Day 1 - Tuesday, January 31, 2017

7:30
Registration and Continental Breakfast
8:15
Co- Chairs Opening Remarks
8:30
Compliance Needs Assessment Strategies: Using Objective Criteria to Evaluate Subjective Needs
9:30
Building and Structuring a Compliance Infrastructure for Life Sciences Companies: Legalities and Ethics
10:30
Morning Coffee Break
10:45
Government Enforcement Trends that Dictate Compliance Protocols: Understanding How the False Claims Act and Anti- Kickback Laws Have Shaped Life Sciences Compliance Programs
11:45
Aggregate Spend Laws and Related Legislation Concerning Interactions with Health Care Professionals and Their Impact on Compliance
12:45
Networking Lunch
2:00
Understanding the Importance of cGMP and Quality Systems Compliance in an Era of Heightened FDA Enforcement
2:45
Life Sciences Advertising and Promotion and Social Media Usage Compliance 1.0
3:45
Afternoon Refreshment Break
4:00
Life Sciences Advertising and Promotion and Social Media Usage Compliance 2.0 – Exploring the Dangers of Off Label Use
5:00
Key Privacy Considerations for Any Life Sciences Compliance Program
5:45
Conference Adjourns to Day Two

Day 2 - Wednesday, February 1, 2017

7:30
Registration and Continental Breakfast
8:15
Chair’s Opening Remarks
8:30
Medical Affairs: Understanding Its Role in Your Compliance Program
9:30
Morning Coffee Break
9:45
Managing Compliance Risks in Clinical Trials and R&D
10:45
Using Audits and Risk Evaluation to Assess the State of Your Compliance Program
11:30
Price Reporting and Reimbursement Compliance
12:30
Conference Ends
12:45
Networking Luncheon (for Workshop B Attendees Only)

Day 1 - Tuesday, January 31, 2017

7:30
Registration and Continental Breakfast
8:15
Co- Chairs Opening Remarks

Angelique Lee-Rowley
US General Counsel and Compliance Officer
GW Pharmaceuticals (Carlsbad, CA)

Geoffrey M. Levitt
Senior Vice President & Associate General Counsel Regulatory, Environmental and Global Supply
Pfizer (New York, NY)

Michael Parini
Executive Vice President and Chief Legal Officer
Vertex Pharmaceuticals (Boston, MA)

8:30
Compliance Needs Assessment Strategies: Using Objective Criteria to Evaluate Subjective Needs

Karen S. Lovitch
Leader, Health Law Practice
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. (Washington, D.C.)

Maria Villanueva Sessions
Latin America Compliance
Zimmer Biomet (Miami, FL)

  • Knowing when it is time to start thinking about a compliance program infrastructure
    • identifying triggers
  • Formulating a work plan for creating a compliance program infrastructure
    • selecting a chief compliance officer
    • creating a compliance committee
    • establishing a reporting structure
    • defining Board of Directors oversight and responsibility
    • allocating resources
  • Developing and implementing an “effective” compliance program
    • identifying key risk areas based on product portfolio, sales model, payor x, co-promotion activity, distribution model and other considerations
    • creating training programs
    • implementing policies and procedures
    • establishing an auditing and monitoring program
    • creating a disclosure program
    • designing an investigation protocol and corrective action process

9:30
Building and Structuring a Compliance Infrastructure for Life Sciences Companies: Legalities and Ethics

Wendy Goldstein
Partner
Cooley LLP (New York, NY)

Kari K. Loeser
Senior Corporate Counsel & Senior Director
Jazz Pharmaceuticals (Palo Alto, CA)

Peter Brensilver
Vice President, Assistant General Counsel, and Chief Compliance Counsel for Pfizer Essential Health
Pfizer (New York, NY)

  • Identifying the seven key elements of a compliance program under the Federal Sentencing Guidelines
    • establish standards and procedures to prevent and detect criminal conduct and promote an organizational culture of compliance
    • appointment of a compliance officer
    • criminal activity and leadership positions
    • training
    • auditing
    • provide incentives for good conduct, punish non-compliant conduct
    • appropriate response to criminal conduct
  • Learning to use these elements to design a flexible and global program that can adapt to corporate growth
    • tailoring objective elements to fit subjective corporate needs
    • learning to think of compliance in global terms – i.e., integral and comprehensive as well as potentially international
  • Collaborating with existing departments and corporate functions to establish compliance structure and get necessary “buy-in”
    • importance of top brass taking ownership of compliance program
  • Examining compliance program implementation vis-a-vis existing company structure
    • which person/department is the best choice to start a compliance program?
  • Legal?
  • HR?
  • Appointment of a compliance officer in small to mid to sized company
    • understanding why this may be the most critical component of a compliance program
  • review of compliance officer provisions in recent CIAs
    • reporting structure for compliance
  • to whom should the compliance officer report?
    • Board of Directors? Legal?
  • and to whom should the CO never report?
  • Where should the compliance department ultimately be placed?
    • can compliance objectives/duties be shared among various departments?
  • separation of departmental duties and implementation of safe guards
  • Dotted line reporting responsibilities
  • compliance liaisons
  • Why compliance should be separate from legal?

