Agenda - Day 3 | PCC 2025 — Pharmaceutical Compliance Congress

7:30am - 8:30am

Conference Registration and Continental Breakfast

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

Showing 3 of 3 Streams

Power Hour A

Power Hour B

Power Hour C

8:30am - 9:30am

Patient Support - The Future of Company-Sponsored Free Genetic and Diagnostic Testing Programs

Update DOJ and OIG on free testing
Implications for wider diagnostic testing
Anti-kickback risks
Implications of recent OIG opinion on one-time genetic test or treatment approval

David King - Executive Director, Head of US Compliance, Alexion Pharmaceuticals
Andrea Kocharyan - Vice President, Legal Development & Compliance, Legal & Intellectual Property, uniQure

9:30am - 10:30am

Social Media, Key Opinion Leaders (KOLs) and Digital Opinion Leaders (DOLs)

What are your guardrails and parameters on influencers?
What do you allow commercial folk to say when it comes to promoting your product?
What does your social media policy look like?
How do you monitor social media? 3^rd party? Monitoring via AI?

Jill Atstupenas - Director, Compliance, Syndax Pharmaceuticals, Inc.

8:30am - 9:30am

SOFT SKILL LAB Pitch, Present, Persuade: How to Become a Powerful Corporate Communicator

How to prepare and write compelling presentations: discover the secrets of brilliant presenting
How to grab and maintain attention: make sure your audience is hearing what you want them to hear
How to look and sound impressive: learn the tricks that the best presenters use

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

9:30am - 10:30am

Managing M&A and Licensing Agreements

Navigate the roles of Compliance, finance, and investor relations
Uncover relevant risk areas and overcome key challenges that could arise during joint ventures and M&A
Assess the impact of CIAs during M&A
Key considerations including DOJ Guidance
Integration phase – Experience post-acquisition impact on employee and Compliance framework
How to prepare for being acquired and to acquire another company

Gregory Moss - Chief Corporate Strategy, Legal Officer and Chief Compliance Officer, Evommune Inc.

8:30am - 9:30am

Creating a Speak-Up Culture of Compliance

Dissecting practical approaches of successful campaigns
How to cultivate a culture of Compliance: from creating open lines of communication to overcoming information barriers
Practical campaign insight: what components were most beneficial in building awareness?
How do you become ‘the voice’ of Ethics and Integrity in your organization?

Masha Goodman-Khan - Senior Director of Compliance & Legal Operations, Vericel Corporation
Molly Joyce - Vice President, Ethics and Compliance Officer, Global Internal Investigations, AbbVie
Loren Becher - Senior Director, Ethics & Compliance Programs and Operations, Emergent BioSolutions

9:30am - 10:30am

SOFT SKILL LAB Adverse Compliance Event: How to Navigate and Manage a Crisis

Essential steps you must take to manage a crisis effectively
Developing resilience: how to keep a clear head and enable your company to thrive
Conducting high-profile investigations and preparing for crisis communications

Fabiana Lacerca-Allen - Senior Vice President, Compliance, Aimmune Therapeutics
Sheila Folayan - U.S. Compliance Officer, Dompe U.S.
Randy Bagwell - Senior Director, Europe Division and Senior IHL Policy Advisor, American Red Cross

10:30am - 11:00am

Networking Break

Showing 1 of 1 Streams

Main Stage

11:00am - 11:45am

Where is the Industry in Terms of Diversity, Equity & Inclusion (DE&I)?

Intersection between Compliance and DE&I programs in pharmaceutical organizations: where and when is it appropriate for Compliance leaders to get involved?
New trends and developments impacting DE&I: evaluating recent changes in public perception
Are new policy developments and AI forces for good or is bias and inequality baked into the system?
Managing the Compliance implications of lack diversity: practical implications, navigating reputational concerns for your business

Sujata Dayal - Independent Board Director, Emergent BioSolutions

11:45am - 12:15pm

PhRMA (Pharmaceutical Research and Manufacturers of America) Address

Impact of recent legislative and administrative developments on drug pricing, reimbursement, and access
US consensus framework: a model for healthcare compliance
Rebate rule redux and the impact of Loper Bright
Implications of Pharmacy Benefit Manager (PBM) reform for manufacturers
340B Drug Pricing Program developments

James Stansel - Executive Vice President, General Counsel and Corporate Secretary, PhRMA

12:15pm - 1:45pm

Networking Lunch

Showing 1 of 1 Streams

Main Stage

1:45pm - 2:15pm

Key FDA Developments and Practical Compliance Take Aways

Gain insight into the current priorities at the FDA’s Office of Prescription Drug Promotion
Regulator insight into the monitoring activities undertaken by organizations

Catherine Gray - Director, Office of Prescription Drug Promotion, US Food and Drug Administration (FDA)

2:15pm - 2:45pm

Transparency Reporting: Centers for Medicare & Medicaid Services (CMS) Open Payments Program

Feedback on audits and lessons learned for the industry to be aware of and apply
Vision and CMS focus going forward
Data insight: how do regulators and investigators use the data? How can companies ensure they know what is in the data and what should they expect regulators to know about their data?

Amy Bedsaul - Open Payments Communications, Centers for Medicare & Medicaid Services (CMS)
Veronika Peleshchuk Fradlin - Director of Division of Transparency Projects (DTP), Centers for Medicare and Medicaid Services (CMS)

2:45pm - 2:50pm

Close of Conference

Day 3Wednesday, 30 April 2025 - ET (Eastern Time, GMT-05:00)

Day 3Wednesday, 30 April 2025 - ET (Eastern Time, GMT-05:00)