Comparison of Georgetown

1
Commercializing Innovations at Georgetown
University
Ruchika Nijhara, Ph.D., MBA, CLP Director Technolo
gy Commercialization Georgetown University 3300
Whitehaven Street, NW Harris Building, Suite
1500 Washington, DC 20007 rn86_at_georgetown.edu
2
Emerging realities in the pharmaceutical industry

• Rapid escalation of the costs of RD
• Emptying product pipelines
• Global tightening of regulatory policy
• Patent expirations on most of the blockbuster
  drugs
• Challenges to IP by generic companies

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Prevailing Wisdom

• Academia is the leading source of innovative
  assets. However, many of such assets are
  under-valued and under-resourced.
• A huge development gap exists between publicly
  financed basic research and privately financed
  clinical development.

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Why does the Gap Exists?
Output From Academia
Industrys Requirements
Early-stage IP
Validated IP
Unclear Market Potential
Clear Market Potential
Incomplete Technology Validation
Validated Technology
Unproven, High Risk Assets
Proven, Low Risk Assets
LACK OF RESOURCES
(Infrastructure, Expertise and Capital)
Development Gap- One of THE Limiting Factor in
Technology Transfer
5
Traditional Models for Technology Maturation in
an Academia

• License to Tech Development Companies
• Sponsored research using Corporate partner funds
• Create a Start-up

However, financing early stage research is
becoming a major challenge
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Georgetown Universitys strategies to bridge the
gap and facilitate commercialization of its
innovations

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Georgetown University

• Georgetown College
• Edmund A. Walsh School of Foreign Service
• Robert Emmett McDonough School of Business
• School of Nursing and Health Studies
• Graduate School of Arts and Sciences
• School of Medicine
• Law Center
• School of Continuing Studies

8
Hospital, a Medical Center, and a NCI Cancer
Center. Technology and Its Development. Its All
Here _at_ Georgetown University.
Georgetown University Medical Center and Medstar
Health have a clinical partnership where MedStar
Health runs the Georgetown University's clinical
enterprise, and Georgetown University runs the
education and research enterprises-which include
the School of Medicine, the School of Nursing and
Health Studies, the Lombardi Comprehensive Cancer
Center and the Biomedical Graduate Research
Organization. These units continue to be known
collectively as Georgetown University Medical
Center (GUMC).
1470 Faculty Centered in cura personalis care
for the whole person. http//gumc.georgetown.edu/
The Lombardi Comprehensive Cancer Center is 1 of
39 National Cancer Institute-designated
Comprehensive Cancer Center, national leaders in
cancer treatment, research and education.
http//lombardi.georgetown.edu/
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Our Commercial Successes
T-Wave Alternans
Whole-body CT Scanner
Allegra
HPV Vaccine
HPV Diagnostic
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Our Offices mission and Obligations

• Development of research into products that
  benefit the public
• Engagement of Georgetown University in the
  founding growth of local businesses (economic
  development)
• Recruit, reward, and retain faculty

A Service to the University, a Partner with the
Faculty, and a Business Generating Revenue
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Our Offices mission and Obligations

• Sometimes misaligned with industry objectives
• Revenue generation is important, but not primary
• Creating and communicating knowledge
• Providing education
• Well-being of humankind
• University and federal (Bayh-Dole) policies are
  important

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Responsibilities of the Office of Technology
Commercialization

• Receive Invention Disclosures.
• Evaluate disclosures.
• Initiate and follow-up on appropriate type of
  protection.
• Market inventions.
• Negotiate License Agreements.
• Monitor patent filings and licenses
• Handle other agreements
• Material Transfer Agreements, CDAs, Collaborative
  Research Agreements
• IP in Sponsored Research Agreements
• Inter-institutional Agreements
• Work with developing new (start-up) companies
• Outreach/education/local commercial development

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Key Considerations in Georgetowns Licenses

