“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
Takeda Pharmaceutical Company has entered a global strategic partnership with China’s Innovent Biologics to acquire rights to two late-stage investigational oncology medicines and an option on an early-stage program, the companies announced October 22. Under the agreement, Takeda will pay
“The complexity is there’s an antibody component, linker-payloads with highly potent toxic agents that need high containment, and linking a biologic with a highly potent small molecule – it’s inherently challenging.” Dr. Harch Ooi, VP of Manufacturing and Chemistry at
“Outsourcing is about giving the things you don’t excel at to someone who does them exceptionally well. That’s what speeds development and delivery,” says Kindeva’s CEO, Milton Boyer. Milton brings nearly 30 years of pharmaceutical manufacturing experience as a contract
Merck and AstraZeneca’s decisions reflect a broader industry exodus as drugmakers cite government undervaluation, lack of competitive environment and prioritise US investment. The UK’s pharmaceutical sector crisis has dramatically deepened this week, with AstraZeneca pausing its entire £650m UK investment
“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
“The manufacturing process doesn’t just produce the product — it determines what the product becomes.” Steven Sullivan, Founder of Linville Bio, brings more than two decades of experience spanning developmental biology, clinical translation, and manufacturing strategy across organizations, including Novartis
