SC4: ASSET REACQUISITION: PLANNING BEFORE OUT-LICENSING

TUESDAY, JANUARY 21 | 5:45 - 8:45 PM (DINNER PROVIDED)

At some point in development, biotechnology companies must decide to develop their asset independently or out-license their asset to a company with resources for the clinic. Early out-licensing can be/is a successful but risky strategy. Returns happen. The return of the asset seems disastrous; but depending on the circumstances for which it was returned and the relationship between the companies, the asset may be re-licensed through great lessons learned and careful management.

Topics to be Discussed:

  • Considerations for the original licensing contract
  • Topics included in the re-acquisition process
  • Order of operations and timing
  • Repackaging and re-licensing the asset
  • Shared experiences

Who Should Attend:

  • Small- to medium-sized biotech company Presidents, CEOs, CFOs, Attorneys
  • Senior staff members involved in contract negotiation
  • Project managers
  • ‘C-’, ‘E’-, and ‘S’-level staff members of any biotech company preparing to license their product

Instructor:

Harris_DebDeb Harris, Managing Director, Industry Special Services, BDO USA LLP

Debra Harris, Director of BioProcess Technology Group, is an experienced biopharmaceutical industry professional with over 27 years of experience in management of all aspects drug development and characterization including antibodies, radio-labeled proteins and other biologics. Experience includes process development, project transfer (within the US and internationally), project management and manufacturing of biologics and generic oncological parenterals, manufacturing site and CMO management, U.S. and international cGMP and manufacturing leadership as well as quality oversight. Before joining BPTG, Deb served as Vice President and Site Head of Abzena’s San Diego, CA, operations engaged in developing production processes, scale up, and GMP production, as well as release of biologics products for use in phase I and II clinical trials. Prior to Abzena, Deb managed quality and product development of generic parenteral oncology products for Sandoz, a Novartis company. She holds a Master’s degree in Biology from the University of California, Irvine.

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