Think you might be interested in a career in pharma, but not quite sure how doctors work for pharmaceutical companies? Listen to this episode to learn about physician roles in drug discovery and development, and see if that might be a potential career path for you!
In this episode of The Career Rx we’ll discuss:
- The phases of drug discovery and development
- How physician expertises fit into each phase to make the biggest impact for patients
- Where your skills might fit into each type of role if you want a nonclinical job in pharma
Today’s episode is a continuation of a series that’s specific to the pharmaceutical, biotech, and medical device industry. In this overview of careers in drug development, I’m going to be giving a simplified summary of each phase, highlighting areas in which physicians play key roles and can make a big difference.
In this Episode:
[1:40] Discovery means discovery
[3:30] Positions where physicians might be involved in phase one
[6:45] Regulatory bodies and medical affairs organizations
[10:15] Why physician to physician communication is so important
[13:45] Understanding clinical significance
[16:20] Where would your interests fit in?
Ready to learn more about exactly how to find those kinds of jobs, or how to critically evaluate your own skills and experience for transferability? Watch this free one-hour webinar on physician jobs in pharma. When you’re ready to get serious, join my course Industry Insider to get you the results you want, faster.
Links and Resources:
Industry Insider – learn exactly how to land a rewarding nonclinical career without a new degree, connections on the inside, prior experience, or a pay cut
The Branding Rx – 18 hours of CME, mastering digital strategies for advancing your career, building your business, and growing your professional brand
LISTEN TO THIS EPISODE:
SUBSCRIBE TO THE CAREER RX PODCAST:
Get every episode on your preferred player…
More for you:
The Speaking Rx learn the business of professional public speaking to establish yourself as a thought leader you are, and get paid for your speaking expertise
Launch an Online Course on Any Budget – know your course will sell before you spend any time or money to create it; plus, the exact logistical blueprint to get paying customers and a way to deliver your course without spending a dime (ready to scale up when you are!)
Thanks for joining me on this episode of The Career Rx!
TRANSCRIPT: Episode 88 – What Physicians Do in Pharma: Drug Discovery and Development
Hey there. I’m Marjorie Stiegler and you’re listening to The Career Rx Podcast, where we tackle the important things they don’t teach you in medical school. Like how to treat your career, like the business it really is, with strategies to accelerate the kind of success that you want, because you deserve a career you love, and a career that loves you back. Are you ready?
Let’s get into it.
Hey, there, welcome back, I’m going to be continuing a series that’s specific to the pharmaceutical, biotech and medical device industry, because I’ve been getting so many questions about what physicians actually do there. Right? What does it mean, to go and work in industry, and obviously, it’s important to know that, so that you will know if that’s the kind of career that you might enjoy, and, and one for which you may be qualified, where you may be able to make a big, big difference to a huge number of patients and their treating physicians.
Today, I’m going to focus on very, very basics, the high level of research around drug discovery and development. So I’m going to give you just again, a high level of the phases. But remember that the purpose of the podcast is about your career. So instead of describing each of the phases in detail, I’m going to be sort of high level and simplified in those phases, but point out areas in which physicians are often part of the process and can make a big difference.
So one of the first important parts about drug discovery and development is, is really that discovery phase, right, this is, you know, you can create and design molecules from scratch, or you can take a look, take a look at existing medicines, sometimes existing treatments for certain disease that have some unanticipated effects and other parts of the body. And so there may be signals about medicines that exist, or molecular compounds that exist, that might be able to be sort of tweaked and manipulated and developed in a way to have a new specific effect. Or, of course, that things can be engineered from scratch.
So this is the biggest umbrella of discovery, and really 1000s and 1000s of compounds are considered in the discovery phase, but really only a tiny fraction look promising enough to move forward into development. So this is really this is very much bench research. So physicians may be involved here, but likely, they’re also PhDs, pharmacists, these are folks who are really doing very deep, deep bench research. So if a medicine looks promising for a specific medical problem, before testing a drug in any humans, there is a preclinical research phase.
And in the preclinical research phase, this has to be conducted, according to FDA requirements. And there are specific protocols and operating procedures for these types of preclinical studies, usually animal testing, and they have to be done to understood dosing and toxicity levels in order to know whether it is safe to be tested in people. There’s FDA oversight, even at this stage.
So let me pause just really quickly and think of the various places so physicians might be involved in that drug discovery and that bench type research physicians might be involved in the next phase is preclinical phase of research, either in conducting the research itself or, you know, more likely in designing it right, and in understanding what kinds of things would be important, clinically meaningful outcomes. And also there are physicians who work in the regulatory bodies, so physicians at the FDA would be evaluating whether or not they think these studies are worthwhile, are they safe? Do they meet the standard, so these are places where physicians can work in the very sort of early preclinical research phases.
