Much has been made of Dr. Ajaz Hussain’s departure from FDA’s process analytical technology (PAT) team; Hussain has moved on to become VP and global head of biopharmaceutical development for Sandoz, and now faces the daunting challenge of commercializing biosimilars. If there were any doubts about the sustainability of the PAT initiative, FDA’s growing PAT team and the PAT champions within industry have taken the ball that Hussain tossed into the air and run with it.
As was made abundantly clear at last month’s IFPAC 2006 conference and exhibit in Arlington, Va., PAT is not only in good hands, it is in the hands of many. Within FDA, the PAT team has just begun training a new crop of contributors, including members of the Center for Biologics.
And PAT’s no longer being driven by FDA, say Chris Watts, Ph.D., and Ali Afnan, Ph.D., key members of FDA’s PAT Policy Development team who now help to carry the baton within the Agency. FDA’s role is to set the tone for continued innovation within the PAT framework and to further open dialogue and trust-building with industry, the two said in an interview with Pharmaceutical Manufacturing’s editors at IFPAC.
The major hurdle for PAT is now getting the international community on board, in harmonization efforts with EU and the rest of the world (ROW). As Ruhi Ahmed, Ph.D., regulatory lead at BioMarin, Inc. (Novato, Calif.), described her predicament of selling PAT initiatives to her management: PAT makes complete sense and may ease regulatory approval in the U.S., but what about the 26 other countries in which the firm markets its products?
Pharmaceutical Manufacturing’s editors sat down with Watts and Afnan to discuss PAT’s present and future. The group was joined by near-infrared spectroscopy and PAT expert Emil Ciurczak, a consultant and member of this magazine’s editorial review board. Excerpts from that interview follow.
P.M.: What’s new with the PAT team these days?
Watts: The changes are really only in the form of additions, with the exception of Ajaz’s departure obviously. At the end of January, we started the next round of training for the team, which includes the centers for Biologics, Drugs, Veterinary Medicine and Office of Regulatory Affairs. This group is much larger, with nearly three times the number we sent through the last time. Then we had 13, and now we have 36. And we try to cover all of the eight regions in ORA — though not every district because that would be impossible.
Afnan: Within OPS, [Director] Helen [Winkle] now chairs the steering committee, replacing Ajaz. Chris and I now report to Helen.
P.M.: What are your top goals and priorities for this year?
Watts: We’re really focusing on getting the next round of training going and implemented. We’re also trying to expand PAT concepts internally. There’s now a section on PAT in the PI [Pharmaceutical Inspectorate] training program, for example. It’s important for us to go beyond the small group that we have and to communicate these concepts throughout the Agency.
Afnan: We’re also looking closely at how we approach PAT as a regulator and how we encourage industry to function as manufacturers. Implementing PAT throughout all the offices of FDA would be a major achievement toward our objectives.
Watts: The thing that I’m most proud of is how the team that we have functions together. They really do work well and value each others’ opinions. And if we can increase that interaction between the review, inspection and compliance officers, then we’ve made significant steps forward.
Ciurczak: A testimony to the work that you guys have done is the fact that none of the team seems to be leaving for what would obviously be higher-paying jobs in the industry.
Afnan: Maybe the pay is better in industry, but Chris said it right. I don’t know how much more we can convey how unique and rewarding working on this team is. We see the need to challenge the norms that we’re used to, and to find different ways of working for change.
Ciurczak: Is there any effort to encourage more companies to say which product they’re applying PAT to — to “name names”? This would allow others can go to their companies and say, ‘Look, Pfizer’s doing this with this drug, AstraZeneca’s doing this. Here’s a product we have that should look at as well.”
Watts: I think we’ve encouraged all the companies that we’ve interacted with. Sanofi-Aventis is one case where a company has been very open, though they haven’t mentioned the product. But the name that you put on it is really irrelevant. The details of the process and the learning that they’ve achieved are most important.