Tagged with USA

USA Kim Moran, SVP & Head of US Rare Disease at UCB, discusses how the company is building on its long-standing heritage in neurology to expand into rare and ultra-rare conditions. She highlights the strategic thinking behind UCB’s growing rare disease portfolio and explains what it takes to successfully bring therapies…

USA Paul Kim, a leading FDA attorney and policy expert formerly at both the FDA and the US Congress, discusses the current shifts within the American life sciences and regulatory landscape. Kim examines the prevailing sentiment of the industry amidst a period of significant structural upheaval and regulatory whiplash. He offers…

USA After 25 years at Genzyme and Sanofi, Chris Hwang joined a biotech startup in China in 2016 to develop advanced bioprocessing technologies that reduce cost of goods while maintaining reliable supply. As CTO of Transcenta, he and his team have advanced continuous bioprocessing, delivering dramatic productivity improvements over traditional batch…

USA Christine Baeder, President of USA and LATAM at Apotex, discusses the company’s evolution following private equity investment, its Generics Plus strategy, and the critical role of the US market. She highlights supply chain resilience, the challenges facing biosimilar adoption, and the need for structural policy reforms to sustain affordability, innovation…

USA Craig Martin, CEO of the Orphan Therapeutics Accelerator (OTXL), discusses the urgent need for a new business model to rescue abandoned clinical-stage programs in the rare disease sector. He details OTXL’s innovative non-profit model, which leverages a collaborative network of partners and unique tax-exempt incentives to liberate stranded assets from…

USA Nasha Fitter, a tech entrepreneur and CEO of the FOXG1 Research Foundation, discusses the radical shift in drug development led by a new generation of sophisticated parent-entrepreneurs. Following her daughter’s diagnosis with the ultra-rare neurodevelopmental disorder FOXG1 syndrome, Fitter co-founded the FOXG1 Research Foundation and Citizen Health. Her mission: to…

USA Tanya Carro details Duchesnay Pharmaceutical Group’s organic expansion from its women’s health core into rare diseases and generics. Operating across three geographic pillars, the privately held firm leverages Canadian pricing discipline and US entrepreneurial agility. Carro emphasizes navigating complex reimbursement landscapes through holistic patient support and securing global supply chains…

USA William Hait, Chief Scientific Advisor of the American Association for Cancer Research (AACR) and Chair of AACR’s Scientific Advisory Council, highlights the society’s position within the global oncology ecosystem as a trusted, unbiased leader facilitating progress from discovery to community impact. Hait details AACR’s focus on prioritizing prevention, early detection,…

USA Frank Bedu‑Addo shares his journey from scientist to co‑founder and CEO of PDS Biotechnology. He highlights promising progress across PDS’s oncology pipeline, including strategic decisions that have helped improve antitumor efficacy through combination therapy, validate science through partnerships with leading institutions, and accelerate timelines to potential regulatory approval. Bedu‑Addo goes…

USA Katherine Stueland, CEO of GeneDx, describes transforming the 26-year-old NIH spinout into a scalable, patient-focused business. Leveraging the Infinity database, strategic biopharma partnerships, AI-driven interpretation, and cost-efficient exome and genome testing, GeneDx accelerates rare disease diagnosis. The company is aiming to assist in the expansion of newborn screening programs as…

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…