DiMasi Digested

  • by: |
  • 04/05/2006

I recently had the privilege of discussing the future of drug development with CMPI advisory council member, Joseph A. DiMasi, PhD, Director of Economic Analysis Tufts Center for the Study of Drug Development, Tufts University.

Here are some tidbits you may find of interest —

Q: How will 21st century science help advance the future of drug development?

A: There are hopeful signs that new technologies and analytical approaches will improve the pharmaceutical R&D process in the 21st century. If successful, they will reduce costs and facilitate getting the right drugs to the right people at the right time. There is a growing recognition that genetic and other biomarkers that predict efficacy and toxicity responses or measure disease progression need to be developed, validated, standardized and included in drug development programs. The resulting increase in predictive power can eventually permit smaller and more informative clinical trials. Sharing of blinded clinical outcomes data from failed as well as successful trials across companies can also improve the efficiency of the clinical development process. Bioinformatics, data mining, and Bayesian statistical analysis can also help. Given the high costs of investigating the numerous drugs that eventually fail in testing, advances in discovery and preclinical development technologies that result in a higher hit rate for successful drugs can substantially reduce development costs.

Q: Will these advances impact cost?

A: All of the above technologies and techniques can lower the overall cost of drug development. It is hard to know how much they will do so, but reductions of one-quarter or one-third in average costs seem attainable from increases in success rates or reductions in development times.

Q: What can the FDA do to facilitate these improvements?

A: There is much that the FDA can do, in conjunction with industry, academia, and other government agencies, to modernize the development and regulation of new medicines. These include collaborations to develop and validate biomarkers, facilitating the analysis of pooled data on outcomes across clinical trials, developing guidance on how pharmacogenetic data can be used in labeling, how to utilize outcomes data from post-marketing drug surveillance, where and when it is appropriate to use Bayesian analysis and observational studies, and the evaluation of and standards for electronic medical records submissions.

Sound familiar?


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
Better Health
Biotech Blog
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
Envisioning 2.0
FDA Law Blog
Fierce Pharma
Fresh Air Fund
Furious Seasons
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
In the Pipeline
In Vivo
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
More than Medicine
National Review
Neuroethics & Law
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmacology Corner
Pharmaceutical Business Review
Piper Report
Prescription for a Cure
Public Plan Facts
Real Clear Politics
Shark Report
Shearlings Got Plowed
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog