Laurent Vernillet
Woodbury,CT
Summary
Performance-driven Vice President with more than 25 years of experience in drug development, Passionate about applying excellent organization and communication skills to manage and lead teams. Persistent leader eager to lead and grow organizations. Skilled in strategic planning, problem-solving, and communication with good understanding of business principles. Collaborative with relentless work ethic.
Overview
25
25
years of professional experience
Work History
Vice President, Global Head of Clinical Pharmacology and Pharmacometrics
Biocryst Pharmaceuticals Inc.
01.2021 - Current
- Overall responsibility for direction, oversight, and team development of global Clinical Pharmacology and Pharmacometrics department
- Responsible for scientific quality of preclinical and clinical pharmacology studies: design, implementation, analysis, interpretation, reporting and regulatory submission
- Responsible for long-range planning for the Clinical Pharmacology function including appropriate capabilities for PK/PD, population PKPD, PBPK and QSP modelling and personnel to support the company portfolio
- Integrates clinical pharmacology knowledge with a broad understanding of and collaboration with related disciplines such as clinical, statistics, regulatory, nonclinical ADME, toxicology to support and impact development decisions
- Partners with relevant stakeholders from discovery through commercialization
- Ensures appropriate PK, PD and PKPD data analyses (including modeling and simulation) are conducted for each study/program
- Key contributor (author/and or reviewer, as required) to high quality clinical pharmacology plans and content for global regulatory documents including protocols, investigator's brochures, briefing documents, IND applications/annual reports, responses to regulatory queries, CSRs, and Clinical Pharmacology and Biopharmaceutics Summary Documents in NDAs/MAAs
- Provides strategic advice to product teams
- Ensures adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
- Oversees clinical pharmacology and pharmacometrics consultants
- Maintains and establishes relationships and agreements with contract vendors
- Supervises, develops, and mentors junior level scientists, both direct reports and via matrix structure in clinical pharmacology teams
- Supports representation of BioCryst clinical pharmacology studies as required to government agencies, key opinion leaders
- Authors/ reviews manuscripts for submission to peer-reviewed journals.
- Cultivated strong relationships with key stakeholders, including customers, vendors, regulators, and community leaders to promote collaboration and long-term success.
- Led cross-functional teams for the successful completion of major projects, resulting in increased efficiency and client satisfaction.
- Demonstrated proficient leadership skills to motivate employees and build competent teams.
- Collaborated with senior management to develop strategic initiatives and long term goals.
Vice President, Clinical and Preclinical Pharmacology
Intercept Pharmaceutical Inc.
01.2020 - 01.2021
- Led preclinical and clinical pharmacology activities across all development programs (primary biliary cholangitis, nonalcoholic steatohepatitis, primary sclerosing cholangitis)
- Lead all clinical pharmacology aspects of clinical trials and program level activities as assigned, providing subject matter expertise to study protocols, statistical analysis plans, interpretation of results, and clinical study reports
- Delivered high-quality evaluation and interpretation of clinical pharmacology data (conventional and population PK, PD and PK/PD analyses, including exposure-response analyses and simulations/predictions)
- Contributed to strategic planning, authoring, and review of regulatory documents providing direct leadership/oversight to clinical and preclinical pharmacology sections of these documents, and serve as primary clinical pharmacology representative in support of regulatory interactions
- Provided subject matter expertise to scientific data disclosures including publications and commercial support documents, ensuring strategic intent is aligned with corporate and R&D strategy
- Provided subject matter expertise and support to externally facing groups, including field medical team, medical information, and commercial organization
- Built productive relationships with investigators, key opinion leaders, and key stakeholders in medical/scientific community
- Participated to meetings with Health Authorities (FDA and EMA/PDCO)
- Represented clinical and preclinical pharmacology projects to corporate partners, investors, and clinical investigators as needed
- Assisted in accomplishing clinical development department and corporate objectives as it relates to preclinical and clinical pharmacology plans across different development programs
- Developed accurate budget projections to support team's goals and provide budget oversight
- Managed personnel performance and develop career growth of Preclinical and Clinical Pharmacology team.
- Cultivated strong relationships with key stakeholders, including customers, vendors, regulators, and community leaders to promote collaboration and long-term success.
- Led cross-functional teams for successful completion of major projects, resulting in increased efficiency and client satisfaction.
- Demonstrated proficient leadership skills to motivate employees and build competent teams.
- Collaborated with senior management to develop strategic initiatives and long term goals.
Executive Director, Head of Clinical Pharmacology (2019-2020)
SK Life Science Inc.
