Agenda - Day 2 | PCC 2025 — Pharmaceutical Compliance Congress

Key Sessions

Robert Ladd

Becoming High-Impact Business Partners: Strategic Relationships with Internal Stakeholders

Gilead Sciences

Anisa Dhalla

Global CCO Spotlight: An International Dialogue and Discussion on Compliance and Risk

UCB

Joseph Philipose

Compliance’s Role in Evolving Privacy Regulation Landscape

Emergent BioSolutions

Christine Zettlemoyer

How to Leverage AI in Compliance Function

Genmab

Day 2Tuesday, 29 April 2025 - ET (Eastern Time, GMT-05:00)

7:30am - 8:20am

Conference Registration and Continental Breakfast

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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 - 9:30am

Becoming High-Impact Business Partners: Strategic Relationships with Internal Stakeholders

Moving past us-versus-them mindset: the future of collaboration, embed systems and ways of working for success
What do Commercial teams want from Compliance and vice versa to be effective
How can strategic relationships with internal stakeholders be optimized in different-sized pharmaceutical organizations?
How can Compliance ensure the business owns its programs, accountable for enforcement, and how can they work together more strategically?

Robert Ladd - Senior Vice President, Chief Ethics & Compliance Officer, Gilead Sciences
Jill Fallows Macaluso - Corporate Vice President & Chief Compliance Officer, Novo Nordisk
Gbubemi Nanna - Vice President, Area Commercial Lead - Mid West, Cardiometabolic Sales, Novo Nordisk
Francisco Ribeiro - Vice President, Chief Compliance Officer, Office of Ethics & Compliance, ImmunoGen

9:30am - 10:30am

Global CCO Spotlight: An International Dialogue and Discussion on Compliance and Risk

What is happening around the world and how will this affect US Compliance thinking?
Where do ethics and Compliance teams intersect with CSR and ESG initiatives?
BIOSECURE Act and its potential implications for pharmaceutical Compliance

Anisa Dhalla - Vice President and Chief Ethics and Compliance Officer, UCB
Jennifer McGee - Senior Vice President, Global Chief Ethics and Compliance Officer, Otsuka Pharmaceutical Companies
Leonardo Silva - Vice President, Chief Compliance & Privacy Officer, Ferring Pharmaceuticals
Tara McCarthy - Partner, Dovetail Consulting Group

10:30am - 11:00am

Networking Break

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Main Stage

11:00am - 12:00pm

Law Firm Benchmarking Session - Chairs of Life Science Groups in Law Firms

What are the next generation of enforcement cases?
Where are companies focusing? Where are we seeing trends?
Insiders’ insight: investigations and types of issues companies are struggling with
Creative strategies being employed to increase market share: key risks and mitigation strategies
How are you seeing your clients utilizing outside counsel and has the role of outside counsel changed?

Lisa LeCointe-Cephas - Partner, Compliance & Investigations, Global Co-Chair, Life Sciences Sector, DLA Piper
George Karavetsos - White Collar Defense, Compliance, and Investigations Practice Group Leader, Buchanan Ingersoll & Rooney

12:00pm - 1:00pm

Industry Pioneers – Progress on the Adoption of AI and Practical Impact on Compliance Thinking

How are organizations managing the expanding responsibilities and priorities in the era of AI?
Balancing and integrating your core company mission alongside the need to keep your organization safe whilst embracing AI implementation
Analyzing the impact of AI implementation on Compliance roles and departments
Implications for your workforce and the effects on culture and staffing
Keeping pace with fast-moving technological advances: leveraging your foundation of ethics in the absence of robust rules and regulations

Franziska Janorschke - Global Head Data Privacy, Digital & AI Compliance; Ethics, Risk & Compliance, Novartis International AG
Daryl Kreml - Chief Enterprise Risk and Compliance Officer, Sage Therapeutics
Natasha Trifun - Head of Compliance for R&D, Global Medical and Global Functions, Alexion, AstraZeneca Rare Disease
Parth Chanda - Founder and CEO, Lextegrity

1:00pm - 2:30pm

Networking Lunch

Power Hour - This interactive format is designed to ignite fresh ideas and drive industry collaboration

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Power Hour A

Power Hour B

Power Hour C

Power Hour D

2:30pm - 3:30pm

SOFT SKILL LAB Practical Communication Strategies to Effectively Publicize and Supercharge Your Compliance Program to Cultivate a Culture of Compliance

Key components of a successful communication program
How to incorporate marketing-style communications and launch sophisticated campaigns
What can we learn from brand marketing to amplify your message?
Applying behavioral psychology tools to promote your message

Alyssa Zeff - Vice President, Davis & Company - Internal Communication Strategy Experts

2:30pm - 3:30pm

Training Effectiveness

Practical tools to measure the effectiveness of training
Tips for avoiding information overloaded
How do you know what individuals have retained: demonstrating Compliance learning in practice
Metrics tracking when staff complete training and whether training is factored into performance management systems

Brian Miller - Senior Director, Global Compliance & Ethics Policies, Learning, and Engagement, Otsuka
Sherri Borgal - Associate Director, Ethics & Compliance, Alnylam
Daniel O’Connor - Senior Vice President, NXLevel Compliance

2:30pm - 3:30pm

Compliance Investigations

Practical tools and tips for handling difficult investigations and joint working with Legal/HR
How to conduct them?
Who conducts them?
Should they always be done under privilege?
How are sanctions determined?
How are investigation outcomes shared with the organization?

