Drug Repurposing Short Course 2020-2021 Final A

NIGMS STTR Award UT2GM130174

DRUG REPURPOSING SHORT COURSE VIDEOS

This Drug Repurposing Short Course is being provided to better equip academic researchers with the required intellectual property (IP) strategy, regulatory knowledge and business considerations that go into commercializing a repurposed drug asset so that these assets can be in the best position to succeed in the market.

SESSION 1:

IP STRATEGIES: CLAIMING NEW METHODS OF USE AND NEW FORMULATIONS, AND LICENSING IP

Introduction to regulatory considerations for 505b2 application
Intellectual Property (IP) considerations for drug repurposing
Two mini case studies: new drug formulations vs new use

Presented by Gaby L. Longsworth, Ph.D., director, Sterne Kessler's Biotechnolgy & Chemical Practice Group, co-chair, Diversity Committee at Sterne Kessler, and LMG Life Sciences "Life Sciences Star", 2016-present.

RECORDING

SESSION 2:

COMMERCIALIZING ACADEMIC REPURPOSING DISCOVERIES: THE TECH TRANSFER AND COMPANY PERSPECTIVES

Working with the inventor/PI
Patenting and other exclusivity issues
Collaboration and negotiations
Due diligence issues
Contracting, goals and reporting
Relationship Management
Confidentiality and other disclosures issues

Presented by Raja Krishnan, former commercialization manager, University of Kentucky Office of Technology Commercialization, and Bruce Bloom, chief innovation officer, Healx. Raja Krishnan will provide an introduction and conclusion.

RECORDING

SESSION 3:

FDA: 505B2 APPLICATIONS AND POSITIONING STRATEGY

Regulatory considerations for drug repurposing
Mini-case studies

Presented by Ken Phelps, president and founder, Camargo.

RECORDING

SESSION 4:

FUNDING OPPORTUNITIES: A NON-PROFIT FOUNDATION

Drugs that have been repurposed successfully and gotten FDA approval
Clinical trials of repurposed drugs
Case study of a success story through the non-profit foundation funding program

Presented by Barbara Goodman, president and CEO of Cures Within Reach, and Pan Pantziarka, Anti-Cancer Fund.

RECORDING

SESSION 5:

INDUSTRY EXPERT PANEL

Moderator-led discussion with industry and regulatory experts on drug repurposing
Opportunity for the audience to ask the experts questions

Panelists: Bruce Bloom, Chief Collaboration Officer, Healx, Jeyanthi Ramasubbu, Founder and Prinicipal, JRPharma Consulting, Kristen Gullo, Vice President of Development and Regulatory Affairs, US WorldMeds, and Douglas Balogh, Director of Life Sciences, Guidehouse

Moderator: Raja Krishnan, commercialization manager, University of Kentucky Office of Technology Commercialization.

RECORDING

RAJA KRISHNAN

COMMERCIALIZATION MANAGER

UK OFFICE OF TECHNOLOGY COMMERCIALIZATION

This Drug Repurposing Short Course was designed by the University of Kentucky Office of Technology Commercialization (OTC), under NIGMS STTR Award UT2GM130174. It was led and managed by Raja Krishnan, former Commercialization Manager at UK OTC. Raja spent more than 15 years working in roles of increasing responsibility in product development for various pharmaceutical companies and led the development through the launch of multiple commercial products.