LIND Leuven June 12 th after meeting notes

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1 LIND Leuven June 12 th after meeting notes 1

2 Content Stellar: Project rationale, objective & scope Who is involved? Partners, contacts Project financials & timelines Governance and some R&Rs Call and selection process Website 2

3 What is it all about? Project rationale, objective & scope

4 May 29th, 2013 Stellar Celebration and Signing of the Charter Agreement 4

5 About Stellar To encourage collaborative research between the academia / research institutes & Janssen R&D in neurodegenerative disorders. In line with J&J Healthy Minds initiative (accelerate progress in the fight against brain disorders that affect millions of people around the world). Janssen R&D will collaborate initially with LIND (KU Leuven, University Hospitals Leuven and VIB) Next phase: other academia from Benelux can join 5

6 Project rationale Gain deeper insight into ND diseases and accelerate delivery of breakthrough options to prevent, diagnose and treat ND disorders (to cover huge unmet medical need) Access and develop high quality science in collaborations with external partners and stimulate scientific exchange. Establish the basis for novel drug discovery programs Collaborations will focus on biology/science originating from the partners which can be further developed in the collaboration. 6

7 Project focus Understanding of ND disease mechanisms Identification of novel drug targets, the validation of these targets or of published targets in line with pharmaceutical industry standards The generation of more relevant experimental cellular or animal models with translational capabilities Earlier and better patient identification and stratification by biomarker, clinical diagnosis and imaging approaches Assessments of therapeutic interventions 7

8 Project scope Specific requirements of projects include: Neurodegenerative disease approaches with (possible) broader applications across diseases General approaches focusing on synaptic plasticity and neuronal connectivity Favourable project elements include: Mutual/common interest between academia and Janssen Multidisciplinary and translational approaches Milestone driven approach Janssen scientist involved in development of full proposals 8

9 Project scope: Exemplified topics Tau related projects (e.g. phosphoryation, spreading, tau species, ) APOE4 centered studies Studies modelling and clarifying the role of identified genetic risk factors Mechanistic and symptomatic therapies (e.g. cognition) Amyloid related projects (e.g. toxicity, identification tox species, production and clearance of plaques, ) Mitochondrial dysfunction Microtubule stabilization Synaptic plasticity/function/neuronal connectivity Protein misfolding/clearance Oxidative stress Neuroinflammation α-synuclein Clinical POC testing Patient segmentation approaches Clinical biomarker approaches The joint Steering Committee will evaluate in addition any original out of the box ideas that might shed new light on the understanding, diagnosis or treatment of these diseases 9

10 Who is involved?

11 Project partners within J&J Innovation Center London Campus Beerse Therapeutic Area Neuroscience C.R.E.A.Te (and Drug development capabilities as needed) 11

12 Project partners - external First call: (Jun 2013) Leuven research institute for Neuroscience & Disease (LIND) only University Leuven University Hospital Leuven VIB Leuven (Vlaams Instituut Biotechnology) Future calls (Jan 2014 onwards, ) LIND + All academia /institutions Benelux who sign up Over time UK, France, Germany, may join 12

Stellar: points of contact Janssen Project lead / project info: Theo Meert PMO: Kim Cryns Contract negotiation/ info: Roger Bone (IC)/Christophe Verbruggen, Pascal Redig (legal) Communication:

13 Stellar: points of contact Janssen Project lead / project info: Theo Meert PMO: Kim Cryns Contract negotiation/ info: Roger Bone (IC)/Christophe Verbruggen, Pascal Redig (legal) Communication: Frederik Wittock Innovation center: Johan Verbeeck / Declan Jones Scientific Lead: John Kemp Call 1: LIND Scientific direction LIND: Bart De Strooper / Wim Robberecht Contract negotiation / info: Jérôme Van Biervliet (VIB) / Bruno Lambrecht (LRD) 13

14 Project financials & timelines

15 Project stellar: Budget aspects Stellar: 5 year period ( ); starting budget 5 MM Euro 2 calls/year (Jan, June) Project duration 2y - evaluation after 1y (envisioned that 50 % of projects will have 1-2 y FU) Budget/project: averaged on 250K/y (500K/project) (deviations allowed based on merit) Projects will be subject to review (technical capabilities, budget needs, ) as part of the process (possible involvement of in kind contributions) 15

16 Governance

Janssen SC Call 1 STELLAR Lead SC PM SC TA IC Joint Research Committee 1 P1 P2 P3 Joint Research Project Committee 1 Joint Research Project Committee 2 Joint Research Project Committee 3 1.

