Recently, I had the honor of interviewing Dr. Jon Rowley, founder and CTO of RoosterBio. RoosterBio, Inc. is a privately held stem cell tools and technology company focused on accelerating the development of a sustainable regenerative medicine industry. Its products are high volume, affordable, and well-characterized adult human mesenchymal stem/stromal cells (hMSCs) paired with highly engineered media systems.
In this interview, we explore RoosterBio’s recent product launches, collaborations, achievements during 2016, and future trajectory.
Interview with Dr. Jon Rowley, CTO of RoosterBio
Cade Hildreth: Recently, you announced a CRADA with the USA ISR, as well as the award of an MTEC contract with BioBridge Global. Could you speak to the importance of these announcements?
Dr. Jon Rowley: The RoosterBio story is unfolding and our recent product launches and partnerships are interesting pieces of our story. We have been developing technologies specifically to address the bottlenecks in Regenerative Medicine that we have not only seen, but have lived.
We are aiming to make it easier for people to develop products incorporating stem cell technologies. If we can make it easier, i.e. simpler, faster and more economical, it will accelerate the development of the entire field of stem cell-based therapeutics. That is our core mission, to accelerate the stem cell-based bio-economy, as well as the global regenerative medicine industry.
All of our recent partnerships build on the foundation of our innovative product platforms. We have commercialized several first-in-class products, including bioreactor media feeds and plug and play bioreactor kits. These offerings essentially allow anyone to become an expert stem cell manufacturer on their first attempt.
What we are aiming to do is radically change the way people use stem cells. When I talk at industry conferences, I emphasize that we are moving towards the industrialization of stem cell technology. One of the big bottlenecks is that it takes forever to get through product development to start a clinical trial. RoosterBio products are designed to specifically address this expensive bottleneck, and we are radically shortening the development timelines of stem cell-based products.
Our customers are finding it faster, simpler and less costly to move through product development and into clinical development. The faster companies can start a clinical trial, the faster they can get to a yes/no answer, saving them years of time and millions of dollars. This is accelerating the whole field!
In the pharmaceutical world, if you are going to fail, you want to fail quickly and fail cheaply. Existing development timelines substantially balloon the developmental costs of drugs. What RoosterBio is trying to do with our manufacturing-focused product platforms is to make anyone an expert cell manufacturer.
In addition, we are creating clinically-compliant product platforms, lowering the regulatory burden/barrier for these manufacturing processes, by doing things such as removing all bovine and xenogeneic materials.
Now that we have launched these products, our plan is to:
- Scale them up
- Thoroughly understand the impact of these more high-tech manufacturing approaches on stem cell function
This is where our CRADA with the United States Army comes into the picture. CRADA stands for a Collaborative Research and Development Agreement. The U.S. Army is very interested in how stem cells can be used to treat poly-trauma injuries in Wounded Warrior applications. So far, the military has not been able to find a consistent stem cell source for translational research, let alone to take into clinical trials. Now, we are collaborating with the U.S Army to directly address their needs.
We signed a CRADA to supply a consistent set of cellular starting materials to the U.S. Army that will allow them to understand the utility and potency of MSCs, as they relate to Wounded Warrior applications (trauma-specific applications), and develop methodologies to incorporate these cells into off-the-shelf battlefield therapeutics.
In addition to the CRADA, we collaborated with the U.S. Army, and also BioBridge Global and StemBiosys, to submit a large MTEC (Medical Technology Enterprise Consortium) grant to the U.S. Department of Defense. The call for applications requested applicants develop/utilize scalable manufacturing technologies for stem cells, ideally xeno-free, getting up to at least the 50 liter bioreactor scale. It felt like the call for applications was written specifically for us.
