Dr. Malcolm John VandenBurg - CV
BSc MBBS FFPM FRCP
D.O.B. 21.12.48
Dr Malcolm Vandenburg is a Specialist in General and Pharmaceutical Medicine.
He is available to give medico-legal expert witness reports and appear as a medico legal expert witness and supply medical written expert opinions in any matters referred to on this page.
QUALIFICATIONS
BSc Upper 2nd Class Hons. Physiology (Cardio-Respiratory, Neurological & Radiation Biology) |
1970 |
MBBS, St Bartholomew's Hospital | 1974 |
MRCP | 1976 |
Joint Committee on Higher Medical Training Certificate in General (Internal) Medicine |
1982 |
Fellow, American College of Clinical Pharmacology | 1991 |
Fellow, Faculty of Pharmaceutical Medicine | 1993 |
Fellow, Royal College of Physicians | 1996 |
Member International Stress Management Association | 1998 |
GMC Specialist Recognition in General Internal Medicine | 2004 |
Law Society Approved Expert Witness | 2004 |
Registered: UK National Crime Operations Faculty | 2004 |
National Police Improvement Agency Expert Adviser Database | 2009 |
KEY ACHIEVEMENTS
1. Established a private practice in sexual health, general medicine, affective disorder and clinical pharmacology. |
2. Established a medico-legal practice and pharmaceutical consultancy |
3. Registered with GMC as Specialist in General(Internal) Medicine. |
4. Founded the London Hospital Hypertension Clinic in 1975 and performed many phase I, II and III studies on anti-hypertensive compounds. |
5. Over 300 publications and research communications. |
6. Founded, supported and managed Romford Cardiovascular Research, a cardiovascular clinical research organisation based at Old Church Hospital, Romford. Trust fund of £300,000 transfered to NHS 2007. |
7. Original member of Merck & Co Worldwide Global Integrated Drug Development Management Committee. |
8. Founded a clinical research consultancy and managed its growth from two people in a portakabin to 150 people in four European centres, South Africa, Australia and the USA. |
9. Negotiated the sale of the company to a Japanese public company. |
10. Managed the resulting global clinical research organisation of 500 people with a turnover of £40 million. |
11. Helped negotiate the sale of the company to a Canadian public company. |
12. Responsible for the worldwide registration of four pharmaceutical medicines and the registration of 30 medicines in UK and Europe. |
13. Developed a management training company centred on the pharmaceutical industry, running skills and personal development workshops with a turnover of £1 million. |
14. Started and negotiated the sale of a clinical pathology company with a turnover of £300,000. |
15. Appointed as founder member of Europe's 500, a foundation sponsored by the European Commission and Earnst and Young, to identify Europe's top entrepreneurs and job creators. |
16. Wrote the book Positive Under Pressure with Gael Lindenfield published by Thorsons. |
17. Supervised Positive Under Pressure workshops for 3,000 UK General Practitioners. |
18. Founded Consultrum (2002) a psychiatric clinical research organisation, a pharmaceutical consultancy and a legal consultancy. |
19. Dad to four wonderful children and two dogs named Will and Duffy. |
PRESENT EMPLOYMENT
1. Physician: I am currently working as a Physician seeing patients referred to me by General Practitioners and other doctors within my areas of expertise, primarily general medicine, sexual health and affective disorders and clinical pharmacology. |
2. Medico-legal Expert Witness: providing opinions for the Court and advising the legal profession in the fields of prescription medicines, illegal drugs, general internal medicine and sexual health. Instructions have been received from solicitors, barristers, Crown Prosecution Services, Police Forces, the Armed Forces, the Police Federation and legal consultancies. |
3. Founder and Director of Positive Under Pressure™:Positive Under Pressure™ is a pressure management company which assists individuals, groups, organisations and Government agencies identify and modify their responses to pressure, so that they gain the benefits of enhanced performance without the negative impact of stress, and addictive coping strategies. The techniques used in Positive Under Pressure™ have now proven useful to over seventy five groups of General Practitioners who use the techniques to modify their own stress levels as well as teaching the techniques to their patients. Seminars have been performed for The Royal College of General Practitioners, The Royal Society of Medicine, The Royal Defence Medical College and the Royal Navy. Training programmes have also been run at The Royal College of Psychiatrists. The book Positive Under Pressure is published by Thorsons |
