The Cell Therapy Catapult: Keith Thompson CEO January 2013

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Keith Thompson explains the role of the Cell Therapy Catapult

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The Cell Therapy Catapult: Keith Thompson CEO January 2013

  1. 1. The Cell Therapy Catapult Keith Thompson CEO January 29 2013 info@ct.catapult.org.uk Catapult is a Technology Strategy Board programme
  2. 2. The Launch of Catapults Hauser Hauser Report • Creating new manufacturing industries for the UK • Better exploiting the UK science base • “Grow and stick” • £200m+ assigned to TSB for 7 Catapults Hauser Criteria • > £10bn pa long term industrial revenue to UK • Exploit a strong existing UK science base • UK absorptive capacity, to capture and retain value • Translational activity to bridge investment gap • Learn from other countries with successful Technology Institutes • Persistence of funding against a long term perspective and low priority on becoming self-financing 2
  3. 3. The Catapults • High Value Manufacturing • Offshore renewable Energy • Satellite Applications • Digital Connected Economy • Transport systems • Future Cities • And 3
  4. 4. 4 Cell Therapy Catapult • Significant unmet medical needs • World class science base supported by forward looking investments from TSB, MRC; Wellcome Trust, NHS, charities • Development and production of cell therapies is complex • NHS as large stakeholder for both research and exploitation • Early enough for UK to establish a strong market position
  5. 5. Mind the (translational funding) gap 5 • • Catapult Little evidence yet that new cell therapies can be developed, licensed and adopted successfully Limited investment from commercial sector • Limited precedents for valuable exits via IPO or acquisition • Most large corporates are observing and waiting • Operational SME’s lack finance and breadth of resources for rapid advance
  6. 6. Addressing current industry barriers to commercialisation Key barriers to commercialisation Pertinent issues for cell therapies Regulatory affairs Regulatory pathways still emerging and can be complex Pre-clinical science Investor avoidance of preclinical phase programmes Clinical development Hard to manage demonstration of clinical safety and efficacy Manufacturing and GMP readiness Move from bench/small scale GMP process to large scale manufacture is complex Supply chain management New model of delivery required Investment readiness Difficult for companies and technologies to attract investment 6
  7. 7. Core Purpose Growing a UK cell therapy industry delivering health and wealth 7
  8. 8. Vision The Cell Therapy Catapult vision is for the UK to be a global leader in the development, delivery and commercialisation of cell therapy. Where businesses can start, grow and confidently develop cell therapies, delivering them to patients rapidly, efficiently and effectively. 8
  9. 9. Mission The Cell Therapy Catapult will grow the industry in the UK to substantial and sustainable levels by : • Taking products into clinical trial, de-risking them for further investment • Providing clinical expertise and access to NHS clinical partners • Providing technical expertise and infrastructure to ensure products can be made to GMP and delivered cost effectively • Providing regulatory expertise to ensure that products can get to the clinic safely in the shortest time • Providing opportunities for collaboration, nationally and globally • Providing access to business expertise, grants and investment finance so that commercially viable products are progressed and investable propositions generated 9
  10. 10. Strategic Goals Pipeline • Increased cell therapies in UK clinical trial and clinical use Value • Investible propositions created leading to cell therapy companies that succeed and stay in the UK Attractiveness • Demonstrating that the UK is the place to do this work, with increased inward investment Goals • Build a £10bn industry 10
  11. 11. Cell Therapy Catapult Outputs Investible therapies (Rounded Phase 2 data package) Industry assisted over barriers Novel technologies licenced to cell therapy companies Contract research which enhances capability of the industry Standards, quality systems, guidance & co-ordinated framework Skilled, trained and experienced professionals 11
  12. 12. Projects 12 Proof of Principle • 4 people, 12 Months, £0.5m, 2-6 ongoing • Scientific, clinical, regulatory, commercial Suitability Non-clinical Suitability • 0.5 People • 3 Months • £20k • 36 pa • 6 people, 24 Months, £2.2m, 2-6 ongoing • Safety, toxicology, GMP proving, assays Clinical • 5 People, 36 Months, £4.6m, 4-8 ongoing • Safety and efficacy, investible data Platform • 3 People, 12 Months, £0.5m, 1-3 ongoing • Generic issues and large collaborations
  13. 13. Project activity Over the Next 5 Years, complete • 150-200 short term suitability and assistance projects • 11-15 proof of principle projects • 5-9 non-clinical projects • 4-6 clinical projects Participate in the creation of 2-4 significant investible propositions Create an environment that increases clinical trials & clinical activity by 50-100% 13
  14. 14. 14 Building The Catapult Catapult is a Technology Strategy Board programme
  15. 15. Assets Finance • £70m core grant from TSB to March 2018 • £10m pa from other grant funders • £10m pa from industry contracts We use our assets to accelerate innovation. Catapults do not give grants. 15
  16. 16. Facilities and Teams Facilities • • 1200 sq m on 12th floor • Capacity for 80-100 people • Adjacent to complementary activities Business Team • • Business development • Health economics • Business models Translational Labs • • Process development • Analytical development • GMP process proving Clinical Trial and Regulatory Team • • Regulatory • Clinical operations 16
  17. 17. Building a Project Portfolio Catapult is a Technology Strategy Board programme 17
