Day 1 - Monday, June 18, 2018

8:00
Registration Begins and Light Refreshments
8:45
Conference Co-Chairs’ Opening Remarks
9:00
The DOJ’s New Corporate Enforcement Policy: An Analysis of Initial Impacts, Results and How Life Sciences Companies Should Assess Risk
10:00
Coffee & Networking Break
10:15

DEMO PANEL

How to Build a Best-in-Class HCP Tool that Mitigates the Biggest Corruption Risk
11:00

INNOVATION CASE STUDY

From Reactive to Proactive: Practical Steps Life Sciences Companies Can Take to Assess, Mitigate, and Remediate Compliance Risks
12:00
Networking Lunch
1:15

DEMO PANEL

Data Mining and Monitoring for FCPA Purposes: Where to Start, How to Identify Red Flags, Allocate Risk and Achieve Buy-In Across your Organization
2:15

DATA PRIVACY & CYBERSECURITY UNDER THE MICROSCOPE

The EU’s GDPR vis-à-vis China’s Cybersecurity Law: Strengthening Data Governance in the Big Data Era
3:00
Coffee & Networking Break
3:15

CASE STUDIES with AUDIENCE POLLING

How to Resolve Complex Challenges Around Gifts, Travel & Hospitality and Sponsorship & Congresses
4:15

CRO COMPLIANCE FOCUS

How CROs Can Mitigate the Greatest FCPA Risks with Products Testing, Touchpoints with Government Officials and Drug Approval Processes
5:00
Conference Adjourns

Day 2 - Tuesday, June 19, 2018

8:00
Light Refreshments
8:30
Conference Co-Chairs’ Remarks
8:35

FCPA & HCF UNIT TOWN HALL

An Assessment of the Enhanced Partnership Between the DOJ’s Healthcare Fraud Unit’s Corporate Strike Force and FCPA Prosecutors
9:30

THIRD PARTY CASE STUDIES with AUDIENCE POLLING

How to Achieve Operational Effectiveness in your Due Diligence and Audit Processes with Vendors and Distributors
10:30
Refreshment Break
10:45
How Smaller, Less Established, Innovative Life Sciences Companies Can Bring Products to Market While Mitigating Compliance Risks, and the Role of the Big Players
11:30

CHINA SPOTLIGHT

Why You Should Care About Revised Legislation on Commercial Bribery, the Newly Established National Supervision Commission, and New Policies on Drug and Medical Device Approval and Innovation
12:30
Networking Lunch
1:45

THINK TANK

Repeat Offenders: How to Mitigate the Risk of Recidivism with FCPA Compliance
2:30

LATIN AMERICA SPOTLIGHT with AUDIENCE POLLING

How to Minimize Risks in M&A Transactions that Involve “Tainted” Assets: Key Considerations from the Seller and Buyer Perspectives in Life Sciences
3:30
Refreshment Break
3:45

CONTEMPORARY CASE STUDY

How Domestic Healthcare Fraud Investigations Expand to Involve Overseas Operations and FCPA Issues
4:30

INNOVATION PANEL

E-Governance in the Life Sciences Sector: Mitigating Risks Inherent in Companies’ Relations with Government by Reducing Face-to-Face Interaction with Officials
5:00
Conference Concludes

Post-Conference Workshops

How Much Is Enough: Conducting Due Diligence Across Various Corporate Transactions – Focus on Vetting Potential Third Party Vendors, M&A Targets and JV Partners

Jun 20, 2018 9:00am – 12:30pm

Speakers

Michelle J. Shapiro
Partner
Dentons (New York, NY)

Mary Shirley
Senior Director, Ethics and Compliance
Fresenius Medical Care North America (Waltham, MA)

How to Mitigate the Corruption Risks of Entering and Operating in High Risk Markets: Life Sciences-Specific Illustrations of Best Practices and Where Companies Have Gone Wrong

Jun 20, 2018 1:30pm – 5:00pm

Speakers

David King
Global Compliance Organization
Merck (New York, NY)

Nate Lankford
Member
Miller & Chevalier Chartered (Washington, DC)

