Having several years of experience in R&D, preclinical efficacy and safety assessment of small molecules since 1986, I am at present Chief Executive Officer and Preclinical R&D Director at CapEval Pharma and CTO & Director of Non Clinical Safety PK & Toxicology at Cytune Pharma. My former positions were CEO, CSO, Head of Preclinical R&D/Drug Safety Department,
Having several years of experience in R&D, preclinical efficacy and safety assessment of small molecules since 1986, I am at present Chief Executive Officer and Preclinical R&D Director at CapEval Pharma and CTO & Director of Non Clinical Safety PK & Toxicology at Cytune Pharma. My former positions were CEO, CSO, Head of Preclinical R&D/Drug Safety Department, Deputy Head of Preclinical Safety and Head of Toxicology, Project Leader at OriBase Pharma, Addex Pharma, DSM (formerly Roche Vitamins), International Toxicology Project Leader and Head of NCD animal experimentation, senior toxicologist/head of non-rodent toxicology/head of special toxicology/head of animal health/study director at WIL Research and then CiToxLAB, two of the most famous Preclinical R&D and safety CRO's in Europe and at Sanofi and F. Hoffmann-La Roche Pharmaceuticals (Roche).
Specialties: > 25 years R&D experience
- Strategic R&D expertise
- Scientific expertise in tox
- Scientific network
- Numerous communications & publications
- Strong communication skills & numerous teaching activities in the field of non-clinical R&D efficacy & safety
- Numerous Due Diligence processes
- Project, program, dept & people management (med chem, biochemists, technicians, SD, study monitors, project leaders)
- Regulatory writing IMPD IND
- International regulatory steering committees & boards
CTO & Director of Non Clinical Safety PK & Toxicology @ From April 2015 to Present (9 months) Nantes Area, FrancePresident @ From January 2013 to Present (3 years) Montpellier Area, FranceChief Scientific Officer, Preclinical R&D Director and co-founder @ Chief Scientific Officer and R&D Global Director
- Leading Scientific Advisory Board
- R&D Department Director, responsible for Scientific Strategy
- Strategic orientation for developing molecules presenting a potential therapeutic interest
- Operation Director
- Assessment and evolution of material and human resource needed for company development and R&D strategy
- Representing the company in front of potential partners and investors. From October 2010 to Present (5 years 3 months) President and CEO @ Preclinical R&D consultant and lecturer for pharmaceutical and biotechnological industries
Preclinical development of pharmaceutical compounds
Ocular and cardiovascular examination
Data analysis/interpretation/reporting (in silico, in vitro, in vivo), safety pharmacology & toxicology
Non-Clinical Drug Safety studies for drug development
R&D strategy from discovery to submission
Issues solving (exploratory and mechanistic study strategy)
Relevance to humans, potential clinical risk assessment
Pharma R&D teaching
Laboratory animal ocular examination teaching. From September 2010 to Present (5 years 4 months) President and CEO @ Management of Non Clinical Development From August 2010 to Present (5 years 5 months) Head of Non-Clinical Drug Safety Department @ Dvping/leading/oversight of R&D preclinical safety department strategy from discovery to the market
In depth knowledge & follow-up of projects, identifying as early as possible & communicating potential project hurdles, suggesting solving strategies
Non-Clinical Drug Safety Activities (safety profiles, hazard & safety assessments, tox, safety pharmacology, etc).
Design, preparation & implementation of vivo/vitro studies to meet regulatory rqrmnts for pre-IND/IND/CTA
Monitoring/coordinating outsourced studies to ensure common understanding, compliance with study protocol/regulatory rqrmnts
Writing/presenting regulatory documents/relevant scientific literature
Link between R&D & clinical departments, providing tox guidance
GLP compliance in designing protocols, analyzing/interpreting the data & preparing relevant documentation
Representing the company in front of investors, international health authorities/potential partners
Dvping & maintaining network of external relations including experts & professionals, authorities
Most successful pharma IPO in last 4 yrs
Orienting/shaping the company dvpt
Supporting business dvpt for Due Dil (in- or out-licensing, acquisitions, partnership & co-dvpt agreements)
Checking Safety Assessments.
