Outsourced Pharma Editorial

  1. A CMC Professional At Sanofi Focuses On Collaborations (And The Right Questions) 4/20/2026

    Manda Pasarkar, Global Regulatory Affairs, CMC Head, Sanofi, has overseen global, multi-billion-dollar portfolios of products from early development to commercialization. She spoke with Chief Editor Louis Garguilo on her outsourcing strategy and philosophy.

  2. Why A Cell Therapy CEO Waited Until Phase III To Outsource 4/16/2026

    Sometimes, you have to go it alone. For a while, at least. The mantra across biotech has long been clear: engage your CDMO early, and let those experts guide you into manufacturing. Matthieu de Kalbermatten, CEO of CellProthera, a regenerative cell-therapy developer, begs to differ.

  3. Field Notes: APEC RHSC's Workshop On ATMP Development And Evaluation 4/15/2026

    Scientific and regulatory leaders in the Asia-Pacific region met recently for an exchange of strategies to strengthen convergence and technical competence.

  4. U.S. Pharma Tariffs And MFN Become Law After April 2 Update 4/15/2026

    Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.

  5. How To Implement Post-Approval Changes On A Global Level 4/14/2026

    To prepare for inevitable process changes after market authorization, this overview provides critical planning advice for assessing risk and minimizing delays.

  6. March 2026 — CDMO Opportunities And Threats Report 4/14/2026

    Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

  7. The Business Case For Continuous Manufacturing In Biologics 4/14/2026

    The question for leadership is not if continuous manufacturing will transform biologics, but when and how quickly to invest.

  8. Forget Tech Transfer. You Need A Cognitive Connection 4/13/2026

    Cognitive transfer is a concept widely studied in psychology. Today it has growing relevance within our industry’s ever-increasing technology transfers, which have been understood in the main as moving development/manufacturing processes/technologies from one stage, one location, or one organization – as when utilizing CDMOs – to another. Time now to zero in on the communicating of tacit or implicit knowledge, i.e., knowledge or experience difficult to extract through data or written explanation. This is where cognitive transfer enters our portal. Here's an analysis.

  9. Mastering Biotech's Insourcing/Outsourcing Trade-Offs 4/10/2026

    Here's a case for the biotech hybrid model, one that relies on a crack team of internal core talent complemented by broad reliance on external vendors.

  10. In Palm Beach The Focus Is On Biotech (Not President Trump) 4/9/2026

    “When I came to Florida,” James Sapirstein says, “I was leaving New Jersey because of tax reasons.” That was 2018. Timing is everything, they say. Sapirstein’s relocation placed him ahead of a broadening and intensifying migration trend – including he believes, a new biotechnology settlement. This is not news to readers – Miami alone seems perennially in the headlines. “Economics drives investors,” Sapirstein says, and Sapirstein is committed spearheading “a new kind of biotech cluster."