december 16, 2011 technology transfer tactics webinar: how your universitys innovations can become a...
TRANSCRIPT
December 16, 2011
Technology Transfer Tactics Webinar:
How your university’s innovations can become a fixture in big pharma’s pipeline
Nurjana Bachman PhD - Business Development Manager
December 16, 2011
Technology Transfer Tactics Webinar:
How big pharma can help you develop innovative therapeutics for patients
Nurjana Bachman PhD - Business Development Manager
Drug identification and optimization
Manufacturing, Marketing and Sales
Clinical Development
One company performed all stages of drug development
Discovery Research, Target Identification
Preclinical Development
Then: Fully-Integrated Pharmaceutical Company
Drug identification and optimization
Manufacturing, Marketing and Sales
Clinical Development
Now: Fully-Integrated Pharmaceutical Network
One company partners to perform all stages of drug development
Discovery Research, Target Identification
Preclinical Development
Academia, other companies, CROs, manufacturing partners
New Pharma Model for Sourcing Ideas
Open Innovation
What does this mean for academia?
Children’s Ranked #1 in US
#1 ranked in:
• Heart and Heart Surgery
• Neurology and Neurosurgery
• Urology
• Orthopedics
• Kidney
• Cancer
#2 ranked in:
• Neonatology
• Diabetes and Endocrine Disorders
• Gastroenterology
#3 ranked in:
• Pulmonary
* US News & World Report, May 2011
World’s Largest Pediatric Research Enterprise
$225M clinical and basic research funding
800,000 sq. feet of research space
40 clinical departments
225 specialized clinical programs
~600,000 inpatient/outpatient visits
8,720 total employees
2 Nobel Prize winners
11 members, Howard Hughes Medical Institute
7 members, National Academy of Sciences
11 members, Institute of Medicine
History of Innovation at Children’s
1869 Children's Hospital Boston opens as a 20-bed facility
1920 Dr. William Ladd devises procedures for correcting various congenital defects
1922 Dr. James Gamble develops a method for IV feeding that saves the lives of thousands of infants at risk of dehydration
1938 Dr. Robert Gross performs the world's first successful surgery to correct a congenital cardiovascular defect
1954 Dr. John Enders wins the Nobel Prize for successfully culturing the polio virus
1971 Dr. Judah Folkman publishes "Tumor angiogenesis: therapeutic implications" in NEJM
1986 Dr. Louis Kunkel identifies the gene for Duchenne muscular dystrophy
1990 Dr. Joseph Murray wins the Nobel Prize for his pioneering work in organ transplantation
From Innovation…
1983 Children's physicians report the first surgical correction of hypoplastic left heart syndrome, a fatal condition.
1986 Dr. Louis Kunkel identifies the gene for Duchenne muscular dystrophy
1990 Dr. Joseph Murray wins the Nobel Prize for his pioneering work in organ transplantation
1998 Dr. Anthony Atala successfully transplants laboratory-grown bladders into dogs, a major advance in the growing field of tissue engineering.
2008 Dr. George Daley discovers how to reprogram human somatic cells to pluripotent stem cells with defined transcription factors.
2008 Dr. Chris Walsh and his colleagues identify several genetic loci associated with Autism
2008 Drs. Vijay Sankaran and Stuart Orkin discover the fetal hemoglobin to adult hemoglobin switch is controlled by BLC11A transcription factor.
Invention Types
Name Company
dmPGE2 (stem cell stimulation)
Von Willebrand Factor
Anti-Neuropilin Antibody
Tissue Engineered Bladder
Pomalidomide
Omegaven
FcRn-Factor VIII
…to Product…
Name Company
Revlimid
Thalidomide
Merge EchoIMS
Neumega
Namenda
Dystrophin Diagnostic
INF2 DNA Sequencing Test
CardioSeal, StarFlex, BioStar
Cannula Needle Set
Patient Communication Board
Plagio Cradle
Quickchange Mutagenesis Kit
Products on the Market Products in Clinical Trials
…and Company
That’s the Bayh-Dole story
So what’s new?
Our Assets
Investigators
Patient samples
Assays
Thought leadership
Patents
Access to alternative funding sources
Translational research infrastructure
Animal models
Expertise
George Daley MD PhD (HHMI)
Marsha Moses PhD
Clifford Woolf, MD, PhD
Christopher Walsh MD PhD (HHMI)
The Academic Medical Center’s Role in Drug Development
Discovery Research, Target Identification
Drug identification and optimization
Manufacturing, Marketing and Sales
Clinical Development
Preclinical Development
IndustryAcademia
Then: Academia a Source
Pharma
Biotech
Academic Medical Center
Foundation
CROVC
Start-up
Other academic Govt
Information, IP
Now: Academia a Development Partner
Pharma
Biotech
Academic Medical Center
Foundation
CROVC
Start-up
Other academic
Govt
New Integrated Functions in the Licensing Office
Business Development
Patents & Licensing
Technology Development
Clinical Trials
Children’s Technology Development Fund
Product
New Company
Post Inc.
Pre Inc.
Prototype Development
Proof of Concept Validation
Licensee
Clinical Trial Validation
Basic Research
TranslationalResearch
Pre-Inc.ŅGapÓ
Opportunity Development
TechnologyDevelopment
FundEach project mentored by
Board member
Technologies selected with
Advisory Board
$50k or $150k awarded for 1 year
product development project with CRO
Research, Target Lead
Manufacturing, Marketing and Sales
Clinical Development
Preclinical Development
The Academic Medical Center’s Role in Drug Development
Patient Treatment
NIH: National Center for Advancing Translational Sciences
Pharma programs: Pfizer, GSK, Eli Lilly, Roche, Novo Nordisk, Sanofi, UCB, Bayer, etc.
Foundations: CF Foundation, LLS, JDRF, Epilepsy Foundation, etc.
Academic programs: e.g. Internal Technology Development Funds
The Academic Medical Center: the new FIPCO?
No– Mission-driven, not profit driven- different incentive structure Multiple funding sources- primary funding from government Without partners, treatments won’t get to patient With more ability, more leverage, and ability to create a better
partnering opportunities Pharma “open innovation” lets us participate in new ways
But– How do we structure it so that it benefits both parties?
Collaboration Partnership Structures
Old way: Sponsored research/licensing: negotiated on a per project basis
New way- on a continuum: From…Company-defined grant programs: application based…
• Company defines access, terms and level of commitment
…To “Strategic Alliances” • Joint Steering Committee decision-making structure• Request for proposals across the institution• Joint project plan development
• Long term commitment
Key Aspects to Consider
Ownership Control (Joint decision-making) Commitment
• Time• Dollars • Really integrating projects into company pipelines• Commitment of internal resources• Ability to get treatment to the patient
Bi-directional knowledge-sharing
Best case scenario: • Specific resources offered • Commitment jointly defined and shared • Information and expertise shared • Value recognized through shared ownership of assets developed• Helps inform our future commercialization efforts
Pharma’s Open Innovation: Advantages to Academia*
Access to complementary expertise and new resources
Forms basis for ongoing communication and relationship
Streamlines negotiations (expectations set up front)
Informs ongoing commercialization efforts
Ability to influence drug development and facilitate getting treatment to patient
* Assumes fair deal structure
How to Become a Fixture in Pharma Pipelines
a.k.a. How pharma can help you develop innovative therapeutics
Understand the breadth of your assets
Understand partners’ needs, goals, resources and limitations
Understand your institution’s needs and limitations
Articulate these to the industry partner
Build long-term relationships
Communication and transparency!
This webinar is sponsored by Merrill DataSite – The Secure Virtual Data Room Solution for the Life Sciences Industry