Dr. Oliver Steinbach

Provide clinical and regulatory strategy, planning, and execution leadership for new CDx product portfolio combining Roche's internal (e.g. Genetech) and external pharma partners’ drugs with esp. Ventana’s histopathology diagnostics for US, EU, China, and Japan clinical trials and markets. • Lead, manage CDx team and associated functional matrix. • Prepare, submit, manage, and monitor CDx test/device regulatory clinical studies with regulators (FDA, EMA, NMPA, PMDA), and notified bodies (EU).

Biopharmaceutical company, founded 2016, NASDAQ-listed, discovery, development, commercialization of innovative microRNA-targeted therapeutics and companion diagnostics for complete metastatic regression. Define and lead late-stage preclinical R&D, (e)IND, biomarker, CDx, and clinical strategy&plans for oligo/siRNA-drug candidates; report to CEO; partnering, merger and exit opportunities; IPO (29m$) support. Build product target profile, clinical®ulatory strategy; contract, monitor trial partners, CROs.

IBS (founded 2016), combining transformative, high-sensitivity imaging and nanomedicine for better, safer diagnosis and therapy in cancer, ASX-listed. Create, execute clinical and regulatory strategy for MagSense® device-led FDA-Breakthrough status combination product for early detection, differential/companion diagnosis, and treatment of selected malignancies; report to CEO; partnering, investor relations; AUD 6M+ raise. Start First-in-Human PoC study within 6 month, manage regulators (FDA, TGA), grants.

Cover over 120 academic centers, commercial partners, international and national alliances and grant agencies in North America; lead both strategy (aligning corporate vision and clinical roadmap across PHILIPS Innovation and Businesses) and operations ; manage Clinical Site Researchers and matrix organization; recruit and supervise Postdocs, MD‐Fellows; FDA submissions and audits; manage Luminary Site and KOL network; chair Joined Steering Committees.

Functioned as head of research department with more than 60 FTE, 15‐20 student interns/ postdocs; reported to Division Head PHILIPS Research Europe. Led various preclinical/clinical biomarker, IVD, companion diagnostics, pathology, interventional imaging, drug delivery, biomedical materials (tissue implants) programs; served as PHILIPS Pharma Alliance Manager. Marketing, educational, M&A, spin-off activities; cofounder internal ethics committee for animal and human studies.

Defined technology investment roadmap with corporate R&D strategy (ca. € 200M annual); reported to VP Discovery Research; managed introduction new research para-digms, technology licensing and transfer; implemented. Led 20 FTE center of excel-lence for high‐content screening, ‘omics, epigentics, toxicology and histology support.

Cofounded ARI, managed Functional Screening and started Bioinformatics, Automation and Biomarker Discovery departments, built local network with cademia and start‐ups. Built from scratch within 1.5 years ARI infrastructure and own functional screening group to identify and validate novel drug targets. Led more than 10 collaboration programs and technology transfers with biotech partners. Selected for corporate high potential development program as only R&D affiliate.

Contributed to built-up of new Functional Genomics Department and managed expression profiling core lab in cross‐functional projects with other preclinical and clinical departments. Initiated multiple collaborations with academic groups. Oversaw hands-on and as Joined Steering Committee Member genomics collaboration and technology transfer with GPC Biotech AG. Contributed to internal R&D project “New Technologies” to advise board on strategic roadmap which led to an international R&D expansion.

• Supervision of research associates, management of various projects in cooperation with GPC Biotech AG and the Institute of Medical and Natural Sciences, Reutlingen. • Training as a Biological Safety Officer (University of Konstanz).

Vertebratenontogenese, embryonale Musterbildung, Determinierung und Differenzierung von Zellen, Wachtumsfaktoren, Induktionsprozesse, Signaltransduktionskaskaden, "second messenger"-Systeme Transkriptionsfaktoren, Onkogene, cis- und transregulatorische Genexpressionselemente Chromosomenarchitektur

1 year internship at MPI für Biochemie, Martinsried: Department of Cell Biology (Prof. Dr. G. Gerisch); Genzentrum, München (Prof. Dr. E.-L. Winnacker), Department of Molecular Biology(Prof. Dr. W. Zilli); Institut für Physiologische Chemie, München (Prof. Dr. W. Neupert); and others

Biochemie, Zellbiologie, Molekularbiologie, Immunologie, Human- und Neurophysiologie Organische Chemie, Naturstoff- und Peptidsynthese, Strukturaufklärung von Biomolekülen Präparative und analytische Proteinchemie, Enzymanalytik und -kinetik Pharmakologie und Toxikologie, Klinische Genetik