And then, you may have, you know, again, a smaller fraction of those medicines or those potential medicines, then move into clinical research, which is a lengthy process. And you know, preclinical research answers some pretty basic questions about the medicine and and perhaps most particularly, about how the medicine interacts with general mammalian physiology as well as safety. This is done to ensure that it’s safe to study in humans, but then the study in humans has to progress in a responsible and stepwise fashion.
First to understand, again, safety and the ideal dose on how to give you know, what’s the route of administration should it be intravenous should it be oral and how it impacts the body. So that’s usually the first type of a human clinical trial. And these are often pretty small studies, if they are successful, a small number of medicines will move on to the next phase. And phase two could enroll up to maybe several 100 people. So it’s larger, but not huge. And it’s with people who have the condition. So no longer healthy volunteers. But now it’s people who have the condition that this is aimed to treat. And of course, the studies go on to continue to monitor the safety information and how it impacts the body and everything else.
But another key purpose of this phase is to understand how it impacts the disease. So the efficacy and side effects, and, and then again, a small fraction of this group, if these medicines are shown to have good safety and good efficacy, then they will move into Phase Three, which is your, your large clinical trials for 1000s, perhaps, of volunteers who have the disease or the condition and they’re studied for a long period of time to really understand in much, much more depth, the efficacy and safety over over a long period of time and the treatment in the course of the disease.
Let me pause here again, to say that in each of these different phases, physicians are involved not only in the design of the studies, but in evaluating the outcomes of the studies and whether or not they are meaningful.
So, you know, what is the threshold for meaningful efficacy, right? What, what kind of benefit does a medicine need to confer in order for that to be clinically meaningful? And importantly, is that different from what’s available today. And this is an area in which physicians are really very much involved not only in the research and development part, but also in the regulatory bodies, so with the FDA and others, and also in medical affairs and medical affairs organizations, within pharmaceutical companies are really charged with understanding the treatment landscape and the external environment in which physicians and patients are currently being treated.
So they’re bringing in that lens of you know, what is really missing today? What would physicians like to have that they don’t have that would make them more effective? What would patients like? I mean, obviously, patients want to be healthy, patients want to be cured, but sometimes, in given diseases, there are other things, you know, they would like different routes of administration, they would like things that are more convenient that they need to take less frequently, that don’t have the same kind of side effects.
So understanding what makes a difference what matters to patients, both in terms of the design, the delivery, the side effects, and and the efficacy. And then also understanding how that matters to physicians is really, really important here. One of the reasons that having physicians involved at this stage is so important is because the FDA has specific guidance about how studies need to be designed in order to standard that the FDA has for approval. And sometimes those endpoints, right, the things that the FDA wants to know about, don’t exactly match up with what physicians care about, or what patients care about.
So when designing a study protocol, it’s really, really important to be sure that sort of both of those spheres are answered, right that the requirements for the FDA in order to determine efficacy and safety are met. And also that the things that the patients and the physicians care about, are studied and can be reported. And sometimes those are one in the same. And sometimes they’re quite different. So making sure that the study protocols and the study design really reflect what’s needed. For all of these various, I’ll call them stakeholders, right, all of the different groups. Most importantly, the patients but in order to be able to give them to patients, obviously has to be approved by the FDA. So you need physicians in all of these parts of the drug development process.
And then, you know, information seeking about the medicines continues after the medicine is approved. So the entire process of doing that clinical research, in order to submit the what’s called the NDA that a new drug application to the FDA for approval, takes a lot of people. It takes many, many, many different kinds of people with a lot of different expertise, but certainly physicians among them and both, you know, sort of bench science oriented physicians in the research and development process, as well as physicians in the regulatory process.
And physicians in the Medical Affairs process to really understand what kind of things are actually a value to develop like what meets a medical need. Because not not everything right that might work is me did right and so physicians clinical expertise there is important and even if the physician is not in that specific area, the physician’s ability to understand from talking to colleagues who do treat that disease, you know, to really understand what their treatment is like, what their needs are, like, what their day to day practice is like, there is a physician to physician connection there and in a way of sort of interpreting the need and the science, that is fairly specific.
