Anna McMahon is director of Regulatory Affairs at Cellares.

Anna McMahon

In this Drug Digest episode, Abzena’s vice president of Regulatory Strategy, Jeff Mocny, and Cellares’ director of Regulatory Affairs, Anna McMahon, examine how evolving regulatory and quality expectations are reshaping biopharmaceutical development and manufacturing.

Drug Digest: Adaptive Trial Design and Regulatory Shifts in Biopharma Development

The biopharmaceutical industry is undergoing a significant transformation as dynamic 

 frameworks evolve to streamline drug development. Recent shifts emphasize modern evidence standards and adaptive trial designs, moving the industry toward more efficient regulatory pathways, according to 

, PhD, vice president of Regulatory Strategy at Abzena, and 

, director of Regulatory Affairs at Cellares, in the latest episode of the PharmTech 

A central theme in this evolution is the transition to risk-based thinking, which allows developers to leverage prior knowledge to optimize manufacturing and 

. By focusing on benefit-risk propositions, organizations aim to bring therapies to market more rapidly while maintaining high safety standards.

Dr. Mockney highlights the impact of these modern trial models on the development lifecycle, saying, "The trial design is really evolved to improve efficiency and ethical standards and development by enabling real-time data and informed decision making. Going back to the risk benefit, this allows us also to leverage prior knowledge, and, drawing data from other sources that can really drive it, foster faster development."

How are companies implementing risk-based quality frameworks?

"The trial design is really evolved to improve efficiency and ethical standards and development by enabling real-time data and informed decision making. Going back to the risk benefit, this allows us also to leverage prior knowledge, and, drawing data from other sources that can really drive it, foster faster development."

Effective implementation requires integrating risk management directly into process design rather than treating it as a post-approval checkbox. This "quality-by-design" approach reduces structural risks by embedding considerations into engineering requirements and standardized workflows. McMahon emphasizes the importance of this proactive strategy. "The more powerful approach is really to embed it into the process design and development from the start, aligning with ICH Q8 quality-by-design principles."

Beyond technical design, fostering a risk-aware organizational culture is essential for long-term compliance. Regulatory bodies are increasingly focusing on how organizational culture influences quality outcomes, encouraging transparency and cross-functional collaboration. As the landscape becomes more data-driven, the industry is moving toward structured data submissions to tighten the link between manufacturing operations and clinical performance, according to both experts.

Jeffrey C. Mocny, PhD, Vice President, Regulatory Strategy, Abzena

Based out of the company’s Bristol, Pa., facility, Dr. Mocny has more than 30 years of experience in drug development. He leads product strategy, regulatory planning, and quality management initiatives across early development and manufacturing. Before joining Abzena, Dr. Mocny served as senior vice president of Regulatory Affairs at ProEd Regulatory. A microbiologist by training, Dr. Mocny has worked extensively in contract research organization settings, specializing in chemistry, manufacturing, and controls regulatory strategy, analytical method development, and phase 1 trial readiness.

Anna McMahon, Director, Regulatory Affairs, Cellares

As directory of regulatory affairs at Cellares, McMahon led the AMT designation for the Cell Shuttle System. With a career spanning both cell and gene therapy (CGT) and diagnostics, McMahon brings expertise in regulatory strategy, compliance, and chemistry, manufacturing, and controls support. Her background is uniquely grounded in hands-on science. She is a licensed ASCP Medical Laboratory Scientist with experience in academic hospital stem cell labs, giving her a practical foundation that strengthens her regulatory work in the CGT space. McMahon holds a Master of Science in Regulatory Affairs from Northeastern University.

® Group editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

Anna McMahon

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