Laurent B. Nicolas
Area:
Clinical Pharmacology- Phase 1 development studies
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"Laurent Nicolas"Bio:
Clinical Pharmacologist, PhD at Actelion Pharmaceuticals Ltd
(Pharmaceuticals industry)
2008 – Present (less than a year)
- Directly and/or indirectly manage projects in the department of clinical pharmacology (CP).
- Plan, design, conduct, evaluate, report and publish CP studies in liaison with appropriate line managers.
- Write study protocols, reports and NDAs within agreed time frames and ensure that they meet regulatory requirements
- Responsible for the pharmacokinetic (PK), pharmacodynamic (PD) and PK/PD components of development plans .
- Represent/assist the Clin pharm dpt in life cycle management teams and in meetings with investigators, experts and health authorities.
- Collaborate closely with representatives from other line units such as preclinical pharmacokinetics, pharmacology, toxicology, CMC, and clinical development.
Clinical Science Specialist, PhD at Hoffmann-La Roche
(Public Company; 10,001 or more employees; Pharmaceuticals industry)
January 2007 – July 2008 (1 year 7 months)
• Study and protocol development for Phase 1
• Scientific input to study development, planning and design: PK/PD, safety toxicity, ECGs, clinical genotyping, biomarker measurements.
• Redaction of study related documents.
• Evaluation, review and analysis of clinical data.
• Communication, presentation and discussion of results to/with Study Management Team and study sites.
PhD, Neuroscience research post doc at Hoffmann-La Roche
(Public Company; 10,001 or more employees; Pharmaceuticals industry)
September 2003 – January 2007 (3 years 5 months)
 Animal models of psychiatric disorders: focus on anxiety
 Behavioral pharmacology
 Biomarker project (anxiety/depression)
 Experimental medicine project (anxiety)
 Supervision and coaching of masters and PhD students
University College London, U. of London
PhD student, Neuroscience, Biochemistry, 2002 – 2003
Université Pierre et Marie Curie (Paris VI)
PhD, Neuroscience, 2001 – 2003
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