An Interview with... Ajay Damani - CEO, CoreRx

An Interview with… Ajay Damani – CEO, CoreRx

What experience do you bring to CoreRx Ajay? Tell us a bit about yourself.

Thank you for the interview and the opportunity. I’ve been working in life sciences Research & Development for my entire career, with the last ten years in the pharmaceutical Contract Development and Manufacturing Organization (CDMO) industry. My prior experiences in the CDMO sector were with Adare Pharmaceuticals and Capsugel (Lonza), where I led global commercial organizations directly, and was a member of the respective leadership teams. Having begun my career in management consulting, I’ve had exposure to a variety of businesses, focusing on the development of growth strategies. As a systems engineer by training, I bring a rigor to my day-to-day work, though strive for balance with a passion for unconventional thinking and collaboration. The aspect of business I enjoy the most is in creating new jobs and opportunities for employee advancement through business growth.

What vision do you have for the business both for the short and medium term?

We are on a mission to become the premier CDMO in the industry. We have recently entered the commercial manufacturing space and are now an end-to-end provider, having successfully launched seven products into the US market. That number will grow to 20+ over the medium term and will include launches into ex-US markets. We started 2021 as a single campus operation based in Clearwater, Florida and added an additional site in San Rafael, California in May. In the near term, we expect to add more sites with the intention to be even closer to our partners. We have added capabilities with the acquisition of Nucleo Life Sciences and will continue to expand our technology platforms. Lastly, while our customer base today is mainly small to mid-size pharma companies in the US, we will broaden our engagement to include larger pharma and partners across Europe and Asia.

Can you give us an overview of the services CoreRx provides to the pharmaceutical industry?

CoreRx primarily focuses on oral solid, oral liquid, and semi-solid dosage forms. Our end-to-end offering spans pre-formulation, formulation development, analytical/stability testing, clinical materials supply and GMP manufacturing. We are oriented around three of the industry’s most challenging problem statements: (1) Speed to Clinic & Market where we have a proven track record in quick to patient formulations; (2) Enhanced Formulations where molecules require bioavailability enhancement or a unique modified release profile; and (3) Customized Solutions where customers have unique equipment or facility requirements that do not fi t within the construct of a typical CDMO. We provide these services to a customer base that spans NBE, NCE, and 505(b)2 product programs.

Can you tell us a bit about the acquisition of Nucleo Life Sciences and how those capabilities and a bicoastal presence are helping CoreRx grow?

We are very excited about the integrated offering that Nucleo Life Sciences allows us to bring to the market. The acquisition is a perfect complement to the existing business in that it is synergistic with CoreRx expertise in early product and process development. Whereas CoreRx had a strong presence on the East Coast, Nucleo had a stronger West Coast presence, and the customer base was 100% complementary. The offering was also complementary– Nucleo and CoreRx both provided fast to clinic dosage form development and enhanced formulations for molecules with challenging target profiles. For molecules facing bioavailability enhancement challenges, Nucleo has industry leading capabilities including spray-dried dispersions (SDD).

Why are pharma companies increasingly looking for integrated services across the value chain?

Good question. Although targets may change, pharma companies remain focused on a few key drivers for successful product development: speed through development with minimal risk, resulting in robust products that achieve the target product profile. Many companies can deliver part of that value proposition, but most cannot deliver on all of it. What I mean is that most CDMOs are designed to deliver on only a part of the value chain. For example, a company focused on early-stage product design rarely has the ability to scaleup and provide a smooth transition to larger scale Clinical Trial Materials and Commercial production.

What kinds of companies make for the ideal organizational/partnership fi t with CoreRx?

We can work with companies of all shapes and sizes–from large multinationals with highly established procedures to “2 women and a molecule” working virtually and on a tight budget. We tend to ask the question the other way around–how can CoreRx be the ideal partner for pharma companies? We have a highly flexible business model that makes us easy to work with, and passionate employees who care as much about our partners’ product as they do.

How does CoreRx differentiate itself from other providers offering similar services?

The CDMO industry is highly fragmented, however there are rarely two companies that look exactly the same. Our differentiation is multi-faceted. First, I would point to our talented and passionate employee base, and state-of-the-art equipment capabilities, including the Gerteis platform. Second, I would point to our impeccable quality track record. Third, our formulation development and analytical services offering in oral solids and liquids is second to none. Fourth, our customer service and project management orientation has led to very high levels of customer satisfaction. Fifth, our turnkey approach to clinical trial materials allows our customers to use us as a ‘one-stop shop’. All of this has resulted in a strong and loyal customer base for the business.

The last point I would make is an intangible one. Our colleagues have a sense of pride and passion that is rarely seen in the industry. We deliver on challenging projects and engage with customers in a highly differentiated way. That’s actually the main reason why I was attracted to CoreRx.

Looking forward, how will CoreRx continue to be an important partner for its current and future clients?

CoreRx is on the move. The future is bright in the pharma industry broadly and in the outsourcing space, and I believe CoreRx is uniquely positioned to better serve customers and therefore grow faster than other CDMOs. We have an owner who is willing to invest behind the business and into value-creating acquisitions that expands our capabilities and allows us to best serve our customers. We are invested in bringing the industry’s best talent to work at CoreRx, and to ensuring strong partnerships with our customers. We will solidify our position as the industry’s center of excellence for the development and production of oral dosage forms- scientifically-oriented, quality driven, and with innovation at our core.