Clinical Guest Contributors

  1. What The FDA's Latest Move On Psychedelics Means For Non-Hallucinogenic Drug Sponsors 8/13/2026

    Taking another angle to the FDA focus on psychedelic research, Enveric Biosciences CEO Joseph Tucker, Ph.D., explores what the FDA’s moves mean for non-hallucinogenic drug sponsors.

  2. What The FDA's Psychedelic Drug Focus Means For Classic Psychedelic Development 8/13/2026

    Complementing an interview with Enveric Bioscience's Joseph Tucker, Ph.D., this Q&A explores Josh Hardman's thoughts on what FDA’s psychedelic focus could mean for classic psychedelic development.

  3. 5 Signs Your Clinical Trial Needs Outside Help 8/13/2026

    Could you use some outside help? The right outside partner can bring the expertise, capacity, and perspective needed to get studies back on track.

  4. How FDA Alignment Is Shaping Opus Genetics' OPGx-LCA5 Development Strategy 8/12/2026

    Opus Genetics shares how FDA alignment yielded a clearer path for its ultra-rare LCA5 gene therapy, shaping trial design, evidence generation, and operations.

  5. Why Vendor Oversight Breaks Down At Handoffs 8/11/2026

    Is a vendor handoff really complete once the file is sent? Not quite. Sponsors still need context, ownership, and evidence to keep trials moving.

  6. Don't Accept This Site-Level Start-Up Bottleneck— Instead, Learn How To Stop It 8/10/2026

    Combining investigator meetings and SIVs can cut site activation timelines in half — if sponsors build a compliance-sound case and involve QA early.

  7. What It Takes To Validate A Biomarker For Real-World, Post-Transplant Care 8/7/2026

    Yelena Bushman, MBA, VP of cell therapy and transplant at CareDx, discusses the operational challenges of validating biomarkers for post-transplant care.

  8. July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing 8/7/2026

    Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.

  9. C-Suite Changes Help Biotech Narrow Focus But Maintain Drive To Treat Fatal Neonatal Brain Injury 8/5/2026

    Newly-appointed leaders at ReAlta Life Sciences discuss their skill sets, their goals for advancing a therapy for hypoxic ischemic encephalopathy (HIE), and how they keep momentum as they strive to help bring this potentially lifesaving therapy to market.

  10. 3 Ways To Solve Data Friction In Modern Clinical Data Management 8/4/2026

    Senior clinical data manager Shasidar Reddy Abbidi shares how to reduce data friction with targeted automation, early standards adoption, and clearer workflows that move data to decisions faster.