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Pre-Conference Workshops

Workshop A — How to Handle Whistleblower Complaints from A to Z: A Complete Guide Amid a Spike in FCPA-Related Complaints

May 8, 2024 9:00am – 12:30 PM

Speakers

Patrick Murphy
Senior Vice President and Global Head of Litigation and Investigations
Fresenius

Katy Choo
Group Vice President, Chief Anti-Corruption Counsel, Chief Investigative Counsel
General Electric

Rina Vazirani
Associate General Counsel & Senior Director
Gilead Sciences

Day 1 - Thursday, May 9, 2024

8:45
Opening Remarks from the Co-Chairs
9:00

FIRESIDE CHAT

DOJ and SEC Enforcement in the Life Sciences Context: From Ephemeral Messaging, FEPA, Self-Disclosure, Clawbacks, M&A, Whistleblowers and More
9:45

NEW DOJ/OIG COMPLIANCE BEST PRACTICES

Putting Protocols into Action: Key Differences, Potential Pitfalls, and New Implementation Hurdles
10:45
Networking Break
11:15

China Hypotheticals

The Anti-Corruption Crackdown in China and Nightmare Scenarios: How Companies Are Now Approaching High Stakes, Intensifying Legal and Compliance Risks
12:15
Voluntary Disclosures: Understanding “Prompt Reporting”, Cooperation Credit, Remediation and When to Engage Outside Counsel
1:15
Networking Lunch
2:30

Leveraging Emerging Technology in Life Sciences Operations

Detecting FCPA Data Triggers and Other Data-Driven Fraud Anomalies with Data Automation, Data Analytics and Artificial Intelligence
3:15
Compensation Claw backs in the Life Sciences Context : The Latest on Resolving Compliance Dilemmas, Implementation Challenges and Conflicts with International Employment Law
4:00
Networking Break
4:15
Case Study: Navigating Discounts Through Distribution Networks
4:45
Challenges for Latin America and the Life Sciences Industry: Market Entry Due Diligence for Public/Private Ventures
5:45
Close of Day One

Day 2 - Friday, May 10, 2024

8:45
Opening Remarks from the Co-Chairs
9:00
New International Life Science Anti-Corruption Compliance Considerations: Measuring and Testing Top-Down Effectiveness and Individual/Corporate Transparency of Compliance Controls
10:00
Third Party Management: Monitoring Distributors, Sub-Distributors, Sub-Dealers and Sales Agents
11:00
Networking Break
11:15
Cross-Border Data Privacy & Cyber Breaches: False Claims Act (FCA) Liability, Cyber Breach Security and China’s New PIPL Measures-and the Interplay with Anti-Corruption
12:00
Life Science M&A/Joint Venture Due Diligence Best-Practices: High-Stakes Decision-Making Around DOJ’s Safe Harbor Policy, Dealmaking Compliance, Privacy, and Post-Transaction Protocols
1:00
Networking Lunch
2:15
The Grey Areas of G&E, Donations, Sponsorship and Hospitality in High-Risk Markets: What Companies are Now Doing to Strengthen Risk Monitoring Around Compliant HCP Relations
3:15
Clinical Trials: The Latest on Managing Unique, Evolving Bribery Risk Factors for Sponsors and CROs
4:00
Networking Break
4:15
WeChat, WhatsApp and the Continuing Ephemeral Messaging Dilemmas: Updating Your Policies on Messaging, Retention Systems, Privacy and Recordkeeping
5:00
Emerging Market Entry and Investigations
5:45
Conference Concludes

Day 1 - Thursday, May 9, 2024

8:45
Opening Remarks from the Co-Chairs

Claudius O. Sokenu
Executive Vice President, Chief Legal and Compliance Officer, Corporate Secretary
Avantor

Natasha Trifun
Executive Director, Head of Compliance, R&D, Global Medical, External Funding and Global Functions
Alexion Pharmaceuticals

9:00

FIRESIDE CHAT

DOJ and SEC Enforcement in the Life Sciences Context: From Ephemeral Messaging, FEPA, Self-Disclosure, Clawbacks, M&A, Whistleblowers and More

Derek Ettinger
Assistant Chief, FCPA Unit, Fraud Section, Criminal Division
U.S. Department of Justice

Ryan Rohlfsen
Partner
Ropes & Gray LLP
Former Senior Trial Attorney, Criminal Division, U.S.

