Welcome to the July issue of The Pipeline from Precision for Medicine, featuring video, articles, and on-demand content. You’ll find new technology for managing trial samples, insights from American Society of Gene & Cell Therapy (ASGCT)2021,best practices for expanding Phase 1/2 studies and more. We hope you’ll find this information valuable as you conquer the complexity inherent in R&D innovation.
The Pipeline features timely insights from our experts in the lab, clinical trials, and data science, designed to help innovative researchers unwind complexity. It is published by Precision for Medicine.
Deborah Phippard, PhD, Global Head of Research
Tobias Guennel, PhD, SVP, Product Development & Systems Integration
Tamiera Harris, PHD, MBA, Sr Dir, Operational Strategy
Phase 1/2 Combination Studies: Best Practices When Moving From Escalation to Expansion
Clinical study designs, specifically those that combine Phase 1 and Phase 2 trials, are becoming increasingly common as sponsors pursue more aggressive clinical development timelines. In this article, discover the best practices and elements to be aware of when managing a Phase 1/2 combination oncology study and how to effectively and efficiently move from escalation to expansion stages.
Digitally Monitor Samples Across Every Site, Lab, and Repository in Real Time
The journey of a clinical sample has become increasingly complex. Watch this 2 minute animated video to see why it’s so hard to maintain visibility into sample collection, processing, and consent status as samples travel independently and are split into derivatives—and what to do about it.
Advancing Gene Therapies: Evaluating Immunogenicity and its Impact on Therapeutic Potential
Deciding which type of immunogenicity assay to use can be challenging. This is especially true because while neutralizing antibodies are generally a subset of total antibodies, there are exceptions. Though this continues to be a subject of vigorous debate, here are some factors to consider when selecting an immunogenicity assay.
Accelerating Precision Oncology with a Novel NGS Screening Initiative
An ambitious next generation sequencing (NGS) initiative is screening thousands of biospecimens—both Formalin-Fixed Paraffin-Embedded (FFPE) and liquid biopsies—for key biomarkers across 11 cancer indications. The 2-part project, run by Precision for Medicine and multiple research partners, will turn these biospecimens into more powerful tools for cancer researchers. FIND OUT HOW TO ACQUIRE THESE BIOSPECIMENS >
Webinar On-Demand: Considerations for the Clinical Development of Cell and Gene Therapies
Couldn’t make it to ASGCT? This popular 2-part panel discussion from the conference features C-suite leaders from advanced therapy companies and Precision experts discussing key opportunities and challenges in cell and gene therapy clinical development.
Podcast On-Demand: Chicago Is Emerging as a Life Science and Biopharma Hub
Why are the life sciences suddenly flourishing in Chicago? Anshul Mangal, President, and Tony Khoury, Executive Vice President, Project Farma, share their insights in this podcast.