Pharmaceutical

Drug or compound development is a generic term used to define the entire process of launching a new drug, compound or device into the marketplace. This process includes drug discovery/product development, pre-clinical research (microorganisms/animals), human clinical trials, legislative approval and commercialization.

New chemical entities known as (NCEs) or new molecular entities (NMEs)) are compounds which emerge from the process of drug discovery. These NCE’s and NME’s have promising agents against a particular biological target thought to be important in fighting or preventing disease. However, much may be unknown about the safety, toxicity, pharmacokinetics and the metabolic processing of this “new compound” in humans, so, it is the primary purpose of drug development to assess these parameters prior to launching a clinical trial.

In addition, many aspects of drug development are focused on satisfying the safety and regulatory requirements of drug licensing authorities with testing. These tests can be made using in vitro methods (isolated cells). Many tests can only be conducted by using laboratory animals, since it is only in an intact organism that the complex interplay of metabolism and drug exposure on toxicity can be examined.
The process of drug development does not stop once an NCE or NME begins human clinical trials. In addition to the tests required to move a viable drug into the clinical trial for the first time, it is also important to ensure that long-term or chronic toxicities are determined, as well as effects on systems not previously monitored (fertility, reproduction, immune system, etc.). The compound will also be tested for its carcinogenicity risk.

If a compound emerges from these tests with an acceptable toxicity and safety profile, and it can further be demonstrated to have the desired effect in clinical trials, then it can be submitted for marketing approval. In the US, this process is called a New Drug Application or NDA as most NCEs, however, fail during drug development, either because they have some high levels of toxicity, or because they not efficacious.

The early phase of drug discovery actually has components of real innovation, components of experimentation and components that involve set routines Innovation, Experimentation, and Commoditization.

Below are several key areas where HCS adds value to the talent stream to enhance research, drug discovery, development and commercialization:

• C-Level Executives
• Pharmaceutical Sales
• Senior Scientist
• Environmental Health and Safety Officer
• Bioanalytical Chemist
• Manager of Manufacturing
• Chief Financial Officer
• Quality Assurance and Quality Control
• Laboratory Managers
• Laboratory Technicians
• Vice President of Marketing
• Micriobiologist

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