Ruchika Nijhara, Ph.D., MBA, CLPRuchika Nijhara, Ph.D., MBA, CLPDirectorDirectorTechnology CommercializationTechnology CommercializationGeorgetown UniversityGeorgetown University3300 Whitehaven Street, NW 3300 Whitehaven Street, NW Harris Building, Suite 1500 Harris Building, Suite 1500 Washington, DC 20007Washington, DC 20007 rn86@georgetown.edurn86@georgetown.edu

Commercializing Innovations at Georgetown University

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?

Early-stage IP

Unclear Market

Potential

IncompleteTechnolog

yValidation

Validated IP

Clear Market

Potential

ValidatedTechnolog

y

Output From Academia Industry’s Requirements

LACK OF RESOURCES

Unproven, High Risk Assets Proven, Low Risk Assets

(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.

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/

1470 Faculty Centered in cura personalis – care for the whole person.http://gumc.georgetown.edu/

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).

Our Commercial SuccessesOur Commercial Successes

T-Wave AlternansT-Wave Alternans

Allegra®Allegra®

Whole-body CT ScannerWhole-body CT Scanner

HPV VaccineHPV Vaccine HPV DiagnosticHPV Diagnostic

• 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 ObligationsOur Office’s mission and Obligations

Our Office’s mission and ObligationsOur 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

Res

earc

hR

esea

rch

P

ipel

ine

Pip

elin

e

LombardiBasic

Science

Phase II/III Clinical Studies

Phase 0/ I Clinical Studies

Embedded Model

VirtualScreening

MedicinalChemistry

ProteinAssays

CellModels

PreclinicalModels

PreclinicalADME/ Tox

Drug Discovery Infrastructure

CHEMICAL BIOLOGY CONSORTIUM

IND enabling studies

LicensesNew companiesCRO/Partnerships

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 PIPELINEEARCH PIPELINE

Criteria for Selecting Projects

Criteria (filter)Target validation(justification)siRNAImmunohistochemistryKnockoutMechanistic studies

Potential Project X

Project Declined or Triaged

CDDAssess Project NeedsValidating studiesStructural modelsChemistryBiologyPreclinical ModelsImagingADME

VirtualScreening

MedicinalChemistry

ProteinAssays

CellModels

PreclinicalModels/Tox

PreclinicalADME

Scale-upChemistry

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/AssaysTechnologies developed at GeorgetownResearch tools and materialsAnimal modelsCenter for Cellular ReprogramingAccess 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 

Ruchika Nijhara, Ph.D., MBA, CLPRuchika Nijhara, Ph.D., MBA, CLPDirectorDirectorTechnology CommercializationTechnology CommercializationGeorgetown UniversityGeorgetown University3300 Whitehaven Street, NW 3300 Whitehaven Street, NW Harris Building, Suite 1500 Harris Building, Suite 1500 Washington, DC 20007Washington, DC 20007 rn86@georgetown.edu

Questions?Questions?