Within the MTEC collaboration (which is actually a DoD awarded contract), RoosterBio is scaling up MSC manufacturing processes to tens of billions of cells in suspension bioreactors, with the final goal being to get to the 50 liter scale (something we’ve already demonstrated in our collaboration with Pall), now with a xeno-free manufacturing process. Running a 50 liter bioreactor is extremely expensive, easily costing over $30,000 dollars in materials to run one bioreactor. Securing an $8 million contract, with a big chunk of it available to RoosterBio to pay for bioreactor development, will allow us to optimize and scale rapidly, while also developing ways to enhance process economics to drive these costs down for the industry.
The U.S. Army’s Institute for Surgical Research’s (USAISR) role is to be the cell characterization experts in order to elucidate MSC potency following expansion using large scale manufacturing platforms since it’s not enough to just grow large numbers of cells; they have to maintain their critical functional attributes.
We have plenty of people say, “Oh yeah, we would love to run it for you, just give us the material for free.” As a small company, we can’t do that. Hence, non-dilutive funding (such as grants and government-awarded contracts) is critical to fund this scale-up development work, while again, ensuring all potency metrics are maintained as we scale up to 50 liters. The USAISR has a very important role there, and this is how the CRADA and MTEC contract are related.
The great thing is that if, for some reason, the potency measures are not maintained, we can catch that and fix the manufacturing process to address it. This is known as “manufacturing science.” It involves simultaneous process and product development, both scaling of the manufacturing process and evaluating and tweaking it based on a scientific approach, to ensure that the product coming out the back end is what is anticipated and needed.
BioBridge, the lead organization for our MTEC work, and StemBiosys have novel xeno-free technologies. We have scalable MSC platforms and bioprocess media systems. The USAISR has cell characterization expertise. Together, we make a powerful and well-equipped team to address MSC scale-up for therapeutic applications.
Cade Hildreth: Congratulations on that powerful collaboration. Could you please tell me more about your recent partnership with Pall Corporation?
Dr. Jon Rowley: Definitely. This Pall relationship is awesome for us, because we have been developing technologies that allow stem cell researchers to scale their manufacturing. We have vials of low passage (i.e. young) stem cells in high volume working cell bank formats right sized for large scale bioreactors. Furthermore, we have commercialized the industry’s first fed-batch stem cell bioprocess media system. These are great products, but require other technologies for them to be implemented by our customers.
In order to scale-up manufacturing within a bioreactor, you need Pall equipment. Pall has single use bioreactors, closed system microcarrier products, single-use disposables, and all the tubing sets and filters needed to perform MSC bioprocessing. Pall Corporation is very focused on cell therapy, and our products help them diversify their product offerings in the Regenerative Medicine space.
Our collaboration with Pall is “two-for-one.” It is a technical collaboration, where we are able to bring our technologies together to develop “plug-and-play” systems for large scale stem cell production. In addition, Pall will be marketing and distributing RoosterBio cell and media systems (with Pall branding) along with their scalable manufacturing platforms, to accelerate cell therapy manufacturing.
Recently, we presented data from our collaborative program with Pall, showing that together we can achieve unprecedented stem cell yields in scale-up bioreactor systems. The data that we presented at BioProcess International demonstrated that we achieved a 35 billion MSC harvest in a 40 liter bioreactor in only eight days using the fully single-use, closed Pad Bioreactor platform!
We have proven that we can get extremely high yields in very short amounts of time. It is the first time ever these yields were accomplished at such a large scale.
Cade Hildreth: Congratulations!
Dr. Jon Rowley: Thank you. When I say that we are trying to radically shorten development timelines, I think we are achieving this. It took four to five months of work to get the system into Pall and scaled up to 40 liters. Typically, a two-year timeframe would be required, but because we had worked it out at a small-scale, Pall achieved rapid success in their 15 liter bioreactor. Then, they rapidly scaled it up to 40 liters, because it was going so well.
Again, we are taking mass chunks of time out of the development of scalable cell manufacturing processes. The idea with Pall is that we can offer these as “plug-and-play” solutions. “Hey, you need to manufacture tens of billions of cells? Here are your cells, here is the media, here is the bioreactor, here are the microcarriers, here are all of your single-use systems.” RoosterBio cannot offer this complete solution alone, and this partnership with Pall will help us get this much-needed product line to market. A very important part of our Pall collaboration is the combination of our technologies. We are bringing together our complementary technologies, so that people do not have to try to put them together themselves.
