White Paper

Placing Drug Strategies On A Solid Foundation For Success

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Small biopharma companies are playing an increasingly vital role in pharmaceutical innovation, now accounting for more than half of all approved therapies originating in the U.S., according to a study published in Q4 2022. As the industry shifts its focus toward smaller patient populations and more specialized therapies, drug development becomes more complex, costly, and risk-laden. The challenge of bringing new, more effective drugs to market quickly, safely, and cost-effectively has led to the adoption of innovative development strategies and business models designed to enhance efficiency and success.

To navigate these challenges, many pharmaceutical companies—particularly small and mid-sized firms—are turning to outsourcing as a strategic solution. The rising demand for end-to-end development, manufacturing, and commercialization services has driven contract manufacturing organizations (CMOs) to expand their capabilities, leading to the emergence of contract development and manufacturing organizations (CDMOs). These integrated partners provide sustainable, streamlined commercialization pathways by offering comprehensive drug substance and drug product development, reducing inefficiencies and accelerating timelines.

This white paper examines the broad trends shaping today’s pharmaceutical development landscape and how these factors are influencing traditional drug development strategies and relationships with outsourced partners. From managing the extreme costs of biopharmaceutical drug development to addressing the complexities of novel therapies in the pipeline, the paper explores how the industry can better leverage CDMO partnerships to drive success from the outset. By offering seamless integration across development stages, CDMOs bring a distinct competitive advantage, ensuring that pharmaceutical programs are strategically positioned for efficiency, compliance, and long-term viability. Engaging with experienced, high-performance CDMO partners provides a foundation of expertise and capabilities that can significantly improve outcomes, from early-stage development through commercial manufacturing.

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