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.
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.
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.
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.