Why Product-Specific Strategies Matter in Advanced Therapy Manufacturing (Part 3)

In the rapidly evolving landscape of advanced therapeutics, industry leaders like Miguel Forte, MD, PhD, CEO, Kiji Therapeutics; president, International Society for Cell and Gene Therapy; and board/executive committee member, Alliance for Regenerative Medicine, advocate for a balanced approach that blends innovation with proven strategies. In an interview with BioPharm International® during the 2025 Cell and Gene Meeting on the Mesa, Dr. Forte emphasized the importance of mainstream solutions to navigate challenges in product development, supply chain management, and market access.

Dr. Forte explains that one key to success is resisting the urge to “reinvent the wheel” and, instead, adapting existing methodologies to meet the specific needs of new therapies. “One of the things that is important for us is [to not] be seen as unicorns and different...We are adopting solutions and approaches that people are comfortable with. We don’t have to reinvent the wheel. We have to use the wheel appropriately for our engine, for our vehicle,” he says.

How can mainstream approaches enhance success in advanced therapeutics manufacturing and supply chain?

Advanced therapies, particularly those requiring decentralized or traditional centralized manufacturing, face unique logistical hurdles, such as extreme cold-chain requirements. Dr. Forte suggests making products easier to administer by “producing different formulations so that physicians can do a weight-adjusted administration by using a combination of formulations,” streamlining the path from freezer to patient arm.

Companies must also address macroeconomic and regulatory factors that affect global distribution. Dr. Forte underscores the necessity of evaluating localized manufacturing options in the United States or Europe to avoid cross-border disruption and enhance value to stakeholders.

Adopting mainstream approaches while tailoring strategies to product specificities optimizes therapeutic delivery, ensures clinical convenience, and future-proofs advanced therapy commercialization, Dr. Forte summarizes. Regularly reassessing supply chain and distribution strategies remains essential as external economic and political conditions change.

Click the video above to view the interview.

Click the following links for Part 1 and Part 2 of Dr. Forte’s interview.

Meeting on the Mesa occurred Oct. 6–8, 2025 in Phoenix, Ariz. Click here for more conference coverage.

About the speaker

Miguel Forte, MD, PhD, CEO, Kiji Therapeutics; Board Member, ARM; President, ISCT

Dr. Forte holds several roles as CEO and co-founder of Kiji Therapeutics, executive chairman of Akatsuki Therapeutics, board member of the Alliance for Regenerative Medicine, StemBond, and Swarm Oncology, and president of the board of directors for the International Society for Cell and Gene Therapy. He holds an MD and specialist in infectious diseases from the Faculty of Medicine, University of Lisbon (Portugal); a PhD in Immunology from the University of Birmingham (Alabama, United States); and a certificate on Health Technologies Economics from the Stockholm School of Economics. He is a fellow of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians in the United Kingdom.