  18. 18. Global cell therapy industry: ‘Cell-able targets’ Established medical practice: e.g. haematopoietic stem cell transplantation Commercial products: Rapidly growing global market Global turnover of $1bn in 2011; rising to $5bn in 2014; driven by diversity of small products (Apligraf, Dermagraft, Provenge made >$100m each in 2011) Therapies in development: Rapidly growing ~ 250 products in clinical development Global pharma involvement: Already Teva, Shire, Sanofi, Pfizer… 18
  19. 19. Projects: Successful Path to Commercialisation 19 Regulatory agency dialogue on plans at each stage -start with the end product in mind and deliver an integrated plan Science • • Efficacy and safety hypothesis and evidence Definition and characterisation of cellular product Clinical • • • • Patient population, unmet medical need, differentiation Safety Robust evidence of efficacy Dose and dosing regimen • • • GMP manufacturing process; release; comparability assays Supply logistics Scale-up / scale –out; Control of cost • • • Pricing and reimbursement plan Defensibility (IP, know-how…) Commercialisation partner Manufacturing Business
  20. 20. Projects and Products UK companies SMEs Big Healthcare Inward investors Trial initiation Manufacturing and distribution Academic pull through Accelerate innovation Create investible propositions 20
  21. 21. Drivers in Portfolio Construction • Current UK and international activity • Cell platform • Technology barrier • Disease • Market size • Market access • Tractability and deliverability • Early wins 21
  22. 22. Diverse cell therapies in clinical trial in the UK; but few are company sponsored Category Cell therapies currently in clinical trial in the UK* Number ~25 Comment Roughly equal numbers of autologous and allogeneic Range of indications from cardiovascular to oncology Bone marrow derived cells still predominate but rising diversity Cell therapies currently in clinical trial in the UK sponsored by a commercial company 4 Majority of studies are Research Council funded and EU consortia studies *verified studies currently on-going; excludes gene therapy & haematopoietic transplantation 22
  23. 23. Bone marrow derived cells still predominate but T-cells are a rising class amongst greater diversity 23
  24. 24. Field is growing beyond the traditional transplant and oncology indications 24
  25. 25. Opportunities for the Catapult (i) significant potential to grow the clinical translation of therapies originating in the UK and to attract inward investment for clinical development (ii) significant potential to grow the number of UK based cell therapy companies (iii) in order to accelerate towards more approved therapies in this space, more larger Phase 2 studies are required, statistically designed and powered to demonstrate efficacy Cell Therapy Catapult Confidential 25
  26. 26. Identifying projects • Catapult widely understood • The door is open to all, at all times • Screen database against our criteria • Initial engagement : suitability project • Selected projects progress • Board decision against published criteria • Portfolio and rationale shown on website
  27. 27. Communication Channels • Pre-clinical and clinical databases • Technology transfer offices • Direct contact • Intermediaries • • • • Grant Funders Industry Groups Charities Investors
  28. 28. Gateway Questions
  29. 29. Project D: Investigate Further
  30. 30. Project E: Return to tracking
  31. 31. A
  32. 32. B
  33. 33. C
  34. 34. Building the Portfolio hESC iPS MSC 36 Immune Cell Other Somatic Blood Bone and cartilage Cardiovascular Dermatology/wound healing Diabetes Gastroenterology Immunology Liver Metabolic Neurological Oncology Ophthalmology Respiratory Other Manufacturability
  35. 35. Building the Portfolio hESC iPS MSC Immune Cell Other Somatic Blood Bone and cartilage Cardiovascular Dermatology/wound healing Diabetes Gastroenterology Immunology Liver Metabolic Neurological Oncology Ophthalmology Respiratory Manufacturability Other 37
  36. 36. What does success look like? Catapult is a Technology Strategy Board programme 38
  37. 37. Success for the Cell Therapy Catapult means.. Leadership in building an emerging industry, addressing barriers to commercial investment Increased numbers of cell therapies in UK trials and clinical use Investible propositions creating successful UK companies Demonstrating that the UK is the place to do this work Being a leader in building a £10bn industry 39
  38. 38. Industry Researchers Cell Therapy Catapult NHS Catapult is a Technology Strategy Board programme Investment
  39. 39. Commercial Development Plan (start with the end in mind) Start Tasks Commercial Development Plan • Innovation • Quality • Data Product • • • • Substance Process Regulation Information 41 Population • Identity • Quantity • Diagnostic Need • • • • Patient Clinician Payer Seller
  40. 40. Investors in Cell Therapy in the UK (Examples of actual investment or declared interest) Govt. Support Medical Charities Commercial Development Plan Financial Investment Corporate Venturing 42
  41. 41. Working models Nature of project 43 Paid for by: Carried out by: Ownership of outputs Catapult owned Catapult Catapult Catapult Contracted Development Client Catapult Client Industry Grant or Catapult Outputs Collaboration Catapult and shared and partner partner
  42. 42. Collaboration 1+1 = 3 Client knowledge + Catapult capabilities = Better outcome Up to 80% 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%
  43. 43. Intellectual Property Ownership Basic Principles: Example: Catapult model does not rely upon income from IP £2m collaboration Urgent new manufacturing process Background IP stays with owner 50/50 Catapult and partner Arising IP shared in commercial transaction Partner: exclusive rights with their product and business In proportion to inputs Catapult: rights outside partners business 45

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