December 30, 2011

Nature of the Beast

Posted in General at 9:10 PM by Solutions2Projects, LLC

I’ve been in biotech long enough to know that the likelihood of organizational success is challenging due to regulatory hoops and the general economics. Fortunately, people and investors continue to chase the dream in hopes of finding the ‘billion dollar drug.’ The reality is that most don’t make it.

We are usually brought into smaller organizations (30-300 people) pre-commercialization or pre-IPO to put in the systems to bring them closer to their organizational goals. For the pre-IPO companies, we help them select and implement systems and IT controls to meet Sarbanes-Oxley requirements. For the pre-commercialization companies, we help them with all of their other system needs including ERP/MRP, document management, complaint handling, NCMR/CAPA, serious adverse events, clinical trial management, calibration/maintenance, and QC systems to name a few. This includes system selection, implementation and validation.

The companies we work with are small and have limited resources (financial and human) and need to work within various constraints. Every project is a challenge (no one likes change!) but the constraints make it even more challenging but not impossible. Due to the resource constraints, we often step in to fill gaps and work so closely with the employees that we become truly invested in their success. This makes it all the more difficult when companies encounter significant challenges because we want them to succeed. We want to celebrate their successes.

What we are seeing is that due to the limited resources, companies are having to make tough decisions about where to spend money and invest human resources. This means they may be waiting until the very last minute to invest in the systems to support commercialization and may not be allowing for sufficient time to effectively implement the required systems. When FDA comes in to inspect, they need to see that the systems and processes have been in place to support the filing and are in place to support commercial release of the product. This creates a dilemma for organizations on the cusp. It becomes a chicken/egg dilemma.

Crystal balls are murky and unreliable. FDA is unpredictable. Resources are limited. What’s the real answer? I wish I knew. I’ve been a part of two biotech layoffs for organizations that are no longer, have helped companies that have been acquired and reorganized, and recently had a client issue a WARN letter to all of its employees. I felt a bit unlucky until I reflected on all of the factors influencing biotech companies and realized it’s egotistical to think it’s me when it’s just the nature of the beast.

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