IFPAC 2010 started with a pre-conference workshop entitled “Implementation of QbD and PAT: A Regulatory Perspective.” Several regulatory agency speakers and industry representatives gave brief presentations, then sat for a Q&A session. Participating were Evdokia Korakianiti (European Medicines Agency), Steven Kozlowski (OPS, CDER, FDA), Frank Holcombe (Office of Generic Drugs, OPS/CDER/FDA), and Christine Moore (NDQA, OPS/CDER/FDA) from the agencies, as well as Robert Baum (Executive Director, Pfizer) and Jim Cheney (Executive Director, Novartis) from industry.
Just a few of the highlights:
Dr. Moore addressed the scientific challenges facing QbD, particularly understanding multivariate approaches and new instrumentation. She informed us that, over the last two years, there were 12 NDAs, 18 INDs, and 6 sNDAs (supplemental NDAs) submitted with QbD as part of the submission. All were in addition to the pilot study (of a dozen products) previously run by the agency.
An interesting point made by Dr. Kozlowski: the ratio of QbD-based submissions for small molecules compared to biologics has been roughly 15 to 1.
Dr. Korakianiti explained that one impediment to rapid acceptance of QbD in Europe was the diversity: the EU consists of 27 member states, many with semi-autonomous agencies within a single country. She admitted that the submissions for biologics were essentially non-existent yet. She did comment that, after a company made a QbD submission, the second was made quickly thereafter. In all, she acknowledged that there were less than two dozen submissions to date.
Dr. Holcombe discussed a shift in approaching generics and QbD: FDA has generated a questionnaire that steps submitters through the process (since they often have much smaller staffs with less experience than larger companies). It does not replace the submission itself, but is intended to lend support.
Baum and Cheney indicated that their companies continue to be committed to PAT/QbD and were looking forward to more submissions. There were no major announcements in their talks.
In any case, no one seemed willing to actually name the products that they were speaking about. It leaves a bit of unease when they speak about “a solid dosage form” or “a biological product.”
More to come tomorrow, as the show begins in earnest today!