Clinical Guest Contributors

  1. Slot Allocation Is A Problem For Patients And PIs In Phase 1 Oncology Trials (Part 1) 4/10/2026

    Given the shift in the size and scope of oncology Phase 1 trials, cohort management and slot allocation strategies must change, too. Nehal Lakhani, MD, Ph.D. explains why competitive slot allocation is no longer optimal for patients or PIs.

  2. There's A Gap In Brain Tumor Research — Here's How We Fix It 4/9/2026

    Brain tumors are some of the most biologically complex and least improved indications. Biochemistry researcher and scientist Catherine Bladen, Ph.D., argues sustained focus is a key to driving real-world progress.

  3. Lessons Learned While Taking Glioblastoma Drug From Bench To Clinic 4/9/2026

    MimiVax CEO Mike Ciesielski recounts the company's transition from academia to industry, hitting on topics like vendor partnerships, FDA conversations, and manufacturer selection. 

  4. The Much-Feared FDA Form 483, Part 3 4/8/2026

    This final installment in this three-part series offers an example of how the misperception of the 483 as a surrogate for overall quality of a firm can lead to policy errors in attempting to mitigate pricing problems with generic drugs.

  5. Considerations For Allergic Rhinitis Trials Are Nothing To Sneeze At 4/8/2026

    Inimmune CEO David Burkhart explains how a GSK layoff led to the formation of a new company focused on treating allergic rhinitis. Here, he shares success from the company's approach to site selection, trial design, and timing.

  6. Redefining Patient Outcomes Measurement Using RWE Data 4/7/2026

    Discover an outcome-channeling framework that organizes patient outcomes into multidimensional domains, emphasing longitudinal trajectories rather than single time endpoints.

  7. Why Clinical And Commercial Development Must Be Integrated Fully And Early For FDA And Reimbursement Success 4/6/2026

    With clear alignment among clinical development, regulatory, and commercial development processes, sponsor companies can better prepare for FDA approval and successful Medicare reimbursement.

  8. With A Clear Focus And Promising Asset, Crystalys Is Skipping Phase 2 Trials For Gout 4/3/2026

    Crystallis President and CEO James Mackay shares insights from the company’s clinical decision-making for dotinurad, including the inclusion of an open label extension. 

  9. RWD Helps Researchers Include More Patients In Lymphoma Research 4/2/2026

    Andrew Evens, DO, MBA, explores how outcomes research and collaboration across academic networks, registries, and industry partners are advancing more inclusive, data-informed approaches to lymphoma research.

  10. Could Study Rehearsals Create A New Standard For Site Readiness? 4/1/2026

    Giving sites the chance to rehearse a trial ahead of their initial study visits could lead to improved readiness, protocol adherence, and participant experience.