There are nearly 3,000 pharmaceutical companies in the United States with revenues of $500 million or less. Most lack the logistical resources to bring their innovative drugs to market and are located in areas with minimal outsourcing support. Alcami originally formed in 2013 when AAI Pharma Services and Cambridge Major Laboratories joined forces; however, the official Alcami brand launched in March 2016 based on the understanding of “two persons and a patent.” We seek to drive change and positively impact the industry by providing much needed support to a key group of innovators that have largely been ignored — though they represent the future.
Our commercial strategy is guided by an educational approach designed to address the unique needs of these smaller firms. We provide leadership and advice when they are still potential customers and proactively disseminate information on the entire drug development process, including regulatory compliance requirements. Most importantly, Alcami serves as more than a contract development and manufacturing service provider; we are a true partner to our customers, offering educational consulting and other support tailored to — and customized for — their specific circumstances.
With approximately 1,000 employees operating at 10 global locations, Alcami provides tailored solutions for small and mid-size pharmaceutical and biotechnology companies by offering individualized and integrated services across multiple areas. We connect our clients with innovative solutions for API development and manufacturing, solid-state chemistry, formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (oral solid dose and parenteral) and packaging and stability services.
Alcami’s ultimate goal is to become an industry-leading contract development and manufacturing organization (CDMO) focused on small and mid-sized pharma customers; we aim to support the most new drug launches on an annual basis.
The first phase of Alcami’s 10-year strategic plan involved building, integrating and forming the company that Alcami is today. This phase was sponsored by Ares Capital Corporation, a leading specialty finance company that provides one-stop debt and equity financing solutions to U.S. middle-market companies and power generation projects.
Given that Ares is focused on financial management, when Ares took on the sponsorship of Alcami, it was recognized by both companies that a sponsor with knowledge of the pharmaceutical industry would ultimately be needed. The search, initiated in early 2018 by Ares, resulted in the selection of Madison Dearborn Partners (MDP) as Alcami’s new sponsor. MDP is a leading private equity investment firm in the United States with a significant amount of experience in the healthcare industry. The firm also has a track record of growing companies by building on platforms through the addition of complementary capabilities, allowing brands to essentially dominate their targeted market segments.
MDP’s sponsorship bolsters Alcami’s business model and approach. As a partner, Alcami will be able to leverage the experience of MDP and its understanding of the pharmaceutical industry. With this support and funding from MDP, Alcami will be able to continue to invest in a strong team and be better positioned for growth.
We are excited about the opportunity to expand our talented employee base and further develop our capabilities. The collective core expertise of the two companies will enable Alcami to solidify our brand and position as we continue to grow. Our customers will also benefit from this sponsorship. The increased financial backing and support we will receive translates into increased capabilities and capacities, including improved service offerings. Importantly, Ares continues to be an investor in Alcami, underscoring its recognition of what we are building, our educational approach and our ability to reach our goal of becoming a leading CDMO.
CDMOs with knowledge about the potential range of indications for a new drug substance, possible synthetic routes and efficient approaches to process optimization and regulatory approvals can provide the best possible service to small and mid-sized pharmaceutical companies. Alcami supports projects at different stages by incorporating three components in all of our offerings: concept to clinic, approval and post-approval. By focusing on science and technology, first-to-market customer service/client relations and innovative business models, we emphasize our relationships and put our customers at ease. As an integrated company, we are able to help our clients get to the clinic as rapidly and efficiently as possible.
Recognizing that most small and mid-sized pharma companies have limited resources, Alcami has developed unique solutions designed to facilitate our development projects. The Extended Workbench Program is a full-time equivalent (FTE) program tailored to each client that includes dedicated lab space, scientists, project management and technical leadership.
Likewise, Alcami OnDemand™ is a customer portal and mobile application that allows Alcami’s clients and prospects rapid and unprecedented access and visualization into their ongoing projects. Over 300 customers currently use the service to seamlessly access analytical testing results. The portal will serve as a single source for customer projects and order management with shared views to manage orders, libraries of compounds, test results and accounting information. It meets market needs for a simplified sample submission process, real-time tracking of sample submissions and projects, customer access to historical data and transparency.
Our ProForm Select integrated offering addresses API process and formulation development in parallel, ensuring that customers avoid process instabilities and missed clinical milestones.
Subscribers to Alcami’s Protect Your Brand program can quickly bridge unexpected gaps in supply without the need to commit to a long-term supply agreement. Three options are available to prevent disruptions from the concept phase through post-commercialization.
Alcami believes that anticipating customer needs is the ultimate driver of business growth. The relationships we establish across the pharmaceutical community are designed to facilitate the implementation of our “customers are a privilege, not a right” and “customer comes first” approach. In addition, our company size and culture, end-to-end offerings and commitment to education contribute to our responsiveness and ability to deliver on time, every time.
As an integrated, agile CDMO offering end-to-end services to small and mid-sized pharma companies, Alcami will further benefit from MDP’s sponsorship by serving as a platform CDMO for further acquisitions and growth. Through this growth, we expect to continue to impact the structure and operation of the pharmaceutical and biotech industry.
There are a number of strategic options for Alcami going forward. We may add capabilities via acquisition and/or through organic growth, looking at both short- and long-term opportunities. MDP’s financial support and experience in the market will ensure that we add the right capabilities that are truly differentiating, meet clear market demands and can be readily integrated and successful from day one.
Any additions we will make can be considered capability extensions — or extensions of services that are already offered by Alcami. Two important areas include biologic drug substance manufacturing (not limited to mammalian and microbial) and end-to-end production of cytotoxics/cytostatics in one facility/location. Alcami already provides biologic development, drug product and testing services and the manufacture of highly potent APIs, with end-to-end integrated production of highly potent drug products in one location as a strategic goal.
When we first began implementing our educational approach with a focus on small and medium-sized pharmaceutical companies, many in the industry were skeptical; however, we have been successful at building a strong CDMO that is having an impact on the industry on a daily basis.
The new partnership with MDP, an experienced sponsor focused on growth, begins a new journey for Alcami toward our next milestones. Together, we will continue to invest in capabilities that will enable us to exceed the expectations of our innovative customer base, including additional education initiatives, new technologies and technical expertise. We will also continue to achieve even greater operational and commercial excellence in all aspects of our business (people, processes and systems) and implement programs that redefine the role of CDMOs — always considering the customer first.
Syed Husain, the commercial leader for Alcami, leverages in-depth experience in sales, business development, marketing and operations for the development and manufacture of small molecules, antibody drug conjugates, peptides and large molecules covering drug substance and drug product. Syed earned a BS in chemical engineering from New Jersey Institute of Technology in 2003 and an MBA from Cornell University in 2009.