GUEST COLUMNISTS

• There's A Gap In Brain Tumor Research — Here's How We Fix It

  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.

• Lessons Learned While Taking Glioblastoma Drug From Bench To Clinic

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

• The Much-Feared FDA Form 483, Part 3

  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.

• Considerations For Allergic Rhinitis Trials Are Nothing To Sneeze At

  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.

• Why Clinical And Commercial Development Must Be Integrated Fully And Early For FDA And Reimbursement Success

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

• With A Clear Focus And Promising Asset, Crystalys Is Skipping Phase 2 Trials For Gout

  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. 

• RWD Helps Researchers Include More Patients In Lymphoma Research

  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.

• Could Study Rehearsals Create A New Standard For Site Readiness?

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