What’s the BIG Deal About TEAMWORK in Pharma?

Much of the work completed in pharma/biotech requires team members with differing skills, experience and expertise. Thus, we work on “cross-functional” teams very often!

Here are a few examples of teams that a physician may be a member of:

Program Team:

As a product is being developed, key players participate in a program team shepherding the product from “candidate selection” through animal studies, into early phase clinical trials, hopefully into later phase clinical trials and ultimately to regulatory approval and marketing (if everything is successful – many programs in drug development fail to gain marketing approval either for safety and/or efficacy reasons).

A program team may consist of:

CMC (chemistry, manufacturing, controls) – these are scientists involved in developing the process by which a product is manufactured (and many details related to quality, assays, etc) 

– I could do an entire blog on “what is CMC”!

Toxicology – study the interactions between biologic systems and drugs.  Design animal studies to assess the safety of compounds and understand the appropriate dosing of therapies. Highly engaged in understanding regulatory guidances regarding toxicology studies.

Pharmacokinetics/Pharmacodynamics – provide expertise on pharmacokinetics – what the body does to the drug; ADME – absorption, distribution, metabolism and excretion and what the drug does to the body (pharmacodynamics).  Model and predict human exposure and provide recommendations on dosing strategy.

Clinical Development – (this is usually an MD! but can be a PhD)… involved in clinical knowledge of disease, writing clinical protocols, determining the appropriate efficacy endpoints and monitoring patient safety.

Clinical Operations – responsible for executing clinical trials, patient recruitment, working with clinical trial site personnel.

Program Manager – the PM (Program Manager) coordinates timelines and integrates the various inputs from each function to insure smooth transitions or hand-offs 

Regulatory – regulatory professionals inform strategy and tactics related to gaining regulatory agency (i.e., FDA) agreement with development plans.  Regulatory team members are experts in the rules and regulations that govern drug development. 

The program team typically meets weekly to provide updates on the progress of the program and discuss various strategies or approaches the team could consider in every step of drug development.  

Other teams that MDs participate in include:

• Scientific Publications Team – team members determine the data available, publication strategy (what journal, timing), and review & submission of publications
• Due Diligence Team – team involved in critically evaluating a potential deal (buying another company or product)
• Safety Team – engage in considering potential safety signals that could arise with a new drug and reviewing safety data from non-clinical and clinical trials

SO MUCH of the work that occurs in pharma/biotech happens in cross-functional teams.  As a physician transitioning into the industry, it is important to understand the requirement to work with team members cooperatively.  The environment is also one in which EVERYONE’s expertise is critical to success!