GUEST COLUMNISTS

• What The FDA's Psychedelic Drug Focus Means For Classic Psychedelic Development

  Complementing an interview with Enveric Bioscience's Joseph Tucker, Ph.D., this Q&A explores Josh Hardman's thoughts on what FDA’s psychedelic focus could mean for classic psychedelic development.

• The Patient Advocacy Strategy Behind Skyhawk's Rapid Enrollment

  Skyhawk’s patient-first approach shows how advocacy partnerships, site engagement, and operational quality can accelerate enrollment without losing focus on patients.

• How FDA Alignment Is Shaping Opus Genetics' OPGx-LCA5 Development Strategy

  Opus Genetics shares how FDA alignment yielded a clearer path for its ultra-rare LCA5 gene therapy, shaping trial design, evidence generation, and operations.

• Why Vendor Oversight Breaks Down At Handoffs

  Is a vendor handoff really complete once the file is sent? Not quite. Sponsors still need context, ownership, and evidence to keep trials moving.

• Don't Accept This Site-Level Start-Up Bottleneck— Instead, Learn How To Stop It

  Combining investigator meetings and SIVs can cut site activation timelines in half — if sponsors build a compliance-sound case and involve QA early.

• What It Takes To Validate A Biomarker For Real-World, Post-Transplant Care

  Yelena Bushman, MBA, VP of cell therapy and transplant at CareDx, discusses the operational challenges of validating biomarkers for post-transplant care.

• July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing

  Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.

• C-Suite Changes Help Biotech Narrow Focus But Maintain Drive To Treat Fatal Neonatal Brain Injury

  Newly-appointed leaders at ReAlta Life Sciences discuss their skill sets, their goals for advancing a therapy for hypoxic ischemic encephalopathy (HIE), and how they keep momentum as they strive to help bring this potentially lifesaving therapy to market.