Day 1 - Monday, June 18, 2018

8:00
Registration Begins and Light Refreshments
8:45
Conference Co-Chairs’ Opening Remarks

Ilana Shulman
Chief Compliance Offic
Hill-Rom, Inc. (Chicago, IL)

Guy Singer
Partner
Orrick, Herrington & Sutcliffe LLP (Washington, DC)

9:00
The DOJ’s New Corporate Enforcement Policy: An Analysis of Initial Impacts, Results and How Life Sciences Companies Should Assess Risk

Patrick Stokes
Partner
Gibson, Dunn & Crutcher LLP (Washington, DC)

Angela Burgess
Partner
Davis Polk & Wardwell LLP (New York, NY)

Brian E. Kowalski
Partner
Latham & Watkins (Washington, DC)

  • How the implications of voluntary self-disclosure have changed in the wake of the new policy
  • How the new corporate enforcement policy is factoring into companies’ decisions on whether or not to self-disclose
  • How companies are evaluating the presumption of declination
  • The enhanced value of cooperation
  • The importance of individual vs. corporate accountability
  • What impact the new corporate enforcement policy could have on potential whistleblowers’ motivation to step forward with an allegation
  • The FCPA guidance’s practical meaning of “aggravating circumstances”
  • The importance and meaning of “recidivism”
    • Eligibility for declination in the case of a previous offense
    • When a previous investigation didn’t result in a penalty but a DPA, declination or other corporate integrity agreement with specific compliance conditions attached

10:00
Coffee & Networking Break
10:15

DEMO PANEL

How to Build a Best-in-Class HCP Tool that Mitigates the Biggest Corruption Risk

Ilana Shulman
Chief Compliance Offic
Hill-Rom, Inc. (Chicago, IL)

Peggy Wagner
Director, Compliance
Hill-Rom, Inc. (Chicago, IL)

This illustrative session will feature a live demonstration of an interactive, in-house-built HCP tool, followed by an in-depth discussion on how to tailor your HCP risk mitigation strategy to the needs of your company. Topics will include:  

  • Best practice illustrations and benchmarking for HCP risk mitigation across geographies and multiple languages
  • Anti-corruption considerations dealing with health care professionals who straddle the public and private sectors
  • Navigating the line between hospitality and bribes
  • Crafting appropriate guidelines for HCP interactions with physicians, pharmacists, hospitals and others
  • Examples of key violations and investigations involving interactions with HCPs
  • Mitigating the risks associated with government-employed HCPs

11:00

INNOVATION CASE STUDY

From Reactive to Proactive: Practical Steps Life Sciences Companies Can Take to Assess, Mitigate, and Remediate Compliance Risks

Christopher McClellan
Head of Compliance Assurance
Shire (Chicago, IL)

Stacey J. Hanna
General Counsel, Ethics & Compliance
Lonza (New York, NY)

Morgan J. Miller
Partner
Paul Hastings LLP (Washington, DC)

  • Improving “before-the-fact” in-house infrastructure:
    • Strengthening monitoring capability
    • Improving your program to increase efficiency in conducting investigations
    • Updating your investigation procedures to add root cause and prior opportunity analysis
  • How to conduct an initial risk assessment and continually identify where your company’s biggest risks lie, and what you can do to remediate them
  • Developing a playbook to identify risks in potential M&A targets

12:00
Networking Lunch
1:15

DEMO PANEL

Data Mining and Monitoring for FCPA Purposes: Where to Start, How to Identify Red Flags, Allocate Risk and Achieve Buy-In Across your Organization

Daniel Garen
Chief Ethics & Compliance Officer
Danaher Corporation (Washington, DC)

Jose Manuel Ayala
Program Director, Global Channel Compliance
Medtronic, plc. (St. Paul, MN)

As Life Science companies develop systems for managing their channel partners to address corruption risks – they are also gaining information on the go-to-market strategy. A well-refined tool can manage risk while still providing information to the commercial organization about how it can capture margins by going direct based on defined “tipping points.” We will providing models during this discussion that demonstrate how to provide an advanced view of how a system can provide critical controls while still delivering value to the business that is separate and distinct from a CRM or other sales tools currently deployed.

