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A Rising Tide (in Early-stage Research) Lifts All Boats?

Ashwin Dandekar

Managing Partner

Given the average cost and time it takes to successfully bring a drug to market ($1 billion, and 10 years), it’s not surprising that pharmaceutical companies have sought to de-risk their R&D portfolios by acquiring later stage, more clinically-advanced molecules. However, The Accelerating Medicines Partnership (AMP), a collaboration between the NIH and 10 drug companies (including several top 10 global competitors), is aimed squarely at the opposite approach – identifying disease areas with high unmet need and then systematically supporting early stage research collaboratively: with funding, scientists, and oversight from both academic and industry partners.

The AMP has twin-fold goals: 1) to drive new therapies in high need disease areas, and 2) to pilot a transformed model of drug development. This model differentiates itself by incorporating a relatively untapped expertise – academic scientists who have deep expertise in the targeted diseases – at the earliest stages of candidate selection. The AMP hypothesizes that this increased emphasis on early stages will increase the quality of candidate selection and therefore the odds of later clinical success (and decrease the risk of costly late-stage failures).

To begin, AMP collaborators will systematically attempt to identify novel and meaningful biomarkers (i.e., that provide diagnostic, prognostic, or treatment response information) and molecular targets in Alzheimer’s Disease, Type 2 Diabetes, and Rheumatoid Arthritis / Lupus. Research plans have already been co-developed by NIH and industry scientists, are overseen by a Steering Committee that also includes Patient Advocacy group representation, and importantly, all participants have committed to sharing the data and findings to the broader scientific community. These pilots span 3-5 years and are budgeted between $41.6 and $129.5 M – with a roughly equal split between the NIH and industry partners.

The question remains whether this relatively modest investment will pay off in marketable diagnostics and therapeutics, and whether this model of industry and academic collaboration will inspire similar programs across other disease areas and other stakeholders. Stay tuned!

Read more at:
(http://www.nih.gov/science/amp/index.htm)
(http://www.forbes.com/sites/johnlamattina/2014/02/07/a-way-to-increase-drug-rd-success-rates/)
(http://www.usatoday.com/story/news/nation/2014/02/04/nih-industry-partnership/5201407/)