Agenda for Day One - Tuesday April 27, 2027 - ET (Eastern Time, GMT-05:00)
- Nhu Tran - Conference Producer, Informa Connect
Pharma has never faced this level of public and political scrutiny at once: pricing anger, tariff pressure, an upended pricing model and an industry fighting to be believed. Compliance isn't a spectator to that fight. It's the function that determines whether the industry earns its credibility back.
- Understand why trust, not enforcement risk, is becoming the real currency the industry trades in
- Explore what it takes for a compliance function to have a seat at the table when the business is under this kind of pressure
- Gain a candid, first-hand account of leading compliance through high-pressure public scrutiny
Every policy, every audit and every hard call made ultimately serves one person: the patient waiting for the medication to work, and to be able to trust it.
As a two-time breast cancer patient and advocate, Heidi combines authenticity, strategic insight, humor, and emotionally compelling storytelling to create presentations that resonate deeply with healthcare professionals, advocacy leaders, corporate audiences, and patient communities. Her work as a caregiver to other cancer patients is at the heart of her mission.
- Heidi Floyd, National Oncology Advocate, Patient Engagement Strategist
A candid look at what’s keeping today’s Chief Compliance Officers up at night, and how they’re adjusting their programs in real time as the ground shifts beneath them
- Define what's in scope for compliance departments in 2027 and where the boundaries should be drawn
- Break down operational silos to build a horizontal, interconnected governance framework across privacy, cybersecurity and evolving enterprise risks
- Navigate the tension between supporting innovation and mitigating risk when enforcement direction remains unclear
- Tara McCarthy - Co-Founder and Partner, Dovetail Consulting Group
- Isabel Duffy - Senior Vice President, Chief Ethics and Compliance Officer, Merck
- Piyush Sharma - Chief Ethics & Compliance Officer, Alnylam Pharmaceuticals
- Soph Sophocles - Chief Compliance Officer, Biogen
- 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
A direct line to what DOJ is watching right now, from the officials setting enforcement priorities for the year ahead. Hear from DOJ:
- Current priorities regarding fraud, waste and abuse in life sciences
- Emerging risk areas, from AI governance to social media to other evolving compliance touchpoints
- Identify what's changing in compliance program guidance and how DOJ expects programs to keep pace
- David Metcalf - United States Attorney, United States Attorney’s Office for the Eastern District of Pennsylvania, US Department of Justice
State enforcement has become its own compliance domain, with priorities and approaches that don't always mirror federal action
- Understand where state enforcement is most active right now across marketing, transparency, pricing and licensure
- How state-level requirements are creating compliance obligations that federal programs don't address
- George Brandley - Chief, Healthcare Fraud Unit, United States Attorney’s Office for the District of New Jersey, US Department of Justice
Hear directly from former prosecutors on how enforcement priorities translate into actual investigations and case decisions, including:
- Latest DOJ actions and investigations and what they signal for the industry
- Updates on healthcare fraud, FCPA and corporate enforcement priorities
- How recent DOJ guidance to prosecutors’ impact pharmaceutical companies
- Evolving landscape of False Claims Act litigation
- Amanda Masselam Strachan - Partner, WilmerHale
- Lee Cortes - Partner, Arnold & Porter
- Paul Perkins - Partner, Morrison Foerster
- Review the seven core elements of an effective compliance framework
- Analyze program design requirements for start-up versus mature organizations
- Manage monitoring and auditing functions when operating with limited budgets
- Identify common early-stage compliance errors and practical methods to avoid them
- Laura Heyduk - Head of Global Compliance, KalVista Pharmaceuticals Inc
- Derek Frueh - Head of NA Compliance & Canadian General Counsel, Leo Pharma
- Identify where compliance and privacy responsibilities overlap across investigations, monitoring and third-party oversight
- Analyze privacy implications when deploying AI-enabled tools within an organization
- Establish practical framework steps to strengthen collaboration between compliance, privacy, legal and IT teams
- Kris Hall - Managing Director, Dovetail Consulting Group
- Monica Sanches - Director, Dovetail Consulting
- Assess whether to bring cross-functional talent into compliance, or embedding compliance inside operational teams, to pull the right stakeholders into the first line early
- Align second-line controls to real workflows and give the third line clear, data-backed auditability
- Build Centers of Excellence that bake compliance into initiatives from day one
- Position compliance as a growth enabler, not a gatekeeper
- Gain business acumen and position yourself for strategic leadership roles across the organization
- Amy Wilson - Vice President, Chief Compliance Officer, Esperion Therapeutics
- Jessica Constant - Associate Director - Compliance & Business Controls, AstraZeneca
- Transition the compliance function from a gatekeeper role to a business enabler without sacrificing regulatory enforcement authority
