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:
- Optimizing PCR in Clinical Trials: Discover how PCR enables early detection, biological endpoints, patient stratification, and real-time monitoring in oncology, gene and cell therapy trials
- Accelerated Assay Development: Examine factors that enable faster assay development and validation, including reagent availability, platform readiness, and timelines critical to dose escalation studies
- Assay Strategy & Selection: Learn from Precision’s experts about designing, validating, and implementing various qPCR and ddPCR assays to achieve clinical and regulatory milestones while balancing sensitivity and cost
- Applications Across Therapeutic Areas: Understand the latest in PCR technology to measure gene expression, vector copy number, biodistribution, shedding, persistence, replication-competent lentivirus (RCL), and pharmacokinetics (PK) and pharmacodynamic (PD) endpoints
- Case Studies in Action: Hear first-hand from leading biotechnology companies on case studies using scientific innovation to advance novel therapeutic milestones in clinical studies
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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.