September 17-18, 2026
Hilton La Jolla | San Diego, CAkeyboard_arrow_right
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Agenda for Day 1 - Thursday September 17th, 2026
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Agenda for Day 1 - Thursday September 17th, 2026
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Showing 2 of 2 Streams
General Session
Networking Break
7:45am - 8:30am
Opening of Conference Registration
7:45am - 8:30am
Continental Breakfast and Networking
Showing 1 of 1 Streams
General Session
8:30am - 8:35am
Informa Connect Welcome
- Holly Willhide - Conference Producer, Informa Connect
8:35am - 8:45am
Chairperson's Opening Remarks
- Celia Eckert - General Counsel, Corporate Secretary, Xencor
8:45am - 9:35am
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
- Michael Hercz - Executive Vice President, Chief Legal & Compliance Officer, Sentynl Therapeutics
- Jenny Alonso - General Counsel and Chief Compliance Officer, Neurelis
- Sheila Abraham - Vice President, Chief Compliance Officer, Dompe US
9:35am - 10:15am
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”
- Alison Fethke - Member, Epstein Becker Green
- George Manahan - Assistant U.S. Attorney, Southern District of California, U.S. Department of Justice
Showing 1 of 1 Streams
Networking Break
10:15am - 10:45am
Networking & Refreshment Break
Showing 1 of 1 Streams
General Session
10:45am - 11:15am
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, Co-Chair, Life Sciences Practice, Sheppard
11:15am - 11:55am
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?
- Stefanie Doebler - Partner, Covington and Burling LLP
- Kathleen Durosseau - Vice President, Chief Compliance & Privacy Officer, GRAIL
Showing 1 of 1 Streams
Networking Break
11:55am - 1:05pm
Networking Luncheon
Showing 1 of 1 Streams
General Session
1:05pm - 1:35pm
FDA at an Inflection Point: Insights from FDA and Capitol Hill on Evolving Enforcement, Compliance, and Policy Priorities
- Hear from former FDA and Congressional staff on how upcoming agency and congressional changes may influence priorities for the regulatory and policy landscape for life sciences companies.
- Identify emerging risk areas based on shifting priorities at FDA and practical considerations for industry.
- Laura Akowuah - Special Counsel, Cooley
- Vince Sampson - Special Counsel, Cooley
1:35pm - 2:15pm
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
- Geneviève Micheaux - Partner, Government Matters & Regulation, King & Spalding
- Andrea Altamirano - Executive Director, Healthcare Compliance, Genentech
- Lori Alarimo - Acting Chief Healthcare Compliance Officer, Executive Director, Genentech Inc.
2:15pm - 2:50pm
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 - General Counsel, Corporate Secretary, Xencor
- Jeff Cohn - General Counsel and Corporate Secretary, Connect Biopharma
- Katy Van Pelt - Vice President, Chief Compliance Officer, Arcus Biosciences
- Melissa Ciurlino - Vice President, Ethics & Compliance Officer, Abbvie
Showing 1 of 1 Streams
Networking Break
2:50pm - 3:15pm
Networking Break
Showing 1 of 1 Streams
General Session
3:15pm - 3:45pm
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
- Suj Patel - Director, Business Risk Services, Baker Tilly
- Cindy Alvarado - Vice President, Compliance, Pacira Biosciences
- Abhiroop Gandhi - Senior Vice President, Compliance & Quality, Rigel Pharmaceuticals
3:45pm - 4:25pm
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 Officer, United Therapeutics
- Sharon Delshad - Senior Director, Compliance Counsel, Travere Therapeutics
- Meena Datta - Partner and Healthcare Co-Chair, Executive Committee Member, Sidley Austin LLP
4:25pm - 5:05pm
COMMERCIAL INSIGHT Drug Pricing and Market Access for New Product Launches
- New product launches 101: key essentials for success
- Checklists for guiding the business on common pricing, coverage, and reimbursement considerations
- Practical dos and don’ts to avoid common trip points
- Meena Datta - Partner and Healthcare Co-Chair, Executive Committee Member, Sidley Austin LLP
- Garlan Adams - Chief Legal Officer and Corporate Secretary, Crinetics Pharmaceuticals
- Hae-Won Min Liao - Vice President, U.S. Legal Business Partner, Gilead Sciences
Showing 1 of 1 Streams
Networking Break
5:05pm - 6:05pm
End of Day 1 and Networking Reception
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