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Biotechnology/Chemical Practice Committee Educational Session AIPLA 2012 Annual Meeting Oct. 25, 2012 Hypothetical Scenario • Recent Publications: – Certain cancer stem cells have dopamine receptors. – Only in CNS in healthy individuals. – In cancer patients, on blood stem cells or breast cancer stem cells. • Invention (Dr. Gold and Post-Doc): – Proprietary stem cell assay. – Identify known psychiatric drugs (dopamine receptor antagonists) that make breast cancer stem cells differentiate into harmless cell types. – Want to develop compounds further and ID novel compounds based on modifying the known compounds. Hypothetical Scenario • IP: – Dr. Gold assigns all the IP to University. Patent app filed. – University unsuccessfully tries to license to established company (too early stage). • Early Stage Research Collaborations: – University/Dr. Gold use NIH’s National Center for Advancing Translational Sciences (NCATS) to help develop their known compounds and test additional compounds available to be ‘repurposed’ from the NCATS. • Pharmaceutical companies have made known compounds available to NIH for preclinical, clinical feasibility studies for new indications. – Dr. Gold develops known and new lead compounds. • All may be eligible for orphan drug regulatory exclusivity for a rare breast cancer subtype having the dopamine receptor. Hypothetical Scenario • Corporate and Funding Structures: – University/Dr. Gold start up “Goldcell” – Shareholders: Univ, Gold, post-doc (also employee). – Virtual company working out of Univ space. • Funding – $150K of seed funding (angel investment) – $100K non-conventional funding - crowd sourcing Jobs Act – Goldcell spends all the money on pre-clinical testing and needs to raise more money. Hypothetical Scenario • Pharma-Industry Collaboration: – Collaboration with University of the Atlantic – Develop companion diagnostic to ID patients with dopamine receptor cancer stem cell. • Consortium: – U of A is a member of consortium of universities working with a big pharmaceutical company. – Screens patients to identify sub population that may be treated with a particular drug. Hypothetical Scenario • Venture Capital: – Competition between conventional VC firm and Pharma Corporate VC firm to be lead investor in Goldcell. – Competition could be resolved by a scenario where conventional VC takes lead investment position and Pharma VC is drawn in b/c of expertise in designing critical studies.