Agenda for Day Two - Wednesday April 28, 2027 - ET (Eastern Time, GMT-05:00)
- How the Fraud Division's creation and the realignment of personnel and FDCA expertise is reshaping enforcement priorities for life sciences
- What the Department's new posture on corporate enforcement, whistleblowers, and self-disclosure signals for compliance programs going forward
- A look at where policy is headed next, and what pharmaceutical compliance leaders should be watching
- Jacob Foster - Deputy Assistant Attorney General, U.S. Department of Justice, Member, Attorney General's Super Intelligence Task Force
The decisions landing on today’s General Counsel increasingly extends beyond strictly legal questions, requiring judgement across compliance, enforcement exposures, business strategy, and enterprise risk.
- Navigate high-stakes decisions when legal, compliance, and business priorities collide
- Shape how GC, CCO, executive leadership, and board align around emerging risks and critical decisions
- Draw the line between acceptable business risk and which the organization cannot afford to take
- Nikki Reeves - Partner, King & Spalding
- Laura Caponi - Vice President, Strategic Risk Management, Bristol Myers Squibb
For many compliance professionals, the reporting structure debate is over. The real challenge is building an effective partnership with legal. Join General Counsel and Compliance leaders for a candid discussion on how to align priorities, build influence, and work together when the stakes are highest
- Navigate the risks and benefits of reporting into legal, from privilege considerations to organizational influence
- Build credibility and trust with General Counsel while demonstrating compliance's strategic value
- Define the partnership during investigations, high-risk decisions, and moments that test alignment
- Explore successful GC-compliance partnerships and the lessons they offer for stronger collaboration and business impact
- Isa Prada - Vice President, Regional General Counsel, Legal & Compliance - LATAM, PTC Therapeutics
- Jesse Siegel - Head of Business Ethics, Ipsen
FCPA enforcement didn’t just resume in 2026, it came back with a shaper, narrower focus that changes where the real exposure sits
- Decode DOJ's new FCPA enforcement priorities, including emerging cartel-nexus theory affecting companies with manufacturing or supply chain exposure in high-risk regions
- Navigate China's new anti-corruption and anti-monopoly guidelines and their impact on pharmaceutical and device companies operating there
- Designing a core compliance program that flexes across increasingly divergent regional requirements
- Scott Hollander - Head, North America Litigation and Governmental Investigations, and Compliance Counsel, Dr.Reddy's Laboratories
OIG has made some of its most significant changes to Corporate Integrity Agreements in over a decade, and the new terms go well beyond the basics.
- Identify what's new in CIA terms including:board accountability, compliance officer independence, AI governance, and more
- Understandhow the terms shape day-to-day compliance operations over the life of an agreement
- Buildmonitoring and reporting structures that would hold up even without a CIA in place
- Saul Helman - President, Epsilon Life Sciences
- Kevin Espinoza - Chief Integrity & Compliance Officer, Indivior
Fraud detection used to start with a tip. Increasingly it starts with a pattern in the data
- Understanding what's driving analytics-first fraud detection
- Examining the data behind the trend
- Learning how organizations deploy analytics in investigations and where tools succeed or fail
- Brook Mischler - Global Director Compliance Solutions - Life Sciences, CaseIQ
- Casey O'Donnell - Investigation Lead, Viatris
- Isabella Carini - Associate Compliance Officer, Global Strategic Solutions & Compliance Analytics Portfolio Management, Abbvie
Outside counsel is advising clients differently than they were a year ago, shaped by everything from state enforcement activity to shifting FCPA priorities
- Track how legal advice on structuring patient support, speaker and pricing programs has shifted in response to recent enforcement activity
- Pinpoint where practice chairs tell clients to be more conservative and where they see more flexibility than expected
- Reveal what questions practice chairs are getting asked more often by in-house counsel and compliance right now
- Stefanie Doebler - Partner, Covington and Burling
- Connect insights across due diligence, monitoring, audits and investigations to identify emerging risks
- Break down silos to build a more complete view of risk across the enterprise
- Leverage smarter processes, data and technology to turn risk information into actionable intelligence
- Hernan Cao - Senior Director, Strategic Risk Management, Bristol Myers Squibb
- Define what effective monitoring and auditing approaches look like in practice
- Pinpoint where the most common gaps exist between current monitoring and what programs should actually be watching
- Implement practical strategies for strengthening your monitoring and audit approach immediately
- Erin Ainsco - Director, Dovetail Consulting
- Laura Heyduk - Head of Global Compliance, KalVista Pharmaceuticals Inc
- Roberta Rima - Vice President, Global Compliance Audit, Monitoring, Analytics, Zimmer Biomet
- Identifying where AI is delivering measurable value across compliance programs
- Balancing innovation with effective governance and oversight
- Evaluating AI tools through the lens of risk, transparency, and accountability
- Determining where AI can enhance compliance outcomes and where human judgment remains critical
- David Amendola, HCC - Director, ResEcon Life Sciences & Healthcare
- Elizabeth Weiss - Vice President, Chief Compliance and Privacy Officer, Invivyd
- Reinforce foundational compliance principles as engagement with rare disease patient communities and advocacy organizations continues to expand
- Navigate evolving patient advisory processes, including increased structure, oversight, and defined timelines for compliant interactions
- Define appropriate boundaries between Medical Affairs, Commercial, and Patient Advocacy teams across pre- and post-approval engagement, including how to respond to requests from patient communities
- Donna White - Vice President, Compliance US, Chiesi USA Inc.