2:15

DATA PRIVACY & CYBERSECURITY UNDER THE MICROSCOPE

The EU’s GDPR vis-à-vis China’s Cybersecurity Law: Strengthening Data Governance in the Big Data Era

Dora Wang
Partner
Morgan, Lewis & Bockius LLP (Shanghai, China)

Livia Zamfiropol
Partner
DLA Piper (Romania)

This expert panel will juxtapose data privacy and cyber security in the EU and China – highlighting the specific impact on life sciences companies and the latest strategies for mitigating corruption risks. Topics examined will include:

  • How companies can respond to the proliferation of data privacy regimes and strengthen their cybersecurity efforts – Takeaways from compliance under China’s Cybersecurity Law
  • Navigating data localization and cross-border data transfer requirements: How to cooperate with foreign government investigations or conduct internal investigations without violating data privacy laws
  • Internal investigations pitfalls and strategies:
    • How to equip your company with the infrastructure to conduct an internal investigation involving data stored in China and the EU
    • How exporting data out of China may trigger liabilities under civil and criminal laws concerning data privacy and state secrets
    • How an employee’s common business travel through the US, China and the EU could turn into a tricky multijurisdictional data privacy issue
  • How to manage data from clinical trials containing highly protected important and personal data under China’s data privacy laws

3:00
Coffee & Networking Break
3:15

CASE STUDIES with AUDIENCE POLLING

How to Resolve Complex Challenges Around Gifts, Travel & Hospitality and Sponsorship & Congresses

Daniel J. Moynihan
Global Compliance Officer - Life Science
MilliporeSigma, A business of Merck KGaA

Ryan Rohlfsen
Partner
Ropes & Gray LLP (Chicago, IL)

Expert speakers will impart best practices and practical tools via an interactive review of the most common transactions that pose significant corruption risks. This is your chance to not only delve into real-life cases, but to also cast your vote and benchmark with your peers.  

  • The company sends an employee on a business trip to attend a conference in Germany. While at the conference, the employee runs into a board member of a state-owned entity that regularly contracts the company. The board member invites the employee for a round of golf that afternoon. The official leaves her wallet in the car, so the employee pays for the golf outing for both of them. What should the employee have done?
  • The company’s local subsidiary is due a 7-figure refund of VAT for sales in Hungary. The official in charge of signing off on the refund asks for a donation to a local charitable organization from your company’s tax advisor not otherwise required by local law. What should the local managing director do?
  • The company is planning to expand its business into China. The company engages a local consultant to assist with the registration process. The local consultant says he can expedite approval. He requests an abovemarket monthly retainer, reimbursement for the registration fees, and an additional 15% fee upon approval of the registrations within the specified time period. Are there any red flags?
  • The Managing Director for Asia Pacific requests approval from Compliance to hold a major regional customer meeting in Singapore. The dates coincide with the Singapore Grand Prix. The hotel prices during the Grand Prix are much higher than the rest of the year.

4:15

CRO COMPLIANCE FOCUS

How CROs Can Mitigate the Greatest FCPA Risks with Products Testing, Touchpoints with Government Officials and Drug Approval Processes

Sandy Ostrowski
Senior Director of Ethics and Compliance
IQVIA (Raleigh, NC)

Adriana Davies
Senior Compliance Director MITG
Medtronic. Minimally Invasive Therapies Group (North Haven, CT)

  • Sponsor obligations to assess and monitor CRO anticorruption compliance: How much due diligence and oversight can be done while remaining at arm’s length during the clinical trial
  • To what extent can a sponsor rely on the CRO’s compliance program vs. conduct due diligence and monitoring
  • Bribery risks facing CROs and others in the supply chain
  • What CROs are doing to prevent improper payments, and reduce bribery risks when interacting with government officials, and  seeking clinical trial and marketing approvals
  • The elements of effective CRO policies and anti-corruption compliance program
  • Reducing the risk of derivative FCPA liability due to CRO non-compliance

