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CBI e-Newsletter/CBI Report

Collaborative Innovation > Transformational Impact

June 2006 - Vol 1, Issue 1

In This Issue

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Welcome to the first edition of CBI's newsletter, CBI Report. We hope you'll enjoy it and find it your link to the vital, growing work of the Center for Biomedical Innovation. We're also proud to announce that CBI has launched a newly revamped website that includes comprehensive information about our programs and research, sponsorship and much more. The past year has been an exciting and busy start for CBI, as you'll discover in this newsletter. Our research programs are moving forward at a terrific pace, and I know you'll find what we are doing of interest and importance.

Regards,
Frank Douglas

CBI NEWS

CBI Launches New Website

CBI has launched a newly designed website--with a new look and feel, more information, and better navigational tools. It will be your link, along with this newsletter, to the entire range of CBI's research and educational programs, conferences and events, links to our sponsors and more.

CBI's Founding Sponsors

CBI is proud to welcome as Founding Consortium Members

  • Altana Pharma
  • AstraZeneca Pharmaceuticals
  • Bayer AG
  • Eli Lilly & Co.
  • Gene Logic, Inc.
  • Merck & Co.

Merck Company Foundation Awards CBI $600,000 Research Grant

The Merck Company Foundation, the philanthropic arm of Merck & Co., Inc., has awarded CBI a three year $600,000 grant through its Program on Pharmaceutical Policy Issues (PPPI).

FDA Office of Policy and Planning Seminar on the Globalization of Clinical Trials Presented by CBI Researchers

At the invitation of Associate Commissioner Randall S. Lutter, Ph.D., CBI researchers Fabio Thiers, M.D. and Ernst R. Berndt, Ph.D. presented an seminar at the FDA Office of Policy and Planning, Office of the Commissioner, in Rockville, Maryland, on June 15, 2006. The title of the seminar, "The Globalization of Clinical Trials: Evidence on Recent Trends" documented the changing allocation of clinical trials, away from Western Europe and Canada, and toward Eastern Europe, Latin America and Southeast Asia. The presentation was based on Dr. Thiers SM thesis at the Harvard-MIT Health Sciences and Technology program. The thesis is currently being written up for possible peer review publication, with Dr. Thiers and his two thesis supervisors, Ernst R. Berndt, Ph.D. and Anthony J. Sinskey, Sc.D. (both Co-Directors of CBI) as coauthors.

SPOTLIGHT ON POST MARKETING SURVEILLANCE

One of CBIs key Transformational Research Projects (TRPs) currently underway in the area of Safety Assessment concerns Post-Marketing Surveillance. This TRP, headed by Ken Mandl, MD, MPH of Harvard Harvard Medical School, will bring cutting edge biomedical informatics technologies to bear on the post-marketing surveillance of new drugs. The model being applied is automated real time population health monitoring. The outstanding work on biosurveillance and automated outbreak detection at the Childrens Hospital Informatics Program (CHIP) at the Harvard- MIT Division of Health Sciences and Technology (HST) has powerful synergies for addressing some of the shortcomings of the current approach to post- marketing surveillance.

Post-marketing surveillance of new drugs is a critically important element of the drug development and commercialization process. Surveillance should detect adverse drug events and reactions once new products are on the market and in widespread use, thereby limiting exposure of the public to hazards of new medications. The current system for monitoring new drug safety, however, has come under intense scrutiny, partly because drug manufacturers are largely responsible for collecting, evaluating, and reporting data from post-marketing studies of their own products. Specific objectives of the TRP are to:

  • Develop the necessary databases and definitions to link, directly or indirectly, medical use to unexpected outcomes.
  • Conduct exploratory analyses with novel methods in both hypothesis driven and unsupervised discovery modes
  • Develop a decision theoretic approach, leveraging the collaborative cross-disciplinary environment of the CBI Safe Haven for rapidly analyzing and responding to signals, balancing the need for sensitive and timely detection of problems against the often lower specificity of early results.

Read more...

EDUCATION

As another vehicle for change, CBI leverages the world class academic strength of MIT and Harvard, in collaboration with industry and government scientists, to train the current and future leaders of biomedical innovation. CBIs growing portfolio of educational initiatives is designed to address the need for scientific, technical, and managerial expertise required for innovating within the industry. Our curricula focus on the intersection of real world experience and cutting edge scientific advancements across a wide range of disciplines within the Schools of Science, Engineering, Management and HST. Among the courses CBI has developed are:

Case Studies in Drug Discovery and Development

This year, CBI introduced a new graduate level course at MIT, Case Studies in Drug Discovery & Development, in a unique new format which incorporated industry R&D executives, presenting actual case studies in drug development. The course was team taught by Frank Douglas, PhD, MD, Steven Tannenbaum, PhD and Anthony Sinskey, PhD. Cross- functional student teams analyzed cases to determine how drug discovery and development might be influenced by new and future technologies. During the course, students identified several novel approaches, including how nanotechnology might be used in developing HIV vaccines, and a new way to screen NNRTI compounds for AIDS.

Biopharm Academy

In January 2007, CBI launches the BioPharm Academy, a program designed to provide early-to- mid career scientists with the tools and knowledge to improve product pipeline productivity and overall cost-effectiveness of healthcare innovation and delivery. This course will be offered to cadres of 25- 30 participants in three one-week sessions over an academic year and is co-taught by faculty from academia, industry and government. Faculty will engage with participants in addressing real-world challenges in selecting targets for drug discovery, evaluating safety and efficacy and navigating the regulatory approval process. Please visit our website for a detailed outline of the curriculum.

EVENTS

To express interest in attending, please contact us at: cbi@mit.edu

Center for Biomedical Innovation

email: mottley@mit.edu
phone: (617) 253-0257
web: http://web.mit.edu/cbi