The pharmaceutical marketplace is more global than ever and, as companies fight for market share in this increasingly competitive landscape, contract development and manufacturing organizations (CDMOs) are becoming more important than ever.
However, competition amongst CDMOs is also mounting. Those looking to stand out in this crowded space must remain nimble, customerfocused and, above all else, poised for growth and prepared change. Though niche market partners will continue to remain important in certain areas, pharmaceutical companies are increasingly turning to CDMOs that can demonstrate not only complete competence across the development and manufacturing spectrum, but also an active desire to increase that knowledge and expand their portfolio of service offerings and capabilities with proven expertise based on the customer’s business requirements.
Of course, close collaboration and partnership will also become more important as drug complexity continues to grow with biologics remaining strong and biosimilars already beginning to crowd the space.
Further, in the face of evolving demands for lower prices, shorter timelines and more effective and patient centric medications, transparency at every stage will become increasingly valuable. However, to turn for a moment to an old yet still applicable adage, knowledge is power. For a CDMO partner to remain truly valuable, it must be able to demonstrate proven market experience throughout the organization and a growth strategy that functions well today and focuses on tomorrow.
WHERE QUALITY AND RELIABILITY INTERSECT!
In every rapidly progressing and scientifically complex industry, experience comes in many forms. In the CDMO space, this is often most apparent though a unique trichotomy that exists between the people within the organization, the time spent in development and manufacturing, and the CDMO’s intent to grow and change in response to market and customer demands.
When experience in all areas aligns well with the overarching goal of the organization, quality products, productive processes and innovative solutions normally follow, but, as important as these offerings may be, one of the most desirable qualities a CDMO can offer is reliability that, at its core, is a cohesive combination of all these elements.
This claim might seem odd in some ways as, for example, quality is always a critical attribute and innovation is top of mind for nearly every small- and large molecule drug manufacturer, but reliability covers all of these factors. At its most basic, reliability simply means doing what you say and saying what you will do. For a CDMO to remain valuable in this changing landscape, reliability is demonstrated by first listening to the customers’ needs and offering viable solutions and then, most importantly, delivering on those solutions as promised, when promised, at a fair price.
At Avara, reliability is the result of close collaboration with our pharmaceutical customers that allows us to deliver unsurpassed customer service and custom-tailored solutions to our customers’ specific needs, from manufacturing to fill-finish operations. Four manufacturing and warehousing facilities offer bulk drug formulation and primary and secondary manufacturing and packaging. Our two primary API manufacturing sites offer experience in large-scale optimization manufacturing as well as smaller, complex chemistry expertise. Our secondary/finished dose form sites have international market experience, including serialization knowledge, with outstanding performance history in manufacturing primary/secondary API manufacturing — including large-scale API manufacturing capabilities — and primary/ secondary packaging solutions. Seamless collaboration between sites and scalable capacity allows us to remain agile, effective, committed and, as all of these elements combine, reliable.
However, for this ideal to hold true, partnership must be a systemic part of the organization. Delivering on scope, schedule, quality/regulatory compliance and price commitments requires attention to detail and collaboration not only between the customer and the CDMO, but also within the CDMO itself.
PARTNERSHIP AND EXPERIENCE FROM THE INSIDE OUT
Just as the relationship between the CMDO and its pharmaceutical company customers must remain transparent and honest, relationships within the organization itself should also be similarly marked with a collaborative effort and a mutual respect and understanding for the larger goals of every customer. This ability to communicate and remain cohesive between various departments and global facilities comes with time and experience in the market. It is simple for a CDMO to tout equipment, capabilities and even capacity, but these features carry little weight without a foundation built on years of industry experience in all levels of the organization. Or, more simply put, people must be the emphasis of the foundation for services to offer real value.