01.2016 - 01.2020
- Led development of 2 compounds in CNS area; one for both adult and pediatric populations (carisbamate) and one in adult population (Phase 1 compound in epilepsy)
- Completed Clinical Pharmacology sections for NDA submission (including clinical pharmacology aid and package insert documents) for one compound in epilepsy (cenobamate)
- Completed 3 manuscripts published in peer reviewed journals and multiple posters accepted at International conferences (AAN, AES) or Clinical Pharmacology meetings (ACCP, ASCPT) for cenobamate
- Completed all deliveries in timely manner for Phase 1, 2 and 3 studies including protocols, PK and PK/PD analyses, population PK/PD analyses and study reports
- Managed personnel performance and developed career growth of Clinical Pharmacology team (3 PharmD and 1 BS)
- Developed Clinical Pharmacology strategies for 4 CNS programs (epilepsy, schizophrenia)
- Supervised conventional and population PK, PD and PK/PD analyses, as well as study protocols/reports and Phase 1 clinical site selection
- Managed budget for clinical pharmacology activities
- Contributed to regulatory documents including Annual reports, Investigator brochures, Briefing documents for Health Authority meetings, and submission packages (including IND/CTA, NDA, PSP and PMDA) for 4 different compounds in CNS area
- Participated to meetings with FDA, EMA/PDCO and PMDA
- Contributed to assessment of potential in-licensing opportunities
- Collaborated with European and Asian partners for non-US submissions (cenobamate)
- Supervised development of IT-Clinical Pharmacology platform for PK, PD and population PK/PD analyses 21 Part 11 compliant.
- Worked closely with organizational leadership and board of directors to guide operational strategy.
- Oversaw financial management, ensuring fiscal responsibility and long-term sustainability for the organization.
- Guided staff through periods of organizational change, maintaining morale and engagement during transitions.
- Forge strong relationships with board members, providing regular updates on organizational progress and soliciting their expertise when needed.
Director, Clinical Pharmacology (Immunology, Metabolism and Virology)
Boehringer-Ingelheim Pharmaceuticals Inc.
01.2013 - 01.2016
- Led matrix teams (approximately 10 individuals each worldwide) including clinical PK/PD, pharmacometrics, phase 1 clinical sites, phase 1 biostatistics, DMPK, translational medicine expert and program medical lead for 5 clinical pharmacology programs
- Developed overall clinical pharmacology plan/strategy for multiple compounds (risankizumab [immunology], CD40L inhibitor [immunology], 11β-HSD1 inhibitor [metabolism], NS5A inhibitor [virology] and 2 biologics in Phase 1 [immunology])
- Contributed to 2 pediatric plans (compounds in immunology indication) and interacted with FDA and PDCO for their approval
- Completed all deliveries including IND/CTA/IB/Briefing documents, protocols, PK and PK/PD analyses, population PKPD study reports for multiple compounds
- Interacted with key opinion leaders during Advisory Boards and presented/discussed key clinical pharmacology findings at international meetings/conferences – Peer reviewed multiple internal manuscripts
- Led clinical pharmacology studies and represented clinical pharmacology department at meetings with Regulatory Agencies (worldwide).
- Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
- Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
- Established culture of continuous improvement by fostering open communication channels and empowering employees to voice their ideas.
- Cultivated positive work environment that fostered employee engagement, increased retention rates, and boosted overall team morale.
Director, Clinical Pharmacology (Cystic Fibrosis, Oncology and Flu)
Vertex Pharmaceuticals Inc.
01.2008 - 01.2012
- Contributed to clinical pharmacology sections for NDA/MAA submission (including package insert) for ivacaftor (indication: cystic fibrosis - CF) and to Phase 4 commitment by leading requested clinical pharmacology studies
- Developed overall clinical pharmacology plan/strategy for lumacaftor and one other compound in development in CF
- Developed pediatric plan for 2 CF compounds (ivacaftor and lumacaftor) and interacted with FDA and PDCO for their approval
- Managed personnel performance and developed career growth of team (2 Ph.D
- And 2 BS)
- Completed all deliveries including IND/CTA/IB/Briefing documents, protocols, PK and PK/PD analyses, study reports for 3 CF compounds (ivacaftor, lumacaftor and 1 other)
- Worked in collaboration with Research Pharmacology/DMPK/Toxicology to develop PK/PD approaches for optimizing selection of lead compounds in oncology for 3 years
- Contributed to clinical development plan, and Phase 1 study protocol and clinical site selection for one anticancer compound
- Supervised flu clinical pharmacology program for 3.5 years
- Led implementation of WinNonlin Autopilot for Clinical Pharmacology group and initiated implementation of Phoenix to replace WinNonlin 5.3 for PK analyses for DMPK and Clinical Pharmacology groups in US, Canada and England
- Communicated clinical pharmacology key findings for ivacaftor and lumacaftor (CF) at international conferences and in peer review journals.
- Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
- Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
- Established culture of continuous improvement by fostering open communication channels and empowering employees to voice their ideas.
- Cultivated positive work environment that fostered employee engagement, increased retention rates, and boosted overall team morale.
Senior Scientist/Group Leader, Late Stage Pharmacokinetics/Pharmacodynamics
Genentech Inc.
01.2006 - 01.2008
- Established clinical pharmacology team for small molecules by hiring/supervising 3 junior and senior scientists (including 1 MD) and mentoring 3 additional scientists for their respective small molecule project (1 Ph.D., 1 PharmD and 1 BS)
- Headed development of 3 anticancer compounds as Pharmacology subteam leader (role including Clinical PK/PD, DMPK, toxicology, chemistry and manufacturing control [CMC] and PD biomarker responsibilities) from Pre-IND to Phase 2 in collaboration with 2 partners
- Completed all deliveries including IND/CTA/IB documentation, protocols, PK and PK/PD analysis, study reports for 3 compounds (vismodegib and 2 other molecules - oncology area)
- Contributed to development of combination studies with biologics and small molecules
- Developed interactions between Pharmacology, DMPK and LSPKPD departments which resulted in initiating/ expanding preclinical PK/PD modeling to better define human exposure target with small molecules
- Reviewed in-licensing drug opportunities (Preclinical/Clinical PK/PD sections)
- Assessed and selected Phase 1 clinical sites for performing clinical PK studies.
- Simultaneously managed several complex projects, meeting all pertinent milestones.
- Championed interdisciplinary collaboration across departments, fostering innovation and creative problem-solving among colleagues.
- Developed innovative solutions to complex scientific problems, enhancing company''s intellectual property portfolio.
- Enhanced team performance by providing expert technical training on new equipment and methodologies.
Assistant Director, Drug Metabolism and Pharmacokinetics/Clinical Pharmacology
TAP Pharmaceutical Products Inc.
01.2002 - 01.2006
- Completed Non-Clinical PK and Clinical Pharmacology sections for NDA submission (including package insert) for one compound in rheumatology (febuxostat) and one in women's health (responsibilities including coordination, writing and review of integrated sections)
- Supervised and coordinated briefing document (Non-Clinical PK and Clinical Pharmacology sections) for End of Phase 2 and Pre-NDA meetings with FDA as well as for FDA responses for these 2 compounds
- Participated to MAA and Japan-NDA for febuxostat in partnership with European and Japanese companies, respectively
- Managed personnel performance and developed career team growth of (2 Ph.D and 3 BS)
- Developed and supervised modeling and simulation activities
- Completed all deliveries including IND/IB documentation, protocols, conventional and population PK and PK/PD analyses and study reports for 3 compounds (febuxostat and 2 other molecules – women's and men's health areas)
- Established and monitored outsourcing budgets for DMPK and Clinical PK/PD activities
- Managed scientific training activities and participation to technical/conference meetings for all departmental scientists
- Reviewed large number of in-licensing drug opportunities (DMPK and PK/PD sections).
- Streamlined communication between teachers, parents, and administrators to foster collaborative learning environment.
- Oversaw recruitment, hiring, and onboarding process for new educators to maintain high-quality teaching staff.
- Implemented effective conflict resolution strategies for resolving issues among faculty members or between students.
- Mentored new teachers through observation, feedback, and professional development opportunities.
Senior Pharmacokineticist and Project Team Representative for Global Pharmacokinetics/Pharmacodynamics/Trial Simulations
Eli Lilly and Co Ltd
01.2000 - 01.2002
- Represented Global PK/PD/TS department for 3 compounds (respiratory, endocrinology and oncology areas)
- Completed clinical PK/PD section of the Briefing Document for End of Phase 2 meeting with the FDA for one compound (respiratory area)
- Contributed to IND/CTA documentation for 3 compounds (respiratory, endocrinology and oncology areas)
- Contributed to the documentation package and meetings with potential buyers for out-licensing an internal compound (endocrinology area)
- Reviewed an in-licensing drug opportunity (DMPK and PK/PD sections)
- Completed all deliveries as planned including protocols, conventional and population PK and PK/PD analyses, study reports for 2 compounds (respiratory and endocrinology areas)
- Developed extensively population PK and PK/PD analysis skills.
