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Pharma Pulse 8/1/25: What Clinical Ops Teams Must Know About Biomarkers in Trials; What is the Timeline for True AI Implementation for Digital Twins?

Key Takeaways

  • Clinical operations teams must consider biomarkers' purpose, technical requirements, and regulatory implications, especially in neurology, oncology, and platform studies.
  • AI-powered digital twins are advancing and may replace control arms, addressing poor trial design and patient-site mismatches in Phase III failures.
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What Clinical Ops Teams Must Know About Biomarkers in Trials

In an interview with Applied Clinical Trials, Michael Miller, COO of Quanterix, emphasized that clinical operations teams must carefully consider the purpose, technical requirements, and regulatory implications of biomarkers in trials—especially as their use expands in neurology, oncology, and platform studies driving accelerated drug approvals.

What is the Timeline for True AI Implementation for Digital Twins?

In an interview with Pharmaceutical Executive, Gen Li, president and founder of Phesi, explained that poor trial design and patient-site mismatches are key drivers of Phase III failures, and emphasized that while true AI-powered digital twins aren't fully implemented yet, their use—especially through digital patient profiles—is rapidly advancing and could partially or fully replace control arms within the next few years.

Q&A: PBM Reform, Other Policy Considerations to Combat Pharmacy Deserts

In an interview with Drug Topics, Michael Murphy, PharmD, MBA, emphasized that addressing pharmacy deserts requires comprehensive PBM reform, expanded reimbursement for pharmacist-provided services, and financial incentives—such as grants or Medicaid supplemental fees—to encourage pharmacies to open in underserved communities and prevent long-term access gaps.

Retrospective Data Highlight Improved Efficacy with Maintenance Therapy vs Treatment Breaks in mCRC: With Connie Lai, MD

In a recent interview, Connie Lai, MD discussed a retrospective, dual-center study in metastatic colorectal cancer showing that patients who continued maintenance therapy after induction chemotherapy experienced significantly improved overall and progression-free survival compared to those who took treatment breaks, with the greatest benefit observed in patients with more than three metastatic sites.

S. Robert Levine, MD, on the DRD Cure Accelerator: A Global Moonshot for Retinal Disease

S. Robert Levine, MD, described diabetic retinal disease (DRD) as a complex neurovascular condition requiring urgent global attention, and introduced the DRD Cure Accelerator as a collaborative initiative focused on modernizing clinical endpoints, advancing precision treatments, and uniting international partners to eliminate vision loss from diabetes.

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