GUEST COLUMNISTS

• The New FDA Era Of Radical Transparency And Pervasive Oversight

  The first half of 2025 has been transformative for biopharmaceutical quality and regulatory affairs, with the FDA leading the charge with four significant changes. Curadian Group's David Grote discusses implications for all four.

• Redesigning Oncology Trials Around Tumor Vulnerability: The Rise of WEE1 And DDR Strategies

  As clinical progress with DNA damage response (DDR) continues to evolve, research must respond with adaptive models, smarter combinations, and biomarker-informed patient selection.

• Rethinking Clinical Development In The Age Of Synthetic Cell Therapy

  Synthetic biology, especially when applied to engineered stem cells, such as induced mesenchymal stem cells (iMSCs), represents a new frontier. But to get these cells to patients, we need to reimagine how we develop and evaluate them.

• How Digital Twins Are Rewriting Clinical Trials

  While the benefits of digital twins to accelerate clinical trials are undeniable, many questions about their use are still unanswered and go far beyond technology.

• 3 Quick Takes From A PI With 100+ Trials To His Name

  Principal investigator Norman B. Gaylis, MD, shares his perspective on patient recruitment, protocol design, and vendor selection.

• Alzheimer's Trial Targeting Amyloid Beta Oligomers Sees Cost Savings, Patient Satisfaction With New Screening

  Acumen Pharmaceuticals' Eric Siemers, MD, discusses their novel Alzheimer's disease screening method and trial design for investigational drug sabirnetug that keeps both the clinical site and patient experience in mind. 

• Insuring Global Clinical Trials: Navigating Risks Across Borders

  Foreign clinical trials insurance is indispensable. Learn its features, its benefits, and why it's needed.

• Misconceptions About Cancer Clinical Trials And How To Overcome Them

  Medical oncologist Wasif Saif, MD, MBBS, discusses many of the misconceptions held by patients and clinicians about cancer clinical trials.