BioCentury This Week Ep. 327 - Where Gene & Cell Therapy Go Next With Evotec's Bernd Mühlenweg
Oct 16, 2025
In this captivating discussion, Bernd Mühlenweg, SVP at Evotec and expert in cell and gene therapy, shares insights on the industry’s challenges and triumphs. He highlights over 130 ongoing trials, the importance of immune shielding, and the evolution of autologous versus allogeneic therapies. Bernd emphasizes the need for regulatory education and addresses manufacturing hurdles. Despite cautious investor sentiment, he sees potential breakthroughs, particularly in regenerative medicine, that could transform patient care and offer durable solutions.
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Field Shifting Toward Regenerative Uses
- Cell and gene therapy is maturing beyond oncology into regenerative indications like AMD, Parkinson's and type 1 diabetes.
- Allogeneic, immune-shielded approaches could enable long-term tissue engraftment and broader commercial viability.
Autologous And Allogeneic Will Coexist
- Autologous and allogeneic approaches will coexist because each fits different clinical needs.
- Regenerative indications needing long persistence will favor allogeneic immune-evasive engineered cells over autologous options.
Engage Regulators And Simplify Engineering
- Engage regulators early and educate them on genetic engineering impacts to shape workable frameworks.
- Limit engineering steps in development to preserve master cell bank stability and reduce mutation risk.