m 4 Biobank Alliance & m 4 Trial Service Center

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1 m 4 Biobank Alliance & m 4 Trial Service Center Services & Consulting in (non-)clinical development

2 m 4 Biobank Alliance Central Access to High Quality Human Biospecimens for R&D

3 The m 4 Biobank Alliance Cooperation Network One-stop Access to Samples of Different Biobanks Source: Department for Pathology, TUM Source: Fotolia The m 4 Biobank Alliance provides access to tissue samples (formalin fixed, fresh and frozen) and to blood samples. Source: Fotolia

4 SERVICES of the m 4 Biobank Alliance Our partner biobanks offer Archive of > tissue and blood based specimens, also matched Broad spectrum of indications Prospective collection according to the user s specifications Source: Department for Pathology, TUM Clinical and anamnetic data, follow up data on demand Analytical services The contact person at Bio M provides an all-round service Single project agreement for all partner-biobanks QA for uniform, high quality of samples and data Coordination of sample and data allocation Scientific and clinical consulting Compliance with high standards for ethics and privacy protection

5 m 4 Biobank Alliance & m 4 Trial Service Center Two Strong Partners for Successful Translation Through close collaboration, m 4 Biobank Alliance and m 4 Trial Service Center offer comprehensive resources for the translation of your project from preclinical to clinical development.

6 m 4 Trial Service Center We guide your project from nonclinical to clinical development!

7 m 4 Trial Service Center (TSC) Our mission We navigate you through the translational development! clinical development nonclinical development Nonclinical development Nonclinical drug development stategies Study designs, planning & management Data review / gap analysis Regulatory documentation Trial preparation Project management Clinical trial protocol Regulatory documentation Consulting on demand Clinical trial Sponsor project management Integration of service providers and study sites Consutling on demand, e.g. regarding monitoring, etc.

8 Our approach Experienced consultants plus a strong network Consulting & resources for your project from a single source! Prof. U. Mansmann Regulatory Biostatistics CROs & Labs Clinicians & Clinical developers Early clinical trial facilities Study sites

9 m 4 Trial Service Center (TSC) Our team: Consultants with longstanding experience Dr. Anneliese Schneider 15+ years industry experience in drug discovery and nonclinical development Senior Expert in Tox, PK, PD (Board Certified) We are your local experts! Lena Mokelke, Dipl.-Biol. 10+ years industry experience in clinical trials Strong project management skills Dr. Martin Sippel Expertise in early drug development Project management and industry consulting experience

10 Selection of references Guidance and services for successful translational development Translational development (I): Comprehensive guidance in the preparation of a Phase I trial We provided advice on the preclinical programs required for the start of clinical development We established a roadmap to enter the clinical trial: Timelines, Roles & Responsibilities, The roadmap was put into practice by our experienced project manager Development and writing of the clinical trial protocol, with mulitdisciplinary input from our network of specialists We also involved service providers from our network Important: Long-term experience of our team to avoid pitfalls!

11 Selection of references Guidance and services for successful translational development Translational development (II): Early advice on preclinical & clinical development strategy Preclinical advice: Results from tox studies were assessed by our team expert By overseeing the whole development process, we assure that regulatory requirements are met Very important: Advice on clinical strategy involvement of experts for the relevant indications from our network

12 Selection of references Guidance and services for successful translational development Preclinical development: General assessment of preclinical program Overall assessment and data evaluation of preclinical safety & pharmacology studies Input by our experienced team expert: Verification of conclusions from preclinical data Advice and recommendations for further procedures in nonclinical development

13 Selection of references Guidance and services for successful translational development For advanced researchers: Our review service Example: clinical trial protocol optimization Our team expert for clinical development initiated study design optimizations during in-depths discussions In close cooperation with our biostatistics partner Prof. Mansmann, we adjusted the number of patients for sufficient statistical power. Also, we enhanced the clarity of trial procedures described in the protocol, leading to a more comprehensive description for study personnel potential for protocol violations is diminished!

14 Selection of references Guidance and services for successful translational development Other topics we advised upon Interaction with authorities Drug-drug interactions, DMPK for small molecules Validation of assays in Personalized Medicine: QM issues for laboratories (in close cooperation with QM experts from our network) Technical validation of assay Clinical validation strategy, trial preparation

15 Thank you! How can we support you? Get in touch with us! Dr. Martin Sippel Phone +49 (0) Mail Web