- Identify where PBM rebate and fee arrangements now carry anti-kickback exposures
- Examine what new transparency requirements mean for PBM agreement structure
- Define how compliance should vet and monitor PBM relationships as third-party risks
- Katherine Matos - Associate General Counsel, Product and Medical Affairs, Definium Therapeutics
- Navigate compliance and privacy considerations across patient support program design and operations
- Address patient consent, data sharing, and the appropriate use of sensitive data information
- Strengthen third-party oversight while preserving an effective patient experience
- Yvonne Osirim - Vice President, Human Health Ethics & Compliance, Merck
- Judy Losey - Senior Director, Associate General Counsel, Sobi Inc
- Create compliance communications that capture attention and drive action
- Apply adult learning and behavioral science principles to improve engagement
- Reinforce key risk messages in ways employees remember and use
- Daniel O’Connor - Senior Vice President, NXLevel Compliance
- Identify what's driving the surge in relator-initiated cases
- Evaluate whether internal reporting channels can compete with whistleblower attorneys
- Learn what relator attorneys assess before filing and where programs fall short
- Averi Price - Senior Vice President, Legal and Chief Compliance Officer, Syndax Pharmaceuticals
Panel (25 minutes)
- Identify where regulatory and compliance exposure is emerging across market access
- Examine how compliance and market access teams are restructuring how they work together
- Share practical mitigation strategies that protect the organization without unnecessarily slowing the business
Community Conversation (30 Minutes)
Join a guided discussion to compare how peers are navigating market access risk, cross-functional responsibilities, and emerging gray areas.
- Karen Lowney - Associate Vice President, Head of the Office of Ethics & Compliance (OEC), Sun Pharmaceutical Industries, Inc.
- Laura Hunter - Counsel, Healthcare Regulatory, Hogal Lovells
- Yelena Ferreira - Vice President, Legal & Compliance, Pharmacosmos Therapeutics
Panel (25 Minutes)
- Compare evolving compliance and privacy expectations across the US, EU, APAC, and LATAM
- Navigate emerging privacy regimes, cross-border data transfers, and regional data requirements
- Balance global consistency with the flexibility to meet local regulatory expectations
Community Conversation (20 Minutes)
Join a guided discussion to benchmark how peers are navigating regional differences across global compliance and privacy programs
- Itzy Wallace - Vice President, Head of Compliance & Risk, Mayne Pharma
- Monica Gutierrez - Senior Compliance Officer of Mexico & Argentina & Chile, Stryker
Panel (25 Minutes)
- Examine current guardrails for influencers and social media engagement
- Identify where FMV and compliance considerations arise across digital activity
- Compare approaches to monitor employees, commercial teams, and external partners
Community Conversation (30 Minutes)
Join a guided discussion to compare approaches to social media oversight, emerging gray areas, and practical guardrails.
- Sarah diFrancesca - Head of US Compliance - Dermatology, Incyte
- Donna White - Vice President, Compliance US, Chiesi USA Inc.
Panel (25 Minutes)
- Examine how DOJ Self-disclosure expectations affect internal investigations
- Navigate the tension between early disclosure and incomplete information
- Discuss compliance to legal communication and escalation when potential misconduct surfaces
Community Conversation (30 Minutes)
Join a guided discussion to compare how compliance and legal teams are approaching escalation, investigations, and self-disclosure decisions
- David Ryan - Senior Vice President, Legal and Chief Compliance Officer., Ardelyx, Inc
- Scott Hollander - Head, North America Litigation and Governmental Investigations, and Compliance Counsel, Dr.Reddy's Laboratories
