Aline Schindelé
Clinical Development Director
Pharmacist with 18 years of clinical research experience, in both Biotech and mid-size CROs
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15 years of clinical project management in various indications & study phases (Phase I-II to pivotal Phase III)
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Geographical reach: Asia, Europe, and the USA
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Clinical advice to support biotechnological companies including conduct of clinical gap analysis, preparation of RFP, CRO selection and oversight, set-up clinical quality procedures and tools, and strategic clinical input
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Complete management of all clinical trial activities including vendor management
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Experience in Regulatory Inspections (Europe & USA)
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3 years of clinical trial monitoring
Experience
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mAb therapy - Phase II & III in ovarian and breast cancer; North America, Europe & Asia
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TKI - Phase II in multiple myeloma, autoimmune & inflammatory diseases; France
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Gene therapy - Phase I/II in rare disease; France
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GMO Vaccine - Phase I/II in HIV; Europe
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Cell therapy - Phase I/II in leukemia; USA
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mAb therapy - Phase II in Acute Ischemic Stroke; Europe
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Immune desensitization therapy - registration Phase III; Canada, USA, Europe & Australia
Meet our other team members
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Marina
Iché
Founder and
CEO
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Ophélie
Orset
Clinical Project
Manager
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Philippe
Drevot
Clinical Development and Project Director
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Juliette
Coignard
Clinical Project
Manager
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Rana
Boussi
Clinical Operations Director
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Anais
Maugard
Clinical Project
Manager
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Céline
Leparquier
Clinical and Regulatory Affairs Director
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Gwenaëlle
Roguet
Clinical Project
Manager