Growing a UK Cell Therapy Industry Delivering Health & Wealth

Transcription

1 Growing a UK Cell Therapy Industry Delivering Health & Wealth Matthew Durdy, Chief Business Officer December 2013 ct.catapult.org.uk Catapult is a Technology Strategy Board programme

2 The Cell Therapy (and Regenerative Medicine) Opportunity *US Market data

3 Why a Catapult? Learning Excellence Leadership Efficiency Risk taking 3

4 Assets -Facilities and Teams Facilities Business Team Business development Capacity for people Health economics Clinical research cluster Business models Global location 1200 sq m on 12th floor Translational Labs and Team Process development Analytical development GMP process proving Clinical Trial and Regulatory Team Regulatory Clinical operations 4

5 Management Team and Board Keith Thompson Chief Executive (Director, Scottish National Blood transfusion Service, Serologicals) Dr John Brown, CBE, FRSE Chairman BTG plc, Acambis, CAT Dr Natalie Mount Dr Stephen Ward Chief Clinical Officer (Director Pfizer, Neusentis. Cambridge, UCL) Chief Operating Officer (Director, Stabilitech, Onyvax. Southampton, Imperial) Matthew Durdy Chief Business Officer (Director, Aqix, Biotec, CDC. Oxford, Chicago) Professor Johan Hyllner Chief Scientific Officer (Director, Cellectis, Cellartis, Vitrolife) Headcount: 65 Professor Marc Turner Non-executive Director Edinburgh, SNBTS Professor Michael Whitaker Non-executive Director NE Stem Cell Institute Tim Edwards Non-executive Director Chairman, Bio Industry Association Dr Zahid Latif Non-executive Director Technology Strategy Board Nick Higgins Non-executive Director Consort Medical, Intercytec 22/11/2013 5

6 Catapult Themes Risk Catapult is a Technology Strategy Board programme

7 Management of Perceived Risk Example Nature Solution EU Regulation Not Understood Expert Advice Risk? Economics GMP Not Clear Not done Prepare Data Expert partner Therapy Not proven Share 7

8 Catapult Themes Funding Catapult is a Technology Strategy Board programme

9 Commercial Development Plan? Start Tasks Product Group Need Commercial Development Plan Innovation Quality Data Substance Process Regulation Information Identity Quantity Diagnostic Patient Clinician Payer Seller 9

10 Funding for cell therapy in the UK Govt. Support Commercial Development Plan Medical Charities Financial Investment Corporate Venturing 10

11 Successful commercialization depends on both regulatory approval and optimal market access Quality Safety Efficacy Comparative Clinical & Cost- Effectiveness; Budget Impact REGULATORY APPROVAL MARKET ACCESS 11

12 Lab - Pilot - Scale Catapult Multi Functional development Pod Commercial Scale Catapult GMP Proving Lab T e c h t r a n sf e r 12

13 Collaboration 1+1 = 3 Client knowledge + Expert capabilities = Better outcome Up to 80% UK Technology Strategy Board Funding available for collaboration with SME Partner Project Input Funding Ratio TSB Grant SME 1m 60% 0.6m Catapult 1m 100% 1.0m Total 2m 1.6m 80%

14 Sharing the outputs and opportunities 14

15 Partners Cooperation on manufacturing platforms Project sourcing and funding International collaboration 15

16 Project Examples Share of expertise Support for in house projects New delivery device to reduce injection pain Phase 2 clinical trials Scale up, Assays, Freezing and distribution of cells Large Cap Company Manufacturing partner, Regulatory, Clinical trial design and delivery Immunomodulation Regulatory, Clinical trial design, business models 16

17 Activities Proof of Principle Scientific, clinical, regulatory, commercial Non-clinical Safety, toxicology, GMP proving, assays Suitability Commercial Development Plan Clinical Safety and efficacy, investible data Platform Generic issues and large collaborations 17

18 Working models and finance Nature of project Paid for by: Carried out by: Ownership of outputs Finance Core Project Catapult Catapult Catapult 70m/ 5 years Contracted Development Client Catapult Client 10m/ Per year Industry Collaboration Grant or Catapult and partner Catapult and partner Outputs shared 10m/ Per year 18

19 Gateway Criteria

20 Building the portfolio hesc ips MSC Immune Cell Other Somatic Blood Bone & Cartilage Cardiovascular Dermatology/Wound Healing Diabetes Gastroenterology Immunology Liver Metabolic Neurological Oncology Ophthalmology Respiratory Other

21 Outputs Life changing therapies Investible propositions Industry changing innovation Skilled leaders UK leadership

22 Summary: The Cell Therapy Catapult Strong first year of growth Laboratories and teams up and running, 60+ Large and small collaborations Matthew Durdy Global interaction Industry success is our success

23 Industry Researchers Cell Therapy Catapult NHS Investment Catapult is a Technology Strategy Board programme