2026 Day 1 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
- Compliance department focus: What is in scope for 2026?
- Expanding the compliance umbrella: Do trade compliance, privacy, cybersecurity, and enterprise risk now fall under compliance?
- Transparency reporting: Should this function sit within compliance or remain under business functions like finance?
- Executive Committee attitudes: Are leadership perspectives on compliance evolving, and how are compliance leaders navigating these changes?
- Strategies for resilience: How can compliance leaders prepare for future regulatory challenges in an era of unclear enforcement?
- Agility in compliance programs: How do you keep your program nimble and ready to adapt as priorities shift?
- Influencing organizational decisions: What are effective ways for compliance to shape key decisions directly or indirectly?
- Emerging technologies: How are companies leveraging AI and data analytics to enhance compliance?
- Tara McCarthy - Co-Founder and Partner, Dovetail Consulting Group
- Isabel Duffy - Senior Vice President, Chief Ethics and Compliance Officer, Merck
- Melissa Lozner - Senior Vice President, Chief Compliance Officer, Regeneron
- Robert Ladd - Senior Vice President, Chief Ethics and Compliance Officer, Gilead Sciences
- Shefali Kothari - Chief Compliance Officer, US, and Country Head, Ethics, Risk and Compliance, Novartis
What should Life Science companies be focused on around combatting fraud, waste, and abuse?
- Expectations around AI governance
- Updates to Compliance program guidance
- Hear directly from U.S. Attorneys on the most recent CIA’s and an analysis of settlement trends
- Areas currently being closely looked at by investigators?
- What methods, analysis, and data are being utilized during investigations?
- Has the Blanche Memo led to an increase in cases?
- SEC perspective and priorities
- Craig Bleifer - Partner, McGuireWoods LLP
- Mackenzie Queenin - Assistant US Attorney and Chief, Health Care Fraud, US Attorney Office, District of Massachusetts (Subject to Final Confirmation)
- Where do their current enforcement priorities lie?
- Are there any practices that Compliance leaders should be on the lookout for within their organizations?
- Will there be a ramp-up on how good enter/exit the US in light of the administration and the direction they are going?
Address on the evolving False Claims Act enforcement landscape facing pharmaceutical companies, highlighting recent trends in government investigations, settlements, and litigation, including through the operation of the DOJ-HHS FCA Working Group
Remarks will offer actionable insights for compliance professionals navigating heightened scrutiny across the life sciences industry
- Brenna Jenny - Deputy Assistant Attorney General, Commercial Litigation Branch, Civil Division, US Department of Justice
- Establish a foundation of Compliance using the seven elements of a Compliance framework
- Are all Compliance programs the same? Building a program for a start-up vs. a fully commercialized organization
- Examining the three foundational questions in the DOJ Evaluation of Effective Compliance Programs
- Reality of operationalize your Compliance program: resources needed for implementation, realities of monitoring and auditing, pragmatic approaches to new trends and risks
- Stephanie Macholtz - Vice President, Healthcare Compliance, Organogenesis
- Yvonne Osirim - Vice President, Human Health Ethics & Compliance, Merck
- Differing phases of your career: explore career development across different stages
- Learn about essential technical and soft skills necessary for success in compliance, including legal knowledge, communication, problem-solving and increasingly the data analytics
- Understand the importance of mentorship, networking, and professional connections in shaping career progression and uncovering new opportunities
- Effectively position yourself for recruiters and hiring managers
- Understanding the nuances of different roles and how to tailor your approach to align with expectations
- How to ask for new opportunities: practical advice on identifying and pursuing new opportunities within your organization or industry
- Joseph Philipose - Senior Vice President, Chief Ethics and Compliance Officer, Emergent BioSolutions
- Andrea Kocharyan - Vice President, Commercial Law and Compliance, uniQure
- Averi Price - Senior Vice President, Legal and Chief Compliance Officer, Syndax Pharmaceuticals, Inc.
- New ideas and solutions to investigator challenges
- Practical tools and tips for handling difficult investigations and joint working with Legal/HR
- How are investigation outcomes shared with the organization?
- Providing clear, C-suite-endorsed messaging that encourages internal reporting
- Strengthening internal complaint pathways in addition to anonymous reporting options
- Approaches for responding to hotline reporters
- David Amendola, HCC - Director, ResEcon Life Sciences & Healthcare
- Beth Reiley - Head of Investigations Global Compliance, Viatris
- Olga Zinavenka - Executive Director, Global Compliance Operations Officer, Keenova
- The importance of documenting your compliance program: practical dos and don’ts
- Does your documentation hold up to potential scrutiny such as litigation?
- Interplay between legal and compliance
- What needs to be privileged? Is privilege compliance documentation a help or hinderance when protecting company against litigation and where is the line?