17 Janssen SC Call 1 STELLAR Lead SC PM SC TA IC Joint Research Committee 1 P1 P2 P3 Joint Research Project Committee 1 Joint Research Project Committee 2 Joint Research Project Committee 3 1. Joint Research Project Committee = PL +Janssen Scientist 2. Joint Research Committee = Lead SC & TA IC supported by PM SC, as delegates from SC, + PL +Janssen Scientist + senior representatives from Academia (LIND) + ad hoc members manages daily interaction on project(s) level 3. Janssen Steering Committee (SC) = senior representatives Janssen + ad hoc members manages programme and call level Ac1 = LIND 17

18 Janssen SC STELLAR Call 1 Call 2 Joint Research Committee 1 Lead SC PM SC TA IC P1 P2 P3 P4 P7 Ac1 = LIND Lead SC PM SC TA IC Joint Research Committee 2 P5 Ac2 Lead SC PM SC TA IC Joint Research Committee 3 P6 Ac3 The same principle of Joint Research Committee is applied for each additional collaboration 18

Janssen SC Stellar Members Group STELLAR Call 1 Call 2

Ac3 The Stellar Members Group has an information sharing

19 Janssen SC Stellar Members Group STELLAR Call 1 Call 2 Joint Research Committee 1 Lead SC PM SC TA IC P1 P2 P3 P4 P7 Ac1 = LIND Lead SC PM SC TA IC Joint Research Committee 2 P5 Ac2 Lead SC PM SC TA IC Joint Research Committee 3 P6 Ac3 The Stellar Members Group has an information sharing function Senior representatives of Janssen and all collaborations 19

20 Janssen Steering committee Permanent members Theo Meert (Lead SC) Husseini Manji Roy Twyman John Kemp Patrick Verheyen Declan Jones (IC TA representative NS) Kim Cryns (PM acts as secretary to the SC) Ad hoc members pending particular expertise or project needs External experts join the SC for the review and selection of the Full Proposals to ensure additional scientific challenge 20

21 Some Roles and Responsibilities

22 Project Lead from academia Overall lead of the project, accountable for project plan and resources Work with Janssen Scientist on Full Proposal (interaction can already be present at Expression of Interest level) Liaise with the responsible Janssen Scientist during the project Organize regular conversations (minimum once a month): progress updates, pitfalls, how to align internal resources within institute, which assets be mobilized?, stimulate innovation, proactively identify issues that may impact results, quality, delivery and timing; work with Janssen Scientist on appropriate resolution. Prepare jointly the required status reports Prepare jointly the presentations for the Scientific review meetings, Can initiate request for temporary secondment (Janssen LIND) 22

23 Janssen Scientist Primary contact for the Project Lead on all project related topics Give input in preparation of Full Proposals (can be involved in Expression of Interest) to align science to Janssen NS strategy (and DAS strategy too) Ensure regular discussions with Project Lead to follow up on project status Liaise between Project Lead and broader Janssen organization; Identification of internal Janssen resources (e.g. availability of knowledge and technologies; availability of experts) to facilitate project progress stimulate access to innovation seek legal advice for IP and publications when appropriate present project status, milestones, next steps in internal meetings like portfolio meetings Ensure joint preparation of documentation and reports where needed. Can initiate request for temporary secondment (Janssen LIND). 23

24 Call process

Call process LIND Assumptions: - charter signed May, 29th, 2013 ( ) - framework agreement in place August 30st, 2013 There will be a two-stage procedure for applications: expression of interest and

25 Call process LIND Assumptions: - charter signed May, 29th, 2013 ( ) - framework agreement in place August 30st, 2013 There will be a two-stage procedure for applications: expression of interest and full proposals. In both cases a proposal in English shall be prepared and must be submitted in electronic Word format using the appropriate template. Application period EOI: Monday, June 10 th, 2013 till Thursday, July 11 th,

26 Call process: Application method The expressions of interest (2-3 pages) have to be submitted in electronic format by the deadline to the LIND contact: Application form can be downloaded from website 26

27 Confidentiality of proposals Prior to the submission of the expressions of interest to Janssen R&D, the LIND contact (legal LRD) will provide Janssen R&D with a non-confidential list of the expressions of interest it intends to submit. Such non-confidential list will be based on topic 1-3 of the expression of interest form. Janssen R&D shall indicate for which of the projects it agrees to receive the detailed expression of interest, and will enter into a mutual confidentiality arrangement, in order to protect the confidentiality (contamination) of those expressions of interest and subsequent full project proposals for which it agrees to receive detailed information under confidentiality. Full expressions of interest will be provided by the VIB contact to the Secretary to the Janssen Steering Committee 27

28 Timeline call 1 & 2 28

29 Criteria for selection Ideas will be selected taking into account a number of factors such as: Relevance to the aim of the call The scientific quality of the proposal (innovation potential, methodology) Focus on addressing roadblocks to translate science into application Novel breakthrough science to understand field, clinical stratification,. Feasibility of the project (plan, budget, resources) Potential of the expected results for future application 29

30 Website & Intralinks

31 Website: VIB hosts website of call1 31

32 Website 32

33 Website 33

34 Intralinks site Will be used as document repository 34

35 35

36 Added after meeting 36

37 Reporting requirements Project leaders will be required to provide status updates to the Janssen Steering Committee: Status updates (one pager) after month 3, 6, 9, 15, 18 and 21 to the Janssen Project Leader. Full presentation of the project details (status, budget, and milestones) to the Janssen Steering Committee at the yearly scientific review meeting (Month 12 and 24). Full Final report latest 3 months after closure of the project All project reports are considered confidential information. 37

38 Eligibility criteria The following conditions need to be met in order for a project proposal to be eligible for submission: The applicant investigator is either: (i) full or part time ZAP at the KU Leuven; or (ii) a group leader at the VIB or KU Leuven; or (iii) a full time MD at the UZ Leuven Postdoctoral level researchers are allowed as coapplicants Registration to LIND 38

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