Shining a Light on the FDA Black Box: A Nonclinical Perspective

| 04:00 PM - 06:00 PM
Cost/fee: FREE
Virtual Event - Registration Required
Claire McDonald
This talk will describe the types of early communications with the FDA and the high level requirements for nonclinical programs supporting clinical development of 4 product types: small molecules, protein therapeutics, prophylactic vaccines and cell and gene therapies. Case studies will be provided.

Speaker: Melanie Hartsough, Independent Consultant at Hartsough Nonclinical Consulting, LLC

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CU Innovations

CU Anschutz

Anschutz Health Sciences Building

1890 N Revere Ct

Suite 6202

Mail Stop F411

Aurora, CO 80045


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