Tagged with US

USA Orla Cloak, CEO of Minaris, explains how the organisation. was formed by integrating Minaris Regenerative Medicine, a dedicated cell and gene therapy (CGT) CDMO, and WuXi Advanced Therapies, which brought both CGT manufacturing and established GMP biosafety testing capabilities. Today, Minaris operates under private equity as two complementary businesses: Minaris…

USA 2026 could mark a turning point for biosimilar adoption in the US. By scrapping requirements for redundant clinical trials and pushing Congress to end the “Interchangeable” label, the FDA has cleared the runway for biosimilars. However, with PBM “rebate walls” and patent thickets still standing, will these lower cost therapies…

USA The FDA’s Sarah Yim discusses the evolving regulatory landscape for biosimilars in the US, the shift toward analytical-heavy reviews over large clinical studies, the legislative push to simplify interchangeability, and the agency’s commitment to increasing market competition and patient access through streamlined development pathways. My goal, and the FDA goal…

USA Philip Macnabb serves as Chief Executive Officer of Curia, bringing 25 years of private equity-backed healthcare experience to his first venture into the CDMO sector. Joining in March 2023, Macnabb leads a globally diversified CDMO with 20 facilities spanning drug discovery through commercial manufacturing, serving predominantly biotech customers whilst maintaining…

USA David Barrett has led the American Society of Gene & Cell Therapy (ASGCT) since 2018, guiding its evolution into the leading professional body for scientists, clinicians, industry leaders and patient advocates in cell and gene therapy. Founded in 1996, ASGCT now sits at the centre of research, education and policy…

USA Matt Heck, founder and CEO of Sentynl Therapeutics, outlines the company’s acquisition-led rare disease strategy following its integration into Zydus Group in 2017. He discusses building a focused portfolio of life-extending paediatric therapies, leveraging orphan drug incentives, prioritising early diagnosis, expanding internationally, and partnering closely with patient foundations to maximise…

USA Jeff Allen is the President & CEO of Friends of Cancer Research, a research policy and advocacy organisation based in Washington, DC. His organisation works to accelerate the development of cancer therapies through evidence-based policy and collaborative research partnerships. Allen highlights the importance of diagnostics and biomarker testing to help…

France France is considered among the leading rare disease markets worldwide, both scientifically and organisationally. The country has cultivated a fully-fledged supporting ecosystem for rare conditions that is today regarded as a benchmark internationally, and which few other countries have proven able to match.   “Back in the mid-2000s, under the…

USA Patients and carers with lived experience of a disease have valuable insights to share with physicians and drug developers alike. This is especially true of rare diseases, defined in the US as those that affect fewer than 200,000 people nationwide and which collectively impact over 30 million Americans. For these…

USA Tony Zook reflects on how decades in pharmaceutical leadership inform his perspective on diagnostics as the backbone of precision oncology. This discussion traces NeoGenomics’ evolution from a haematology specialist to a broader oncology platform spanning therapy selection, next-generation sequencing (NGS), and molecular residual disease (MRD). Set against the realities of…

USA Dr Anthony Letai reflects on how a career spanning cancer biology, clinical oncology, and translational research is shaping his early priorities as Director of the National Cancer Institute. The conversation examines how NCI is navigating a shifting global research landscape while accelerating innovation, strengthening evidence-based decision-making, and reinforcing confidence across…

France As global vaccine development grows more complex and capital more selective, Valneva is sharpening its identity and returning decisively to its roots. The company’s decision to close its Nantes site and re-centralise French operations in Lyon is more than operational streamlining; it signals a strategic recommitment to one of Europe’s…