Novel drug development gets an impetus when academia, SME s and global companies combine their strengths. Clinical. Clinical Phase IIa.

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1 SME Partnership Call Jon de Vlieger & Jorg Janssen April 17, 2012 This presentation has been used during the information session on April 17. The Info Sheet document, version April 20, 2012, contains the final information regarding the SME partnership call. Novel drug development gets an impetus when academia, SME s and global companies combine their strengths Pharmaceutical Research & Development Process Discovery & concept development Proof of concept Product development Target Discovery Lead Discovery Lead Opt Safety & CMC Clinical Phase I Clinical Phase IIa Phase IIb Phase III Registration Phase IV Ac cademia (incl. clinicians) La arge com mpanies Exploratory research: disciplinary / technology driven, broadly applicable Basic research partly in-house; partnering to obtain access to new knowledge/insights E.g. development of validation models and feedback from clinical trials Financial power to finance clinical trials (beyond scope of TI Pharma) Spe ecialized SME s Dedicated focus on development of specific technology/ies or a specific indication Technology driven Disease oriented

2 The Strategic Research Program is based upon a matrix of Therapeutic Areas and Enabling Technologies Therapeutic Enabling areas technologies Therapeutic Target Finding, Validation & Animal Models Lead Selection and In-Silico Modeling Predictive Drug Disposition and Toxicology Biomarkers and Bio-sensoring Drug Formulation, Delivery and Targeting (Auto-)Immune Diseases Cardiovascular Diseases Enabling Technologies are relevant to research across the Therapeutic Areas Cancer Infectious Diseases Therapeutic Areas based on Priority Medicines (WHO) Brain Diseases Special overall Research Platform: Drug Discovery, Development and Utilization Efficiency improvement Early regulatory input Pharmaceutical Prod. Technologies Open innovation is about networks Drug discovery and development: a networked model (illustrative) ti Academia SME s (Specialty) Pharma CRO s

3 Major deals between big Pharma and SME s are an important driver for the Dutch sector Examples of deals between SME s and major Pharma SME: Galapagos Prosensa Merus Topic: Auto-immune RNA interference Antibodies against disease alliance for Duchenne cancer Big Pharma: Abbott GSK Novartis Deal value: USD 1.35 billion EUR 518 million EUR 152 million The current TI Pharma research program was built in 4 calls for proposals a fifth call is now open 2006: 1st call for proposals, bottom up, EUR 160 million, 25% private participation 2007: 2nd call for proposals, filling of gaps in portfolio, EUR 80 million, 25% private 2009: Joint call for proposals, together with CTMM and BMM, EUR 5 million, 25% private 2011: Value Creation Call, follow up for successfull projects, >EUR 15 million, >40% private 2012: SME Partnership Call, focus on SME partnerships, >7.5 million, >40% private

4 The SME Partnership Call focuses on partnerships p of SME s with academia, big industry and/or other SME s The call is open for potential ti projects with SME s in the lead The SME Partnership Call follows a timeline with maximum time for applicants The first year follows a 2:2:1 division in funding the subsidy funds SME s and academic groups Selection criteria follow the topsector ambitions The call is open for potential projects with SME s in the lead Only SME s can submit a proposal The Principal Investigator of the project can be of any of the partners Projects have to last at least 18 months, starting at January 1st, 2013 the latest As an indication, TI Pharma aims to start 6 projects, with a subsidy contribution of around 500 k per project At least two private parties, of which at least one SME, have to contribute to the project At least one academic group has to be involved The European definition of SME will be used to determine the qualification of a private partners as SME, see: link to EU SME definition At the time of submission of an EoI, all partners should have a legal entity and be capable to start working on the project as of January 2nd 2013

5 The SME Partnership Call follows a timeline with maximum time for applicants Timeline SME Partnership Call all dates are in 2012 Applicants 7-6 EoI deadline 27-8 Full proposal deadline 17-9 Signed LoI deadline 19-9 Presentation to committee Update on contract neg. Time (wk) TI Pharma 30-3 Call open 17-4 Info session 15-6 Feedback on EoI 14-9 Comments reviewers to applicants 28-9 Decision communicated to applicants Deadline for signing contracts The Expression of Interest phase is mandatory, but no selection is made The Expression of Interest t is a 2 page information document, a format is available, a Word format can be downloaded on April 20 EoI s are used to provide feedback to applicants and to prepare the full proposal review process Deadline for submitting an EoI is Thursday, June 7, 2012, 23:59 hrs If applicable, feedback on the EoI will be provided by TI Pharma Expression of Interest are not used for selection (In case of doubt: do submit an EoI!)

6 The Full Proposal submission deadline is on August 27, Letters of Intent have to be signed by September 17 The Full Proposal phase is open only for submitters of an EoI A Word format is available as of April 20 Deadline for submission is on Monday, August 27, 2012, 23:59 hrs In view of the summer, signed Letters of Intent from all partners can be submitted later: deadline Monday, September 17, 2012, 23:59 hrs Applicants can present their proposal p to the selection committee on September 19, 2012 Selection of project proposals is done by the Executive Board, with input from the International Scientific Review Committee Applicants can present their proposal to this selection committee on Wednesday, September 19, 2012 In the presentation the applicants can include rebuttal on comments by external peer reviewers Reviewers comments are sent to the applicants by Friday, September 14, the latest

7 The first year follows a 2:2:1 division in funding the subsidy funds SME s and academic groups Funding Execution Private (SME s, industry, health foundations, 40%) Academia Subsidy (40%) SME s Academia (20%) Industry The financial boundary conditions are tailored to SME s and academic groups The funding of the actual project costs in 2013 has to be 40% private, 20% public, 40% subsidy After 2013 there is no subsidy available for the project. The subsidy contribution in 2013 is directly linked to the private contribution with a maximum of 40% of the actual project costs SMEs and academia are allowed to contribute up to 100% in kind to the project The contribution of Non SME private parties (e.g. large pharma companies) should at least be half in cash and the rest in kind The subsidy has to be used for costs made at SME s and academic groups in the Netherlands. In case Health Foundations participate in the consortium, they count as private partner and their contribution should be 100% in cash

In 2014 and beyond, a fee for TI Pharma services has to be taken into account For 2014 and beyond

The fee for the governance is 5% of the project budget - The fee for services depends on the

is being detailed Too much is yet unknown to include a possible TKI toeslag in the budget The

ambitions Topsector LSH ambitions SPC selection criteria Scientific quality (33%) Business

8 In 2014 and beyond, a fee for TI Pharma services has to be taken into account For 2014 and beyond a reasonable fee for use of the TI Pharma governance and services has to be taken into account - The fee for the governance is 5% of the project budget - The fee for services depends on the needs of a consortium Within the topsector policy a TKI toeslag for multilateral collaborations is being detailed Too much is yet unknown to include a possible TKI toeslag in the budget The financial guidelines are available as of April 20, 2012 Selection criteria follow the topsector ambitions Topsector LSH ambitions SPC selection criteria Scientific quality (33%) Business activity (33 %) Medical need: quality of Medical need: quality of life, combined with sustainable healthcare (33%)

9 Formats: (as of April 20, 2012)

Rules and Procedures for IMI Calls for proposals. IMI Webinar 17 July 2017

Rules and Procedures for IMI Calls for proposals IMI Webinar 17 July 2017 Outline 1. Introducing IMI 2. Participation rules 3. Funding rules 4. Intellectual property rules 5. From Call to grant award 6.