Expert Details

Clinical Epidemiology, Public Health Medicine, Drug Safety, Clinical Trials

ID: 730074 United Kingdom

Expert is Director of Pharmacoepidemiology in a Public Health Consultancy providing advice and expertise to the public, regulators and medical professionals on the evaluation and safety monitoring of drugs in the European Community. He has: conducted state-of-the-art pharmacoepidemiological studies including electronic healthcare database studies, and studies with de novo data collection; undertaken Strategic Reviews for Clients related to Regulatory requirements, Drug Safety, Market Access and Product Positioning and designed information and analysis plans for Regulators and Clients to meet specific safety questions including post-marketing regulatory requirements for safety surveillance and Physician Compliance to label; he has designed and conducted relative effectiveness studies. He has excellent working knowledge of European databases and networks. He is Honorary Senior Lecturer in Epidemiology at Faculty of Medicine, Imperial College London; Co-Principal Investigator on £20M Health Monitoring Programme for British Police Force. He has strong interests in cancer, cardiovascular, perinatal and vaccine epidemiology and expertise in the design, management and implementation of various kinds of epidemiological research including randomized controlled trials, case control, cohort, and spatio-temporal analyses of large observational datasets. He has published in international journals and presented to a wide variety of audiences including the Royal Society, Drug Information Association (DIA), the ICBD and WHO International Symposium on Prevention & Epidemiology of Congenital Malformations, Maxillofacial Surgical unit at Great Ormond Street Hospital and is member of the: International Society for Pharmacoepidemiology (ISPE), European Medicine Agency (EMA) Steering Group on PROTECT; EMA ENCePP; UK Faculty of Public Health Medicine.

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Education

Year	Degree	Subject	Institution
Year: 1987	Degree: BSc	Subject: Biochemistry	Institution: Imperial College London
Year: 1998	Degree: MSc	Subject: Epidemiology and Public Health	Institution: London School of Hygiene and Tropical Medicine
Year: 2001	Degree: PhD	Subject: Epidemiology and Public Health	Institution: Imperial College London

Work History

Years	Employer	Title	Department
Years: 2010 to Present	Employer: Undisclosed	Title: Director	Department:
Responsibilities: Head of Unit on Benefit-Risk assessment of licensed Medicines in Europe
Years	Employer	Title	Department
Years: 2007 to 2010	Employer: i3 Drug Safety, United Health Care	Title: Senior Epidemiologist	Department:
Responsibilities: Senior researcher on Benefit-Risk assessment of licensed Medicines in Europe and USA
Years	Employer	Title	Department
Years: 2003 to 2007	Employer: Department of Epidemiology & Public Health	Title: Senior Lecturer	Department: Faculty of Medicine, Imperial College London
Responsibilities: Senior Lecturer and Course Organizer at Imperial College Faculty of Medicine, London
Years	Employer	Title	Department
Years: 2002 to 2003	Employer: Department of Epidemiology & Public Health	Title: Research Fellow in Epidemiology	Department: Faculty of Medicine, Imperial College London
Responsibilities: Senior researcher in Epidemiology at Imperial College Faculty of Medicine, London
Years	Employer	Title	Department
Years: 2001 to 2002	Employer: Department of Epidemiology & Public Health	Title: Research Associate	Department: Faculty of Medicine, Imperial College London
Responsibilities: Research Associate in the Small Area Health Statistics Unit (SAHSU) at the Department of Epidemiology & Public Health, Faculty of Medicine, Imperial College London. Conducted numerous large-scale state-of-the epidemiological studies.

Government Experience

Years	Agency	Role	Description
Years: 2003 to 2007	Agency: Home Office UK	Role: Principal Investigator	Description: Expert was responsible for overseeing a National Health Screening Programme for the British Police Force, under the supervision of the Home Office, UK Government

Career Accomplishments

Associations / Societies
Member of the International Society of Pharmacoepidemiology (ISPE); Member of the UK Faculty of Public Health (MFPH); Member of the Pharmaceutical Information and Pharmacovigilance Association (PIPA); Member of the Drug Information Association (DIA)

Publications and Patents Summary
He has written over 100 peer review publications and scientific reports.