9:45

NEW DOJ/OIG COMPLIANCE BEST PRACTICES

Putting Protocols into Action: Key Differences, Potential Pitfalls, and New Implementation Hurdles

Rebecca Orttel
Vice President, Chief Ethics and Compliance Officer
Medtronic

Amid continuing increased DOJ enforcement postures, and newly introduced U.S. Department of Health and Human Services (OIG) compliance program guidelines, how are life science multinationals designing compliance program updates to meet both DOJ/OIG expectations? What are the key differences and compliance nuances between these two compliance program guidance measures and what are the critical implementation tips, tools, and roadblocks to look out for?

10:45
Networking Break
11:15

China Hypotheticals

The Anti-Corruption Crackdown in China and Nightmare Scenarios: How Companies Are Now Approaching High Stakes, Intensifying Legal and Compliance Risks

Adam Yoffie
Executive Director, Head of C&E Investigations and Integrity Line
Bristol Myers Squibb
Former Trial Attorney, Criminal Division U.S. Department of Justice

Lamia Matta
Global Head of Investigations
3M Healthcare

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Susanne M. Hanchar
Associate Vice President – Global Ethics and Compliance, Anti-Corruption & Investigations
Eli Lilly and Company

Yuet Tham
Parter
Sidley Austin

Building upon the pre-conference workshop, this interactive, practical session delves select, highly complex issues affecting the life sciences and healthcare sectors in China. Benefit from enhanced benchmarking by using our anonymous polling systems!

  • The anti-corruption crackdown in China: How might this campaign negatively impact HCPs and advances in healthcare?
  • Critical regional compliance implications for life science companies such as pricing, reimbursement, and market access issues
  • Navigating WeChat and WhatsApp communication landmines: Document sharing, data retention
  • Data protection and blocking statutes: Balancing these laws with DOJ and SEC expectations for FCPA compliance
  • What go-to-market considerations are most important in crafting a winning strategy in response to rapid health reforms taking place in China?

12:15
Voluntary Disclosures: Understanding “Prompt Reporting”, Cooperation Credit, Remediation and When to Engage Outside Counsel

David Last
Partner
Cleary Gottlieb
Former Chief, FCPA Unit, Fraud Section, Criminal Division U.S. Department of Justice

Daniel Grooms
Partner
Cooley LLP
Former Assistant United States Attorney and Criminal Chief U.S. Department of Justice

Claudius O. Sokenu
Executive Vice President, Chief Legal and Compliance Officer, Corporate Secretary
Avantor

During this highly anticipated session, gain invaluable insights from former DOJ officials, leading private and in-house practitioners on how to update your disclosure calculus in the wake of recent DOJ announcements.

Topics will include:

  • To disclose or not disclose
  • What constitutes “a reasonably prompt time” to disclose?
  • The extent of possible cooperation credit-and what is now expected amid recent DOJ policy and guidance updates

1:15
Networking Lunch
2:30

Leveraging Emerging Technology in Life Sciences Operations

Detecting FCPA Data Triggers and Other Data-Driven Fraud Anomalies with Data Automation, Data Analytics and Artificial Intelligence

Gina Salcedo Lannin
Manager, Insights and Analytics
Takeda

Corey Dunbar
Managing Director
BDO

Incorporating data analytics into your compliance program has instantly changed from a “nice to have” to a “must have” element of your program. This session on data monitoring, data analytics and AI for life sciences will provide you with practical knowledge about outsourcing or implementing your own data analytics platform. Ensure the right questions are being asked of your data to gather the right information to get to the right answers.

  • Effective ways to automate, including when your company has multiple, different systems
  • Ensuring that data feeds and monitoring tools are working in real time
  • Developing processes for determining if an internal investigation is necessary and any additional action
  • Identifying which transactions to monitor and how to monitor them, including gifts and donations
  • Deciding which pre-approval systems need to be set up before rolling out a monitoring program
  • Understand how data analytics interactions affect your risk profile
  • Measuring data analytics effectiveness on spotting FCPA data triggers
  • Build it or buy it?
  • See real-world examples of the impact of data analytics/AI/Machine learning on life sciences compliance

3:15
Compensation Claw backs in the Life Sciences Context : The Latest on Resolving Compliance Dilemmas, Implementation Challenges and Conflicts with International Employment Law

Roger O’Sullivan
General Counsel, Corporate Secretary & Chief Compliance Officer
CDx Diagnostics

How should life sciences companies be structuring their employee compensation packages accordingly and better position themselves in the event of a DOJ inquiry or investigation?

