Clinical Pharmacologist Working in Drug Safety
Patrick Twomey is a physician scientist and clinical pharmacologist.
He is trained as an Internal Medicine physician and realized a couple of years into his practice that he did not love clinical medicine. Given he was a chemist before going to medical school he already had an interest in the pharmaceutical industry.
Being active duty Army after residency, he had the opportunity to apply to a Clinical Pharmacology fellowship at Walter Reed Army Institute of Research and felt this would be a great way to combine drug development and his medical career. The fellowship was a 2-year commitment and after he finished a role for him at Walter Reed was available for him so he stayed as Director of Clinical Pharmacology for 6 years. In this role he worked in Infectious Diseases, focused on development of small molecules for malaria and vaccines for various infectious disease.
After leaving the Army he moved to the Bay area of California and took his first pharma role at Genentech. Initially he was hired in the clinical pharmacology group and has now transitioned to a role in drug safety.
What is Clinical Pharmacology?
Patrick provided a great one sentence description:
“to find the right dose of a drug, given to the right patient and at the right time”
He also explained that often we think of clinical pharmacology as phase 1 clinical trials where the pharmacokinetics (PK) and pharmacodynamics (PD) of a drug are explored. But as he explains, it is more than just phase 1 studies.
There is tremendous variability in how patients respond to drugs. Most of this variability is explained by factors including metabolism, liver function, renal function, absorption (if given orally), bioavailability (if given subcutaneously). Clinical pharmacologists assess all of the data and provide a clinical picture of how a person’s body deals with a certain drug or compound. This functional area utilizes computer modeling and simulation and mathematical models to predict the human body response to medications.
Most of the people that Patrick worked with in clinical pharmacology were PhDs or PharmDs with extra training in pharmacology. Years ago, many pharma companies hired physician clinical pharmacologists to conduct Phase 1 clinical trials. Now much of that work is outsourced to contract research organizations (CROs). Thus, many physicians with clinical pharmacology experience are now in phase 1 centers (examples include PRA and Celerion) or CROs.
I asked Patrick if he would recommend a physician do a clinical pharmacology fellowship: His advice was if they are early in career and this is a key interest then yes, there are great civilian programs including Johns Hopkins and Indiana University. However, it could be a major financial hit for a physician years in clinical practice; thus, he would not necessarily say this is critical. A physician can get this experience in a phase 1 unit.
Now in Drug Safety, which at Genentech is called the “Clinical Safety Community”
At Genentech, Drug Safety is divided into “early” and “late” stage development. Those that focus on early are evaluating safety from phase 1 and phase 2 clinical trials and those working on late stage are focused on phase 3 and beyond. Through networking and understanding Genentech more broadly, Patrick realized that early phase drug safety was an area of interest for him and he was able to move into his current role as Medical Safety Director.
Drug safety doesn’t require a specific specialty area although clinical experience is important. Patrick works with physicians that are internists, pulmonologists, anesthesiologists and others.
In pharmacovigilance, another term for drug safety, you are looking for safety signals so there is a focus on evaluating data and using epidemiology to understand if a side effect is really linked to the drug. There is also a regulatory aspect of the role requiring submitting regulatory reports summarizing the drug safety.
In early drug safety, Patrick works with pre-clinical (pre-clinical is the drug development area prior to a drug being studied in humans – it includes in vitro and in vivo studies) colleagues to understand the molecule and think through science of expectations of the safety of the molecule. Based on the pre-clinical data, he makes the best prediction as to what safety issues may occur with the drug and helps develop the “first in human” trials to be as safe as possible for the patients. He also helps to write the regulatory documents required to document these safety considerations such as the Investigator’s Brochure (IB).
“Our goal is to make sure that safety is the priority and
that patients are getting good drugs that are safe”
What’s his work schedule?
Patrick works 3-4 days per week in the office and 1-2 days per week from home.
He is a firm believer in the importance of face time with colleagues. Networking is important as there is a lot of cross-functional team work and you need to develop relationships within the company to have people to go to with questions.
Patrick’s advice for “getting your foot in the door”:
For resident and fellows that are considering the pharmaceutical industry:
“get that clinical experience” – it is a misconception that pharma only wants people with a medical degree – we want physicians to understand what clinicians and patients go through – getting clinical experience it is important
To gain clinical trial experience:
Gain experience by working in clinical trial centers – work as a sub-investigator, refer patients for clinical trials. Do what you can to gain exposure to clinical trials.
Networking:
As physicians we are not as skilled at networking when in practice; however, building your networking is key! It is a skill to be practiced.
So many of us in the pharma industry get our jobs through networking. Meet people at conferences, connect on LinkedIn, send emails to connect with people and examine your medical school colleagues to see if anyone is working in the pharma industry and reach out to them.