Delivered as a Hybrid Event
April 28-30, 2025The Ritz-Carlton, Tysons Corner | McLean, VAKey Sessions
Heather Stewart
Chief Compliance Officer Panel: Drivers for Change and Challenges for the Year Ahead
AstraZeneca
Mackenzie Queenin
Trends in Life Science Enforcement Cases
District of Massachusetts
Jacob Foster
Examining Federal DOJ Enforcement Initiatives: Key Focuses, Successes and Trends
U.S. Department of Justice
Donna White
Off-Label Communication: Compliance and Governance Implications of Scientific Information for Unapproved Use (SIUU)
Chiesi USA Inc.
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Day 1 - ET (Eastern Time, GMT-05:00)
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Day 1 - ET (Eastern Time, GMT-05:00)
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7:30am - 8:20am
Conference Registration and Continental Breakfast
Showing 1 of 1 Streams
Main Stage
8:20am - 8:30am
Informa Connect Welcome and Chairperson's Opening Remarks: Main Stage
- Neil Falkingham - Senior Vice President, Chief Compliance Officer, GSK
8:30am - 8:40am
2024 Year in Review Video Reveal Presented by Potomac
8:40am - 9:40am
Trends in Life Science Enforcement Cases
- Hear directly from U.S. Attorneys on the most recent CIA’s and an analysis of settlement trends
- What is currently being closely looked at by investigators?
- What methods, analysis, and data are being utilized during investigations?
- Mackenzie Queenin - Assistant U.S. Attorney, Deputy Chief, Health Care Fraud Unit, District of Massachusetts
- Charlene Keller Fullmer - Assistant United States Attorney, US Attorney’s Office, Eastern District of Pennsylvania
- Amy DeLine - Assistant Director, Consumer Protection Branch, United States Department of Justice
- Craig Bleifer - Partner, McGuireWoods
9:40am - 10:10am
Examining Federal DOJ Enforcement Initiatives: Key Focuses, Successes and Trends
- Key components of DOJ self-disclosure and whistleblower programs
- How will DOJ’s new whistleblower program fill the gaps with existing programs?
- Are there any ‘grey zones’ between self-disclosure and whistleblower programs for organizations to navigate?
- Practical monitoring activities that companies can do that provide investigators with assurances that the company’s Compliance and control environment is adequately designed and implemented
- Jacob Foster - Principal Assistant Chief, Criminal Division, Fraud Section, U.S. Department of Justice
10:10am - 10:40am
Networking Break
Showing 1 of 1 Streams
Main Stage
10:40am - 11:30am
Managing Activist Agencies and Courts: How to Successfully Challenge Federal Regulations
- Opportunities for (bio)pharmaceutical and medical device companies to challenge rulemaking through federal agencies
- Practical compliance implication of Loper Bright Enterprises v. Raimondo
- Legal opportunities to challenge Medicare Price Negotiation Under the Inflation Reduction Act (IRA)
- Risks and potential challenges to changing Lab Developed Testing (LDT) rules
11:30am - 12:30pm
Chief Compliance Officer Panel: Drivers for Change and Challenges for the Year Ahead
- Given that fewer high-profile CIAs and fines exist, do you see functional leadership / the Executive Committee’s attitude changing towards Compliance and, if so, how are you managing that change?
- What do Compliance teams have to put in place today to withstand future scrutiny of regulators?
- How can Compliance leaders ensure they are in better shape to address future challenges and improve resilience to adverse events?
- What is the remit for Compliance: where should and where shouldn’t Compliance be involved in a business?
- Strategies for embracing the expanding remit of Compliance while also maintaining focus on core Compliance competencies
- Differentiating “Legal Compliance” risks from “Quality Compliance” risks when the CCO oversees QA
- Identifying employee matters that can/should be handled by Compliance versus those that should be handled by HR
- Sharing business insights with Commercial while respecting their independent business judgment
- How, if at all, has Loper Bright changed your Compliance program or your personal approach?
- Heather Stewart - Deputy Chief Compliance Officer & VP - Ethics & Transparency & Global Sustainability, AstraZeneca
- Shefali Kothari - Chief Compliance Officer, US, and Country Head, Ethics, Risk and Compliance, Novartis
- Isabel Duffy - Senior Vice President, Chief Ethics and Compliance Officer, Merck
- Steve Cohen (subject to final confirmation) - Vice President - Chief Ethics and Compliance Officer, North America and Canada, Eli Lilly
- Joe Mack - Vice President and Head, US Office of Compliance, Bayer
Showing 1 of 1 Streams
Networking Lunch
12:30pm - 2:00pm
Networking Lunch
The CCO and GC Summit Exchange and Networking Lunch Hosted by RLDatix* provides world-class thought leadership and is designed to deliver high-quality information that C-suite leaders can develop into an action plan. Collaborate with your distinguished colleagues to gain valuable insights through an interactive and engaging working group. Attendees must be a CCO, VP, or GC and currently employed by a life sciences manufacturer. *By invitation only
- Donna White - Vice President, Compliance Officer, Chiesi USA Inc.
