GUEST COLUMNISTS

• 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.

• Biotech Ecosystem Helps Advance A New Approach To Inflammation Into Trials

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

• Synaptic Regeneration And The Future Of Alzheimer's R&D

  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.

• FDA Form 483 Responses: The Difference Between Explaining An Observation And Demonstrating Control

  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.