New Consortium Addresses Major Problem of the Biopharmaceutical Industry: Getting the Dose Right

Consortium Members Meet to Advance the State-of-the-Art in Dose Finding Studies – Future Meeting Planned for This Year

CAMBRIDGE, Mass.--(BUSINESS WIRE)--The Cytel-organized Dose Finding Consortium met in Philadelphia on Thursday, April 4. The meeting featured both consortium member discussions and an open session on early stage dose-related clinical trial methods and practices.

This cooperative forum initiated by Cytel in November 2012, addresses the gap left after PhRMA discontinued their Working Group on Adaptive Dose-Ranging Studies in 2011. The meeting featured prominent industry and academic speakers including Prof. Anastasia Ivanova, Associate Professor, Univ. of North Carolina, and Dr. Naitee Ting, Sr. Principal Statistician at Boehringer-Ingelheim. Attendees included experts from some of the most forward-thinking companies representing Amgen, Boehringer-Ingelheim, CSL Behring, GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, and Shire Pharmaceuticals.

The consortium's goals are to move the state-of-the-art forward in identifying optimal doses; to encode those practices into commercial validated software; to ease regulatory acceptance with more innovative methods – including adaptive trials – and apply them in practice more quickly.

Escalating costs make it more urgent to improve early drug and biologic development to better inform confirmatory trial design. A recent update of Tufts Center for the Study of Drug Development (CSDD) estimate1 estimates the fully capitalized cost of bringing a new drug to market has reached $1.5 billion. A large proportion accounts for discontinued developments where a lack of accurate, timely dose estimation is a significant contributor to failure.

Good dose estimation serves to increase treatment efficacy and reduce unnecessary patient exposure with the possible consequential rise of adverse event rates.

The Dose-Finding Consortium is helping materially towards that goal by supporting robust clinical study designs, while advancing both the methodologies and their successful implementation. Consortium members praised the opportunity to work together on meaningful advances in the science, and shared software tools.

Jim Bolognese, Cytel's Consortium Director, commented, "Cytel, as we've consistently done beginning with our Exact Statistics software through to East®, will publish its methods enabling anyone to code them. In addition to our adaptive dose-finding commercial software, Compass®, advanced simulation software is also available to consortium members to test and validate new ideas for better of dose optimization."

This consortium is important not only to member companies, but also to the greater biopharma industry as pre-competitive collaborations usually bring the most rapid advances.

1 DiMasi JA, Grabowski HG. The cost of biopharmaceutical R&D: is biotech different? Managerial & Decision Economics 2007;28:469-479, update in preparation by DiMasi, CSDD.

About Cytel

Our mission at Cytel is to improve success rates in the development of drugs, biologics and medical devices. We do this by improving clinical trials through innovative application of statistical science, operations research, and new computational methods

We are leaders in adaptive trial design and implementation. All 25 leading biopharma companies rely on our technology in their clinical studies.

Contacts

Cytel
Michael Weitz, 617-661-2011
Director of Marketing
[email protected]

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