GUEST COLUMNISTS

• Assigned Slot Allocation Offers A Fair Solution For Oncology Phase 1 Trials (Part 2)

  In part two of this series on slot allocation, Nehal Lakhani, MD, Ph.D. proposes assigned slot allocation as an alternative to competitive placement and discusses how the approach might benefit patients and sites.

• Slot Allocation Is A Problem For Patients And PIs In Phase 1 Oncology Trials (Part 1)

  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.

• 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.