AAPS PharmSci 360: CMC Strategies, Part 3

PharmTech spoke with Alfred Rumondor, PhD, director, Development Sciences Licensing and Acquisitions,at AbbVie, and Swita Singh, PhD, senior director and strategic CMC leader at Bristol Myers Squibb (BMS), to learn more about their upcoming panel discussion, Navigating CMC Strategy in the Current Landscape, at AAPS PharmSci 360, which is being held from October 25-28 in New Orleans. In part 3 of this 3-part interview, Rumondor and Singh, discuss the challenges involved in chemistry, manufacturing, and controls (CMC) risk management.

Dr. Singh argues that the biggest obstacle is organizational. There is a lack of risk tolerance that shows up culturally and in how teams are resourced. Quality assurance and regulatory careers have been shaped by the belief that more data are always safer, says Singh, so even when science supports a leaner control strategy, organizations default to adding testing back in “just in case.” This reflex, she says, quietly replaces science-based decision-making with risk aversion disguised as rigor.

On the resourcing side, companies fund execution-heavy work like running processes and assays generously but underinvest in the upfront cross-functional risk assessment that a genuine risk-based strategy requires, according to Singh. The result is thin or backfilled risk assessments that collapse under scrutiny. Singh ties this directly to recent FDA flexibility, such as no longer requiring 3 process performance qualification lots or allowing deferred phase 1 CMC data. She notes that this regulatory flexibility goes unused if a company’s internal risk tolerance hasn't caught up.

Singh and Rumondor are participating in the panel, Navigating CMC Strategy in the Current Landscape, at AAPS PharmSci 360. The panel will bring together representatives from BMS, Pfizer, AbbVie, and Merck to discuss regulatory expectations, emerging modalities, speed to market, resourcing, and AI implementation. Rumondor describes the event as a valuable in-person opportunity for cross-company collaboration, where one can compare perspectives with peers from other firms and hopes attendees leave with practical considerations they can apply to building their own CMC strategies.

Click the video above to watch the interview.

Click here to watch part 1

Click here to watch part 2

About the Speakers

Alfred Rumondor, PhD, is Director, Development Sciences Licensing and Acquisitions, at AbbVie.

Dr. Swita Singh holds a Ph.D. in Pharmaceutical Sciences and brings over fifteen years of distinguished expertise in Chemistry, Manufacturing, and Controls (CMC) development across biologics, antibody drug conjugates, and small molecules, with a proven record of driving strategic initiatives, optimizing complex business processes, and leading cross-functional teams to achieve regulatory and operational excellence. Recognized for delivering innovative, end-to-end CMC strategies that guide programs from early clinical development through successful commercialization, she has cultivated talent and shaped organizational culture throughout her career, while her commitment to stakeholder communication and cross-functional collaboration has consistently advanced program objectives across the industry. Having built her expertise at Pfizer and Eli Lilly and Company, Dr. Singh currently serves at Bristol Myers Squibb (BMS), where she continues to lead CMC strategy in support of transformative therapeutic development.