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CapEval
- CEO
2010 - maintenant
voir www.capeval-pharma.com
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Cap&Val
- CEO and founder
2010 - maintenant
- NCD consulting: toxicology, drug safety, pharmacokinetics, pharmacology, interactions and/or negotiations with Regulatory Authorities.
- Business plan implementation and development. New market opportunity development.
- Consulting experience.
- Strategic Business Development.
- Help for identifying, analysing, structuring and developing new business opportunities and specific market-focused strategies as well as fulfilment of international registration requirements.
- Scientific and administrative management of R&D, including safety and project management.
- Consultancy pharma/biotech/diagnostic/CROP Science industry development.
- Responsible for Sales/Marketing (consultancy/studies), Finance & Planning. Profit & Loss responsibilities.
- Ensuring GLP compliance of outsourced studies.
- Strategic orientation for developing client molecules presenting a potential therapeutic interest. Solving R&D issues.
- Assessment and evolution of material and human resources needed for client development and R&D strategy.
- Representing the company in front of regulatory authorities, potential partners. Help for Due Diligence opportunities (partnerships/acquisitions).
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OriBase Pharma
- Directeur Scientifique
2010 - 2012
Chief Scientific Officer and R&D/Toxicology Global Director
- Scientific and administrative management of R&D, including safety
- Supervision of design, execution and reporting of all discovery and toxicological studies and research projects
- Supervision and administrative responsibility (budget and HR) of the operating staff (technical, scientific and project management - ensuring adequation between R&D needs and provision of resources and expertise).
- Ensuring safety, contract and GLP compliance.
- Adjusting resources and allocating workload to cost-effectively meet deadlines.
- Organizing Scientific Advisory Board
- R&D/Tox Department Director, responsible for Scientific Strategy
- Strategic orientation for developing molecules presenting a potential therapeutic interest
- Assessment and evolution of material and human resources needed for company development and R&D strategy
- Representing the company in front of potential partners and investors.
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Addex Pharmaceuticals
- Head of Non-Clinical Safety
2006 - 2010
Global Director of Non-Clinical R&D Drug Safety (toxicology) department
- Scientific and administrative management of the department, including safety
- Responsible for developing and leading the strategy of the R&D preclinical department (toxicology, efficacy and safety evaluation) and for the oversight of the development of non-clinical safety strategies from discovery to the market.
- In depth knowledge and follow-up of projects, identifying as early as possible and communicating potential project hurdles, suggesting solving strategies.
- Responsible for all Preclinical Activities (safety profiles, hazard and safety assessments, toxicology, safety pharmacology, pharmacokinetics, PK/PD, links with clinics, proof of concept, pathology and project management).
- Developing the design, preparation and implementation of in vivo and in vitro studies related to all non-clinical development activities to meet regulatory requirements for pre-IND and IND/CTA submission.
- Designing and managing studies in toxicology, safety pharmacology, pharmacology, drug metabolism, pharmacokinetics and pharmacodynamics and all studies related to preclinical assessment of safety and efficacy.
- Monitoring and coordinating outsourced studies to ensure common understanding, compliance with study protocol and regulatory requirements.
- Responsible for writing and presenting preclinical parts from regulatory documents.
- Relevant scientific literature review related to NCD.
- Link between research and discovery and clinical departments, providing them with toxicology guidance.
- Responsible for GLP compliance in designing protocols, analyzing and interpreting the data and preparing relevant documentation.
- Representing the company in front of investors, international health authorities and potential partners.
- Developing and maintaining a network of external relations including experts and professionals, authorities.
- Most successful pharma IPO in the last 5 years in Europe.
- Orienting and shaping the development of the company.
- Supporting business development for Due Diligence (in- or out-licensing, acquisitions, partnership and co-development agreements).
- Checking Safety Assessments.
- Transforming efficacious molecules into clinical candidates and marketed drugs.
- Screening molecules using new models and developing new drugs, establishing PK/PD relationships.
- Responsible for CRO selection, budget, monitoring & GLP/GCP conformity.
- Recruiting, attracting, motivating, retaining, managing, training and developing technicians, medicinal chemists, biochemists, study directors, study monitors, scientists (veterinarians, biologists), project leaders, group leaders and laboratory heads, strategic management and coordination of international teams.
- Managing and budgeting Global Preclinical R&D Drug Safety (toxicology) Department (Capital and Operating) and all other resources, contributing to the productivity and to the conduct and quality of studies by assuring the efficient management and coordination of teams and resources available and by requesting other resources when needed.
- Creating and managing global ethics committee in order to obtain AAALAC accreditation, supervising writing of global SOP’s and Guidelines.
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F. Hoffmann-La Roche
- Toxicology Project Leader Head of Animal Experimentation
1999 - 2005
- Responsible of Toxicology Projects.
