Preclinical feature articles

  1. How One Biotech Is Using FDA 505(b)(2) To Get Drugs To Patients Quicker And Cheaper 10/9/2024

    Terran Biosciences CEO Sam Clark, MD, Ph.D. explains how his team is leveraging the 505(b)(2) regulatory pathway to get its new schizophrenia drug to patients quickly and affordably. 

  2. The Small Biotech's Checklist For FIH Trials 8/27/2024

    Getting medicine to its first patients is enormously complex with many players and moving parts. These are the critical steps.

  3. The Future Of MDMA-Assisted Therapy After FDA Rejection — Where Do We Go Now? 8/16/2024

    After the recent FDA rejection of MDMA-assisted therapy for PTSD, psychedelic drug developers and mental health experts alike are asking (and answering), "Where do we go now?"

  4. $25 Million Awards Help Cancer Researchers Make Clinical Trial Inroads 5/9/2024

    Cancer Grand Challenges — a global research initiative cofounded by Cancer Research U.K. and the National Cancer Institute in the U.S. — supports cancer research that aims to answer some of the field’s most dire questions and pertinent needs.

  5. What's Needed To Keep Tinnitus Research From Going Quiet 3/18/2024

    Finding effective treatments for tinnitus has often been circuitous and frustrating for many patients. Tinnitus expert Marc Fagelson, Ph.D., explores the current treatment landscape and what can be done to improve outcomes for patients.

  6. FDA's Updated Guidance On Human Genome Editing: New Implications & Remaining Questions 2/27/2024

    On Jan. 29, 2024, the FDA released the final version of the guidance document on human gene therapy products incorporating genome editing. This article shares what changed between the draft and now final version of the guidance, and what open questions remain for the industry and scientific community to help resolve.

  7. Vulnerable Populations Need Safer, More Effective COVID-19 Antivirals 9/8/2023

    Although COVID-19 is no longer a public health emergency, elderly and immunocompromised individuals remain vulnerable to severe outcomes. Drug developers, therefore, must adapt to deliver next-gen oral antivirals through clinical trials that incorporate the lessons we have learned during the pandemic and address the needs of these high-risk patients.

  8. Is Osteoarthritis Cure — ARPA-H NITRO — Rocket Fuel Or TNT? 8/21/2023

    The U.S. federal government just unveiled a moonshot to fix osteoarthritis. Rumored to be funded at $1 billion and launched out of the new Advanced Research Project Agency for Health (ARPA-H), the Novel Innovations for Tissue Regeneration in Osteoarthritis, or NITRO program, plans to cure OA in five years. But can it be done?

  9. The Critical Role Of Medical Affairs In Discovery Through Phase 2 Clinical Trials 8/14/2023

    When is the right time to engage medical affairs? If you're not sure when MA should make its debut, consider these 11 unique medical affairs contributions that should begin in discovery, be directly connected to other cross-functional deliverables, and continue through launch to support a successful R&D program.

  10. BIO 2023 Takeaways: AI, Accelerated Approval, Patient Diversity 6/15/2023

    On the heels of what felt like the biggest BIO International Convention in years, we’ve compiled a handful of impressions from attendees representing small and mid-size biotech/pharmas, consultancies, and professional organizations.