- Jill Fallows Macaluso - Corporate Vice President & Chief Compliance Officer, Novo Nordisk
Showing 3 of 3 Streams
Fundamentals
Intermediate
Advanced
2:00pm - 2:45pm
Building a Compliance Program Framework
- Establish a foundation of Compliance using the seven elements of a Compliance framework
- Examining the three foundational questions in the DOJ Evaluation of Effective Compliance Programs
- Managing risk: what is your Compliance philosophy in response to risk?
- Timothy Roberts - Global Chief Compliance Officer, Legend Biotech
- Laura Heyduk - US Compliance Lead, Biogen
2:45pm - 3:30pm
Galvanizing your Compliance Framework into Action
- How do you take a codified framework and put it into action?
- Reality of operationalizing 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
- Natasha Trifun - Head of Compliance for R&D, Global Medical and Global Functions, Alexion, AstraZeneca Rare Disease
2:00pm - 2:45pm
Fine Tune Your Compliance Programs Based on OIG and DOJ Guidance
- Update on new OIG Advisory Opinions
- Lessons learned from OIG guidance for effective compliance
- Updated DOJ (guidance March 2023) and OIG guidance – a year and a half on what progress has the industry made?
- How to apply guidance in practice, communicate it to the C-Suite, how do you gain support for initiatives and push for real change using guidance?
- Focus on Compliance incentives and rewards and the use of data analytics
- Stuart Glass - Compliance Officer, Biogen
- Ashley Riley - Director, Healthcare Compliance, BeiGene
2:45pm - 3:30pm
How to Evaluate Your Compliance Program
- How to measure the effectiveness of your Compliance program
- Who is best placed to measure Compliance effectiveness?
- Practical steps and processes to identify vulnerabilities and develop a plan to improve
- Evidencing continual growth to your Executives and Board
- Emily Mason - Vice President, Worldwide Compliance and Business Ethics, Amgen
- Jeffrey Lemay - Executive Director, Compliance & Ethics Officer, Jazz Pharmaceuticals
- Eric Baim - Managing Director, Dovetail Consulting Group
2:00pm - 2:45pm
The Evolving Role of Compliance Leaders
- What is the actual role of the CCO and other leadership roles in 2024 and beyond?
- How to structure senior roles differently and still operate with authority and independence
- To what extent are the GC and CCO functions being separated?
- Examining the specificities and variances in roles of a GC and CCO: Is Compliance more operational or strategic?
- Typically, as companies grow the GC and CCO function split – what is the threshold for the split?
- What fits into Compliance? Traditional Compliance vs. expanding remit to organizational risk
- Steve Vincze - Founder and CEO, TRESTLE Compliance
- Tyler Wiseman - Chief Legal Officer, Elevar Therapeutics
- Elysa Mantel - Senior Counsel II, Kite Pharma
- Daniel Moynihan - General Counsel, Ono pharma and Former Chief Compliance Officer, EMD Serono
2:45pm - 3:30pm
Advancing Compliance Functions and Influencing Boards and Executive Committees
- How can Compliance functions help Executive leaders and Boards meet their obligations?
- What data to supply and at what level of granularity to help business insight
- Government guidance on expectations of Board members
- Training new board members on Compliance: practice information and guidance to fulfill responsibilities
- How to get cross-functional assurance presentations up to the Board/Executive Committee level
- Casey Horton - Managing Director, Epsilon Life Sciences
- Saul Helman - President, Epsilon Life Sciences
- Shannon Kelley - Chief Compliance Officer, Madrigal Pharmaceuticals
- Cindy Cetani - Chief Integrity & Compliance Officer, Indivior
- Christie Camelio - Chief Compliance Officer, Global Compliance, Insmed Incorporated
3:30pm - 4:00pm
Networking Break
Topic Intensives - Delve into the detail with practical scenarios and hands on approaches
Showing 4 of 4 Streams
Leveraging Data and Monitoring
3rd Party Engagement
Field Facing Interactions and Patient Support
Emerging Risks
4:00pm - 4:45pm
How to Effectively Leverage Data to Enhance Compliance Programs
- Getting to grips with the basics: practical questions to be asking the data to get meaningful outputs
- Where should we be using analytics to enhance effectiveness?
