A CRADA Diary: Part I

By Agnes Shanley, Editor in Chief For the past two years, a novel Cooperative Research and Development Agreement (CRADA) involving FDA and the software company Conformia has been looking at bumps on the road to science-based manufacturing. In this first of several interviews, CDER’s Office of Pharmaceutical Science director, Dr. Helen Winkle (HW), and Conformia cofounder Anjali Kataria (AK) share their views on the CRADA’s progress. – How did the idea for this program come about? – Conformia had given a number of briefings to FDA about the drug development space. The Agency felt there were gaps in its understanding of the issues, but they appear to have realized that, as a third party, we had a different perspective than an operating pharma company. We offered some middle ground. We’re trying to raise issues that are important to helping the industry understand the underpinnings of ICH Q8, Q9 and the emerging Q10, especially since drug companies will have to file applications in a new way, using the principles of Quality by Design. – Have there been any surprises so far? – What surprised me is that there are bottlenecks on both sides, on industry’s and on FDA’s, as the Agency attempts to get reviewers, inspectors and policy makers alike to adopt QbD across the board. Under the pilot CMC program, three companies have announced that they’ve been approved under the new paradigm, but that’s a very limited group. Moheb Nasr at FDA is very committed to QbD, but who else is committed on the inspection and policy side? What kind of integration is occurring between these two groups? That connection is not visible to the industry yet. The biggest challenge for FDA has been in the small molecule side of the business. The Office of Biologics has already had a team