10:30
Morning Coffee Break
10:45
Government Enforcement Trends that Dictate Compliance Protocols: Understanding How the False Claims Act and Anti- Kickback Laws Have Shaped Life Sciences Compliance Programs

Katherine Lauer
Partner
Latham & Watkins LLP (San Diego, CA)

Kathleen McDermott
Partner
Morgan Lewis & Bockius LLP (Washington, D.C.)

  • Overview of the federal False Claims Act and state federal anti-kickback laws as they apply to the life sciences industries
    • safe harbors
  • How actions brought under these laws against life sciences companies have used “real world” applications of the Codes and Guidance to prove violations?
  • Exploring the evolution of enforcement actions from sales and marketing violations to medical affairs deviations
  • Reviewing circumstance in which corporate executives and employees have been indicted in addition to the company
    • The Yates Memo
  • Exploring settlements and Corporate Integrity Agreements (CIAs)
    • understanding the terms of CIAs and what compliance lessons can be gleaned from them
  • Predictions for future enforcement trends
    • pricing and reimbursement?
  • Implementing best practices through compliance protocols to avoid situations giving rise to violations

11:45
Aggregate Spend Laws and Related Legislation Concerning Interactions with Health Care Professionals and Their Impact on Compliance

Jenny Alonso
General Counsel and Compliance Officer
Prometheus Laboratories Inc. (San Diego, CA)

David L. Kirman
Partner
O’Melveny and Myers LLP (Los Angeles, CA)

Sheva J. Sanders
Partner
Stinson Leonard Street LLP (Minneapolis, MN)

  • Overview of existing state aggregate spend laws, i.e., Physician Payment Sunshine laws and the importance of developing compliance protocols to fit their requirements
  • Identifying required disclosures under these laws
  • Review of carve outs and exceptions
  • Learning from previous reporting cycles
  • Mitigating exposure to government enforcement and liability stemming from transparency
  • Developing compliance protocols that account for Sunshine and state requirements
  • Proactively using Sunshine data for internal auditing and monitoring and internal investigations

12:45
Networking Lunch
2:00
Understanding the Importance of cGMP and Quality Systems Compliance in an Era of Heightened FDA Enforcement

Demme Doufekias
Partner
Morrison & Foerster LLP (Washington, D.C.)

Seth Mailhot
Partner
Michael Best & Friedrich LLP (Washington, DC)

  • Identifying essential elements of cGMP and quality systems compliance and incorporating them into your global compliance program
  • What departments should be involved to coordinate in the development of a proactive and effective quality system?
    • what is the role of compliance in this implementation?
  • Examining the FDA’s approach to quality systems in light of new agency enforcement initiatives
    • what does the agency expect?
    • what must you now do to demonstrate compliance during an inspection?

2:45
Life Sciences Advertising and Promotion and Social Media Usage Compliance 1.0

Micheline Awad
Director, Regulatory Affairs – Advertising & Promotion
Neurocrine Biosciences, Inc. (San Diego, CA)

Paul M. Kirsch
Vice President, Regulatory Affairs
Iroko Pharmaceuticals, LLC (Philadelphia, PA)

Peter O. Safir
Senior Counsel
Covington & Burling (Washington, D.C.)

Karen Weaver
Chief Counsel - Regulatory
Becton Dickinson & Co. (Franklin Lakes, NJ)

  • Overview of the Office of Prescription Drug Promotion (OPDP), Advertising and Promotional Labeling Branch (APLB) & Office of Compliance – duties, responsibilities, and enforcement authority
  • Identifying the role of the FTC in the advertising and promotion of drugs
  • Exploring advertising requirements for prescription versus non-prescription products
  • Overview of the promotional materials submission and review process
  • Dissecting the FDA’s draft guidances on promoting a drug or a medical device on Internet/Social Media platforms
  • Devising response strategies to third-party misinformation about a drug or a medical device posted on a Social Media platform
    • Considerations for how to respond to third-parties and what type of information to include in a response
  • Examining mobile apps for the life sciences industry
  • Analyzing the factors that may lead you to not use social media to promote a product
  • How does a drug or device company’s Internet or social media presence impact its responsibility to monitor adverse events?
  • Reviewing examples of social media practices: ways to navigate social media platforms

3:45
Afternoon Refreshment Break
4:00
Life Sciences Advertising and Promotion and Social Media Usage Compliance 2.0 – Exploring the Dangers of Off Label Use

Angelique Lee-Rowley
US General Counsel and Compliance Officer
GW Pharmaceuticals (Carlsbad, CA)

Geoffrey M. Levitt
Senior Vice President & Associate General Counsel Regulatory, Environmental and Global Supply
Pfizer (New York, NY)

Saul Perloff
Partner
Norton Rose Fulbright US LL (San Antonio, TX)

  • Defining off-label promotion in light of recent First Amendment case law
  • Exploring the role of the label in advertising and the perils of off-label promotion
  • Labeling, promotional labeling and advertising: how it works
    • Risk management
    • Timing
  • FDA compliance and non-compliance: what you can and cannot say
  • Employing FDA guidance on use of the internet and social media
  • Science and Medical Developments: What happens to labeling when new science is published or an interpreter reinterprets a critical study?
    • What must you do?
    • What can you say?