- What are you doing to measure Compliance effectiveness and analytics of risk?
- Leveraging data: how are departments leveraging data in their Compliance programs?
- Ed Sleeper - Chief Ethics and Compliance Officer, Veloxis Pharmaceuticals
- Abhiroop Gandhi - Vice President, Compliance, Rigel Pharmaceuticals
4:45pm - 5:30pm
Strategies to Advance Your Monitoring Programs
- Strategies and tactics on what should be monitored and how
- Practical monitoring activities: in-person, document reviews, and big data
- Role of data analytics in monitoring programs
- Advancing monitoring activities across the business: is it possible to reframe monitoring to business insight gathering?
- Meeting OIG guidance: utilizing CIAs as roadmaps to deliver holistic monitoring programs
- How can audit and monitoring work together in partnership?
- Gus Papandrikos - Executive Director, Internal Audit and Monitoring Risk Detection, Daiichi Sankyo
- Jean McKiernan - Partner, Dovetail Consulting Group
4:00pm - 4:45pm
Advancing 3rd Party Engagement and Risk Management
- Examining approach, key focuses, key roles and top challenges
- How do you operationalize 3rd party engagement and risk management?
- What are the risks: emerging sanctions as part of 3rd party risks – Russia and Iran, modern slavery and human trafficking
- How do you work together (if at all) with Internal Audit and Enterprise Risk Management and/or Quality?
- Jesse Birnbaum - US Compliance Director, BioNTech US Inc.
- Neeraj Gupta - President & CTO, Cresen Solutions
4:45pm - 5:30pm
Risks from External Funding: Grants, Contributions, Corporate Contributions
- Deep dive into how you are truly evaluating entities that you are giving money to
- Managing your reputational risk: practicalities of vetting organizations
- What governance do you have in place to ensure 3rd parties are free from improper inducement?
- Keren Tenenbaum - US General Counsel and Chief Compliance Officer, Ascendis Pharma
4:00pm - 4:45pm
New Wave of Field Facing Interactions and Challenges
- Examining field interactions i.e. Sales, Market Access, Medical Science Liaison, Nurse Educators, Field Reimbursement Manager etc.
- What functions exist? How do they work together? How do you address "fatigue" from Customers who only want one point of contact and remain compliant?
- How are commercial and medical relationships developing? Examining guardrails and blurring boundaries between medical education and sales/promotion
- Developing a cohesive international strategy: what is your approach and how does this work outside the US?
- How do you strike the right balance and still position your company to be aggressive and competitive
- Michelle Scharfenberg - Senior Vice President, Chief Ethics & Compliance Officer, Avanos Medical
- Karen Lowney - Head of the Office of Ethics & Compliance (OEC), Sun Pharmaceutical Industries, Inc.
4:45pm - 5:30pm
Patient Advocacy: New Growing Risk for Compliance?
- How are organizations managing Compliance surrounding patient advocacy and patient education groups?
- Examining differing approaches on transfer of value in meals, speaker honorarium etc
- Internal guidelines and what are they spending on patients, are they allowing alcohol etc?
- How is this spend tracked, and by whom to make sure you don't pay patients "too much"?
- Is there a cap for overall spend per patient/caregiver?
- How is FMV determined?
- What is the role of the Patient Advocate vs Patient or Caregiver?
- How, if at all, does the analysis change post-approval vs. during research?
- Kari Loeser - Vice President & Chief Compliance Officer, Cytokinetics
- Michael Joachim - Head of US Ethics & Compliance, Sanofi
4:00pm - 4:45pm
Game Changer: Shifting Priorities and Capabilities to Mitigate Risks in Business GenAI Solutions
A step-by-step illustration of where Compliance can play a role to mitigate risk in engineering of GenAI business solutions
- Understand the development process of GenAI business solutions
- Learn how GenAI engineering can limit compliance risk
- Explore ways to design GenAI controls
- Build your AI capabilities to be a strategic partner to the business
- Michael Shaw - Principal, Global Head of Risk & Compliance, ZS Associates
4:45pm - 5:30pm
Off-Label Communication: Compliance and Governance Implications of Scientific Information for Unapproved Use (SIUU)
- 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 what practical guardrails can be put into place
- Donna White - Vice President, Compliance Officer, Chiesi USA Inc.
- Amy Wilson - Vice President, Chief Compliance Officer, Esperion Therapeutics
5:30pm - 5:35pm
Close of Day One and Networking Reception
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