Pharma Companies Form a Clinical Information-Sharing Consortium - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Pharma Companies Form a Clinical Information-Sharing Consortium


ePT--the Electronic Newsletter of Pharmaceutical Technology

The Critical Path Institute (C-Path) announced last week the formation of the Coalition Against Major Diseases (CAMD), a formal consortium of pharmaceutical companies, research foundations, patient-advocacy groups, health organizations, and regulatory agencies, which will share information on clinical trials for treatments for neurodegenerative diseases. C-Path is a nonprofit organization focused on facilitating collaborative efforts among scientists from government, academia, patient-advocacy groups, and the private sector to support the US Food and Drug Administration’s Critical Path Initiative, a regulatory science initiative designed to improve medical innovation.

CAMD released a new open database of clinical-trial information from participating pharmaceutical companies to enable information-sharing among companies and researchers on a global basis. The database includes information from 11 industry-sponsored clinical trials involving 4000 Alzheimer’s disease patients. The database is designed to share information to enable the design of more efficient clinical trials for Alzheimer’s disease and in the future will include such information relating to Parkinson’s disease, Huntington’s disease, and other neurodegenerative diseases.

In addition to sharing data, the pharmaceutical members of CAMD have agreed to use the new common data standard established for Alzheimer’s disease by the Clinical Data Interchange Consortium (CDIC). CDIC is a standard-setting organization that establishes standards relating to the acquisition, exchange, submission, and archive of clinical-research data and metadata.

CAMD is led and managed by C-Path, which is funded by a cooperative agreement with FDA and a matching grant from the Science Foundation Arizona, a public–private nonprofit organization focused on facilitating science-based initiatives. Pharmaceutical companies participating in CAMD are Abbott (Abbott Park, IL), AstraZeneca (London), Bristol-Myers Squibb (New York), Eli Lilly (Indianapolis, IN), Forest Laboratories (New York), Roche/Genentech (Basel), GlaxoSmithKline (London), Johnson & Johnson (New Brunswick, NJ), Novartis (Basel), Pfizer (New York), and sanofi-aventis (Paris). CAMD also includes advisors from government and government research agencies, including FDA, the European Medicines Agency, the National Institute of Neurological Disorders and Strokes, and the National Institute on Aging.

“The US Food and Drug Administration has supported and actively participated in this innovative and unprecedented public-private partnership from its inception,” said Joshua Sharfstein, FDA’s principal deputy commissioner, in a C-Path press release. “The agency is strongly committed to CAMD and other regulatory science collaborations that can speed safe and effective treatments to the public.”

In addition to CAMD, C-Path also manages the Predictive Safety Testing Consortium, a pharmaceutical-industry collaboration that shares internally developed laboratory methods among the major pharmaceutical companies and researchers to predict the safety of new treatments before they are tested in humans.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
26%
Attracting a skilled workforce
29%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
31%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here