Industry, FDA, and modeling vendors are taking other steps to hone their model-building skills. For one, new PK data-management
systems will up both the quantity and the quality of clinical pharmacology data. These repositories represent a major investment
but promise to accelerate retrieving, manipulating, and validating data references. With this technology, datasets can also
be shared more easily.
FDA has proposed a new collaborative regulatory process, the End of Phase IIa Meeting, to discuss modeling, trial design,
and other MBDD issues before Phase III program decisions are set. The agency's aim is to promote MBDD techniques for the design
of trials, not just for analysis leading to the exact wording of labels and FDA regulatory decisions. A pilot consisting of
10 to 12 meetings in various therapeutic areas was completed last September, and the feedback was positive. But FDA is far
from having sufficient staff to do End of Phase IIa meetings for every drug candidate.
On the Path to Pharma's Future
The intense pressures on drug companies are forcing new ways of approaching drug development. Successful collaboration in
HIV lit the way, and some firms are repeating its lessons in other areas. Tightly focused, professionally managed collaborations,
such as the biomarker and drug-safety initiatives, are showing promise. More than that, they are persuading members to share
nonproprietary data and overcome ingrained tendencies to keep their intellectual property under lock and key. More and deeper
collaborations lie ahead. Meantime, relationships between sponsors and FDA are becoming less adversarial through the End of
Phase IIa meetings and other processes, creating new channels for additional communication and collaboration on program designs.
But all of this is only a beginning. The obstacles in many cases are immediate and easy to quantify, while the benefits—however
huge in theory—are hard to put numbers to and not exactly on a next-day-delivery schedule. Companies don't come into collaborations
with the capability to contribute equally. They must find incentives to overcome potentially crippling "free rider" problems.
Funding and staff remain high hurdles, especially at FDA. Legal permissions needed for sharing take time to put in place.
But any long-view risk/reward calculus leads to only one conclusion: Collaboration must not only continue but increase. The
biggest risk for industry is not taking a risk. We have no choice but to walk the Critical Path together.
Dan Weiner is a senior vice president and the chief technology officer at Pharsight firstname.lastname@example.org
Mark Hovde is the senior vice president of marketing email@example.com