4. Pharmaceutical Consultancy: I offer advice to the Pharmaceutical, Biotechnology and Healthcare industries. I advise on both business development and registration of pharmaceutical products and medical devices. The clinical development programmes I have been responsible for are attached. |
RECENT EMPLOYMENT
1. Psychiatric Clinical Investigator: I worked with Dr Cosmo Hallström, Consultant Psychiatrist, at the Capio Nightingale Clinic Chelsea, performing psychiatric clinical studies. These include studies in depression, anxiety and panic. |
2. Director of Same Day Doctor: A private medical clinic comprising medical, sexual and psychological clinics in Harley Street, employing three doctors, two nurses, two practice managers, three administrators and additional staff as needed. |
3. Editor-in-Chief: of Dilemmas and Solutions in Global Drug Development, PJB Publications. |
4. Parents Under Pressure: I was responsible for the parent support groups at the Capio Nightingale Adolescent Mental Health Unit at Radnor Walk, Chelsea, supporting parents through the stress of having their children admitted to this hospital and having mental health problems. |
5. Honorary Clinical Assistant: In Renal Medicine to Professor John Cunningham, The Middlesex and University College London. |
MEDICAL TRAINING / PRE REGISTRATION EXPERIENCE
Locum House Physician to Drs Black and Dawson in General Medicine & Gastroenterology, St Bartholomews Hospital |
Jul 1973 – Sept 1973 |
House Surgeon,to Mr Page, Paine and Devereux, Urology, Vascular & General Surgery, North Middlesex Hospital |
Oct 1973 – Mar 1974 |
House Physician, to Dr Hayward, Wykehan-Balme & Spurrell, General Medicine, Cardiology & Rheumatology, St Bartholomew's Hospital. |
Apr 1974 – Sep 1974 |
PRE REGISTRATION EXPERIENCE
Senior House Officer in General Medicine, The London Hospital, Whitechapel Senior House Officer in Accident & Emergency Senior House Officer in Venerology to Dr Ambrose King Senior House Officer in General Medicine & Gastroenterology to Dr Wright Senior House Officer in General Medicine and Respiratory Medicine to Drs Hughes and Hickman |
Oct 1974 – Dec 1975 |
HIGHER PROFESSIONAL TRAINING
Lecturer in Medicine, the London Hospital, Whitechapel on the Medical Unit, Director, Professor Ledingham. |
1976 - 1980 |
Honorary Registrar in General Medicine to Prof Ledingham and sexual health to Drs Dunlop and Rodin.. All medical unit positions gave experience as the most senior doctor on the unit during 'admission takes' for the firm. The unit was on 'take' 1/5 and 1 weekend in 5. When the NHS position was as an Honorary Registrar, there was no senior registrar on call. Cover was provided to all other Junior staff at the hospital. Clinics were two general medical clinics a week for Prof Ledingham and Prof. Floyer and either an Endocrinology clinic for Prof Cohen or a nephrology clinic for Dr Goodwin or Marsh. A clinic in sexual health was continued and patients were managed on the wards. |
Jan 1976 – Jun 1976 |
Honorary Registrar in Cardiology to Dr Wallace- Brigden and Alistair MacDonald. Experience involved training in left and right ventricular cathetrisiton M mode and later 2D echocardiography, pacemaker implantation both permanent and temporary, and ahrythmia assessment. There were three cardiology clinics a week and a general medical clinic was continued. Additional experience was obtained in being responsible to the consultant for the running of the coronary care unit and cardiac doctor on call on a 1 in 4 rota. |
Jul 1976 – Dec 1976 |
Honorary Registrar in Medicine to Prof Mike Floyer. Experience as before. In addition I was prime mover in establishing the London Hospital Hypertension Clinic under the guidance of Professor J M Ledingham. My responsibilities included staffing and funding the Unit, and I was involved in prioritising research within it. The clinic had both a service and a research commitment. I advised general physicians on the management and investigations of hypertensive patients, as well as having referrals direct from general practice. The research carried out in the clinic forms the basis of many of my publications. A screening programme was established in general practice to identify patients with high blood pressure. Advice and guidance were obtained from Prof. Colin Dollery (Hammersmith Hospital) and Professor Robertson (MRC Blood Pressure Unit, Glasgow) in the establishment of such programmes as well as the management of specialist hypertension units. The London Hospital Clinic was one of the first in the UK. |
1977 |
Honorary Senior Registrar in General Medicine to Profs Ledingham, Floyer and
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1977 - 1980 |
Honorary Lecturer in Medicine, The London Hospital.
