Day TwoWednesday, 26 April 2023 - EST (Eastern Standard Time, GMT-5)

8:00am - 8:30am

Continental Breakfast

Showing 3 of 3 Streams

Workshop 1

Workshop 2

Workshop 3

8:30am - 10:30amFree

Building a Compliance Program from the Ground Up

Daryl Kreml - Vice President, Chief Compliance Officer, Sage Therapeutics
Erica Powers - Head of US Commercial Compliance and Compliance Operations, Sage Therapeutics
Dhara Moro - Associate Director, Compliance Operations, Sage Therapeutics
Joy Dowdle - Partner, Life Sciences & Healthcare Practice, Paul Hastings
Piyush Sharma - Chief Ethics & Compliance Officer, Alnylam Pharmaceuticals
Elaina McEwan - Senior Manager, Life Sciences Consulting Group, Paul Hastings

8:30am - 10:30am

Navigating the “New” US Privacy Landscape — How to Set a Course for Compliance with New and Emerging U.S. State Privacy Requirements

Kris Hall, JD, CIPP/CIPM - Managing Director, Dovetail Consulting Group
Dennis Barnes - Managing Director, Dovetail Consulting Group, LLC

8:30am - 10:30am

Senior Compliance Leadership Symposium

Terra Buckley, JD - Vice President, Head of Compliance Advisory Services, MedPro Systems

10:30am - 11:00am

Networking and Refreshment Break

Showing 3 of 3 Streams

Workshop 4

Workshop 5

Workshop 6

11:00am - 11:45amFree

Update on Recent DOJ Pronouncements Affecting Compliance Programs, Investigations, and Self-Disclosure

Craig Bleifer - Partner, Akin Gump Strauss Hauer & Feld LLP
Tim Roberts - Ethics, Risk & Compliance, US Pharma, Novartis Pharmaceuticals Corporation
Lori Russell - Senior Vice President, Corporate Integrity and Chief Compliance Officer, bioMerieux

11:45am - 12:30pm

2022 Wrap-Up: Privacy, Pricing, Drug Disposal, and Transparency - What's Trending for States in 2023

11:00am - 12:30pm

From Detecting to Preventing — An Interactive Workshop on the Full Lifecycle of Monitoring

Jonathan Wilkenfeld - President, Potomac River Partners
Adam Oakley - Director, Potomac River Partners

11:00am - 12:30pm

Creating a Compliance Guide to Environmental, Social and Governance Involvements (ESG)

Emily Mason - Vice President, Compliance, Amgen
Kirsten Liston - Principal and Founder, Rethink Compliance LLC

12:30pm - 1:30pm

Networking Luncheon

Showing 4 of 4 Streams

Market Access Compliance

Risk and Monitoring

Data and Digitalization

Professional Development and Training

1:30pm - 2:15pm

Privacy Protection in Data Sharing and Trial Transparency with Quantitative Re-Identification Risk Analysis

Zach Weingarden - Director, Product Solutions, TrialAssure

2:15pm - 3:00pm

Using Data, Analytics, and Industry Learnings to Enhance Auditing and Monitoring across your Patient Support Programs (PSPs)

Sameer Singh - Director, Life Sciences Advisory (Risk & Compliance), KPMG US
Jordan Seiferas - Managing Director, Analytics and AI, KPMG
Quinton Kinne - Associate Director, Patient Engagement and Customer Solutions, Johnson & Johnson

1:30pm - 2:15pmFree

Playbook for Risk Assessment and Identification

Jim Dawson - Vice President, Compliance Solutions, qordata

2:15pm - 3:00pmFree

Options for Reporting Lines to Manage Compliance Risks

Meena Datta - Partner, Sidley Austin LLP

1:30pm - 2:15pm

Getting Compliant Communications Right in the Texting Era—How to Navigate the New Frontier for Pharmaceutical Companies and Healthcare Provider Engagement

Katherine Buckley - Principal, PwC US
Tyler Jorgenson - Principal, Customer Transformation, PwC US
Jeff Burlin - Director, Twilio Executive Engagement Programs, Twilio