  • Compensation arrangements for positions that pose higher risks of compliance issues:
    • Senior executives
    • Sales professionals who interact with HCPs
    • Sales professionals who frequently interact with HCPs who are government officials
  • Multi-jurisdictional, international clawback implications:
    • U.S. jurisdictions: Navigating different definitions and interpretations of what kinds of compensation constitute “wages.”
    • Resolving conflicts between U.S. and foreign employment law
  • Implementing compensation structures that reward and incentivize compliant behavior
  • Integrating compliance efforts into company functions
    • Compensation committees
    • Employee performance evaluations
    • Who will be administering the protocols?

4:00
Networking Break
4:15
Case Study: Navigating Discounts Through Distribution Networks

Mara Senn
Executive Global Compliance Leader
GE Healthcare
Former Trial Attorney, Criminal Division U.S. Department of Justice

  • Pre-deal contract modeling
  • Managing complex performance agreements
  • Aggregating distributor payments
  • Payment reporting, analytics and calculations
  • Controls around inflated margins: How to design appropriate discounts for distributors and sub-distributors

4:45
Challenges for Latin America and the Life Sciences Industry: Market Entry Due Diligence for Public/Private Ventures

Liana Cunha
Compliance Director, Latin America
Thermo Fisher Scientific

Raquel Zambrano de Leon
Ethics, Risk & Compliance, Innovative Medicines Head for Canada and Latin America
Novartis

Sergio Pinto
Senior Director, Regional Sector Lead
Johnson & Johnson

Esther Flesch
Partner
Miguel Neto Advogados

Topics will include:

  • Public versus private doctors and handling their specific FCPA issues
  • Mexico
    • AMID and regional codes of ethics and transparency with HCPs
  • Brazil:
    • ABAC and other legal standards that need to be on your radar: Fostering ethics and integrity in the market/society amid public sales law
    • Interfarma and ABIMED: Regional codes of ethics
  • Colombia:
    • Specific laws and requirements: SAGRILAFT and Business Transparency and Ethics Program (PTEE), Colombian legal regulations
    • ANDI HCP codes of ethics and transparency

5:45
Close of Day One

Day 2 - Friday, May 10, 2024

8:45
Opening Remarks from the Co-Chairs

Claudius O. Sokenu
Executive Vice President, Chief Legal and Compliance Officer, Corporate Secretary
Avantor

Natasha Trifun
Executive Director, Head of Compliance, R&D, Global Medical, External Funding and Global Functions
Alexion Pharmaceuticals

9:00
New International Life Science Anti-Corruption Compliance Considerations: Measuring and Testing Top-Down Effectiveness and Individual/Corporate Transparency of Compliance Controls

Ash Aggarwal
Principal
Global Commercial Compliance IQVIA (UK)

Ciara Farrell
Vice President, Associate General Counsel and Global Head of Ethics and Compliance
ICON Plc (Ireland)

Nicole Willms
Partner
Pohlmann & Company (Germany)

Amid increased global enforcement postures and compliance program standards, it is critical that multinational life sciences companies ensure that their programs are pressure-tested (and re-tested) toward mitigating individual/corporate liability risks and strengthening corporate culture.

  • Global anticorruption enforcement efforts and comparisons to the FCPA:
    • The UK Economic Crime and Corporate Transparency Act
    • EU Anti-Corruption Directive
  • The interplay of GDPR with anti-corruption compliance efforts
  • Assessing compliance controls in an era of remote and hybrid work
  • Where do global anti-corruption efforts intersect with data privacy compliance requirements?
  • How to evaluate your training and controls by means other than audits
  • Ensuring that your program is aligned on paper and in practice

10:00
Third Party Management: Monitoring Distributors, Sub-Distributors, Sub-Dealers and Sales Agents

Michael Pacella
Vice President, Chief Ethics and Compliance Officer
Dentsply Sirona

Drew Northern
Vice President, Chief Ethics and Compliance Officer
Cook Group Inc. and Cook Medical

Matt Couillard
Vice President, Product Development
TDI

The tools required for effective third-party management for life sciences companies continue to change. Added to this is the reality that certain jurisdictions present unique, heightened risks and obstacles to tailoring your program to each specific context. This session will allow candid discussion and life-science-specific benchmarking around third-party risks and evolving compliance and geopolitical realities.

