Experience in FP7 KBBE BLUEGENICS grant participation

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1 Experience in FP7 KBBE BLUEGENICS grant participation Lidija Harjaček, PhD Project Management Director Horizon 2020 Information Day Zagreb, December 18 th Copyright 2013 Galapagos NV

2 Fidelta Zagreb Specialized in pre-clinical drug discovery services integrated drug discovery stand alone services (chemistry, DMPK, pharmacology, toxicology) in depth expertise in inflammation, infection and macrocyclic chemistry Registered as Research Organization in Croatia Over 100 highly qualified scientific staff >250 publications and >65 PCT applications in last decade Collaboration with Academia 17% 8% 10% 36% Medicinal Chemistry Analytical Chemistry Mollecular Modelling Scale-up DMPK In vitro Pharmacology 10% 9% 2% 8% In vivo Pharmacology Toxicology & LAS 2

3 Four key cogs of drug discovery All under one roof at Fidelta From target to preclinical development: Patient Primary cells/tissues Translational In vivo animal models In vitro assays Cell health Target organ toxicity General toxicology Efficacy Safety Medicinal chemistry 3 DMPK CADD In vitro ADMET In vivo PK PK/PD Custom synthesis Scale-up Bioanalysis Discovery analytical services Early development Structural studies and interactions

4 Sustainable track record in R&D 1952: Research Institute established by Pliva azithromycin, one of world s best selling antibiotics, developed in these labs 2006: acquired by GlaxoSmithKline GSK Macrolide DPU and Integrated Research Unit 2010: acquired by Galapagos Internal Outsourcing 2013: established as commercial CRO fee for service division 4

5 Galapagos: leading European biotech 830 staff, research sites in 5 countries, HQ in Belgium 2 divisions: Services Galapagos R&D 2010 respiratory models 2005 target discovery compound libraries chem; screening; preclin services in vivo PK toxicology inflammation infection models 2013 proprietary target discovery platform large pipeline: 5 clinical, 6 PCC, 30 discovery programs major risk sharing alliances with big Pharma (GSK; Lilly; J&J; Servier) AbbVie deal for GLPG0634- GLPG to receive up to $1 billion in milestones + double digit royalties 5

6 BlueGenics From gene to bioactive product: Exploiting marine genomics for an innovative and sustainable European blue biotechnology industry (311848) SEVENTH FRAMEWORK PROGRAMME THEME 2 FOOD, AGRICULTURE AND FISHERIES, AND BIOTECHNOLOGY Collaborative Project (large-scale integrating project targeted to SMEs) 6

7 How we got involved 7

8 Project full title: Proposal acronym: Type of funding scheme: Work programme topics addressed: Name of the coordinating person: Project initiation date/duration: BlueGenics From gene to bioactive product: Exploiting marine genomics for an innovative and sustainable European blue biotechnology industry BlueGenics Collaborative Project (large-scale integrating project targeted to SMEs) KBBE (Innovative marine biodiscovery pipelines for novel industrial products) Prof. Dr. Werner E.G. Müller, Aug 2012 / 4 year project Total EU contribution: 6,000,000 EU contribution to Fidelta: 512,000 (50% reimbursement of total costs) 8

9 Background and objectives Blue Biotechnology- biotechnological use of marine organisms Marine organisms (sponges)- rich source of novel substances for biotechnology and biomedicine E.g. efficient defense mechanisms against viruses, bacteria or eukaryotic organisms Industrial exploitation using traditional approaches is limited Natural sources are limited and often inaccessible Complex and costly isolation procedure- typically compound mixtures Bluegenics Objectives: start from the genes encoding the bioproducts, and apply recombinant technology to obtain larger quantities needed for initial testing combine with chemical synthesis to get larger quantities/ analogues profile compounds in preclinical studies, leading to clinical studies 9

10 List of participants Coordinator P1 Universitätsmedizin der Johannes Gutenberg, Universität Mainz, UMC-Mainz Germany Industrial partners (SMEs/non SMEs): P2 ManRos Therapeutics ManRos France P3 BIOALVO S.A. BIOALVO Portugal P4 NanotecMARIN GmbH NANOTEC Germany P5 Sæbýli ehf. SAEBYLI Iceland P6 Prokazyme ehf. PROKAZYME Iceland P7 Fidelta Ltd Croatia P8 Biotrend S.A. BIOTREND Portugal Nonprofit R&D biotech company: P9 Matis ohf. MATIS Iceland Academic partners (in addition to the coordinator): P10 Università degli Studi di Napoli Federico II UNINA Italy P11 University of East Anglia, UEA United Kingdom P12 Rheinische Friedrich-Wilhelms-Universität Bonn RFWUB Germany P13 Muséum National d'histoire Naturelle MNHN France P14 Uppsala University UU Sweden P15 Ruder Boškovic Institute, Center for Marine Research, RBI Croatia ICPC partner: P16 National Research Center for Geoanalysis, Chinese Academy of Geological Sciences, NRCGACAGS, China 10

11 Graphical presentation of work packages WP1. Bioprospecting Sampling Extract preparation Cultivation Sponge bacteria interaction WP leader: MNHN WP2. Screning Bioactivity Identification Screening platforms Target oriented screening WP leader: BIOALVO Pert diagram: WP4. Genomics (Functional) genomics cdnas/genes involved Bioactive peptides Disease-relevant kinases WP leader: UMC-Mainz WP3. Isolation Structure elucidation Secondary metabolites Bioactive peptides WP leader: UNINA WP5. Metagenomics Gene mining Metagenomic libraries PKS gene clusters Genome mining WP leader: RFWUB WP6. Chemical Synthesis and Chemogenetics Chemical synthesis Engineered biosynthesis WP leader: UEA WP7. WP9. Intellectual Property, Technology Transfer, Market Analysis WP leader: ManRos Upscaling WP leader: MATIS WP8. Preclinical studies WP leader: GALAPAGOS Fidelta WP10. Demonstration WP leader: PROKAZYME WP11. Dissemination, Communication, and Plan for Using and Disseminating the Knowledge WP leader: NANOTEC Clinical studies (Phase I Phase IV) - Endusers - Commercialization* 11

12 Fidelta role Set-up a number of testing systems in vitro and in vivo (relevant for inflammation, bone remodelling, in vitro toxicity, etc.) Guide the selection of promising compounds for progression Advise on screening cascade up to preclinical candidate Advise on preclinical development Help attract potential industry partners 12

13 Summary of impressions Finding opportunities/partners Networking is important Look beyond your immediate fields of interest Grant application process Experienced coordinator is key Important to clarify accountabilities and expectations Get familiar with rules, finance and IP aspects After approval Initial stage of project- partners each working on their parts Interactions mostly at project meetings (once every 6 months) Collaboration opportunities with partners outside project scope? 13

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