• Scope of Licensed Technology
• Economics
• Assignment Rights
• Sublicensing Rights
• Effect of Termination on Sublicenses
• Diligence Obligations
• Termination Rights

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Economics

• Typical forms of Consideration
• Reimbursement of Patent Costs
• Equity (where University policies permit)
• Milestones
• Pre-commercialization
• Post-commercialization
• Sublicense Revenue Sharing
• Royalties
• Basis of Royalties
• Scaling of Royalties with Sales
• Stacking
• Combination Products

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Flexibilities

• Open to granting non-exclusive know-how license,
  or other arrangements if work is on-going
• E.g., Sponsored research or consulting services
  if work is on-going at the University

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Key Elements of Exemplary Practice

• Appropriately, qualitatively and quantitatively
  staffed office.
• Customer-Friendly Orientation-e.g. Efficiency,
  rapid turnaround
• Clear Policies and Procedures- e.g. flexible
  consulting and COI policies, Transparency
• Supportive University Culture- e.g Tech transfer
  as a key element of social mission.

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Established Infrastructure and Allocated
Resources for Translational Research

• Center for Drug Discovery - The center uses
  interdisciplinary approach to design, synthesize
  and test potential drug candidates against novel
  molecular targets.
• Access to large, diverse, and growing patient
  population for clinical trials through clinical
  partnership with MedStar
• Clinical Investigators Provide key
  translational strategies to demonstrate early
  proof-of-concept studies in patients.

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Center for Drug Discovery

• Identifies and synthesizes candidate drug
  compounds for selected molecular targets
• Validates targets/ compounds in cell models and
  pre-clinical studies, and
• Provide supporting experiments, large scale
  synthesis and consultation for each candidate
  molecule for submission of an investigational new
  drug (IND) application

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Drug Discovery Infrastructure
Research Pipeline
Phase 0/ I Clinical Studies
Lombardi Basic Science
Phase II/III Clinical Studies
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Center for Drug Discovery at Georgetown

• Prioritized Georgetown University Medical Center
  candidate molecular targets for drug discovery
  and development
• Advanced 14 potential drugs through preclinical
  studies
• Received National recognition
• Patents
• Publications
• Grants
• 1 of 11 sites selected for NCI chemical biology
  consortium
• International recognition
• Strategic partnerships in China, Brazil and other
  countries
• CDD cultivates and expands translational medicine
  at GUMC.
• Developed partnerships with biotechnology
  companies seeking funding through the Small
  Business Innovation Research (or SBIR) program.

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RESEARCH PIPELINEEARCH PIPELINE
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Criteria for Selecting Projects
Potential Project X
Project Declined or Triaged
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Center for Drug Discovery at Georgetown

• Prioritized Georgetown University Medical Center
  candidate molecular targets for drug discovery
  and development
• Advanced 14 potential drugs through preclinical
  studies
• Received National recognition
• Patents
• Publications
• Grants
• 1 of 11 sites selected for NCI chemical biology
  consortium
• International recognition
• Strategic partnerships in China, Brazil and other
  countries
• CDD cultivates and expands translational medicine
  at GUMC.
• Developed partnerships with biotechnology
  companies seeking funding through the Small
  Business Innovation Research (or SBIR) program.

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Other Resources at Georgetown University

• Know-How/Assays
• Technologies developed at Georgetown
• Research tools and materials
• Animal models
• Center for Cellular Reprograming
• Access to patients and clinicians for clinical
  trials

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Georgetown Universitys strategies for value
creation

• Alumni expert network
• Accelerator to mature early stage technologies
• EIR program with McDonough School of Business
• Using Interns
• Strategic research/clinical collaborations with
  Industry
• Entrepreneurs

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Visit us at http//otc.georgetown.edu   Follow
_at_GUOTC 
Questions?
Ruchika Nijhara, Ph.D., MBA, CLP Director Technolo
gy Commercialization Georgetown University 3300
Whitehaven Street, NW Harris Building, Suite
1500 Washington, DC 20007 rn86_at_georgetown.edu