True we don’t carry an FBI badge like the facsimile of the one pictured above, but feel free to call us G-men (and women) anyway.
That’s because as drug developers we must, by law, strictly adhere to the “G-regulations” as in GLP, GCP, GMP, and GDP. The “G” in this case stands for “Good” not “Government” even though the last word in drug development belongs to the FDA and other regulatory/governmental agencies not the pharmaceutical companies.
The idiom, “good enough for government work,” which has come to mean subpar or barely adequate, does not apply here since these G-regulations are, without exceptions, mandatory and pharmaceutical companies like EpicentRx must specifically and particularly follow the rules set forth in them on penalty of disqualification, fines, or even criminal prosecution.
Good laboratory practice (GLP) regulations cover all nonclinical laboratory studies in support of FDA Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications and FDA marketing approval. GMP or Good Manufacturing Practices relate to the manufacturing and quality control testing of pharmaceutical products. GCP or Good Clinical Practice is the standard around which human trials are designed, conducted, recorded, and reported. GDP or Good Documentation Practice refers to the legal requirement for documentation to be ALCOA, that is attributable, legible, contemporaneously recorded, original and accurate.
Key to successful GLP, GCP, GMP, and GDP is GTP—Good Teamwork Practices, which Dr. Tony Reid, EpicentRx CEO, and Allison Pratt, EpicentRx Head of Human Resources (HR), really get behind. So does Scott Caroen, Director of Clinical Operations, and Meaghan Stirn, VP of Special Projects (whatever that means).
Par for the course at EpicentRx are regular team meetings, brainstorming sessions, informal discussions, and of course—shameless plug—these incredibly informative blog posts 😂, all of which help to maintain cohesiveness, esprit de corps, and compliance with the G-regulations.
That said, as inveterate G-men and women, only once did we ever say, “Freeze!”—during a cryotherapy procedure to kill cancer cells in mice.