faculty Director. The announcement was made by MIT Vice President for Research and Associate Provost Claude Canizares. CBI will also launch a new Faculty Advisory Committee with broad representation of faculty from across MIT's schools as well as the Harvard-MIT Division of Health Sciences and Technology (HST).
"CBI's model of cutting edge, collaborative research across intellectual and institutional boundaries holds unqiue promise for fostering innovation in health care," Canizares said. "MIT is pleased to support this exciting model under the excellent leadership of Dr. Hirsch and Professor Sinskey, who are bringing together an outstanding team of MIT faculty, students and other key players from industry and government to transform the field."
The charter members of the Faculty Advisory Committee will be Ernst R. Berndt, Louis E. Seley Professor of Applied Economics, and Steven R. Tannenbaum, Professor of Biological Engineering, who have played important roles in CBI's transition and have been CBI Co-Directors since its founding. Other Faculty Advisory Committee members will be named within the coming few weeks.
According to Dr. Hirsch, who has served as Interim Executive Director since last summer, other new positions will be added over the next month to round out the CBI team, including two Distinguished Fellows (a retired senior executives from industry). Other new positions will be created to help CBI manage the growing number of events, outreach and communications, and program management. Job descriptions and applications for these positions are being developed and will be posted shortly.
Dr. Hirsch also announced that Assistant Director of Finance & Administration Sherene Aram has taken a post as Administrative Officer at HST. "Sherene has been at CBI since the beginning, playing a vital role throughout. She's been an important part of our transition, and she'll be greatly missed. We wish her the best, but she's not going far-CBI and HST are closely affiliated, and we look forward to continuing our collaboration."
An Exciting Year Begins
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There's so much to tell as the New Year begins! First, I'm honored and proud to be permanently appointed the Executive Director of CBI; I look forward to working closely with Professor Tony Sinskey, our Faculty Director, and the soon-to-be-appointed Faculty Advisory Committee. MIT Vice President for Research and Associate Provost Claude Canizares, Professors Ernst Berndt and Steven Tannenbaum were enormously helpful throughout the transition process, as were so many in the MIT community. The support and help of so many of you, CBI's members, was tremendous in creating our leadership model and moving forward with a new vision of CBI. It's been an incredibly busy and productive few months. Here are just a few highlights of developments:
*In November, CBI's Strategy and Policy Council met. We outlined our plans, and received valuable feedback and strategic advice on how we are moving ahead. We are pleased to announce that MIT's Program on the Pharmaceutical Industry (POPI) has merged with CBI. POPI was founded in 1991 with a major grant from the Alfred P. Sloan Foundation. We look forward to working even more closely with our POPI colleagues in the coming months. Sincerely, |
CBI Research Aids Students, Industry, and Our Mission
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CBI's focus on creating breakthrough research in biomedical innovation presents new and exciting opportunities for both undergraduate and graduate students with potentially profound impacts on how we can improve the safety, efficacy and quality of biomedical therapeutics. We are also providing students with exceptional experiences that will help them take their place as future leaders in research and development. One example: I recently directed a semester-long project with two MIT Sloan School of Management MBA students, both MIT biology undergraduate majors, that examined differences in the development, approval, pricing and marketing phases among vaccines, other biologics and traditional small molecule pharmaceuticals. Initiated by a gift from Merck, we examined the entire life cycle of a new therapy - from discovery and intellectual property protection through clinical development, FDA approval, and post-launch surveillance. Vaccines, almost taken for granted, are little studied, particularly when compared to small molecule pharmaceuticals and large protein biologics. By interviewing key players at companies, state public health agencies, the FDA, the CDC, physicians, industry trade organizations and others, we found that the vaccine approval process is much more stringent with higher safety standards and more costly Phase III trials than other types of medicine. This presents greater problems for companies developing such vaccines. Another project, initiated by the FDA and conducted with the help of six undergraduate and graduate students, studied how clinical trials are undertaken and how the process has changed over time. Study team members examined confidential medical reviewers' summaries, studied how trials were designed and how the approval process addressed safety and efficacy concerns. They spent two weeks at the FDA and then gained remote computer access at the FDA's Stoneham, MA office. The results of the study offer the FDA vital new information on how drug trials have changed in recent years, offering critical comparative background that can help the agency in the future. Not only did both of these CBI-affiliated projects offer important new information to companies and regulators that can have a substantive impact on vaccine approvals and drug trails, but it gave students a deeper grounding in regulatory approval processes and fuller understanding of the interrelations among federal agencies, industry, and physicians--and gave them new tools for their future careers in the field. These are a couple of great examples of how CBI is fulfilling its mission to help transform healthcare today and for the future. Regards, |
CBI Calendar
January 15, 2008: "Sensors for Bioprocessing" Workshop (open to members of BioMAN research program and invited guests).
March 13, 2008: "Safety Surveillance: Leveraging Knowledge from Other Industries" (open to members of Safety Surveillance research program and invited guests).