Though Avara is a relatively young CDMO, our leadership team consists of industry veterans who understand the outsourcing market from both perspectives and strive to apply that understanding to every customer interaction; our commitment to the Avara Promise has been rewarded with repeat business. This experience allows Avara to offer a unique perspective while empathizing with and understanding unique industry challenges; however, as should be the case with any reliable industry partner, this experience extends well beyond leadership and into every position and facility within the company. Through the strategic acquisition of proven facilities that meet the Avara grade, spread across two continents, Avara has worked to maintain experience by retaining personnel with every acquisition. That being said, Avara will not take on sites that have a history of poor performance. In addition to allowing us to show a commitment to our employees, this effort enables us to run smoothly with a lean organization and has produced a diverse team of highly competent, motivated professionals who are dedicated to providing unmatched service in the interest of holding true to promises.
Experience, however, means little in the face of stagnation. True experience comes with time and develops with a desire to do more, and to do better, when faced with challenges new and old. This means that, in the CDMO marketplace of tomorrow, continuous improvement will become increasingly valuable. Processes such as Lean Six Sigma allow organizations to remain effective and comfortable with what they know while also growing with their customers and anticipating what these customers need now and, even more so, may need in the future.
ACQUISITIONS FOR TOMORROW
Last year, Avara acquired three proven facilities (Shannon, Ireland; Norman, Oklahoma; and Avlon, Avonmouth, England) and celebrated the one-year anniversary of our 2015 acquisition in Arecibo, Puerto Rico. Each of these facilities added additional capabilities and/or capacity to Avara’s growing service portfolio, with each site offering years of experience, cGMP facilities and a proven track record of success in, among other things, process development, commercialization of NCEs and the production of several blockbuster products. Acquisitions have been instrumental in enabling Avara to provide a world-class experience to its customers — a >99% customer service satisfaction level for five years and counting — while also offering expertise in nearly every position within the organization.
As we look toward the future of the industry and Avara itself, acquisitions remain a critical part of our larger strategy to become the most admired contract manufacturing and technical services company in the pharmaceutical and biopharmaceutical marketplace. Overall, Avara will continue to expand its portfolio with a focus on key regions around the world, including emerging markets, and services that can add or be complementary to our existing offerings. With FDA- and cGMP-compliant operations, we strive to maximize production while minimizing associated issues and serving customers at various stages of development and production, all while meeting rigorous quality expectations and various regulatory requirements.
To ensure that that we continue to meet the growing demands of the industry, Avara is also committed to expanding our global development and manufacturing expertise into the area of biopharmaceutical drug development. We recognize the unique needs associated with the production of these often-sensitive medications and understand that, in order to remain a reliable partner in this competitive market, our solutions must expand to support global growth. However, as Avara plans for the future through developments in internal expertise and acquisitions, the customer experience remains central. We believe additional capabilities will allow Avara to better serve new and existing customers but, as the foundation of our organization is built on the prioritization of customers to optimize the outsourcing experience, every decision will have our customers’ and our experienced employees’ best interests in mind.
AVARA PHARMACEUTICAL SERVICES — FULL SERVICE, FULL CIRCLE
With Tim Tyson, a global leader in the pharmaceutical industry at the helm, Avara Pharmaceutical Services was created to help revolutionize the CDMO experience in preparation for the changing demands of the pharmaceutical industry. The larger leadership team, in turn, brings over 100 years of combined experience in various areas — including manufacturing, finance and sales — that complement Tyson’s direction and the experience of Avara’s global staff. When paired with the strength and stability of Avara’s parent company, American Industrial Acquisition Corporation, the organization is positioned and prepared to leverage its expertise in an effort to help redefine the meaning of partnership in the outsourcing market.
ABOUT THE AUTHOR
Tim Tyson
Chairman and CEO, Avara Pharmaceutical Services
Tim Tyson, Chairman and CEO of Avara Pharmaceutical Services, is Chairman and previously CEO of Aptuit. Prior to that he was President and CEO of Valeant Pharmaceuticals and served as President of GlaxoSmithKline Global Manufacturing & Supply, where he had responsibility for over 100 manufacturing sites and outsourced manufacturing worldwide. Mr. Tyson holds a bachelor’s degree in engineering from the United States Military Academy at West Point and MBA and MPA degrees from Jacksonville State University (USA).
LinkedIn www.linkedin.com/in/tim-tyson-89543a39
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