Life Science Leader

Source: Life Science Leader This week's episode of the Business of Biotech was recorded at the BIO Convention in San Diego, where guest Maha Radhakrishnan, M.D., Executive Partner, Private Equity, at Sofinnova, spoke about her move from big pharma and biotech to private equity investing, and what makes a late-stage asset deal work.

FDA’s draft “plausible mechanism” framework gives individualized genetic therapies a clearer path to market, but questions remain, write experts at Morrison Foerster. Connect With Life Science Leader:

By Ben Comer, Chief Editor, Life Science Leader Bouncing around the San Diego Convention Center’s 2.6 million square feet for four days is its own kind of flustery exercise, but in the age of Zoom it’s a more-than-welcome excursion. It’s hard to complain about a summertime work trip to San Diego. BIO 2026 featured a mix of off-site events, onsite panels, scheduled and impromptu interviews, and some in-person Business of Biotech recordings (look out for those in the coming weeks, posted here).

Get more Life Science Leader insight with our FREE newsletter. Newsletter | July 5, 2026 BALANCING RISKS WITH REWARDS Doctors are prescribing GLP-1 therapies for an evergrowing number of patients, but treatment isn’t one-size-fits-all, and sometimes the risks aren’t clearly communicated.

LISTEN NOW: OUR LATEST PODCAST EPISODES Check out the latest episodes from Better Biopharma, Cell & Gene: The Podcast, and Business of Biotech. As a member of the Life Science Connect community, you have access to content beyond our weekly newsletters, including our podcast series.

For drugmakers, approval is only the beginning; the real test is converting scientific breakthroughs into sustained commercial success, explains ARS Pharma CEO Richard Lowenthal. How To Accelerate Early-Phase Oncology Trial Purpose-built early-phase oncology sites can enroll patients within 7–10 days post-activation while maintaining quality and diversity; academic centers often lag due to complexity and saturation. Connect With Life Science Leader:

Guest Column | June 29, 2026 By Alan Minsk, Laura LaBrie, and Grace Gluck The U.S. Food and Drug Administration’s Office of Prescription Drug Promotion's (OPDP’s) 2026 untitled letters do more than identify a handful of promotional missteps. Read together with the agency’s concentrated enforcement activity in September 2025, they suggest that OPDP may be placing greater practical emphasis on consumer takeaway and net-impression analysis when evaluating direct-to-consumer promotion.

NEW APPROACHES FOR DIFFICULT DISEASES This week’s selections from Life Science Leader offer encouraging signs of early successes in hard-to-treat conditions, or at least a roadmap to get there. From a regulatory perspective, FDA created a flexible framework that could lead to more “Baby KJ” success stories — cures for genetic ultra rare diseases. Experts at Morrison Foerster examined the framework and its implications for drug developers.

Strengthening contamination control requires more than isolated checks. Explore how a holistic approach to single-use system (SUS) integrity can strengthen contamination control, improve operational efficiency, and meet evolving regulatory expectations in manufacturing. Product‑wet integrity testing offers a more realistic view of filter performance when water-based methods fall short.

Digital Ecosystem For Process Intensification Process intensification can only reach its full potential with a strong digital foundation. Discover how Sartorius digital solutions—combining automation, orchestration, and predictive analytics—enable connected, compliant, and data-driven biomanufacturing. Download the white paper to learn how a unified digital ecosystem supports efficiency and scalability across the entire process chain. Learn more here.