I am a senior regulatory pharmaco-toxicologist with extensive experience (20 + years) in both biotech and blue chip international pharmaceutical companies and working as a consultant. I have a proven track record of delivering multiple small and large molecule projects to clear decision milestones, submissions to, and interactions with health authorities up to licence (e.g. IND's, IMPD's, CTD's), with full knowledge of GLP/GXP standards and regulatory guidelines (ICH, CHMP, FDA, WHO). In addition, supported a number of international projects to solve industry challenges, as well as writing regulatory position paper and guidelines (WHO).
I've worked across a number of therapeutic areas, including vaccines, CV, CNS, Oncology, Respiratory, Infectious diseases and more recently, diabetes, with a background knowledge in cell and developmental biology, immunology, molecular biology. I have good scientific and medical writing skills with experience in writing regulatory documents, study protocols, reports, scientific papers, position papers, project proposals and scientific presentations.
Director: Non Clinical (Toxicology/Pharmacology) Lyon, France
Since March 2017
Accountable for the delivery of the toxicology and pharmacology studies/strategy for R&D from pre phase I onwards, focused on product improvement in therapeutic area of diabetes.
Line manager responsibilities: leading/developing the non clinical team, ensuring timely deliver and managing budgets. Put in place cost effective strategies: eg one project provided a saving of 400k plus.
A member of the senior management team involved in partner alliance responsibilities supporting joint projects, due diligence etc.
Consultant non clinical regulatory services/toxicology Lyon, France
Since November 2015
Providing non clinical /toxicology support to drug/vaccine development programs; a reliable and flexible service to meet the clients needs.
Design non-clinical toxicology and safety pharmacology strategies to support all phases of drug and vaccine development, from discovery onwards. Manage study placement at a CRO (start to finish).
Preparation and /or review of regulatory dossiers to meet health authorities needs around the world eg IND's IMPD's, CTA's, CTD', MAA's, BLA's, including preparation of investigators brochures (non clinical section).
Medical and scientific writing (papers, articles, abstracts) plus preparation of presentations.
Hazard identification/Risk assessmnets - toxicology evaluations, extractable and leachables, REACH.
Support in due diligence.
Project support: putting together project bids, managing project deliverables etc.
If I can support your business needs or you have any questions, please do not hesitate to send me an email.
Head of Non Clinical Safety Marcy-l'Étoile, France
January 2006 --- June 2015
- Responsible for the delivery of all toxicology strategies and regulatory submissions (IND, IMP, CTA, CTD's module 3/4) from Phase I to post license for vaccines/adjuvants and monoclonal antibodies.
- Built the department and developed the non-clinical team to deliver sucessful dossiers to business cost and time. Leadership and management responsibilities, include team and budget management. Manage a 3-4 million euro budget, set up contracts with CRO's. Have full understanding of GLP/GXP and regulatory guideliens
- Contributor author to WHO guidelines for adjuvanted vaccines, 2013
- Member or chair of strategic forums to approve clinical, pharmacology and toxioclogy stragies as well as member of legal committee sanctioning final approval to proceed to Phase 1 onwards, reviewing clincial and non clinical data.
- Authored and published SOP's, Study plans, study reports, scientific papers.
- Interact and developed good working relationship with various health authorities e.g. FDA, EMA, PMDA, influenced strategic outcomes. Recently started working with emerging markets: India and China
- Involved in various international projects: HESI project (2011-2104): adjuvants and autoimmunity. Worked with the EMA, developed project proposal and international workshop, leading to publication*. IMI project: biovacsafe; EFPIA representative plus project manager for one work stream and facilitative coach for another. Co-lead (with GSK) and co-author of position paper re: safety assessemnt of process residues/contaminants in vaccines. Active member of Biosafe.
- Invited speaker and chair of various international meetings, including SOT and JSOT.
Global Toxicology Project Leader Alderley Edge, United Kingdom
September 1996 --- December 2005
- Delivered toxicology strategies, toxicology study plans, report and regulatory dossiers for various therapeutic projects: oncology, respiratory, CV, CNS, infectious diseases, for small molecules and monoclonal antibodies via various delivery routes: oral, IM, SC, IV.
- Interacted with numerous regulatory boards: MHLW, FDA
- Led global cross functional problem solving teams and worked on the development of biomarkers for renal and cardiovascular toxicities.
- Company representatvie for HESI project: assessing predictivity of pre-clinical toxicity (2002-2010- vice chair 2008).
- Lectured at Brighton and Hatfield University
- Wrote and published various scientic papers.