2:15pm - 3:00pm

FMV Needs Assessment and Contracting

L. Kathleen Durousseau - Vice President, Chief Compliance Officer, Rigel Pharmaceuticals, Inc.
Julie DeLong, CFA - Senior Managing Director, Ankura
Dhara Moro - Associate Director, Compliance Operations, Sage Therapeutics

1:30pm - 2:15pm

Rethinking and Revolutionizing the Compliance Officer Role

Seth Whitelaw, JD - Editor, Policy & Medicine Compliance Update
Daryl Kreml - Vice President, Chief Compliance Officer, Sage Therapeutics
Ann Beasley - Chief Compliance Officer, Zai Lab
Jake DeBoever - Vice President, Chief Compliance Officer, Dermavant Sciences

2:15pm - 3:00pm

Recruiting Top Compliance Talent and Preparing for Success

Avis Goode - Director, Healthcare Compliance, Johnson & Johnson
Lori Kagan - Executive Director, North American Compliance, Kyowa Kirin, Inc.

3:00pm - 3:30pm

Networking and Refreshment Break

Showing 4 of 4 Streams

Market Access Compliance

Risk and Monitoring

Data and Digitalization

Professional Development and Training

3:30pm - 4:15pm

Models of Engagement with Medical and Commercial

Dominick DiSabatino - Partner, Sheppard Mullin
Francisco Riberio - Chief Compliance Officer, ImmunoGen
Jeremy Lutsky - Associate General Counsel, Tolmar
Jean McKiernan - Partner, Dovetail Consulting Group

4:15pm - 5:00pm

Understand Approval Process and Monitoring of Social Media Channels

Assess how to work with influencers and FMV associated with this
Compare and contrast the understandings with branded vs. unbranded programs
Explore the regional understandings on social media

Donna White - Vice President, Contracts & Compliance, Chiesi USA Inc.
Samantha Sutherland - Director, Baker Tilly
Lori Russell - Senior Vice President, Corporate Integrity and Chief Compliance Officer, bioMerieux

3:30pm - 4:15pmFree

Navigating the Legal Considerations of Patient Assistance

Sara Frank - Principal, Choate, Hall & Stewart LLP
Kristen Dooley Perriello - Principal, Choate, Hall & Stewart LLP
Kelly Pitt - Vice President, U.S. General Counsel and U.S. Head of Compliance, MorphoSys US Inc.
Mia Harmon, JD - Chief Compliance and Privacy Officer, PAN Foundation

4:15pm - 5:00pmFree

Optimize Third-Party Oversight and Due Diligence

Blair Shaw - Global Program, Senior Director, Vendor/Third party Compliance, Otsuka
Gretchen Reyes Cseplo - Head, Risk Management, Ethics, Risk & Compliance,, Novartis

3:30pm - 4:15pm

Telehealth and Digital Health

Fred Medick - Assistant General Counsel, Genentech
Stefanie Doebler - Partner, Covington and Burling LLP

4:15pm - 5:00pm

Living in the New Normal—Navigating Compliance and Investigations in a Post-COVID World

John Rademacher, CPA, CFE - Principal, Forensic Sciences, Charles River Associates
Bjoern Dupre - Director, Compliance Monitoring and Investigations, Bayer
David Amendola - Global Compliance Risk Evaluation and Management, Convatec
Jacob Elberg - Associate Professor, Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall University School of Law

3:30pm - 5:00pm

Practical Guidance for Developing Tomorrow’s Compliance Leaders

Daniel O'Connor - Senior Vice President, NXLevel Compliance
Erica Powers - Head of US Commercial Compliance and Compliance Operations, Sage Therapeutics
Jim Gibney - Executive Director, Corporate Compliance, Global Compliance Programs, Regeneron Pharmaceuticals Inc.
Despie Roddenberry - Director, Compliance, Dermavant Sciences

5:00pm - 6:00pm

Close of Day Two and Networking Reception