GUEST COLUMNISTS

• Navigating Elsa's AI Transition: Practical Guidance To Safeguard Confidential Information (Part 3)

  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.

• Caregivers: The Missing Line Item In Trial Budgets

  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.

• A New Biomarker Risk Score May Improve Prognosis And Trials In Idiopathic Pulmonary Fibrosis

  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).

• Reformulating An In-Clinic IV To At-Home Injection Puts Patients At The Center

  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.

• Reminder: FDA Approval Is Not Synonymous With Commercial Success

  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. 

• What Sites, Sponsors, Vendors, And CROs Can All Agree On

  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.

• AI Amplifies Capabilities But Also Risks: Learn The Legal Consequences Of AI In Clinical Research

  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.

• Is It Time To Replace RECIST — Or Just Add AI?

  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.