Clinical Guest Contributors
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AI Amplifies Capabilities But Also Risks: Learn The Legal Consequences Of AI In Clinical Research
4/16/2026
Companies that successfully use AI are those that understand technology magnifies accountability. Anyone that fails to internalize that lesson could find themselves defending the very systems they relied on to bring those products to market.
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Is It Time To Replace RECIST — Or Just Add AI?
4/16/2026
Immunocore Chief Regulatory and Quality Officer Mark Moyer explains why new tools, including AI-based approaches, may better capture cancer treatment response than existing measures, such as ir-RECIST.
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India Opens The Fast Lane For Drug Development
4/15/2026
New in 2026, extensive reforms to India’s clinical trial rules are slashing approval timelines in half and eliminating licenses that once took months to obtain.
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U.S. Pharma Tariffs And MFN Become Law After April 2 Update
4/15/2026
Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.
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Clinical Trials Succeed When Patients Talk — And The Entire Ecosystem Listens
4/15/2026
Patient advocate and founder of MIB Agents Ann Graham knows intimately the importance of including patient feedback into trial design. She explains value of — and offers practical advice — for doing just that.
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What Really Moves The Needle In Primary Immunodeficiency Research And Treatment
4/14/2026
Kedrion Biopharma's Nisha Jain details how researchers can improve trials for primary immunodeficiency and shares four factors for improvement.
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First-In-Human Porcine Kidney Transplant Trial Builds On Expanded Access Success
4/13/2026
eGenesis CEO Mike Curtis discusses the first-in-human trial of EGEN-2784, which they're studying whether a porcine kidney can restore near-normal quality of life while awaiting a human transplant.
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Assigned Slot Allocation Offers A Fair Solution For Oncology Phase 1 Trials (Part 2)
4/10/2026
In part two of this series on slot allocation, Nehal Lakhani, MD, Ph.D. proposes assigned slot allocation as an alternative to competitive placement and discusses how the approach might benefit patients and sites.
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Slot Allocation Is A Problem For Patients And PIs In Phase 1 Oncology Trials (Part 1)
4/10/2026
Given the shift in the size and scope of oncology Phase 1 trials, cohort management and slot allocation strategies must change, too. Nehal Lakhani, MD, Ph.D. explains why competitive slot allocation is no longer optimal for patients or PIs.
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There's A Gap In Brain Tumor Research — Here's How We Fix It
4/9/2026
Brain tumors are some of the most biologically complex and least improved indications. Biochemistry researcher and scientist Catherine Bladen, Ph.D., argues sustained focus is a key to driving real-world progress.