  • Updating best practices for a risk-based program tailored to a specific country/region
  • Strengthening contractual agreements with distributors and sub-distributors
  • When and how much to train distributors and sub-distributors
  • Strengthening your due diligence with tier one and tier two distributors and resellers and contractual risk flagging process and procedures
  • How to vet distributor past-history around prior accusations, improper affiliations, and the strength of their own compliance programs
  • On the ground obstacles to monitoring third party conduct, including distribution and sub-distribution networks
  • Knowing how far down the supply chain to go: When to stop
  • Concrete examples of addressing resistance to follow-up questions after an initial questionnaire

11:00
Networking Break
11:15
Cross-Border Data Privacy & Cyber Breaches: False Claims Act (FCA) Liability, Cyber Breach Security and China’s New PIPL Measures-and the Interplay with Anti-Corruption

Gina Nese
Vice President, Associate General Counsel Compliance and Privacy Officer
Align Technology

Marcus A. Asner
Partner
Arnold & Porter

With the vast amounts of data stored on servers and in the cloud, and the ever-increasing sophistication of threat actors, life science organizations must contend with a complex multinational regime of data protection laws. The sheer number of them — and the differences in definitions, standards and exceptions between them — presents a challenge for an organization when a data breach occurs.

  • Complying with the GDPR’s breach notification obligations
  • US: Navigating a handful of federal laws, including breach notification provisions
  • UK Data Protection Act
  • Brazil’s data protection regime (LGPD)
  • Navigating China’s 2023 update of its Personal Information Protection Law (PIPL)
  • DOJ’s Civil Cyber Fraud Initiative: Using the FCA to enforce cyber requirements
  • Cyber breach security and prevention, particularly for medical device companies:
    • Reviewing remote access protocols
    • Segmenting data into different networks
    • Understanding ransomware demands and reporting

12:00
Life Science M&A/Joint Venture Due Diligence Best-Practices: High-Stakes Decision-Making Around DOJ’s Safe Harbor Policy, Dealmaking Compliance, Privacy, and Post-Transaction Protocols

Dan Spicehandler
Vice President, Compliance - Commercial Divisions
Stryker

Natasha Trifun
Executive Director, Head of Compliance, R&D, Global Medical, External Funding and Global Functions
Alexion Pharmaceuticals

Joshua Drew
Partner
Miller & Chevalier Chartered

  • DOJ’s M&A Safe Harbor Policy: Steps to take when you discover FCPA violations
  • The benefits and practicalities behind self-disclosure:
    • Specific requirements as to the timing of disclosure and remediation
    • Remediation and restitution: Potential criminal exposure at the target company
    • What constitutes a “reasonableness analysis?”
    • Misconduct discovered during “bona fide, arms-length M&A transactions”
  • Spinoff mergers:
    • Assessing the scope of risk relative to whole company acquisitions » Allocating assets and liabilities between the parties
    • Third party and regulatory consents

1:00
Networking Lunch
2:15
The Grey Areas of G&E, Donations, Sponsorship and Hospitality in High-Risk Markets: What Companies are Now Doing to Strengthen Risk Monitoring Around Compliant HCP Relations

Jason Cofield
Vice President & Compliance Officer
Foundation Medicine

Andrew Cliver
Head of Compliance, North America
Siemens Healthineers

Tatiana Martins
Partner
Davis Polk & Wardwell LLP

Topics will include:

  • When donations can cross the FCPA line
  • Responding to scrutiny over improper influence of healthcare providers through travel, gifts, entertainment — particularly in sponsorship of educational meetings and conferences
  • When it is appropriate to retain a foreign healthcare provider for advisory services and compensate for their time
  • Virtual calls, mobile app meetings and their associated compliance risks, as well as the value of engaging HCPs on the virtual stage
  • Using HCPs as social media influencers
  • Sending HCPs to industry conferences
  • What level of due diligence is now required before outreach to an HCP?
  • How companies are operationalizing controls around HCP conflicts of interest

3:15
Clinical Trials: The Latest on Managing Unique, Evolving Bribery Risk Factors for Sponsors and CROs

Michael T. Henry
Director, Compliance Counsel
Ionis Pharmaceuticals

Brian Kowalski
Partner
Latham & Watkins

  • Ensuring partners in global clinical trials are developing processes to determine the legitimacy of and need for clinical trials
  • What CROs are doing to prevent improper payments, and reduce bribery risks when interacting with government officials, and seeking clinical trial and marketing approvals
  • Sponsor obligations to assess and monitor CRO anti-corruption compliance: How much due diligence and oversight can be done while remaining at arm’s length during the clinical trial
  • Effective monitoring and auditing plans for foreign clinical trials
  • Mitigating bribery risks when engaging local doctors

4:00
Networking Break
4:15
WeChat, WhatsApp and the Continuing Ephemeral Messaging Dilemmas: Updating Your Policies on Messaging, Retention Systems, Privacy and Recordkeeping

