“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
HHS Secretary’s unprecedented move to terminate 22 federal mRNA contracts sends shockwaves through biotech sector and raises critical questions about U.S. pandemic preparedness The pharmaceutical industry woke up to a fundamentally altered landscape this week as Health and Human Services
Cell and gene therapies (CGTs) represent a revolutionary approach to treating previously incurable diseases, offering new hope for patients with genetic disorders, cancer, and other life-threatening conditions. However, bringing these complex therapies to market presents unique manufacturing challenges that differ
According to epidemiologist Dr. Katelyn Jetelina, the United States could be experiencing its most significant disruption to vaccine policy in 70 years, with anti-vaccine advocates now controlling federal vaccine recommendations for 330 million Americans. This assessment comes from Dr. Jetelina,
The escalating military conflict between Israel and Iran has reached a critical juncture, with Iran’s parliament voting to close the Strait of Hormuz in response to U.S. military actions on 22nd June 2025. This potential closure of the world’s most
“This enterprise is lacking congressional support. The host of prior leaders in this policy space have left,” warn biodefense advocates pushing for renewed bipartisan commitment Jennifer Alton, President of Pathway Policy Group, delivered this stark assessment during a biodefense policy
Presented by Rodrigo Rial – Business Manager, VIVUNT Oncology Sterile oncology drug manufacturing operates at the crossroads of scientific precision and life-critical patient care. These therapies often involve highly potent active ingredients, requiring exceptional containment and meticulous aseptic handling. The
Unlocking Value Through Strategic Alignment and Flexibility Emerging biotech and pharmaceutical companies consistently face the intricate challenge of balancing time, cost, and risk. As these organisations strive to develop novel therapies and bring them to market, meticulous resource management is
In an era where remote collaboration is no longer optional but essential, Federica Fraschetti of MSD shared insights at CDMO Live 2025 on how to build high-performance virtual factory teams across sponsor and contract development and manufacturing partners. The session,
As the pharmaceutical landscape continues to face disruption from global events, supply chain volatility, and evolving regulatory expectations, the nature of partnerships between biopharma companies and CDMOs must evolve beyond transactional engagements. At CDMO Live 2025, Rocco Paracchini, Director at
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