GUEST COLUMNISTS

• 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.

• India Opens The Fast Lane For Drug Development

  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.

• U.S. Pharma Tariffs And MFN Become Law After April 2 Update

  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.

• Clinical Trials Succeed When Patients Talk — And The Entire Ecosystem Listens

  Patient advocate and founder of MIB Agents Ann Graham knows intimately the importance of including patient feedback into trial design. She explains value of — and offers practical advice — for doing just that.