Teamwork gets the job done

Career Profile By Mengsong Li, PharmD

If you had asked me 5 years ago what I planned to do after pharmacy school, the thought of being an industry pharmacist would not have even crossed my mind. Now, as a mentor to many students at Rutgers University who ask me about my future career goals, I cannot imagine working in another setting other than industry.

What is clinical development?
After pharmacy school, I started my career in the Rutgers Pharmaceutical Industry Fellowship (RPIF) program in translational pharmacology at Merck. As a clinical scientist working in early clinical development, my responsibility is to assess the safety and pharmacokinetics of Merck’s drug candidates and deliver the most promising ones to our late clinical development colleagues. I have had the opportunity to work on trials that span many therapeutic areas such as oncology (Keytruda), vaccines (Merck Ebola Candidate), and diabetes.

Working in early clinical development requires careful interpretation of preclinical/animal data, followed by designing and executing multiple clinical studies to determine the drug’s pharmacokinetic (PK) profile and its optimal dose in patients. We work in teams with experts from many different fields, such as statistics, formulation, pharmacokinetics, and clinical supplies. Together, we collect and analyze data in order to determine the compound’s strategy moving forward, as well as how to distill this information to what a clinician reads in the package insert. Almost every section of a drug package insert is written based on clinical research data either from its sponsor company or other clinical practice investigators.

For example, take a 70-year old female patient who presents to the ER with a diagnosis of pneumonia caused by Pseudomonas aeruginosa. You decide to prescribe antibiotic X, however, before you administer the medication, you might consider the following: Is this drug effective against the offending bacteria? Is this drug dosed differently in female patients versus male patients? Will this drug need to be adjusted renally? Are there any drug–drug interactions? These are all questions that my team and I must anticipate and then answer through our research in clinical development, so that the right dose can be given to the right patient at the right time.

What can a pharmacist contribute?
As an industry pharmacist, the clinical knowledge you bring is invaluable to the drug development team. I can contribute to many aspects of the project, including strategy (analyzing the current market, evaluating primary literature, and determining the right indications for the compound), operations (writing protocols and other medical documents, addressing concerns with drug preparation, administration and handling), and of course, clinical review of the data from our studies.

As a clinical scientist, my primary focus is to put patients first. During the course of a trial, I perform medical monitoring reviews of patient charts and data to ensure that they are safe. My education has helped me immensely in assessing patients’ adverse events, concomitant medications, labs, and PK data … you name it.

What’s most gratifying to me working in industry is that at the end of the day, everyone on the team is working toward the same goal of bringing innovative health care products to those in need.