An oncologist in Europe wants to prescribe a new cancer drug for a patient who has failed all prior treatments.
The only problem is that the drug could be months away from European approval, and relocating the patient to the U.S., where it's already approved, is far from practical. What to do?
The doctor might turn to IDIS World Medicines, an organization that specializes in supplying drugs on a named-patient basis prior to approval, and basically serving as a middleman between patients and drug companies.
Founded in 1987 to supply needed drugs to patients in the UK market, IDIS later branched into Europe and now supplies more than 600 drugs each month to patients in 60 countries through expanded access programs, either while a drug application is under review or through exceptions granted on a compassionate basis for individual patients who have no treatment alternative.
Original co-founders Michael Crane and Amanda Gould "really felt that there was an opportunity to supply drugs, particularly into the UK market, that were not available [there]," said IDIS Managing Director Natalie Douglas, who has headed up the privately held firm since conducting a management buyout in September.
"This demand was coming directly from hospitals and pharmacies looking for drugs that were approved in another country and that they believed would be most appropriate for a particular patient," she said.
On average, IDIS sources on average about 20 pre-launch medicines daily, supplying "a lot in the oncology field at the moment," as well as HIV and other indications to areas in which those drugs might not be approved but could be potentially lifesaving, she added.
In some cases, IDIS even gets to patients drugs that are not approved in any market. Those typically are in indications for which there are not suitable alternatives, and use of the drugs still must be approved by a local regulator.
IDIS manages the entire procurement process, often beginning with a request from a hospital or pharmacy for a particular drug for a specific patient, though sometimes IDIS is approached directly by a drug company that has received demand in regions where a drug has not yet been approved.
From there, the company takes responsibility for supplying the drug, arranging for regulatory approval to use the drug on a named-patient basis, as well as monitoring the drug's pharmacovigilance, maintaining storage, providing patient information in a number of different languages and managing overall quality assurance. IDIS also guards against the potential for patients to receive counterfeit drugs.
"We're essentially a conduit to ensure ethical supply and to ensure that patients get exactly what they're supposed to get," Douglas told BioWorld Today.
Doctors or drug companies trying to maneuver through the process on their own might not have the expertise or resources to manage the supply. They also might be dealing "in markets where they're not familiar with the customs and legislation," Douglas said. "That's why companies choose to work with us. We take on all that responsibility."
But, she cautioned, it's "not an opportunity for drug companies to supply their drugs outside of a normal approval process. What we're really talking about is plugging a gap when there is an unmet medical need."
Since IDIS maintains confidentiality agreements with most of the drug companies it works with, Douglas could not provide specific examples of IDIS' work. But she said that the company procures many FDA-approved drugs, particularly the "key oncology lines" and supplies them to European territories.
IDIS employs about 95 people, but "there's no doubt our business is expanding rapidly, so we'll definitely be increasing our work force over the next two years," Douglas said.
The company is a for-profit organization backed by VC investments. It's based in Weybridge, UK, with offices in Paris; Munich, Germany; Dublin, Ireland; and Rome.