What we asked: “Looking ahead to the next 5–10 years, what will be the key disruptors and/or what can be improved upon in the pharma industry?”
Response from: Alex Drennan, Senior Director, Manufacturing, Alcami
Over the next 10 years, there is so much opportunity for the industry to further advance drug development and manufacturing. From a drug development standpoint, one of the main barriers remains the regulatory complexity of entering various markets. The industry has come a long way recently to align and harmonize regulations, but further alignment would help support early phase programs.
From a manufacturing standpoint, the industry continues to be impacted by long lead times and difficult supply chain issues. Single-use and ready-to-use technologies have drastically increased manufacturers’ capabilities to be flexible and nimble; however this can be impacted by slow moving supply chains. Eliminating cleaning validation or verification can allow programs to be transferred within a matter of weeks or months versus up to a year, and enables CDMOs to transfer in multiple products simultaneously. Additional capacity within the industry to support this initiative will drastically aid in the rapid advancement of early phase programs and get products to clinic and market much faster. Along these same lines, further advancement in the understanding of extractables and leachables to perform studies as efficiently as possible and potentially minimize future requirements would further facilitate the transition and adoption of single use technologies for all types of products in the industry.
Response from: Tyler Ewald, Senior Director, Oral Solid Dose Operations and Packaging Services, Alcami
Advancements in research and technology have pushed the pharmaceutical industry into an exciting era of unprecedented change. Over the next decade, developments in oral formulation technology could enable large molecules – such as insulin – to transition from intravenous to oral delivery, meaning greater patient convenience. Additionally, improvements in oral formulations of immunotherapies may provide a more accessible alternative to current intravenous cancer treatments to make home administration a reality.
It would be impossible to talk about the future without mentioning artificial intelligence and machine learning. These tools have been touted as the next big thing in drug discovery and development, with a host of promising applications that could spread across the entire spectrum of our industry. Beyond this, I should also note that paving the way towards increased global regulatory harmonization is something we should all aim for; simplifying the approval process and reducing the need for multiple submissions is, above all, the only way we can ensure new therapies reach patients efficiently.
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