Client background 

A commercial-stage biopharmaceutical company based in the U.S. with nearly 150 employees. The company utilizes a unique administration platform to deliver molecular therapies to patients living with diseases who have high, unmet medical needs.  

The business challenge 

The company revolutionized the delivery of a 60-year-old drug, which had gradually lost the confidence of physicians throughout the years, through a novel method of administering the product to patients. In addition to needing to demonstrate the value, safety and efficacy of their product, the company needed to develop and implement a full-fledged compliance program within an 18-month timespan before the launch of their therapy, all while transitioning to having a new management team oversee and run the company.

Baker Tilly’s solution-driven approach 

Baker Tilly was engaged with the company prior to receiving FDA approval for their novel therapy and while building out its commercial and medical affairs functions. During this time, management also needed a robust compliance program in a compressed time frame. The company decided to outsource this work and their compliance function to Baker Tilly. 

To help, Baker Tilly first conducted a risk assessment to understand the company’s unmet compliance and ethics needs. By doing this, Baker Tilly was able to help the company build out a robust set of compliance policies and procedures throughout their organization, including:  

• Establishing controls for evaluating the expertise of key opinion leaders (KOLs) and establishing fair market value (FMV) rates when engaging with healthcare professionals (HCPs) for consulting and speaker program engagements 
• Ensuring complete, accurate and timely compliance of spend transparency reporting obligations throughout all levels of the organization 
• Adhering to the Prescription Drug Marketing Act (PDMA) by providing accountability for product and promotional samples 
• Navigating the complexity of having to decipher and become compliant with the myriad state drug price transparency reporting program requirements throughout the U.S. 
• Conducting thorough monitoring and auditing of the field activities associated with the operations of the company’s hub and pharma distribution networks 
• Overseeing the company’s investigations hotline as well as fielding and addressing inquiries related to allegations against company personnel, including sales rep activities, questionable HCP engagements, etc.  

Throughout the strategic risk assessment as well as the development and implementation of these numerous compliance activities, the Baker Tilly team worked hand-in-hand with the company’s C-Suite, including the CFO, CEO and CCO, to remain nimble and agile to additional concerns and issues along the way.  

The accomplished results  

Instead of having to engage with several consulting firms to address the wide range of compliance support the company needed, the organization was able to consolidate and outsource all its needs to Baker Tilly’s team of life sciences specialists. The biopharmaceutical company was also able to save money and resources by eliminating the need for hiring, training and managing FTEs that were solely dedicated to compliance by completely outsourcing this function. This allowed the company’s CFO and the rest of the executive team to have a reliable business advisor by their side that delivered timely compliance advice, which helped drive strategic business decisions and meet the needs of their organization leading up to the launch and post-launch of their product.