Day 1 - Wednesday, March 9, 2016

8:00
Registration and Continental Breakfast
9:00
Co-Chairs’ Welcoming Remarks and Introduction of Keynote Speaker
9:30
Keynote Address — Lessons Learned from the Most Recent Investigations, How to Modify Corporate Practices to Not Run Afoul of New Enforcement Priorities and Identifying Current Areas of Concern
10:00
AMARIN and PACIRA: What will They Mean for First Amendment Defenses to Allegations of Off-Label Promotion and FCA Claims for both Pharma and Medical Device Companies?
11:15
Morning Refreshment Break
11:30
Economics and Regulatory Shifts Abroad: Keeping Up with Industry Changes in a Global Marketplace
12:30
Networking Lunch
1:45
U.S. Attorney’s Office Roundtable: The Enforcers Speak
3:15
Afternoon Refreshment Break
3:30
Individual Accountability for Corporate Wrongdoing: The Ripple Effect of DAG Yates September Memo and Enforcement that Follows
4:45
Social Media: Marketing Gold Mine or Compliance Minefield?
5:30
Conference Adjourns to Day 2

Day 2 - Thursday, March 10, 2016

8:30
Registration and Continental Breakfast
9:00
Co-Chairs’ Welcoming Remarks
9:15
In-House Roundtable on Commercial Trends in Pharma: A Conversation on Where the Industry is Now and Preparing for Where it’s Going
10:30
Morning Refreshment Break
10:45
The Federal Anti-Kickback Statute and the Sales and Marketing of Drugs in Today’s Healthcare Environment
12:00
Preapproval Activities and Early Commercialization Planning: Establishing Ethical Parameters Between Commercial and R&D
1:00
Conference Adjourns
2:00
Interactive Working Group On Upgrading Your Pharmaceutical Compliance Program
5:00
Workshop Adjourns

Day 1 - Wednesday, March 9, 2016

8:00
Registration and Continental Breakfast
9:00
Co-Chairs’ Welcoming Remarks and Introduction of Keynote Speaker

Holly Pierson
Owner, Managing Partner
Pierson Law LLC

Peter Etienne
Senior Counsel, Ethics & Compliance
Baxter International Inc.

Todd H. Halpern
Associate General Counsel, Regulatory Law
Pfizer Inc. (Madison, NJ)

9:30
Keynote Address — Lessons Learned from the Most Recent Investigations, How to Modify Corporate Practices to Not Run Afoul of New Enforcement Priorities and Identifying Current Areas of Concern

Carmen M. Ortiz
United States Attorney
District of Massachusetts (Boston, MA)

10:00
AMARIN and PACIRA: What will They Mean for First Amendment Defenses to Allegations of Off-Label Promotion and FCA Claims for both Pharma and Medical Device Companies?

David Ralston
Senior Director/Associate General Counsel Business Conduct
Gilead Sciences (Foster City, CA)

Ted L. Radway
Assistant United States Attorney
U.S. Attorney’s Office, District of Columbia

Kenneth M. Abell
Chief, Health Care Fraud, Civil Division
U.S. Attorney’s Office, Eastern District of New York

  • The jury’s still out: Preparing for the ripple effect of the Amarin decision without jumping the gun
    • Don’t pick the fruit before its ripe: What compliance protocols to adjust and more importantly when
    • Updating sales team training to capitalize on this window of opportunity without creating more risk as developments continue to unfold
  • Differential impact between sales teams and managed market teams
  • The pros and cons to preemptive litigation strikes against the FDA

11:15
Morning Refreshment Break
11:30
Economics and Regulatory Shifts Abroad: Keeping Up with Industry Changes in a Global Marketplace

Todd H. Halpern
Associate General Counsel, Regulatory Law
Pfizer Inc. (Madison, NJ)

Cheryl J. Scarboro
Partner
Simpson Thacher & Bartlett LLP (Washington, DC)

  • Battles between the FDA and foreign governments: With increasing scrutiny by the US government of overseas facilities and practices, is your compliance program prepared?
  • GMPs and inspections
    • Updating your GMPs to meet with changes in industry standards abroad
    • Lessons learned from India: Addressing inspection concerns overseas
  • Foreshadowing of the political and economic climate and the impact on enforcement priorities and how you conduct business
    • Preparing for a new administration here at home
    • China
    • Brazil
    • EU
  • Individual liability: Updates on what other nations share the DOJ’s focus on prosecuting individual culpability.
  • Changing international demands
    • Reimbursement
    • Clinical trials and data integrity
  • International Sales Teams: Addressing updates on Global Anti-Bribery mandates and FCPA standards with your overseas sales force

12:30
Networking Lunch
1:45
U.S. Attorney’s Office Roundtable: The Enforcers Speak

Marie Spencer
Special Assistant Attorney General, Medicaid Fraud Control Unit
New York State Office of the Attorney General

David S. Schumacher
Assistant United States Attorney
District of Massachusetts

Richard Hayes
Deputy Chief, Civil Division
U.S. Attorney’s Office, Eastern District of New York

