5 Steps to Prepare to Launch: Unraveling and Sequencing the Commercial/Compliance DNA for Start-up Specialty Pharma/ Biotech Co.'s

Are you a CEO, Board Member or Private Equity Investor of a specialty pharmaceutical/biotech company focused on rare diseases with products in Phase III clinical trials?

If you are, then to date, you have undoubtedly been focused on the science and the next round of funding to build your "baby," your dream come true, your passion ... your biotech company. You are likely either a physician, a Ph.D scientist, a former Pharma executive, some combination of these, or all of the above. You have been utterly consumed, working feverishly, passionately to build your core team, to attract top talent and investors, to meet research and funding milestones ... all in a relentless effort to bring a breakthrough therapy to market for the benefit of patients and their families, who are likely suffering from a rare disease with little if any other alternatives. It's been go, go, go...go!

Now, you can see in the distant but fast-approaching horizon that moment when all this effort will bear fruit -- the moment you receive FDA approval to launch your product. You are anywhere from 18, 12 or even 6 months out from anticipated approval. You may even have won expedited review. Wow! This is the moment that you, your scientists, your team, your investors and most importantly, your patients have been waiting for!

You have likely hired a General Counsel, who on the one hand is likely experienced in intellectual property issues and general corporate matters, but on the other hand may have only a smattering, if any, knowledge of the specific commercial compliance requirements to launch and commercialize a product. You appreciate that these commercial compliance requirements need to be addressed...but don't want to do too much too soon...you need to keep things moving fast.

You also likely have either begun the search for or have hired a Chief Commercial Officer to lead and develop the extensive commercial launch plans and to build out the commercial sales and marketing team.

BUT, what you likely haven't done is hire a Chief Compliance Officer. Yes, you know it's important and you are fully supportive of having the appropriate and necessary compliance program in place...but at the right time. For now, it can wait. After all, the biggest risks and focus for federal and state regulatory enforcement authorities revolve around the sales, marketing and pricing of FDA-approved products. Co-pay patient assistance programs, HIPAA privacy, pricing, off-label marketing, anti-kickback concerns with regard to physician interactions, false claims, and associated federal and state reporting requirements are the hot, bread and butter compliance issues that arise in a commercial context today. As you are not there yet, you can put commercial compliance on the back burner. Right? Funding is tight, as it always is, and, let's face it, once you hire the Compliance Officer, the freedom, flexibility, speed and nimbleness that you have enjoyed to date will be reduced and constrained by the requisite new policies, procedures, training, auditing, monitoring...etc., etc., etc. Right? Why impose those costs and constraints now? Technically, there is no law that requires it now, right? So why not wait until there is a more imminent need? Isn't timing everything?

Timing AND Trust Are Everything

Yes, timing is everything, but so is trust. Trust takes time to earn. So the time to integrate and evolve your commercial compliance program is in fact, now. If done properly, this is an opportunity to create an effective commercial culture that unleashes the maximum energy of your commercial team to compete and win confidently and, yes, compliantly.

It's about integrating appropriate, scaled, measured, thoughtful compliance solutions into the the DNA of commercial strategy, tactics and execution. It's about creating a cohesive commercial compliance team that is built on a foundation of trust.

As with all human relationships, trust is built over time and comes from repeated interactions that demonstrate shared commitment, shared reliability, shared dependability and...shared success. Yes, it's about winning, but winning the right way, the ethical and compliant way. Launch time or even a few weeks or months before launch, is certainly not when you want to start the trust-building process. If you want to do it right, start now.

The Right Strategy, Tactics and Execution Will Determine Your Commercial/Compliance Success

Over the past 16+ years, much has been learned about how best to implement life science commercial compliance. Much like in the world of science and biotech where the innermost workings of our DNA has come to be understood and mapped to develop custom therapies for patients and rare diseases, so too the commercial/compliance DNA has been unraveled, sequenced and understood to produce a much more effective life science commercial compliance business model. Both government regulators and private practitioners have a much more detailed understanding of the specific risks, timing and scaling up of an effective commercial compliance program. What in retrospect was more of a meat cleaver approach to commercial compliance, is now much more surgically precise, and as a result, both more cost-effective and operationally effective.

As with any major initiative it is important to take a moment to step back and thoughtfully assess the "big picture." Start with the end in mind and identify key drivers/factors that pertain to your unique set of circumstances. Define what "success" looks like from a commercial/compliance perspective. Then gain consensus around this definition and develop a joint commercial/compliance strategy that integrates commercial goals and timing within an agreed upon compliance structure. Sequence, roll out and scale up your commercial operations in unison with carefully coordinated compliance processes and compliance structural elements in an efficient, effective effort. Explore new solutions to meet unique challenges by identifying and applying key core principles. How do you best engage patients, physicians and providers without running afoul of compliance issues? Pre-launch? Post-launch? How do you appropriately balance the appearance and fact of high prices with patient benefits with co-pay assistance programs? How do you best communicate publicly both the benefits and the risks of your product in any SEC-regulated disclosure? Identify specific tactics to execute the strategy effectively and consistently. Then... execute, execute, execute, while measuring continuously, adjusting as needed, and reporting/communicating results.

This can only be done well by commercial and compliance colleagues that trust and respect each other, who with sleeves rolled up, tackle each challenge with shared commitment and passion to achieve a common, clearly defined, shared goal. So don't wait to put in place your Chief Compliance Officer and Commercial Compliance Program. Start now to build that foundation of trust and you will experience a successful launch that will meet your commercial goals and your compliance requirements. Most importantly, you will build and put in place a solid foundation, a company culture built on trust, that will position you for many successful launches in the future and will win the respect of your employees. By the way, by doing so, you will also earn the trust of patients, investors, shareholders...and government regulators, increasing your companies reputational capital and reducing your risk to whistleblowers and enforcement actions. Truly a win, win, win outcome across the board! The time to build trust is now.

5-Step Process for Commercial/Compliance Success

Accordingly, the following is a recommended 5-Step Process for Commercial/Compliance Success:

Step 1: Define Success & Gain Consensus

Step 2: Develop a Shared Commercial/Compliance Strategy

Step 3: Map Out a Detailed Shared Execution Plan

Step 4: Execute Your Plan Collaboratively

Step 5: Measure & Report Your Results

If you'd like more information as to how best to develop this 5-Step Commerical/Compliance Process for your particular company and identify the specific risk-based sequencing of compliance program implementation to achieve commercial compliance success, please feel free to contact me directly at [email protected] or call me at 617-800-3704. I look forward to helping you build the foundation of trust necessary for your commercial compliance success.