Additional Experience

Expert Witness Experience
Expert acted as Expert Witness to the Leicestershire Police Force in providing an assessment of the potential association between occupational radio use and cancer (2004)

Training / Seminars
Expert was Course Organizer and Senior Lecturer at Imperial College Faculty of Medicine, London (2003-2007). His teaching included: International Health (module 1 of MBBS BSc Epidemiology and International health); Health Screening (MSc Modern Epidemiology); Tools of Clinical Science (4th year MBBS BSc medical students); Advanced Topics in Bio-Medicine: Module on Genes and the Environment (4th year MBBS BSc medical students); Randomized Controlled Trials (1st & 2nd year MBBS medical students); Critical Appraisal Skills (1st & 2nd year MBBS medical students); Epidemiology (1st & 2nd year MBBS medical students)

Training / Seminars

Expert was Course Organizer and Senior Lecturer at Imperial College Faculty of Medicine, London (2003-2007). His teaching included:
International Health (module 1 of MBBS BSc Epidemiology and International health);
Health Screening (MSc Modern Epidemiology);
Tools of Clinical Science (4th year MBBS BSc medical students); Advanced Topics in Bio-Medicine: Module on Genes and the Environment (4th year MBBS BSc medical students);
Randomized Controlled Trials (1st & 2nd year MBBS medical students); Critical Appraisal Skills (1st & 2nd year MBBS medical students); Epidemiology (1st & 2nd year MBBS medical students)

Marketing Experience
Expert has designed information and analysis plans with Pharmaceutical Clients to meet specific Safety Questions including post-marketing regulatory requirements for safety surveillance and physician compliance to label. He has implemented EU-RMP Epidemiological review of disease (indication) and adverse drug reactions for European Clients. He has undertaken Strategic Reviews for Clients related to Regulatory requirements for drugs, Safety Assessments, Market Access and Product Positioning (based on considerations such as Disease significance, Relative Effectiveness and Population characteristics). He has designed and conducted Relative Effectiveness studies and helped Clients with responses to Regulatory Agencies. He has Conducted state-of-the-art prospective and retrospective studies including prospective studies with de novo data collection. In particular, he worked as lead study Principal Investigator and Epidemiologist on large prospective phase IV studies for Pfizer, BMS, Johnson and Johnson, Sanofi Pasteur and NovoNordisk. He has worked extensively with the Pharmaceutical Industry in a consulting capacity advising on methodologies and scientific study designs. He has excellent knowledge of US and European databases and research networks – e.g. Proprietary Ingenix RDM, Premier Inc. Perspective TM Comparative Database, GPRD, THIN, Danish Population-based Registers, Prescribed Drug Registry, EPIC (European Cancer Register ½ Million Cohort), UK BSR Biologics Register (Rheumatoid Arthritis), UK Biobank. He has strong background in pediatric and cancer epidemiology; investigated relationship between maternal exposure to drugs in first trimester and pregnancy outcome at Imperial (in particular, NTDs and antiepileptic drugs); lead researcher at Imperial on lymphoma. A Summary of therapeutic areas within which he has particular expertise: cancer (lymphoma, lung, gastro-esophageal), CNS, hepatic injury, cardio-vascular and vaccine development. He is a Drug Information Association (DIA) Clinical Forum conference speaker: Practical use of Pharmacoepidemiology in Clinical Drug Development (Ljubljana Oct 20-23, 2008). He is also a member of the UK Pharmaceutical Information and Pharmacovigilance Association (PIPA), ENCePP, EMA PROTECT and Member of UK Faculty of Public Health Medicine (MFPH).

Marketing Experience

Expert has designed information and analysis plans with Pharmaceutical Clients to meet specific Safety Questions including post-marketing regulatory requirements for safety surveillance and physician compliance to label. He has implemented EU-RMP Epidemiological review of disease (indication) and adverse drug reactions for European Clients.
He has undertaken Strategic Reviews for Clients related to Regulatory requirements for drugs, Safety Assessments, Market Access and Product Positioning (based on considerations such as Disease significance, Relative Effectiveness and Population characteristics). He has designed and conducted Relative Effectiveness studies and helped Clients with responses to Regulatory Agencies.
He has Conducted state-of-the-art prospective and retrospective studies including prospective studies with de novo data collection. In particular, he worked as lead study Principal Investigator and Epidemiologist on large prospective phase IV studies for Pfizer, BMS, Johnson and Johnson, Sanofi Pasteur and NovoNordisk.
He has worked extensively with the Pharmaceutical Industry in a consulting capacity advising on methodologies and scientific study designs.
He has excellent knowledge of US and European databases and research networks – e.g. Proprietary Ingenix RDM, Premier Inc. Perspective TM Comparative Database, GPRD, THIN, Danish Population-based Registers, Prescribed Drug Registry, EPIC (European Cancer Register ½ Million Cohort), UK BSR Biologics Register (Rheumatoid Arthritis), UK Biobank.
He has strong background in pediatric and cancer epidemiology; investigated relationship between maternal exposure to drugs in first trimester and pregnancy outcome at Imperial (in particular, NTDs and antiepileptic drugs); lead researcher at Imperial on lymphoma.
A Summary of therapeutic areas within which he has particular expertise: cancer (lymphoma, lung, gastro-esophageal), CNS, hepatic injury, cardio-vascular and vaccine development.
He is a Drug Information Association (DIA) Clinical Forum conference speaker: Practical use of Pharmacoepidemiology in Clinical Drug Development (Ljubljana Oct 20-23, 2008). He is also a member of the UK Pharmaceutical Information and Pharmacovigilance Association (PIPA), ENCePP, EMA PROTECT and Member of UK Faculty of Public Health Medicine (MFPH).

