The Cell Therapy Catapult Keith Thompson CEO January 29 2013 info@ct.catapult.org.uk Catapult is a Technology Strategy Board programme
The Launch of Catapults 2 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
The Catapults 3 • High Value Manufacturing • Offshore renewable Energy • Satellite Applications • Digital Connected Economy • Transport systems • Future Cities • And
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
Mind the (translational funding) gap 5 • 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 Catapult IPO or acquisition Most large corporates are observing and • waiting • Operational SME’s lack finance and breadth of resources for rapid advance
Addressing current industry barriers to 6 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
Core Purpose 7 Growing a UK cell therapy industry delivering health and wealth
Vision 8 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.
Mission 9 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
Strategic Goals 10 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
Cell Therapy Catapult Outputs 11 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
Projects 12 Proof of Principle • 4 people, 12 Months, £0.5m, 2-6 ongoing • Scientific, clinical, regulatory, commercial Non-clinical Suitability • 6 people, 24 Months, £2.2m, 2-6 ongoing • Safety, toxicology, GMP proving, assays Suitability • 0.5 Clinical People • 3 • 5 People, 36 Months, £4.6m, 4-8 ongoing Months • Safety and efficacy, investible data • £20k • 36 pa Platform • 3 People, 12 Months, £0.5m, 1-3 ongoing • Generic issues and large collaborations
Project activity 13 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%
14 Building The Catapult Catapult is a Technology Strategy Board programme
Assets 15 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.
Facilities and Teams • Facilities • 1200 sq m on 12 th 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
Building a Project Portfolio 17 Catapult is a Technology Strategy Board programme
Global cell therapy industry: ‘Cell - able targets’ 18 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…
Projects: Successful Path to Commercialisation 19 -start with the end product in mind and deliver an integrated plan Regulatory agency dialogue on • Efficacy and safety hypothesis and evidence Science • Definition and characterisation of cellular product plans at each stage • Patient population, unmet medical need, differentiation • Safety Clinical • Robust evidence of efficacy Dose and dosing regimen • • GMP manufacturing process; release; comparability assays Manufacturing • Supply logistics • Scale-up / scale – out; Control of cost • Pricing and reimbursement plan Business • Defensibility (IP, know- how…) • Commercialisation partner
Projects and Products 20 UK companies SMEs Big Healthcare Inward investors Trial initiation Manufacturing and distribution Academic pull through Accelerate innovation Create investible propositions
Drivers in Portfolio Construction 21 • Current UK and international activity • Cell platform • Technology barrier • Disease • Market size • Market access • Tractability and deliverability • Early wins
Diverse cell therapies in clinical trial in the 22 UK; but few are company sponsored Category Number Comment Roughly equal numbers of autologous and allogeneic Range of indications from Cell therapies currently in cardiovascular to oncology ~25 clinical trial in the UK* Bone marrow derived cells still predominate but rising diversity Cell therapies currently in Majority of studies are Research clinical trial in the UK 4 Council funded and EU sponsored by a commercial consortia studies company *verified studies currently on-going; excludes gene therapy & haematopoietic transplantation
Bone marrow derived cells still predominate 23 but T-cells are a rising class amongst greater diversity
24 Field is growing beyond the traditional transplant and oncology indications
Opportunities for the Catapult 25 (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
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
Communication Channels • Pre-clinical and clinical databases Technology transfer offices • • Direct contact Intermediaries • • Grant Funders • Industry Groups • Charities • Investors
Gateway Questions
Project D: Investigate Further
Project E: Return to tracking
A
B
C
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