In conversation with Nina Bauer: CAR-T milestones, navigating investment landscapes, and the three Ps of CGT

What inspired your journey into CGT?

My journey began 17 years ago with an academic interest in tissue and organ regeneration. As the first cell therapies gained approval, I saw an opportunity to contribute to their commercialization and have been involved ever since.

What has been the most pivotal development in the past decade?

The approval of CAR-T therapies, particularly Kymriah in 2017, was a watershed moment. It validated the field and proved that complex, individualized therapies could be developed, approved, and delivered to patients.

What excites you most about the current landscape?

The first clinical data for in vivo CAR-T therapies is by far the most exciting development, alongside the expansion of CAR-T beyond blood cancers into autoimmune diseases and even early signs of success in solid tumors.

Equally transformative is the advancement of non-viral gene delivery in combination with gene editing. Together, these approaches signal a pathway toward greater accessibility and affordability; two things this field urgently needs to become a mainstay of modern medicine.

What is one piece of advice you would offer to researchers entering the field today?

In today’s funding and geopolitical climate, focus is everything. I see three core areas that need attention:

1. Clinical development planning—Select indications and patient populations carefully, and plan how to manage them through clinical development into commercialization. Substantial preclinical data are essential to secure funding.

2. Health economics and manufacturing—Pricing and reimbursement depend on achieving sustainable COGs as well as well thought out health economic and competitive dynamics. Understand what price point is viable and ensure your manufacturing strategy can deliver.

3. The three Ps—Patients need education to drive demand, physicians need training to prescribe confidently, and payers need robust evidence of value to support reimbursement.

What developments do you expect to shape CGT in the next 5–10 years?

For autologous CAR-T, scaling to treat large autoimmune populations will require either making it a procedural product, like dialysis, or moving toward off-the-shelf solutions that combine small molecules, mRNA, or other modalities and potentially allogeneic approaches.

For gene therapy, viral approaches are likely to remain dominant for now, but innovations such as stable producer cell lines could help lower costs. Looking further ahead, I am optimistic about platform-based strategies, such as basket trials for gene editing, as demonstrated by initiatives like Danaher’s Beacon program, which could streamline development and bring therapies to patients faster.

Outside of work, what are your hobbies?

I am currently learning a new language, which is proving to be a real challenge. I have also been traveling extensively, exploring regions both overseas and within the US. Seeing how people live, love, and think in different cultures is deeply humbling and provides an invaluable perspective.

What do you enjoy listening to?

I rely on the NPR app daily for news and insights, and I also enjoy the AltNPS account on BlueSky; make of that what you will.

What is your favorite snack?

Wasabi almonds and roasted seaweed snacks, particularly the salty or wasabi varieties, are my go-to favorites.

Biography

Nina Bauer is a trained neuroscientist whose career rapidly centered on the cell and gene therapy space, holding various technical and commercial roles at the Scottish Center for Regenerative Medicine (Edinburgh, UK) and the Cell and Gene Therapy Catapult (London, UK). She deepened her global commercial experience establishing Lonza’s autologous Cell Therapy Business and strategic positioning by incorporating the Cocoon™ technology with a vision for near-patient manufacturing (Basel, Switzerland), as well as leading commercial teams at MilliporeSigma/Merck KGaA (Boston, MA, USA) focusing on the cell therapy product portfolio, gene therapy manufacturing services and CRISPR IP licensing. Aside from large corporate and public sector leadership roles, Nina established her start-up and C-suite acumen as the Chief Commercial Officer for FloDesign Sonics (Wilbraham, MA, USA), leading to the company’s acquisition by MilliporeSigma, as well as a wide range of advisory board engagements.

Affiliation

Nina Bauer PhD MBA, Cell and Gene Therapy Consultant, Board Member, Strategic Advisor, Boston, MA, USA

Authorship & Conflict of Interest

Contributions: The named author takes responsibility for the integrity of the work as a whole, and has given their approval for this version to be published.

Acknowledgements: None.

Disclosure and potential conflicts of interest: The author has no conflicts of interest.

Funding declaration: The author received no financial support for the research, authorship and/or publication of this article.

Article & Copyright Information

Copyright: Published by Cell & Gene Therapy Insights under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Attribution: Copyright © 2025 Nina Bauer. Published by Cell & Gene Therapy Insights under Creative Commons License Deed CC BY NC ND 4.0.

Article source: Invited.

Revised manuscript received: Sep 25, 2025.

Publication date: Oct 29, 2025.