Tension Between Quality Regulatory Paradigm and Pharma’s Innovation, Acceleration and Harmonization Imperatives in Spotlight

Pfizer VP and Global CMC Head Roger Nosal is among prominent pharma thought leaders who are articulating the growing tension between the existing quality regulatory paradigm and the pharma imperatives of innovation, development/review acceleration, continuous improvement and regulatory harmonization.

In a keynote presentation at the ISPE/FDA/PQRI Quality Manufacturing Conference in June in Alexandria, Virginia, Nosal focused on this tension and the difficulties it is causing industry. Evolving the paradigm is critical in pursuing these imperatives, he stressed, and he provided insight on what the shift needs to entail.

The ICH Q12 effort to increase the regulatory flexibility to make CMC improvements as learning is gained across the product lifecycle has put the underlying paradigm problem into higher relief. Nosal is among the thought leaders that are bringing their wealth of experience to bear in trying to better understand and address it. [See IPQ November/December 2015 for an in-depth review of the intensifying global lifecycle regulatory dialogue that the ICH Q12 effort is helping spur.]

In introducing Nosal at the conference, J&J Quality and Compliance VP and Chief Quality Officer Francois Sallans highlighted the contributions Nosal has made to the advancement of quality by design (QbD) and global regulatory harmonization through his service on various PhRMA, ICH, ISPE, PQRI, AAPS, ACS and DIA technical committees. Nosal’s 35 years of experience at J.D. Searle, Monsanto, Pharmacia and Pfizer has included 22 years in regulatory CMC. Prior to his regulatory role, Nosal was a medicinal chemist focused on product and process development and analytical control, and author of 24 patents, reflecting his work with 5HT3/4 agonists/antagonists and Cox-2/serotonin inhibitors and other substances.

At the beginning of the presentation, the Pfizer CMC topsider projected onto the screen a clear statement of the underlying theme – that the pharmaceutical industry is now “at a crossroads” where “breakthrough therapies, accelerated development and transformative technical innovation are poised to shift the conventional regulatory paradigm and improve quality assurance.”

Currently, “increasingly divergent global regulatory expectations and lengthy approval times for manufacturing optimizations and continuous improvement initiatives pose a significant punitive burden for product supply chains and barriers to innovation.”

Reducing these regulatory barriers, Nosal stated, demands “global regulatory convergence, collaboration among regulatory authorities, and incentives to establish a new quality paradigm.”

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