Industry Practice

DISCOVERY

Discovery is the initial stage (non-GLP) in the drug R&D process. It aims to understand the nature and causes of a disease through identifying proteins known as “targets,” which are critical to the survival or spread of a disease-causing organism. Through analyzing, testing, and re-testing tens of thousands of drug compounds, scientists and researchers seek to narrow these compounds to a select few that positively affect the disease target (“hits”) and that will eventually lead to them becoming drug candidates.

PRECLINICAL

Pre-Clinical is the 2nd stage in the drug development process. Up to 250 drugs that passed through Discovery are tested in-vitro (test tube) and then in-vivo (animal studies), following Good Laboratory Practice (GLP) guidelines.  The goal is to identify up to five of the tested drugs that will be safe and effective enough to be submitted to the FDA through an IND application before advancing to clinical, human trials.

EARLY PHASE CLINICAL 

Phase I is the initial phase of clinical trials, often known as “first-in-man” studies, and is focused primarily on the drug’s safety. It is tested in a group of approximately 20-100 generally healthy human patients using PV methods.

Phase IIA is primarily focused on the dosing (Phase IIa) and effectiveness (Phase IIb) of the drug, although safety continues to be monitored. It is generally administered and tested on approximately 100-500 patients affected by the disease or condition being targeted.

LATE PHASE CLINICAL

Phase III trials involve a much larger and diverse group of affected patients, with approximately 1000-5000 receiving the drug. This phase is the longest and costliest, is critical in determining the drug’s safety and effectiveness and provides the basis for labeling instructions. Upon successful completion of Phase III, a New Drug Application (NDA) is filed with the FDA and, if approved, can then be brought to market with ongoing surveillance and analysis (Phase IV).

MANUFACTURING

A GMP (Good Manufacturing Practice) is a process that ensures products are consistently produced and controlled through quality standards. The is goal is to minimize risks involved in any bio-pharmaceutical production that cannot be fixed through testing a final product.

GMP (Good Manufacturing Patrice) comprises all aspects of the production cycle, starting from materials, premises, and equipment to the training and quality control of the staff.  Significant details within written procedures are essential for each process that could impact the quality of the finished product. Systems to provide documented evidence of the correct procedures are consistently followed at each step in the manufacturing process.