Transcript Nijihara_-_Georgetown_U_Commercialization_051315

Commercializing Innovations at Georgetown University
Ruchika Nijhara, Ph.D., MBA, CLP
Director
Technology Commercialization
Georgetown University
3300 Whitehaven Street, NW
Harris Building, Suite 1500
Washington, DC 20007
[email protected]
Emerging realities in the pharmaceutical
industry
• Rapid escalation of the costs of R&D
• Emptying product pipelines
• Global tightening of regulatory policy
• Patent expirations on most of the blockbuster drugs
• Challenges to IP by generic companies
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.
Why does the Gap Exists?
Output From Academia
Industry’s Requirements
Early-stage
IP
Incomplete
Technology
Validation
Validated
IP
Unclear
Market
Potential
Unproven, High Risk Assets
Validated
Technology
Clear
Market
Potential
Proven, Low Risk Assets
LACK OF RESOURCES
(Infrastructure, Expertise and Capital)
Development Gap- One of THE Limiting Factor in
Technology Transfer
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
GEORGETOWN UNIVERSITY’S
STRATEGIES TO BRIDGE THE GAP AND
FACILITATE COMMERCIALIZATION OF
ITS INNOVATIONS
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
Hospital, a Medical Center, and a NCI Cancer
Center.
Technology and Its Development. It’s All Here @
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 Institutedesignated Comprehensive Cancer Center, national leaders in cancer treatment,
research and education.
http://lombardi.georgetown.edu/
Our Commercial Successes
Whole-body CT Scanner
T-Wave Alternans
Allegra®
HPV Vaccine
HPV Diagnostic
Our Office’s 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
Our Office’s 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
• 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
Key Considerations in Georgetown’s Licenses
•
•
•
•
•
•
•
Scope of Licensed Technology
Economics
Assignment Rights
Sublicensing Rights
Effect of Termination on Sublicenses
Diligence Obligations
Termination Rights
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
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
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.
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.
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
Drug Discovery Infrastructure
Capacity 30 projects
Virtual
Screening
Medicinal
Chemistry
Protein
Assays
Cell
Models
Preclinical
Models
Preclinical
ADME/ Tox
Research
Pipeline
Drug Discovery Infrastructure
Phase 0/ I
Clinical
Studies
Lombardi
Basic
Science
Phase II/III
Clinical
Studies
Embedded Model
Licenses
New companies
CRO/Partnerships
CHEMICAL
BIOLOGY
CONSORTIUM
IND enabling studies
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.
RESEARCH PIPELINE
EARCH PIPELINE
Criteria for Selecting Projects
Potential Project X
Criteria (filter)
Target validation(justification)
siRNA
Immunohistochemistry
Knockout
Mechanistic studies
Project
Declined
or Triaged
CDD
Virtual
Medicinal
Screening Chemistry
Scale-up
Chemistry
Protein
Assays
Assess Project Needs
Validating studies
Structural models
Chemistry
Biology
Preclinical Models
Imaging
ADME
Cell
Preclinical
Models Models/Tox
Preclinical
ADME
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.
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
GEORGETOWN UNIVERSITY’S 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
Visit us at http://otc.georgetown.edu |
Follow @GUOTC
Questions?
Ruchika Nijhara, Ph.D., MBA, CLP
Director
Technology Commercialization
Georgetown University
3300 Whitehaven Street, NW
Harris Building, Suite 1500
Washington, DC 20007
[email protected]