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| FDA’s MRCT Guidance Is Here. Are You Ready? | Geography once stood in for diversity — but genetics, standards of care, and epidemiology don’t follow borders. FDA’s new MRCT guidance makes it clear: global data fails if it doesn’t apply to U.S. patients. This new whitepaper by Precision’s CMO and former FDA Oncology Division Director, Dr. Harpreet Singh, explains what regulators expect and how to position your program for approval. Download the whitepaper. |
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By Arnaud Deladeriere, Ph.D., Cell & Gene Consulting Inc. | Patient access often gets mischaracterized solely as a cost and pricing issue. A discussion among industry leaders reaches a deeper, more complex conclusion. | |
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| Unanticipated Roadblocks In Ovarian Cancer Drug Development | Article | By Andrew Zupnick, Ph.D., Worldwide Clinical Trials Oncology | Ovarian cancer trials demand unique strategies. Improve outcomes by aligning imaging with biomarkers and selecting sites based on verifiable surgical capacity and community referral pipelines. |
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