Mark Scallon

Principal at Baker Tilly US, LLP

Speaker

Mark has over 20 years’ experience working with clients in the life sciences industry to transform their compliance function. Mark has particular expertise in compliance program development, process design, compliance auditing & monitoring, risk assessments, global spend transparency reporting, global investigations, privacy, pricing and anti-bribery and corruption. He has assisted a number of life science organizations with identifying existing and emerging compliance risks to develop practical recommendations which align company policies and procedures with industry practices, guidelines, regulations and laws.

Experience:

• Executed global spend transparency projects for over 50 companies, including assessment, strategic road mapping and technology implementations
• Executed a third-party distributor audit program for a mid-sized medical device company focused on identifying FCPA/ABAC risks •Conducted, under attorney-client privilege, pre-IRO audits across multiple risk areas for a large, global biotech company
• Developed compliance program framework for a growing compliance function at a mid-size biotherapeutic company that was looking to expand globally
• Completed Fair Market Value (FMV) Assessment for healthcare professionals in the US and globally. Assessments resulted in the provision of FMV rates and documented methodologies across a number of physician specialties and geographies. Completed GDPR and California privacy assessment and implementation projects for 3 biotech companies
• Executed multiple audits and process assessments related to external funding requests, including medical education grants, charitable contributions/foundations, sponsorships, etc.
• Conducted HUB audits to identify key areas of risk and recommended corrective actions to mitigate exposure
• Designed and implemented a global monitoring program for a large biotech company, which included parameters associated with cross functional risk activities
• Conducted multi-year IRO assessments for seven companies operating under a CIA and/or DPA with the OIG and/or DOJ. IRO assessments focused on sales and marketing practices, including off label marketing, government pricing/rebate calculations and spend transparency reporting
• Developed training program for mid-sized pharmaceutical company and biotherapeutic company
• Assisted a top 15 pharmaceutical company with the design of their auditing and monitoring program
• Implemented projects to conduct live monitoring of over 200 speaker programs and 100 field ride alongs per year
• Conducted outsourcing work to fulfill state price reporting obligations in the US for a top 10 pharmaceutical company