The second key aspect is that we are a small company, and while we could raise money to greatly expand our sales force, that takes time and energy. Pall has a very large bioprocess sales force with approximately 400 global sales people and about 70 bioprocess specialists that can sell our products worldwide.
They have now launched our products and will be scaling the distribution of RoosterBio products to rapidly get them into the hands of scientists and engineers around the world.
Cade Hildreth: That is fantastic.
Dr. Jon Rowley: Thanks, Cade, we are really happy to be partnering with such an innovative bioprocess company such as Pall. First, they have this massive bioprocess commercial engine that we are now plugged into to rapidly increase our worldwide audience. We have shipped our products to 16 different countries right now, but our reach is still limited because of the size of our internal sales and marketing teams.
Pall has branded our products as AllegroTM Unison hMSCs and AllegroTM Unison Bioprocess Media. We have our logo on the labels, stating that these products are “Manufactured by RoosterBio.”
Now, we can focus on developing kick-ass, hi-tech products that are going to be the next wave of cutting-edge tools and platforms for cell therapy manufacturing. This also allows Pall to focus on the sales and marketing for us, which is an area where they excel. There is great synergy between the two company’s products and expertise.
Cade Hildreth: Makes sense. How did the Pall relationship start? Did you seek them out or did they seek you out?
Dr. Jon Rowley: I have been collaborating with lots of people within industry over the last 10 years. I published papers on stem cell bioprocessing with scientists from Pall Corporation. We have known them for so long, that they were on a short list of likeminded companies to call.
It was a short list of companies that had complementary products, without overlapping product lines. Pall was the one that made the most sense and presented the most mutual benefit.
Cade Hildreth: Fantastic, that is an awesome summary of RoosterBio’s key accomplishments during 2016 – the CRADA, the MTEC contract with BioBridge Global and StemBioSys, and the Pall Corporation collaboration.
Are there other key accomplishments that have marked RoosterBio’s path?
Dr. Jon Rowley: From a partnering perspective, that is the key matrix. Again, none of those partnerships would make any sense if we had not launched our bioprocess products within a year of them. These partnerships are based on the foundation that our product lines are specifically designed to advance the manufacturing sciences and product development aspects of regenerative medicine.
Regarding internal accomplishments, RoosterBio has doubled in size since January 2016, without raising any additional capital. We have been growing, we have been developing our business, and we are still working on raising money. With our businesses being so strong, we have been able to expand and grow organically.
We found a market niche that hadn’t been addressed. Nearly all the stem cell products out there are focused on the basic researchers, which is good, but that is not our target market. The basic researchers have certain needs. In fact, we do not call our cells “research grade.” Technically, if cells are not suitable for using in humans, they are called “research grade,” but we like to call our cells “development grade.” Our products are highly differentiated in the market because we are focusing on the people that do product and process development. These people have different problems than the basic researchers and need high volumes of well-characterized, high quality cells. We provide them with the cells, media and platforms to achieve their aggressive and ambitious goals.
Cade Hildreth: What types of new hires have you made this year?
Dr. Jon Rowley: We are bringing on a strong team of people with mesenchymal stem cell (MSC) backgrounds. We have added to our Development, Production, and Sales teams. Our hires have largely been made to support analytical development, strengthen up our assays, improve our manufacturing process development, and support the MTEC grant.
We have also expanded our Product Development and Manufacturing Operations, a group which tripled since January. Now, we are assembling our Regulatory and Quality Teams.
Cade Hildreth: What are your goals for 2017?
Dr. Jon Rowley: Our goals in 2017 will be to make sure that the Pall relationship is successful, as well as to scale our business. Scaling our business is our number one goal.
I am a big fan of the “lean startup” approach to entrepreneurism. A startup is not like a beginning small business. A startup is actually a high-risk endeavor, which is either going to work or is not going to work.
