Mayo Clinic is expanding its commitment to biologic medicine by launching a new collaboration with a California-based startup aimed at accelerating the development of new breakthroughs in the space.
The initiative with National Resilience Inc. will include collaborative lab space in Rochester, a combined effort to attract biotech companies to sponsor clinical trials of biologics at Mayo Clinic and a potential future business incubator.
Many researchers view biologics — which are pharmaceuticals made from a living organism — as the next frontier in medicine. Biologic drugs are drawn in part from cells, blood, enzymes, tissues, genes or genetically engineered cells.
The clinic said it aspires to "establish Rochester as a center for biomanufacturing regenerative technologies."
Mayo's effort will have a special focus on complex and rare diseases. Biologics can target specific parts of your immune system and therefore offer the promise of addressing conditions that have otherwise been difficult to treat.
Gene therapy and cell therapy are two commonly known examples. Biologics are increasingly being used to treat cancer as they can attack specific cancer cells. Insulin, which is essential for diabetes patients, was first discovered in 1921 but was reclassified as a biologic in 2020 by the U.S. Food and Drug Administration.
"We don't want to just be treating (patients) for the rest of their lives," said Julie Allickson, the Michael S. and Mary Sue Shannon Family Director of Mayo Clinic's Center for Regenerative Medicine. "Possibly, we have the potential with the biologics to cure them."
San Diego-based National Resilience focuses on technology to improve the biomanufacturing process. It was founded in 2020 but has already raised more than $2 billion in equity financing.
The startup has 11 facilities in North America with more than 1 million square feet of manufacturing space and more than 1,600 employees.
Rahul Singhvi, CEO of Resilience, said, "Our mission is to democratize access to medicines."
Mayo and National Resilience are not forming a joint venture but will have collaborative space in the Two Discovery Square building in downtown Rochester. They will work together on biomanufacturing for early-stage cell and gene therapeutics.
Mayo's strength is the development of a drug or biologic and getting it to early-stage clinical trials, but it then likely would license medications to biotech or pharmaceutical companies.
"I really think we're at the time where we need to be able to collaborate with industry to accelerate the discovery work. I do see a lot of industry and Big Pharma looking to be able to collaborate with academic health centers such as Mayo Clinic," Allickson said.
Mayo already has numerous biologics in the pipeline. It has about 30 active clinical trials in regenerative biotherapeutics. Allickson said that Mayo Clinic has 11 manufacturing clean rooms in Rochester. Mayo Clinic has additional clean rooms in both Arizona and Florida.
A report from Dublin-based Research and Markets estimated the global biologics market at $294 billion in 2021, which is expected to grow to $502 billion by 2027. The report said that growth is being driven by an increase in the diagnosis of chronic diseases, creating a demand for more advanced drugs.
Neil Schauer, owner of Schauer Biologics Consulting in Milford, Mass., has 35 years of experience in the biopharmaceutical industry. His firm works with startups in the field.
"The potential is tremendous," Schauer said of the medical possibilities of biologics.
Schauer cited Enbrel, a drug to treat rheumatoid arthritis made by California-based Amgen, as a good example of a recognizable biologic. Another is Humira, which is used to treat arthritis and other conditions. Both Enbrel and Humira are injectable drugs.
Boston and San Francisco are currently the main hubs for emerging biologics companies, Schauer said.
A startup company will generally need about $160 million to get a drug through three rounds of clinical trials before commercialization. It will also take up to 10 years to get through that process, Schauer said.
Complex and rare diseases present their own challenges.
"The challenge with [complex and rare diseases] is that it's hard for industry sometimes to go forward to treat those disorders where there's only a small population of patients," said Allickson. "But at the Mayo Clinic, we have that opportunity."
Mayo itself can do small-scale production of biologics for a smaller group of patients.
Frank Jaskulke, vice president of intelligence for the Medical Alley Association trade group, said that Minnesota does not have many companies working to develop new biologics.
"It's a big, big opportunity for the region," Jaskulke said.