December 16, 2011Technology Transfer Tactics Webinar:

How your universitys innovations can become a fixture in big pharmas pipeline Nurjana Bachman PhD - Business Development Manager

December 16, 2011Technology Transfer Tactics Webinar:

How big pharma can help you develop innovative therapeutics for patients Nurjana Bachman PhD - Business Development Manager

One company performed all stages of drug developmentThen: Fully-Integrated Pharmaceutical Company

Now: Fully-Integrated Pharmaceutical NetworkOne company partners to perform all stages of drug developmentAcademia, other companies, CROs, manufacturing partners

New Pharma Model for Sourcing IdeasOpen Innovation

What does this mean for academia?

Childrens 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

Worlds Largest Pediatric Research Enterprise$225M clinical and basic research funding800,000 sq. feet of research space40 clinical departments225 specialized clinical programs~600,000 inpatient/outpatient visits8,720 total employees2 Nobel Prize winners11 members, Howard Hughes Medical Institute7 members, National Academy of Sciences11 members, Institute of Medicine

History of Innovation at Childrens

1869Children's Hospital Boston opens as a 20-bed facility1920Dr. 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 1938Dr. Robert Gross performs the world's first successful surgery to correct a congenital cardiovascular defect1954Dr. John Enders wins the Nobel Prize for successfully culturing the polio virus1971Dr. Judah Folkman publishes "Tumor angiogenesis: therapeutic implications" in NEJM1986Dr. Louis Kunkel identifies the gene for Duchenne muscular dystrophy1990Dr. Joseph Murray wins the Nobel Prize for his pioneering work in organ transplantation

From Innovation

1983Children's physicians report the first surgical correction of hypoplastic left heart syndrome, a fatal condition.1986Dr. Louis Kunkel identifies the gene for Duchenne muscular dystrophy1990Dr. Joseph Murray wins the Nobel Prize for his pioneering work in organ transplantation1998Dr. Anthony Atala successfully transplants laboratory-grown bladders into dogs, a major advance in the growing field of tissue engineering. 2008Dr. George Daley discovers how to reprogram human somatic cells to pluripotent stem cells with defined transcription factors. 2008Dr. Chris Walsh and his colleagues identify several genetic loci associated with Autism2008Drs. Vijay Sankaran and Stuart Orkin discover the fetal hemoglobin to adult hemoglobin switch is controlled by BLC11A transcription factor.

Invention Types

to ProductProducts on the MarketProducts in Clinical Trials

NameCompanydmPGE2 (stem cell stimulation)Von Willebrand Factor

Anti-Neuropilin Antibody

Tissue Engineered Bladder

Pomalidomide Omegaven FcRn-Factor VIII

NameCompanyRevlimidThalidomideMerge EchoIMSNeumegaNamendaDystrophin DiagnosticINF2 DNA Sequencing TestCardioSeal, StarFlex, BioStarCannula Needle SetPatient Communication BoardPlagio CradleQuickchange Mutagenesis Kit

and Company

Thats the Bayh-Dole story

So whats new?

Our AssetsInvestigatorsPatient samplesAssaysThought leadershipPatentsAccess to alternative funding sourcesTranslational research infrastructureAnimal modelsExpertiseGeorge Daley MD PhD (HHMI)Marsha Moses PhDClifford Woolf, MD, PhDChristopher Walsh MD PhD (HHMI)

The Academic Medical Centers Role in Drug DevelopmentIndustryAcademia

Then: Academia a SourcePharmaBiotechAcademic Medical CenterFoundationCROVCStart-upOther academicGovtInformation, IP

Now: Academia a Development PartnerPharmaBiotechAcademic Medical CenterFoundationCROVCStart-upOther academicGovt

New Integrated Functions in the Licensing Office

Childrens Technology Development FundEach project mentored by Board memberTechnologies selected with Advisory Board$50k or $150k awarded for 1 year product development project with CRO

The Academic Medical Centers Role in Drug DevelopmentNIH: National Center for Advancing Translational SciencesPharma 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 structureMultiple funding sources- primary funding from governmentWithout partners, treatments wont get to patientWith more ability, more leverage, and ability to create a better partnering opportunities Pharma open innovation lets us participate in new waysBut How do we structure it so that it benefits both parties?

Collaboration Partnership StructuresOld way:Sponsored research/licensing: negotiated on a per project basis

New way- on a continuum:FromCompany-defined grant programs: application basedCompany defines access, terms and level of commitmentTo Strategic Alliances Joint Steering Committee decision-making structureRequest for proposals across the institutionJoint project plan developmentLong term commitment

Key Aspects to ConsiderOwnershipControl (Joint decision-making)Commitment TimeDollars Really integrating projects into company pipelinesCommitment of internal resourcesAbility to get treatment to the patientBi-directional knowledge-sharingBest case scenario: Specific resources offered Commitment jointly defined and shared Information and expertise shared Value recognized through shared ownership of assets developedHelps inform our future commercialization efforts

Pharmas Open Innovation: Advantages to Academia* Access to complementary expertise and new resourcesForms basis for ongoing communication and relationshipStreamlines 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 Pipelinesa.k.a. How pharma can help you develop innovative therapeutics Understand the breadth of your assetsUnderstand partners needs, goals, resources and limitationsUnderstand your institutions needs and limitationsArticulate these to the industry partnerBuild long-term relationshipsCommunication and transparency!

This webinar is sponsored by Merrill DataSite The Secure Virtual Data Room Solution for the Life Sciences Industry

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