By Thomas Lee
ROCHESTER, Minnesota – When a clinical drug trial fails — and they often do — everyone loses. Patients don’t receive new treatments. Companies, investors, and hospitals see precious time, money, and resources evaporate into smoke.
“There’s nothing more expensive than a trial that doesn’t work,” said Dr. Wayne Nicholson, a Mayo Clinic anesthesiologist who often works with pharmaceutical makers.
By collaborating with Upper Saddle River, N.J.-based Centerphase Solutions Inc., the Mayo Clinic is trying to improve its chances. The non-profit clinic recently acquired a minority equity stake in Centerphase, which is developing ways to speed drug industry-sponsored clinical trials run by major academic research institutions like Mayo . Founded in late 2009 by veterans of Merck Capital Ventures, Centerphase has already raised $2.6 million from investors.
The start-up hopes to tap one of Mayo’s most prized assets: Its electronic medical record database of more than seven million patients. By reviewing patient medical histories, diagnostic data, pathologies and lab results, Centerphase and Mayo hope to identify and enroll the right patients for a particular clinical trial, effectively eliminating the guess work that often plagues drug development, said Centerphase CEO Gary Lubin.
Drug trials are expensive, often messy and rarely produce a genuine blockbuster. Only three in ten new drugs generate enough revenue to sustain research and development, pressuring drug companies to bring more products to market, according to Tufts University’s Center for the Study of Drug Development.
The center estimates that global sales of drugs with expiring patents between 2009 and 2012 were $88 billion.Balance that against the more than $1 billion, seven-yera price tag for commercializing a drug.
“The simple fact is that product launches are not keeping pace with patent expirations,” said CSDD director Kenneth Kaitin. “Clinical development time for novel protein products, which now averages seven years, is unlikely to decrease due to disease complexity, growth of study protocols that lengthen studies and difficulty recruiting and retaining volunteers.”
Finding and enrolling the right number of patients is crucial to launching a clinical study, Mayo Clinic’s Nicholson added.
Drug companies normally pay Mayo, which conducts thousands of clinical trials a year, based on the number of patients it enrolls in each study, he said. If Mayo can’t meet its patient goals, drug companies could either kill the study or find another hospital to recruit patients. Either way, Mayo loses money.
Lubin says the solution lies in Mayo’s Enterprise Data Trust system, which holds the EMRs of seven million patients. Based on those records, Mayo and Centerphase can select appropriate patients for each study, helping to speed clinical trials and eliminate potential errors that could delay or sink the project, he said. (Patient identities are kept confidential.) Dr. Nicholson says the collaboration could also help Mayo generate more revenue by advising drug companies on research and development before clinical trials.
“There is a limited number of large institutions with a very well-developed electronic patient database,” said Lubin, the former chief technology officer of Merck Capital Ventures, the drug giant’s investment arm that manages more than $100 million.
Experts say the drug industry could benefit enormously from EMRs, also known as electronic health records. Beyond identifying patients for studies, EHR data could help pharmaceutical companies determine the most promising therapies and compounds to pursue well before the clinical trial stage, according to a recent report by Deloitte Consulting. The report estimates it takes three years and $11 million to evaluate a potential drug target.
EHRs can also help companies locate biomarkers, genetic information that allows researchers to predict how a patient might respond to a particular drug and what side effects they might experience. Companies can then devote time and money only to therapies with the best chance of being safe and effective.
“By employing EHR data during research, companies can build an expanded understanding of safety and effectiveness earlier in the R&D process,” according to the Deloitte report. “With this knowledge, researchers will be able to make well informed decisions to terminate the pursuit of ineffective targets and unsafe leads before progressing to the next phase in the R&D process.
“Given that the average Phase I clinical program costs $15.2 million, improving the quality of decision making during research can significantly drive cost reductions for the development organization."