Clinical Guest Contributors

  1. Navigating Elsa's AI Transition: Practical Guidance To Safeguard Confidential Information (Part 3) 4/22/2026

    With FDA's Claude-to-Gemini transition underway within Elsa, Kimberly Chew, Esq., and Michael Yang, Esq., offer advice for proactive risk management to safeguard trade secrets and regulatory outcomes in part three of this series on Elsa's AI transition.

  2. Caregivers: The Missing Line Item In Trial Budgets 4/21/2026

    More than 60 million Americans are caregivers, holding up a system and clinical research enterprise, yet they are mostly uncompensated for their efforts. That needs to change, says Denise N. Bronner and Marsha Calloway-Campbell.

  3. A New Biomarker Risk Score May Improve Prognosis And Trials In Idiopathic Pulmonary Fibrosis 4/21/2026

    A new biomarker risk score developed by the Pulmonary Fibrosis Foundation's PROLIFIC consortium could serve as the latest prognostic or predictive tool in clinical trials and care. for those diagnosed with idiopathic pulmonary fibrosis (IPF).

  4. Reformulating An In-Clinic IV To At-Home Injection Puts Patients At The Center 4/20/2026

    For Soligenix, reformulation was not a detour but a necessary step toward optimizing a therapy for real-world use. Discover how the team reformulated its drug delivery from in-clinic to at-home administration.

  5. Reminder: FDA Approval Is Not Synonymous With Commercial Success 4/17/2026

    Life sciences expert Rena Roseberg, Ph.D., warns that research and commercial efforts cannot operate within a vacuum. Here, she shares best practices on developing a therapeutic product with solid understanding of its commercial viability. 

  6. What Sites, Sponsors, Vendors, And CROs Can All Agree On 4/17/2026

    Experts representing sponsors, sites, vendors, and CROS discussed at Life Sciences Future SW the pain points and the opportunities that lie ahead in clinical research.

  7. AI Amplifies Capabilities But Also Risks: Learn The Legal Consequences Of AI In Clinical Research 4/16/2026

    Companies that successfully use AI are those that understand technology magnifies accountability. Anyone that fails to internalize that lesson could find themselves defending the very systems they relied on to bring those products to market.

  8. Is It Time To Replace RECIST — Or Just Add AI? 4/16/2026

    Immunocore Chief Regulatory and Quality Officer Mark Moyer explains why new tools, including AI-based approaches, may better capture cancer treatment response than existing measures, such as ir-RECIST.

  9. India Opens The Fast Lane For Drug Development 4/15/2026

    New in 2026, extensive reforms to India’s clinical trial rules are slashing approval timelines in half and eliminating licenses that once took months to obtain.

  10. 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.