Virtual 21st Annual Pharmaceutical
and Medical Device Ethics and
Compliance Congress

Virtual Online Video Live and Archived
November 4 – 6, 2020


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KEYNOTE SPEAKERS

Craig Carpenito, JD

United States Attorney, US Attorney’s Office, District of New Jersey; Former Senior Counsel, Northeast Regional Office, US Securities and Exchange Commission; Newark, NJ

Susan Dentzer

Visiting Fellow, Duke-Margolis Center for Health Policy; Former Editor in Chief, Health Affairs; Former Health Correspondent, PBS NewsHour; Washington, DC

Robert I. Dodge, JD

Assistant Director, FCPA Unit, US Securities & Exchange Commission; Former Assistant U.S. Attorney, US Attorney’s Office, Western District of Michigan; Former Assistant Section Chief, Environmental Defense Section, US Department of Justice; Washington, DC

Robert W. Dubois, MD, PhD

Interim President and CEO, National Pharmaceutical Council (NPC); Former Chief Medical Officer, Cerner LifeSciences; Washington, DC

Gustav W. Eyler, JD

Director, Consumer Protection Branch, Civil Division, US Department of Justice, Washington, DC

Catherine (Katie) Gray, PharmD

Acting Director, Office of Prescription Drug Promotion (OPDP), US Food and Drug Administration, Silver Spring, MD

Matthew J. Lash, JD

Trial Attorney, Consumer Protection Branch, US Department of Justice, Washington, DC

Andy Mao, JD

Deputy Director, Fraud Section, Civil Division, Elder Justice Initiative Coordinator, US Department of Justice, Washington, DC

Dan Mendelson, MPP

Founder, Avalere Health, Operating Partner, Welsh, Carson, Anderson & Stowe, Board, Centrexion Therapeutics Corp., Washington, DC

Mary E. Riordan, JD

Senior Counsel, Office of Counsel to the Inspector General, Office of Inspector General, US Department of Health and Human Services, Washington, DC

Gregg Shapiro, JD

Assistant US Attorney and Chief, Affirmative Civil Enforcement Unit, US Attorney’s Office, District of Massachusetts, US Department of Justice, Boston, MA

Edie Stringfellow, MA

Director, Diversity & Inclusion, MassBio, Marketing Director, We Are Allies, Boston, MA

FEATURING THE ANNUAL CHIEF COMPLIANCE
OFFICERS ROUNDTABLE

November 4, 2020; Invitation-only; No Cost. CCOs interested in attending may contact Debra Scanlon, Administrator, Pharmaceutical Compliance Forum at info@pharmacomplianceforum.org.

AdvaMed UPDATE

Christopher L. White, JD

Chief Operating Officer & General Counsel, Advanced Medical Technology Association (AdvaMed), Washington, DC

PhRMA UPDATE

Julie Ritchie Wagner, JD

Assistant General Counsel, PhRMA; Former Senior Counsel, Office of Counsel to the Inspector General, US DHHS; Washington, DC

OIG ANALYTICS/AI UPDATE

Renata Marziarz Miskell

Senior Advisor to the Chief Data Officer, Inspector General, US Department of Health and Human Services, Washington, DC

DOJ SPEAKER PROGRAMS UPDATE

Jake Lillywhite, JD

Assistant US Attorney, Civil Division, US Attorney’s Office, Southern District of New York, US Department of Justice, New York, NY


AGENDA AT A GLANCE

(sessions subject to change)

WEDNESDAY, NOVEMBER 4


CONCURRENT CCO ROUNDTABLE AND MINI SUMMITS I & II

INVITATION-ONLY, CLOSED CCO ROUNTABLE
(10 am EST – 12:15 pm EST)
10:00 am
Welcome & Introductions
10:10 am
OIG Presentation on Technology (Big Data, Analytics and AI) and Compliance
10:40 am
AdvaMed & PhRMA Reports
11:00 am
DOJ Presentation on High Risk Compliance Issues related to Speaker Programs
11:30 am
Facilitated, Interactive Discussion Video Roundtables on Promotional Programs (Up to 20 each; pre-assigned)
12:00 pm
Reports from Discussion Roundtables
12:15 pm
Adjournment

