March 12, 2018 PAP-Q1-18-CL-004
Historically, growth in the pharmaceutical industry has been driven by large pharmaceutical companies developing blockbuster drugs. That is no longer the case. Many companies today are focused on the development of treatments for diseases that afflict much smaller patient populations. A majority of these firms are founded by academic researchers that have discovered new molecules with desirable biological activities. Indeed, the success rates of smaller firms are often higher; the Tufts Center for the Study of Drug Development reports that smaller firms developing small-molecule drugs have higher clinical approval success rates than large companies.1
There are nearly 3000 pharmaceutical companies in the US with revenues of $500 million or less. Despite the fact that these firms often have very limited resources and sometimes little knowledge of the regulatory approval process, approximately half can be found in locations with minimal outsourcing support. This presents a challenge for innovators. This significant sector has, until recently, largely been neglected by the rest of the CDMO industry.
Alcami, through the establishment of many different types of relationships, is seeking to address this issue. The company was built to serve thriving new drug innovators also known as “two persons and a patent.” Given the unique needs of this segment of the industry, Alcami has implemented a commercial strategy guided by an educational approach that seeks to address the needs of these smaller firms.
One element involves investment in industry trade associations. In many cases, these industry groups still place a heavy emphasis on large pharma. However, Alcami is serving as the voice for small and emerging pharmaceutical and biotech companies to drive change and positively impact the industry, and creating forums for this. Driving these efforts is the recognition that small and medium-sized firms are the innovation engine of the pharmaceutical industry and represent its future.
The second aspect of our commercial strategy is to provide companies that aren’t familiar with the drug development and approval process with the information they need to be successful. Through various physical and digital events, we bring crucial knowledge about everything, from what data is needed to meet CMC requirements, to submitting regulatory applications, to ensuring robust process development, scale-up and supply chain solutions to support clinical trials and launch.
Providing small and medium-sized drug developers with knowledge is not the only way Alcami is helping this important sector of the industry. We are also committed to introducing first-to-market initiatives designed to enhance the customer experience, particularly for smaller clients with limited resources.
For companies that lack full-scale laboratories, Alcami offers the Extended Workbench Program, a full-time equivalent (FTE) program tailored to each client’s needs. The program includes dedicated lab space and scientists along with dedicated project management and technical leadership, 24/7 digital access and flexible resources. The goal is to provide customers with a seamless solution integrated with their own operations.
Alcami has also developed a customer portal, Alcami OnDemand™ that serves as a single source for customer project and order management with shared views to manage orders, libraries of compounds, test results and accounting information. It meets the market need for a simplified sample submission process, real-time tracking of sample submissions and projects, customer access to historical data and transparency. Alcami OnDemand™ gives our clients and prospects rapid access and visualization into ongoing projects.
In 2017, Alcami launched a fully interactive virtual tour experience for clients and potential customers to see our sites before visiting them. Alcami’s Virtual Lab addresses our prospects’ needs to save time and resources when deciding on a partner. The virtual experience is available online at www.alcaminow.com/virtual-lab, linked from our website, and has been featured at industry events throughout the year, with our Igloo Vision Ltd. viewing theater. We are now expanding the experience into virtual glasses so we can take the experience on the road to our clients and into our sales offices.
Those companies looking to implement a dual sourcing strategy but who lack the resources to secure a permanent second sourcing option can turn to Alcami’s industry leading offerings like Protect Your Brand. Subscribers to this program can quickly bridge unexpected gaps in supply without the need to commit to a long-term supply agreement. Alcami will validate a product, maintain the required capacity and be ready to rapidly begin production in accordance with US and international regulatory compliance requirements if needed. Three options are available to prevent disruptions during the concept phase through post-commercialization.
Why would a CDMO want to take on this role? Small and emerging pharmaceutical firms rely extensively on third-party services across the entire drug development and commercialization cycle. CDMOs that can provide integrated, end-to-end solutions and support these companies throughout the entire process can contribute to their success. As importantly, CDMOs with knowledge about the potential range of indications for a new drug substance, possible synthetic routes, efficient approaches to process optimization and regulatory pathways — and how to pull all of these components together — can provide the best possible service.
At Alcami, we believe that the success of small and medium-sized pharmaceutical companies is essential for continued growth of the industry. We have established integrated capabilities, combined with educational programs, specifically to meet the needs of these important customers. In addition, we treat every customer — whether a first-time, emerging pharmaceutical firm preparing for clinical trials or a small/midsize pharma company gearing up for launch and commercialization with multiple projects — equally. Each and every customer deserves the same amount of respect and attention — delivering on project objectives is important for all projects, regardless of size.
Associations are an integral part of the pharmaceutical industry. On the global, national and regional levels, these organizations bring members of the entire value chain together using a variety of mechanisms, from trade shows to educational conferences and workshops. Regional associations, in particular, provide local forums where CDMOs like Alcami can learn more about small and medium-sized pharmaceutical developers and the local markets in which they operate. They provide a means for showcasing new ideas and reveal to the rest of the pharmaceutical community which universities and startups are driving innovation.
At larger trade shows, however, smaller firms have found it difficult to garner attention from pharmaceutical companies and larger service providers. With the launch of our first-to-market Alcami After-Hours™ networking events at conferences including BIO International and CPhI Worldwide, Alcami is alleviating this problem. These networking sessions are specifically designed to foster personal connections between Alcami experts and the scientists and executives (often the same people) from small and medium-sized pharmaceutical companies. We want to make sure that potential customers get to know the people behind Alcami.
As smaller pharmaceutical firms have limited resources, it is often not possible for them to attend valuable events. Alcami, as part of its educational approach, has developed alternative outreach efforts to ensure that all firms seeking to learn about the drug development and approval process have access to the information they need.
Quarterly educational events are held at our sales offices globally, in order to bring the CDMO concept to the customer — a key step in the educational process of turning their concepts into medicines. These educational forums and other custom events will focus on critical topics related to the development and launch of drugs within the US. Educational opportunities range from structured workshops to informal discussions on what is needed to take a drug through the development process. They include participation by both Alcami scientists and external experts and are intended to provide existing and potential customers with the information they are seeking.
In the US, Alcami is involved in an academic partnership with the University of North Carolina Wilmington (UNCW). Since July 2016, we have collaborated to develop two courses designed to enhance workforce education and prepare students for a career in pharmaceutical sciences. In Spring 2017, an elective course designed to provide students with an overview of the drug development process from concept to commercialization, focusing specifically on current good manufacturing practices (cGMP), was co-taught by the Alcami team, while a laboratory-based course was offered in the fall. We are also involved in co-research with UNCW at the Marine Biology Center (MARBIONC) in Wilmington, North Carolina. This partnership reflects our commitment to building and maintaining strong relationships with the communities in which we operate. We feel privileged to be able to share our expertise with the university’s students.
Effective relationships can make a difference. Industry-related partnerships, relationships with consultants, collaborations with universities, internal relationships that enable truly integrated customer support, educational relationships with potential customers and strategic partnerships with existing clients are all crucial. Anticipating customer needs is the ultimate driver of business growth. The relationships we establish across the pharmaceutical community are designed to connect us to clients at every level and facilitate the implementation of our “customer are a privilege, not a right” 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.
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.