Samantha Sutherland

Director at Baker Tilly US

Speaker

Samantha has more than 11 years of experience providing compliance and ethics as well as risk advisory services to the life sciences industry. She has acted as an interim chief compliance officer, provided fair market valuations for physician consulting arrangements, bona fide service fees, and clinical/pre-clinical research and assisted in all activities related to designing, implementing and operationalizing a global healthcare compliance program.

Specific experience:

• Conducted risk assessments of various activities across function areas for pharmaceutical and medical device manufacturers to identify gaps in current processes and provided recommendations for improvements and effective compliance monitoring
• Acted in leadership position for fair market value (FMV) service offering with activities including, but not limited to, creating internal work documents and processes, developing and qualifying potential client leads, conducting internal team trainings, leading large global FMV engagements (more than $150,000), etc.
• Determined global fair market value (FMV) rate structures for healthcare professionals (HCPs) and certain non-HCPs performing consulting services (advisory boards, speaker programs, training, ad hoc) for pharmaceutical manufacturers
• Conducted manufacturer survey and identified information relevant to benchmarking best practices within the life sciences industry for assessing, documenting and approving bona fide service fees
• Estimated the FMV of services received within fee-for-service arrangements that satisfied the qualitative prongs of the bona fide service fee test as defined by the Centers for Medicare and Medicaid Services (CMS)
• Evaluated “current state” processes, procedures and documentation to support manufacturer in its efforts to comply with government price reporting obligations and proposed a “future state” process to increase efficiencies