Currently, there are two great forces at work that are disrupting traditional models for advancing drug therapies from discovery to commercial production and distribution. This transformation, when complete, will impact the biopharmaceutical supply chain significantly and potentially achieve outcomes that were considered impossible a short time ago.
The first is scientific innovation, which the industry has been talking about for a while. Healthcare innovations, driven by advancements in clinical pharmacology, are being introduced at an unprecedented pace. The quantity and quality of encouraging early-phase drug therapies are challenging the traditional pharmaceutical supply chain and demanding far more agility from biopharma companies, contract development and manufacturing organizations (CDMOs), clinical and contract research organizations (CROs), and regulatory bodies like the U.S. FDA and the EMA.
The second is not something we anticipated — the urgency with which treatments and vaccines are being developed to combat the COVID-19 pandemic. If a vaccine is ready by early 2021, as many experts believe, it will be on a timeline like nothing we have experienced. Commercial biopharmaceutical development timelines have always been measured in years, not months. If the anticipated COVID-19 vaccine timeline is achieved, it will be difficult to accept a return to the traditional timelines.
CDMOs will play a critical role as healthcare supply chains are transformed, and the changes are happening faster than anyone could have predicted. CDMOs have long possessed the agility to quickly repurpose facilities and production lines for emerging market needs and the requirements of specific drug sponsor clients.
At Pharmaceutics International, Inc. (Pii), we were expecting this transformation. We began modernizing our facilities and analytical labs precisely for the kind of change now underway, one that demands a more responsive biopharmaceutical supply chain. Additionally, we recognized that, to deliver a better organizational response, we needed to develop some additional skills. We went to work becoming more collaborative, flattening our organization for quicker decision-making, and placed a premium on professional project management to deliver client outcomes on time, or even early. These organizational changes also enable us to manage our capacity better and more predictably and be ready to flexibly respond to drug shortages when they are experienced by healthcare providers.
Pii is a U.S.-based CDMO located in Hunt Valley, Maryland. The experienced scientists, engineers, and staff at Pii pride themselves on solving difficult problems; it is part of their DNA. In addition to knowing how to innovate for the future needs of the biopharmaceutical industry, Pii has expertise in developing and manufacturing complex parenteral drugs and possesses a wealth of analytical testing, formulation development, and manufacturing capabilities across a variety of dosage forms. Its Hunt Valley campus has four aseptic suites with lyophilization capabilities, and the talented professionals at Pii stand ready to help!
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