Jacob T. Elberg
Chief, Health Care & Government Fraud Unit
U.S. Attorney's Office, District of New Jersey

Zachary Cunha
Assistant United States Attorney
District of Rhode Island (Providence, RI)

Kriss Basil
Assistant United States Attorney,
District of Massachusetts

Moderator:

Laura G. Hoey
Partner
Ropes & Gray, LLP (Chicago, IL)

DOJ announced it has no intentions on letting up on its pursuit of fraud and abuse in this industry, to the contrary, it has indicated civil and criminal prosecutions of individuals will be on the rise. With new government regulations and guidance for enforcement priorities, don’t miss this unique opportunity to hear directly from the enforcers as they share their insights and touch on:

  • Anti-Kickback priorities and the latest pitfalls
  • FCA: Enforcers perspectives on the qui tam bar now and recent cases
  • Shifts in negotiations and conditions of CIAs
  • The Sunshine Act and Open Payments and its impact on investigations

3:15
Afternoon Refreshment Break
3:30
Individual Accountability for Corporate Wrongdoing: The Ripple Effect of DAG Yates September Memo and Enforcement that Follows

Margaret Price
Corporate Compliance Director
Upsher-Smith

John Vagelatos
Chief, Affirmative Civil Enforcement, Civil Division
U.S. Attorney’s Office, Eastern District of New York

Adam J. Katz
Assistant United States Attorney Civil Health Care Fraud Coordinator
United States Attorney’s Office Northern District of New York

Laura M. Kidd Cordova
Assistant Chief, Criminal Division, Fraud Section
United States Department of Justice

  • The Yates Memorandum and Individual Accountability
    • Main points and directives
    • Takeaways and their practical implications
  • What do “extraordinary circumstances” include when it comes to corporate resolutions providing individual protections or immunity
  • What are the DOJ’s gravest concerns and investigation triggers for individual culpability
  • Recent developments in enforcement: Cases and lessons learned thus far
  • What should this mean for your compliance program
    • What documentation is the DOJ looking for and do you currently record it?
    • Measures taken to prepare more vulnerable individuals in your organization
    • Upgrading protocols to detect fraud and abuse that could seemingly implicate those who in reality lack knowledge or involvement
    • Checks and balances to safeguard oversight on all levels of the corporate hierarchy

4:45
Social Media: Marketing Gold Mine or Compliance Minefield?

Albert DaCosta
CEO
Paragon 28

Teresa Ford
Partner
Law Offices of Teresa Ford, PC

  • YouTube, Twitter, Instagram, Facebook, even Pinterest can be a tool, but which is the best platform for your audience?
    • What has worked and what hasn’t
    • Metrics to determine effectiveness: Are likes and reposts enough?
    • Practical measures to determining which avenue has the least risk for your pipeline or each product
    • Ignorance is not a defense: Understanding native advertising and its inherent risks
  • Celebrity Endorsement: Is exposure to 42.4 million followers and 450K likes worth the risk of a warning letter?
  • To respond or not respond: The pros and cons of ignoring negative comments and reviews
  • Doing business in the digital age: Realistic considerations to staying off the radar completely
    • Is that even an option today?
    • What does lack of digital presence say about your brand?
  • Best practices for addressing your sales force’s individual postings

5:30
Conference Adjourns to Day 2

Day 2 - Thursday, March 10, 2016

8:30
Registration and Continental Breakfast
9:00
Co-Chairs’ Welcoming Remarks

Holly Pierson
Owner, Managing Partner
Pierson Law LLC

Todd H. Halpern
Associate General Counsel, Regulatory Law
Pfizer Inc. (Madison, NJ)

9:15
In-House Roundtable on Commercial Trends in Pharma: A Conversation on Where the Industry is Now and Preparing for Where it’s Going

Paula Taylor Whitfield
Senior Director, Assistant General Counsel BioMedicines Business Unit
Eli Lilly & Co. Inc.

Kevin M. Ryan
Director, Compliance, New products
Novo Nordisk, Inc.

Jennifer Santos
Sr. Corporate Counsel
Vertex Pharmaceuticals (Boston, MA)

Moderator:

Michelle D. Axelrod
Principal
Porzio Bromberg & Newman P.C.

  • Reflecting on the biggest changes in how drug companies do business
    • Is it really a new era of sales and marketing?
    • Redefining the “customer” and customer interactions
    • Patient programs, advocacy and engagement
  • Multi-country product launches and the challenges of global marketing
  • Anti-kickback v. FCA enforcement in 2016 – What do we expect?
  • Lessons Learned: Do new approaches in business and issues raised by recent cases, enforcement actions and in the media require a new/different approach or a change in focus for Legal and/or Compliance? How should companies (big or small) dedicate their resources to adjust to the new commercial model?

10:30
Morning Refreshment Break
10:45
The Federal Anti-Kickback Statute and the Sales and Marketing of Drugs in Today’s Healthcare Environment

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

David Layfer
Senior Counsel, Commercial Legal
Abbvie

Richard S. Liner
Senior Counsel, Compliance and Investigations
Bayer HealthCare, LLC

Carol Ann Poindexter
Partner
Norton Rose Fulbright US LLP (Washington, DC)

With changes in provider budget’s and governmental expectations of quality of care and focus on health outcomes, dodging anti-kickback triggers is like walking through a minefield. Gain guidance from industry leaders on some of the pharmaceutical industries most concerning yet unavoidable facets of business.

