Transcript background slides

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.