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NEU2: Novel Drugs for Neurological Diseases - Advancing Pharmaceutical Innovation in Germany

Explore the cutting-edge research and innovative projects of NEU2, a consortium dedicated to discovering and developing new medications for neurological conditions like Multiple Sclerosis. Learn about the high-tech strategies and successful pre-clinical trials shaping Germany's pharmaceutical industry. Discover the key stages of drug discovery, from target validation to clinical trials, and the strategic approach towards neuroprotection and regeneration. Get insights into the collaborative efforts and funding mechanisms driving the innovative efforts in pharmacological advancements. Join the mission to turn science into success and revolutionize the landscape of neurological drug development.

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NEU2: Novel Drugs for Neurological Diseases - Advancing Pharmaceutical Innovation in Germany

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  1. Neue Wirkstoffe gegen neurologische Erkrankungen New Drugs againstneurologicaldiseases 3. IHK Nord – Biotechnologiekonferenz Fleesensee, 26. April 2012 NEU² - ein integriertes Kompetenzkonsortium zur Entdeckung und Entwicklung neuer Medikamente gegen Multiple Sklerose

  2. “Pharmaciestothe World” Germany’s pharmaceutical industry dropped out of nearly all rankings of top firms by the mid-2000s

  3. High Tech Strategie der Bundesregierung Annahmen: > In Deutschland gibt es weiterhin exzellente Innovationen > Akademie, Biotech und Pharma brauchen sich gegenseitig mehr denn je > Es müssen neue Modelle für die Zusammenarbeit entwickelt und erprobt werden BioPharma– Der Strategiewettbewerb für die Medizin von morgen (BMBF initiiert)

  4. BioPharmaWettbewerb Ausschreibung in 2008: 1. Runde: 37 Projektskizzen; externe und interne Bewertung 2. Runde: 10 Projektskizzen vollständig ausarbeiten; erste Förderung 3 Gewinner: NEU²(Bionamics), LDC (MPG), NeuroAllianz (Bonn Univ.) Budget: S : € 100 Mioöffentl. Förderung für 5 Jahre (3 x 20 Miofür 3 Jahre, 40 Miofür 2 Jahre) plus > € 100 Mio privater Gelder

  5. Pre-clinical Trials Filing + Marketing Idea Research Clinical Trials Target Validation Lead Optimization NEU2 Kompetenzkonsortium Medeon Fokus: Multiple Sklerose

  6. The Drug Discovery and Development Process Target validation Animalmodels Clinical Trial Design Complexity Target Identification Assay Development Clin. Inv.: Phase I, Phase II Hit Profiling (Biology, ADME/T) Lead Optim., Med. Chem, Tox Focused Libraries kg-production Libraries: Design, Synthesis, Selection Upscaling, GMP material, Formulation Miniaturisation Processes, SOPs, Automation (u)HTS IND Success factors Target Know-How Process Know-How Indication expertise Process Know-How Clinical expertise time

  7. KombinationausgewiesenerExpertisen Target validation Animalmodels Patient recruitment Complexity Target Identification Assay Development Clin. Inv.: Phase I, Phase II Hit Profiling (Biology, ADME/T) Lead Optim., Med. Chem, Tox Focused Libraries kg-production Libraries: Design, Synthesis, Selection Upscaling, GMP material, Formulation Miniaturisation Medeon (u)HTS IND Scale Success factors Process Know-How Indication expertise Process Know-How Target Know-How Clinical expertise Time

  8. NEU²- Strategie Leitlinien in der Projektauswahl: Neuroprotektion, oder sogar Neuroregeneration. Toleranz Induktion. Innovative (oder sogar spekulative) Ansätze. Oral verfügbare Medikation. Diagnosis, Vorbeugung, Biomarker and Medikamente sind gleichbedeutend. Produktorientierter Ansatz. Kooperative Interaktionen: Aufgaben, Risiken und Erfolge sollen fair getragen und geteilt werden Der Konsortialvertrag gibt die „Spielregeln“ vor; plus bilaterale Vereinbarungen.

  9. Projektportfolio PtJ approved and running projects PtJ approved but terminated projects Submitted to PtJ for approval * financing under discussion ** retracted due to sponsor drop out *** finished project

  10. NEU² Mitglieder und ihre Rollen Project Management Project Sourcing Academia / others Third Parties Medeon Private + Public Funding Commercialization PlatformContributions

  11. Entwicklung der Strukturhinein in den privatenSektor P R O J E C T S “Our mission is to identify, evaluate, secure, finance, develop and commercialise innovative life science projects!”

  12. Unterstützungvor Ort ! 50% 50% innovative projects Potential project provider for bionamics

  13. Vielen Dank ! ”…We turn ScienceintoSuccess…“ Bionamics GmbH Schauenburgerstraße 116 D-24118 Kiel Falkenried 88 D-20251 Hamburg info@bionamics.de www.bionamics.de www.neu-quadrat.de

  14. Projekt Fluss P1, P2, P3, … Pi Project ideasandproposals (PPF) supportedbyCoordinator NEU² SteeringCommittee (SC) ~ quarterlymeetings scientific rationale, strategy fit, risk/benefitratioandmarketrelevance SC Project Assessment identificationofsponsorsintern / extern €1 €2 €3 €i Project Teams (PLi+ Psi+ …) alignment, committmentandplanningofprojectpartners Pi€i Final budget check by SC (joint) projectapplication BMBF/PtJ co-financing, legal framework projectcontract Approval Monitoring Project Leader* Project Team NEU² SC** projectperformance* projectmonitoring** Commercialisation, market

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