Q: What is the greatest insight gained from attending the 2015 ISPE/FDA quality week?
A: In discussions with industry and FDA colleagues, it is clear that understanding supply chain risks is the key to understanding risk of drug shortages. Over the past 10-15 years, the pharma industry has done an excellent job of reducing supply chain costs. However, we may have pushed our focus on efficient supply chains too far, contributing to the increase in quality issues and/or drug shortages in this same period. We recognize that, while we can learn much from supply chain structures in other industries like automotive or apparel, our risk tolerance in pharmaceuticals is different. New developments are changing our risk profile (e.g., shift from primary care to specialty care). Our burgeoning small and large molecule pipelines require agility that mature pipelines did not. The explosive growth in biologics demand will challenge our global capability to respond.
is the head of global biologics operations and global engineering at MedImmune/AstraZeneca and the 2015 chair for ISPE’s international board of directors.
Q: What is the key to a successful quality risk management approach in pharma?
A: Do not lose sight of the big picture. This goes beyond putting in place a safety net and implementing risk tools at key processes. The question is, “How will an organization continue to assure quality control?” To succeed, the long-term vision and integration of a risk management platform must support the long-term goals and strategy of the corporation. This starts with having a forward-thinking mentality. As risk managers we often find ourselves focused on the details or identified risks. However, while these are critical to the overall function of the specific process, understanding the interactions and linkages of the “components” has the greatest impact to the organization in identifying areas for risk-control measures. Meanwhile, build flexibility into each component to allow room for evolvement. It is a delicate balance between thinking long term, while not losing sight of the day-to-day.
JASON URBAN, PH.D.
is director of global quality risk management and compliance at Celgene.
Q: How is the shift toward biologics and biosimilars changing the life sciences industry landscape, and what should executives be doing to capitalize?
A: More companies are adopting the “modality-independent” approach (i.e., agnostic to whether the drug is a chemical or a biologic) to finding a therapeutic, which is a shift from the previous pharma versus biotech dichotomy. This is enabling technologies to cross over, and organizations are able to think broadly with more innovations. For example, a drug delivery technology typically applied only to a small molecule drug now can be married with a biologic or biosimilar, thus creating a new therapeutic that has a different profile and may have broader benefits. Biosimilars could be made into biobetters. As biologics mature, product differentiation will be the anchor for any new development program. Success now depends on how well these approaches are proactively strategized and executed so that both therapeutic and economic benefits can be achieved.
SESHA NEERVANNAN, PH.D.
is VP of pharmaceutical development at Allergan and oversees a wide variety of CMC (chemistry, manufacturing, and controls) activities related to drug development from early discovery to commercialization.