- Increased customer satisfaction by addressing and resolving complaints in a timely manner.
- Handled customer complaints quickly and professionally to restore customer confidence and prevent loss of business.
- Enhanced company reputation by providing exceptional customer service and support.
- Developed and maintained positive customer relations and coordinated with team members to properly handle requests and questions.
Education
Doctorate Diploma (Ph.D.) in Experimental and Clinical Pharmacology -
Rene Descartes University
Diploma for Superior Studies specializing in Pharmacokinetics and Drug Metabolism -
University of Paris-South
National Doctor of Pharmacy Diploma (PharmD) -
Rene Descartes University
Technical University Diploma, major in Applied Biology with option Biological and Biochemical Analyses -
University Technical Institute
Technical Bachelor's Diploma in Biochemistry -
National School of Chemistry, Biology and Physics
Skills
- Coaching and Mentoring
- Cross-Functional Collaboration
- Decision-Making
- Critical Thinking
- Strategic Planning
- Adaptability and Flexibility
- Team Leadership
- Relationship Building
- Time Management
- Verbal and written communication
- Professionalism
- Complex Problem-Solving
Scientificcommunication
55 Oral Presentations and Posters
57 Publications
1 Book chapter
3 Patents
Scientificcommunity
Fellow of American College of Clinical Pharmacology (ACCP)
Full member of American Society for Clinical Pharmacology and Therapeutics (ASCPT)
Member of the Honors and Awards Committee for ACCP (2011-2018)
Member of the Public Policy Committee for ACCP (2018-2020)
Member of the Credentials Committee for ACCP (2020-Present)
Abstract reviewer for Annual Meetings of ACCP and ASCPT (2016-2023)
Member of the ACCP Program Committee in 2015, 2017 and 2023
Peer reviewer of Clinical Pharmacology and Therapeutics (CPT) journal
Instructionalexperience
1992, 2000, Mentored university students enrolled in Doctor of Pharmacy, Diploma for Superior Studies (DMPK specialization) and Ph.D. (DMPK specialization) programs at Rene Descartes University in Paris (France) and University of Paris-South in Chatenay-Malabry (France)
Recognitionawards
- 1992, Thesis Award (Laroze Foundation Prize)
- 2005, President's Award (TAP Pharmaceutical Products Inc.)
- 2007, Genentech Recognition Award for Extraordinary Productivity/Work
- 2010, Vertex Recognition Awards for Personal and Teamwork Achievements
- 2012, Vertex Recognition Awards for Teamwork Achievements
- 2018, ACCP “Excellence in Achievement”
Languages
French
Native or Bilingual
German
Elementary
English
Native or Bilingual
Timeline
Vice President, Global Head of Clinical Pharmacology and Pharmacometrics
Biocryst Pharmaceuticals Inc.
01.2021 - Current
Vice President, Clinical and Preclinical Pharmacology
Intercept Pharmaceutical Inc.
01.2020 - 01.2021
Executive Director, Head of Clinical Pharmacology (2019-2020)
SK Life Science Inc.
01.2016 - 01.2020
Director, Clinical Pharmacology (Immunology, Metabolism and Virology)
Boehringer-Ingelheim Pharmaceuticals Inc.
01.2013 - 01.2016
Director, Clinical Pharmacology (Cystic Fibrosis, Oncology and Flu)
Vertex Pharmaceuticals Inc.
01.2008 - 01.2012
Senior Scientist/Group Leader, Late Stage Pharmacokinetics/Pharmacodynamics
Genentech Inc.
01.2006 - 01.2008
Assistant Director, Drug Metabolism and Pharmacokinetics/Clinical Pharmacology
TAP Pharmaceutical Products Inc.
01.2002 - 01.2006
Senior Pharmacokineticist and Project Team Representative for Global Pharmacokinetics/Pharmacodynamics/Trial Simulations
Eli Lilly and Co Ltd
01.2000 - 01.2002
Doctorate Diploma (Ph.D.) in Experimental and Clinical Pharmacology -
Rene Descartes University
Diploma for Superior Studies specializing in Pharmacokinetics and Drug Metabolism -
University of Paris-South
National Doctor of Pharmacy Diploma (PharmD) -
Rene Descartes University
Technical University Diploma, major in Applied Biology with option Biological and Biochemical Analyses -
University Technical Institute
Technical Bachelor's Diploma in Biochemistry -
National School of Chemistry, Biology and Physics
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