Preclinical feature articles

  1. 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?

  2. 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.

  3. 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.

  4. FDA Seeks Input On AI Adoption In Drug Development And Manufacture 6/13/2023

    The FDA released two discussion papers for consideration: Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products and Artificial Intelligence in Drug Manufacturing. The papers identify current and potential areas for AI adoption.

  5. 3 Questions On Precigen's Cell Therapy Studies 6/13/2023

    Clinical Leader recently touched base with Helen Sabzevari, Ph.D., CEO of Precigen, about the biopharma’s clinical-stage research in the CAR-T therapeutics space. The company currently has six products in its clinical pipeline, including three that use its UltraCAR-T platform.

  6. Tapping Into AI/ML Partnerships To Advance Drug Discovery With Recursion Pharma 6/8/2023

    "TechBio" company Recursion Pharma has entered agreements to acquire AI/ML company Cyclica for $40 million and Valence for $47.5 million. To learn about the acquisitions and the future of AI/ML in drug discovery and development, we caught up with Recursion’s CEO Chris Gibson.

  7. Perfused Organ Models: An Alternative To Animal Testing 6/6/2023

    Animal testing has been a long-standing practice in biomedical research, providing valuable insights into disease mechanisms, drug efficacy, and safety. However, ethical concerns, limitations of animal models, and increasing awareness of animal welfare have prompted the development of alternative methods — like perfused organ models (POMs).

  8. How Predictive Can Regulatory Drug Abuse Potential Investigations Be in Animals? 5/31/2023

    Is addiction attributed to “the animal or the human within us” or is substance abuse unique to humans? This question has intrigued me since the EMA guidance on Non-clinical Investigation of the Dependence Potential of Medicinal Products in 2006 and the FDA guidance on Assessment of Abuse Potential of Drugs in 2010 have requested the performance of dedicated studies in animals. Let's take a closer look at the matter.

  9. What If We Could Do Clinical Trials Before We Do Clinical Trials? 5/26/2023

    New techniques are not only proving to be more effective than animal testing but will herald a completely new way of investigating novel treatments. Using these techniques, like human chip models, medical researchers will be able to actually run “clinical trials” before testing a drug in live humans. 

  10. More Focus And Funding Becomes Crucial To Curing Colorectal Cancer 4/12/2023

    Advancements in the treatment of colorectal cancer have undoubtedly been made in recent years, but unfortunately, they are not enough to combat this deadly disease. Fight Colorectal Cancer President Anjee Davis addresses the critical lack of funding for colorectal cancer clinical trials and treatment options.