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Keynote Speakers Presentations
Role of Preclinical ADME (Absorption, Distribution, Metabolism and Excretion) and PK/PD in Drug Discovery and the Support Offered by Duke PK/PD Core
Ivan Spasojevic, PhD
Preclinical Toxicology Studies to Support IND Submissions
Vijay Kale, BVSc, MVSc, PhD, DABT, ERT (BMS)
Good Laboratory Practices (GLP) in Nonclinical Toxicology Studies
Vijay Kale, BVSc, MVSc, PhD, DABT, ERT (BMS)
*GLP training requirement by the end of March 2025
Links require a Duke Net ID/Password to access.
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
Keynote Speakers Presentations
Translating Research to Clinical Development – The Regulatory Process
Bruce Burnett, PhD, RAC
Working with Duke’s Office of Regulatory Affairs and Quality to Navigate the Investigational New Drug (IND) Application Process
Erika Segear, PhD, RAC
Links require a Duke Net ID/Password to access.
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
Keynote Speakers Presentations
Innovation and Drug Development in Academia: Context and Perspective
Evan Kharasch, MD, PhD
Working Backwards from the End: The Drug Development Process and its Implications for Start-Up Companies
Jeff Welch, PhD
How the Duke Office of Translation and Commercialization (OTC) Aligns with Duke’s Research and Innovation Mission
Bryan Baines, RP
Working with OEP to Find and Manage Sponsored Research Opportunities
Ed Pagani, PhD
Links require a Duke Net ID/Password to access.