The development cost of a pharmaceutical drug can easily run between $500 million to $800 million, and clinical trials alone can cost between $1 million and $2 million per day in lost future revenues. So imagine a service that could reduce by a year the time it takes to perform a clinical trial, analyze the results and submit them to the US Food and Drug Administration (FDA).
That’s the dream of Stockholm-based Clinitrac, which has produced a working prototype of its GSM-based wireless solution geared to the problem of initiating, gathering, analyzing and accessing the information generated through medical clinical trials. The time to market is, of course, dependent on loads of factors, but probably refers to larger, longer trials.
Clinitrac received $3 million in seed funding in May 2000, mainly from BrainHeart Capital and HealthCap, but also netted stakes by the Swedish Industry Fund and others. The company is currently entering a second round with the original funders, to the tune of an additional “three to four times that amount,” and are seeking to bring in an additional, US-based venture partner to the fray.
The company has yet to produce revenues, but its working prototype is impressive. It has already cut a deal with Psion for the Netpad and is in discussions with a major PDA manufacturer. And it has had meetings with US GSM operators to ensure that Clinitrac’s product will have all the GSM network coverage it needs when it offers its product to US markets in 2001.
Patients enter information on a half-brick-sized Psion NetPad, which has a wireless Internet connection, a touch-activated screen and enough shock absorption around its edges to tolerate a month in a New York City public secondary school. The information is then transferred back to the company performing the testing, and made immediately available to doctors, scientists, product managers and developers.
“This sounds like an interesting technology,” said Nick Woolf, biotech analyst for ABN AMRO. “There are other companies in clinical trial services who claim to have various systems – voice recognition systems and others – but it’s certain that real-time information on a clinical study is valuable.”
Clinical Trials Today
The process is, in a word, revolutionary. Today, patients are asked to fill in paper forms, and they often forget, fill them in late or inaccurately. This information is delivered to a doctor after 30 days, which means that a patient who repeatedly misses his noontime dosage or has an adverse reaction to a drug would not be identified until after at least a month.
“The biggest problem with clinical trials,” said Clinitrac CEO Andreas Segerros, “is keeping the patient in the trial. Once they blow the protocol a certain number of times, you need to take them out. Our product would allow monitors to see, on a daily basis, that Mr. Thompson over there keeps missing his 3 p.m. pill, and call him early enough to keep him in the study by making sure he took the drug.”
That indicates a level of involvement and monitoring of tested subjects unheard of today. Currently, paper forms are stacked up from around the world, flown to central data processing facilities and keypunched into systems before anyone can even have an idea of the nature of the data.
The major risk, Woolf said, is getting the product out there and recognized as a clinical trial service. Most large pharmaceutical companies, he said, contract out much of the work of clinical trials to Contract Research Organizations (CROs).
“Today there are CRO subcontractors that do nothing but take dirty paper forms filled in by patients and scan in the results,” said Henrik Linder, Clinitrac’s clinical research operations senior director. “[Our] system gives you clean data, digitally, directly where you need it and in real time. And when we approach the pharmaceutical companies, they’re like, “Finally! Thank you!””
There are potentially several areas in the pharmaceutical industry where a product like this could be used to affect both savings for the end user as well as increased profits for the manufacturers. Traditionally, on approval of a drug, the onus is on the drug companies to appeal to the FDA in order to maintain a high price – the FDA is in effect negotiating on behalf of the American Medicaid system, which will pay or not pay for a drug based on the assessment of the FDA.
The pharmaceutical company will argue that a) the thing took them years and billions of dollars to research, b) it meets an immediate, and heretofore unaddressed, need of the general public, and c) the quality of life improvement, or simply the decrease in necessary medical attention required by a patient taking this drug, is so compelling as to justify a higher dose or daily cost of the drug.
Clinitrac said its product can help in this process as well, by allowing pharmaceutical manufacturers to have access to a broader-than-ever range of quality-of-life questions, or information above and beyond the physical effects of the drug.
For example, in addition to hard medical questions of efficacy to a patient on a clinical trial for a drug that attacks skin rash, they would also be asked questions such as: “In the last week, how often did embarrassment about your condition cause you to make more conservative clothing choices?”
The answers to questions such as these would enable pharmaceutical makers to argue that in addition to straight efficacy, the drug in question has a positive impact on the patient’s quality of life – a compelling argument for a higher price for the drug.
“As a monitoring tool it could be extremely effective,” said ABN AMRO’s Woolf, although he stopped well short of saying that the technology alone would amount to a stronger negotiating position. “Whether you can correlate the monitoring tool to a gain of negotiating points with the FDA, HMOs and other reimbursement agencies would be difficult to claim.”
He added: “These guys need to team up with a Quintiles or a Covance,” referring to two of the larger CROs. “Because those are the ones that already have the relationships and access to clinical hospitals.”
Absolutely true, Clinitrac agreed. For now.
But the company is convinced that eventually pharmaceutical companies will see the savings involved in their real-time offerings, and Clinitrac won’t be keeping many friends in the CRO world for long.