5:00
Conference Adjourns

Day 2 - Tuesday, June 19, 2018

8:00
Light Refreshments
8:30
Conference Co-Chairs’ Remarks
8:35

FCPA & HCF UNIT TOWN HALL

An Assessment of the Enhanced Partnership Between the DOJ’s Healthcare Fraud Unit’s Corporate Strike Force and FCPA Prosecutors

Daniel Kahn
Chief, FCPA Unit
U.S. Department of Justice Fraud Section, Criminal Division

Joseph Beemsterboer
Chief, Healthcare Fraud Unit
U.S. Department of Justice Fraud Section, Criminal Division

Hank Bond Walther
Partner
Jones Day (Washington, DC)

Announced in July 2017, a formalized partnership between the DOJ’s Health Care Fraud Unit’s Corporate Strike Force and its FCPA Unit affirms the DOJ’s focus on the life sciences industry. This prosecutor town hall will expound the partnership between the two Units, assess any modifications in their approach to enforcement, and highlight how this announced collaboration enhances enforcement capabilities. Don’t miss this opportunity to hear about why life sciences outfits are taking steps to manage continued scrutiny of their business operations – both domestically and internationally – with regard to FCPA and anti-corruption compliance.

9:30

THIRD PARTY CASE STUDIES with AUDIENCE POLLING

How to Achieve Operational Effectiveness in your Due Diligence and Audit Processes with Vendors and Distributors

Lisa Estrada
Chief Compliance Officer
Fresenius Medical Care (New York, NY)

Jill Dailey
Vice President and Chief Compliance Officer
Incyte Inc. (New York, NY)

Gary F. Giampetruzzi
Partner
Paul Hastings LLP (New York, NY)

  • Best practices for managing international distributor and vendor networks with limited financial and personnel resources
  • Best practices for evaluating your third party risks to adequately rank and prioritize them
  • Striking the right balance with due diligence: How much is “too much” and how much is “sufficient”
  • How to decide whether to keep the due diligence process in-house or outsource to local law firms or other service providers
  • Implementing adequate audit controls along your chain of distributors and sub-distributors
  • How to make sure your distributors have adequate compliance controls in place
  • What to do if a third party refuses to share data for privacy and/or proprietary reasons
  • Considerations for third party employees in positions most exposed to compliance risks (e.g., finance, IT and data, cyber security, business development, sales, clinical research)

10:30
Refreshment Break
10:45
How Smaller, Less Established, Innovative Life Sciences Companies Can Bring Products to Market While Mitigating Compliance Risks, and the Role of the Big Players

Matt Wetzel
Vice President & Assistant General Counsel
AdvaMed (Washington, DC)

Arivee N. Vargas
Director, Office of Business Integrity and Ethics
Vertex Pharmaceuticals, Inc. (Boston, MA)

  • The basic building blocks: Practical examples of small companies undertaking early-stage R&D and life sciences work
    • How to bring your product(s) to market and mitigate “early-stage” risks
    • How to reconcile startups’ desire to remain attractive to potential buyers with anticorruption requirements
  • How to guard against “growing too fast” and allocating resources appropriately while meeting investors’ expectations
  • Examples of various sources of funding for smaller, innovative companies (such as venture capital) and how they might impact compliance
  • How the “big players” can assist smaller life sciences outfits: Discovery of new drugs, medical device innovations, adoption of novel technologies, acquisition appetite, etc.

11:30

CHINA SPOTLIGHT

Why You Should Care About Revised Legislation on Commercial Bribery, the Newly Established National Supervision Commission, and New Policies on Drug and Medical Device Approval and Innovation

Kevin M. Ryan
Senior Director, Ethics & Compliance
Novo Nordisk (New York, NY)

Bingna Guo
Partner
O'Melveny & Myers LLP (Beijing, China)

Jianwei (Jerry) Fang
Partner
Zhong Lun Law Firm (Beijing, China)

