Tuesday, December 11, 2012

Alliance Deal of the Year Nominee: Transcelerate

It's time for the IN VIVO Blog's Fifth Annual Deal of the Year! competition. This year we're once again presenting awards in three categories to highlight the most interesting and creative deal making solutions of the year. The categories are: M&A Deal of the Year, Alliance Deal of the Year, and Exit/Financing Deal of the Year. We'll supply the nominations (a half dozen in each category throughout December) and you, the voting public, will decide the winners (by voting early and often, commencing once we've announced all the nominees). Strap yourselves in, it's The Race for the Roger™.

When a new research and development initiative works both the words “transform” and “accelerate” into its name, that provides a pretty good clue what it is all about. TransCelerate BioPharma, a joint effort to alleviate bottlenecks in the pharmaceutical R&D process unveiled in September, brings together the common interests of 10 otherwise ultra-competitive big pharma companies. And hell if you can get ten pharma companies to agree on the terms of an alliance, even one under the vague umbrella of 'open innovation,' well that deserves a nod from us.

The non-profit, which will share the results of its work with all of its members, has set an initial goal of reaching “definitive milestones” for five action items by the middle of 2013.

Those priorities are:

• A shared user interface for investigator site portals, to make it easier for trial investigators to access the information they need to participate in a study;
• A mutually recognized trial site qualification and training;
• A risk-based site-monitoring approach and standards;
• Uniform clinical data standards; and
• A model for supplying trials with comparator drugs.

“We’re hoping that we can catalyze the creation of centralized site qualification and training,” chairman and (then-)acting CEO Garry Neil told us in September (Neil handed over the CEO reins to Dalvir Gill on Dec. 10). “In other words, can we get to a point where an independent third party can specify what would be the requirements for site qualification for an individual investigator or a whole site? Then, can we come up with some way of certifying those sites so that one wouldn’t have to go in as an individual sponsor and certify each site over and over again, which often happens because many investigators will do trials for multiple sponsors.”

Going by the characterization of many industry observers, there are 12 big pharma companies at present (give or take another mega-merger, which for all we know could in the works as you read). One suspects that anything Abbott Laboratories, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Pfizer, Sanofi and Roche/Genentech all can agree upon must comprise some fairly universal issues.

Merck and Novartis are not charter members of TransCelerate, although Neil, a former corporate VP at J&J, told “The Pink Sheet” DAILY that “This isn’t just for big companies. This is for medium-sized and small companies. We know how much work and innovation is coming out of these small companies, so we’re very interested in having them join.” So Merck, Novartis and biopharma firms of all sizes joining on later has not been ruled out. Neil also expects academia, regulatory agencies, contract research organizations and patient advocacy groups to play a significant role in TransCelerate’s work.

Intended to be a virtual initiative, the non-profit will be headquartered in Philadelphia but have no staff at the start other than Neil. Instead, full-time equivalents from the 10 charter companies will work together on the goals. Each participating company is contributing an undisclosed amount of money to the effort, along with the FTEs, Neil said.

Once the deliverables are ready for implementation, he said, the expectation is that each member company will adapt those to its practices, but not necessarily all at the same rate.

“It wouldn’t make sense for a company to come into this and do this work unless they were planning to implement it,” he explained. “Individual companies may do that on a different time table.… At the end, I think all of the member companies will come up with an implementation plan for at least one of the initiatives. Some will be doing all five, and some will be somewhere in between.”

--Joseph Haas

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