Tara Kennedy - Senior Director Ethics & Compliance, North America, Apellis Pharmaceuticals
Audrey Perlow - Senior Director, North American Healthcare Compliance, Grifols
Gavin Proudley - Head of Third Party Risk Proposition, Dow Jones Risk & Compliance, Dow Jones

2:30pm - 3:30pm

The Fundamentals of Good Data: Preliminary Steps to Getting the Most Out of Your Analytics

Practical considerations for meeting OIG, CMS and DOJ expectations for data access, knowledge and assessments.

Who: Internal resources to engage, train and help influence change
What: Practical considerations for gathering data from field interactions to system reports
Where: Key source systems and tools, configuration best practices, and control considerations
Why: Challenges with data quality, completeness, and integrity
How: Dos and Don’ts of Auditing and Analytics

3:30pm - 4:00pm

Networking Break

Topic Intensives - Delve into the detail with practical scenarios and hands on approaches

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Transparency in Practice

Managing Privacy and Data Risks

AI in Practice

4:00pm - 4:45pm

Speaker Bureau Programs - Benchmarking Session

Sharing practical takeaways from speaker program benchmarking
Analyzing the key components of successful speaker programs
Practicalities of meeting restrictions and regulations to ensure compliant speaker programs
Best practice for designing policies to ensure the success and integrity of your speaker program

Michael Young - Senior Director, Potomac River Partners
Adam Oakley - Senior Director, Potomac River Partners

4:45pm - 5:30pm

HCP Perspective on Transparency Reporting

Fresh perspective on vendor interactions with HCPs
Policies and guidelines from HCP perspective on how they are allowed to engage with pharma, speaker bureau, food & beverage, speaking consulting
How to work together to maximize engagement in a compliant way

Tanya White - System Compliance Operations Officer, Yale New Haven Health, Yale University
John Kelly - Partner and Chair, Healthcare Department and Industry Practice, Barnes & Thornburg

4:00pm - 4:45pm

Compliance’s Role in Effective Data Management and Governance

As data risks outside of privacy evolve, how does Compliance navigate an organization’s evolving data risk landscape?
Other data risks to consider: data transfer, storage, data set management, data visibility, data platform considerations, data reporting, and data sharing across R&D, Medical, and Commercial functions
Compliance’s role in data management and governance of risk

Jennifer Sanfilippo - General Counsel and Chief Compliance Officer, Melinta Therapeutics
Gina Nese - Vice President Associate General Counsel Compliance and Privacy Officer, Align Technology

4:45pm - 5:30pm

Compliance’s Role in Evolving Privacy Regulation Landscape

How do you set up privacy programs considering the varying privacy requirements and an ever-changing landscape?
As privacy considerations grow for your business, where does it sit and how do you operationalize it? Compliance vs. Legal department vs. independent privacy officer?

Joseph Philipose - Senior Vice President, Chief Ethics and Compliance Officer, Emergent BioSolutions
Christie Dougherty - Associate Director, Ethics & Compliance, Global & US Privacy, Alnylam Pharmaceuticals

4:00pm - 4:45pm

AI Use Cases and Governance Across your Organization

Practical approaches to changing Compliance policies to reflect AI
How to develop a robust AI policy: governance models and practical dos and don'ts

Jeanille Gatta - Compliance Director, AstraZeneca
Fred Medick - Assistant General Counsel, Genentech
Jim Dawson - Vice President, Compliance Solutions, qordata

4:45pm - 5:30pm

How to Leverage AI in Compliance Function

How can AI make Compliance departments more effective? Overview of AI capabilities and role requirements
Operationalizing AI within your Compliance department: examining practical use cases:
- How to spot risks when AI is used across different departments in your business
- How can you screen and monitor what is going on with AI across your business?
- Application of AI tools for data analytics
- Transforming training programs

Christine Zettlemoyer - Senior Vice President, Global Head of Compliance, Risk, and Data Privacy Program, Genmab
Christian Dingler - Senior Director Risk Management, Global Compliance, Insmed
Gaurav Sharma - Vice President, Product Management, RLDatix Life Sciences

5:30pm - 5:35pm

Close of Day Two