Q&A with Wheeler Bio’s Jesse McCool: Innovating how emerging biopharmas do business from right here in OKC

VeloCityOKC: In your own words, what is Wheeler Bio?

McCool: Wheeler Bio is a new type of biomanufacturing company that is built to accelerate the translation of therapeutic innovation into clinical impact. Our business model, coupled with proprietary manufacturing process technology, allows us to integrate drug discovery with drug development in a unique way that better meets the needs of emerging biopharma companies. Emerging biopharmas are the venture-backed biotech companies at the root of early-stage medicine development and are driving an outsized portion of innovation and new product development. We primarily serve these customers which typically do not have consistent and timely access to high-quality contract manufacturing services. By integrating our development platform parallel to drug discovery, we offer a novel pathway for drug developers that is faster, easier and more predictable.

Why was it important for Wheeler Bio to plant its flag in Oklahoma City?

Oklahoma City has invested in its biotech economy for over 30 years, so there is already a critical mass of trained talent and key assets here. OKC has an existing biotech workforce and an emerging group of local venture capitalists who have been investing in medicines and next-generation therapeutics. All that activity stirs up opportunities for service providers like Wheeler, both by ensuring that we can fill our hiring needs quickly and that we have robust access to customers.

Part of the equation is also the ease of doing business in Oklahoma. OKC was recently ranked the top city in North America for ease of conducting business. Wheeler is well-positioned for growth in this low-cost, business friendly, geographically centralized hub that is equidistant from both major coastal biopharma ecosystems. The population here is young, educated and growing. And there’s a very cool vibe downtown.

I should also say that my wife, Joanna, and I, like many other transplanted residents, have grown to appreciate “The Big Friendly” in more ways than one. Our engagement with community, culture, new friends and schools has had a positive impact on our OKC longevity. We moved our family here in 2013 from the Boston metro and have found an open arms reception at every new turn. OKC is full of resilient, hardworking people who, honestly, are just great at building things. I would love to see this city emerge from its historical dependence on volatile industries like energy. I think this community has room to develop out more verticals and to truly diversify the economic base, because of the people we have here.

In recent years, building Oklahoma City’s Innovation District has been a heavy focus of the community. This includes a significant investment from the citizens in the most recent MAPS initiative. Was this kind of support instrumental in deciding to locate Wheeler in the Innovation District?

Wheeler Bio will eventually be located in the new development in the Innovation District. 

Oklahoma has invested in biotech assets, generally, for over 30 years and a large bulk of these are in the Innovation District. Also, over three-quarters of all NIH funding in Oklahoma flows into the 1.3 square mile area that constitutes the district, so we knew we wanted to be proximate to all these thought leaders and skilled professionals. When you see the research institutes, physical proximity, and the focus on incubators and space for entrepreneurial discovery, that sends a strong signal of future commercialization activity. The Innovation District is just the next wave of public support when it comes to “ecosystem building.” The Innovation District brings people together, creates collisions and collaboration across industry intersections, and lays the groundwork for commercializing ideas.

Read more about the exciting investment in the innovation district. 

You came to Oklahoma City from Boston, one of the biggest biotech hubs in the world, so I think you have an interesting perspective. In your opinion, why does Oklahoma City have such potential in biotech?

Number one is that Oklahoma City already has most of the component pieces that medical researchers and entrepreneurial medicine developers look for. There are established institutions here with a great deal of overlooked capacity. For example, we have clinical trial centers, like Stephenson Cancer Center, that are experts in early clinical phase research. Stephenson is ranked first in the nation for new patient accruals, and that is a big deal when you are a clinical research service provider like Wheeler Bio where some of the conversations center around clinical trial coordination. Under- enrollment in clinical trials is one of the major pain points facing medicine developers. So, when we are working with emerging biopharma customers, one of the conversations we always have with them is, "Maybe we can introduce you to doctors at Stephenson and help de-risk your clinical trial process." It’s a nice added benefit we feel that we can offer.

