Clinical Guest Contributors

  1. Safety Is The Mantra In Kivu Bioscience's ADC Trials For Solid Tumors 5/29/2026

    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.

  2. Taking On Patient Recruitment From Another Angle — The Payer 5/28/2026

    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. 

  3. Clinical Trial Ads, Informed Consent, And Half-Hearted Regulation 5/27/2026

    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.

  4. FDA's HALO Platform And Elsa 4.0: Five Critical Risks For Sponsors 5/26/2026

    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.

  5. Biotech Ecosystem Helps Advance A New Approach To Inflammation Into Trials 5/26/2026

    BioAegis Therapeutics CEO Susan Levinson, Ph.D., talks about the role of partner and regulatory support in bringing their investigational immunotherapy into the clinic.

  6. Synaptic Regeneration And The Future Of Alzheimer's R&D 5/22/2026

    For too long, treating Alzheimer’s disease has been a case of “managed decline.” We need to move beyond slowing disease progression toward achieving tangible functional recovery.

  7. FDA Form 483 Responses: The Difference Between Explaining An Observation And Demonstrating Control 5/22/2026

    ADRES Bio's Rivka Zaibel walks sponsors through the proper response to an FDA Form 483, emphasizing the need to show understanding and control of the situation.

  8. Judgement-Based Project Management Builds Partners' Trust 5/21/2026

    Project managers often operate under rules that govern how and when they execute tasks. But that doesn't always include room for individual judgment. But judgement, argues Jason Bork, is the differentiator in successful partnerships.

  9. How Did You End Up In Clinical Research? 5/20/2026

    To commemorate Clinical Trials Day, we asked clinical researchers to share their story, answering, "How did you get into clinical research?"

  10. From CRO Management To Networked Governance: The New Quality Imperative 5/20/2026

    The clinical research industry once emphasized transactional vendor management, but now it requires broader governance to enable the level of quality that enables scalability and success.