GUEST COLUMNISTS

• 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.

• The Much-Feared FDA Form 483, Part 2

  Dr. Robert Califf argues that FDA Form 483, while useful for identifying issues in clinical research, is often applied punitively, causing reputational harm and unnecessary complexity. He advocates for a contextual, quality‑focused approach supported by AI and modernized guidelines to improve evidence generation efficiently.

• Opus Genetics Shows Proper Planning Is Key To Adaptive Trial Design

  Opus Genetics CEO George Magrath, MD, shares the team’s experience with an adaptive Phase 1/2 trial design for an ocular gene therapy.

• Building A Future-Proof, GxP-Compliant IT Infrastructure

  Learn how a structured IT evaluation framework can help companies model total compliance costs, request vendor qualification evidence, and embed governance requirements into infrastructure selection.

• The Much-Feared FDA Form 483

  Dr. Robert Califf explains that FDA Form 483 is often misunderstood as a final judgment, when it is actually an initial notice of potential issues found during inspections. He argues the form should be seen as a tool for quality improvement, not a proxy for overall performance, and he calls for more efficient processes to reduce unnecessary anxiety and delays.