Stephenson Cancer Center

OKC is also small enough that we can easily have those kinds of conversations. In Boston, there are multiple universities with medical schools, and you have to navigate relationships with each one. Here, OU Medical is the only one in town and they’re very collaborative. The ecosystem here is well aligned because there isn’t much internal competition. I can pick up the phone and talk to Jason Sanders (senior vice president and provost of the University of Oklahoma Health Sciences Center) about some of our customers. He can then pick up the phone and connect us with James Battiste (MD and Ph.D. at OU Health), Kelly Stratton (MD at OU Health) or somebody who is working on immuno-oncology. Now, with a few phone calls, Stephenson is in line for a clinical trial using material from one of our customers.

Finally, because our ecosystem is integrated and easy to work with, we can help get drugs to the clinic faster. This allows us to source more novel drugs from partners like Boston-based discovery company Alloy Therapeutics. It's much more meaningful for people working at Wheeler—even on the line— to know that their work has a huge impact on patients. Patients in Oklahoma will benefit from exposure to these novel medicines, and that’s a very good reason to be excited at work every day.

Talk a little more about your partnership with Alloy.

Wheeler Bio is a joint venture formed in partnership with Alloy Therapeutics (Alloy), based in Lexington, Mass., and Echo Investment Capital (Echo), based right here in OKC. Alloy is a drug discovery platform company. Simplifying matters, Alloy has hundreds of molecules—representing novel drugs— in the pipeline. Echo is a locally based multidisciplinary investment firm that has deployed more than $1.2 billion in capital across industries. Echo focuses on connecting strong investment opportunities with often overlooked Midwestern assets to unlock unique growth pathways. This joint venture fits Echo’s thesis, and unlocks capabilities for Alloy, by creating a pipeline from Boston-based research and discovery to OKC-based manufacturing.

Essentially, Wheeler’s biomanufacturing programs will integrate with Alloy Therapeutic’s preclinical antibody platforms and discovery capabilities. Wheeler is going to be the preferred manufacturer for Alloy’s pipeline of promising molecules. The goal is to get around a hundred molecules into the clinic over the next 10 years. Most of these molecules, which are monoclonal and bispecific antibodies, are in the oncology space or the autoimmune space. Because we have clinical trials sites in those disciplines here in Oklahoma, many of these molecules will impact Oklahoman patients. For me, that is very meaningful.

It sounds like there are not a lot of companies out there who are doing exactly what you are trying to do in Oklahoma City.

There is nobody doing exactly what we are doing, the way we've set up our business model and technology platform. There are several manufacturers in the U.S. but most of them are large manufacturing companies that prioritize large multi-year contracts over small-batch orders. I call them small-batch orders because, if you are a drug developer, you might go to a contract manufacturer to order only one batch for your preclinical toxicology, PK and PD studies. Then you might order another batch for your clinical Phase 1 trials. After that, you're done with the manufacturer for a while.

Then you go to your clinical trials and your animal studies in your toxicology. Once you demonstrate safety in animals, then you can move on to your Phase 1 safety trials in humans. Human safety trials in Phase One constitute 20 patients, sometimes up to a hundred. Those are small-batch orders. For large manufacturers, it is hard for them to give small customers the attention that they deserve because the revenue is not much compared to multi-year commercial manufacturing orders.

We are flipping that model on its head because we feel that, for entrepreneurial medicine discoverers, this process is broken and doesn’t serve their needs. Over 90% of next-generation drugs are being developed by these emerging biopharma companies. These “venture-backed biotechs” do not have the cash to build manufacturing capacity, so they outsource these needs, oftentimes $8-10 million in manufacturing services. We are coming to the market from a location in the country that is much more cost-effective, so we have added flexibility to offer the best possible deal to these customers.

Obviously, the focus for Wheeler Bio is helping biotech startups. Is being on the ground floor with these companies a big draw for you?

