NIGMS STTR Award UT2GM130174

DRUG REPURPOSING SHORT COURSE

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

DATE: Thursday, November 19, 2020

TIME: 11:00 a.m. - 12:00 p.m. ET

  • 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.





SESSION 2:

COMMERCIALIZING ACADEMIC REPURPOSING DISCOVERIES: THE TECH TRANSFER AND COMPANY PERSPECTIVES

DATE: Wednesday, December 9, 2020

TIME: 11:00 a.m. - 12:00 p.m. ET

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

SESSION 3:

FDA: 505B2 APPLICATIONS AND POSITIONING STRATEGY

DATE: Thursday, February 25, 2021

TIME: 11:00 a.m. - 12:00 p.m. ET

  • Regulatory considerations for drug repurposing
  • Mini-case studies

Presented by Ken Phelps, president and founder, Camargo.




SESSION 4:

FUNDING OPPORTUNITIES: A NON-PROFIT FOUNDATION

DATE: Thursday, March 11, 2021

TIME: 11:00 a.m. - 12:30 p.m. ET

  • 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.

SESSION 5:

INDUSTRY EXPERT PANEL

DATE: Thursday, April 29, 2021

TIME: 11:00 a.m. - 12:30 p.m. ET

  • 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.

RAJA KRISHNAN

COMMERCIALIZATION MANAGER

UK OFFICE OF TECHNOLOGY COMMERCIALIZATION

This Drug Repurposing Short Course is managed by Raja Krishnan, commercialization manager for the Office of Technology Commercialization (OTC). His primary responsibilities include assessment, marketing and licensing of intellectual property focused on the life sciences area covering inventions from UK’s Colleges of Pharmacy and Medicine. Previous to that 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.