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Management SkillsExecutive CoachingDesign and implementation of innovative and global regulatory strategies (European and USA) in order to expedite product development mostly in the field of : - Regenerative Medicine - Tissue Engineered products - Advanced therapies (ATMP) - Cell and Gene therapy - Drug Device Combination products - Drug/cells delivery devices, - Implantable devicesDisease areas (mainly) : - Rare diseases, - Orthopedics, - Wound healing, - Ophthalmology, - Digestive and reconstructive surgery
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President And FounderAs-IrisRennes, Fr
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President & FounderAs-Iris Aug 2023 - Present
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Senior AssociateHumanim Life Sciences Jan 2023 - Present -
Independent ConsultantFreelance Aug 2022 - Jul 2023
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Chief Development Officer (Cdo)Orchard Therapeutics Mar 2021 - Jul 2022London, United Kingdom, GbHead of Regulatory Affairs and Program Leads/Management Group -
Chief Regulatory OfficerOrchard Therapeutics Sep 2016 - Mar 2021London, United Kingdom, Gb
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Executive Vice PresidentVoisin Consulting Life Sciences Jan 2015 - Aug 2016Paris, Paris, FrResponsible of the definition of the Corporate Strategy and Business Development implementation plan. Participation in the structuration of the Company to allow future growth (internal and through acquisition) Managerial and expertise responsibilities. Acts as senior Advisor on Advanced Therapies Medicinal Products (ATMPs, in particular on cell and tissue based therapies), combination products (drug/device combinations) and medical devices related projects (incl. e- and m-health). Facilitation of communication between Authorities and Developers to expedite access to the market: Close relationships with regulatory agencies and business partners, in particular regular contact with FDA, Notified Bodies and European and National (Drug/Device) Agencies in order to define, design and support implementation of regulatory strategies adapted to innovative healthcare products. This necessitates very often communication and co-assessment between different Authorities and different expertise (for example: parallel scientific advice with European Medicines Agency (EMA) and national Health Technology Assessment Bodies (HTABs)). Active participation in Industry Associations, in particular Europabio (European Association for BioIndustry) and ARM (Alliance for Regenerative Medicine). Working Groups on Advanced Therapies, Personalized Medicine and Combination Products. Member of the Board of Editors of the SCRIP Regulatory Affairs Journal -
Executive Director, Medical Devices, Combination Products And Cell And Tissue Based TherapiesVoisin Consulting Life Sciences Jul 2009 - Dec 2014Paris, Paris, FrVoisin Consulting Life Sciences assists biotechnology, pharmaceutical and medical technology companies in the design and implementation of innovative and global regulatory strategies in order to expedite product development.Products include drugs, biologics, medical devices, combination products, advanced therapy products, as well as borderline products (food supplements and cosmeceuticals).Voisin Consulting collaborates with start-ups and medium-size companies to bring products to the market in the most efficient and cost-effective manner, within an evolving regulatory framework.
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Project Director, Medical Devices, Combination Products And Advanced Therapy Medicinal ProductsVoisin Consulting Life Sciences Jun 2002 - Jun 2009Paris, Paris, FrGlobal director for the medical devices, combination products and cell therapy sector at Voisin Consulting. Management of projects involving the design and the implementation of regulatory strategies for the development, evaluation and marketing of medical devices (including in vitro diagnostics), combination products (i.e. drug/device; drug/diagnostics) and borderline products. Preclinical and clinical program design and implementation, risk based approach, regulatory strategy (CE marking, 510k, PMA, pre-IDE, Request for Designation/Qualification, Scientific Advice, Centralized MAA for ATMPs) and scientific writing.Specialization in cell based therapies (so-called Advanced Therapy Medicinal Products (ATMPs) in Europe) and in particular in human tissue engineered products (hTEPs). Participation in the Europabio’s Advanced Therapies working group. Active involvement in the development of the European Regulation and guidelines on Advanced Therapy Medicinal Products.
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Scientific DirectorMeditest International 1999 - 2002Co-founder of the company.Regulatory consulting. Development strategy, pre-clinical and clinical evaluation, CE marking and reimbursement procedure of medical devices. Elaboration of quality guidelines for auditing medical services.
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Project ManagerMedtronic 1997 - 1998Minneapolis, Mn, UsAt Sofamor-Danek, acquired by Medtronic, Scientific adviser and coordinator of the research and development projects on biomaterials (with in particular programs focused on resorbable bone substitutes, Calcium Phosphate ceramics as adequate carriers for bone cells or other osteoinductive factors, neural patches). Elaboration of clinical studies protocols in collaboration with surgeons.
Anne Dupraz Poiseau Skills
Anne Dupraz Poiseau Education Details
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Ecole De Coaching De ParisExecutive Coaching -
Leiden UniversityBiomaterials
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Nantes UniversitéBiomaterials
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Freie Universität BerlinBiomedical Engineering And Biomaterials
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Université De Technologie De Compiègne (Utc)Biomedical Engineering
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Technische Universität BerlinBiomedical Engineering And Materials
Frequently Asked Questions about Anne Dupraz Poiseau
What company does Anne Dupraz Poiseau work for?
Anne Dupraz Poiseau works for As-Iris
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Anne Dupraz Poiseau's current role is President and Founder.
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What schools did Anne Dupraz Poiseau attend?
Anne Dupraz Poiseau attended Ecole De Coaching De Paris, Leiden University, Nantes Université, Freie Universität Berlin, Université De Technologie De Compiègne (Utc), Technische Universität Berlin.
What are some of Anne Dupraz Poiseau's interests?
Anne Dupraz Poiseau has interest in Science And Technology, Health.
What skills is Anne Dupraz Poiseau known for?
Anne Dupraz Poiseau has skills like Biotechnology, Medical Devices, Stem Cells, Cell Therapy, Clinical Development, Ce Marking, Life Sciences, Strategy, Regulatory Affairs, Cell, Clinical Trials, Pma.
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