  • Revision of the country’s Anti-Unfair Competition Law and recent enforcement cases: Interpreting the likely impact on the enforcement of commercial bribery (B2B)
  • Implications of China’s National Supervision Law and the establishment of the National Supervision Commission
  • What this new legislation means for the retention and detainment of individuals suspected of corruption
  • How the legislation will affect life sciences companies that have significant interaction with state-owned entities such as hospitals and healthcare providers
  • The practical implications of the recently issued and implemented:
    • “Innovation Opinion” (“Opinion on Deepening the Reform of the Regulatory Approval System to Encourage Innovation in Drugs and Medical Devices”)
    • “Imported Drug Decision” (“Decision to Adjust Relevant Items concerning Imported Drug Registration”)
  • How medical device makers can expect to be affected by the “Technical Guidelines For Accepting Foreign Clinical Trial Data For Medical Devices”
  • How and why companies must make sure they have the “right” person in place to interact with and respond to government questions

12:30
Networking Lunch
1:45

THINK TANK

Repeat Offenders: How to Mitigate the Risk of Recidivism with FCPA Compliance

Joshua Foster
Vice President, Global Compliance Operations
Zimmer Biomet (Hicksville, NY)

Guy Singer
Partner
Orrick, Herrington & Sutcliffe LLP (Washington, DC)

  • Juxtaposing the Zimmer and Orthofix cases: A practical discussion of similarities and differences in how the authorities and companies handled the respective matters:
    • Resolutions
    • Monitorship
    • Discovery of additional improper conduct
  • Viewing recidivism in the context of the DOJ’s new FCPA guidance/corporate enforcement policy
  • Discussion on how the DOJ and SEC view and assess a repeat FCPA breach
  • Best practices from those who have been subject to repeat enforcement
  • A second wave of DPAs and FCPA settlements: How recent repeat enforcement action has differed from past DOJ and SEC practices
  • Whether regulators are less inclined to consider a declination for repeat offenders
  • A deep dive into whether the SEC and DOJ are moving from a joint and/or parallel investigation and enforcement model to separate ones
  • How companies can internally handle an investigation the second time around

2:30

LATIN AMERICA SPOTLIGHT with AUDIENCE POLLING

How to Minimize Risks in M&A Transactions that Involve “Tainted” Assets: Key Considerations from the Seller and Buyer Perspectives in Life Sciences

Salim Jorge Saud Neto
Partner
Saud Advogados (Rio de Janeiro, Brazil)

  • How to assess the opportunities and challenges created by asset sales of companies that have been or are involved in an anti-corruption compliance breach and/or under investigation
  • Priorities of risk minimization – a question of perspective: The view from the CCO’s office and the law firm’s office
  • How to dissect the M&A transaction into its individual stages and components to allow for the weighing of risks: due diligence, financing, corporate culture
  • Successor liability: What Brazilian law stipulates about what makes a company compliant in an M&A deal
  • M&A in the context of a leniency agreement, and how a draft law to decrease liability as part of a leniency agreement could boost M&A activity
  • Post-leniency deals: Buying a company or a company’s asset that has settled a compliance breach with a leniency agreement
  • Assessing the statute of limitations regarding successor liability: Deciding whether to put the deal on hold for a specific time
  • How to evaluate your anti-corruption risk when buying an entire company versus acquiring part of a company’s business operations
  • The seller’s perspective: How to make your company or an asset within your company attractive to potential buyers, and how this differs depending on the buyer’s origin and main jurisdiction of business operations

3:30
Refreshment Break
3:45

CONTEMPORARY CASE STUDY

How Domestic Healthcare Fraud Investigations Expand to Involve Overseas Operations and FCPA Issues

Gerard Leeman
Regional Compliance Officer, Americas
MilliporeSigma, EMD Performance Materials (Boston, MA)

Gary DiBianco
Partner
Skadden, Arps, Slate, Meagher & Flom LLP (Washington, DC)

  • Practical lessons from domestic fraud investigations that have evolved into multijurisdictional investigations
  • How cooperation between the DOJ Healthcare Fraud Unit and FCPA Unit will affect compliance programs and defense of government investigations
  • Likely areas of current focus by U.S. regulators, including marketing practices, R&D, funding, and sponsoring.

