The odds on drug development are almost universally acknowledged as daunting, to put it mildly. Historically, every new drug that enters the clinic has about a 1-in-10 chance of success. And the drugs that do make it all the way are typically in the clinic for more than a decade at a cost of a billion dollars-plus.
Those stats, of course, just don't work. Too much time. Too much money. Too much failure.
So now the emphasis is on devising a new way to develop drugs. And there's a considerable amount of consensus on what has to change. In large organizations, responsibility has to be pushed down to smaller groups who are given the power to make key decisions. There have to be clear timelines to reach key clinical milestones--particularly when it comes to proof-of-concept. And you have to use what we know about drug technology to find a shorter path to Phase III data. Anyone looking for examples of that need only consider some of the recent successes in the cancer field, where it's possible for PoC data to deliver a clear picture on the remaining clinical and regulatory risk in play.
Next week at BIO, I'll be moderating a discussion with a group of biotech and pharma experts who have thought long and hard about doing clinical development right, and how we can all change things for the better. Our panel includes Mene Pangalos, the EVP of innovative medicine at AstraZeneca ($AZN); Jason Gardner, head of the Center of Excellence in External Drug Discovery, GlaxoSmithKline ($GSK); Jill Milne, CEO of Catabasis Pharmaceuticals; Bernard Munos, the founder of InnoThink, and Jim Burns, head of Sanofi's ($SNY) Boston hub.
We've already registered more than 250 biopharma execs for our presentation--a clear sign of just how crucial this mission has become. And we hope you'll join us for the event on the morning of Tuesday, June 19, at the Westin Waterfront in Boston. Register here for one of the few remaining seats. -- John Carroll, editor-in-chief. Follow me on Twitter and LinkedIn.