Personal Statement

I have over 14 years clinical trials experience, the majority of this in four different UK Phase I CRO clinics. I have worked on over 300 studies of all early phase study designs covering all therapy areas including biologicals, vaccines and medical devices as either Principal Investigator or Sub-investigator. I am accredited PI in First in Human studies in the UK and have ALS Provider Certification status. I obtained my Diploma in Pharmaceutical Medicine through passing the examination with the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of United Kingdom. I obtained CCT Specialist status in Pharmaceutical Medicine after completion of Higher Medical Training in Pharmaceutical Medicine in the UK. Most of my experience is in early phase drug development, taking compounds from preclinical through to proof of concept patient studies. I have also worked in MHRA Clinical Trials Unit as Medical Assessor assessing and critiquing over 100 CTAs across all phases of drug development from various biopharmaceutical companies & academic organisations and have been involved in assessing many drug development programmes from various biopharma companies globally in MHRA Scientific Advice Meeting. Prior to joining the pharmaceutical industry. I have 12 years experience in NHS hospital medicine after qualified in Medicine from Aberdeen University, Scotland including 8 years Specialist Registrar training in Diabetes & Endocrinology/General Internal Medicine and also obtained MRCP(UK) through passing the examination in the UK. My specialist therapy areas are Diabetes, Endocrinology, Obesity, Osteoporosis, Lipidology, Cardiovascular Medicine & General Medicine. I am now an independent Consultant in Pharmaceutical Medicine with my expertise across all phases of drug development whilst my main interest remains in early phase studies.

I am a Fellow Member of the Faculty of Pharmaceutical Medicine. I am also an Educational Supervisor, Senior Specialty Adviser & Examiner of the Faculty of Pharmaceutical Medicine. I also sit as a member of the Specialist Advisory Committee in Pharmaceutical Medicine involving in all education and training matters in Pharmaceutical Medicine.

Experience - Pharmaceutical

July 2013 – May 2017; Quotient Clinical Ltd

Medical Fellow/Associate Medical Director

  • Principal Investigator for over 30 studies of all types of study designs, including FTIM, phase 0 (microdose), ADME/IV Microtracer, inhaled, formulation selection and specialist PK / GI absorption studies
  • Assisting and Deputising for Medical Director as & when required including Business Development & Client visits
  • Responsible for working with clinical operations to ensure safe and efficient conduct of all studies in the unit
  • Line management responsibilities for team of physicians including being Educational Supervisor for a PMST trainee at Quotient Clinical
  • Regular internal and sponsor driven GCP training

March 2012 – June 2013; ICON Development Solutions

Senior Director/Chief Principal Investigator March – June 2013; Senior Clinical Research Physician March 2012 – March 2013

  • Principal Investigator for 8 studies of all types of study designs, including FTIM, PD pain model, GI Endoscopy and insulin/glucose clamping studies
  • Assisting and Deputising for Medical Director as & when required
  • Responsible for working with operations to ensure safe and efficient conduct of all studies in the unit
  • Line management responsibilities for team of physicians
  • Regular internal and sponsor driven GCP training

September 2010 – March 2012; Simbec Research Ltd

Senior Research Physician

  • Principal Investigator for 10 studies of all types of study designs, including FTIM, phase 0 (microdose), ADME & Gamma Scintigraphy GI studies
  • Assisting and Deputising for Medical Director as & when required
  • Responsible for working with operations to ensure safe and efficient conduct of all studies in the unit
  • Line management responsibilities for team of physicians
  • Regular internal and sponsor driven GCP training

January 2010 – August 2010; Clinical Trials Unit, Licensing Division, MHRA

Senior Associate Medical Assessor

  • Assess the medical aspects of clinical trial authorisation applications including the preparation of assessment reports, consultation with internal and external expertise and the assessment of any additional data needed from the applicant in determining risk/benefit for clinical trials. Work with colleagues in other scientific disciplines
  • Monitor the on-going safety of authorised clinical trials to ensure that UK public health is protected
  • Participate in the monitoring of the emerging safety profiles of investigational Medicinal Products being developed in UK clinical trials and take Regulatory action where appropriate
  • Provide clear and reliable scientific and regulatory advice to companies and trial sponsors to facilitate the better development of products and conduct of trials
  • Participate in national and EU regulatory activities as appropriate
  • Maintain MHRA strategic information systems with complete and auditable records of the assessment process
  • Assess and critique advertising and promotional material of orphan medicinal products

