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Inside the Lab Training and education, Profession, Laboratory management

A Rather Unconventional Career

At a Glance

  • Industry careers offer pathologists the opportunity to be directly involved in developing new therapeutics
  • Pathologists have a firm understanding of clinical, laboratory, and translational medicine – all key skills needed in industry
  • The ability to understand and interpret medicine through the lens of laboratory values and data means that pathologists are uniquely suited to working with clinical investigators and overseeing the execution of clinical trials.
  • If you’re considering making the move to industry, find the program you’re most interested in and go for it!

Early on in medical school, I had two key realizations that led me to pathology. The first was my fascination with understanding the mechanisms of disease. I often found myself focused on pathophysiological mechanisms during my clinical rotations, which wasn’t the most efficient way to practice medicine. I couldn’t really help it, though; it’s just the way I process information and think through situations. I also participated in a “year-out” program offered by the University of Rochester’s Department of Pathology, which led to my second realization: I wanted a research-oriented career. During my year-out program, I learned that laboratory medicine training was the fastest route to a career in clinical research.

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Most of the people I know who started out as laboratory medicine residents ended up taking the traditional route – training in both anatomic and clinical pathology (AP and CP). I think that this was driven at least in part by the reductions in grant-funded research. Without confidence in the ability to secure research funds, you need to be sure you’re widely employable. Academic positions are much fewer and farther between than general pathology positions, and general pathology, of course, requires training in both AP and CP. Those colleagues who stuck with laboratory medicine tended to specialize in hematopathology because of the demand.

After completing my three-year laboratory medicine residency at the University of California, San Francisco, I went straight into an associate medical director position at a biotech company.

I did things a little differently. After completing my three-year laboratory medicine residency at the University of California, San Francisco, I went straight into an associate medical director position at a biotech company. The first several years I spent in biotech was like fellowship training in a way, so I guess you could say I specialized in drug development.

Lured into biotech

It was the opportunity to help push forward the development of a new drug – something that could improve the prognosis for an entire population – that drew me into industry. During my residency, I was fortunate enough to meet Lori Kunkel, the Chief Medical Officer at Proteolix, a small biotech company in South San Francisco. She’s a hematologist/oncologist by training, and had moved into drug development. She told me about her time at Genentech and the key role she played in developing Rituxan. When I completed my residency, I was offered a position with Proteolix. Here I was, with the chance to help bring a new therapy to patients with refractory multiple myeloma. I’d reviewed some of the data demonstrating that the drug worked, and I spoke to some of the clinical investigators on studies whose patients went from being hospice-bound to getting their lives back. How could I not be attracted?

I started as an associate medical director and the primary medical monitor for a Phase II trial treating multiple myeloma with carfilzomib, a second-generation proteasome inhibitor. I was also the medical backup for this pivotal trial that was the basis for accelerated approval. I supervised the day-to-day activities of the trials and was the primary medical contact for the clinical investigators. It was also my job to review the data being generated from all of the sites, looking for any adverse events that might herald a trend. And because of my background in pathology, I was involved with a lot of the preclinical and translational research activities too.

In laboratory medicine, we’re trained to understand what’s going on with patients based on lab values, progress notes and conversations with our clinical colleagues.

In laboratory medicine, we’re trained to understand what’s going on with patients based on lab values, progress notes and conversations with our clinical colleagues. We provide our knowledge and support as consultants to the primary medical team and work with them to understand and interpret the laboratory data in the context of a specific patient. The relationship between a medical monitor and the investigators on a clinical trial is fairly similar; we work together and use our different, but complementary, knowledge and experience to evaluate the data, both at the individual patient level and for the entire clinical trial cohort. Pathologists have the additional advantage of understanding laboratory test development; that’s critical in the age of companion diagnostics.

I’ve been really lucky in terms of projects. I was spoiled with my first program, carfilzomib. It gave me a lot of experience in managing critical Phase II trials, as well as in launching the global Phase III trials needed for full registration. Plus, it culminated in carfilzomib’s accelerated approval in 2012. I then moved to the biotech company Plexxikon Inc., where I led clinical programs for a small molecule tyrosine kinase inhibitor called PLX3397 and designed the initial proof-of-concept trials for several other inhibitors. I’ve also had the opportunity to launch the first set of clinical trials for a very interesting small molecule inhibitor of glutaminase, which is thought to be a key player in tumor metabolism. Now, as the Chief Medical Officer at OncoSec Medical, I’m working with a talented team of businessmen and women, scientists and engineers to develop intratumoral immunotherapies.

