Day OneTuesday, 25 April 2023 - EST (Eastern Standard Time, GMT-5)

7:15am - 8:15am60 mins

General Session

Main Conference Registration and Continental Breakfast

8:15am - 8:20am5 mins

General Session

Informa Connect Welcome

Allie Spica - Portfolio Manager, Informa Connect

8:20am - 8:30am10 mins

General Session

2022 Year in Review, Presented by Potomac River Partners

8:30am - 8:40am10 mins

General Session

Informa Connect Welcome and Chairperson’s Opening

Michael Clarke, JD, CCEP - Vice President, Global Chief Compliance Officer, ConvaTec
John Oroho - President & General Manager, RLDatix Life Sciences Division & Porzio Life Sciences

8:40am - 9:15am35 minsFree

General Session

CMS Audits Are Here. Are You Ready?”—A 360-Degree Overview of What You Need to be Prepared for an Audit

Audrey DeGuarde - Vice President, Global Transparency, Porzio Life Sciences, LLC
Keren Bisnauth, JD - Director, Compliance Services, Porzio Life Sciences, LLC

9:15am - 10:00am45 minsFree

General Session

Chief Compliance Officer Luminary Panel

Jeff Rosenbaum - Partner, Co-Founder, Dovetail Consulting Group
Gregory Moss - Chief Corporate Strategy, Legal Officer and Chief Compliance Officer, Evommune, Inc.
Jennifer McGee - Senior Vice President, Global Chief Ethics and Compliance Officer, Otsuka Pharmaceutical Companies
Michael Clarke, JD, CCEP - Vice President, Global Chief Compliance Officer, ConvaTec
Cari Gallman - Chief Compliance and Ethics Officer, Bristol Myers Squibb Company

10:00am - 10:30am30 mins

General Session

Networking and Refreshment Break

10:30am - 11:10am40 minsFree

General Session

Innovation Address — Behavior Science and How Pharma Should be Thinking About It

Mark Lightowler, PhD - Founder and CEO, Phorix Limited

11:10am - 12:10pm60 minsFree

General Session

Keynote Enforcement Panel

Emily Hodge - Partner, Choate, Hall & Stewart LLP
Christopher Terranova - Senior Trial Counsel, Civil Division, Department of Justice
Abraham George - Attorney, US Attorneys Office, District of Massachusetts
Gabriel Scannapieco - Assistant Director, Consumer Protection Branch, United States Department of Justice

12:10pm - 1:40pm90 mins

Networking Luncheon

12:10pm - 1:40pm90 mins

Closed-Door Luncheon

Closed-Door CCO and GC Luncheon Summit

Tiffany Christian - Vice President, Legal & Compliance, LEO Pharma Inc.
Fabiana Lacerca-Allen, JD, LLM - Senior Vice President, Compliance, Aimmune Therapeutics

1:40pm - 2:10pm30 minsFree

General Session

FDA Keynote Address — Hot Topics, Guidance and Enforcement

Catherine Gray, PharmD - Director, Office of Prescription Drug Promotion, FDA

2:10pm - 2:50pm40 mins

General Session

What’s Next in Pharma—Confronting a Challenging Macroeconomic Environment with Innovation

Tim Canonico - Partner, Health Industries Advisory Products Leader, PwC
Brian Riewerts - Partner, Pharmaceutical and Life Sciences; Risk & Regulatory Leader,, PwC

2:50pm - 3:30pm40 minsFree

General Session

Crisis Management Best Practices and Preparations

Seth Lundy - Partner, King & Spalding
Sally Yates - Partner, Special Matters and Government Investigations, King & Spalding

3:30pm - 4:00pm30 mins

General Session

Networking Break

4:00pm - 4:45pm45 mins

Small and Emerging Companies

Industry Playbook on Making the Most of Your Resources

L. Kathleen Durosseau - Vice President, Chief Compliance Officer, Rigel Pharmaceuticals, Inc.
Kelly Pitt - Vice President, U.S. General Counsel and U.S. Head of Compliance, MorphoSys US Inc.
Jennifer Sanfilippo - General Counsel and Chief Compliance Officer, Melinta Therapeutics
Genevieve Spires - Senior Legal Counsel, Melinta Therapeutics

4:00pm - 4:45pm45 minsFree

Mid to Large-Size Companies

Infusing Innovation into Compliance

Katie Jacyna - Director/VP, Product Management, Helio
John Poulin - Partner and CTO, Helio Group
Bjoern Dupre - Director, Compliance Monitoring and Investigations, Bayer
Kelli McGillicuddy - Standards & Governance Global Lead for Biosimilars Business Unit (BBU), Biogen

4:00pm - 4:45pm45 mins

Medical Device Companies

State of the Industry on New and Emerging Risks

Sujata Dayal - Vice President & Global Chief Compliance Officer, Medline Industries
Katherine Norris, MPA - Senior Managing Director, Healthcare & Life Sciences Compliance, Disputes and Economics, Ankura

4:45pm - 5:30pm45 mins

Small and Emerging Companies

Product Launch Considerations —Creating a Pre-Commercial Compliance Checklist

Alison Fethke - Counsel, Health Care, Ropes & Gray LLP
Kays Sawaged - Head of Compliance & Ethics, BioXcel Therapeutics
Holly Kramen - Chief Compliance Officer and Associate General Counsel, Iveric Bio
Ashley Riley - Director, Healthcare Compliance, BeiGene

4:45pm - 5:30pm45 minsFree

Mid to Large-Size Companies

Novel Approaches to Integrate and Embed Compliance

Russell Rose - Senior Manager, Deloitte
Cindy Cetani - SVP, Chief Integrity & Compliance Officer, Indivior
Steve Cohen - Associate Vice President, Ethics and Compliance, LUSA/Canada, Eli Lilly and Company
Emily Mason - Vice President, Compliance, Amgen

4:45pm - 5:30pm45 mins

Medical Device Companies

Transparency & Aggregate Spend Reporting

Chelsea Ott - Director, Global Regulatory, MedPro Compliance Advisory Services, MedPro Systems, LLC

5:30pm - 6:30pm60 mins

Close of Day One and Networking Reception