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April 27-29, 2027
Gaylord National Resort & Convention CenterNational Harbor, MDKey Sessions
Chairperson's Review of Day Two
James Stansel
PhRMA Address – Navigating the Policy Landscape
PhRMA
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Agenda for Day Three - Thursday April 29, 2027 - ET (Eastern Time, GMT-05:00)
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Agenda for Day Three - Thursday April 29, 2027 - ET (Eastern Time, GMT-05:00)
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Showing 2 of 2 Streams
Networking
[Breakfast & Learn]
7:45am - 8:20am
Conference Registration and Continental Breakfast
8:00am - 8:20am
[Breakfast & Learn] Small & Emerging Company Compliance Exchange – Building for What Comes Next
Navigate the realities of building and evolving compliance within a smaller organization. Connect with peers to share practical approaches, tackle common challenges and prepare your program for what comes next.
- Prioritize with limited resources: Where should compliance focus when your team can’t do everything?
- Build for where you’re going: Create policies, processes and infrastructure that can evolve as the organization grows.
- Navigate growth milestones: Compare approaches as companies move through clinical development, commercialization and expanding teams.
Showing 1 of 1 Streams
General Session
8:20am - 8:30am
Chairperson's Review of Day Two
Showing 3 of 3 Streams
Commercial Compliance
Innovation & Emerging Compliance
Legal & Enforcement
8:30am - 9:15am
[Panel] The Line Compliance Has to Hold – Medical Affairs & Commercial Collaboration
- Identifying where the medical-commercial firewall blurs in practice
- Maintaining MSL and field team guardrails under operational pressure
- Designing internal governance that supports scientific advancement
- Yvonne Osirim - Vice President, Human Health Ethics & Compliance, Merck
- Joseph Mack - Vice President, Head, US Office, Compliance, Bayer
9:15am - 9:20am
Transition Break
9:20am - 10:05am
SIUU – Scientific Information on Unapproved Uses
- Clarify where unapproved-use communication becomes unclear in practice
- Establish MSL sharing boundaries and guardrails
- Evaluate scientific platform strategies for HCP engagement
- Tracy Palmer Berns - Senior Vice President, Chief Compliance & Quality Assurance Officer, Ionis Pharmaceuticals
8:30am - 9:15am
[Fireside Chat] Pharma's Digital Health Footprint — Telehealth Partnerships & DEA Flexibilities
- Navigate DEA telehealth rule uncertainty and state-level divergence in manufacturer programs
- Manage anti-kickback exposure when manufacturer funding intersects with telehealth prescribing
- Establish effective third-party digital health vendor oversight
9:15am - 9:20am
Transition Break
9:20am - 10:05am
AI Is Watching Your Speaker Program – HCP Engagement in the New Era
- Leverage AI tools to transform HCP engagement tracking and oversight
- Identify where speaker program compliance risk has shifted in the last two years
- Implement practical guardrails for AI-assisted engagement monitoring
- Sean Kennedy - Head of Compliance, Moderna Therapeutics
8:30am - 9:15am
[Fireside Chat] TrumpRx, MFN, & the New DTC Model – What Compliance and Legal Needs to Know
- Evaluate/DTC requirements and identifying manufacturer agreement gaps
- Assess Best Price and Medicaid rebate interactions with direct-to-consumer pricing
- Examine promotional and marketing compliance in non-HCP sales channel
- Itzy Wallace - Vice President, Head of Compliance & Risk, Mayne Pharma
9:15am - 9:20am
Transition Break
9:20am - 10:05am
Cybersecurity Fraud – DOJ’s Newest Enforcement Theory
- Analyze DOJ's first cybersecurity fraud settlement establishing security failures as fraud liability
- Assess why inadequate cybersecurity measures now trigger FCA enforcement actions
- Develop governance frameworks aligning IT security with compliance requirements
- Keren Tenenbaum - Chief Compliance Officer, Chief Counsel, Digital, and Tech, Zoetis
Showing 1 of 1 Streams
Networking
10:05am - 10:30am
Networking Break
Showing 1 of 1 Streams
General Session
10:30am - 11:00am
FDA Keynote – Drug Advertising & Promotion
FDA’s scrutiny of consumer-facing promotion hasn’t slowed down, and the tools they’re using to enforce it keep evolving.
- Current priorities and scrutiny on consumer-facing promotion
- How FDA is using AI dashboards to flag violations across social media, influencer content, and even chatbot interactions
- What’s upcoming rulemaking could mean for risk disclosure requirements going forward
- Sean Keveney - Chief Counsel, Food and Drug Administration (FDA)
11:00am - 11:30am
HHS & CMS Address – Program Integrity, Fraud & Abuse
A direct line from HHS and CMS legal leadership on the evolving program integrity landscape and priorities around fraud and abuse. Gain insight on:
- CMS program integrity priorities and evolving areas of focus
- Fraud and abuse risks across federal healthcare programs
- Considerations for compliance and legal teams navigating increased oversight
- Elizabeth Kelley - Deputy General Counsel & Chief Legal Officer for CMS, U.S. Department of Health and Human Services (HHS)
11:30am - 12:00pm
PhRMA Address – Navigating the Policy Landscape
A look into how PhRMA interprets and shaping the evolving policy environment, from pricing and access to IP and FDA policy.
- Assess the changes for compliance and legal under the current administration
- Identify where industry sees alignment with where policy is head and where real tension remains
- Evaluate where compliance and legal should be doing heading into the next year
- James Stansel - Executive Vice President, General Counsel and Corporate Secretary, PhRMA
Showing 1 of 1 Streams
Networking
12:00pm - 12:30pm
Fuel & Focus Networking Luncheon
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General Session
12:30pm - 1:00pm
Industry Reflects – Navigating the Administration’s Regulatory Landscape
Enforcement priorities have shifted, self-disclosure expectations have changed, and a reshaped pricing model has created new compliance questions that didn’t exist before. Join a panel of industry leaders to reflect candidly on what it all means and where to take it from here
- Assess the changes for compliance and legal under the current administration
- Identify where industry sees alignment with where policy is head and where real tension remains
- Evaluate where compliance and legal should be doing heading into the next year
- Nahrin Marino - Head of Legal, Interim General Counsel and Chief Ethics and Compliance Officer, Astellas Pharma
- Sheila Abraham - Vice President, Chief Compliance Officer, Dompe U.S.
1:00pm - 1:45pm
Closing Keynote – Carrying It Forward
A reflective close on what it takes to lead compliance programs through a period of real change, and where the work continues from here.
- What sets apart the compliance leaders who thrive amid constant change
- Practical next steps for putting what you’ve heard into practice
- Daryl Kreml - Head of Ethics and Compliance, Takeda Oncology
Showing 1 of 1 Streams
Close of Day
1:45pm - 1:50pm
Close of Conference
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