Fundación. Discovering the Future
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1 Fundación Discovering the Future November 2013
2 About us Independent, Non-profit Research rganization established as a Privatepublic partnership between Government of Andalucía (Spain) University of Granada (Spain) Merck Sharp and Dohme de España S.A. ur Mission Discovery of new bioactive compounds and innovative therapies for unmet medical and industrial needs.
3 At a glance RESEARCH SERVICES Microbial collections Microbial Genetic Banks Natural Products Libraries 50 yrs expertise in Drug Discovery 5 Drugs in the market Collaborations with industry & academia High Throughput Screening Natural Products Chemistry Compound Structural Elucidation Bioanalytics Preclinical Safety Genome mining New Compound Discovery Patents Collaborations Publications Academia & Industry
4 Natural Products: untapped sources of novel drugs Unique chemical space compared to synthetic libraries Potency and selectivity derived from extended evolution selection Underexplored microbial sources of novel compounds utstanding scaffold starting points for new drug candidate development Privileged structures: excellent templates for the synthesis of novel, biologically active, natural product-like molecules Combinatorial compounds (N 13506) Natural Products (N: 3287) Drugs (N: 10968) Dobson, Nature % of new chemical entities in the last 20 yrs are natural products or derived from natural product scaffolds (Newman and Cragg, 2012)
5 Natural Products - the source of leading marketed drugs Antimicrobials Antitumor Immunosuppressors Thienamycin Caspofungin (Imipenem, Merck) (Cancidas, Merck) Cardiovascular Paclitaxel (Taxol, BMS) Romidepsin, FK228 (Istodax, Celgene) Neurodegeneration Cyclosporin (Sandimmune, Novartis) Lovastatin (Mevacor, Merck) Fingolimod (Gilenya, Novartis) NP-derived from fungal myriocin Immunomodulator, Multiple sclerosis Rapamycin (sirolimus) (Rapamune Pfizer)
6 Natural Products leads and clinical candidates Antimicrobials, antitumorals, immunosuppressors, metabolic disease H H H H 2 C H Kibdelomycin, antibacterial Topo II isomerase inhibitor H H CCH 3 H N H H N H Platensimycin, antibacterial Fatty acid synthesis inhibitor Ac H H H CH Enfumafungin, antifungal H H H CCH 3 Parnafungins mrna polyadenylation inhibitors N PM Microtubule polymeration Salinosporamide Proteasome inhibitor Epoxomicin Proteasome inhibitor Halimide, tubulin-depolymerizing agent Immunomycin immunosuppressor Arphamenine A Aminopeptidase inhibitor Mycestericin immunosuppressor HN H H NH DMAQ-B1, Insulin mimetic
7 Maximizing chemical diversity by maximizing biodiversity Microbial Collection > strains fungi, actinomycetes & other bacteria (ex. MSD) Natural Products Libraries extracts & fractions Extracts ready for screening Development of new extracts Plant extracts Microbial Genetic Banks Genome DNA libraries for gene mining
8 Microbial Collection Built for Discovery of new drugs and industrial products for unmet needs in medicine and industry riginates at the Merck Sharp & Dohme CIBE Global Screening Center. 50 Years track record of success in drug discovery from Microbial sources Continuously growing, currently > strains (fungi, actinomycetes and unicellular bacteria) Proven genetic and chemical diversity
9 Natural Products Extracts Library Taxonomic, chemical and biological data annotation Ready-made modules or tailored to specific requirements of partners Screening at MEDINA or at external partner site Robotically integrated for faster and efficient screening Ready-made Tailor-made extracts & fractions Specialized, differing in Chemical Space
10 Access to collection and exploitation Volume Diversity Taxonomically Geographically Ecologically > Microbial strains extracts & fractions Genome banks Exclusivity Proprietary isolations Reliability Traceability from origins, in digital format Fully integrated Discovery Research Through Collaborations & Partnerships 10
11 Drug Discovery Engine Screening Approach Extracts & fractions collections from microbial fermentations High Throughput Screening Hit Confirmation & LC/MS dereplication Hit Selection Bioassay-guided Isolation Structural Elucidation HPLC-MS & NMR 3-6 months
12 Technology Platforms & Related Services High Throughput Screening High Content Bioimaging Isolation of Natural Products Analytical Chemistry Services Microbiology Fermentation Access to genomes Bioanalysis Metabolomics Toxicology profiling & functional screening Translational / clinical R&D support Structural Elucidation
13 Technology Platforms Assays for any type of target (enzyme/ whole cell/ immunoassay) Automation /robotics / secure information processing Most HTS formats and readouts supported- high content imaging Stringent validation and statistical analysis / quality control system BSL-2 biocontainment facilities High Throughput: data points /month
14 Technology Platforms 20 years of Natural Product Chemistry expertise Complete structure elucidation of molecules Parallel fractionation of large numbers of samples Complete structure elucidation of molecules Detailed chemical analysis of extracts of natural origin MS readouts at every stepfast dereplication and identification of new molecules
15 Technology Platforms Genomic/metabolic analysis: enzyme and gene discovery Bioprospectingbuilding libraries / accessing diversity Natural product/ metabolite expression detection and optimization High throughput culture, fermentation, extraction, optimization and scale-up
16 Technology Platforms Bioanalytics & Metabolomics State-of-the-art platform high resolution automated sample handling systems High precision measurements in large numbers of biological samples Biomarker discovery and Diagnostics by HPLC-MS/MS and NMR Highest efficiency in cost, time and quality. Early toxicological and pharmacological studies of new drugs and metabolites
17 Technology Platforms Toxicology & Translational / clinical R&D support Drug metabolism and metabolite identification In Vitro ADME-Tox Pharmacokinetics in high throughput Wide variety of functional bioassays and tailored assay development Cytotoxicity, Cardiotoxicity, Neurotoxicity
18 Drug Discovery - Collaboration Agreements Partners Academia Industry Early discovery Hit to lead Preclinical Phase I Phase II Phase III Contract Research Programs Shared Success Programs ut Licensing
19 Drug Discovery Current Research Areas Infectious Diseases Gram negative Tuberculosis Aspergillosis Parasitic Diseases Malaria Leishmaniasis Trypanosomiasis ncology Kidney Breast Pancreas Lung Neurodegeneration Amyotrophic lateral sclerosis Neuroprotection
20 Drug Discovery Research Pipeline Gram (-) MDN-0057* Anti Infectives Tuberculosis Antifungals MDN-0080 & MDN-0096 MDN-0018* Parasitic ncology Malaria Leishmaniasis Trypanosomiasis PI3K Pathway (Breast, Colon, Lung & Gastric Cancer) Nuclear Translocation Pancreatic Cancer MDN-0109 to MDN-0112 MDN-0088 MDN-0105 MDN-0090 Neuro degeneration Parkinson Amyotrophic Lateral Sclerosis (ALS) MDN-0113 MDN-0005* *Patent applications filed Patent application under preparation
21 Current Partners & Collaborators Industrial Partners Academic Partners & Consortia
22 perational flexibility for collaborations Input from Partner Define &/or supply targets, assays, processes, libraries Project Execution entry/exit point specified by partner: Biology Chemistry Pharmacology utput to partner
23 Avda Conocimiento 3, Parque Tecnológico Ciencias de la Salud Granada, SPAIN Tel: Fax:
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