Breaking Barriers with PCR: Innovative Solutions for Clinical Trial Success
Date: September 03, 2025
Duration: 60 minutes
Learn how PCR-based molecular monitoring is accelerating personalized trials in gene therapy, cell therapy, and oncology. Experts from Precision for Medicine, Avidity Biosciences, and Indaptus Therapeutics share insights on generating actionable data and aligning assay design with trial goals.
Topics Covered:
- PCR in Clinical Trials: Enable early detection, patient stratification, and real-time monitoring in oncology and gene/cell therapy.
- Faster Assay Development: Explore factors like reagent access and platform readiness that accelerate validation for dose escalation.
- Assay Strategy & Selection: Insights on designing qPCR/ddPCR assays to meet clinical and regulatory goals while managing cost and sensitivity.
- Therapeutic Applications: Use PCR to assess gene expression, vector copy number, biodistribution, shedding, RCL, and PK/PD endpoints.
- Real-World Case Studies: Learn how biotech leaders apply PCR innovations to advance novel therapies in clinical trials.
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Speakers
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Jie Yang, PhD
Senior Scientific Liaison, Precision for Medicine. Jie is an immunologist with deep expertise in translational assay design for biomarker‑guided trials. Former MD Anderson Cancer Center post‑doc in tumor immunology. Leads biomarker assay development and implementation of cutting‑edge platforms across pre‑clinical and clinical programs.
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Michael J. Newman, PhD
Founder and Chief Scientific Officer, Indaptus Therapeutics. Cancer‑immunotherapy pioneer with 50 years’ experience across academia, pharma, and biotech. Led oncology discovery at Sandoz and Novartis and has advised 35+ companies on R&D strategy. Holds a PhD from Harvard and completed post‑doctoral research at Cornell.
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Josiah Herzog, PhD
Senior Scientist, Avidity Biosciences. Neuromuscular‑disease specialist with extensive experience crafting biomarker assays for diverse therapeutic modalities. Earned his PhD in Molecular & Cell Biology from Brandeis University. Will share how Avidity and Precision developed an exon‑skipping assay to support a Duchenne muscular dystrophy trial.