Mediwales Finance and Funding Event:

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1 Mediwales Finance and Funding Event: Cardiff, March 22 nd 2012 Translational Research Funding for Companies Dr Tim Knott Business Development Manager, Technology Transfer The Wellcome Trust

2 Overview of Wellcome Trust Funding schemes open to industry How to apply What we look for in a proposal Terms and conditions

3 The Wellcome Trust Independent charitable foundation with strong international presence Supports over 3000 researchers in more than 40 countries Endowment at the time of Sir Henry Wellcome s death in 1936 ~ 3 million after duties Endowment today ~ 14.5bn Anticipated grants this year 650m0M annually Supporting the brightest minds to achieve extraordinary improvements in health

4 Technology Transfer Translational Funding Investments Creative Research Science Funding Translational research awards PRI* Technology Transfer Capital growth of endowment * PRI: Programme Related Investments - Investments made by foundations to support charitable activities that involve the potential return of capital. Equity & Equity Long/Short Absolute Return & Buyout Healthcare & Venture Property & Infrastructure Private Equity We help to bridge the gap between fundamental research and commercial application. We fund applied research and development projects worldwide to a stage where they are attractive to a follow-on funder.

5 Technology Transfer Translational funds available m 2010/11 YTD 82.2m 72.7m GBP ( ) Millions Health Innov India H'care Med Eng SDD SACs STA TA 40.3m 61.7m 63.9m m 15m 15.8m 0 1.8m 02/3 03/4 04/5 05/6 06/7 07/8 08/9 09/10 10/11 YTD Funding Year

6 Technology Transfer Geographic Distribution UK 89% US 5% Ireland 1% India 1% Belgium 1% Italy 1% Singapore 2%

7 Number of applications received 350 Companies Institutions /3 03/4 04/5 05/6 06/7 07/8 08/9 09/10

8 Technology Transfer Diversity of Translation Funding Medical Devices Diagnostics Therapeutics Enabling Technology Regenerative Medicine Vaccines

9 Technology Transfer Diversity of Translation Funding Respiratory & Pulmonary Other Musculo-skeletal Cardiovascular & Circulatory Veterinary Ophthalmic Oncology Gastrointestinal Infectious Diseases Metabolic & Endocrinology Neurology

10 Technology Transfer Award statistics 206 projects supported Range: 25k M Average award, 1.5M million committed 652 million leveraged 3 M&A by Pharma 7 product launches 14 projects into the clinic Diagnostics for the Real World Ltd

11 Technology Transfer Funding Schemes Translation Awards Health Innovation Challenge Fund Strategic Translation Awards Seeding Drug Discovery R&D for Affordable Healthcare in India

12 Health Innovation Challenge Fund 100m, 5 year, funding partnership supported in equal measure by the Wellcome Trust and the Department of Health. Objective: Stimulate the development and uptake of innovative products, technologies and interventions for the benefit of patients in the NHS and other healthcare systems Supports UK-led projects targeting unmet/poorly met healthcare needs Provide translational funding for projects with proof-of-principle and potential for clinical use or adoption within five years Take product, technology or intervention to stage at which sufficiently developed to be attractive to follow-on funders or investors Encourage collaboration of companies, academia and clinicians to better confront today s healthcare challenges Funding: Two rounds per year in 2012 and 2013 with up to 10m available per round Operates a menu of specific themes No cap on project funding (typically 1m-2m)

13 Types of projects Health Innovation Challenge Fund Menu of theme topics for each call during 2012 and 2013: Clinical applications of genetics Early detection and diagnosis of chronic diseases Trauma and emergency medicine Software-based clinical management tools Re-purposing of medicines and medical devices Projects to offer technology and solutions that can be: Seamlessly integrated with established infrastructure, systems and resources currently in use Scaled up from local to national level i.e. not reliant on specialised centres or expertise which can hinder widespread adoption

14 Entry & exit criteria Health Innovation Challenge Fund Entry Positioned as translational funding scheme to accelerate clinical application of projects that are well advanced along development pathway Feasible for potential benefit to be demonstrated in patients within 5 years Projects must have already demonstrated proof-of-principle, supported by experimental data (and in vivo where feasible) Early stage research or basic science projects will not be supported Exit First testing in man completed within duration of project (typically 3 years) Attractive for follow-on funding via corporates, VC, not-for-profit, e.g. NIHR, or NHS adoption

15 Application Process Preliminary Application Risk Analysis Milestones IP & Legal Commercial Strategy Corporate Background Triage (Funding Committee) Full Application Expert Opinions Due Diligence Funding Committee Scientific & Technical Competitors Regulatory Competence

16 Themes common to successful applications Clear healthcare need Potential for substantial impact Step-change in innovation Strong scientific rationale & evidence Competitive advantage / differentiation Strong team with competence & skills to deliver Background assets & new assets for exit Good project plan with clear objectives & milestones Appropriate resources Value for money

17 Commercial terms ACADEMIC o Host institution leads on exploitation o Up to 30% top-slice then 65% : 35% net revenue split SME o Unsecured Convertible loan o Repayment options at Trust discretion (Base rate + 2%) o Direct equity PUBLICLY LISTED COMPANIES o Milestones & royalties OTHER o Bespoke Step in rights to ensure achievement of charitable mission

18 Joint Secretariat Health Innovation Challenge Fund Based at Central Commissioning Facility, Twickenham Simon Bradshaw BSc MBA Assistant Director Direct Tel: Based at Wellcome Trust, Euston Rd, London Dr Tim Knott Business Development Manager Technology Transfer Division Direct Tel:

19 Translation Awards Response-mode funding designed to bridge the funding gap in the commercialisation of new technologies in the biomedical area Focus on: Applied R&D projects that address an unmet need in healthcare or applied medical research Early stage projects considered too risky by the investment community Looking for: Projects covering any aspect of healthcare technology development Projects must have a realistic chance that the innovation will be developed further by the market Eligibility: UK based not-for-profit research institutions, including those funded by the MRC, Cancer Research UK, and Research Councils Commercial organisations (subject to a programme-related investment agreement) Overseas organisations (by invitation only Strategic Translation Awards)

20 Wellcome Trust supporting innovative drug discovery Seeding Drug Discovery years 3-6 month 6-12 month month 12 month Development (years) Target Discovery Assay Development Hit to lead Lead Optimisation Pre-clinical Evaluation IND filing Functional genomics Proteomics In vitro / in vivo disease association 1 and 2 ry assay development Hit finding strategy Crystallography / pharmacophore Medicinal chemistry optimisation Biochemical / ADMET assays in vitro / in vivo pharmacology Pharmacokinetic / dynamics Early Toxicology package Process Development Small scale GMP manufacture To develop drug-like, small molecules that will be the springboard for further R & D by the industry in areas of unmet medical need

21 Technology Transfer TTD Web Page

22 Technology Transfer