- Deputy Head of Safety
- Responsible for developing and leading the strategy of the R&D department (efficacy and safety evaluation) and for the oversight of the development of non-clinical safety strategies from discovery to the market.
- In depth knowledge and follow-up of projects, identifying as early as possible and communicating potential project hurdles, suggesting solving strategies.
- Responsible for provision of safety profiles of candidate compounds in defined teams. Supervising preparation of Safety Assessments. Maintaining key expertise & answering questions on toxicology.
- Planning, contracting, monitoring and reporting of all categories of toxicological studies.
- Preparation of hazard and safety assessments and responding to safety issues of products with focus of toxicology.
- Participation to the decision for the release of products for first entry in man in defined new substance release committees.
- Identification and assessment of new trends in toxicology and providing up-to-date support.
- Maintaining of external and internal scientific networks.
- Management. Transversal: Scientists for analytical support & technical support ca. 10 projects, 8 non-toxicologists; 4 toxicologists (safety assessment & toxicology studies). Indirect: Study Directors from CRO’s, ca. 5 CRO’s, 15 scientists.
- Solving administrative, financial, scientific & operational issues. Encouraging innovation.
- Participating to recruitment of new toxicologists.
- Responsible for CRO selection & budget. Monitoring business performance and GLP conformity.
- Designing and managing studies for preclinical assessment of safety and efficacy.
- Monitoring and coordinating outsourced studies to ensure common understanding, compliance with study protocol and regulatory requirements.
- Responsible for writing and presenting preclinical parts from regulatory documents.
- Link between research and discovery and business development departments, providing them with toxicology guidance.
- Responsible for GLP compliance in designing protocols, analyzing and interpreting the data and preparing relevant documentation.
- Representing the company in front of authorities and potential partners.
- Developing and maintaining a network of external relations including experts and professionals, authorities.
- Orienting and shaping the development of the company. Supporting business development for Due Diligence (in- or out-licensing, acquisitions, and co-development agreements).
- International Toxicology Project leader (responsible for toxicology assessment from discovery to full development) and Head of Animal Experimentation.
- Organizing & conducting meetings. Implementing networks. Coordinating & developing integrated strategic & operational plan for projects in collaboration with international project teams/Managing the overall scientific & financial assessment of preclinical projects in all stages of R&D.
- Responsible for developing and leading the strategy of the R&D preclinical department (efficacy and safety evaluation) and for the oversight of the development of non-clinical safety strategies from discovery to the market.
- In depth knowledge and follow-up of projects, identifying as early as possible and communicating potential project hurdles, suggesting solving strategies.
- Responsible for Preclinical Activities (toxicology, pharmacokinetics, PK/PD, safety pharmacology, proof of concept, links with clinics, project management); proof of concept in different fields.
- Regular interactions (providing advices) with R&D scientists, cross-functional project teams, marketing & business units.
- Training, coaching, mentoring and supervision of junior scientists. Responsible for toxicology teaching.
- Preparation of regulatory documents for submission to regulatory bodies (IB, CTA, IND, CTD, CTX, NDA, expert report…)/assessment of new drugs. Meetings/communications with international health authorities (FDA).
- Design of project-specific research programs investigating sci
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CIT Centre International de Toxicologie
- Directeur Toxicologie
1996 - 1999
- Head of non-rodent & special toxicology department (agrochemicals and pharmaceuticals).
- Scientific and administrative management of toxicology
- Supervision of design, execution and reporting of all discovery and toxicological studies and research projects
- Supervision and administrative responsibility (budget and HR) of the operating staff (technical, scientific and project management - ensuring adequation between needs and provision of resources and expertise).
- Ensuring safety, contract and GLP compliance.
- Adjusting resources and allocating workload to cost-effectively meet deadlines.
- Responsible for developing and leading the strategy of the department.
- Leading projects in all phases of product life cycle (research, development, market phase).
- Scientific & financial discussions with third parties (customers, academic experts...).
- Authorised laboratory researcher (No. 007261).
- Presenting the company & its services to potential clients/ensuring appropriate programs are offered. Attracting new clients. Improving business development & increasing turnover.
- Reviewing study reports.
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Hazelton France Pharmakon Europe (Ricerca)
- Directeur d'Etudes Head of Animal Health
1992 - 1996
- Head of animal health (hierarchical responsibilities on technical staff).
- Study Director in toxicology (agrochemicals and pharmaceuticals) /Responsible for ophthalmological & cardiovascular examinations. Presenting the company & its services to potential clients. Attracting new clients/Increasing turnover.
- Responsible for developing & the introduction of innovative studies, including:
. continuous infusion: 3-month macaque & minipig studies & intraperitoneal studies in rats &
. therapeutic efficacy: experimental urinary infections in dogs, haemorrhage following hepatectomy, intravitreous tolerance.
. osteoarticular /CNS pathologies.
