Vann Parker is the Head of Regulatory Consultancy (North America) for Precision for Medicine. He received his PhD in Molecular Biology from The California Institute of Technology and spent the past 30 years supporting biopharmaceutical and drug development. He currently focuses on strategies for clinical development and interactions with FDA and other regulatory agencies. In addition to support of pre-IND activities, Vann has supported sponsors throughout the drug development process including applications for Fast Track, Breakthrough Therapy and Orphan Designations, formal meetings with FDA and full NDA/BLA submissions.
Considerations for Your Pre-IND Meeting With the FDA
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FDA Draft Guidance Encourages Broader Inclusion Criteria in Oncology Trials
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FDA Accelerated Approval for Oncology Therapeutics: Clinical Trial Considerations
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FDA Procedural Guidance: Expansion Cohorts in FIH Oncology Clinical Trials
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