05.09.26 -- Outsourced Pharma - Best Of April

It sets off a real tension – ideological, economic, even personal. But what would happen if the U.S. government cut direct financial support for “biotechnology research,” leaving it entirely to investors, private and public markets, and bigger pharma? "Our industry’s mind-meld says with no government largesse our biotech industry collapses," writes Chief Editor Louis Garguilo. It's an "outlandish hypothetical," but he asks for a few minutes to go through this. And he has help in making his case.

Manda Pasarkar, Global Regulatory Affairs, CMC Head, Sanofi, has overseen global, multi-billion-dollar portfolios of products from early development to commercialization. She spoke with Chief Editor Louis Garguilo on her outsourcing strategy and philosophy.

Seema Singh of Daiichi Sankyo represents today’s global regulatory leadership in the biopharmaceutical sector. She reflects what the highest expectations should be for all CDMOs, whether your organization is an exacting Japan Pharma, or a start-up biotech in the U.S. Here are her key actions for creating an optimal outsourcing relationship.

Discover how solutions driven by artificial intelligence can enhance compliance, optimize workflows, and drive efficiency in biopharma operations.

Sterile fill–finish is a critical, tightly regulated stage for biotechs, demanding strong contamination control, smart CDMO selection, and awareness of capacity, scalability, and regulatory hurdles.

A cell therapy manufacturing model built on precision planning, digital execution, lifecycle‑ready CMC systems, and transparent collaboration to achieve high reliability and reduce variability across programs.