AdaptabilityIndependenceInterest in knowledgeOptimismOrganizationProactivityProblem solvingResiliencySelf-confidenceSelf-disciplineSociabilityStrategic thinkingTrustDependabilityCreative thinkingCritical thinkingCuriosityDiligenceEfficiencyFlexibilityKindnessPerspectiveAnalytical thinkingAssertivenessAuthenticityCollaborationCoordinationWillingness to compromiseCommunicative
molecular biologyPhase IIIPhase IVPhases of clinical development (phase I to IV)Position PaperPowerPointPre-clinical researchPreclinical regulations and practicesPrenatal developmentProblem-solving methods and troubleshootingPhase IIPhase IMonitoring Study ProgressNegotiationNew Drug Application (NDA)oncologyPCRpeople managementPharmaceutical IndustrypharmacologyPharmacovigilanceProject ManagementProtocolTeam LeadershipToxicologyUnderstand how results translate to practiceUnderstand levels of research evidenceUnderstanding of regulatory guidelinesVaccinesWestern BlottingInformed Consent DocumentsWriting Study Procedures and SOPsSOPSerious Adverse Event (SAE)R&DRegulatory affairsRegulatory RequirementsRegulatory submissionsRespiratoryRT-PCRSafety concerns (such as therapeutic ratio with respect to possible adverse effects)Scientific methodologyScientific Writing BiochemistryMolecular & Cellular BiologyDrug and vaccine developmentBiopharmaceuticalsCross-functional team leadershipDNADNA extractionDNA sequencingDrug development processDrug regulatory authoritiesDrug safety assessmentEMABiomarkersAnimal trial R&D Scientific writing Phase IActions and modes of action of drugs in the human speciesActions and modes of action of human physiologyAllergy and immunologyAnimal ModelsEnglishFDAIMPDIn VitroIn VivoINDInfectious diseasesInflammationInformed Consent ProcessKnowledge of the drug development processMarketing Authorisation Application (MAA)ImmunologyImmunohistochemistry (IHC)GCPGood Laboratory Practice (GLP)Good Publication Practice (GPP)GynecologyHospitalsICH GCP guidelinesMedical writing Animal models Cell biologyBiological Drug DevelopmentCancerCardiovascular diseasesInternational Project ManagementToxicologyBudgetingDrug DevelopmentPreclinical Safetysafety assessmentInvestigative SafetyReport WritingSmall moleculesVaccinesadjuvants
Skills and Expertise
Conduct literature searchesCollaborate with project teamCollaborate with principal investigatorCollaborate with medical team Analyze dataAdjust processes Coordinate regular advisory boardcoordinating research projects Create SOPsCoachCoach staffDirect co-workersDevelop regulatory strategyDesign studyDesign scientific projects (in biology)Data analysisAdjust processes and methodsAssign activitiesNetworkObserve trends in dataPrepare final reportProvide benefit risk assessmentPublish scientific projectsRead medical literatureReport dataReview medical reportsManuscript preparation and reviewManuscript preparationbudgeting of R&D activitiesCommunicate with sponsorCreate study documentsCreates a collaborative team environmentExecute scientific projectsGenerate regulatory submissions Handle callsmanaging a small teamWork under specific instructions Interact with nursesWritten presentationInteract with pharmacistsInteract with nursesInteract with CROsOrganise steering committeeOrganize scientific projects (in biology)Writing regulatory documentsWrite protocolsWrite papersInteract with physiciansInteract with pre-clinical scientistsOrganise meetingsOral presentationManuscript reviewManage projects resourceslifescienceLiaise with research teamLiaise with doctorsLate-stage regulatory filing (MAA, BLA)Write medical reportsStorytellingSolve problemsAttend steering committeeAttend seminarsAttend investigator meetingAnalyze data Write papers Search literature on clinical trials Report data Interpret dataBiomarker ResearchEvaluate licensing opportunitiesReview study protocolsReport study conclusionsRegulatory submissionsRegulatory documentationProvide trainingPresent at steering committeePrepare regulatory documentsEvaluate protocols Interact with physiciansManage multiple projectscollaborate with project teamsmanage project resourcespreclinical protocolsstudy directingstudy monitoringproject probable outcomework cross functionalyManage complexityAdvise on strategy
Ph.D. in Biological sciences from University of Manchester in 1996
Bachelor of science in Applied Biology from Manchester Metropolitan University in 1992
Nursing in RGN from Kingston Hospital in 1987
Training and Certification
Coaching Psychology in 2014 Certification