Could you describe your career trajectory?
My first exposure to my current field of work came during my bachelor’s program, where I completed a 6 month cooperative education fellowship at Merck in the Drug Metabolism and Pharmacokinetics (DMPK) group; a department I had not previously even known existed. My project exposed me to the typical in vitro experiments conducted by this group and made use of my developing experience in LC-MS/MS-based bioanalysis. After I graduated, I accepted a position at AstraZeneca, within the same department where I worked as a bioanalyst for several years and had begun to gain exposure working on project teams. Entering graduate school, I felt having that experience was really helpful in setting my career and graduate paths.
After grad school and my postdoc at Washington State, I took a job as a ‘Scientist 1’ in the Department of DMPK and Clinical Pharmacology with a smaller pharma company (Theravance with ~250 -300 people), working alongside several UNC and AstraZeneca Alumni. I was brought on to both serve as a DMPK project team representative and introduce new in vitro assays to address specific project questions. Given the relatively small toxicology department at the time, and general flexibility with smaller companies, I often wore the ‘Toxicology Department hat’, an experience I found valuable at that point in my career – with the chance to do a little bit of everything. For example, I contributed to a New Drug Application which is submitted to the FDA after clinical trials, even though I was in DMPK research which generally takes place during the pre-clinical trial phase. I think that was a really helpful experience to have coming out of my postdoc.
However, intending to become more specialized within my field and closer to my family on the east coast, I took a position at AbbVie three years ago where I am a Principal Research Scientist supporting immunology and fibrosis programs from discovery through Phase I.
Describe your current role and what a normal workday or work week is like.
I still work within DMPK but my role as a DMPK Project Representative no longer includes any time in the lab. My time supporting project teams generally involves devising strategies on which assays to use to test the metabolism, safety, and transportation of potential therapeutic compounds generated by our chemists (the screening funnel used in early drug discovery). On a weekly cycle, we receive data from our scientists and interpret it to determine which of several targets/compounds would be the best to further pursue. I then also recommend what next steps to take to follow up on any interesting effects we see. As the chemical space for discovering a clinical candidate narrows, the needs tend to evolve to thoroughly characterize ADME properties of a few compounds, and identify potential risks early on. The role tends to be part scientist and parts logistics manager.
There is an appreciable amount of time communicating data and information both within and across functions or providing summaries for my supervisor for senior leadership. Often I find presentations can be thrown together with an emphasis on speed, which would have made my graduate advisor cringe while other times a very polished message and communication is integral.
In my organization, I support projects mostly in the immunology and fibrosis therapeutic areas and have defined myself within the organization as one of the few with inhalation drug discovery experience (thanks to the Curriculum and my time at Theravance), at last finding my niche. One other interesting facet of my job is that I support both projects that are solely those of Abbvie and also collaborate on projects with other (often smaller) companies, with novel technologies. Typically these collaborations have unique challenges depending on the contractual agreement they may have with AbbVie and what information may or may not be shared. At times I am needing to be creative to address issues with metabolism when I am not allowed to know the structure of the compound in question.
Where does DMPK fall within the process of bringing a new drug to market?
When creating a new drug, there are two major phases: (1) drug discovery and (2) drug development. To simplify, discovery is the very early stages of identifying a target, screening and optimizing compounds, and identifying a candidate for clinical development and development typically begins right before clinical trials begin (with GLP tox studies and regulatory document submission) through the clinical phases. DMPK tends to pick up in the middle stages of discovery and can carry on through clinical development. Typically, there will be some strong evidence that chemistry can make compounds that have demonstrated efficacy in a preclinical pharmacology model, and the DMPK rep will work with several functions to begin to optimize these active chemotypes with improved drug-like properties and assess potential liabilities. When we believe we have a strong molecule suited for clinical evaluation Good Laboratory Practice (GLP) toxicology studies are done along with other required studies to understand the ADME properties and expected human pharmacokinetics. Eventually leading to the preparation of regulatory submission to gain permissions to enter Ph 1 trials (and beyond).
Can you describe some of the different roles you’ve seen toxicologists hold at the various pharmaceutical companies you’ve worked at?
I have mainly worked in DMPK, but the people in DMPK generally have a diverse set of education and research backgrounds and it is not unusual to have some with toxicology training as it is considered a highly multi-disciplinary function. In my experience, the most common interactions I have with classically trained toxicology come in the department of Preclinical Safety. The department may have different names within different organizations, but they will generally be most focused on identifying safety risks earlier on and designing appropriate GLP studies to support clinical development plans (assess risk, and inform patient monitoring plans, etc.). In larger organizations, this department may be supported by more specialized roles. For example, in our organization, we have an Investigative Toxicology group which is a bit more academic in the sense that they are suited to designing experiments for very specific questions or circumstances to understand a specific observation, whereas data in other supportive assays is often higher throughput or from a predefined assay or study design. If we see an interesting or unexpected outcome from one of our assays, the investigative tox group will design specific assays to figure out what’s going on.
What are some of the skills you gained during your PhD training which have contributed to your success in the workplace?
There are certainly serval skills that are developed in an accelerated manner in my graduate training that I have found critical. Of course, much of the classroom training gives extensive subject area knowledge that allows me to guide teams, make recommendations, and devise program strategies. I may suggest two other key areas are collaboration and communication. I always considered myself a team player, but in graduate training, you do learn to work with and communicate with many people both within your field or with different backgrounds to work towards a common research goal. With regards to communication, particularly in an organization this size, it’s a really important skill to have and to continue to develop via multiple platforms (e.g., formal and informal presentations, verbal interactions, E-mail, reports, etc.).