Brigitte Assouline work email
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Over 20 years’ experience in Preclinical Development Management, Scientific, Regulatory, Business and Intellectual Property expertise acquired in High Tech and BioTech Drug Developers startups and academic institutions.Driving the Preclinical strategy and Delivering results - from defining the Preclinical yearly objectives and budget to managing research and associated Regulatory Files (Tox, PK/PD, INDs) and coordinating CROs & Academic teams. Project Management – leading cross-functional efforts and teams, actively building bridges across organizational boundaries and delivering projects on time and on target.Business management acumen – focused on opportunity analysis including IP, scientific and legal evaluation of potential collaboration with a wide range of industry and academic strategic partners. Intellectual Property expertise - Scientific & Clinical Contracts, Legal issues, writing and filing of new Patents, coordination of worldwide IP attorneys’ activity.
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Preclinical Development Director & Intellectual Property ManagerCytheris Oct 2000 - Aug 2013Issy-Les-Moulineaux, FranceMember of the Board of Directors, reporting to the company CEOPreclinical development global responsibilities: • Managing non-clinical development strategy for innovative therapeutic candidates through different stages of development (recombinant proteins, glycolipids) • Designing and managing GLP and non-GLP non-clinical drug development• Coordinating all related activities (costs, timing, and risk management) and direct overview & management of outsourced activities (CROs, academic collaborations) • Preparing key project documentation for Regulatory submissions (INDs in Europe, America, Asia, South Africa) and maintaining update knowledge of EMA, FDA and ICH guidance's and regulatory requirementsAchieved non-clinical development program for recombinant Interleukin-7 up to phase II and for Alpha-C-galactosyl Ceramide to early stage, 9 publications in international reviews Legal department (I.P. & Contracts) responsibilities: - Intellectual Property: • Managed Patent portfolio and provided strategic decisions for patenting• Performed prior art searches, oversaw competing patent survey and patents analysis• Worked collaboratively with patent attorney to respond to office actionsCo-inventor of 3 patents on Interleukin-7 among which 2 main patents granted worldwide- Contracts:• Managed R&D Contract portfolio until contract close-out• Prepared proposals, reviewed, negotiated and managed contracts (CDA, MTA, CTA, licensing contracts) in line with company strategic objectives and project requirements• Worked with the company senior management team and proactively engaged Clinical, Regulatory, Manufacturing and Business Development teamsWin-win approach, worldwide activity, Resolve disputes (100% amiable)Work independently and as part of a team with rapidly changing deadlines and priorities -
Freelance ConsultantE.S.A.Bio® 1999 - 2000Paris La Défense, France• On behalf of LVMH Company Fragrances and Cosmetics, conducted a Feasibility evaluation of Industrial project. Implementation of High-Throughput Screening (HTS) technologies for chemical and biological discovery. Performed biological and I.P. state in the art Provided strategic and scientific advice and developed requirementsExpertise acquired industrial project management field• Under the supervision of D. GUERRE (I.P. Attorney, Lyon, France), co-redacted an industrial property guidebook applied to biotechnologies compliant with ESABIO I.P. Education Expertise acquired in Intellectual Property field
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Research EngineerUniversity Of Paris V- Inserm U428 1997 - 1999Paris, France“Thrombosis Risk and Haemostasis Mechanisms” Laboratory (Dir.: Pr. M. AIACH)Research project “Expression in eukaryotic system of Factor X mutants”: Performed construction of Factor X mutants, Transfection in eukaryote systems, Expression, purification and characterization of recombinant molecules and monoclonal antibodiesAcquired expertise in the fields of molecular biology, cell culture, biochemistry and biotechnology
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Research EngineerUniversity Of Paris V - Je 351 Dred 1992 - 1997Paris, FranceGenetic Molecular LaboratoryResearch project “Neurofibromatosis Type I (NFI) genetic disease”: Involved in research projects for direct and indirect diagnostics. Implemented automated molecular biology technological platforms. Involved in scientific team coordination (students and guest researchers). Implemented GLP/QA-QC policiesAcquired expertise in the fields of molecular biology, genetics and biotechnology - 10 publications in international reviews
Brigitte Assouline Skills
Brigitte Assouline Education Details
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E.S.A.Bio®, Université Léonard De Vinci, Paris La DéfenseMaster Degree -
U.F.R. Cochin Port-Royal, Paris, FranceMolecular Biology -
University Of Paris Xii, FranceCell Biology And Physiology
Frequently Asked Questions about Brigitte Assouline
What is Brigitte Assouline's role at the current company?
Brigitte Assouline's current role is Director - Preclinical Development & Intellectual Property.
What is Brigitte Assouline's email address?
Brigitte Assouline's email address is br****@****ail.com
What schools did Brigitte Assouline attend?
Brigitte Assouline attended E.s.a.bio®, Université Léonard De Vinci, Paris La Défense, U.f.r. Cochin Port-Royal, Paris, France, University Of Paris Xii, France.
What skills is Brigitte Assouline known for?
Brigitte Assouline has skills like Immunology, Biotechnologie, Intellectual Property, Ip Management, Contract Management, Biology, Pharmaceutical Industry, Pharmacology, Pre Clinical Studies, Business Strategy, Biotechnology, Molecular And Cellular Biology.
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brigitte assouline
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Brigitte Assouline
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