Other Relevant Experience
He worked on WHO Oral Polio Virus Vaccination (OPV) Projects (Africa); as a Field Officer for several mass vaccination programmes (MVPs); and was involved in determining OPV immunogenicity in MVPs compared to routine immunization by collecting serum samples and assessing type-specific seropositive rates (1993-1997). He is Co-Principal Investigator of the UK-government sponsored British Police Health Monitoring Programme (240,000 personnel); he wrote the tender and ethics/consent documents, data collection and Health Screening SOPs; managed large team (40 staff members); in charge of nurse training; led executive Force meetings with Police Chief Constables, Heads of Department (HR and Occupational Health); reported to Home Office Steering Committee. He was Involved in the successful design and pilot of National Cohort Programme to assess Mobile Phone Use and long-term Health (focus particularly on brain cancer and neurodegenerative diseases). He presented his findings to Royal Society in London. He was involved in the design, management and analysis of studies on risk factors associated with Neural Tube Defect (NTD), Down Syndrome and Cleft lip/palate-affected pregnancies in England and Wales; his work was done in collaboration with Great Ormond Street Hospital, the National Congenital Anomaly Register and National Down Syndrome Cytogenetics Register. He wrote the successful proposal and supervised £1M Bio-repository build at Hammersmith Hospital, Imperial College, London. He has substantial experience of analyzing large complex databases e.g. Proprietary Ingenix RDM (c.12 million US health plan members with medical and prescription benefit coverage), Premier Inc. Perspective TM Comparative Database (US hospital clinical and economic database), UK General Practice Research Database (GPRD) (longitudinal medical records from primary care), European Prospective Investigation of Cancer (EPIC) & UK National Congenital Anomaly databases, Swedish Prescribed Drug Registry (and related cancer, mortality and census databases), Danish Registry data

Other Relevant Experience

He worked on WHO Oral Polio Virus Vaccination (OPV) Projects (Africa); as a Field Officer for several mass vaccination programmes (MVPs); and was involved in determining OPV immunogenicity in MVPs compared to routine immunization by collecting serum samples and assessing type-specific seropositive rates (1993-1997).
He is Co-Principal Investigator of the UK-government sponsored British Police Health Monitoring Programme (240,000 personnel); he wrote the tender and ethics/consent documents, data collection and Health Screening SOPs; managed large team (40 staff members); in charge of nurse training; led executive Force meetings with Police Chief Constables, Heads of Department (HR and Occupational Health); reported to Home Office Steering Committee.
He was Involved in the successful design and pilot of National Cohort Programme to assess Mobile Phone Use and long-term Health (focus particularly on brain cancer and neurodegenerative diseases). He presented his findings to Royal Society in London.
He was involved in the design, management and analysis of studies on risk factors associated with Neural Tube Defect (NTD), Down Syndrome and Cleft lip/palate-affected pregnancies in England and Wales; his work was done in collaboration with Great Ormond Street Hospital, the National Congenital Anomaly Register and National Down Syndrome Cytogenetics Register.
He wrote the successful proposal and supervised £1M Bio-repository build at Hammersmith Hospital, Imperial College, London.
He has substantial experience of analyzing large complex databases e.g. Proprietary Ingenix RDM (c.12 million US health plan members with medical and prescription benefit coverage), Premier Inc. Perspective TM Comparative Database (US hospital clinical and economic database), UK General Practice Research Database (GPRD) (longitudinal medical records from primary care), European Prospective Investigation of Cancer (EPIC) & UK National Congenital Anomaly databases, Swedish Prescribed Drug Registry (and related cancer, mortality and census databases), Danish Registry data

Fields of Expertise

biostatistics, cancer epidemiology, epidemiology, occupational epidemiology, pharmacoepidemiology, reproductive epidemiology

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Expert Details

Clinical Epidemiology, Public Health Medicine, Drug Safety, Clinical Trials

Education

Work History

Responsibilities:

Responsibilities:

Responsibilities:

Responsibilities:

Responsibilities:

Government Experience

Career Accomplishments

Additional Experience

Fields of Expertise