5:00
Key Privacy Considerations for Any Life Sciences Compliance Program

Daniel A. Cody
Partner
Jones Day (San Francisco, CA)

Marilyn A. Moberg
Partner
Reed Smith LLP (Los Angeles, CA)

  • Applying HIPAA and HITECH protocols to pharmaceutical, biotechnology and device companies
  • HIPAA Privacy Rule compliance
    • identifying the essential elements of HIPAA privacy compliance and incorporating them into your global compliance plan
  • HIPPA Security Rule compliance
    • essential elements, required
    • documentation and risk analysis
  • Examining business associate requirements

5:45
Conference Adjourns to Day Two

Day 2 - Wednesday, February 1, 2017

7:30
Registration and Continental Breakfast
8:15
Chair’s Opening Remarks

Angelique Lee-Rowley
US General Counsel and Compliance Officer
GW Pharmaceuticals (Carlsbad, CA)

Geoffrey M. Levitt
Senior Vice President & Associate General Counsel Regulatory, Environmental and Global Supply
Pfizer (New York, NY)

Michael Parini
Executive Vice President and Chief Legal Officer
Vertex Pharmaceuticals (Boston, MA)

8:30
Medical Affairs: Understanding Its Role in Your Compliance Program

Retta Riordan
President
Riordan Compliance LLC (Apex, NC)

Ashley Watson
Senior Vice President, Deputy General Counsel and Chief Ethics & Compliance Officer
Hewlett-Packard Company

  • Defining medical affairs within the purview of the Codes and Guidance
  • Understanding the importance of medical affairs compliance to your overall global compliance program
  • Reviewing critical changes in the PhRMA Code 2008 relative to medical affairs compliance
    • CME
    • grants
    • promotional materials
  • How pharmacovigilance and adverse events reporting under FDAAA should be factored into your compliance program
  • How medical affairs has become a hot bed of compliance enforcement actions
  • Exploring the proper relationship between sales and marketing and medical affairs
  • Developing guidelines for post-marketing studies
  • Examining off-label use concerns
    • guidelines for off-label communications
    • role of MSLs in these communications
  • Advisory board protocols

9:30
Morning Coffee Break
9:45
Managing Compliance Risks in Clinical Trials and R&D

Masha Chestukhin
Partner
Arnold & Porter LLP (Washington, D.C.)

Daniel Kracov
Partner
Arnold & Porter LLP (Washington, D.C.)

  • How to develop a comprehensive compliance program relative to clinical trials and R&D
  • Compliance considerations for:
    • subjects
    • investigators
    • sites
    • CROs and other vendors
    • financing
  • Clinical trials registration and results requirements under FDAAA
  • Review of PhRMA’s Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results
    • clinical trial registries
    • summaries of all clinical-trial results
    • ghostwriting prohibitions
    • disclosure of financial conflicts of interest

10:45
Using Audits and Risk Evaluation to Assess the State of Your Compliance Program

Bryant Aaron
Vice President and Chief Compliance Officer
Novartis (East Hanover, NJ)

Loren H. Brown
Partner
DLA Piper (New York, NY)

  • Using risk management principles to develop a meaningful and effective compliance audit program for your compliance department
  • Improving existing audit program through the incorporation of innovative risk management techniques
  • Assessing the proper roles of inside and outside auditors
  • Analyzing audit results: how to develop strategies for managing and minimizing identified risks
  • Safeguarding against unforeseen, undefined risks

11:30
Price Reporting and Reimbursement Compliance

Stephanie Trunk
Partner
Arent Fox LLP (Washington, D.C.)

Judith Waltz
Partner
Foley & Lardner LLP (San Francisco, CA)

  • Compliance guidelines for participating in Medicare, Medicaid, VA and DoD programs
  • Price reporting authorities, programs and vocabulary
    • CMS
  • Medicaid
    • Best Price: AMP
  • Medicare: Parts B and D
    • ASP
    • ASP + 6
    • CAP
    • WAMP
    • VA/ DOD
  • GSA, FSS
  • Special pricing and reimbursement compliance concerns for devices
  • Devising price reporting strategy assessments
  • When and how should companies best communicate changes in price reporting methodologies to appropriate authorities
  • Red flags that regulators and enforcers look at when investigating price reporting fraud and abuse?
  • How to best involve your compliance department in price and reporting and reimbursement matters

12:30
Conference Ends
12:45
Networking Luncheon (for Workshop B Attendees Only)