April 2, 2008:
9:30-11:30 AM: "The Role of Government in Innovation," Roundtable Discussion moderated
by Charles Cooney, PhD, Robert T. Haslam Professor of Chemical Engineering. Participants
to include Julie Gerberding, MD, MPH, Director of the CDC; Alan Krensky, MD, Deputy
Director, Office of Portfolio Management and Strategic Initiatives, NIH; Robert
Langer, ScD, Institute Professor, Kenneth J. Germeshausen Professor of Chemical
and Biomedical Engineering, MIT; Mark McClellan, MD, PhD, AEI-Brookings Institution Joint Center for Regulatory Research; Edward Roberts, PhD, David Sarnoff Professor
of Management of Technology, MIT.
April 2, 2008:
2:00-3:00 PM: Julie Gerberding, MD, MPH, Director of the CDC, launches CBI's new lecture
series, "Transforming Biomedical Innovation," introduced by MIT President Susan
Hockfield.
Spring '08: Watch for another lecture in this series by Dr. Roger Perlmutter, EVP, R&D, Amgen
October 23-24, 2008: 3rd Annual CBI Stakeholders' Summit.
CBI Research Highlights
Placebo Study
SEEKING INTERESTED CONSORTIUM MEMBERS to collaborate with CBI, the McGovern Institute for Brain Research at MIT, and the Brain Resource Company (BRC) on a new study focused
on identification of biomarkers associated with placebo response. The study will
leverage BRC's database of integrated clinical biomarkers and the design/infrastructure
of the ISPOT-D trial which aims to identify biomarkers associated with depression
and treatment response (study drugs: escitalopram, venlafaxine, and sSertraline).
Unlike prior efforts to identify placebo biomarkers, collaborating companies will
not be asked to share proprietary data. Opportunity open to a limited number of
corporate sponsors. Contact Gigi Hirsch, ghirsch@mit.edu for further information.
Biomanufacturing
A Steering Committee meeting was held on Dec 6th, where we launched BioMAN membership model. Proposed new project areas include: BioMAN Futures and Sensors for Bioprocessing. On Jan 15, 2008, we will hold a meeting for the Sensors Working Group at MIT.
On Jan 30th, the BioMAN group will be working with NIH, NIST, and FDA on a session at IFPAC at their Baltimore Conference on research and technology needs for PAT. Contact: Elizabeth Bruce, ej_bruce@mit.edu.
Safety Surveillance
The Safety Surveillance research team is rapidly expanding. New MIT faculty members include George Apostolakis (Nuclear Science & Engineering), Dimitris Bertsimas (Sloan School of Management), Forbes Dewey (Biological Engineering), Dan Frey (Mechanical Engineering & Engineering Systems), Richard Larson and Konstantinos Katsikpoulos
(both Engineering Systems), Nancy Leveson (Aeronautics and Astronautics), Deborah
Nightingale (Aeronautics and Astronautics), and Roy Welsh (Sloan School of Management).
Discussions are underway with other potential members. These individuals bring valuable
expertise and experience from other industries in data mining; signal detection;
quantitative modeling; risk assessment/management; decision analysis; system dynamics;
and change management in highly regulated industries, among other areas. We look
forward to sharing plans for a scaled-up, integrated research program and an upcoming
CBI workshop with members of this Working Group. We will also share plans with potential
new collaborators that we meet through our participation in an invitational workshop
hosted later this month by CBI Strategy and Policy Council member Mark McClellan,
MD, PhD, at the Brookings Institution. Contact: Gigi Hirsch, ghirsch@mit.edu.
We are now drafting a white paper on Risk Communication in the context of our Safety Surveillance program. If you would like to collaborate on this, please contact Gigi Hirsch, ghirsch@mit.edu.
Stratified Medicine
Site visits by Ernie Berndt and Mark Trusheim focused on stratified medicine have
led to fruitful discussions with cross-disciplinary teams at Lilly and Merck. This
research program seeks to develop a semi-quantitative decision framework for use
by corporate decisionmakers in biotechnology, pharmaceutical, and diagnostics companies,
as well as by policymakers. Discussions are now underway to identify specific compounds
within corporate portfolios that can be analyzed as a first step in populating the
decision-framework. Contact: Gigi Hirsch, ghirsch@mit.edu.
CBI Publications
CBI has a growing list of publications, white papers, and masters theses on a variety of research topics conducted by CBI researchers and affiliates.
Please visit the Publications section of our website to view recent publications, including:
Publications:
- Challenges to Establishing a Regulatory Framework for Approving Follow-on Biologics: A Background Paper
- Trends in the Globalization of Clinical Trials.
- Cost-Benefit Analysis of the FDA: The Case of the Prescription Drug User Fee Acts
Center for Biomedical Innovation
email: mottley@mit.edu
phone: (617) 253-0257
web: http://web.mit.edu/cbi
