By Ken VanLuvanee

There appear to be two diverging strategies emerging in the life sciences industry these days – mega-consolidation (mergers and acquisitions) aimed at “efficiencies of scale,” and leaner, more focused organizations that make use of the best resources at the right times, regardless of where those resources exist (most life sciences companies are now divesting, partnering, and focusing).

The former model has been tested repeatedly and has led to results that rarely met projected expectations, while the latter continues to show promise. Using a more extended, expertise-on-demand model, though, requires vision and courage to pursue a new pathway, the ability to say, “just because no one has done it before, doesn’t mean it’s wrong.”

Isn’t that really the essence of the science we’re looking to develop anyway – new therapies that no one’s created before?

Maybe the best way to advance new science is with a new business model. Over the 22ish years I’ve been in the life sciences industry, I’ve seen our systems evolve from paper to initial computerized systems to extremely complex systems designed to drive not only compliance, but also “organizational business process improvement” across increasingly large and complex global companies.


As our business models have changed and our fastest growing, most adaptable companies are smaller organizations, our technology systems have not. Smaller, more focused and nimble life sciences companies are still saddled with choosing only large, complex systems to meet the regulatory burden. These systems have failed to adapt to our industry’s changing models.

Bottom line, unless you’re a global “Top 50″ largest pharma company, the regulatory compliance systems available today simply weren’t developed to meet your needs. They were most likely developed to meet the needs of the (likely former) leviathan that was on your business card two or three companies ago.

Services Expertise

We’re seeing, as an ongoing trend, a rise in smaller companies focused on either one therapeutic area or a small number of development candidates. As such, these companies approach development largely as a project, with peaks and valleys of skills need, rather than a steady flow that justifies keeping full time staff for each area of expertise.

In that business model, it makes sense to find true experts who can meet the skills need on demand and with the flexibility to deliver under your timelines and business model. Using these external experts brings several benefits:

  • Budget – This is the most obvious. You only pay for the services you need, when you need them. Yes, you’ll likely pay a higher hourly rate when compared to a salaried employee (although fully loaded costs make this debatable), but in almost all cases, you’ll save money by only using those services when needed.
  • Enhanced Expertise – One of the true advantages of using external experts, even for things that are “routine operations” in larger companies, is that you can often contract with someone who has far more expertise in a particular area than if you bring in a full-time employee. This higher level of experience and expertise often brings with it stronger solutions and more options.
  • Broader Perspective – Most external experts have worked for and with several companies, thus, have seen a very broad swath of available options. Good ones (and why would you choose to work with any, but the best?) bring not only scientific or operational expertise, but also practical knowledge of what options work in practice vs. theory…and why. Again, this leads to a broader array of stronger options for your development program.
  • Flexibility – Obviously by bringing in experts to both help plan (always a good idea) and execute specific areas of your development program, you can ensure you get exactly what you want, when you want it and no more. This strategy helps conserve capital, maintain organizational focus, and streamline operations. Your therapy is what matters, not expanding the office space. Right?

Facet Life Sciences was established to meet the needs of smaller companies, with smaller footprint, focused software and expert services intended to help smaller companies focus on their own core needs.

Talk to us about what we can do to help you achieve Regulatory Success!