  • Payments for Investigator-Initiated Studies and kickbacks in the form of referrals from manufacturers to providers
    • Specialty pharmacies
    • High referring physicians
  • Patient Support Programs: Guidelines for safer care while avoiding landmines
    • Reimbursement assistance
    • Nurse services
    • Patient Assistance Program/Free product
  • Lessons learned from this year’s biggest cases
    • Avoiding allegations of value outside of the agreement
    • Keeping an eye on consultants
    • Kickback or Rebate
      • How to structure rebate contracts to avoid Anti-Kickback violations
      • Negotiations tips for contracting with PBMs
  • Pricing and Formularies: Balancing coverage and risk

12:00
Preapproval Activities and Early Commercialization Planning: Establishing Ethical Parameters Between Commercial and R&D

Kirk Ogrosky
Partner
Arnold & Porter LLP

Deborah A. Logan
Senior Counsel, Branded Pharmaceuticals
Endo Pharmaceuticals Inc. (Malvern, PA)

  • Firewall between the scientific/medical and commercial (sales, marketing, promotional) business
    • Reasons for the firewall
    • Parameters of the firewall
      • Information sharing: data, results, publications, ISRs, medical grants, KOL relationships, preapproval labeling
        • What can be shared and when?
      • External sales reps, internal marketing, portfolio planning, corporate communications
    • Being mindful of potential enforcement challenges to such partnerships
  • How crucial insights from Commercial during early stages of R&D
    • The value of knowing what is important to patients, physicians and payers
    • Aligning cross-functional collaborations
      • Selling each silo on their connection and benefit to the outcome
      • Who else needs to be at the table to ensure across the board appreciation of the bigger picture

1:00
Conference Adjourns
2:00
Interactive Working Group On Upgrading Your Pharmaceutical Compliance Program

Emily R. Schulman
Partner
WilmerHale (Boston, MA)

Scott R. Grubman
Partner
Chilivis, Cochran, Larkins & Bever LLP (Atlanta, GA)

Peter Venaglia
Managing Partner
Schaeffer Venaglia Handler & Fitzsimmons, LLP (New York, NY)

Holly Pierson
Owner, Managing Partner
Pierson Law LLC

Building on the foundation of the main conference, sharpen your new tools with this interactive session of best practices for pharmaceutical organizations, both large and small. The pharmaceutical industry remains under fire with new regulatory demands; increased prosecution of individuals, ongoing global challenges; new, less-than-bright-line guidance from the government; and multi-million dollar settlements continuing to roll in. Take this rare opportunity to ask any unanswered questions on how the knowledge from earlier panels can be tailored to your company’s specific needs in this interactive forum focused on best practices and practical knowledge.

  • Preparing the C-Suite for increased prosecution of individuals in the pharmaceutical industry
    • Protocols to make sure the right internal decision maker(s) are involved
    • The danger of silos
      • Getting everyone in the same room: Who do you need around the table?
      • Crucial agenda topics that need to be shared from each department
      • Best practices to ensuring necessary protocol changes get approved and implemented before it’s too late
  • Updating your training programs to prepare your sales team and consultants for heightened individual prosecution
    • Best practices to assist your salesforce on how to remain compliant without stagnating their numbers
    • Creating checks and balances to oversee outside reps and consultants, domestically and abroad
  • RAMPs: Risk assessment and mitigation programs
    • Why more and more companies are implementing them outside of government oversight
    • Product by product v. companywide: Pros and cons
    • Benefits to RAMP v. RMP: Is there a downside to ongoing assessment?
  • Corporate Integrity Agreements: Considerations before signing, during oversight, and what to expect after reaching the finish line
    • The negotiation process: Strategies for give and take
    • Practical pre-execution steps
    • Protocols to ensure executive certifications are accurate
    • Life after government oversight: How to maintain that structure of compliance in your pharmaceutical organization
  • How small and medium size companies can adapt compliance protocols to fit their resources
    • Determining which areas of compliance require the most attention given your company’s specific pipeline
    • Prioritizing resources within a more modest compliance budget
  • M&A concerns for both large and small drug companies
    • Preparing for an opportunity: How having a well-established compliance programs in place can make you a better candidate to be acquired
    • After the ink dries: How to synchronize your culture of compliance with that of the newly acquired
  • The False Claims Act: Lessons learned from this year’s biggest prosecutions against pharmaceutical companies
  • Best practices for drafting contracts that satisfy your HCP’s needs while also protecting your interests
  • Conducting internal audits and ensuring confidentiality
  • HIPPA and global digital privacy: Best practices to remain in compliance and manage security risks
  • Considerations for expanding your pipeline to include medical or combination devices

2:00 p.m. – 5:00 p.m.
(Registration and Networking Lunch for Workshop Attendees Only at 1:15 p.m.)

5:00
Workshop Adjourns