The other thing that is another role for physicians in all of these studies, is pharmacovigilance. So this is a physician who is specifically charged with overseeing the safety of the trials, and then also in an ongoing way pharmacovigilance after the medicine is approved, there are physicians involved in reviewing any and all reports of adverse events that come in, after the medicine is approved, to basically take, you know, may have a an understanding of whether or not those adverse events are related to the medicine.
And if a sufficient number of the same kind of thing come up, you know, then there’s an investigation to really understand if there’s a connection there. So there are roles in safety, that are in both the trials, and postmarketing, which is that phase four, and people do obviously continue to conduct studies after medicines are approved. So, this is generally called phase four, this is postmarket studying, and, and this continues to look at safety and efficacy, usually the patient population is also people who have the disease.
And it is either you know, against a different kind of treatment or a different kind of standard of care, it’s answering a different question than the questions that were required for the FDA approval. And it’s not always done by the company that is, you know, that has developed the medicine, it might be done independently, by outside researchers.
And along the way, as this research is being conducted, obviously, it’s also being published, right, it’s being written about, there are posters being presented, manuscripts being developed, and submitted to journals and data being presented at medical conferences. And so physicians are all often involved in those activities as well. And really, throughout the pharmaceutical industry, and, and sort of the more broad biotech and device industry.
The physicians, you know, one of the core roles of the physician, is to really interpret the science for everyone else, because as you can imagine, there are an enormous number of people who are employed by these companies, both the pharmaceutical companies, the research organizations, the the government bodies, like the regulatory bodies, there’s a lot a lot of people, and not all of them are physicians, but they do all need the physician input to help them to understand whether or not they are interpreting the studies and the outcomes of the studies accurately and what does it mean.
And, you know, we’ve all sort of heard, even in medical school, when you think about the difference between something being statistically significant and something being clinically significant, which is sort of more subjective, right, and helping people to be able to understand, what does the study mean? What does the study not necessarily mean?
What are some of the limitations of the study? What is some of the context that people ought to consider while they’re looking at the results, because, you know, these studies are obviously, they’re enormous efforts, they’re extraordinarily expensive. And they only progress, small percentages kind of down the line there from that early preclinical research all the way through approval. And so that’s done very, very thoughtfully to be sure that really only the most important medicines that are going to make a big difference for patients are, are moving along through that process.
And the physician input is absolutely necessary to interpret that. And it’s also very important at the very earliest parts, to help to think about what should the story study protocol be? What should we be looking at? What are the things that make a difference to physicians and to patients?
Right, so in terms of actual bench bench research, in terms of publications, and presentations, and all of that kind of thing that you’re well familiar with academically that happens as well, in terms of safety and monitoring safety across the trials, also being a trial monitor the medical monitor or a physician accountable for the study to be sure that the studies are done, according to protocol. Right?
That’s obviously very, very important that that quality be maintained. And then discussions with the regulators, including a lot of documentation and things that are written up. There are physicians involved in just so many of these different spheres. So very broadly pharmacovigilance clinical trials, medical affairs, and then that early, you know, research and development research discovery piece.
And so while this probably sounds extremely broad, that’s because it is and really no physician holds all of these roles, they are kind of broken out into these little buckets, where, you know, a medical affairs physician is not involved in the design of the preclinical study protocol, most likely, right? Perhaps in a very small startup, that person gets to do things across the board.
But as the companies get bigger and more established, you have different physicians in different parts of this process. And you also have different physicians working in different therapeutic areas, meaning, you know, different types of diseases, different types of medicines.
So there are lots and lots and lots of ways that physicians can be involved, either with the pharmaceutical companies themselves, or with third party clinical research organizations, who often are the ones conducting these studies on behalf of the companies or with the regulatory bodies like the FDA. So really, anywhere you turn and whichever type of environment might feel best to you.
There are opportunities for physicians, and that’s kind of what they look like. I realize it’s pretty hard to imagine a day-in-the-life without really doing it. But there’s so much mystery I find in people asking me, you know, like, what do you do all day. So I hope this overview is helpful to understand the really broad swath of what it might mean to be a physician in drug development.
If you think you may be interested in transitioning from the clinical work that you’re doing today, into a pharmaceutical role, please come check out Industry Insider, it’s my course in which I outline for you the steps that are needed in order to position yourself appropriately so that you can showcase the right kinds of skills that will make you a competitive candidate for these kinds of jobs because I promise you, even without any prior experience at all, and perhaps not even with the clinical specialty that that is on the job application.
You have many, many skills, critical thinking skills and other just sort of core physician leadership skills to bring to the table that are very, very high value so I can show you how to make that transition. If you’re interested. Come check out the show notes. My course, Industry Insider. That’s it for today. Bye for now.