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Aline Schindelé
Clinical Development Director

  • LinkedIn

Pharmacist with 18 years of clinical research experience, in both Biotech and mid-size CROs

  • 15 years of clinical project management in various indications & study phases (Phase I-II to pivotal Phase III)

    • Geographical reach: Asia, Europe, and the USA

  • 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

  • Complete management of all clinical trial activities including vendor management

  • Experience in Regulatory Inspections (Europe & USA)

  • 3 years of clinical trial monitoring

Experience

  • mAb therapy - Phase II & III in ovarian and breast cancer; North America, Europe & Asia

  • TKI - Phase II in multiple myeloma, autoimmune & inflammatory diseases; France

  • Gene therapy - Phase I/II in rare disease; France

  • GMO Vaccine - Phase I/II in HIV; Europe

  • Cell therapy - Phase I/II in leukemia; USA

  • mAb therapy - Phase II in Acute Ischemic Stroke;  Europe

  • 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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Céline

Leparquier

Clinical Operations Director

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Laurence

Damier

Clinical Project Manager

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Audrey

Mabanza

Clinical Project Manager

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