2026 Day 2 Agenda - ET (Eastern Time, GMT-05:00)
- Audience icebreaker activities during the Chair’s opening session
- Lisa LeCointe-Cephas - Chief Compliance Officer, Johnson & Johnson Innovative Medicine
- FCPA takeaways for updating risk management, internal investigations and compliance strategies
- Navigating tariffs and sanctions - how are compliance teams adapting to new geoeconomics trends
- What does it now take to manage a global team, keep everyone on the same page and tackle compliance calls?
- Establishing compliance standards across varied geographies: developing a core program with regional flexibility
- Kate Godfrey - Senior Vice President, Global Chief Compliance Officer, Karl Storz
- Anisa Dhalla - Head of Global Ethics & Business Integrity, UCB
- Maurice Cresenzi Jr. - Industry Practice Leader, Moody's
- Collaborating with HR to integrate compliance into a company’s culture and foster an inclusive and engaged workplace
- Why and when employees feel comfortable speaking up
- Practical strategies to empower employees
- Insights from recent government guidelines on fostering a strong compliance culture
- Proactive steps to identify and address issues before they escalate
- Jill Fallows Macaluso - Corporate Vice President & Chief Compliance Officer, Novo Nordisk
- Matthew Bintliff - Director, Employee Experience, Novo Nordisk
Decoding OIG enforcement: scrutinizing recent OIG settlements and their implications
Turning guidance into controls: aligning programs with OIG’s guidance and recent advisory opinions
- Meredith Williams - Attorney, Former Senior Counsel, Office of Counsel to the Inspector General of the U.S. Dept. of Health & Human Services, MW Associates PLLC
- Katherine Matos - Associate GC, Product and Medical Affairs, Definium Therapeutics and Former Senior Counsel, Office of Counsel to the Inspector General of the U.S. Dept. of Health & Human Services
- Commentary on the latest developments from DOJ
- Update on DOJ’s health care fraud, FCPA, and other corporate enforcement
- DOJ guidance to prosecutors and its significance for pharmaceutical companies
- The current state of False Claims Act litigation
- Amanda Masselam Strachan - Partner, Wilmer Hale
- Lee Cortes - Partner, Arnold & Porter
- Diane Seol - Of Counsel, Choate
- Analysis of the most recent Executive Orders impacting (Bio)pharmaceutical companies
- Implications of the Big, Beautiful Bill and Most Favoured Nations Pricing
- Update on FDA activity
- Litigation against the Administration
- Stefanie Doebler - Partner, Covington and Burling
- Scott Liebman - Partner and Chair, FDA Regulatory & Compliance; Co-Chair, Life Sciences, Sheppard
Compliance is shifting from dashboards to decisions, from detection to prevention. This session spotlights how leading organizations are using AI to transform fragmented audit, monitoring and investigations data into actionable insights that drive faster, smarter risk decisions. Through real-world case studies, we’ll explore what’s working now and what’s next.
You’ll hear how companies are:
Using AI-driven analytics to flag anomalies, detect emerging risks, and optimize field and digital monitoring.
Turning disparate data into prioritized risk insights that guide proactive action.
Building right-sized, cost-effective AI capabilities across pharma and biotech.
Leveraging automation to reduce investigation time, cut costs, and improve accuracy.
Harnessing predictive analytics and GenAI to shape the future of compliance operations.
- Michael Shaw - Principal, Global Head of Risk & Compliance, ZS Associates
- Steve Kim - Sr. Director, Ethics & Risk Management Analytics, Pfizer
- Marcus Green - Vice President, Risk Analytics and Monitoring, GSK
- Christine Giglio - Senior Director, Compliance & Ethics, Bristol-Myers Squibb
- Practical experience of navigating across different regions
- Strategies for ensuring organizational compliance effectiveness
- Samantha Sutherland - Director, Baker Tilly US, LLP
- David Falcone - Vice President, Global Compliance, Merz Aesthetics
- Kirt Kraeuter - Executive Director, ERC Advisory, Policy & Learning, Novartis
- Uncover key insights and actionable strategies to ensure your organization is truly audit-ready.
