Bringing one new drug to the public typically costs a pharmaceutical or biotechnology company on average more than $1 billion and takes an average of 10 to 15 years. Our comprehensive portfolio of services, spanning preclinical through post-approval, features integrated laboratory, Phase I-IV and consulting services to help you decide on an exit strategy. Few scientists are interested in starting a moderate to large sized pharmaceutical company. New drugs and devices begin in the laboratory with scientists including engineers, chemists and pharmacologists, who identify anatomical, physiological, cellular and genetic factors that play a role in specific diseases or injuries. It can take three to six years of further clinical testing in patients, for one of these compounds on average to ultimately be approved as a marketed drug or device for treatment. Our expertise guides you through the decision process of what you want our assistance with; large venture capital or simply proving efficacy and safety in animals before partnering with a large company.
In the preclinical stage of drug development, an investigational drug must be tested extensively in the laboratory to ensure it will be safe to administer to humans. This is one place we have extensive experience assisting investigators communicate with the regulatory agencies and achieving the IND.
Further testing following this stage can take from one to five years and must provide information about the pharmaceutical composition of the drug, its safety, how the drug will be formulated and manufactured, and how it will be administered to the first human subjects.
- Preclinical Technology. During the preclinical development of a drug, laboratory tests document the effect of the investigational drug in living organisms (in vivo) and in cells in the test tube (in vitro).
- Chemistry Manufacturing and Controls (CMC)/Pharmaceutics. The results of preclinical testing are used by experts in pharmaceutical methods to determine how to best formulate the drug for its intended clinical use. For example, a drug that is intended to act on the sinuses may be formulated as a time-release capsule or as a nasal spray. Regulatory agencies require testing that documents the characteristics — chemical composition, purity, quality and potency — of the drug’s active ingredient and of the formulated drug.
- Pharmacology/Toxicology. Pharmacological testing determines effects of the candidate drug on the body. Toxicology studies are conducted to identify potential risks to humans.
In the United States, results of all testing must be provided to the U.S. Food and Drug Administration (FDA) and/or other appropriate regulatory agencies to obtain permission to begin clinical testing in humans. Regulatory agencies review the specific tests and documentation required to proceed to the next stage of development. This is another area that our experience can help guide you through the processes.