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1981 - 1985 |
Honorary Lecturer in Clinical Pharmacology to Prof Paul Turner, Professor of
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1981-87 |
Director and Co-ordinator of Cardiovascular Research, Old Church Hospital, Romford, Essex. In conjunction with Dr Stephens, I established a research charity in this District General Hospital, undertaking studies in cardiovascular disease. There were five clinics a week, one each in Hypertension, Angina, Heart Failure, Ahrhythmias and Emergency Referrals. I also attended two NHS clinics in General Cardiology. The unit undertook ½ the NHS workload at the hospital. The publications resulting from this work in the unit are throughout my Publications Lists. |
1985 - 1995 |
Director and Trustee of Romford Cardiovascular Research I have been a Director and Trustee of the Unit which was handed over to the NHS in June 2003. The research funds were donated to the NHS trust in November 2004. |
1996 - 2003 |
COLLEGE AND N.H.S. ADMINISTRATIVE RESPONSIBILITY
Throughout employment at the London Hospital and Merck Sharp & Dohme, I was formally involved in the teaching of both medical students and junior hospital doctors studying for
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1977 - 1987 |
PHARMACEUTICAL INDUSTRY EXPERIENCE
Director of Clinical Research, Merck Sharp & Dohme
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1981 - 1985 |
PREVIOUS EMPLOYMENT
Chief Executive Officer, ROSTRUM Group Limited
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1986 - 1995 |
President and CEO, IBRD-ROSTRUM GLOBAL, a multi-national clinical
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1995 - 1998 |
OTHER INFORMATION
Editor: St Bartholomew's Hospital Journal, 1970 – 1971
Managing Director: St Bartholomew's Hospital Journal, 1972 - 1974
Member: Organising Committee of Bartholomew Fair, the Festival celebrating St
Bartholomew's Hospital 850th anniversary.
Chairman, the London Hospital Silver Jubilee Festival Committee, 1977
Senior Management Programme Ashridge Management College.
European School of Business Administration, Senior Managers MBA Programme
INCEAD, Fontainebleau.
Author: Positive Under Pressure, Published by Thorsons.
Author: Good Clinical Practice for Investigators.
Author: Standard Operating Procedures for Investigators.
Editorial Board: Journal of Good Clinical Practice.
Editorial Board: Applied clinical Trials Journal.
Reviewer: British Journal of British Pharmacology.
Reviewer: Journal of Human Hypertension.
Editor-in-Chief: Dilemmas and Solutions in Global Drug Development, PJB
Publications.
KEY SKILLS
Clinical Investigator * Good knowledge of the clinical trial process and GCP. |
Pharmaceutical Physician * Broad range of therapeutic knowledge and contact with opinion leaders * Able to collect and critically analyse data and information from the company literature, searches and academics, to construct the best critical path for product development and registration * Co-ordinating author of 30 clinical expert reports in cardiovascular, CNS, antibiotic and many other therapeutic areas. * Leader of crisis management team in support of four products. * Networking and influencing abilities enabling the distillation of divergent opinions from regulators and consultants across national boundaries to develop plans in line with the company's strategy which are endorsed by these critical groups * Sound track record of developing practical clinical operation plans with critical go/no-go decision points, especially fast track 2A studies * An ability to get research presented and published for key meetings and journals. I have over 75 peer-reviewed articles and a larger number of presentations, many in conjunction with leading experts in the fields of my interest. |
