Alfred Rumondor, PhD, CMC Support for Due Diligence for External Assets at AbbVie.

Alfred Rumondor, PhD

AAPS PharmSci 360: CMC Strategies, Part 2

 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, to learn more about their upcoming panel discussion, Navigating CMC Strategy in the Current Landscape, at 

, which is being held from October 25-28 in New Orleans. In part 2 of this 3-part interview, Rumondor and Singh, discuss how chemistry, manufacturing, and controls (CMC) teams navigate modalities with little regulatory precedent, plus where AI is delivering real value in CMC work.

Singh addresses the challenge facing cell and gene therapy products, in vivo gene editing, and cell-based combination products, which is that modalities often lack established regulatory guidance. Singh suggests that when precedent doesn't apply, teams should return to the core statutory and quality standards of identity, strength, quality, purity, and potency, then build a control strategy around the modality’s specific risk factors.

She also recommends deliberately leveraging adjacent precedent, even without direct guidance for a given modality, relevant precedent from related modalities may still apply. She urged sponsors to engage the FDA early and often through formal pathways like INTERACT meetings and Type B pre-investigational new drug approval meetings, rather than waiting for guidance documents to be issued; these programs exist specifically for precedent-free scenarios, and proactive engagement helps bring the agency along the development journey.

Finally, Singh advised planning for iteration from the outset: new, precedent-free modalities inevitably require more comparability work as manufacturing is refined, so companies should establish a comparability protocol and a banked reference material strategy from day one rather than reacting later.

Rumondor provided his insight on how AI is reshaping CMC work by simplifying tasks once considered labor- and resource-intensive, using computational approaches to accelerate work that previously took significant time and effort. He emphasizes that AI doesn’t eliminate the need for experimentation but enhances it. As an example, he points to solid-form selection during development, where AI—paired with computational modeling—can help investigate potential stable forms, dramatically cutting the number of required experiments and enabling faster, more comprehensive form selection. He notes this is just one of many role-specific applications, all pointing toward smarter, faster work with fewer resources.

Click the video above to watch the interview.

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In a preview of their panel discussion at AAPS PharmSci 360 2026, Alfred Rumondor, PhD, AbbVie, and Swita Singh, PhD, Bristol Myers Squibb, discuss navigating CMC requirements for new modalities and AI’s involvement in CMC. 

AAPS PharmSci 360: CMC Strategies, Part 1 

 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 

, 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.

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

, is Director, Development Sciences Licensing and Acquisitions, at AbbVie.

Swita Singh, PhD, Senior Director and Strategic CMC Leader at Bristol Myers Squibb

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.

In a preview of their panel discussion at AAPS PharmSci 360 2026, Alfred Rumondor, PhD, AbbVie, and Swita Singh, PhD, Bristol Myers Squibb, discussed how CMC review practices are evolving and what that means for manufacturing strategy.

Alfred Rumondor, PhD

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