GUEST COLUMNISTS

• 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.

• Taking On Patient Recruitment From Another Angle — The Payer

  Medzown CEO Jennifer Carter, MD, discusses the challenge of patient recruitment and how coalescing around clinical care data might be a better “in” for recruitment. 

• Clinical Trial Ads, Informed Consent, And Half-Hearted Regulation

  Should informed consent really start with clinical trials ads? And if not, why do IRBs need to be involved in their approval? Paul Ivisin unravels the tangled web of IRBs, regulators, and clinical trial advertisements.

• FDA's HALO Platform And Elsa 4.0: Five Critical Risks For Sponsors

  Discover five critical risks created by HALO's architecture and Elsa 4.0's expanded capabilities. Then, learn how to implement practical safeguards sponsors to implement immediately.