4:30

INNOVATION PANEL

E-Governance in the Life Sciences Sector: Mitigating Risks Inherent in Companies’ Relations with Government by Reducing Face-to-Face Interaction with Officials

Leah Lorber
Assistant General Counsel, Dispute Resolution and Prevention, Legal Central Functions
GlaxoSmithKline plc (Washington, DC)

Megan Gordon
Partner
Clifford Chance US LLP (Washington, DC)

E-government solutions can play a significant role in alleviating corruption risks by reducing the time spent face-to-face with government officials. This is especially pertinent and promising for the life sciences sector where – in many countries across the globe – touchpoints with government officials are inevitable when doing business. The panel will address:  

  • The relation between the use of e-governance and reduction in corruption risks
  • How e-governance can mitigate other bribery risks:
    • Facilitating tendering and procurement processes (e-tendering and e-procurement)
    • At the border: Trade and customs duties processes
    • Product (drug, device) approval and registration
  • How private industry and life sciences companies can take steps in order to make use of technologies made available by governments
  • Making the business case: How to get topexecutive buy-in and promote the benefits of using e-governance tools made available by governments
  • When not to use government technology
  • How blockchain technology (as adoptedby some governments to fight bribery) can mitigate corruption risks for companies

5:00
Conference Concludes

How Much Is Enough: Conducting Due Diligence Across Various Corporate Transactions – Focus on Vetting Potential Third Party Vendors, M&A Targets and JV Partners

Jun 20, 2018 9:00am – 12:30pm

Michelle J. Shapiro
Partner
Dentons (New York, NY)

Mary Shirley
Senior Director, Ethics and Compliance
Fresenius Medical Care North America (Waltham, MA)

What is it about?

This practical deep dive has been tailored to address the complex challenges of conducting due diligence across three of the most common scenarios: Third Parties, JV and M&A. Take part in this intensive, peer-to-peer discussion to find resolution to practical scenarios, identify tips and pitfalls, and best practices for minimizing risk exposure for your company. A small group setting will provide a unique opportunity to benchmark best practices with others who share the same or similar challenges.  
  • How to implement a risk-based approach to vetting new third parties
  • How to devise a coherent transaction road map to hit the ground running
  • How to solve the most common third party due diligence risks and pitfalls
  • Tools to successfully uncover potential relationships with government officials during your due diligence process
  • Determining if, how and what third party due diligence should be outsourced based on risks
  • What to do if your due diligence reveals that a proposed third party vendor, prospective joint-venture partner or M&A target does not share your anti-corruption commitment
  • How to conduct due diligence on uncooperative third parties
  • What type of due diligence findings will enforcement agencies expect you to have in your files?

How to Mitigate the Corruption Risks of Entering and Operating in High Risk Markets: Life Sciences-Specific Illustrations of Best Practices and Where Companies Have Gone Wrong

Jun 20, 2018 1:30pm – 5:00pm

David King
Global Compliance Organization
Merck (New York, NY)

Nate Lankford
Member
Miller & Chevalier Chartered (Washington, DC)

What is it about?

(Registration begins at 1:00 pm)   The corruption pitfalls in high risk markets are elusive and manifold, with rising local enforcement heightening the stakes. The biggest questions typically revolve around how the requirements differ from one country, jurisdiction or regulatory body to the next. By way of practical examples from the life sciences industry, this expert workshop will delve into real-life cases where companies have encountered and overcome highly complex, unique challenges of operating in high risk markets.  
  • How to effectively tailor your compliance program to high risk markets, while ensuring appropriate baseline standards globally
  • How multi-jurisdictional anti-corruption prosecution and enforcement have become the “new normal”
  • How to run a profitable business without falling afoul of local legislation in high risk markets
  • How to strengthen HQ oversight of local teams in high risk markets
  • How to address data privacy challenges in implementing compliance processes and conducting investigations in high risk markets
  • Effective strategies on how to stay abreast of anti-corruption legislation developments ex-USA
  • How to manage visits from local enforcement authorities (a/k/a “dawn raids”)
  • Unique challenges related to entrenched local pharmaceutical distributors
  • How to make local anti-corruption legislation work in your company’s favor, such as receiving credit or leniency for having a corporate anti-corruption program in the event of a compliance breach
  • How to develop a corporate training and communication strategy for your global workforce working in high risk markets “without scaring them” about potential penalties of non-compliance