Pharmaceutical physician with deep expertise across the drug development lifecycle

Biography

I am a UK-qualified senior pharmaceutical physician and independent consultant with more than 35 years' experience spanning the NHS, pharma industry, MHRA and consultancy sector. I provide critical analysis, strategic insight and understanding of the regulator mindset to support client decision making, advise on risks and opportunities and optimise regulatory pathways.

Following primary medical qualifications in 1992, I spent around 5 years in hospital-based general medicine, during which I gained the postgraduate MRCP qualification. I then worked for around 5 years in pharma, which included a role as Acting Medical Head of the GlaxoWellcome Clinical Pharmacology Unit, and experience as principal investigator/co-investigator on more than 30 Phase I and II studies.

I then became a medical assessor (reviewer) at MHRA — the UK medicines regulator — and worked for both main divisions for over 20 years, across a wide range of therapy areas, product categories and UK/EU regulatory procedures, including a senior EU role as a UK alternate on the CHMP scientific advice working party. During this time I gained the additional postgraduate DipPharmMed qualification.

In 2021 I moved to tranScrip, a  UK consultancy offering a bespoke service to biotech and pharmaceutical companies of all sizes, across a broad range of therapy areas, covering new and established drugs, from early development through to Marketing Authorisation and subsequent product lifecycle management.  I will continue to work closely with tranScrip (now a part of TMC Pharma)  as an affiliated consultant.

Outside of these roles I am a fellow, senior examiner and officer of the examination board for the UK Faculty of Pharmaceutical Medicine.