AAPS PharmSci 360: CMC Strategies, Part 1

PharmTech spoke with Alfred Rumondor, PhD, CMC due diligence for external assets at AbbVie, and Swita Singh, PhD, Senior Director and Strategic CMC Leader at Bristol Myers Squibb, 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 1 of this 3-part interview, Rumondor and Singh discussed how chemistry, manufacturing, and controls (CMC) review practices are evolving and what that means for manufacturing strategy.

Singh identified the most consequential shift as a move from informal, reviewer-dependent flexibility to formal, risk-based flexibility applied consistently across the product life cycle. She pointed to Operation TrailBlazer and updated phase 1 CMC guidance as examples, stating they are reducing required manufacturing data pre-investigational new drug application (IND). Singh also pointed out that cell and gene therapy programs no longer need 3 independent process performance qualification batches and can flex specifications for small-batch production. AI-driven tools and emerging credibility frameworks are reinforcing this trend by helping generate cleaner data packages for faster, more consistent regulatory decisions.

Singh cautioned, however, that companies must build “risk justification muscle” rather than simply accepting flexibility at face value. Reduced requirements should be treated as deferral, not elimination, of data obligations; organizations need clear plans for when deferred data will be generated and which milestones trigger it. She emphasized investing early in comparability infrastructure, leveraging platform and prior-knowledge pathways, and engaging proactively with regulators.

Rumondor addressed the pressure to compress development timelines. He argued the real question isn’t whether compression is safe, but how to do it properly by working smarter rather than skipping steps. He cited premature form selection without adequate screening as a common shortcut that later may bring costly bridging and comparability studies, increasing both timeline and program risk. Compressed timelines are achievable, but only when teams rigorously plan the full development path upfront, according to Rumondor.

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.