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Getting clinical trials right, and right the first time, is crucial for biopharma companies, especially as the cost of getting a drug to market is skyrocketing. Matthew Herper estimates in "The Truly Staggering Cost Of Inventing New Drugs"--which ran in Forbes in February--that drug development costs have reached the eye-watering level of somewhere between $4 billion and $11 billion. R&D returns have therefore fallen drastically and are around half what they were 10 years ago, explains Ian Shott, managing director and principal consultant at Shott Consulting: "Attrition is the overriding driver of cost, with a preclinical success rate of 0.01% and a success rate in the clinic of 10% or less."

The larger part of the cost of clinical-stage drug development comes from clinical trials. According to Timothy Scott, president of the U.S.-based pharmaceutical chemistry development organization, Pharmatek Laboratories, Phase II costs can range from $4,000 to $20,000 per patient. So, the last thing a drug developer wants is any kind of interruption of a trial, or to have to start a trial all over again, and this makes the reliable supply of clinical trial material (CTM), whether manufactured in-house or outsourced to a contract manufacturing organization (CMO), absolutely critical.

"An interruption in the provision of the clinical trial material … could require that trial to be conducted over again," Scott says. "And … there is the cost of missed opportunity in the marketplace. If the drug being developed has the potential of being a billion-dollar drug, that is nearly $3 million in lost revenue every day the drug is not on the market."

Clinical trial supply isn't just an issue for investigational drugs. Some clinical trials compare the study drug against a placebo; however, others, particularly those for serious diseases for which it would be unethical to withdraw active treatment, compare with a marketed drug or another investigational drug. Other trials combine an investigational drug with another drug in a combination therapy. It's vital for these trials that there is a constant supply of the comparator or combination drug as well as the investigational drug. Maintaining this kind of reliable clinical trials supply needs a robust supply chain. "This requires complex planning to orchestrate the various elements that need to be brought together to have the right supplies ready in the right place at the right time," says Gerry Hepburn, chief operating officer, vice president and general manager, clinical supply services, Catalent Pharma Solutions. Click here to download the full ebook>> -- Suzanne Elvidge (email)

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