Transforming efficacious molecules into clinical candidates/marketed drugs
Screening molecules using new models & dvping new drugs, establishing PK/PD relationships
CRO selection, budget, monitoring & GLP/GCP conformity
Recruiting, attracting, motivating, retaining, mnging, training/dvping technicians, med chem, biochem, SD, SM, scientists (veterinarians, biologists), project/group leaders & laboratory heads, strategic mngt & coordination of international teams
Managin/budgeting R&D Drug Safety Department (Capital & Operating) & all other resources, contributing to the productivity & to the conduct & quality of studies (assuring the efficient mngt & coordination of teams/resources available/requesting other resources) From September 2006 to August 2010 (4 years) Toxicologist/Deputy Head of Safety @ Tox Projects
R&D strategy (efficacy/safety evaluation)
In depth project knowledge/follow-up, identifying as early as possible/communicating potential project hurdles, suggesting solving strategies
Safety profile provision of candidate compounds in defined teams. Supervising preparation of Safety Assessments. Maintaining key expertise & answering questions on tox
Planning/contracting/monitoring/reporting tox studies
Hazard/safety assessments/responding to safety issues of products
Decision for the release of products for first entry in man/defined new substance release committees
Identification/assessment of new trends in tox/providing up-to-date support
Maintaining external/internal scientific networks
Mngt. Transversal: Scientists for analytical support & technical support ca. 10 projects, 8 non-toxicologists; 4 toxicologists (safety assessment & tox studies). Indirect: Study Directors from CRO’s, ca. 5 CRO’s, 15 scientists
Solving administrative, financial, scientific & operational issues. Encouraging innovation
Recruitment of new toxicologists
CRO selection & budget. Monitoring business performance/GLP conformity
Designing/mnging studies for preclinical assessment of safety/efficacy
Monitoring/coordinating outsourced studies to ensure common understanding, compliance with study protocol/regulatory requirements
Writing/presenting preclinical parts from regulatory documents
Link between R&D/business dvpt departments, providing them with tox guidance
GLP compliance in designing protocols, analyzing/interpreting the data/preparing relevant documentation
Representing the company in front of authorities/potential partners
Dvping/maintaining network of external relations including experts/professionals/authorities
Orienting/shaping company dvpt. Supporting business dvpt for Due Dil (in- or out-licensing, acquisitions/co-dvpt agreements). From October 2005 to August 2006 (11 months) Toxicology Project Leader/Head of Animal Experimentation @ Intnl Tox Project leader (responsible for tox assessment discovery to full dvpt) & Head of Animal Exp
Organizing/conducting meetings. Implementing networks Coordinating/dvping integrated strategic/operational plan for projects in collaboration with intnl project teams/Mnging overall scientific/financial assessment of preclinical projects in all stages of R&D
Dvping/leading/oversight of R&D preclinical strategy from discovery to the market
In depth knowledge/follow-up of projects, identifying as early as possible/communicating potential project hurdles, suggesting solving strategies
Preclinical Activities (tox, pharmacokinetics, PK/PD, safety pharmacology, proof of concept, links with clinics, project mngt)
Regular interactions (providing advices) with R&D scientists, cross-functional project teams, marketing & business units
Training, coaching, mentoring & supervision of junior scientists Responsible for tox 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 intnl health authorities (FDA)
Design of project-specific research programs investigating scientific mechanisms, responsibility for non-clinical safety studies, responsible for work, resource planning & strategies for projects to optimize selection & dvpt strategy of new clinical candidates
Collaborating closely with colleagues in other sites in Europe/USA/Japan
Mnging the work of R&D scientists, identifying & taking into consideration issues, resolving conflicts
Meetings/communications with intnl health authorities.
Monitoring studies in all phases of product life cycle (research, dvpt, market phase)
Scientific & financial discussions with third parties (partners, CRO’s, academic experts, regulatory agencies)
Ca. 8 Due Dil/yr (in-, out-licensing or co-dvpt) & profile assessment of possible new candidates, ensuring a smooth & fruitful partnership From February 1999 to September 2005 (6 years 8 months) Senior Toxicologist/Head of Non-Rodent Toxicology @ - Head of non-rodent & special toxicology department.
- 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. From March 1996 to January 1999 (2 years 11 months) Study Director in Toxicology/Head of Animal Health (Hazleton/Pharmakon/MDS) @ - Head of animal health
- Study Director in toxicology/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 pathologies.
. CNS pathologies. From March 1992 to February 1996 (4 years) Doctor in Veterinary Medicine @ From October 1990 to February 1992 (1 year 5 months) Veterinary Biologist @ From September 1989 to September 1990 (1 year 1 month) Study Director in Toxicology @ From January 1989 to August 1989 (8 months)
Post Doctoral Certificate, Animal Experimentation @ Ecole nationale vétérinaire de Lyon From 1994 to 1995 other, Cardiovascular physiology @ Université Louis Pasteur (Strasbourg I) From 1994 to 1994 Post Doctoral Certificate in Ophthalmology, Satistics @ Pierre and Marie Curie University/Paris From 1993 to 1994 Specialisation in Ophthalmology, Ophthalmology @ Ecole nationale vétérinaire de Toulouse From 1991 to 1992 Post Doctoral Certificate in Ophthalmology, Ophthalmology @ Toulouse National Veterinary School From 1991 to 1992 Doctor in Veterinary Medicine, Veterinary Medicine @ Nantes Medicine University From 1989 to 1990 Libourne service de santé des armées From 1989 to 1989 Doctor in Veterinary Medicine, Pharmacology and Toxicology @ Nantes National Veterinary School (ENVN Oniris) From 1984 to 1989 CES Nantes Talencelycée Clemenceau Olivier Loget is skilled in: Projects, Project Management, Drug Development, Pharmaceutical Industry, Lifesciences, Clinical Development, Biotechnology, Toxicology, GLP, CRO, In Vivo, In Vitro, FDA, Biochemistry, R&D
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