Agenda - 2026 Agenda - Day One: Thursday, September 17th | PCC West

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Networking Break

7:45am - 8:35am

Continental Breakfast & Networking

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General Session

8:35am - 8:40am

Informa Connect Welcome

Holly Willhide - Conference Producer, Informa Connect

8:40am - 8:50am

Chairperson's Opening Remarks

9:00am - 9:50am

CHIEF COMPLIANCE OFFICERS PANEL Drivers for Change and Challenges for the Year Ahead

Insight into what is top of mind for Chief Compliance Officers (CCOs)
Examine priorities when it comes to building your own compliance program
Executive insight into building the next generation of compliance
CCOs’ perspectives on the big questions everyone is asking: “What is coming down the pike? And what should we be looking out for as a compliance program?”

Jean McKiernan - Partner, Dovetail Consulting Group
Kevin Ryan - Vice President, Chief Compliance Officer, Acadia Pharmaceuticals Inc.
Kate Godfrey - Senior Vice President, Global Chief Compliance Officer, Karl Storz
Michael Hercz - Executive Vice President, Chief Legal & Compliance Officer, Sentynl Therapeutics Inc.
Jenny Alonso - General Counsel and Chief Compliance Officer, Neurelis, Inc
Sheila Folayan - Vice President, Chief Compliance Officer, Dompe U.S.

9:50am - 10:30am

ENFORCERS SESSION Analyzing Enforcement Shifts

Examine recent investigations from the DOJ and their implications
What are the methods, analysis and data being utilized during investigations?
Insight into DOJ’s enforcement and crackdown on “Fraud, Waste & Abuse”

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Networking Break

10:30am - 11:00am

Networking & Refreshment Break

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General Session

11:00am - 11:30am

LAW FIRM UPDATE Current Enforcement Trends and Regulatory Actions

Expert legal insight into the current enforcement landscape
Latest updates from the FDA and the OIG
Analyze trends and themes from the receipt of Untitled Letters from OPDP and determine the practical considerations and consequences
Glean vital next steps to update your compliance program to withstand future scrutiny

Scott Liebman - Partner and Chair, FDA Regulatory & Compliance; Co-Chair, Life Sciences, Sheppard

11:30am - 12:10pm

Emerging Industry Shifts Following FDA Scrutiny of DTC Advertising

Implication of the increased scrutiny from the FDA with DTC advertising
An overview of the intersections between DTC, telehealth and TrumpRx
What does the future of the promotional landscape look like with continued focus in this area?
How will these shifts impact compliance for the foreseeable future
What is off-label promotion these days?

Kathleen Durosseau - Vice President, Chief Compliance & Privacy Officer, GRAIL

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Networking Break

12:10pm - 1:40pm

Networking Luncheon

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General Session

1:40pm - 2:20pm

COMMERICAL INSIGHT Navigating the Journey from Regulatory Approval to Global Expansion

Learn how to best prepare your program to move beyond U.S. approvals
Gain insight into key differences between the U.S and European compliance process
Hear how to establish compliance standards across varied geographies – develop a core program with regional flexibility

Andrea Altamirano - Executive Director, Healthcare Compliance, Genentech
Lori Alarimo - Deputy Healthcare Compliance Officer, Executive Director, Genentech Inc.

2:20pm - 3:00pm

Cultivating an Organization-Wide Compliance Mindset

Share best practices to embed compliance into the fabric of your culture
Practical approaches to foster transparency and help your employees feel comfortable when highlighting ethical concerns

Celia Eckert - Senior Vice President, General Counsel & Corporate Secretary, Xencor
Jeff Cohn - General Counsel and Corporate Secretary, Connect Biopharma
Katy Van Pelt - Vice President, Head of Ethics & Compliance, Arcus Biosciences

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Networking Break

3:00pm - 3:30pm

Networking Break

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General Session

3:30pm - 4:10pm

Pragmatic Examples of Leveraging AI in Compliance Functions

Current AI initiatives in Compliance – benefits, challenges, and lessons learnt
Examining pros, cons and best practice for moving toward automation and quality data
The path forward - exciting possibilities and key risks to consider
How can AI be used for audit, investigation and training preparations?
Leveraging cross-departmental collaboration through AI

Jake DeBoever - Senior Vice President, Compliance & Ethics, McKesson
Cindy Alvarado - Vice President, Compliance & Compliance Counsel, Pacira Biosciences, Inc.

4:10pm - 4:50pm

Compliance Considerations for Patient Support & Patient Services Programs

The evolving interactions between commercial teams and patients
Practical compliance considerations for Patient Speaker and Patient Ambassador Programs
Practical guardrails to help unblur the lines between medical, commercial and patient engagement

Amanda Foster - Senior Director Corporate Compliance – Market Access and Privacy, United Therapeutics
Sharon Delshad - Senior Director, Legal Compliance Counsel, Travere Therapeutics, Travere Therapeutics

4:50pm - 5:30pm

COMMERICAL INSIGHT Drug Pricing for New Product Launches

New product launches 101: key essentials for success
Examine launch, inspection and PDUFA readiness initiatives
Learn about funding considerations in the pre-launch environment
Practical dos and don’ts to avoid common trip points

Garlan Adams - Chief Legal Officer and Corporate Secretary, Crinetics

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Networking Break

5:30pm - 6:30pm

End of Day 1 and Networking Reception

2026 Agenda - Day One: Thursday, September 17thThursday, September 17, 2026