ENTERPRISE SPONSOR: Steriles
Pharmaceutics International, Inc. (Pii), one of That's Nice's Road to 2021 sponsors, discusses how the company is evolving its partnership models or geographic footprint to meet the future of healthcare?
Pharmaceutical outsourcing models are continuously shifting. One valuable lesson from the current COVID-19 pandemic is that focusing on building capacity and capabilities based only on the short-term needs of the biopharma industry can create a fragmented, tenuous supply chain and can ultimately lead to drug shortages, as well as shortages of critical healthcare equipment and supplies.
Pii and other CDMOS have a responsibility to help the industry transform to best serve the needs of an evolving healthcare system. We know that future healthcare will increasingly require drug development and manufacturing that is far more agile than it is today. Going forward, manufacturing companies should be able to reliably produce small batches of highly complex, potent drug formulations for smaller but better-understood patient populations.
When we anticipate the future, we consider the critical role that CDMOs will have in a drug therapy supply chain and the healthcare ecosystem it serves. At Pii, our preparation for the future has three elements: facility modernization, organizational skills, and communicating our capabilities to the industry.
First, we created a campus in Hunt Valley, Maryland with 70 manufacturing suites, including four aseptic lines, all supported by a robust system of analytical labs. The design is ideal for supporting early development through scale-up manufacturing of complex drug compounds, including parenterals, for which we know the demand will be growing significantly over the next decade. Most recently, we added a state-of-the-art GENiSYS R Aseptic Filling and Closure System that delivers incredible efficiency, reducing waste in highly valuable drug processes and leveraging automation to eliminate personnel contact with the filling line. Additionally, we believe we can address a critical need related to 503B drugs and drug shortages faced by healthcare providers in hospitals and hospital networks. We’re currently working on systems that will enable us to rapidly manufacture specific drug products in great demand or unexpectedly on a drug shortage list.
Second, we prioritize finding people with the right experience and skills in positions to best serve our clients. The future is going to demand faster drug development — done right the first time. We understand that cross-functional collaboration within CDMOs and between the CDMO and drug sponsor clients is critical for success, which is why we place a premium on collaboration and continuously work to improve our skills.
We also have learned the importance of project management in delivering client outcomes. We have professionalized our project management team to serve as agents for our clients and to fuel collaboration. They are among the first members of the Pii team to meet with clients and are instrumental in framing projects, assembling the right talent, driving communications, and anticipating problems before they occur.
The third component in this strategy involves how we communicate our value and capabilities to the market. Drug sponsors should easily be able to find a CDMO with the capabilities, capacity, and culture they desire. This process should not require a year or more of several re-starts and key personnel changes or being added to a waitlist until specific facility space becomes available. We’re exploring new ways of communicating what we do more effectively so that when a drug sponsor contacts us, they are confident in our ability and, likewise, we know they’re the right fit for us.