1999 - present

Independent Consultant in Pharmaceutical Medicine

Have worked with the largest multinational and small national pharmaceutical and biotech companies on a wide variety of projects.  These include:

• defining target product profiles, devising drug development strategies and conducting portfolio analysis;
• devising and executing early development plans for new molecular entities including designing and overseeing conduct of first in human, pharmacokinetic and proof of concept Phase I and II studies;
• serving on and chairing data monitoring committees for Phase I - IV clinical trials. 
• preparing clinical overviews, summaries and briefing documents for regulatory submissions in Europe, USA, Canada and Australia, handling responses to questions, preparing and making presentations to the regulatory authorities; 
• conducting due diligence and advising on in-licensing and co-development opportunities;
• designing and running training courses for physicians and scientists;
• providing pharmacovigilance services;
• providing consultancy on organisational change and process improvement;
• serving as an expert witness to the court;
• serving on and chairing governance committees of contract research organisations

1996-1999

Medical Director and subsequently Chief Executive Officer of BIOS (Consultancy & Contract Research) Ltd

Responsible for medical affairs and provision of consultancy services to clients in all aspects of clinical drug development and registration.  Responsible for direction and management of Divisions of Clinical Pharmacology, Medical Writing, Clinical Research, Statistics & Data Management and Regulatory Affairs, approximately 100 staff including Finance, Business Development and IT. Established a 26 bed Clinical Pharmacology Unit at North Hampshire Hospital staffed by BIOS personnel. 

1995-1996

International Director of Clinical Study Units, GlaxoWellcome plc

Responsible for running a 24-bed Clinical Pharmacology Unit at Northwick Park Hospital and placement of all studies both in-house and contracted out.  Managed some 20 CPU staff and 25 clinical research scientists in the USA and UK.  Contributed to design of studies and methodologies in the early evaluation of compounds and for the later regulatory package.  Served as advisor and administrator to the Research Ethics Committee.  Instrumental in development, review and maintenance of Standard Operating Procedures. 

Head of Clinical Pharmacology,
The Wellcome Foundation Ltd

Established a group of physicians, scientists and clinical research nurses, which took on a pivotal role in Wellcome’s exploratory drug development. Responsible for construction and subsequent management of a twelve-bedded Clinical Investigation Unit at King’s College Hospital.  Devised and executed plans for evaluating the human pharmacology of a large number of novel compounds.  Provided consultative input into the design of clinical trials at all phases of drug development.  Responsible for design, analysis and reporting of pharmacokinetics of all clinical trials conducted by the Medical Division. Developed pharmacodynamic techniques in psychopharmacology, respiratory function and non-invasive cardiovascular measurement. Wrote Clinical Expert Reports and Summaries for regulatory submissions world-wide. Played a key strategic role in advising the R & D Directorate on go / no go decisions for full development. Chaired Quality Improvement Teams and contributed to the management of rapid change in the Medical Division of 300 staff.

1982-1985

Clinical Pharmacologist, The Wellcome Foundation Ltd

Established models of analgesia in volunteers and used these in early evaluation of a novel synthetic enkephalin in man with subsequent assessment of its central, respiratory, cardiovascular and endocrine effects. Used variety of techniques to assess the activity of opioid agonists and antagonists and other CNS active drugs. Conducted a variety of PK and metabolic studies.

1977-1982

Resident in Internal Medicine and Attending Physician

Ben Gurion University of the Negev, Beer Sheba Israel.

1975-1977

Senior House Officer posts in Endocrinology / Medicine, Respiratory / Infectious Diseases / Medicine and Neurology,

The Royal Postgraduate Medical School Hammersmith Hospital London,Northwick Park Hospital, Harrow and the National Hospital for Nervous Diseases, London

1974-1975

House Physician and House Surgeon

King’s College Hospital, London.

1986-1990

Honorary Lecturer and Clinical Assistant

Dept of Medicine King’s College School of Medicine & Dentistry

1990-

Honorary Senior Lecturer in Medicine

Dept of Medicine King’s College School of Medicine & Dentistry

1968

BSc (Hons) 2/i

King’s College, London

1971

PhD

Dept of Pharmacology, King’s College London

1974

MBBS (Hons Therapeutics)

Kings College Hospital, London

1976

MRCP

Member of the Royal College of Physicians (UK)

1981

Board Certification in Internal Medicine Israel

1992

FRCP

Fellow of the Royal College of Physicians

1994

MFPM

Member of the Faculty of Pharmaceutical Medicine

1995

FFPM

Fellow of the Faculty of Pharmaceutical Medicine

1973

Cargill Prize in Ophthalmology

1999

Clinical Pharmacologist Cum Laude of  Society of Apothecaries, London

2003 -

Chairman of Board of Examiners

2003 -

Member of Faculty Board

British Pharmacological Society
Royal Society of Medicine
Jewish Medical Association
Association for Human Pharmacology in the Pharmaceutical Industry

Executive Editor of British Journal of Clinical Pharmacology