Pharmacometrician

What do you do?

I support translation of in vitro and in vivo preclinical data to application applications that are relevant to humans using mathematical modelling. This involves using the data from preclinical studies to build mathematical models that describe the data and help to establish and explain relationships of exposure to a chemical or drug (pharmacokinetics) to a response that is either beneficial (pharmacodynamics) or detrimental (toxicodynamics).

These relationships can be based on relatively straight-forward mathematical correlations that use data-fitting for description or can be more complex and mechanistic in nature where biological processes are used to drive the mathematics. The models are typically built using preclinical data and can then be extrapolated to humans using scaling concepts or what is known about physiological differences in preclinical species and humans. Once the model is developed, it can be used to make predictions regarding data that may not be observed in advance.

Common applications of the mathematical modelling that I do can be to predict starting and efficacious doses in humans for drugs in development, identifying and defining sources of variability in exposure and response in individual patients to better predict dose requirements for efficacy, understanding a potential drug-drug interaction and helping to inform dose adjustments that may be required, and many other applications related to how exposure to a drug or chemical changes in humans and the subsequent impact on a response.

What does your typical day involve?

As with many careers, there really is no such thing as a typical day as each problem and strategy that I encounter is unique.

Having said that, some of the day to day aspects of my responsibilities include discussions with stakeholders on the development of modelling strategies to answer critical questions about their drug or chemical, helping with interpretation of available data and relevance to humans, using software to develop models and run simulations to answer questions at hand, assist with study design or project progression decisions based on the information that I provide, participate in scientific discussions with other team members to help brainstorm solutions to a challenge that they may be encountering on their project, and summarizing results of a project in a scientific report that may be used for regulatory submission.

Do you work mostly on your own or as part of a team?

I have an opportunity to both work individually and as part of a team. When working on a specific project and developing a mathematical model to help explain the data, I spend much of my time independently with the data and the software. In addition, I am often involved with a multi-disciplinary project team comprised from different areas of expertise related to development of the target chemical.

This team consists of chemists, biologists, financial stakeholders, toxicologists, clinical scientists, and many others that can all provide input into the model that is being developed and help with understanding of the data in a broader sense. It is also important for me to understand the specific questions that the team may have that are relevant to their area of expertise so that a useful and robust model can take all of these into consideration. Some team members may have questions about how to formulate the material to best suit human administration, some may have questions about appropriate doses to run in animal studies, some may have questions about what dose will be required in humans to provide efficacy, and the list goes on. 

It’s important to understand perspectives of all team members so that the most useful model can be developed. Finally, I am also a part of a team of other modelling scientists. We all work somewhat independently on models that we may be building, but we also work together to overcome specific challenges that we may be having with a project, so there are often meetings to present and discuss problems that individuals may be having on their projects.

What is it like socially where you work?

There is a strong sense of “Team” in my organization. This “team first” attitude is strong within my immediate team members, but is also prevalent across other areas of the organization. There are many within the larger organization that have expertise in different disciplines, but we are all working toward a similar goal that may be to bring a new drug to market or understand how a chemical may impact humans if marketed, so it’s important to work together.

There are also many clubs and social organisations within the company that give you an opportunity to connect with others that may have similar interests as you, whether work related or not.

How long have you been in your current role?

3 years

What qualifications and experience do you have?

I have a Bachelor of Science degree in Biology with a Minor in Chemistry and 25 years of experience in drug development.

When and why did you decide on a career in the pharmaceutical industry?

Interestingly, I didn’t initially decide on a career in the pharmaceutical industry, I was actually planning to work in the agricultural industry. After finishing University, an opportunity presented itself in pharmaceutical development, so I took it without having other options at the time. It didn’t take long in that first position to see the interesting science that I could be involved in and the impact that I could make in helping others, so my career fate was sealed soon after.

How has your career developed since you left university?

My first position was actually as a technician in a group that was more oriented towards toxicology assessments and working in the lab directly running animal studies. I later ended up taking a position in pharmacokinetics where I was able to connect working in the lab running animal studies with actually running pharmacokinetic analysis, which is where I learned the basic concepts of exposure/response modelling.

Then I had the opportunity to work as part of a discovery/early development team at a prominent biotech where I supported the progression of drugs using pharmacokinetic and pharmacodynamics modelling as part of the drug development team. Eventually, this led to my current role where I am primarily able to focus on using my experience and skills to support others with mathematical modelling to advance their projects.

Do you think additional qualifications or experience would be an advantage for someone entering the industry now?

I entered this field at a time when the power of mathematical modelling to support drug development was really just taking off. This allowed me to gain “on the job” training and develop my skills through experience actually doing the work. Today, there are many more opportunities to get some of this knowledge through academic experience as well as internships, externships and post-docs.

I think that there is more of an expectation for individuals to have some basic background experience in this area prior to being hired into a position doing this type of work. A PhD along with as much experience during an academic career actually building models and using the various software that is available would certainly provide an advantage today.

What are you most proud of in your career?

I am most proud that I feel like I have a positive impact on the life of others. I have had opportunities to provide information that helped a drug progress to the market to help patients in need and have also helped provide information to companies that helped them make important decisions on the direction they were going with a particular product and I feel honoured that I have had the chance to do both.

What one piece of advice would you give to someone seeking a career in the pharmaceutical industry?

Take advantage of whatever opportunities are presented to you and become as much of an expert in the entire drug development process as you can. Focusing on a specific discipline is certainly helpful in some ways, but everything that we do is integrated and it’s important to understand how your contribution fits into the bigger picture to provide the most benefit.

I also highly recommend not being afraid to take a few chances. When I left University, I never would have expected to be doing what I am today, nor would I have expected to have such a great career in this field. I took a chance and it paid off and I’ve been able to do some really great things while being paid to do them.