NEW YORK (GenomeWeb) – The Harvard Business School has received several dozen ideas for its Precision Trials Challenge, the deadline for which is fast approaching.
In January, HBS launched the Precision Trials Challenge, hoping to generate ideas to speed personalized drugs and tests to market quickly by "reinventing the clinical trials process." The funds for the challenge will come from a $20 million gift that the Robert and Myra Kraft Family Foundation gave to HBS last fall.
"We've started here because it's such an apparent problem for all drugs to get through the trials process cheaper and faster," HBS professor Richard Hamermesh told GenomeWeb. "The sense was that with this very generous gift with the Kraft family … this would be a good place to start."
Robert Kraft, CEO of Kraft Group and owner of the New England Patriots, pledged the funds in honor of his wife, Myra Kraft, who passed away in 2011 from ovarian cancer. During her illness Kraft learned about precision medicine from Broad Institute founding Director Eric Lander.
Harvard Business School and the Broad Institute plan to use the funds to speed development of personalized treatments through collaborations between the medical, research, and investor communities in Boston. The Precision Trials Challenge is one way the school is trying to get the life sciences community involved and encourage new thinking about the longstanding problems in drug development.
More than a decade ago, industry observers were estimating that it cost around $1 billion to garner market approval for a drug. HBS estimates it now costs $1.5 billion and more than a decade to achieve this. In 2014, the Tufts Center for the Study of Drug Development estimated that such costs had rocketed to $2.6 billion.
The conventional wisdom after the Human Genome Project was completed was that genomic and other biomarker approaches were going to elucidate disease biology, allowing drugmakers to identify targets with the best chance of success, reducing attrition rates, and lowering costs. That future hasn't yet come to fruition. There are different theories for why not, but some drug industry experts believe that increasing knowledge of genomics has actually added complexity, cost, and uncertainty, as the reimbursement and regulatory environment for diagnostics remains in flux.
Greater genomics knowhow should have improved the speed and efficiency of the drug development enterprise, but since it hasn't, "I'm looking for solutions to crack the code," Hamermesh said. "That's why we're doing the challenge, for new thinking on it."
So far, there have been more than 30 submissions. But there are many more in draft form, and most of the submissions are finalized within 72 hours of the deadline. The challenge is accepting applications until March 13.
Hamermesh noted that contributors seem to be coming at the problem from a number of different angles, by focusing on ways to reduce the number of patients enrolled in a trial, identifying predictive biomarkers earlier, using big data, and comparing successful and unsuccessful trial designs.
Kelvin Stott, for example, who is a pharma R&D systems architect, has proposed setting up a secure database, through which patients can be matched to clinical trials anonymously, "rather like blind online dating." Trials for precision drugs often require recruitment of patients who have a specific molecular profile, but these markers might be rare in the population. This could further extend the already lengthy clinical trials recruitment process, which can take between six months to two years.
But within Stott's plan, a patient would provide a biological sample to his or her doctor, who would submit it with a reference code (removing the patient's identifying information) along with a medical history to the testing bank. The testing bank analyzes the sample, and stores the data, reference code, and doctor's name in an encrypted database. Then, when the database yields a clinical trials match, the patient is alerted and with the physicians help, can give conditional consent, so that his or her identity is revealed only when selected for the study. Both the drugmaker and patient's identities are unmasked when they both provide full consent.
Jennifer Monti, a cardiology fellow at the University of Pennsylvania and founder of early-stage device firm Shock Analytics, wants to improve precision drug development by tackling variants of unknown significance (VUS). "Current solutions to this problem do not take seriously that data on variants should be rapidly available to patients or that patients should be invested in development of basic and translational science related to their VUS," Monti wrote.
She proposed developing "a home" for aggregate VUS data where patients' mutations are tracked and they are provided notice when new information becomes available. This system would also allow doctors and genetic counselors to review emerging data on VUS of interest and place patients with VUS into cohorts so they can be further followed and assessed.
"There's an array of ideas we're seeing," Hamermesh said. These challenges have been "stumping all the experts so, maybe, we can reach out a little broader."After the March 13 deadline, judges will evaluate the submissions and rate them across different categories. HBS will then consider the collective opinions of the judges and generate a short list of finalists, which will be further vetted by an expert panel to pick the three winners by the end of April.
The winner of the Precision Trials Challenge will receive $50,000. Two runners up will receive $25,000. The money can used to "take their idea to the next level," Hamermesh said. But, even more than the money, the benefit of the challenge is getting feedback from the larger community, he noted.
As for the rest of funds provided to HBS by the Kraft family, the school is crafting a strategic plan for using that money and will announce the details in a few months. HBS has said it will also fund a series of challenges led by the Crowd Innovation Lab at Harvard, Broad Institute, and Kraft Foundation aiming to "break precision medicine data bottlenecks" by identifying useful algorithms and software. The first challenge in this series will take place between March 11-25.
Meanwhile, the ideas for the Precision Trials Challenge are submitted via an open online forum, and anyone interested in these issues can comment on a proposal, suggest improvements to it, or question its feasibility. For example, in response to Monti's proposal on building a "home" for VUS data, one commenter wondered since there are a number of companies and delivery systems building databases to work on this very problem, would they partner or compete with Monti's project?
The winners of the challenge will be able to showcase their ideas at a conference this fall hosted by Partners HealthCare Personalized Medicine, the same event where the competition was announced last year.
"The real value of this challenge is the amplification of the idea and sharing the idea more broadly," Cara Sterling, director of the HBS Health Care Initiative, told GenomeWeb. "That's the change we're hoping to make."