A world of outsourcing awaits - part I drug discovery

When a biopharma company outsources a function of the drug discovery process it is usually done for one of two purposes during the late discovery stage: the screening of compounds and/or the preclinical testing of compounds.

Screening compounds for their selectivity of action, absorption, distribution and metabolism helps to identify potential failings in the compound's biopharmaceutical properties and to prioritise the movement of high-potential compounds through the pipeline.

The main subcategories within the screening process include: identifying targets and leads; lead prioritisation; and lead identification.

In the process of identifying targets and leads, researchers find and isolate a drug target, usually a protein, but sometimes DNA or RNA, and learn more about its functions and how these influence disease.

The researchers then identify and carry out studies on molecules that interact with the drug target and eventually identify potential lead molecules that have an effect on the target, in order to begin developing a drug that acts on this specific target.

Lead prioritisation involves selecting the most appropriate leads on which to spend the time, money, and effort required in order to move them to the human testing phase.

The leads prioritised are then tested to confirm their effects on the drug target. Additional screening for toxicities, as well as research to develop and validate the manufacturing process, is then carried out to select the most promising compounds for preclinical development. This is termed lead identification.

Preclinical testing of a compound involves extensive lab testing of a compound to make sure it is safe to move forward into clinical testing on humans. Testing at 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, manufactured and administered.

The main areas within preclinical development include: in vitro/in vivo studies; chemical manufacturing controls/pharmaceutics and pharmacology/toxicology.

In vitro testing involves investigating the drug in cells in a test tube; in vivo studies investigate the drug in living organisms.

Chemical manufacturing controls/pharmaceutics relates to the pharmaceutical methods used to determine how to best formulate a drug to achieve the optimal chemical composition, purity, quality and potency of the active ingredient.

Pharmacological testing determines the effects of the candidate drug on the body, while toxicology studies identify any risks to humans.

Outsourcing some or all of the above functions at the preclinical level is popular with drug firms because it frees up precious in-house resources - it is estimated that a massive 5,000 drug compounds need to be investigated for every one successful drug that reaches the market.

The rapidly growing market for drug discovery outsourcing services will increase 15 per cent over the next three years to reach $7bn (€5.5bn) by 2009.

However, while the benefits are clear, there are also risks involved in early-phase outsourcing that pharma companies should be aware of, according to a recent report by Bridgehead International, titled "Legal aspects of outsourcing contracts in the pharmaceutical industry: A practical guide."​

This stage of drug development has an especially high level of uncertainty. Researchers may not completely understand key physical and chemical aspects of the drug, and the analytical and process methodologies are not likely to be as fully validated or robust as they will be later, warns the report.

In addition, the compound's intellectual property (IP) position, especially relating to its synthesis, may not be fully established and thus is potentially vulnerable.

Furthermore, drug companies my need to shop around to find a number of different contractors that can provide the adequate level of specialised testing required throughout the various preclinical stages.