The age of cell and gene therapy is here. The FDA has already approved more than 30 cell and gene therapies since 2017, and the global AAV manufacturing market is continuing to expand. Science, however, has outpaced the infrastructure.
Before startups run into a roadblock from an inability to test their hypothesis, many run into a roadblock from a lack of infrastructure. It’s not unusual for startups with less access to capital (i.e., those that can’t raise big Series A rounds) to spend much of their capital on facility development rather than on research.
The Manufacturing Problem Nobody Is Talking About
It’s difficult and expensive to manufacture cell therapies, and it’s hard to scale. According to research from the NIH, the manufacturing of cell therapies is challenging because it requires a large amount of cells, requires a sterile environment, must satisfy regulatory agencies, and must be scaled from a clinical environment to a commercial manufacturing environment. The manufacturing of AAVs is also a major hurdle, as manufacturing standards are immature and production is expensive. For startups, infrastructure can be a huge expense well before a single cell is used. The founder could spend months securing a lease, purchasing equipment, and building a space rather than making scientific progress.
The Hidden Tax on Early Stage Biotech Founders
Before a single cell can be manipulated in a start up, the founders must overcome huge obstacles in infrastructure, including:
- A new BSL-2 lab could cost hundreds of thousands to millions of dollars.
- Instruments like flow cytometers and bioreactors can cost hundreds of thousands of dollars each.
- Lab leases can be long-term commitments.
- Often incubators require equity in the startup.
The result is simple; the money that should be used for the science is used on facilities. This is especially true for founders from minority backgrounds, who often have less access to capital.
Dr. David Kiewlich Was the Solution
Dr. David Kiewlich has a long track record in biotech, including 28 years in the industry, 6 startups, and a focus on oncology and cell-based therapies. As a founder, he experienced this problem. When he started his first company, he spent 18 months finding a lab space instead of working on his science.
This lead him to create BADASS Labs (Bay Area Disruptor And Startup Support Labs). The mission is simple: to give any scientist the space to do what they need to do, without taking equity, claiming IP, or dictating how long a startup needs to operate before they leave.
What Cell Therapy Lab Space Looks Like
Founders are able to access all of the equipment they need in a BSL-2 lab, including flow cytometers, biosafety cabinets, cell culture space, microscopes, centrifuges, qPCR systems, and more. BADASS Labs also gives its members 24/7 access to the lab, so they can perform experiments when it suits them. Pricing is also simple and flat-fee, without unexpected charges for equipment, facilities, or staff, and with a minimum lease time of three months rather than multiple years. Perhaps most importantly, BADASS Labs takes no equity and claims no intellectual property, which enables the founders to retain the equity as their companies evolve.
The Proof Is in the Numbers
The failure rate for startups varies widely from sector to sector, but the failure rate reported for companies in the BADASS Labs portfolio is 89%-95%.
To date, the portfolio of member companies has raised over $900 million between them. By eliminating the expense and time required to set up independent labs, BADASS members can start research projects sooner rather than later, and can spend their precious resources on research rather than construction.
Accessible for Innovators Who Are Typically Left Out
Biotech has been slow to diversify and expand representation, especially among leadership roles, but also for founders and entrepreneurs. For the scientists who have trouble raising capital and lack existing investor relationships, the high infrastructure costs are just too high, which leaves them out of the innovation process.
BADASS Labs is eliminating the equity requirements, reducing upfront costs, and offering transparent pricing for those with fewer resources, to open up more opportunities for scientists who come from backgrounds that typically do not find themselves in the lab. It is not about preferential treatment, it is about giving all the good ideas an opportunity to prove themselves, regardless of the background of the founder who came up with it.
From Lab to the Clinic
BADASS is not just a physical location; it also supports BADASS member companies with mentorship and education. Bringing advanced therapies to the patients requires a team to guide founders and their companies in the regulatory, manufacturing, fundraising, and commercialization areas.
Founders get guidance from an experienced scientific team. They join a community of other founder-led companies, receive investor connections to fund and grow their projects, and participate in educational activities that cover everything from grant applications to GMP manufacturing.
Expanding the Program
BADASS recognized that affordable and accessible biotech infrastructure was not just a Bay Area problem. The company added a location in Salt Lake City, a city that BADASS believes offers similar innovation and talent pools as the rest of the state without the costs associated with being close to venture capital hubs.
Additional sites also give BADASS Labs more collaboration opportunities with the other biotech sites as well as strengthening the ecosystem for its founders.
“Succeed or Learn, There Is No Fail”
The goal here is to help founders do science properly without short-term demands or a sense of urgency to succeed to the exclusion of all other factors. Without the distraction of building out and paying for expensive infrastructure or having arbitrary timelines dictate their success, BADASS labs can validate or fail to validate their ideas, pivot when needed, and let their discoveries point them in the directions they need to go.
The success rates that BADASS Labs are boasting about are from this process of eliminating all of the unnecessary burdens on the founder so they can just build good drugs.
How Can BADASS Labs Help My Company?
For the biotech companies that are already funded and have a strong capital base, and who want the flexibility and control of a dedicated space that they design, own, and operate as a stand-alone lab may be worth the added time and costs to the founders.
But if your cell and gene therapy startup is at a pre-seed, Seed or Series A, and is trying to validate their platform with a limited amount of capital, shared labs can increase capital efficiency. BADASS Labs is ideal for the founder who has the time, resources and capital to grow, but wants the flexibility to start right away or the protection of equity and IP that they are going to be investing in.
Stop Paying the Lab Tax on Your Science
The cost to build and maintain the labs, purchasing the equipment, and even more importantly to the founder and investors in the company – having to take expensive equity dilution – can all go toward the real research, which is the foundation of cell and gene therapy. We do not have scientists wasting their time in search of labs or wasting money building them.
BADASS Labs was created to shorten the path to innovation by removing infrastructure as a bottleneck, and provide a place where founders can access the right equipment, the right people, and the right resources to build their research platform and move towards clinical studies.
There are cell therapy companies today working on the next generation of drugs. The real question is whether your lab environment is one that accelerates your company’s science, or hinders it.