Agenda

1:00–1:30 P.M. PT | OPENING BRIEFINGS Hot Topics in Regulatory, Privacy, and Compliance Timely opening briefings from Nathan Downing, Amanda Johnston, and Paul Rothermel.

BUILD   |   1:30–2:10 p.m. PT Regulatory strategy, evidence, and product decisions How companies navigate FDA and EU regulatory requirements, anticipate challenges, minimize risk, and make informed decisions throughout the product lifecycle.

MODERATOR Nathan Downing Gardner Law Managing Attorney

Dr. Cord Willhöft Fieldfisher Partner, Co-Head, Life Sciences & Healthcare

Alex Vayser Concur Biophotonics / Videra Surgical Founder & CEO

Jeffrey Lau Glaukos Associate General Counsel

LAUNCH   |   2:10–2:50 p.m. PT Commercialization and marketplace risk How companies can commercialize products while managing the risks that arise when products, data, patients, providers, and field teams begin interacting in the marketplace.

MODERATOR Paul Rothermel Gardner Law Managing Attorney

Sameena Habib Medtronic Global R&D AI & Data Counsel

Chase Leavitt Mobia Medical General Counsel

Brian Kelly Advanced Bionics VP, Chief Compliance Officer

GROW   |   3:05–3:45 p.m. PT Managing a more complex compliance environment How companies navigate evolving enforcement priorities and healthcare fraud risks through auditing, monitoring, and compliance controls as promotional activities and commercial programs expand.

MODERATOR Amanda Johnston Gardner Law Partner

Shannon Treviño SpyGlass Pharma General Counsel

Karyl Haskell OrthAlign VP, Regulatory Affairs & Quality Assurance

Liana Edgar HeartFlow Corporate Counsel

ASK THE EXPERTS   |   3:45–4:15 p.m. PT Questions for industry counsel Bring your regulatory, privacy, and compliance questions to an interactive discussion.

MODERATOR Mark Gardner Gardner Law Founder & Managing Partner

Melissa Hoffman Edwards Lifesciences VP, Lead Counsel, TMTT

Christopher Shurland Asahi Intecc USA Managing Counsel

Sara Kerrane Glaukos VP, IP, Regulatory & Litigation Counsel

Join from anywhere. Connect in Newport Beach. In-person attendees are invited to the networking reception immediately following the program. Register Here

1:00–1:30 p.m. PT

Hot Topics in Regulatory, Privacy, and Compliance

Gardner Law Attorneys Nathan Downing, Paul Rothermel, and Amanda Johnston will open the program with three 10-minute briefings on timely regulatory, privacy, and compliance developments affecting medical products companies and their implications for legal and business priorities.

1:30–2:10 p.m. PT

Build:
Regulatory strategy, evidence, and product decisions

Moderator: Nathan Downing

Panelists: Dr. Cord Willhöft (Partner, Co-Head of Life Sciences & Healthcare, Fieldfisher), Alex Vayser (Founder, CEO, Concur Biophotonics & Founder, Videra Surgical), and Jeff Lau (Associate General Counsel, Glaukos)

Panelists will examine how companies navigate FDA and EU regulatory requirements, develop clinical evidence, and align product claims with intended use. The discussion will also address how data governance, privacy, cybersecurity, and early compliance decisions affect regulatory risk, commercialization, and investment or acquisition diligence.

2:10–2:50 p.m. PT

Launch:
Commercialization and marketplace risk

Moderator: Paul Rothermel

Panelists: Sameena Habib (Global R&D AI & Data Counsel, Medtronic), Chase Leavitt (General Counsel, Mobia Medical), and Brian Kelly (VP, Chief Compliance Officer, Advanced Bionics)

This panel will explore legal and operational risks associated with developing and commercializing AI-enabled technologies, evolving privacy requirements, promotional claims, reimbursement, and patient engagement. Panelists will also discuss managing data collection, sales practices, vendor oversight, and coordination across legal and business functions.

2:50–3:05 p.m. PT

Refreshment Break

3:05–3:45 p.m. PT

Grow:
Managing a more complex compliance environment

Moderator: Amanda Johnston

Panelists: Shannon Treviño (General Counsel, SpyGlass Pharma), Karyl Haskell (VP Regulatory Affairs and Quality Assurance, Orthalign), and Liana Edgar (Corporate Counsel, Heartflow)

As companies expand their products, markets, and commercial activities, regulatory and compliance obligations become increasingly complex. Panelists will discuss government enforcement priorities, healthcare fraud risks, internal investigations, and practical approaches to strengthening compliance programs through auditing, monitoring, third-party oversight, and internal controls.

3:45–4:15 p.m. PT

Ask the Experts: Regulatory, Privacy, and Compliance Q&A

Moderator: Mark Gardner

Panelists: Melissa Hoffman (Vice President, Lead Counsel: TMTT, Edwards Lifesciences), Christopher Shurland (Managing Counsel, Asahi Intecc USA), and Sara Kerrane (Vice President, Intellectual Property, Regulatory and Litigation Counsel, Glaukos Corporation)

The program will conclude with an interactive Q&A moderated by Mark Gardner. In-person and livestream attendees can submit questions to senior in-house attorneys about regulatory strategy, privacy, compliance, enforcement, and other legal and operational challenges facing medical products companies.

4:15 p.m. PT

Networking Reception

Certifications

The program has been submitted for approval for 3 CLE credits with the Minnesota and California State Bars and 3 RAC certification credits with the Regulatory Affairs Professional Society.

Contact

For questions about registration, livestream access, or continuing education credit, please email office@gardner.law.