It is exciting to work with emerging biopharma companies. Again, we are creating a new type of service model. We share in the long-term product economics from getting drugs to the market, and that drives total alignment between Wheeler and our customers. Some of our fees are not charged upfront. Rather, we will assess fees later—when we hit a particular clinical milestone for instance— and assume some of the risks that the customers typically take on. We are trying to create a new way of outsourcing. We want to share risks and, by doing that, we think we can solve some of the fundamental issues that plague the development of biologics.

Success in biosciences has been building for decades in OKC. 

The pandemic has led to a lot of debate about offshore manufacturing, especially centered around BioPharma. Do you think Wheeler Bio will play a role in any of this?

Reshoring is happening all around the world. I think different countries are dealing with it in different ways. COVID certainly has demonstrated to the public how fragile and how challenging the supply chain is for medicine, and a lot of the pharmaceuticals in the U.S. are manufactured offshore. A significant portion of the raw materials that go into making pharmaceuticals are manufactured offshore too. We will have a very small part to play in this much larger movement, but we are definitely part of that broader mission. Bringing critical manufacturing capacity back to the U.S, especially when it comes to developing novel drugs that can save and improve lives, will bolster national resilience.

People doing biologics drug development right now, including for antibody drugs, have to take their lead molecule to companies like WuXi Biologics in Shanghai and have them do process development. WuXi makes the cells for them, does process development, spends around 12 months on it, and then sends that drug back to the U.S. Then, the drug developer will conduct clinical trials here in the US. So, there is a significant amount of wasted time, handoffs and tech transfer across the process. If we are going to continue to see growth in the biologics— which we are— I don't think that is sustainable. We need more capacity at home, integrated alongside the other nodes of development.

You talked a little about how the local workforce is a big positive. I imagine for Wheeler Bio to achieve want you want, making sure that the talent pipeline stays full is a big focus of yours.

We have got a great workforce training infrastructure here with Oklahoma CareerTech. It's an award-winning career training system. There are a host of transferable skills that people here in other jobs already have and the rest of the skills that are needed to be on the floor in a complex manufacturing environment can be taught either on the job or through a specialized curriculum that partners like CareerTech can develop relatively quickly.

There is great momentum around workforce here. We already have a good, critical mass of people that are trained in biomanufacturing. For example, Cytovance employs 350-375 people that do biomanufacturing every day. There are also companies in Norman, like ARL, that do GMP-type analytical testing, so there is a critical mass of companies that all share the same objective of preparing the career pipeline here locally.

That is, there’s a strong baseline in OKC. If we design purposeful courses in biomanufacturing-dedicated training facilities, and put real equipment in those facilities, we can offer compelling, hands-on, real-world career preparation. We are partnered with Dr. Marcie Mack at CareerTech and Katy Boren at the Innovation District on this, but it is a huge investment. Right now, we are focused on locking down our partnerships, developing an actionable roadmap—including curriculum development— and then going after federal dollars, which are more available than ever right now as a response to COVID-19.

What are some things the local community can do to make sure this momentum in bioscience continues?

Oklahoma City's Innovation District

I encourage the public to pay attention to local policy and helping support policy that bolsters Oklahoma’s scientific and business communities. For instance, there are several proposed or recently passed bills attempting to drive more VC dollars into our state. If executed correctly, these can support early and growth-stage Oklahoma-based companies, generating much needed economic diversification. Oklahoma could also do more to support critical investments in jobs of the future, through incentivizing private spending on R&D and workforce training. The global economy will only grow more complex with time, so Oklahoma-based companies must reinvest in knowledge and advanced skills to remain competitive. We are behind—but catching up—in these areas.

Finally, supporting Oklahoma in gaining access to more federal dollars, like NIH and NCI (National Cancer Institute) funding, is vitally important. Foundational research funding has always been a hugely impactful economic stimulus and has been the workhorse of strong tech-based economies on the coasts. Increasing our share of this funding would have a huge impact on Oklahoma biotech.