GUEST COLUMNISTS

• 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.

• 3 Ways To Solve Data Friction In Modern Clinical Data Management

  Senior clinical data manager Shasidar Reddy Abbidi shares how to reduce data friction with targeted automation, early standards adoption, and clearer workflows that move data to decisions faster.

• How Visible Is Your Clinical Trial To AI?

  Ross Jacksons explores how clinical trials show up — it at all — in AI tools and what that means for sponsors' approach to publicizing trial information.