- Casey Horton - Managing Director, Epsilon Life Sciences
- Grant Ostlund - Senior Director - Strategy & Operations, Ethics & Compliance, Novo Nordisk
- Saul Helman, M.D., MBA, - President, Epsilon Life Sciences
- Understanding the different types of Board opportunities and positions and what is required for each
- Overview of HHS-OIG’s expectations and recommendations for Board oversight of ethics and compliance
- Essential competencies: critical skills and experiences that help compliance leaders transition to board service
- Writing your Board resume: understanding elements will help you stand out
- Building your board profile: developing the visibility, network, and credentials that open boardroom doors
- Tools and tips for running a compliance committee that align with HHS-OIG Guidance
- Mahnu Davar - Partner, Arnold & Porter
- Sujata Dayal - Independent Board Director, Emergent BioSolutions
- Felicia Heimer - Head of Rare Disease Compliance, Worldwide Compliance & Business Ethics, Amgen and Co-Author of OIG's Practical Guidance for Health Care Governing Boards on Compliance Oversight
- Scope of your compliance – what sits at the core of a compliance program?
- Evaluating current team capabilities against future skill requirements
- Skills needed for your program: considering outsourcing, offshoring, automation, local workforce etc
- Technical solutions: to what extend can automation help?
- Upskilling your workforce: considering the traditional background skills for compliance, what new skill sets do you need to instill or seek out?
- Managing prioritization for new skills: Compliance manager vs data scientist – how do you sell benefits between one or another?
- Shefali Kothari - Chief Compliance Officer, US, and Country Head, Ethics, Risk and Compliance, Novartis
- Rore Middleton - Vice President, Compliance and Ethics, Blueprint Medicines
- Melanie Polloway - Vice President, Chief Ethics & Compliance Officer, Daiichi Sankyo, Inc.
- Why Compliance professionals must upskill their data literacy
- Key advice and common trip points for data ethics, data systems and mapping data flow within your organization
- Tools to help you advance your data analytics output and insights
- How data can underpin compliance conversations and amplify your message: powerful tools to strengthen compliance-related discussions
- Bryan Timer - Executive Director, Innovation, Digital Enablement, and Analytical Solutions, Merck
- Aaron Leskow - Associate Director of Healthcare Compliance, Immunocore
- Strategies and tactics on what should be monitored
- Best practice for live monitoring activities
- Role of data analytics in monitoring programs
- Advancing monitoring activities across the business: reframing monitoring to business insight gathering
- How can audit and monitoring work together in partnership?
- Jeff Hyre - Vice President of Sales, Healthcare & Life Sciences, Global Relay
- Christine Zettlemoyer - Senior Vice President, Chief Compliance & Risk Officer, Genmab
- Interpreting the latest EO and DOJ guidance impacting R&D
- Examining HCP interactions under R&D
- Examining risk exposure and approaches to designing policies to mitigate risk
- Nikki Reeves - Partner, FDA & Life Sciences, King & Spalding LLP
- Roberta Rima - Vice President, Global Compliance Audit, Monitoring, Analytics, Zimmer Biomet
- Natasha Trifun - Head of Enterprise Compliance & Risk, AstraZeneca
Common trip points and cross-functional working
How to clearly define the difference between Legal, Compliance, and Regulatory risk
- Bethany Hills - Partner, White & Case
- David Ryan - Senior Vice President, Legal and Chief Compliance Officer, Ardelyx, Inc
- Luanna Saulino - Health Care Compliance Officer, J&J Innovative Medicine
- How are you tying the different elements of your compliance program together?
- Who and how to measure the effectiveness of your Compliance program
- How do you then identify what is driving lower scores so that you can effectively manage that particular risk?
- Evidencing continual growth to your Executives and Board
- Brian Van Hoy - Vice President, Compliance, G&M Health LLC
- Al Park - Senior Compliance Officer – Global Monitoring, Auditing and Third-Party Risk Management, Jazz Pharmaceuticals
- Kelly Tope - Head of Ethics and Business Integrity Governance, Operations & Risk Management NA & Global Specialty Care, Sanofi
- Tools to simplify your risk assessments, focus on what truly matters, and leverage them as a powerful driver of Compliance
How to adapt your risk assessment approach based on company size, pre-commercial or commercial, and aligned with your operational realities
From paper to practice: turning risk assessments into action plans
Practical tips to get the most value from your risk assessment process
Benchmarking risks to track progress and trends over time
- Colleen Doyle - Senior Director Risks, Insight, and Management, Novo Nordisk
- Erica Powers - Former Vice President, Chief Compliance Officer, Sage Therapeutics
This private gathering is designed exclusively for the most senior Compliance leaders, offering a unique opportunity to share insights, foster meaningful peer connections, and engage in advanced programming tailored to the evolving challenges of top Compliance leadership.
Key Features:
- Confidential Peer Discussions: Engage in open and secure conversations with fellow leaders
- Leadership-Focused Discussion: Participate in sessions designed to address strategic leadership challenges
- Forward-Thinking Insights: Explore innovative approaches and future trends in leadership
- Jill Fallows Macaluso, Esq., RN, - Corporate Vice President & Chief Compliance Officer, Novo Nordisk
- Donna White - Vice President, Compliance US, Chiesi USA Inc.
