GUEST COLUMNISTS

• DDW 2026 Signalled The Next Era Of Competitive Landscape In IBD

  At the DDW 2026 meeting, the IBD landscape was portrayed as increasingly competitive and diversified, with emerging players and novel mechanisms challenging established standards of care.

• What Is Computer Software Assurance, And What Are Its Benefits?

  Kamila Novak reviews final computer software assurance (CSA) guidance and what it means for those working on medical device clinical trials.

• The FDA Is Rudderless And Clinical Trials Are Left Adrift

  Former commissioner Marty Makary, MD, left the FDA in May 2026. In his wake, he left an agency facing yet another wave of uncertainty. Denise N. Bronner attempts to navigate the latest change and offers advice for those seeking stability.

• Expanding Access To Cell Therapy Trials Beyond AMCs And Into The Community

  CEO Paul J. Hastings discusses Nkarta's decision to bring outpatient dosing into the community setting, including how it communicated with the FDA on safety and how the changes will improve patient access. 

• What's The Role Of HEOR For A Clinical Researcher? A Perspective From ISPOR 2026

  On the heels of ISPOR 2026, discover what relevancy HEOR has in the world of clinical operations.

• Why Tolerability Will Drive The Next Wave Of Obesity Treatments

  For the next generation of obesity medicines, enhancing how patients experience therapy will inform discovery and development efforts and may ultimately determine long-term success.

• Why Cell And Gene Therapy Has Not Reached More Patients — And Why Clinical Operations Is The Bridge
• Safety Is The Mantra In Kivu Bioscience's ADC Trials For Solid Tumors

  Kivu Bioscience CEO Mohit Trikha, Ph.D., contends that safer ADCs enable higher effective dosing and could elicit a better response in solid tumors. In this Q&A, he also discusses how parallel trial execution, global site strategy, and stakeholder collaboration support rapid, data-driven development.