Leveraging partnerships with experienced third-party organizations like contract research organizations (CROs), contract manufacturing organizations (CMOs), and contract development and manufacturing organizations (CDMOs) is a valuable strategy for biotech, life science and pharmaceutical companies looking to maximize their capabilities in the therapeutic landscape. These partnerships allow companies to access specialized expertise and infrastructure, enabling them to navigate the complexities of research, development, and manufacturing more efficiently.
In this article, Susan Lynch-Smith, Head of Business Development at Douglas CDMO, explores the pivotal role that CRO, CMO, and CDMO collaborations play in advancing R&D, accelerating drug development timelines, and supporting commercialization efforts.
The journey of drug development and manufacturing is complex and involves numerous components. From initial discovery to market commercialization, each phase requires not only strict compliance with regulatory standards but also careful attention to safety, efficacy, scalability, and market demand.
To bridge resource gaps and streamline processes, biotech and pharmaceutical companies often partner with specialized third-party vendors such as CROs (Contract Research Organizations), CMOs (Contract Manufacturing Organizations), and CDMOs (Contract Development and Manufacturing Organizations).
Understanding the unique contributions each organization offers to the drug development life cycle is important for companies when making informed, strategic decisions regarding their products.
“Companies have a lot of homework to do before they choose a partnership that is right for their needs. They need to be clear on their project goals, their expectations, their resource allowances, and be prepared to uphold their contractual obligations.”
Susan Lynch-Smith, Head of Business Development, Douglas CDMO
What is a CRO?
A contract research organization, or CRO, assists biotechnology, pharmaceutical and life science companies by focusing primarily on the research phase of drug and therapy development. CROs provide essential services such as designing and conducting clinical trials, managing regulatory requirements, and ensuring compliance with health authorities. CROs bring deep expertise and specialized resources to the table, enabling their clients to streamline the clinical research process. By partnering with a CRO, companies can navigate the intricate landscape of clinical trials, from protocol development to final reporting, helping companies to advance therapeutic candidates efficiently.
And a CMO?
A contract manufacturing organization, or CMO, supports biotechnology, pharmaceutical and life science companies with the manufacturing aspect of drug substances. CMOs focus on scaling up production and ensure that the manufacturing processes are efficient, compliant, and capable of producing high-quality products under the strictly regulated conditions required by global health authorities. By leveraging the expertise and infrastructure of a CMO, companies can maintain focus on their core activities, while ensuring their products are manufactured to a high standard. This is essential for companies looking to outsource production to ensure capacity and quality without investing heavily in manufacturing infrastructure. CMOs also bring extensive experience in navigating the complexities of global regulatory compliance, providing end-to-end support that ensures smooth transitions from development to commercialization.
How about CDMOs?
Quite simply, contract development and manufacturing organizations, or CDMOs offer the full range of services from drug development through to commercial manufacturing, along with packaging and distribution. By offering this end-to-end, fully integrated service, CDMOs enable pharmaceutical, biotechnology and life science companies to meet all their requirements through a single provider. This approach often enhances production efficiencies, minimizes technology transfer risks, and accelerates the time it takes for products to reach the market. CDMOs bring specialized expertise and advanced technology to support the entire lifecycle of a product, from formulation and process development to large-scale manufacturing, making them an invaluable partner in navigating the complexities of the pharmaceutical industry.
The CDMO industry
The CDMO industry is constantly growing, driven by the rising demand from companies seeking to outsource their development and manufacturing requirements. Increasing drug production complexity, the need for specialized expertise, and a shift towards cost-saving outsourcing strategies are all factors that are driving the CDMO business growth explains Susan.
“The pharmaceutical industry is rapidly expanding – advancements in technologies such as AI and robotics can make it difficult for biotech and pharma companies to keep up with all the resources required for drug development. CDMOs invest heavily in their R&D infrastructure so that they can offer a hub of specialized resources, which can be tailored to a company’s specific needs.”
Susan Lynch-Smith, Head of Business Development, Douglas CDMO
Spotlight on Douglas CDMO
“Time, cost, and quality,” are the three elements that Susan lists when asked what makes a successful CDMO. “There’s a joke in the industry that you can’t have all three, something is always missing,” laughs Susan, “this is where Douglas CDMO differentiates itself from other CDMO players; it really does offer all three, which is quite rare in my experience.”
Douglas CDMO headquarters are based in New Zealand, placing it in the southern hemisphere. Susan is based in the United States and praises the geographical location of the business, describing it as a strategic advantage, “it’s a small world these days; digital technology has really benefited global partnerships.” The time zones enable global partners to hand over tasks or issues at the close of their workday, facilitating a nearly 24-hour operational cycle. This arrangement can significantly accelerate project timelines, as work continues around the clock, potentially reducing time to market.
Susan also touches on the accelerated regulatory and ethical processes in New Zealand, which can be particularly cost-beneficial when compared to the lengthy processes in the US. New Zealand’s clinical trial regulatory processes are straightforward and streamlined. Medsafe, New Zealand’s regulatory authority, typically issues decisions on clinical trials within 45 calendar days, providing a significant strategic advantage for companies that partner with New Zealand CDMOs. “Time trumps money,” states Susan, “money can always be made back, but you can never make back time.” The ability to start clinical trials swiftly makes for long-term cost savings, as project milestones can be met more efficiently with shortened timelines.
Quality control and assurance is crucial for a CDMO’s success. “Douglas CDMO has an outstanding reputation for quality in the industry,” Susan states. High standards contribute towards regulatory compliance, product efficacy, safety and client trust. Effective quality measures also support innovation and market position, optimizing operational performance and differentiating CDMOs in a competitive landscape. Susan believes that successful companies have quality ingrained in their culture, a principle embodied at Douglas CDMO, which she describes as “passionate, knowledgeable, and enthusiastic about their work.”
The power of CDMO partnerships
Forging a partnership with a CDMO is not just a business arrangement; it’s a strategic alliance where both entities have a common goal. The stakes are high, but the rewards can be substantial. The right collaboration can propel innovative therapies, from conception to market, and is critical for navigating the complexities of the pharmaceutical landscape.
Susan Lynch-Smith, Head of Business Development, Douglas CDMO
About Susan Lynch-Smith
Susan brings over 20 years of experience in the pharmaceutical industry, excelling in business development and strategic growth. Currently, she serves as the Head of Business Development at Douglas CDMO, from her location in North Carolina.
Her previous roles include senior positions at Bushu Pharmaceuticals, Sai Life Sciences, STA Pharmaceutical, Singota Solutions, and UPM Pharmaceuticals.