72 Contract Pharma contractpharma.com June 2021

Kristin BrooksManaging Editor, Contract Pharma

R ecently, NovaQuest Private Equity acquired CDMO Cor-eRx, Inc., based in Clearwater, FL. CoreRx, a provider of clinical and commercial development and manufacturing

services to small to mid-sized pharma and biopharma clients, was founded in 2006 and specializes in complex formulation challenges. The company offers pre-formulation, formulation, analytical and stability, clinical manufacturing, commercial man-ufacturing, and packaging services.

This transaction supports future growth for CoreRx in part-nership with NovaQuest, leveraging its expertise in pharmaceu-tical services and enabling technologies to enhance the business for its customers.

In connection with the NovaQuest investment, CoreRx will continue to build out its capabilities, adding technologies and in-creasing scale to enhance service offerings. Todd R. Daviau, Ph.D., MBA, President and CEO of CoreRx, provides insight into market trends, opportunities, and the greatest motivators for outsourcing in today’s market.

Contract Pharma: What are the current pharma/biopharma trends impacting CDMOs and services?

Todd R. Daviau: To some extent, it depends on the client. Most of the larger pharma clients have their supply chain and logistics sorted out – even having secondary and back-up suppli-

ers. For the smaller clients who don’t have the resources, I think we will continue to see supply chain and logistics get a lot of coverage as the industry continues to ramp up to meet the un-precedented need to vaccinate the global population. Delays in some raw materials as well as packaging supplies will continue as manufacturers strive to return to pre-Covid-19 employment lev-els. Additionally, in the aftermath of Covid-19, companies need to fi nd a way to minimize supply chain risk by fi nding and work-ing with alternatives sources.

CP: Where do you think the biggest opportunities lie?TD: I believe that we will continue to see a trend towards bio-

availability enhancement, not just since small molecules continue to lead the charge when it comes to product approval, but also due to the growing number of bioavailability enhancement tools available to formulators today.

We are also seeing smaller companies working towards com-mercializing products themselves rather than selling their mol-ecules in Phase 2. This is creating more opportunities for the CDMO marketplace – especially those CDMOs, like CoreRx, that are able to offer technical expertise from the drug substance characterization through product development. And because of this expertise and the number of technologies available to us, we do not just offer up one formulation approach because that’s the

CEO SPOTLIGHT:Todd R. Daviau, CoreRxFollowing the recent investment from NovaQuest, CoreRx plans for the future.

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NEWSMAKERS: CORERX

only equipment we have. We don’t just push a client towards API in capsule, or spray drying because that is our only technology. Rather, we look holistically at the client’s target product profile and create a number of prototypes that meet their demands and ultimately give them a commercially feasible product.

CP: What expertise is needed in today’s market?TD: At CoreRx we have a history of getting our clients across

the finish line. The ability to remain flexible, to be able to pivot as the needs of our clients change, is a hallmark that sets CoreRx apart in this industry. The tools we have at our disposal – be it spray drying, Gerteis roller compaction, etc. – are a part of what we offer to our clients, but it’s our people that truly sets us apart. The ability to listen and understand the needs of our clients and give them a product that meets their target product profile and performs in the clinic, is what we continue to offer in order to succeed.

We also continue to broaden the range of service offerings to our clients. We have recently expanded our analytical capabilities to include some large-molecule analytical capabilities. Our new Product Development Center, which opened last year, has several large purpose-built formulation development suites and a large central analytical laboratory. We also continue to add to our ana-lytical and formulation arsenals by adding equipment resources to support our oral liquids, oral solids and semi-solids including enhanced permeation testing capabilities.

CP: In what areas do you expect to grow and expand as a result of the acquisition by NovaQuest?

TD: CoreRx has a strategic plan in place that evolved with the NovaQuest investment. We continue to execute on this plan and accelerate that plan when the opportunities arise. That said, we will continue to add technologies and capabilities to expand the services we offer to our clients, increasing scale, and when the opportunity arises, expand inorganically through acquisition to add capabilities or technologies that enhance our service offer-ings to our clients.

We also continue to expand our Quality Management Sys-tems to include things like Master Batch Records, Test Methods and Specifications, as well as implementation of a new ERP Sys-tem and LIMS systems to more closely align with the growing needs of our commercial clients.

CP: Where are you looking to add capabilities or expand?

TD: We will continue to be active from a strategic standpoint and look at adding complementary services such as sterile fill & finish, some specialized microbiology and raw material testing capabilities as well as finished product testing capabilities.

Our goal is to be the local development partner to our clients throughout the world, and to be able to offer them comprehensive services to meet their growing needs both in the U.S. and abroad.

CP: What are some of the challenges pharma/biopharma companies face in today market?

TD: Because travel is still limited by many countries, I think we will continue to see virtual interactions with clients as the norm for the immediate future, and possibly beyond 2021. These ongoing travel restrictions have presented challenges to the

Pharma and Biopharma community in identifying and validating their confidence in new vendors. At CoreRx, we have leveraged a variety of multi-media platforms to engage with clients remotely over the Web for technical, business and project discussions. We are also using these services (Zoom, Teams, etc.) for virtual tours and quality audits. Embracing these technologies has allowed clients to still get the personal experience that they are looking for and provide them as close to an in-person assessment of our facilities, people and infrastructure as you can get.

CP: What are some of the greatest motivators for outsourcing in to-day’s market?

TD: The evolution of the pharma/biopharma sector over the past 30 years is no different than any other industry. Over time, companies start to understand what aspects of their business are truly core competencies, and what aspects are not. In our sector, we have seen the larger Pharma organizations pivot around this core competency concept over the past 20 years, focusing more on the discovery and commercial aspects of their business, and outsourcing the pre-IND through commercial aspects of drug development to third party services providers. The benefit they get as it relates to the drug product development and manu-facturing space is to offshore large fixed assets that may not be completely utilized at times, while benefiting from the experi-ences that service providers gain from dealing with a vast array of projects/molecules.

When it comes to formulation development, you can also evaluate the market to find the right formulation approach or technology that is available to solve your compound’s problem, without having to make the internal investments in both the cost of the technology or experienced personnel. This model has only become further enhanced, as the smaller pharma/biophar-ma companies are now in many ways the R&D engine for large Pharma and Biopharma, running virtual organizations that, for the most part, outsource all their development needs. CP

Todd R. Daviau, Ph.D., MBAPresident and CEO, CoreRx

Todd Daviau, an accomplished scientific leader, brings over 30 years of pharmaceutical experi-ence and knowledge to CoreRx, as well as being one of principal

founders. Prior to founding CoreRx, he served as Director of the Analytical and Pre-Formulation Laboratory for MDS Pharma Services in Tampa, FL. In this role, he directed the analytical group of over 20 scientists responsible for all the analytical, stability, and pre-formulation activities in support of over 75 stability, formulation and/or manufac-turing projects. Dr. Daviau was also a strategic analytical team member with Nova Pharmaceuticals (later Guilford Pharmaceuticals), and involved in a number of NDA pro-grams, including the development of Gliadel®.

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