MINI SUMMITS I & II

MINI SUMMITS I (10 am EST – 11 am EST)

— I: Building Ethics and Integrity into your Compliance Program
— II: Practices in Operationalizing Speaker Programs
— III: State Price Transparency and Reporting Requirements
— IV: Operationalizing Updates to the Sunshine Law

MINI SUMMITS II (11 am EST – 12:15 pm EST)

— V: Third Party Management Beyond Due Diligence: Selecting, Integrating and Managing Third Parties throughout the Relationship Lifecycle
— VI: Fraud and Abuse Risks Related to COVID-19 Relief
— VII: Annual Medical Device Roundtable
— VIII: Navigating Interactions AND Compliance Concerns with HCPs during a Pandemic

OPTIONAL LIVE INTERACTIVE TOPIC DISCUSSIONS
(12:15 pm EST – 1:00 pm EST)
(Open to all; May move among sessions.)

OPENING PLENARY SESSION (1 pm EST – 5 pm EST)
1:00 pm
Welcome and Introduction: PCF Co-Chairs
1:15 pm
Keynote: OIG Update by Mary Riordan
2:00 pm
US DOJ Keynote
3:15 pm
FDA Keynote
3:45 pm
Annual Chief Compliance Officer Fireside Chat
5:00 pm
Adjournment

THURSDAY, NOVEMBER 5, 2020


CONCURRENT MINI SUMMITS III & IV

MINI SUMMITS III (10 am EST – 11 am EST)

— IX: Compliance Considerations for Rare and Ultra Rare Drugs
— X: Best Practices of Conducting Investigations
— XI: Compliance Monitoring in a Virtual World
— XII: Compliance Challenges Posed by Small Organizations
— XIII: Managing Monitorships to Maximize Effectiveness
— Mini Summit XIV: Patient Services Compliance Survey (Year 4) Update

MINI SUMMITS IV (11:15 am EST – 12:15 pm EST)

— XV: Enforcement Actions on Fraud and Misuse of Patient Support Programs
— XVI: Compliance Risk Assessment Alignment to Enterprise Risk Management
— XVII: Reflections on a Successful Co-Promotion Partnership
— XVIII: Government Enforcement Trends
— XIX: FDA Regulatory Updates for Compliance Professionals
— XX: SEC Compliance: Living in the Material (Non-Public Information) World

OPTIONAL LIVE INTERACTIVE TOPIC DISCUSSIONS
(12:15 pm EST – 1:00 pm EST)
Open to all; May move among sessions.)

PLENARY SESSION (1 pm EST – 5 pm EST)
1:00 pm
PCF Co-chair Welcome and Introductions
1:15 pm
COVID-19 and Vaccine Development Update
1:45 pm
Equity, Diversity and Inclusion Keynote Address
2:15 pm
Implementing, Equity, Diversity, and Inclusion Roundtable
3:15 pm
US DOJ and US SEC Update on FCPA Enforcement
4:15 pm
Advanced Patient Engagement Strategies
5:00 pm
Adjournment

FRIDAY, NOVEMBER 6, 2020


CONCURRENT MINI SUMMITS V & VI
MINI SUMMITS V (10 am EST – 11 am EST)

— XXI: Social Media Communication, Including Promotion of Products Across Borders
— XXII: Risk Management for Interactions with Specialty Pharmacies
— XXIII: Privacy, GDPR and California Consumer Privacy Act – What’s Next
— XXIV: DOJ’s Fundamental Question: “Does the Corporation’s Compliance Program Work” in Practice?
— XXV: Update on Expedited CIA and Key Components

MINI SUMMITS VI (11:15 am EST – 12:15 pm EST)

— XXVI: Engagement and Support for Board Oversight of the Compliance Program
— XXVII: Research and Development Compliance Challenges
— XXVIII: Managing Communication Issues during a Crisis or an Emerging Post-crisis Environment
— XXIX: Market Access and Payer Interactions
— XXX: Key Learnings from Enforcement Actions in the Opioid Crisis

OPTIONAL LIVE INTERACTIVE TOPIC DISCUSSIONS
(12:15 pm EST – 1:00 pm EST)
Open to all; May move among sessions.)

