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April 27-29, 2027
Gaylord National Resort & Convention Center | Oxon Hill, MDWe Will See You in 2027!Key Sessions
Brook Mishler
Transforming Compliance Data into a Strategic Asset - Macro Trends and Outlier Patterns
CaseIQ
James Stansel
PhRMA (Pharmaceutical Research and Manufacturers of America) Address
PhRMA
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2026 Day 3 Agenda - ET (Eastern Time, GMT-05:00)
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2026 Day 3 Agenda - ET (Eastern Time, GMT-05:00)
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Registration
7:30am - 8:30am
Conference Registration and Continental Breakfast
Showing 3 of 3 Streams
Topic Intensive A
Topic Intensive B
Topic Intensive C
8:30am - 9:25am
Pillars on Shifting Ground: Executing a Resilient Compliance Program
- OIG Guidance: Summary of 7 Elements
- Pillar 1: Establishing a Firm (Governance) Foundation
- Value of a Compliance Assessment/Gap Analysis
- Prioritization of Needs
- Size, culture, past experience with government agencies
- Algorithmic Auditability
- The Independent CCO
- Pillar 2: Stabilizing the Human Element
- Training from top-bottom
- Behavioral Diagnostics
- Enforcement with Equity
- Pillar 3: Real-Time Reinforcement—Auditing, Monitoring & Due Diligence
- Continuous Monitoring as a Safety Net
- Built in processes
- Creating a "speak up culture" so employees are comfortable reporting or raising compliance concerns/issues
- M&A-Stress Testing
- Continuous Monitoring as a Safety Net
- Pillar 4: The 120-Day Race to Resolution
- Hotline Trust in a High-Stakes Era
- Strategic Disclosure
- David Fisher - President, TDI Solutions
- Sara Simon - Compliance Director, Legal Affairs and Compliance, IBSA USA
- Catherine Kaucher - Health Care Compliance Director, Johnson & Johnson
9:25am - 10:20am
Commercial Risks in Patient Support Programs
- How businesses co-ordinate patient support and the relationship between commercial teams and patients
- Examining different roles engaging with patients including Nurse Educators, Patient Education Liaison, and Patient Advocacy groups
- Practical compliance considerations for Patient Speaker programs and Patient Ambassador Program
- Examining differing approaches on transfer of value in meals, speaker honorarium etc
- Internal guidelines and spend for patients, and practical questions such as if alcohol is allowed etc?
- Eliza Andonova - Partner, Global Regulatory, Hogan Lovells
- Brian Sharkey - Head of NA, Compliance and Ethics, Teva Pharmaceuticals
8:30am - 9:25am
Navigating Data Privacy: What Compliance Professionals Need to Know
- Privacy essentials for pharmaceutical companies
- How do you set up privacy programs considering the varying privacy requirements and an ever-changing landscape?
- As privacy considerations grow for your business, where does it sit and how do you operationalize it? Compliance vs. Legal department vs. independent privacy officer?
- Erin Wagenberg - Director, Dovetail Consulting Group
- Danielle Green - Senior Director, Legal & Compliance, Savara
- Laurie Kathleen Durousseau - Vice President, Legal, Chief Compliance & Privacy Officer, GRAIL
9:25am - 10:20am
Embedding Compliance into Organizational Culture
- Understanding the DOJ and FCPA focuses for compliance culture
- How do you measure the culture of compliance?
- How to cultivate a culture of Compliance
- How do you become ‘the voice’ of Ethics and Integrity in your organization?
- Ethical conduct with compliance – understanding group think, deviance etc
- Carrie Amezcua - Shareholder, Buchanan
- Elizabeth Weiss - Vice President, Chief Compliance and Privacy Officer, Invivyd
- Maria Villanueva - Director, Ethics and Compliance, BioTissue
9:25am - 10:20am
Navigating Social Media
- Fundamentals of a social media policy
- What are your guardrails and parameters on influencers
- Social media personalities and FMV
- Commercial teams on social media: where is the line when posting, liking and reposting?
- How do you monitor social media? 3rd party? Monitoring via AI?
- Global risks e.g. EU /ABHI
- Kathleen Boozang - Professor of Law and Dean Emeritus, Seton Hall Law School
- Derek Frueh - Head of NA Compliance & Canadian General Counsel, Leo Pharma
- Amy Wilson - Vice President, Chief Compliance Officer, Esperion Therapeutics
Showing 1 of 1 Streams
Networking
10:20am - 10:50am
Networking Break
Showing 1 of 1 Streams
Main Stage
10:50am - 11:40am
Transforming Compliance Data into a Strategic Asset - Macro Trends and Outlier Patterns
- How are you supporting the business with your compliance data?
- Shifting the perception of compliance data from a regulatory obligation to a tool for driving business performance and protecting enterprise value.
- Utilizing analytics to demonstrate how compliance initiatives contribute to operational success.
- How to share compliance data effectively across teams, including sales and commercial, with clear purposes and transparency.
- Can compliance data help identify macro trends and areas requiring attention: connecting compliance softness and performance.
- Brook Mishler - Global Director Compliance Solutions - Life Sciences, CaseIQ
- Marcus Green - Vice President, Risk Analytics and Monitoring, GSK
- Piyush Sharma - Chief Ethics & Compliance Officer, Alnylam Pharmaceuticals
- Daryl Kreml - Head of Ethics and Compliance, Takeda Oncology
11:40am - 12:20pm
Transparency Reporting: Centers for Medicare & Medicaid Services (CMS) Open Payments Program
- Developments in audits: are we going to see more scrutiny in what companies are doing? What do we need to be doing differently going forward?
- Data insight: how do regulators and investigators use the data? How can companies ensure they know what is in the data and what should they expect regulators to know about their data?
- New enhancements and developments on the horizon
- Amy Bedsaul - Open Payments Communications, Centers for Medicare & Medicaid Services (CMS)
- Kathleen Ott - Compliance and Policy Lead for Open Payments, Centers for Medicare & Medicaid Services (CMS)
- Veronika Peleshchuk Fradlin - Director of Division of Transparency Projects (DTP), Centers for Medicare and Medicaid Services (CMS)
12:20pm - 12:50pm
The Ripple Effects of a Shifting Payer Landscape on Compliance
- Impact of recent legislative and administrative developments on drug pricing, reimbursement, and access
- PBMs on shaky ground: examining the instability of Pharmacy Benefit Managers and its implications for the healthcare ecosystem
- Rebates and Pharma Impact: understanding how rebate changes will primarily affect pharmaceutical companies and spill over into the medical device sector via GPOs
- Implications of provider sector challenges: consequences of rising premiums and the growing physician exodus as the provider sector reaches a tipping point
- Industry-wide implications: highlighting how the evolving payer and provider dynamics directly impact Life Sciences companies and their stakeholders
- Meena Datta - Healthcare & Life Sciences Co-Chair, Executive Committee Member, Sidley Austin LLP
12:50pm - 1:20pm
PhRMA (Pharmaceutical Research and Manufacturers of America) Address
- Impact of recent legislative and administrative developments on drug pricing, reimbursement, and access.
- James Stansel - Executive Vice President, General Counsel and Corporate Secretary, PhRMA
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Close of Day
1:20pm - 2:20pm
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