“CDMOs and Biotechs will both die,” warns NKILT Therapeutics CEO as he talks candidly about the funding crisis stalling cell therapy development, predicting widespread consolidation across biotechs and CDMOs unless the industry shifts toward risk-sharing partnership models that align manufacturing
RESOURCE A Target Product Profile (TPP) is a strategic document, a bridge connecting the drug’s development plan with its eventual marketing label. The TPP describes the desired characteristics of a drug, such as its indication, target population, efficacy, safety profile,
“The biology of aging guides our science — but regulatory conversations are about patient benefit and clinical outcomes. Framing is critical.” Eric Leire is CEO of GenFlow Biosciences, a Belgian biotech developing gene therapy-based interventions targeting age-associated diseases via the
This guest editorial is by Kishore Hotha, PhD, MBA, President, Dr. Hotha’s Life Sciences LLC Chemistry can fail in drug development. Unexpected impurity profiles, scale-up variability, conjugation instability, containment exceedances—these are real and consequential. Anyone who has led a CMC
Guest Editorial by Dainius Guzauskas CMC Professional, former Project Leader at Rentschler Biopharma, former Senior CMC – Regulatory Manager at InflaRx Recent Complete Response Letters (CRLs) from the FDA have sparked fierce debate across industry forums, with many calling for CMC
In an industry where the wrong manufacturing partnership can derail a drug program, and the right one can accelerate it, biotech leaders face mounting pressure to make smarter, faster decisions about their CDMOs. But are they asking the right questions?
The 2026 J.P. Morgan Healthcare Conference revealed a shift in global pharmaceutical power dynamics, with China’s biotech sector commanding ever increasing attention from Western investors and executives who acknowledged the region’s transformation from manufacturing hub to innovation leader. You Cannot
“Life has not become simpler and easier. It’s become more complex. Success requires acknowledging this complexity early and building flexibility into every aspect of the business model.” Renée Aguiar-Lucander is the CEO of Hansa Biopharma, appointed in April 2025. Renée
“CDMOs are partners with deep, extensive technical expertise that can be leveraged strategically—not just a restaurant where you pick from a menu.” Marta Kijanka, founder of MK Bioconsultancy, is a strategic project manager and CMC consultant who guides early-stage biotech
As the pharmaceutical industry grapples with geopolitical tensions, regulatory shifts, and technological disruption, the question of what constitutes a strong external partnership has never been more critical. We asked industry leaders across CDMOs, biotechs, and technology providers to share their