- Learn how to identify and address common gaps in program documentation, processes, and data before they become audit findings.
- Understand how audit readiness projects can be leveraged to enhance broader compliance effectiveness and support organizational messaging.
- Walk away with practical takeaways to help your team not only navigate a CMS audit, but also drive lasting improvements in compliance operations.
- Rore Middleton - Vice President, Compliance and Ethics, Blueprint Medicines
- Katie Kelly - Associate Director, Compliance Operations, Ionis Pharmaceuticals
- Jonathan Wilkenfeld - President and Founder, Potomac River Partners
Get inspired with three rapid-fire, 10-minute case studies that deliver actionable insights. Learn how industry leaders tackle real-world challenges, uncover upside opportunities, and optimize resources for success.
- Heather McCollum - Vice President, Compliance, Shionogi
- Jennifer Sanfilippo - General Counsel and Chief Compliance Officer, Melinta Therapeutics
- James Accumanno - Vice President, Legal & Chief Compliance Officer, Karyopharm Therapeutics
- How can we ensure we are communicating in every way we can communicate whilst remaining compliant?
- Interactions with GPOs – examining the types of interactions with field roles, what they can talk about and what can they do
- Medical commercial interactions: helping Compliance keep pace with agile approaches
- Considerations when using scientific platforms to engage HCPs
- Kimberly Gregorio - Vice President, Commercial Excellence and Client Engagement, P360
- Peter Agnoletto - Ethics and Business Integrity Global Head for aT1D&CVM Franchise and US General Medicines Strategic Advisor, Sanofi
- Alicia Whittlesey - Partner, Porzio, Bromberg, & Newman
Get inspired with three rapid-fire, 10-minute case studies that deliver actionable insights. Learn how industry leaders tackle real-world challenges, uncover upside opportunities, and optimize resources for success.
- Jim Dawson - Vice President, Compliance Solutions, qordata
- Sarah Venable - Director of Data Science and Risk Analytics, GSK
- Bryan Timer - Executive Director, Innovation, Digital Enablement, and Analytical Solutions, Merck
- Nuances for communications for unapproved use of approved products
- What are people doing in the field? What is being allowed to be shared by Medical Science Liaison professionals (MLS) and practical guardrails that can be put into place
- Mihaela Carsin - Compliance Business Lead, AstraZeneca
- Compliance’s role in strategic risk leadership
- Risk intelligence: translating compliance knowledge into strategic decision-making frameworks
- How to work collaboratively and cross functionally
- How is risk management informed by own monitoring and data, and all integrate together
- How are people handling risk assessment process: new ways of working
- Eric Baim - Partner, Dovetail Consulting Group
- Jackie Stanley - Senior Compliance Counsel, AI, Digital Health, and Medicines, M&A, Pfizer
- Blair Shaw - Vice President & Senior Compliance Officer, Cencora
Get inspired with three rapid-fire, 10-minute case studies that deliver actionable insights. Learn how industry leaders tackle real-world challenges, uncover upside opportunities, and optimize resources for success.
- Daniel O’Connor - Senior Vice President, NXLevel Compliance
- Heidi Chandonnet - Senior Director, Compliance, Deciphera Pharmaceuticals
- Melissa Grossman - Associate Director, Compliance, PharmaEssentia USA
- Navigating the payer and lobbying landscape for the Life Science industry
- Understanding areas of risk for market access activities
- Interplay between commercial teams, market access teams and Compliance
- Developing risk mitigation strategies
- Margaux Hall - Partner, Ropes & Gray
- Karen Lowney - Associate Vice President, Head of the Office of Ethics & Compliance (OEC), Sun Pharmaceutical Industries, Inc.
- Brandon Goodman - Vice President Legal, Global & Market Commercialization, BioNTech US
