The Mayo Clinic has jumped into an interesting little experiment in drug development that might best be called micro pharma.
Mayo is one of the partners in a new company called Vitesse Biologics, which is more or less just a virtual umbrella company that will itself give birth to at least five new companies. Each one of these micro pharma companies will consist mostly of a single drug development research project.
With luck — and with Mayo’s help — each of the five little companies will develop their drug candidate through the point called proof of concept and then get sold. In their short corporate lives, they will never have a real headquarters or even any employees.
The reason to do drug development in this kind of a micro company is speed. The global drug giants collectively known as Big Pharma can do a lot of things well, but moving drugs quickly through the early part of a development process is no longer one of them.
The folks at Mayo Clinic say they are pretty excited about the approach of Vitesse, too, even though it wasn’t their idea. The executive dean for research at Mayo Clinic, Greg Gores, said he and his colleagues can see it working fine for other things Mayo does, including helping develop new medical devices.
Mayo Clinic was brought into Vitesse by Baxter International, the suburban-Chicago-based health care giant that will soon be completing the process of spinning off its drug-related businesses into a separate publicly held company called Baxalta.
This business had revenue in 2014 of about $6 billion and spent more than $800 million on research and development. That’s a small company compared with a global drug giant like Pfizer, yet the Baxalta business shares with its bigger competitors the challenge of coming up with promising new medicines to sell.
It’s hardly a new problem for Big Pharma, as costs of development have gone up along with the time it takes to get a new drug through to regulatory approval.
One way that Big Pharma has tried to solve the development problem is to acquire or license promising drugs developed by smaller companies and then finish the development process. That led big companies to establish corporate venture capital arms to fund promising start-ups.
That’s the group at Baxter, called Baxter Ventures, that first approached Mayo Clinic to talk about a new drug development model.
As Gores described it, he and his colleagues were receptive to the idea, because they have often wondered why drug companies weren’t involving an academic medical center like Mayo Clinic far sooner in the process.
The drug companies traditionally identified the most promising candidates themselves and then did a lot of the early development work. Only later did the companies look to big medical centers for advice or as places to help conduct big clinical trials.
“That all took a long time,” he said. “What we need is some sort of earlier strategic partnering to accelerate the pace of bringing new drugs to the patients who need them.”
Gores noted that the “vitesse” in Vitesse Biologics is French for “speed.”
Mayo Clinic’s other partner in this deal, a specialty drug development firm called Velocity Pharmaceutical Development, also has a word for speed in its name. It’s the 2011 creation of a venture capital firm in San Francisco called Presidio Partners.
As described by Stuart Sedlack, a senior vice president of Velocity Pharmaceutical, the decisionmaking process at what got dubbed Vitesse Biologics will not be cumbersome at all, even with three partners seated at the table.
The way it’s going to work, he said, is that Velocity will to have primary responsibility for identifying the right therapeutic agents for Vitesse, then putting together the development plan and budget. Because it’s what Baxalta is most interested in, Velocity will be looking in the broad areas of diseases related to the blood or immune system, as well as cancer.
In addition to other services, Baxalta will figure out the best form for the drug — oral, for example — and how to manufacture it in a stable and usable form. It will also provide funding.
Baxalta and Mayo Clinic get to weigh in on the choice of drug candidate and project plan, and then Mayo Clinic will keep the project rolling, including running the first trials.
“These are really proof-of-concept studies,” Gores said. “They demonstrate how the drug works, whether it’s safe in humans, what is the efficacy signal. You want to make sure you got the right drugs in the right patients before you move on to the more laborious and expensive late phase trials.”
Not everything will be known when the early trials wrap up, like the optimal dosage. But by then the partners should know that the drug is generally safe to use and can be effective at treating disease.
In the model developed for Vitesse, it will then be decision time. Baxalta, at that point, will have the option to acquire the drug and then run the far bigger trial that would be required when seeking regulatory approval to sell it.
That kind of a positive outcome presumably would make the Mayo Clinic a little money for having jumped into this venture, but Gores put this commercial project squarely in the tradition of Mayo Clinic.
“We realized that no entity can be insular … in addressing the unmet needs of its patients,” he said. “We have to partner with industry and pharma to help accelerate the pace.”