Mark Scallon is a principal with Baker Tilly’s digital solutions practice. He has more than 20 years of experience working with clients in the life sciences industry to transform their compliance function. Mark has particular knowledge in compliance program development, process design, compliance auditing and monitoring, risk assessments, global spend transparency reporting, global investigations, privacy, pricing, and anti-bribery and corruption. Over the last 20 years, Mark has assisted life science organizations with identifying existing and emerging compliance risks to develop practical solutions aligning company policies and procedures with industry practices, guidelines, regulations and laws.
- Executed global spend transparency projects for more than 50 companies, including assessment, strategic planning and technology implementations
- Executed a third-party distributor audit program for a midsized medical device company focused on identifying Foreign Corrupt Practice Act (FCPA) and Anti-Bribery/Anti-Corruption (ABAC) risks
- Conducted, under attorney-client privilege, pre-independent review organization (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 U.S. and globally, resulting in the provision of FMV rates and documented methodologies across a number of physician specialties and geographies
- Completed General Data Privacy Regulation (GDPR) and California privacy assessment and implementation projects for three 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 monitoring of email communications, speaker programs, advisory boards and CME events
- Conducted compliance risk assessments through the analysis of compliance and magnitude parameters
- Developed training program for midsized pharmaceutical and biotherapeutic companies
- Assisted a top 15 pharmaceutical company with the design and implementation of their global auditing and monitoring program
- Implemented projects to conduct live monitoring of over 200 speaker programs and 100 field ride-alongs per year
- Conducted multi-year IRO assessments for seven companies operating under a Corporate Integrity Agreement (CIA) and/or Deferred Prosecution Agreement (DPA) with the Office of the Inspector General (OIG) and/or Department of Justice (DOJ); IRO assessments focused on sales and marketing practices, including off label marketing, government pricing/rebate calculations and spend transparency reporting
- Conducted outsourcing work to fulfill state price reporting obligations in the U.S. for a top 10 pharmaceutical company
- “Policy and Medicine Compliance Update,” editorial board
- “Compliance Auditing and Monitoring,” instructor, INSEAD’s Healthcare Implementation Leadership Program in Fontainebleau, France, 2019
- “Navigating Drug Price Transparency Laws and the Role of Compliance,” instructor, PCF’s Twentieth Annual Pharmaceutical and Medical Device Compliance Congress, 2019
- “Third Party Monitoring and Oversight to Manage Key Risks,” instructor, CBI’s Managing HCP Interactions Conference, 2019
- “Speaker Programs – Best Practice Benchmarking,” moderator, CBI’s Pharmaceutical Compliance Congress, 2019
- “Automate Compliance Monitoring Activities to Expand Scope and Reduce Cost,” instructor, CBI’s Compliance Monitoring Conference, 2019
- “Emerging Trends in Transparency Disclosure Around the World,” instructor, CBI’s Transparency and Aggregate Spend Conference, 2018
- “Moving Beyond Compliance – Integrating a Culture of Ethics into Your Organization’s DNA,” moderator, CBI’s Pharmaceutical Compliance Congress – Latin America in Panama City, Panama, 2018
- “Patient Assistance Programs Summit,” instructor, CBI’s West Coast Compliance Congress, 2018