June 2009 – December 2009; Simbec Research Ltd

Senior Research Physician

  • Principal Investigator for 2 studies of all types of study designs, including FTIM, phase 0 (microdose), ADME & Gamma Scintigraphy GI studies
  • Assisting and Deputising for Medical Director as & when required
  • Responsible for working with operations to ensure safe and efficient conduct of all studies in the unit
  • Line management responsibilities for team of physicians
  • Diabetic Clinic (one half day per week)
  • Regular internal and sponsor driven GCP training

June 2002 – May 2009; Covance CRU Ltd

Clinical Research Physician

  • Review of sponsor generated protocols
  • Production of protocols following review of sponsor generated investigators brochure
  • Liaising with sponsor to produce protocol amendments
  • Presentation of protocols and amendments to Ethics Committee
  • Training and mentoring of physicians
  • Training of study staff in study specific procedures
  • Managing workload balance and organising physicians to ensure best use of physician time and safe conduct of studies
  • Working within the planning team to ensure efficient and safe day to day running of the clinical unit
  • Generating and updating SOPs to improve volunteer safety and data quality
  • Working as part of a team on methodology development studies, including HV models of pain and appetite & food satiety
  • Sub-investigator on phase 1 studies
  • Writing of Volunteer Informed Consent Documents
  • Volunteer screening and selection
  • Volunteer safety and welfare during studies, including review and management of AEs
  • Ensuring appropriate assessment and reporting of AEs
  • Input on Covance and sponsor generated protocols, including studies for FIH and biomarker development
  • Conduct of medical procedures on wards as required by studies
  • Regular internal and sponsor led GCP training

Experience – non-pharmaceutical

Oct 2009 – Dec 2009
Clinical Observer (half day per week) Diabetes clinic, Llandough Hospital, Cardiff & Vale Teaching NHS Hospitals Trust
Oct 1996-June 2002
Specialist Registrar in Diabetes & Endocrinology, General Medicine, Leeds Teaching Hospitals Trust/Yorkshire Deanery
Oct 1995-Sep 1996
Clinical Assistant (1 session/week) in General Medicine (Endocrinology), Stockport Acute Hospital Trust
Aug 1995-Sep 1995
Locum Registrar in General Medicine, Royal Oldham Hospital
May 1994-July 1995
Registrar in Diabetes & Endocrinology, General Medicine, Newcastle Teaching Hospitals Trust
Feb 1994-May 1994
SHO in Nephrology, Royal Liverpool University Hospital
Feb 1993-Jan 1994
SHO in Cardiology & General Medicine, South Cleveland Hospital, Middlesbrough.
Aug 1992-Jan 1993
SHO in Elderly Medicine & General Medicine (Gastroenterology), North Tees General Hospital
Aug 1990-July 1992
SHO Rotation in General Medicine & Related Specialties (Medicine for the Elderly, Radiotherapy & Clinical Oncology, Diabetes & Endocrinology, Cardiology), South Tyneside District Hospital & Newcastle General Hospital
Aug 1989-July 1990
Pre-Registration House Officer in General Medicine & Surgery, North Tees General Hospital, Stockton on Tees, Cleveland

Publications

  • Leung P, Quinn N, Belchetz P

    Amiodarone-induced thyrotoxicosis: not a benign condition. int j clin pract jan-feb 2002;56(1):44-6

Education

  • May 2016

    Royal College of Physician Educational Supervisor Accreditation Workshop (2 day) Course
    Liverpool, UK

  • Nov 2014

    Advanced Life Support Provider Course
    Nottingham (Resus Council UK)
     

  • July 2013

    FFPM

  • Mar 2013

    Management of Medical Emergencies in Phase I Clinical Research Unit Course
    ICON Development Solutions

  • Apr 2012

    Management of Medical Emergencies in Phase I Clinical Research Unit Course
    ICON Development Solutions

  • Feb 2011

    Advanced Life Support Provider Course
    Leeds (Resus Council UK)
     

  • July 2010

    Completion of Higher Medical Training and entry on to Specialist Register for Pharmaceutical Medicine
    Faculty of pharmaceutical Medicine, Royal College of Physicians

  • Oct 2009

    Pharmacovigilance Course (module for HMT)
    Drug Safety Research Unit, Southampton

  • Feb 2009

    MFPM

  • 2008

    Diploma of Pharmaceutical Medicine (passed the exam)

  • Sep 2007

    Critical Appraisal Course
    Drug Safety Research Unit, Southampton

  • Jan 2007

    Advanced Life Support Provider Course
    Coventry (Resus Council UK)

  • 2005

    Diploma in Pharmaceutical Medicine
    003-2005, Welsh School of Pharmacy course attended

  • 1993

    MRCP(UK)

  • 1989

    MBChB
    Aberdeen Medical School (1984-1989)

Hobbies & Interests