Tawni Koutchesfahani, Vice President, General Manager at Minaris Advanced Therapies, shared a post on LinkedIn:
“As we closed out 2025, let’s celebrate what our field accomplished, and getting real about what 2026 needs to bring.
2025 highs:
- CAR-T kept advancing: Breyanzi now approved for 5 cancer types, which is the the most of any CD19 CAR-T.
- MSK’s stem cell therapy for Parkinson’s showed genuine promise in Phase 1. Dopamine-producing neurons transplanted into the brain with no serious side effects after 18 months.
- First-ever therapy for MacTel (Encelto) allogeneic encapsulated cell therapy.
2025 reality checks:
- Novo Nordisk shut down their entire cell therapy unit (three programs (Type 1 diabetes, Parkinson’s, heart failure) all discontinued. When a $300B pharma can’t make the unit economics work, it’s a signal the industry needs to hear.
- 8 of 28 EMA-approved cell/gene therapies are now unavailable pulled from market because the business models didn’t hold. Great science doesn’t automatically equal sustainable commercialization.
My predictions for 2026:
- Manufacturing becomes the ultimate competitive advantage. The companies that master scalable, cost-effective production will define the next decade.
- Allogeneic will have its breakthrough year. Autologous therapies are transformative, and expensive. 2026 is when off-the-shelf therapies prove they can compete on both efficacy and economics. The NK cell space is where you should be watching closely.
- CDMO innovation will accelerate. Innovators with their CDMOs need to start with outcomes-based contracts, risk-sharing agreements, installment models as the traditional MSA payment structure might be old ways.
- Oh, and the players who crack sustainable reimbursement models will own the landscape.
I’ve spent 20 years in this industry watching manufacturing evolve from the overlooked function to the most mission-critical capability in biotech. 2026 feels like an inflection point.
If you’re tackling the hard problems where you need manufacturing excellence, commercial scale-up, and operational transformation in cell/gene therapy, Minaris Advanced Therapies Philadelphia is your partner.
Here’s to a 2026 where we deliver more, reach more patients, and prove that transformative medicine can also be sustainable business.
Happy New Year!”