Aurélie Boucard

• Definition and optimization of the strategy and scope of preclinical and regulatory activities: global vision of the development of drug candidates from the early phases (proof of concept) through the full tox-package supporting IND/CTA filling. • Risk assessment and definition of mitigation plans. • Coordination of the activities from the preclinical phases respecting regulatory processes, timelines and budget. • Cross-functional management: close collaboration with the other departments (Discovery, Clinic, Regulatory, CMC, Intellectual Property, Finances and Legal). • Collaboration with safety and regulatory experts, CROs, KOLs and international industrial partners. • Review of the regulatory documentation (IND, IB, Special Protocols, Briefing Document), discussions with the Agencies (FDA, EMA) • Team management: establishing team objectives, task allocation, overseeing and advising junior and senior team members (PhD, PharmD profiles).

• Design of comprehensive protocols for in vitro and in vivo preclinical studies according to EMA/FDA requirements. • Monitoring of preclinical subcontracted studies: respect of the timelines, milestones and budgets. • Writing/ updating of the nonclinical modules of the regulatory documentation (IND, IB, Briefing Document). • Independence and responsibility in decision making and task execution. • Therapeutic area: Neurosciences.

Coordination of national and international multicentric studies: design and management of the study, selection and monitoring of the CROs, analysis and reporting of data. • Transversal management: interface between Discovery, Clinic, Regulatory, CMC, Biostatistics, Intellectual Property and Financial partners and colleagues. • Contribution to regulatory dossier: preparation of the pre-IND briefing package (EMA, FDA), Investigator Brochure, Scientific advice. • Early clinical development: study monitor support during Phase 1. • Drug candidate entering in Phase 3. • Therapy area: Cardiovascular (heart failure and infarction)

• Screening and characterization of drugs: protocol design, monitoring, analysis of results of insourced and outsourced studies. Respect of delay, cost and contractual aspects. • Two leads entered in Phase 2 and 3, respectively. • Identification of new biomarkers: operational manager of the Biomarker platform. • Therapy areas: Neurosciences (Alzheimer, Epilepsy, ALS, CMT), Type 2 Diabetes, Biomarkers.

• Evaluation of toxic effect of leads on CNS and Respiratory system: monitoring of studies, protocol and report writing, responses to internal and external audits. • Compliance with regulatory standards (ICH, GLP). • Training and supervision of technicians and engineers. • Customer relationships.

• Pharmacological and behavioral study: technical work and analysis of the data.

Neurosciences, Physiology, Statistics.