Welcome to your September issue of The Pipeline from Precision for Medicine, featuring a new white paper, articles, and on-demand content—including the development of at-home tests for COVID-19, insights into successful tissue cross reactivity (TCR) studies, a new partnership to accelerate and diversify trial recruitment, and more.
We hope you’ll find this information valuable as you conquer the complexity inherent to 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.
Amanda Woodrooffe, PhD SVP UK Labs
Rebecca Houliston, PhD Principal Scientist
Jeff Daniels, MBA, Executive Director of Strategic Marketing
Karen Richards, RAC, SVP In Vitro Diagnostics and Quality Karen
COVID-19 diagnostics: Moving from laboratory to home-based testing
Throughout the pandemic, the FDA has clearly committed to providing prompt guidance to COVID-19 response efforts. This article, written by Precision’s Karen Richards, RAC, and published by Regulatory Focus, traces the shift from testing in healthcare facilities to home-testing, and the related regulatory challenges and triumphs.
New White Paper: Successfully Conducting Tissue Cross-Reactivity Studies
Assessing tissue cross-reactivity (TCR) is key to helping minimize risk of harm in first-in-human studies for therapeutic antibodies and antibody-like molecules. This insightful paper shares critical considerations to ensure your TCR study generates the requisite robust data to support pre-clinical decision-making and regulatory submissions.
NEW eBOOK: Critical Biospecimens: How to Source, Optimize, and Utilize Them in Drug and Diagnostic Research
Complex, well-curated biospecimens are the cornerstone of today’s research. This series of articles published by Genetic Engineering & Biotechnology News shares best practices and leading-edge developments in their sourcing, utilization, and storage.
Geo-targeted Data Expands and Accelerates Clinical Trial Recruitment
Precision for Medicine has partnered with Trialbee, a patient matching and enrollment platform, to extend trial recruitment to a more diverse, targeted patient community—specifically locating those who could be a match for trials in oncology, rare and orphan diseases, and cell and gene therapies.
In this one-hour webinar, a panel of experts—including Precision for Medicine’s Karen Richards—discuss issues from compliance to communications to crafting pre-submission meetings.
We’ll have an active presence at this fall at Immuno-Oncology Summit, Meeting on the Mesa, and the Immunogenicity and Bioassay Summit. Come to our presentations, stop by our booth, and learn from our experts. We look forward to seeing you there.