What do you want to do? What do you want to get into? Do you want to get your products to the market quickly? You have to figure out if you have a product that is a good market fit and can get good traction. If this is not the case, how do you reconfigure the product to make it fit before you run out of money?
We have had a good market fit for our products from the get-go. We got our early adopters, now it is time to “cross the chasm” and get a wider audience for our products. The number one thing RoosterBio has to do is scale our business, and ensure Pall Corporation’s success in dramatically increasing our sales and visibility.
We are ramping up our manufacturing operations to support a much greater market for our products. To do that, the startup challenge is to scale your operation without sacrificing quality. People use RoosterBio products because of our quality is exceptional every single time. Our clients have an excellent experience every time. We have done it well so far and have already gone through a couple of scale-ups, without any hiccups.
We are still in a Frederick Technology Incubator, so we need to graduate from this incubator and move into our own facility. That is going to be a major goal for next year, making that move to accommodate our growing team.
Simultaneously, we need to make sure that we support both our internal sales, as well as our external sales through Pall Corporation so that we can come to market with our next wave of products, all focused on radically shortening the development timeline for regenerative medicine products that incorporate stem cells. We are not coming out publicly with what exactly those are, but there will be multiple exciting product launches in 2017.
We have changed how people are using stem cells for their product and process development work. The next question is: how do we dramatically reduce the time required to move from research work into the clinic?
In 2017 and beyond, we will stick to our core mission of accelerating regenerative medicine and the translation of stem cell based products to benefit patients. I think we were at the right place at the right time in the industry. Nonetheless, there will be a lot of celebration here when our products directly impact a patient within a clinical trial. MSC method of action is complex. You need a good, well manufactured product, which is consistent. That is one challenge that we are trying to address.
Cade Hildreth: Are you planning to keep RoosterBio a MSC specialist? Or, will you consider expanding into other stem cell types in the future?
Dr. Jon Rowley: That is a great question. I think of RoosterBio as a stem cell raw material company. As people are incorporating stem cells into their clinical products, they need to access to consistent starting materials.
Mesenchymal stem cells (MSCs) are a stem cell type around which we could create a viable, revenue-generating company. As we expand our products over the next 5-10 years, any stem cell type with a reasonable market that is being used in a variety of applications may represent an opportunity.
As it becomes apparent what stem cells have a reasonable market and require a consistent and robust starting material, I could see us getting into that area. Our manufacturing expertise can be applied to any type of cell, whether it is a T-cell, a pluripotent stem cell, or a different type of cell. However, right now, in RoosterBio’s early stages, we need to stay focused as a company. I see us maintaining our focus on MSCs for at least another 2-4 years as we build our company, making it sustainable, and reinvest our profit into next generation products. After those steps, I could see other stem cell products on the horizon.
We are keeping a very close eye on the stem cell world for technologies that fit into our philosophy.
Cade, do you follow the Chinese zodiac?
Cade Hildreth: Not very closely. How come?
Dr. Jon Rowley: 2017 just happens to be the “Year of the Rooster.”
Cade Hildreth: Wow, it is your year. That timing is fantastic.
Dr. Jon Rowley: When I see our story unfolding, we have a great foundation. If you visualize the pyramid around which our company is built, RoosterBio has great technology, innovative products, and there is market need for manufacturing technologies which our products address. We are also supported by partners that will accelerate our success.
We are benefiting from funding to scale our manufacturing, provided by the MTEC grant, and Pall’s assistance will provide complementary product pairings, cobranding opportunities, and a global distribution network. These events are setting us up for success in 2017 and beyond.
According to the Chinese zodiac, the prophecies have been written. Now RoosterBio is shepherding the Regenerative Medicine field into a New Year filled with scalable stem cell manufacturing processes for all, as we continue to execute to our business plan.
Cade Hildreth: All of this is exciting. Congratulations again on all you have achieved in 2016!
Thank you for sharing your vision of Roosterbio with our audience. It has been my pleasure to do this interview with you!