“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
“When I walked into the tech transfer, we were a million dollars over budget, six months behind schedule, and struggling to make a single successful batch,” says Amy Gamber. Amy Gamber, Executive Director, Lifecycle Lead at Kyverna Therapeutics, specializes in
As cell and gene therapies, RNA-based platforms, and antibody-drug conjugates accelerate toward commercialization, the pharmaceutical industry must develop analytical methods robust enough to characterize increasingly complex therapeutic modalities while remaining flexible enough to evolve with emerging science. PharmaSource asked analytical
“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
Carole Delauney warns that sterile injectable manufacturing “is not just fill-finish”—a misconception that can cost biotech companies millions and even derail entire drug development programs. She notes, “This is unfortunately not commonly recognized in the industry, but it is a
“CMC success is rarely the product of last-minute fixes. It comes from embedding strategic foresight, regulatory awareness, and cross-functional collaboration from day one.” — Evelien Stalmeijer Evelien Stalmeijer, Chief Cell & Gene Therapy Consultant at eXmoor Pharma, brings deep expertise
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,
RESOURCES The need for a strategic, comprehensive approach to your drug development journey is essential for success. The journey of a novel therapeutic from a lab concept to a market-approved medicine is complex, time-consuming, risky, and costly. The average likelihood
