Nat Ricciardi was not the only keynote speaker at ISPE's meeting in Orlando, at a hotel right within Disneyland, this week. Also on the program was a marketing director for Disney. (And now for a brief digression...to avoid reading it, scroll down to the next subhead in bold to read the important part ): I confess that I rolled my eyes when the program change was announced (ISPE had originally planned to have an "imagineer," rather than a marketer, speak at the event), only to find that he was an excellent speaker who brought up some of the challenges that the company faces (notably, energizing poor performers) and techniques that the company uses for brainstorming and process improvement, all quite relevant to drug development and manufacturing. His talk was also full of promos for the company---as a parent of three, I've heard entirely too much from Disney over the years, and, horrifying as this may sound, had never even been anywhere near a Disney theme park --- and (to echo the drug industry's most popular mantra) by design. In Orlando, one can almost hear the giant sucking sound of money being vacuumed from pockets, and all with a plastic smile and the strains of "It's a small world after all" piping in. As the speaker put it, Disney's new competitors aren't other theme parks, but home repair and construction contractors and even orthodontists. (I say, make the repairs on the house and fix the kids' teeth first, although I realize that a trip is warranted) If one can't help but admire, even if begrudgingly, Disney's ingenuity, one must also credit ISPE for finding crowd-pleasing destinations and organizing its programs so well. Next year's program will be at another sure-fire hit destination: Las Vegas (which has always ranked high on my must-to-avoid list, but then I'm a contrarian). OK. Rant over Dr. Moheb Nasr on QbD If "saving the best for last" was the intent, then the leading keynote speaker at the event was FDA's Dr. Moheb Nasr, Director of the Office of New Drug Chemistry, who started his talk by summarizing all the challenges facing drug development and manufacturing. (For the record, FDA's P.R. staff really needs to have a new publicity photo of Dr. Nasr taken; in the existing one, he appears unfriendly and forbidding, neither of which would describe him in person.) "The industry's supply of drugs is adequate and of sufficient quality," he said, but pharma remains slow to innovate and to embrace new technologies. He also mentioned the Nickerson/Macher study. Dr. Nasr went on to discuss ICH's vision for quality, walking through the goals for Q8 (design space), Q 9 (risk management) and Q 10 (quality systems). As he put it, the term "quality by design" is still misunderstood within the industry, even though it has been around for so long. Nasr went on to talk about FDA's CMC Pilot Program, which allows applicants to propose a regulatory strategy specific to a product and/or process. He also discussed needs and gaps, highlighting the need for control, quality control and change control:
- new manufacturing platforms
- continuous processing
- process intensification and increased use of microreactors (we're covering this regularly in the magazine, and adoption is increasing, at least in labs)
- new control platforms, to facilitate PAT, real-time release, and statistical process control.