Terri Segura
Vice President, Global Compliance Investigations
Zimmer Biomet

Jennifer L. Chunias
Partner
Goodwin Procter

Martine M. Beamon
Partner
Davis Polk & Wardell LLP

How are life sciences companies reviewing ephemeral business communications policies and procedures, as well as emerging privacy, security, and employment law scrutiny? Don’t miss this critically important session as we discuss:

  • The new expectations for retaining business records and correspondence
  • Use of emojis as an emerging messaging risk: Corporate malfeasance and cross-cultural complications
  • Data privacy issues that can affect compliance with DOJ data retention policies
  • How the life sciences industry is updating messaging app policies, procedures, and monitoring
  • When to restrict or prohibit the use of messaging apps to company-owned
  • The three biggest ephemeral messaging dilemmas for life sciences: » Mitigating WeChat messaging and document sharing and retention risks when operating in China
    • Reviewing data privacy policies and regulations: Ensuring that all business communications can be reviewed in high-risk jurisdictions like China, Latin America, and India
    • Implementing internal investigations

5:00
Emerging Market Entry and Investigations

Maria Villanueva Sessions
Vice President, Compliance Officer, and Head of HR
Ra Medical Systems

Kunal Gupta
Partner
Trilegal (India)

  • The corruption landscape in key emerging markets, including recent headlines and scandals
  • China’s new laws and regulations aimed at both bribe payors and recipients
  • India’s slew of legislative and regulatory developments impacting compliance requirements and investigative procedures
  • Africa’s anti-corruption enforcement trends and how they are threatened by an uptick in political transitions
  • The importance of including key contractual provisions and audit rights and mechanisms

5:45
Conference Concludes

Workshop A — How to Handle Whistleblower Complaints from A to Z: A Complete Guide Amid a Spike in FCPA-Related Complaints

May 8, 2024 9:00am – 12:30 PM

Patrick Murphy
Senior Vice President and Global Head of Litigation and Investigations
Fresenius

Katy Choo
Group Vice President, Chief Anti-Corruption Counsel, Chief Investigative Counsel
General Electric

Rina Vazirani
Associate General Counsel & Senior Director
Gilead Sciences

What is it about?

Life science multinationals have experienced a recent surge in whistleblowing activity. This session will delve into the latest legal changes and enforcement trends, and give you the tools you need to revisit existing whistleblower policies and make sure they fit new legal requirements coming into force across the EU and U.S.

Topics will include:

  • Trends and specific challenges related to FCPA-related whistleblower complaints
  • Step-by-action plan for handling the complaint, interviews and litigation risk
  • Whistleblowers that continue to bring False Claims Act actions against life sciences companies, particularly those that lack the fundamental controls necessary to comprise adequate healthcare fraud and abuse compliance programs
  • Asia Pacific-related whistleblower report trends: Meeting confidentiality obligations and local law requirements
  • Whistleblower risks when implementing reductions in the workforce
  • EU Whistleblower Protection Directive: Key Considerations for the Life Sciences Sector
    • Fostering internal, rather than external, reporting
    • Encouraging individuals to report centrally, while ensuring that the worker also has the option to report locally
    • Retaliation:
      • retaliations including “psychiatric or medical referrals”
      • continuing to monitor its relationship with a whistleblower and to keep records of management decisions

Workshop B — A Life Sciences Roadmap to Legal and Compliance in China: The Most Misunderstood Anti-Bribery, Trade, Blocking Statute, Data Security and Antitrust Requirements

May 8, 2024 1:30pm – 05:00 PM

Nathan Bush

Nathan Bush
Partner
DLA Piper

What is it about?

At this in-depth working group, you will benefit from a detailed review and assessment of critical changes affecting the legal and compliance landscape in China. Learn how life sciences companies are tailoring their compliance programs to the Chinese context and navigating known and unknown risk factors. In addition to speaker-prepared reference materials for your work, the workshop offers critical know-how for your business operations in China.

  • A view from the ground – the latest legal developments and the most critical or common compliance risks
  • Data protection and blocking statutes in China: Balancing these laws with DOJ and SEC expectations for FCPA compliance
  • Evolving enforcement priorities on anti-bribery, penalty trends and key takeaways from local and international cases
  • Status and key takeaways from recent sanctions cases — and practical tips for monitoring potential legislation and new sanctions targets
  • How multinationals are evolving their programs in response to global trade tensions
  • Revisiting gift, entertainment, hospitality and sponsorship policies
    • Navigating the interplay of business and compliance pressures