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?
- Robert Ladd - Senior Vice President, Chief Ethics and Compliance Officer, Gilead
- Steven Cohen - Vice President, Chief Ethics and Compliance Officer, North America, Eli Lilly
- Isabel Duffy - Senior Vice President, Chief Ethics and Compliance Officer, Merck
- Melissa Lozner - Senior Vice President, Chief Compliance Officer, Regeneron
- Tara McCarthy - Co-Founder and Partner, Dovetail Consulting Group
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
- 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?
- DOJ-HHS-CMS partnerships enforcement priorities
- Latest updates from the working group and what Life Science organizations should be doing proactively
- 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
- 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, Legal Development & Compliance, Legal & Intellectual Property, uniQure
- 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
- Melanie Polloway - Vice President, Chief Ethics & Compliance Officer, Daiichi Sankyo, Inc.
- Beth Reiley - Head of Investigations Global Compliance, Viatris
- 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?
- Grant Ostlund - Senior Director - Strategy & Operations, Ethics & Compliance, Novo Nordisk
- Saul Helman - President, Epsilon Life Sciences
- Casey Horton - Managing Director, Epsilon Life Sciences
- Understanding the different types of Board opportunities and positions and what is required for each
- 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
- Sujata Dayal - Independent Board Director, Emergent BioSolutions
- Felicia Heimer - Senior Director, Rare Disease Compliance, 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
- 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?
- Yvonne Osirim - Vice President, Human Health Ethics & Compliance, Merck
- Christine Zettlemoyer - Senior Vice President, Global Head of Compliance, Risk, and Data Privacy Program, 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
- Roberta Rima - Vice President, Global Compliance Audit, Monitoring, Analytics, Zimmer Biomet
Common trip points and cross-functional working
How to clearly define the difference between Legal, Compliance, and Regulatory risk
- David Ryan - Senior Vice President, Legal and Chief Compliance Officer, Ardelyx, Inc
- 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
- Al Park - Global Program Effectiveness & Insights Leader, Worldwide Compliance & Business Ethics, Amgen
- 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 Risk Director - Risk Insight & 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 - Corporate Vice President & Chief Compliance Officer, Novo Nordisk
- Donna White - Vice President, Compliance US, Chiesi USA Inc.
