Clinical Guest Contributors

  1. One Drug, Three Indications: How Small ClinOps Teams Manage Multi-Trial Execution 6/17/2026

    Having the same number of clinical programs as team members might sound crazy, but for Step Pharma, it has become one of their biggest strengths.

  2. Rare Disease Nonprofits: De-Risk Development With Orphan Drug Designation And Early Talks With The FDA 6/17/2026

    For nonprofit organizations, Orphan Drug Designation is the start of a disciplined, forward-looking regulatory strategy, but it's not the only factor in success. H. Greg Thomas, Ph.D., shares his advice for de-risking orphan drug development.

  3. The Compliance Problem With Excel Trackers And Other Computational Tools — And How AI Can Help 6/16/2026

    Everyday computational tools such as Excel are simple and easy to use, but they carry risk. Learn how these tools might not adhere to 21 CFR Part 11, and discover how AI can help keep them compliant.

  4. To Prevent Parkinson's Disease, We Need New Biomarkers 6/16/2026

    Parkinson's disease research has shifted toward prevention and prodromal intervention but success with disease-modifying and preventive therapies depends on validated PD-specific biomarkers. AC Immune Cofounder and CEO Andrea Pfeifer explains.

  5. What It's Like To Advance A Cell Therapy Through The Japan Entry Acceleration Program 6/15/2026

    Ernexa Therapeutics President & CEO Sanjeev Luther details having one the of 10 coveted spots in the Japan Entry Acceleration Program (JEAP) that supports cell therapy development and market entry in Japan.

  6. A Blueprint For Addressing Underserved Patient Populations 6/12/2026

    Does our current approach to clinical research truly serve the patients who face the greatest needs? Insmed Inc. CMO Martina Flammer, MD, MBA, explores how to better meet patient needs.

  7. Why Clinical Data Standards Matter In An AI-Driven World 6/11/2026

    Novartis technology and scientific computing expert Bill Illis discusses what changes sponsors must make to the R&D data landscape to achieve sustained, meaningful progress — with the help of AI — to bring new therapies to patients faster.

  8. How The Quiet Data Standards Revolution Is Impacting Drug Approval 6/11/2026

    Principal Statistical Programmer Varun Debbeti details the role data standards play in approval timelines, detailing shortfalls of current the model and CORE, Dataset-JSON, and SDTM v3.0 stand to make an impact.

  9. Designing Trials For Disease Modification: Cereno Scientific's Approach To Pulmonary Arterial Hypertension 6/10/2026

    Cereno Scientific’s Rahul Agrawal discusses the scientific and strategic rationale behind extending the company’s Phase 2b study duration and how the company incorporated regulator and patient input.

  10. What's Wrong With Site Benchmarking? A Site-Centered Perspective On Its Alignment, Transparency, And Use 6/9/2026

    Benchmarking is widely used and highly valued, yet trust in it is limited. The League Benchmarking Working Group has set out to standardize how site metrics are defined, contextualized, and applied.