CLOSING PLENARY SESSION (1 pm EST – 4 pm EST)
1:00 pm
PCF Co-chair Welcome and Introductions
1:15 pm
Roundtable on Implications of the Election for Lifesciences, including Pricing and Cost Containment Policy
2:00 pm
Using Data Analytics and Automation to Drive Smarter, More Effective and Cost-Effective Compliance Programs
2:45 pm
Annual AUSA Roundtable
3:00 pm
The Post-Pandemic Compliance Department of the Future: Virtual, Ethics, Integrity and More
4:00 pm
Adjournment

FEATURING THE ANNUAL CHIEF COMPLIANCE
OFFICERS FIRESIDE CHAT

Dennis K. Barnes, JD CPA

Vice President, Global Governance, Risk & Compliance, Mayne Pharma; Former Vice President, Compliance & Risk Management, Global Compliance Officer, PAREXEL International; Raleigh-Durham, NC

Mark Graves, JD, MBA

Senior Vice President and Chief Compliance Officer, MiMedx; Former Director, Global Patient Experience & Value, UCB; Former Senior Director, Pharmaceutical Products Division, Abbott; Marietta, GA

Nancy A. Grygiel, JD

Senior Vice President, Chief Compliance Officer, Amgen; Former VP Compliance, Corporate & International, Allergan; Former Senior Director Global Compliance, Mylan; Newbury Park, CA

John Knighton, JD

Chief Compliance Officer, TherapeuticsMD; Former Vice President, Head of Global Compliance, Orexigen Therapeutics; Boca Raton, FL

Tara R. Shewchuk, JD, LLM

Vice President and Deputy, Office of Ethics & Compliance, Medtronic; Former Senior Director, Ethics and Compliance, Abbott (now AbbVie); Former VP, Chief Compliance, Privacy & Security Officer, Resurrection Health Care (now Ascension/AMITA); Minneapolis, MN

Tom Gregory, MBA

Partner, Forensic & Integrity Services, EY, Atlanta, USA (Moderator)

AND A ROUNDTABLE ON IMPLEMENTING
EQUITY, DIVERSITY AND INCLUSION BY

Michael R. Clarke, CCEP

Vice President, Global Chief Compliance Officer, ConvaTec; Former VP, Corporate Compliance, Indivior; Former VP, Ethics & Compliance, Americas, Actavis; Former VP & Compliance Officer, Biomet Spine & Bone Healing Technologies; Bridgewater, NJ

Sujata Dayal, JD

Vice President & Global Chief Compliance Officer, Medline Industries; Former VP Healthcare Compliance & Privacy, Johnson & Johnson; Former Global Chief Compliance Officer and Corporate VP, Biomet; Chicago, IL

Jill Fallows Macaluso

Corporate Vice President, Chief Ethics, Compliance & Privacy Officer, NovoNordisk, Princeton, NJ

Robert A. Ladd, JD

Vice President, Global Head Integrity & Compliance, Novartis, Oncology; Former General Counsel, GE Healthcare; Former Global Head of Compliance Training, Goldman Sachs; Former Senior Corporate Counsel, Pfizer; New York, NY

Latarsha Stewart, JD, MS

Vice President, Head of Compliance, Servier Pharmaceuticals; Former Head of Compliance, Global Oncology Business Unit, Takeda Oncology; Boston, MA

FEATURED FACULTY

Khelin N. Aiken, JD

Partner, Baker & McKenzie LLP; Former Regulatory Counsel, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), Washington, DC

Sergio Alegre, JD

Vice President, Global Compliance, Osmotica; Former Executive Director Compliance, Pacira; Bridgewater, NJ

John T. Bentivoglio, JD

Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud, and Chief Privacy Officer, US Department of Justice; Washington, DC

Richard Bistrong, MA

Chief Executive Officer, Front-Line Anti-Bribery LLC, Contributing Editor, FCPA Blog; Former Confidential Human Source (CHS) and Cooperating Witness, FBI and US DOJ; Former Cooperating Witness, City of London Police, HMRC and CPS, UK; New York, NY