Business Below, I list a few of the comments made about me by a Human Resource Director, of one of my major clients: * 'Excellent communications skills' * 'Strategic thinker – not entrenched in the now or the past' * 'Proven commercial acumen and ability' * 'Commercial experience in environments of rapid growth and change' * 'Intellectual agility and stamina' * 'Visionary – not necessarily detail conscious, but able to view the wider picture and associated issues' * 'Technical knowledge' * 'The ability to distil issues, quickly and concisely, resulting in identification of pertinent points and required action' * 'Outcome focused' * 'Influencing abilities' * 'Networker' * 'A contributor of ideas – an active participant in meetings' * 'Willingness and ability to challenge the status quo, leading to positive outcome/solution' * 'Persuasive' * 'Financially aware/competent' |
PUBLICATIONS
These are shown on the attached list and are grouped according to my areas of interest and available on request:
SECTIONS:
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POSITIVE UNDER PRESSURE™ PUBLICATIONS & SEMINARS
INVITED TALKS | |
The Sunday Times Personal Development Show | JUNE 1997 |
The Sunday Times Personal Development Show | JUNE 1998 |
The Royal Society of Medicine | JUNE 1998 |
Institute of Personnel & Development | OCT 1999 |
Mind, Media & Medicine | MAY 2000 |
The Human Resources Forum | MAY 2000 |
PROGRAMMES HAVE BEEN PERFORMED FOR: | |
* The Royal Society of Medicine * The Royal College of General Practitioners * The Royal College of Psychiatrists * Royal Defence Medical College * The Royal Navy * HM Treasury * University of Wales * Association of Accounting Technicians * Pfizer * Pharmacia * International Business Communications * 60 seminars have been performed for local GP Tutors as part of refresher courses, study days or weekly meetings * 10 seminars have been performed for Human Resource Departments in the Healthcare sector * 5 seminars have been performed for NHS Trusts * University of Portsmouth |
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ARTICLES: | |
* Personal Development Training Pharmaceutical Times, September 1994, p26-27 * Self Confidence for Success Pharmaceutical Marketing, September 1994, p41-42 * 5 Rs for Keeping Positive Under Pressure Business Now, August 1997, issue 94 * Positive Under Pressure Training Officer, December 1998, Vol 34 No 10, p303-305 * Grace Under Pressure Sales Director, November 1998, p63 * Is your job a health hazard? Health & Fitness, May 2000, p51 * Be Positive Under Pressure Business Executive, Winter 2000, p6-8 * The Stress-free Life Plan Family Circle, November 2001, p58 – 60 |
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CONTRIBUTIONS TO ARTICLES: | |
* Coping with Stress BMA News, March 1999 * I want to Dive into Life Now, Not Push it Away Zest, May 1999 * Tackle Stress Before it Tackles You The Times, June 1999, p3 * Overworked, Over Stressed, Over Here The Independent on Sunday, August 1999, p9 * Health Report – The Working Weak The Observer Magazine, February 2000 p17 * Expert Tips for Time Management The Sunday Times, March 2000, p4 * Positive under pressure Sunday Express, June 2000 * How your body reacts when you get dumped The Mirror, July 2000 * Off work again, eh? Real Business, July/August 2000 * From stress to serenity Here's Health, July 2000, p44 * How are you coping with pressure? New Impact, August 2000, Issue 6 Vol 6 * Health Report Observer Magazine, September 2000 * Take control of your health Home & Life, October 2000 * Ready to relax Accounting Technician, October 2000 * Are you hooked on being busy? Woman's Weekly, November 2000, p22 * How to pick up early signs of stress The Observer, 12 November 2000 * How to avoid suffering from stress The Observer, 19 November 2000 * How to deal with stressed-out colleagues The Observer, 26 November 2000 * Your Body The Mirror, November 2000 * Occupational Hazards Shape, January/February 2001 * Hurry Sickness Daily Express, August 2001 * The Break-up Body Daily Mail, 17 September 2001, p42-43 * What Type of Eater Are You Daily Express (ExpressWoman), 20 August 2002, p32-33 * I Juggle Too Much Woman, 10 February 2003, p29 |
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PRESS: | |
