Thursday, December 06, 2012

Growing Pains: The Trouble with Being an Emerging Pharma Player Today

Today’s guest post is from Becky Holloway, Product Marketing Manager at Revitas, a Drug Channels sponsor. In this post, Becky describes the compliance and contract management challenges facing mid-sized pharmaceutical manufacturers.

On December 13, Revitas will be sponsoring a live webinar entitled “A Survival Guide for Emerging Growth Pharmaceutical Companies”. Becky will be joined by Eric Newmark of IDC Health Insights to discuss the state of the pharmaceutical mid-market today. Becky will also talk with Stephanie Kupski of Cangene Corporation, an emerging pharmaceutical manufacturer. Check it out!

Growing Pains: the Trouble with Being an Emerging Pharma Player Today
by Becky Holloway, Product Marketing Manager, Revitas

The old adage “the only constant is change” is attributed to the Greek philosopher Heraclitus. I secretly believe he must have worked in the pharmaceutical industry. Today, under economic and political forces outside of their control, pharmaceutical manufacturers are faced with enormous pressure to achieve profitability while remaining compliant with increasing regulatory scrutiny. These challenges are hard enough for the well-established veterans in the field—you can see how daunting they are for emerging players.

Mid-sized life sciences companies are not cut any breaks due to size or growth status. They face the same requirements for government compliance as their larger counterparts but with a fraction of the resources, mindshare, or infrastructure the competition enjoys. This puts commercial success for emerging companies at significant risk. When you don’t know what you don’t know and the stakes are as high as they are in the pharmaceutical industry, the consequences are big. Revenue can be lost, profitability suffers—all negatively impacting the company’s ability to create and deliver quality products to patients at a reasonable cost.

Mid-market pharmaceutical companies are unique among other mid-sized companies in several ways. Unlike other industries where revenue and employee numbers are usually fair indicators of market position, the profile of an emerging company in the pharmaceutical world can be tricky to define. Revenue, product portfolio, and workforce are unreliable indicators by themselves. In fact, they may combine in unexpected ways to establish the company’s true market position.

You very likely fit the profile of emerging growth companies in the pharmaceutical industry if:
  • You have a handful of employees, but that’s going to change in the near future.
  • You don’t have any revenue yet, but your market cap is in the billions.
  • You don’t have an FDA-approved product, but you have several products in late-stage clinical trials.
The situation may sound bleak. Settlements with the government and their corresponding monetary penalties are both up over 1000% percent in the past decade. In fact, the first six months of this year saw greater monetary fines (over $6 billion) than the entire previous year did. A majority of these cases involve overcharging government programs, giving mid-sized pharmaceutical companies a real reason to pause and examine how they are currently handling their government pricing.

Don’t despair, however. There is reason to be hopeful if you are a company in this emerging growth category. While balancing commercial profitability with compliance requirements is a tall task, there are solutions. Keep these three recommendations in mind.

Start early—My grandmother used to say, “Little kids have little problems. Big kids have big ones.” This is true for companies as well. It is always easier to identify problems, define processes, and establish solutions when a company is smaller. This doesn't mean that large enterprises shouldn't seek solutions to their contracting, pricing, and compliance issues, but rather it is impetus for those in early stages to seek out solutions before problems get overly complicated, ill-defined, and resistant to change. And the good news today is that with the emergence of cloud technology, there are solutions which are affordable, require almost no upfront capital expenditure, and can be implemented quickly with no IT maintenance requirement.

Acknowledge the information gap—This can be a real sticking point. No one likes to admit they don’t know something. However, in the pharmaceutical industry, it can come back to bite you in a big way. Government rules and regulations must be followed. But of course, the government regulations, pricing calculations, and processes for pharmaceutical companies are anything but simple. Partnering with industry experts from both a technology as well as a knowledge standpoint will serve you in good stead as you plan for the future.

Look end-to-end—The easy way to solve problems is to look for stop-gap measures. This is how home-grown and manual systems turn into corporate nightmares. Since everything in the pharmaceutical supply chain is so interconnected – like a spider’s web – the solution should be too. Think big picture. Look for solutions that don’t just address the immediate rebating issue you might be experiencing or the chargeback scalability problem, but look at the full scope of the issues – both upstream and downstream. Think outside your immediate department. How is Legal impacted? What about Finance, or Sales? How does your creative contracting process feed into your complex pricing execution engine? Is it integrated with your government compliance efforts? It should be. Does it contain an iron-clad audit trail? You’ll need one. How does it connect with your ERP system? The best solutions will be ones that are integrated, seamless, and holistic.

Please join Revitas on December 13th for a live webinar entitled “A Survival Guide for Emerging Growth Pharmaceutical Companies.” We will be joined by a leading industry analyst as well as one of our mid-market clients to discuss these issues and the benefits attainable by moving to the cloud to increase scalability, profitability, and compliance.

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