Agenda - 2026 Agenda - Day Two: Friday, September 18th | PCC West

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Networking Break

7:45am - 8:40am

Continental Breakfast & Networking

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General Session

8:40am - 9:10am

Solution Summit

9:10am - 9:20am

Chairperson's Review of Day One

9:20am - 10:10am

KEYNOTE PANEL Future Proofing your Compliance Program – Doing More with Less

Learn all about automation within compliance programs and the emerging risk areas that follow
Glean new ideas on where to focus and consolidate resources
Evaluate current team capabilities against future skill requirements
How can you best maintain an agile program?

Lauren Thal - Vice President, Compliance, Tolmar Inc.
Brenda Crabtree - Senior Director, Commercial Legal & Compliance, Kura Oncology
Tim Stow - Global Head of Ethics & Compliance, Galderma
Abhiroop Gandhi - Senior Vice President, Compliance & Quality, Rigel Pharmaceuticals

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Networking Break

10:10am - 10:40am

Networking & Refreshment Break

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General Session

10:40am - 11:20am

Proactive Risk Management: Strengthening Your Compliance Infrastructure

Best practices for identifying and mitigating compliance risks when engaging third-party vendors and partners
Effective monitoring strategies that extend beyond initial due diligence and onboarding
Examine the benefits and challenges of ongoing monitoring approaches versus point-in-time assessments to optimize your third-party risk management program
Enterprise risk management – do compliance teams have that responsibility?

Felicia Heimer - Head of Rare Disease Compliance, Worldwide Compliance & Business Ethics, Amgen and Co-Author of OIG's Practical Guidance for Health Care Governing Boards on Compliance Oversight

11:20am - 12:00pm

Developments for Diagnostic Support Programs – Impacts of Federal Guidance on Free Testing

Updates from the DOJ and OIG on free testing- are there implications for diagnostic testing as a whole? What are the anti-kickback risks?
Analyze implications of recent OIG opinion on one-time genetic test or treatment approval
What is the current relationship status between diagnostics and labs as a result?
Inducement risk beyond free testing – copay assistance, patient support and value-added services
Safe harbor protections and exceptions – when do free testing programs qualify for regulatory protection?

Thomas Gnielinski - Vice President Law, Associate General Counsel, Bridgebio
Kari Loeser - Vice President & Chief Compliance Officer, Cytokinetics

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Networking Break

12:00pm - 1:30pm

Networking Luncheon

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General Session

1:30pm - 2:10pm

Guardrails for the New Wave of Field Facing Interactions

Explore new go-to market strategies and how to best maintain existing guardrails
How are commercial and medical relationships evolving?
Delineate the differences between medical education and sales/promotion and discuss best practices moving forward

Tara Kennedy - Senior Director Ethics & Compliance, North America, Apellis Pharmaceuticals
Patrick Mooty - Vice President, Head of Compliance, Dyne Therapeutics
Peter Lee - Vice President, Chief Compliance Officer, Kura Oncology

2:10pm - 2:50pm

Assessing the Impact of Federal and State Privacy Laws

Examining the ongoing debate between federal and state privacy laws and their implications
Regulatory, privacy and promotional risks raised with the applications of digital therapeutics, wearables, companion apps and RWE collection
Explore the intersections between telemedicine and privacy
Addressing the California Consumer Privacy Act (CCPA) and its interplay with sector-specific federal regulations (i.e. HIPAA) - how this impacts the creation of harmonized compliance frameworks

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Networking Break

2:50pm - 3:20pm

Networking Break

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General Session

3:20pm - 4:00pm

Patient Advocacy in Transition – Identifying and Mitigating Compliance Risks

Trace the transformation of patient advocacy functions from pure philanthropy to strategic partnerships – understanding the compliance implications of this shift
Fair market value considerations, testimonial restrictions, and guardrails for patient advocacy
Learn essential strategies for maintaining clear separation between patient advocacy funding and commercial/promotional activities
Examining the roles between Patient Advocate v. Patient or Caregiver

Jeremy Lutsky - Vice President, Associate General Counsel, Compliance, Beren Therapeutics
Maria Robles - Senior Associate General Counsel and Chief Compliance and Privacy Officer, MannKind Corporation

4:00pm - 4:40pm

Fresh Approaches to Training Methodologies

Practical ways to incorporate Adult Learning Principles into your training program
Explore outside the box ideas to develop engaging training modules– where can I implement AI?
Novel approaches to promote retention of materials

Valorie Webb - Associate Director, Corporate Compliance Privacy, Shockwave Medical
Stacey Foote Larrier - Senior Director of Compliance, Dynavax Technologies

4:40pm - 4:45pm

Chairperson's Closing Remarks and Close of Conference

2026 Agenda - Day Two: Friday, September 18thFriday, September 18, 2026