* Winning at the Career Game Institute of Directors Central London Newsletter, Oct 1994 Institute of Directors Central London Newsletter, Jan 1995 * Positive Under Pressure Luncheon Mossimann's newsletter, October 1995 * Thriving on pressure Training Update, July 1998 * Manual Labour Daily Express, May 2000 * Book Review People Management, June 2000 * Preview, latest books, tapes & events Health & Fitness, July 2000 * Three of a kind… stressbusters and pressure points Management Today, July 2000 * Bookshelf - new books that might change your life Zest, July 2000 * Positive Under Pressure Pharmaceutical Physician, September 2000, Vol 11 No 2 * Family doctors 'taking on too much' Stafford Express & Star, 30th April 2001 Wolverhampton Express & Star, 30th April 2001 Kidderminster Express & Star, 30th April 2001 Dudley Express & Star, 30th April 2001 Lichfield & Burntwood Express & Star, 30th April 2001 Walsall Express & Star, 30th April 2001 Cannock Express & Star, 30th April 2001 * GPs 'taking on too much work' Evening Telegraph & Post (Dundee), 30th April 2001 * 'System relies on workaholics', says expert The News (Portsmouth) 30th April 2001 * Question mark over the effect of GPs' protest Newcastle upon Tyne Journal, 30th April 2001 * Workaholic GPs are a suitable case for stress treatment Birmingham Post, 30th April 2001 * Family doctors take on too much work, says expert Western Mail (Cardiff), 30th April 2001 * Over-stressed GPs 'taking on too much work' PA News, 30th April 2001 * Expert says GPs are now learning to deal with stress General Practitioner, May 2001 * Maximising your potential Clinical Research Focus, Vol 6, No 3 * El Estres Me Sienta Bien Tercera, Chilean Newspaper 27 December 2002 |
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CONTRIBUTIONS TO INTERNET SITES: | |
* Friend or Foe? (Men's Health) netdoctor.co.uk, January 2000 * Christmas Advice icommerce.ie, December 2000 * Saying 'No' helps GPs' stress doctorsworld.com, April 2001 * GPs shut surgeries over workloads ITN.co.uk/news, June 2001 * Stressbusting's guide to what to read and listen to now stressbusting.co.uk/help * Good times, bad times - stress in the good old days Channel4.com * Work Pressure – Can you handle it? topjobs.co.uk – instant expert article |
PUB MED LISTED PEER REVIEWD ARTICLES
1: Andrews D, Gouda MS, Higgins S, Johnson P, Williams A, Vandenburg M.
3: Dews I, VandenBurg M.
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Drug Development Programs Planned and Managed by Dr M J VandenBurg (PHASE IIA)
Go/No-go studies for:
A potassium channel activator
Calcium sensitiser
Insulin sensitiser
Anti-anginal
Anti-rheumatic disease modifier
Obsessive compulsive disorder
Anti-depressant
Anti-asthmatic
H2 antagonist
Many anti infectives
Drugs for hypertension
- Heart failure
- Angina and Arrhythmias
Impotence
NSAID's
Oral inotropes for CHF
Anti nausea drugs
Drugs for pain
Peripheral vascular disease
Homeopathic for flu
Irritable Bowel Syndrome
Alcohol abuse
Phase III programs for:
Three converting enzyme inhibitors
Beta-blocker
H2 antagonist
Anti-cancer agents
Many anti-infectives
Aids therapy
Potassium channel activator
Alcohol Addiction
Non-steroidial anti-inflammatory drugs
Parkinson's therapy
Vaccines for Hepatitis B
Wound dressings
Raised IOP
Phase IV programs:
Anti hypertensives
Antibiotics
H2 antagonist
Non-steroidial anti-inflammatory drugs
Anti-anginal
Anti-Bleeding Compounds.
Diuretic
Analysis, Study Reports, Safety and Efficacy Summaries, IND safety updates, NDA Filings and European
Clinical Expert Report for:
* Anti-arrhythmic
* Hypnotic
* Anti-epileptic
* Anti-Infective
Complete European submissions for:
* Anti-hypertensives
* Anaesthetics
* Drugs for heart failure,
* Angina
* Anti-cancer agents
* Anti-anaemic products
* Drugs for bladder outflow
* Anti-platelet agents
* Antihistamines
Safety reports for many drugs relating to:
Cardiac, Hepatic, Renal and Photo Toxic Safety Issues as well as safety in stomach and colon
Only the major programs have been listed, single studies and consultancy projects have been carried out in
almost all therapeutic areas as well as some niche areas such as:
* Cachexia in Aids
* Gene Therapy
* Autologous Transplantation and transfusion
* Blood substitutes
* Wound Growth Modifiers
* Anti oxidant in cardio vascular disease
* Alzheimer's
* Hepatitis A and B
* Anti-fungal
* Syjrogens Syndrome
* Anti-thrombotics