Joseph Calarco

Vice President, Compliance, Nabriva Therapeutics; Former Chief Compliance Officer, NEOS Therapeutics; Former Director, Compliance & Ethics, US Operations, Bristol-Myers Squibb; Lansdale, PA

Christie Camelio

Chief Compliance, Ethics & Risk Management Officer, TG Therapeutics; Former Vice President, Deputy Global Chief Compliance Officer, Celgene; New York, NY

Cynthia Cetani

Chief Integrity & Compliance Officer, Indivior; Former Group Integrity & Compliance, Head, Compliance Operations, Novartis International AG; Richmond, VA

Katherine Chaurette, MS, JD

Vice President Healthcare Law and Compliance, Blueprint Medicines; Former Sr. Director, Regulatory and Commercial Law, Regeneron; Former VP, Legal, Head of Health Law, Regulatory, Market Access, Marketed and Launch Products, Sanofi; Jamaica Plain, MA

Masha Chestukhin, MSJ

Associate Director, Compliance Officer R&D, IA, FMV, Sanofi Genzyme; Former Senior Manager NA Compliance, Sanofi; Jamaica Plain, MA

Yvonne Clark, JD

Corporate Compliance Counsel, Spark Therapeutics; Former Commercial Counsel, Merck; Philadelphia, PA

Clarissa Crain

Senior Manager, Deloitte; Former Analyst, Commercial Operations, Cephalon; Philadelphia, PA

BJ D’Avella, MBA

Group Leader, Life Sciences Consulting Group, Paul Hastings, New York, NY

Ethan Davis, JD

Partner, King & Spalding LLP; Former Acting Assistant Attorney General, Civil Division, US Department of Justice; Washington, DC

Kimberly Davis, JD

Chief Compliance Officer, Kaleo, Richmond, VA

Anisa Dhalla

Global Chief Compliance Officer, UCB, Inc.; Former Manager, Regulatory Affairs, Solvay and Mikart; Atlanta, GA

Sarah diFrancesca, JD

Partner, Dinsmore & Shohl LLP, Cincinnati, OH

Stefanie A. Doebler, JD

Of Counsel and Co-chair, Health Care Practice Group, Covington & Burling LLP, Washington, DC

Tara D’Orsi, JD

Executive Vice President, Chief Compliance Officer and General Counsel, Kyowa Kirin North America; Former Senior Counsel, Reliant Pharmaceuticals; New York, NY

Margaret Feltz, MA, JD

Vice President, Ethics & Compliance, Purdue Pharma; Former Compliance Counsel, Boehringer Ingelheim; Stamford, CT

Christine Fiore, MBA

Executive Director, Ethics and Commercial Compliance, Boehringer Ingelheim; Former Group Director Ethics and Compliance, Smith & Nephew; Ridgefield, CT

Gary F. Giampetruzzi, Esq.

Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc.; New York, NY

Virginia “Ginny” A. Gibson, JD

Partner, Hogan Lovells LLP; Former First Assistant U.S. Attorney, Eastern District of Pennsylvania, US Department of Justice; Philadelphia, PA

Thomas M. Glavin, JD

Chief Compliance Officer for the Americas, Olympus Corporation of the Americas; Former Vice President, US/Americas Compliance Officer, Shire; Center Valley, PA

Betania Glorio, LLM

Global Compliance Officer, Healthcare, Merck KGaA; Former Senior Director, Legal and Compliance EMEA, Horizon, Raptor and Onyx; Darmstadt, Germany

Gejaa T. Gobena, JD

Partner, Hogan Lovells; Former Deputy Chief, Fraud Section, Criminal Division; Former Trial Attorney, Civil Division, Fraud Section, US Department of Justice; Washington, DC

Thomas Goimarac, MBA, CHFP

Managing Consultant, Berkeley Research Group, LLC (BRG), Phoenix, AZ

Adam Greene, JD, MPH

Partner and Co-chair, Health Information & HIPAA Practice, Davis Wright Tremaine LLP; Former Senior Health Information Technology and Privacy Specialist, Office for Civil Rights, HHS; Washington, DC

