From our global regulatory offices to the onsite clinical research unit, SGS Nutrasource's 100+ scientific and technical specialists have the skills and expertise you need to bring your project from idea to reality.
Today we sat down with Anna Metcalfe, RAC, V.P. Pharmaceutical Sciences, to learn more about how she got to where she is today, what makes her tick, and what's new in the clinical and regulatory field.
Tell us about your current role and what it entails.
Many companies contact SGS Nutrasource as they lack the expertise in-house and are looking for advice on how to develop or market their product. My role is to provide strategic advice and leadership and determine the type of regulatory services needed.
During the COVID-19 pandemic, there has been an urgent need for disinfectants and hand-sanitizers, as well as face masks and full personal protective equipment (PPE) for everyone. This has certainly been a unique situation in assisting many companies to complete various regulatory activities necessary to market these urgent supplies, where timing has been critical.Typically, I am involved in product development activities, for example with drugs, medical devices, biologics, combination products, etc., and start with a detailed regulatory strategy to identify the path to market approval or a gap assessment of the data that is available.
How did you get started in the industry?
During my high school years in the U.K. I found myself leaning towards the sciences and especially the drug world. I chose summer jobs in pharmaceutical companies and worked in the labs analyzing chemicals and learning about drug development. This is where I first heard about thalidomide and the tragedy that this drug caused.
It had a huge impact on me, and it was not a surprise to anyone that I studied Pharmacology at University and obtained an Honours B.Sc. I was going to find the cure for cancer. After finishing my degree, I came to Canada and started a career in research and then transitioned to the pharmaceutical industry.
I initially worked in setting up clinical trials and contributed to the development and successful registration of several important oncology drugs, and other fields. After my initial dislike of completing forms and huge amounts of paperwork, I now enjoy positioning data in drug submissions and negotiating marketing approvals for products.