My current job is as a consultant in vaccines and biotherapeutics to the Coalition for Epidemic Preparedness Innovations (CEPI) and to the World Health Organization. I am also a consultant to the Generics and Biosimilars Initiative (GaBI) and Section Editor for Vaccines of the journal Biologicals.
As a consultant, I am asked to provide guidance and advice on issues relating to the quality, safety and efficacy of vaccines and biotherapeutics, including novel medicines derived through recombinant DNA technology. In this capacity I need to be up-to-date in scientific developments in the field through reading and assessing the vast and fast-moving scientific literature and through participation in scientific meetings. Over the past two years I have been particularly involved with Typhoid Conjugate Vaccine, Enterovirus 71 vaccine and especially Covid 19 vaccines. Since the beginning of the Covid 19 pandemic, I have been exceptionally busy and involved with SARS CoV 2 vaccine development and regulatory issues.
I have a BSc in biochemistry, PhD in microbial biochemistry and DSc in microbial pathogenicity from the University of Wales and professionally am a Chartered Chemist and Fellow of the Royal Society of Chemistry (C Chem, FRSC).
When the time came to apply for a postdoctoral fellowship, I was keen to move to a new environment, especially to North America. I chose to go to the National Research Council of Canada (NRC) in Ottawa because there I would be changing my area of research from straight biochemistry to the rapidly evolving and exciting field of molecular biology. I then accepted a Teaching Fellowship at McMaster University, Hamilton, Canada to continue with research in molecular biology. My role was to supervise several graduate students, undertake some teaching responsibilities and carry on with my research on protein synthesis in halophilic bacteria becoming particularly interested in transfer RNA, a key component of the protein synthesis machinery of all organisms.
After four years in Canada, I was offered a position at the UK Medical Research Council (MRC) National Institute for Medical Research (NIMR), Mill Hill, London, with a radical change to my research programme. This was to study the molecular biology of how pathogenic bacteria cause disease in animals and humans. I was appointed to the Scientific Staff of the MRC for 5 years in the Laboratory of Bacterial Infectivity at Mill Hill, after which I was invited to apply for an Unlimited Appointment. Following a formal interview at the MRC in London, I was then appointed to an Unlimited Appointment position (where I could have stayed until my retirement) and continued my research in microbial pathogenicity at the molecular level.
I was at Mill Hill altogether for just over 10 years when I was invited to move my laboratory to the National Institute for Biological Standards and Control (NIBSC) which was originally part of the MRC. This was an opportunity for me to not only continue my research in microbial pathogenicity and immunoprophylaxis, but also to become more involved with matters of wider concern in medicine, especially in the area of newly emerging biotechnologies and the standardization, quality control and clinical testing of new vaccines. My duties and responsibilities at NIBSC included research into microbial pathogenicity/regulatory research in bacterial vaccines, Chair ofthe NIBSC Advisory Group on Biotechnology, which provided scientific and regulatory advice to the UK Medicines Control Agency (now named Medicines and Health Products Regulatory Agency, MHRA), the European Community (EC) Committee on Prorietary Medicinal Products, the EC Biotechnology Working Group, pharmaceutical industry, European /British Pharmacopoeia and WHO on products derived by novel biotechnologies as well as standardization and control of bacterial vaccines especially whooping cough and meningococcal vaccines. I was also appointed the Institute’s Biological Safety Officer.
I worked for the NIBSC for fourteen years during which time I was appointed to the Special Appointment grade, Senior Scientific Staff (equivalent of Professorial rank at a British University). Over this period, I became very much involved with the activities of the WHO since the Institute is a WHO International Laboratory for Biological Standards and I interacted with many colleagues in academia, regulatory and research agencies all over the world. I also travelled widely to Geneva and globally with my work.
In 1994, I was appointed Chief Biologicals, and later Coordinator, Quality Assurance and Safety of Biologicals, WHO, Geneva, Switzerland. Here I was responsible for WHO's international programme in biological standardization, developing international standards both written and physical, for assuring the quality, safety and efficiacy of vaccines, blood and blood products and biotherapeutic products, including biotechnology derived medicines. I was also Secretary of the long established WHO Expert Committee on Biological Standardization and responsible for links with WHO International Laboratories for Biological Standards and collaborating centers, (NIBSC, Potters Bar, UK, Laboratory of the Dutch Red Cross, Amsterdam; Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, USA). I also represented WHO at the World Trade Organization Technical Barriers to Trade Committee.
On my retirement from the WHO at the end of 2002 (WHO retirement age at that time was 62, I joined the Biologics and Genetic Therapies Directorate (BGTD), Health Canada, first as Associate Director General and later as Director General (DG). The BGTD is the authority in Canada responsible for the regulatory oversight of vaccines, blood products, cells tissues and organs for transplantation, biotherapeutics, including gene therapy, and radiopharmaceuticals and had a staff of about 330 at that time. I also became a Visiting/Adjunct Professor in the Department of Medicine, University of Ottawa and Distinguished Leaders in Medicine Lecturer, Faculty of Medicine, Dalhousie University, Nova Scotia, Canada in 2006.
Whilst at Health Canada, I was heavily involved both in Canada and internationally with the WHO and the Pan American Health Organization (PAHO) in several key files, including plant derived biologicals, regulatory preparedness for SARS and pandemic influenza vaccines, pneumococcal conjugate and meningitis B vaccines, BSE/vCJD and West Nile virus issues, and developments relating to the evaluation of similar biotherapeutic products. During the influenza pandemic (2009 - 2010), I was advisor to the Canadian Deputy Minister and Minister of Health, which included participating in briefings and press conferences along with the Minister and the Chief Public Health Officer. From 2009- 2011, I was a Member of the Chief Public Health Officer’s (Canada) H1N1 Influenza Virus Science Advisory Committee.
Since returning to the UK in November 2011, I have been acting as consultant as indicated above. I was also appointed to the UK Commission on Human Medicines’ Clinical Trials, Biologicals and Vaccines Expert Group and the British Pharmacopoeia Commission, Panel of Experts on Biological and Biotechnological Products (terms of appointment ended in 2017).
My qualifications, early research experience in microbial pathogenicity as well as the considerable experience I gained of working with health institutions in the UK, Canada and Europe, especially international organizations such as the WHO, are highly relevant to the job I am doing now.
In your early career be prepared to move from one research laboratory to another in order to broaden your horizon, your perspective of the research topic in question and approaches in different settings. My advice would be to move from laboratory to laboratory, ideally in different countries, but not too often. Generally, it is better to move say every 2-3 years than to stay in one lab throughout your early career. Aim to get experience in an European country and possibly USA, Canada or Australia and then settle down to longer periods at your chosen institution. Moving too often in your later career is generally not too attractive to prospective employers in this area. Many organizations in the health sector, including Non-Governmental Organizations (NGOs), have offices in different countries. The organization I currently work with, CEPI, has many young people of many disciplines working to the benefit of human health globally from Oslo and from offices in London and Washington.
A sound basic science degree, with an MSc, PhD or MD, as appropriate, provides an opportunity to work in academia, industry (although I have never worked in industry) or government worldwide. Science can also offer the opportunity of seeing the world and experiencing the richness of different cultures. I have valued very much the opportunity to visit, meet and work with colleagues in different countries ranging from UK, Canada, Switzerland, China, USA, Iran, Iceland, Russia, Norway, Australia, New Zealand, Brazil, Cuba, South Africa, Ghana, Burkina Faso and the Middle East, to name but a few.