Michael Hercz, JD

Senior Vice President and General Counsel, Sentynl; Former Vice President, Law & Chief Compliance Officer, Victory Pharma; Former Executive Director, Enterprise Risk Management, Amgen; Solana Beach, CA

Emily Huebener, MA

Senior Manager, Health and Life Sciences Forensic & Integrity Services, EY, Chicago, IL

Briannon Irwin, JD

Senior Managing Consultant, Berkeley Research Group (BRG); Former Judicial Law Clerk, The Supreme Court of Pennsylvania; Washington, DC

Michael Joachim, JD

Head of Ethics & Business Integrity, Specialty Care, Sanofi Genzyme, Cambridge, MA

Marci Juneau, MBA

Partner, Helio Health Group, Atlanta, GA

Catherine Healy Kanzler, JD

Head, Global Compliance Operations, Olympus Corporation of the Americas, New York, NY

Ben Kaye-Smith

Senior Vice President Ethics, Risk & Compliance, AveXis; Former Corporate Health Safety Environment Manager; Former Global Head Integrity & Compliance Risk Review & Prevention, Novartis; Switzerland

Jonathon L. Kellerman

Executive Vice President, Global Chief Compliance Officer – Advisor, Office of Ethics & Compliance, Allergan Aesthetics, an AbbVie company; Former Executive Vice President, Global Chief Compliance Officer; Allergan, Madison, NJ

Andrea L. Kocharyan, JD

Vice President, Head of Legal & Compliance, Zealand US; Former VP, Head of Legal Affairs, Sumitomo Dainippon Oncology; Former VP, US General Counsel & Compliance Officer, EVO Biologics; Cambridge, MA

Keith Korenchuk, MPH, JD

Vice President and Chief Compliance Officer, DH Diagnostics, a Danaher Company, Chevy Chase, MD

Kirt Kraeuter, MGA

Senior Director, Corporate Compliance at Moderna; Former European Compliance Director, Otsuka; Former, Executive Director, Worldwide Compliance Committee & Monitoring, Bristol-Myers Squibb; Yardley, PA

Nancy Libin, JD

Partner and Co-Chair, Privacy & Security, and Technology Practice, Davis Wright Tremaine LLP; Former Chief Privacy and Civil Liberties Officer, US Department of Justice; Washington, DC

Jodi Lindsey, JD

Vice President, Healthcare Counsel and Head of U.S. Compliance, Alkermes; Former Associate Director, Commercial Compliance, Biogen; West Roxbury, MA

Kari Loeser, JD

US Healthcare Compliance Officer, Relypsa; Former Senior Counsel, Jazz Pharmaceuticals; Former Senior Manager, Genentech; Redwood City, CA

Joshua Marks, JD

Vice President, Chief Ethics & Compliance Officer, Boehringer Ingelheim; Former Executive Division Counsel, Corporate Compliance Officer & Asst. Secretary, Ben Venue Laboratories; Ridgefield, CT

Jane Mathews, LLM, JD

Vice President and Chief Compliance Officer, Lexicon; Former Assistant General Counsel, Sunovion; Former Senior Counsel-Managing Attorney – Head of Litigation, Hoffmann-La Roche; Ringwood, NJ

Heather McCollum, JD, MHA, CCEP-I

Director, Compliance, Shionogi, Florham Park, NJ

Jennifer McGee, JD

Vice President & Chief Compliance Officer, Otsuka America Pharmaceutical, Rockville, MD

Kathleen McGovern, JD

Global Investigator, Healthcare & Crisis Management Advisor, EY; Former Senior Deputy Chief, Fraud Section, US Department of Justice; Washington, DC

Jenny McVey, MS, PHD

Compliance Risk Strategy & Management, Novo Nordisk, Compliance Lead, Hands International, Editorial Board Member, Policy & Medicine Compliance Update, Princeton, NJ

Patrick Mooty

Head of Compliance, Sumitomo Dainippon Pharma America, Marlborough, MA

Gregory S. Moss, LLB

Executive Vice President, General Counsel and Corporate Secretary, Chief Compliance Officer, Kadmon Holdings, New York, NY

