One of the biggest obstacles facing pharmaceutical companies is the decade or more it can take to complete three phases of clinical trials required for government approval of a new drug and ultimately to bring that drug to market.
And within the clinical trial process, the biggest hurdle is most often the difficulty in enrolling enough eligible patients who meet the clinical trial criteria.
In recent years, this has been an area of intense focus as dozens of companies have sprung up trying to bridge this gap and find as many eligible patients as possible as quickly as possible.
Enter El Segundo-based MedVector Corp., which has developed a telehealth platform that essentially turns the office of a treating physician for an eligible patient into an extension of the clinical trial site. The aim: to enable physicians to enroll their eligible patients in clinical trials without having to become clinical trial investigators themselves.
“The entire industry is focused on identifying more patients for clinical trials,” said Scott Stout, co-founder and chief executive of MedVector. “But in our opinion, this is the wrong approach. You need to both identify and have access to eligible patients. And the gatekeeper is treating physicians.”
According to Stout, many physicians are reluctant to refer their patients to clinical trials out of fear of losing their patients – either temporarily or permanently – as those patients get treated for their condition elsewhere. If the clinical trial can be conducted in the physician’s office using a telehealth platform, the patient stays with that physician for all treatment, guaranteeing no interruption in the physician’s revenue stream.
And of course, the patient no longer needs to travel to the clinical trial site, which often is in another city or even another state. For many patients, such travel is not a financial or practical option, which means they may miss out on getting the latest advancements in treatment.
Stout, who hails from the private banking industry, decided to launch MedVector six years ago after discovering that hospitals shunned the idea of referring patients to offsite clinical trials for fear of losing the patient revenue.
The other key component was the rapid advancement in telemedicine services, which made visible communication between a clinical trial site operator and an offsite physician’s office possible.
MedVector’s telehealth device, which it is now beginning to deploy in physicians’ offices, allows the principal investigator for a new drug at a clinical trial site to conduct trial sessions with physician offices – which could be just down the street or hundreds of miles away. The principal investigator instructs the treating physician and his or her medical staff precisely how to monitor patients’ response to the drug. This could include details on exactly when to take the patient’s blood pressure or obtain imaging. And the principal investigator gives precise instruction on dosing with the drug.
MedVector’s telehealth device also has the capability to calibrate the monitoring devices, such as blood pressure cuffs, to ensure they are giving accurate readings.
“The whole point is to run the exact same patient protocols at the remote doctor’s office as you would at the clinical trial site,” said Brad Hightower, chief executive and founder of Hightower Clinical in Oklahoma City and one of MedVector’s earliest customers.
Free – at first
Stout said that – for the moment at least – MedVector is offering the use of the telehealth device for free to physician offices, in a bid to gain broader acceptance. Eventually, he said, the goal is to charge $500 per telehealth visit.
Of course, to provide the telehealth device and service for free requires outside money. Stout said MedVector has raised $3 million to date – with a significant chunk of that funding underwriting this effort.
Stout added that MedVector is now in the midst of trying to obtain $5 million to $10 million more in outside funds. That fundraising effort could have become much more difficult except for one key decision Stout made a year ago. At that time, Stout was approached by a buddy from his days as a private wealth banker in Beverly Hills. This buddy was working for Silicon Valley Bank and tried to coax Stout into moving MedVector’s banking account from Charlotte, North Carolina-based Bank of America to Silicon Valley Bank.
“I decided to stick with Bank of America, and now it appears we really dodged a bullet,” Stout said. “While we might not have lost our deposits, it would have raised a whole other set of unwelcome issues just as we’re trying to raise additional funds.”
Once MedVector raises the funds, the plan is to intensify efforts to get its telehealth device and the capabilities it offers accepted by physicians and clinical trial site operators.
But this could prove challenging as MedVector is only one of several companies trying different approaches to solve the key problem of clinical trial operators having difficulty finding eligible patients.
“There is a big push by pharma companies and regulators to increase the size and diversity of the patient pool for clinical trials,” said Robin Roberts, co-founder and chief operating officer of Novartis Biome in San Francisco, an innovation hub established by Basel, Switzerland-based pharma giant Novartis.
Some companies, including Hollywood Hills West-based Topography Health, have tried to turn more physicians into formal clinical trial investigators. Others, such as Science 37 Holdings Inc. – formerly of Culver City but now in Morrisville in North Carolina’s Research Triangle region – have set about scouring databases for more eligible patients.
With MedVector’s approach, Roberts sees two major challenges. The first is ensuring the accuracy of the data collected.
“We can do the telehealth piece where physician and the principal investigator can see the patient,” Roberts said. “But how are you collecting the endpoints to make sure the data are usable for FDA submission?”
Roberts said the effectiveness of MedVector’s telehealth approach should become more apparent over time.
The other key challenge, he said, is developing the best financial model to make this decentralized clinical trial approach work.
“The standardized model in clinical trials is for the principal investigator to receive payouts depending on patient visits,” Roberts said. “The model needs to be adjusted now to include physicians who are not principal investigators but who are bringing eligible patients to clinical trials.”
Stout did not have a firm answer on who exactly would be signing the payments once MedVector emerges from its current “pre-revenue” phase. He said it is possible that the clinical trial site operator would pay. Or the pharmaceutical company developing the drug would pay. Or some combination of the two.
“In the end, it will be the pharma companies that will pay as they are the ones who will benefit the most from speeded up clinical trials,” he said.