Building a new standard of CDMO in Fishers, IN: Q&A with Cory Lewis, Founder and CEO

In May of 2022, INCOG BioPharma officially opened its new facility on the northeast side of Indianapolis in Fishers, IN, to support biopharmaceutical companies bringing injectable therapeutics to market. The flexible fill-finish facility, equipped with state-of-the-art equipment, creates a better path to market by combining improved speed, flexibility, risk mitigation, and reduced administrative complexity—enabling biotech and pharmaceutical companies to rapidly scale from clinical to commercial readiness production under one roof.

Below is a summary of a conversation with Cory from a podcast hosted by Raman Seghal called Molecule to Market. Hear how Cory discusses his journey and answers biopharma stakeholder questions about INCOG BioPharma’s leadership, its new site in Fishers, and the company moving forward.

Cory, can you give us an overview of who you are, how you got into the CDMO sector, and what you do at INCOG BioPharma today?

After graduating from Indiana University, I started my career with Baxter in Chicago in 1996. I spent several years in finance and marketing, then ultimately had the opportunity to get exposure to the CDMO business in early 2002. From 2002 to 2008 I worked at a location in Bloomington, Indiana at a site now referred to as Baxter BioPharma Solutions. Then, in 2009, I joined Tedd Green [INCOG BioPharma’s COO and co-founder] at Cook Pharmica and stayed on with that company through the acquisition with Catalent—and ultimately departed Catalent in February of 2019.

I really wasn’t sure what my next step was, but that’s ultimately what led us to where we are today with INCOG BioPharma. Going back through my 25 years in the industry and 20 years in the CDMO space is what ultimately led me to what is INCOG BioPharma. As the CEO and Founder of the company, I can’t be everywhere at once. So, we’ve got to rely on the team to be able to execute, across all parameters of the business. We’ve assembled an experienced, flexible, nimble, and responsive team that can react to fast-changing manufacturing demands of biotech companies. Speed to market is essential and we’ve optimized our nimble “COG” to work together so that we can get the job done. And we’ve created great results. That’s a core component of INCOG BioPharma.

Would you tell us more about your experience growing Cook Pharmica from 2009 to the $950 million acquisition by Catalent in 2017?

Certainly, so that was April of 2009 when I made the decision to move to Cook Pharmica. I had the opportunity to talk to Tedd Green, who was (serving as) interim President at the time, and we hit it off very quickly. I made the decision to come join him, leading the business development activities there. At that time, they had been in business for five years and had 200 employees and was, what I though was going to be, a significant growth opportunity.

As I got into Cook Pharmica, I quickly figured out we had our hands full. We had very few customers and we were spending significant cash flow supporting our drug substance business. We were investing heavily to bring on drug product manufacturing. But we had less than five customers and it was truly a startup. We put a lot of effort into turning this company into a success story by focusing on our approach to customer acquisition differently. We grew the team to north of 850 employees who were really focused on getting product to patients and really focused on customer service. We clearly had great assets, great technical capabilities, strong quality systems, but the thing that I liked about Cook Pharmica was our customer-centric mindset. And that’s what the CDMO market needs and that’s why I’m really excited about INCOG BioPharma. We’re bringing these elements to the surface: best in class equipment, best in class processes and systems, and ultimately, having the best focus on customer service to get product to patients. I couldn’t be more excited about where we are now with our facility, the installation of our OPTIMA Multi-Use filling line, and capacity to support biopharmaceutical customers with sterile injectable filling.

Describe the new Fishers site of INCOG BioPharma and the Fishers Life Sciences and Innovation Park?

In terms of INCOG BioPharma’s facility, we opened our 90,000 sq. ft. facility in May. Our investment in world-class facilities and state-of-the-art injectable manufacturing and flexible filling equipment supports both clinical and commercial projects to get transformative treatments to patients who need it faster.

For the surrounding life sciences manufacturing ecosystem in Central Indiana, the scale and magnitude of what’s to come is astonishing. Fishers has had close to $1 billion in life sciences investment in the last 24 months, and we’re glad to be at the front of this growing presence. Our location is within a one-day’s drive of about 80% of the entire U.S. population. The Indianapolis airport hosts FedEx’s second largest hub in the world, making it ideal for time-sensitive biopharmaceutical supply chain logistics. Over the past months, numerous global biopharma manufacturing and supply chain constituents, such as List Bio, Genezen, and Stevanato Group, have broken ground on their respective North America manufacturing hubs. We also have a long history of manufacturing in the state of Indiana. I think what makes this a great area for recruitment is Central Indiana’s combination of people who understand life sciences with other great companies like Eli Lilly & Company, Zimmer-Biomet, and Roche Diagnostics, for example.

When will cGMP activities be available at the Fishers, IN, facility?

We have taken on three projects since opening the facility, including one project that is a commercial pre-filled syringe. We are commencing the technical transfer process for these projects, and we expect to be filling drug product into components on our multi-use filling line by October 2022.

What is INCOG BioPharma’s production capacity in 2022 and into 2023?

Once media fills have been completed and the line is primed and ready, the OPTIMA multi-use filling line has throughput capacity of up to 9,000 units per hour, supporting with 100% in-process-controls to ensure accurate filling volumes with every single unit.

While capacity typically depends on various container sizes and the customer’s formulation volume of the drug product, on a general capacity level, INCOG BioPharma has capacity for 40,000,000 units per year across vial, syringe, and cartridge formats.

Is INCOG BioPharma conducting live, in-house tours of the Fishers, IN facility?

Yes, one standout aspect of our customer-focused experience is our transparency. Come see what it’s like in our on-site client offices, where you can be part of the project every step of the way with nothing but large glass panes in between you and the formulation and filling suites. We’d be more than happy to share some of our Hoosier hospitality to make your experience fantastic.

Looking to future expansion and capabilities — what is INCOG BioPharma’s goal for the Fishers facility in terms of fill/finish capacity?

Our 16-acre campus has been master planned to support rapid expansion to include a total of up to six filling lines, supported by up to 12 automated packaging and visual inspection lines suitable for large-scale, high-throughput projects. In fact, we are actively planning for the installation of a second filling line and automated inspection and packaging capabilities that will be installed within our existing footprint.

Is there anything else you’d like to add?

The only thing that I would say, and this isn’t directly related to INCOG BioPharma, but to whomever might be reading: don’t take the easy route. The easy route is just that, it’s easy. And I can tell you firsthand that this journey of starting a company, is not easy. It’s hard work, but it’s also extremely rewarding. We acquired a piece of land that undeveloped. We built a new facility on this site, brought in state-of-the-art equipment, and are building a team with unparalleled customer focused attributes. I come to work every day having fun. Is it hard? Yes. But when you put in the effort and you’re able to see these things coming alive, it can be very rewarding. And that’s encouraging. Whatever you’re doing in your day-to-day area, put in the extra effort to get your product to patients—because it’s going to be a lot more rewarding when you know that you made a positive difference in a patient’s outcome.



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    INCOG BioPharma Services
    12050 Exit 5 Parkway
    Fishers, IN 46037