Agenda
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Day 1
May 9, 2024
FIRESIDE CHAT
DOJ and SEC Enforcement in the Life Sciences Context: From Ephemeral Messaging, FEPA, Self-Disclosure, Clawbacks, M&A, Whistleblowers and More
Derek EttingerAssistant Chief, FCPA Unit, Fraud Section, Criminal DivisionU.S. Department of Justice
Charles CainChief, FCPA UnitU.S. Securities and Exchange Commission
Ryan RohlfsenPartnerRopes & Gray LLPFormer Senior Trial Attorney, Criminal Division, U.S. Department of Justice
NEW DOJ/OIG COMPLIANCE BEST PRACTICES
Putting Protocols into Action: Key Differences, Potential Pitfalls, and New Implementation Hurdles
Gwen ChapmanChief Compliance OfficerIllumina, Inc.
Mason HubbardSenior Anti-Corruption CounselGilead Sciences
Margaret PriceVice President, Chief Compliance OfficerAtricure
Gene IngogliaPartnerA&O Shearman
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?
Networking Break
China Hypotheticals
The Anti-Corruption Crackdown in China and Nightmare Scenarios: How Companies Are Now Approaching High Stakes, Intensifying Legal and Compliance Risks
Adam YoffieExecutive Director, Head of C&E Investigations and Integrity LineBristol Myers Squibb
Former Trial Attorney, Criminal Division
U.S. Department of Justice
Lamia MattaGlobal Head of Investigations3M Healthcare
Susanne M. HancharAssociate Vice President – Global Ethics and Compliance, Anti-Corruption & InvestigationsEli Lilly and Company
Yuet ThamParterSidley Austin (Hong Kong)
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?
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 SpicehandlerVice President, Compliance - Commercial DivisionsStryker
Natasha TrifunExecutive Director, Head of Compliance, R&D, Global Medical, External Funding and Global FunctionsAlexion Pharmaceuticals
Joshua DrewPartner 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
Networking Lunch
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 LanninManager, Insights and AnalyticsTakeda
Corey DunbarPartner, Data Forensics Practice LeaderBDO
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
Compensation Clawbacks in the Life Sciences Context : The Latest on Resolving Compliance Dilemmas, Implementation Challenges and Conflicts with International Employment Law
Christina O. HudSenior Compliance Counsel, Global InvestigationsPfizer, Inc.Former Acting Chief & Senior Trial Counsel, Health Care Fraud Unit U.S. Department of Justice
Adam FalkowitzHead of Legal, North AmericaGetinge
Tatiana MartinsPartnerDavis Polk & Wardwell LLP
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?
Networking Break
Mara SennExecutive Global Compliance LeaderGE 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
Challenges for Latin America and the Life Sciences Industry: Market Entry Due Diligence for Public/Private Ventures
Liana CunhaCompliance Director, Latin AmericaThermo Fisher Scientific (Brazil)
Sergio PintoSenior Director, Regional Sector LeadJohnson & Johnson (Brazil)
Esther FleschPartnerMiguel Neto Advogados (Brazil)
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
Close of Day One
Day 2
May 10, 2024
New International Life Science Anti-Corruption Compliance Considerations: Measuring and Testing Top-Down Effectiveness and Individual/Corporate Transparency of Compliance Controls
Ash AggarwalPrincipal, Global Commercial ComplianceIQVIA (UK)
Ciara FarrellVice President, Associate General Counsel and Global Head of Ethics and ComplianceICON Plc (Ireland)
Nicole WillmsPartnerPohlmann & Company (Germany)
Leon C. G. LiuPartner, Head of Government Enforcement and InvestigationsJunHe LLP (China)
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
Michael PacellaVice President, Chief Ethics and Compliance OfficerDentsply Sirona
Drew NorthernVice President, Chief Ethics and Compliance OfficerCook Group Inc. and Cook Medical
Matt CouillardVice President, Product DevelopmentTDI
Jonathan StevensPartnerPaul Hastings, LLP
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
Networking Break
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 NeseVice President, Associate General Counsel Compliance and Privacy OfficerAlign Technology
Marcus A. AsnerPartnerArnold & Porter
Ericka WatsonFounderData Strategy Advisors
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
Voluntary Disclosures: Understanding “Prompt Reporting”, Cooperation Credit, Remediation and When to Engage Outside Counsel
David LastPartnerCleary GottliebFormer Chief, FCPA Unit, Fraud Section, Criminal Division U.S. Department of Justice
Daniel GroomsPartnerCooley LLPFormer Assistant United States Attorney and Criminal Chief U.S. Department of Justice
Claudius O. SokenuExecutive Vice President, Chief Legal and Compliance Officer, Corporate SecretaryAvantor
Jay HoltmeierPartnerWilmerHale
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
Networking Lunch
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
Andrew CliverHead of Compliance, North AmericaSiemens Healthineers
Brian KowalskiPartnerLatham & Watkins
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
Olivia RadinPartnerKing & Spalding LLP
Rina VaziraniAssociate General Counsel & Senior Director Gilead Sciences
- 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
Networking Break
WeChat, WhatsApp and the Continuing Ephemeral Messaging Dilemmas: Updating Your Policies on Messaging, Retention Systems, Privacy and Recordkeeping
Terri SeguraVice President, Compliance Officer, AmericasZimmer Biomet
Jennifer L. ChuniasPartnerGoodwin Procter
Martine M. BeamonPartnerDavis 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
Maria Villanueva SessionsDirector, Ethics & ComplianceBioTissue
Juan Luis FuentesDirector, Healthcare Compliance, Government Affairs & PolicyJohnson & Johnson
Angela MainSenior Vice President, Global Chief Compliance Officer & Associate General Counsel, Asia PacificZimmer Biomet (USA)
- 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