Since entering biotech, my role in drug development has evolved. I started out managing the day-to-day execution of clinical trials, medical monitoring, and data analysis and interpretation; now I’m the central person responsible for devising the clinical and regulatory strategy for a candidate therapy and managing diverse groups, including clinical operations, data management and clinical science. But don’t get me wrong – being in a small company setting, I’m still heavily involved in the details of running the clinical trials.

The biggest thing I’ve experienced in biotech – something I couldn’t have experienced if I’d stayed in laboratory medicine – is the incredible satisfaction of helping to bring new therapies to patients with cancer. It’s a great feeling to know that my work is directly contributing to making treatments that may improve survival for an entire population of patients.

Making the move

I think the biggest hurdle to getting pathologists into biotech and pharma is that so few of them are aware of the available opportunities. Before spending time at Proteolix, I had no idea these jobs even existed.

But pathologists bring a very different skill set to the table – one that’s very important to understanding the mechanisms by which novel therapeutics can impact the course of a given disease. Pathologists’ knowledge of pathophysiology and what diseases look like under the microscope and in laboratory assays is invaluable. We can provide a context for evaluating the findings in preclinical toxicology animal studies and have a key role in the evaluation of arguably the most critical marker of a new drug’s potential success – target engagement and pharmacodynamic activity. Pathologists have a very natural role in industry – bridging the gap between the industry’s research laboratories and the clinical investigators.

I think that the key challenges for pathologists trying to move into industry, outside of diagnostics, include the lack of exposure to opportunities and the fact that industry professionals don’t always understand our knowledge base. Often, clinical opportunities in industry are aimed at those who have trained in internal medicine or, in the context of cancer therapeutics, hematology/oncology. Pathologists are often overlooked, I think, because people don’t realize that our medical knowledge extends beyond what we do at the microscope or in the clinical lab. Hiring managers don’t necessarily realize that our knowledge base essentially spans all of medicine because we serve as consultants to all clinicians. This is not to say that we’re experts in every field, but that isn’t really what industry needs. Industry needs people who have a broad understanding of medicine and diagnostic technologies and who know when and how to work with their clinical colleagues to answer specific questions.

Succeeding in industry certainly takes a person who isn’t afraid to tackle issues they’ve never previously managed. You have to be prepared to learn on the fly and make decisions based on very imperfect or partial information. But these challenges are not unique to anyone who has been trained in medicine and they can be overcome. Don’t be afraid to ask for opinions. Ask your colleagues; ask your clinical collaborators; ask for advice from people whose intellect you respect, even if it isn’t in their area of expertise. They may have great ideas.

Finding opportunities in industry is about actively seeking out the people working on your program of interest. Find out what research is going on at your institution and try to get involved; make an effort to speak to people at scientific or medical conferences. Don’t let an advertised job description discourage you from seeking out an opportunity you want, either; the descriptions tend to be generic and very few of them will be explicitly for pathologists. If you find out about an opportunity that interests you, talk to people and figure out ways to speak to the hiring manager for that position. Finally, never be shy about contacting someone directly.

A world of opportunity

Pathology training provides a firm foundation for understanding clinical, laboratory, and translational medicine. These are all key skills needed in the drug development industry.

Consider that the knowledge base of someone with pathology training is very broadly applicable. Don’t limit yourself to positions that are specifically posted for pathologists; find the program you’re most interested in and go for it!

Don’t be afraid to reach out to people directly. Most hiring managers are very open to people with alternative training or expertise. They’re primarily interested in someone who is motivated, intellectually creative, scientifically critical and, for these positions, medically competent.

Do I have any professional regrets? Nope – none at all.

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About the Author
Mai H. Le

Mai H. Le is Chief Medical Officer at OncoSec Medical, Inc., San Diego, California, USA.

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