Kristin Mykulak, JD

Assistant General Counsel, Litigation & Compliance, Dr. Reddy’s Laboratories, Princeton, NJ

Amy Pawloski

President, Strategic Versatility; Former Global Compliance Operations Officer, Endo; Phoenixville, PA

Veleka Peeples-Dyer, JD

Partner and Chair, North America Food and Drug, Administration (FDA) Practice Group, Baker & McKenzie LLP, Washington, DC

Brad Powers, JD

General Counsel and Chief Compliance Officer, Lumos Pharma; Former General Counsel and Chief Compliance Officer, Office of the CEO, NewLink Genetics; Des Moines, IA

Ariadna Quesada, MPP, MSJ

Compliance Director International EMEA, Hillrom; Former Ethics and Compliance Officer, The Netherlands, AbbVie; Former Compliance Director International, DaVita Kidney Care; Amsterdam, Netherlands

Kristin Rand, JD, MA

Head, Corporate Compliance and Global Risk Officer, Moderna; Former Vice President & Chief Compliance Officer, Seattle Genetics; Boston, MA

Kelly N. “Nikki” Reeves, MPA, JD

Partner and Co-chair, Life Sciences and Healthcare Industry Group, King & Spalding LLP, Washington, DC

Chapman Richardson

Global Head, Data Consumerization, Sanofi; Former Executive Director, Global Next, Generation Digital, Novartis; Bridgewater NJ

Kevin Ryan, MS, JD

Vice President, Chief Compliance Officer, ACADIA; Former Director, Ethics & Compliance, Novo Nordisk; San Diego, CA

Jennifer Santos, MPH, JD

Head of Global Corporate Compliance Operations, Vertex Pharmaceuticals; Former Associate General Counsel, Tufts Medical Center; Boston, MA

Jonathan Sayegh, JD

Associate Director, Compliance & Ethics, Sunovion, Marlborough, MA

Eric Siegel, MBA, JD

Vice President, Head of Compliance US, Idorsia Pharmaceuticals US Inc.; Former Chief Compliance Officer, Jazz Pharmaceuticals; Former Senior Investigator, Office of the Inspector General, City of Philadelphia; Philadelphia, PA

Paul Silver

Principal, Regulatory & Compliance Life Sciences Leader, Deloitte Advisory, Deloitte, Atlanta, GA

Melissa Tearney, JD

Partner and Co-chair, Litigation Department, Choate, Hall & Stewart, Boston, MA

Bryan Timer, MA

Director, Data Analytics & Transparency, Merck and Co, Inc., Kenilworth, NJ

Elizabeth Weiss, JD

Assistant General Counsel, Pfizer; Former Research Chemist, Ortho Clinical Diagnostics; Peapack, NJ

Seth B. Whitelaw, JD, LLM, SJD

President and Chief Executive Officer, Whitelaw Compliance Group, LLC; Editor, Life Science Compliance Update; Senior Fellow & Adjunct Professor, Life Sciences Compliance, Mitchell Hamline School of Law; West Chester, PA

Amy Yuda, MSJ, CHC, CQA, CCEP

Compliance Officer, PolarityTE, Salt Lake City, UT

2020/2021 GLOBAL PHARMA/MED DEVICE
ETHICS & COMPLIANCE CONGRESSES


VIRTUAL TWENTY-FIRST ANNUAL PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS

Virtual Online Video Event Live and Archived
Sponsored by Pharmaceutical Compliance Forum
Media Partners: Harvard Health Policy Review, Health Affairs and Policy & Medicine Compliance Update
November 4 – 6, 2020
www.PharmaCongress.com

VIRTUAL FOURTEENTH INTERNATIONAL PHARMACEUTICAL AND MEDICAL DEVICE ETHICS & COMPLIANCE CONGRESS

Virtual Online Video Event Live and Archived
Sponsored by International Society of Healthcare Compliance Professionals (ETHICS)
Media Partner: Policy & Medicine Compliance Update
February 22 – 25, 2021
www.InternationalPharmaCongress.com



A HYBRID CONFERENCE AND INTERNET EVENT