Drug Safety Expert 514143 CA(S)


Expertise Description

I have more than 30 years experience in the Pharmaceutical industry. My expertise includes drug development, drug safety, side effects, and regulatory affairs. I have experience with medico-legal matters, such as informed consent, malpractice, negligence, incompetent practice on the part of medical professionals, mental health. My experience with many therapeutic areas include: oncology (hematological and solid tumors), diabetes, obesity, anti-infectives (anti-bacterial and anti-viral), pulmonary (asthma, COPD), influenza, women’s health, bone (Paget’s disease and osteoporosis), lupus, arthritis, transplantation, autoimmune diseases, Anti-malarials, and CNS (psychiatry, Alzheimer’s disease). I have also worked with small and large molecules, including gene therapy, and Biosimilars. My practice has specialized in rare and neglected diseases, with a strong background in drug safety, and how that interfaces with drug information functions. I have over 10 years of expert witness experience.

Areas of Expertise


Consulting Experience

My consulting experience includes working with various aspects of regulatory and company development strategy.


Professional Experiences

I am the president of my own company, which is a regulatory and drug development consultancy based in San Diego, California. I have worked with small and large pharmaceutical companies, assisting them at the various stages of the drug development process, including European strategic regulatory affairs. I began my career as a pharmacist in the UK, after which I completed a Ph.D. I have worked for large and small pharma companies.


Relevant Experiences

I am an FDA expert. I have experience with oncology drugs, and I understand the requirements for drug development as they relate to medicines and supplements. Issues around claims for supplements is also something I can provide detailed input on.

I have Over the Counter Experience as well as experience working in pharmacies where supplements are sold.


Education

Degree Subject Institution
Ph.D. Safety Assessment of Medicines: Pre and Postmarking University of Wales Cardiff
B.Pharm. Pharmacy King's College London

Licenses Certifications

Board certified in Regulatory Affairs – Regulatory Affairs Certification

Awards & Affiliation

Member of Royal Pharmaceutical Society of Great Britain (M.R.Pharm.S.)
Member of the American Society of Clinical Oncology (ASCO)

Primary Affiliation

Member of Royal Pharmaceutical Society of Great Britain (M.R.Pharm.S.)



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