- Implement communication strategies to secure a seat at the table earlier in the corporate decision-making process
- Establish long-term credibility and alignment with commercial, medical and legal counterparts
- Leverage everyday compliance advisory decisions into broader strategic influence across the wider organization
- Sarah diFrancesca - Head of US Compliance - Dermatology, Incyte
- Andrea Kocharyan - Senior Vice President, Commercial Law and Compliance, uniQure
- Identify realistic board of directors opportunities available specifically to compliance leader
- Analyze the unique components and formatting elements that make a board-level resume stand out
- Implement strategies to build executive visibility, expand professional networks and gain relevant credentials
- Evaluate common missteps made when pursuing a first board seat and methods to avoid them
- Aisha Ghazi Babar - General Counsel, Chief Compliance Officer & Corporate Secretary, Pierre Fabre
- Mahnu Davar - Partner, Co-Chair - Life Sciences & Healthcare Regulatory Practice, Arnold & Porter
- Tara Dorsi - Executive Vice President, General Counsel, Kyowa Kirin
- Identify realistic board of directors opportunities available specifically to compliance leader
- Analyze the unique components and formatting elements that make a board-level resume stand out
- Implement strategies to build executive visibility, expand professional networks and gain relevant credentials
- Evaluate common missteps made when pursuing a first board seat and methods to avoid them
- Ludovica Fabriza - Associate Director, US R&D Compliance, Novo Nordisk Inc
- Janet Ahn - Governance & Strategic Alliances Lead, Ebi North America and Global Specialty Care LEBI & GS, Sanofi
Work through real AI governance dilemmas in small groups. Facilitators will guide discussions, capture insights and help you benchmark approaches against what other compliance teams are doing right now.
- Evaluating and approving AI use cases
- Define ownership across compliance, legal, privacy and IT
- Build flexible governance frameworks designed to mitigate risk while allowing responsible AI adoption
- Determine where to use AI to facilitate governance and controls over licenses and credentials
- Jon Wilkenfeld - President, Potomac River Partners
- David Falcone - Vice President, Global Compliance, Merz Aesthetics
- Andrea Altamirano - Executive Director, Healthcare Compliance, Genentech
Work through real compliance challenges in small groups. Facilitators will guide discussions, capture insights and help you benchmark approaches against what other compliance teams are doing right now.
- Responding to evolving business and compliance challenges
- Applying policies across organizations of different sizes
- Balancing business objectives with effective compliance oversight
- Sharing practical approaches and lessons learned with peers
- Sandija Chowdhury - Senior Vice President & Chief Compliance Officer - Region US, Fresenius Kabi LLC
(Closed Door, Invite Only – 65 Minutes)
The hardest calls in compliance don't get made in public. Join the most senior compliance leaders for off-the-record conversation about what it takes to lead at this level
- Partake in confidential discussion on the toughest strategic calls only a Chief Compliance Officer must make
- Gain a candid look at where compliance leadership is headed as the role keeps expanding
- Real talk on navigating board relationships and executive expectations at the highest level
- Address how to give the board a true horizontal view of compliance across GxP, cyber, finance, procurement and IT instead of fragmented, vertical reports
Eligibility: Attendees must hold the position of Chief Compliance Officer (CCO) / Head of Compliance or Vice President (VP) and be currently employed by a life sciences manufacturer.
*** This is an invite only session. Attendees must meet the eligibility requirements. Informa Connect reserves the right to qualify participants. To reserve your seat, email @nhu.tran@informa.com
The job keeps expanding. The pressure keeps building. Join experienced compliance leaders as they share what's helped them stay effective without burning out
- Discover what separates compliance leaders who burn out from those who build long, durable careers
- Discuss practical habits for staying sharp and effective over the long run
- Learn from peers who’ve navigated the hardest stretches of the job
- Brian Sharkey - Head of NA, Compliance and Ethics, Teva Pharmaceuticals
(Closed Door, Invite Only – 70 Minutes)
The hardest calls in compliance don't get made in public. Join the most senior compliance leaders for off-the-record conversation about what it takes to lead at this level
- Partake in confidential discussion on the toughest strategic calls only a Chief Compliance Officer must make
- Gain a candid look at where compliance leadership is headed as the role keeps expanding
- Real talk on navigating board relationships and executive expectations at the highest level
Eligibility: Attendees must hold the position of Chief Compliance Officer (CCO) / Head of Compliance or Vice President (VP) and be currently employed by a life sciences manufacturer.
*** This is an invite only session. Attendees must meet the eligibility requirements. Informa Connect reserves the right to qualify participants. To reserve your seat, email @nhu.tran@informa.com
