Innovation in Life Sciences The View from the Bench Chris Mason University College London

Life Sciences Innovation What is it? How is it produced in universities? Basic science + translation Barriers to academic innovation In addition to the scientific pursuit If and how scientists think about regulation? If and how scientists think about end products?

What is Life Sciences Innovation? Satisfy genuine “market” need Incremental step versus step change Disruptive technology Ethically acceptable Ability to be translated/commercialized Ability to eventually produce a safe, effective product at a price acceptable for routine clinical practice

How is Life Science Innovation Produced in Universities? Nature + Nurture World-Class Scientists World-Class Support + Infrastructure

Ability to Join-Up the Dots Aggregation Essential

Adult Stem Cell Therapy

Stem Cell Source

Adult Stem Cell Therapy 1-2 mm biopsy 2-3 weeks growth T-E Cornea Healthy eye Select stem cells Remove scar tissue Damaged eye Before operation After operation

Barriers to Innovation Funding Time Complexity – Challenges of multi-disciplinary research Academic demands Patenting issues Academia/industry linkage Basic science versus translation

Academia/Industry Linkage Academia-commercial collaboration challenging but encouraged Technology Strategy Board Unidirectional travel only (UK) Fear of IP reach-through Inappropriate valuation/expectation of academic IP Pieces of jig-saw only Lack of suitable UK partners/companies

Funding Cost of life science research +++++ Grants Full Economic Cost Grants Novel but not blue sky Hypothesis driven Proof of concept required/Pilot study ?Available funding

Seed Funding Spin-out company funding/Seed funding Pier not a bridge Lack of follow on funding – “Valley of Death” Angel + VC Need to develop technology for longer… Incubate in university labs ?Funding mechanism Not hypothesis driven

International Collaborative Funding Challenging but increasingly possible EU Framework Funding International Stem Cell Forum CIRM/MRC – MoO Complex IP issues Challenging + time consuming to initiate + manage

Time Life science experiments – Long duration Multiple repeats/Statistically significant Grant application time-lines – Long “Miss the boat” Time to commercial application – Decades Time to translation – Many years…

Complexity – Challenges of Multi-Disciplinary Research Multi-disciplinary life science becoming the norm Funding challenges Who is responsible/Cross council funding Falling in the cracks Management of grant inc. timing complex Risk of being service provider IP – Who owns?

Academic Demands Increasing demand to measure output RAE Pressure to publish Increasing student load/expectation Less than 25% grant applications successful Shortage of postdoc talent Challenge of competing with industry/city

Patenting Issues Misunderstood by scientists +++++ Publish versus patent Time consuming Lack of integration scientist/IP department Too little incentive plus not part of RAE output cf peer-reviewed papers Infrastructure demands Keeping compliant lab books Time-line Patent applications frequently dropped - £££ Time to develop versus patent life

Basic Science Versus Translation What exactly is “translation”? Basic science – THE BASIS of university research Funding only for hypothesis driven research Publication challenges Lack of joined up thinking Science, Translation, Commercialization UCL/LBS collaboration PhD/MBA

Must Collaborate Early RESEARCH TRANSLATION RESEARCH TRANSLATION

Science + Translation Mike Lester

Regulation Basic science - Compliance required Translation Paperwork +++ Translation Good Laboratory Practice (cGMP) Good Clinical Practice (cGCP) Good Manufacturing Practice (cGMP) £££££ + challenging to fund Time consuming (No RAE value) Service not research BUT ESSENTIAL

University Hospital GMP Facility Collaboration with Julie Daniels, UCL IoO/Moorfields Eye Hosp.

Clinical Trials Time consuming + complex to set up Lack of university GMP resources CMOs expensive + slow NHS – not an easy environment for research Service driven Funding challenging Negative results – Hard to publish

Requirement for Journals of NEGATIVE results

End Products Innovation or just fascinating science? Medical device c.f. biopharmaceutical Timescale Cost Commercialization cycle e.g. MAbs Product or service? Commercial or imbedded?

How is Life Science Innovation Produced in Universities? Nature + Nurture World-Class Scientists World-Class Support + Infrastructure

How is GREAT Life Science Innovation REALLY Produced in Universities? Chance Collaboration Cash

Innovation in Life Sciences The View from the Bench Chris Mason University College London