Operating a clinical trial in what is a tightly regulated industry requires comprehensive, big picture thinking. Risks remain at all stages of the clinical supply chain, and they can make the difference between a successful study, or no study at all. Adrian Collins, Production Manager at Almac Clinical Services explains, whilst businesses are continuing to navigate the COVID-19 pandemic, sponsors face challenges that require strategic planning and should avail of appropriate assistance, particularly in one area of clinical trial expertise – clinical packaging.
Extract:
‘The Importance of Clinical Trial Packaging and The Benefits in Outsourcing Your Small Molecule Packaging to a CDMO‘
With so much focus on the emergence of biologics in recent years, it would be easy to surmise that the demise of small molecule drug development is imminent. That, however, is not the case. Undoubtedly, biologics and biosimilars are among the most advanced therapies available and have had a game changing impact across multiple therapeutic areas, from oncology to arthritis and to autoimmune diseases. Yet, while the biologics market growth is predicted to increase at a CAGR of 11.9% to USD 625.6 million by 2026, a renaissance in small molecule drug development is challenging the industry narrative surrounding the long-term viability of investing in research and development (R&D) of small molecule drugs.
In fact, the pipeline for new drug manufacture continues to be dominated by solid oral dose formulations, with almost half (46%) of drugs in the development pipeline administered orally. Furthermore, small molecules are recording the highest number of FDA approvals for decades and accounted for around 70% of New Molecule Entities (NME) approved for use by the FDA over the last five years.
There are also more small molecule phase I trials taking place than ever before, with in excess of 7,500 launched or entering development over the past five years. Growth in small molecule drug development is great news for patients, especially across oncology and orphan disease areas where investment is currently most concentrated. However, it does raise the stakes for sponsors when it comes to achieving return on R&D investment. Increased competition, coupled with mounting study complexity, targeted patient populations and investor driven need for speed makes optimising the processes that underpin successful clinical trials management, mission critical. One way to achieve this, while reducing risk and accelerating time to market, is to outsource vital components, such as clinical packaging strategy and implementation, to Contract Development and Manufacturing Organisations (CDMOs).
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