6th Annual Pharmaceutical Counsel's Guide to Off-Label Communications

Wednesday, July 15, 2009

About

DON'T BE THE NEXT TARGET OF OFF-LABEL PROMOTION CLAIMS!

Designed specifically to address the needs of in-house counsel and senior executives in the pharmaceutical industry, t his annual event will provide you with the most up-to-date tools for tackling the latest legal and regulatory developments. You will hear about successful compliance plans, effective business practices, and winning litigation tactics from leading in-house counsel, compliance and regulatory officers, and expert attorneys who represent the pharmaceutical industry.

Off-label promotion is one the biggest current triggers of government scrutiny in the pharmaceutical industry. Being aware of the current case law and guidelines that regulate and govern off-label communications is the bare minimum you must do. To manage such communications with confidence and mitigate potential liability, you must implement and monitor proper compliance and training programs and be ready to defend against any investigation or claim.

Contents & Contributors

About

DON'T BE THE NEXT TARGET OF OFF-LABEL PROMOTION CLAIMS!

Designed specifically to address the needs of in-house counsel and senior executives in the pharmaceutical industry, t his annual event will provide you with the most up-to-date tools for tackling the latest legal and regulatory developments. You will hear about successful compliance plans, effective business practices, and winning litigation tactics from leading in-house counsel, compliance and regulatory officers, and expert attorneys who represent the pharmaceutical industry.

Off-label promotion is one the biggest current triggers of government scrutiny in the pharmaceutical industry. Being aware of the current case law and guidelines that regulate and govern off-label communications is the bare minimum you must do. To manage such communications with confidence and mitigate potential liability, you must implement and monitor proper compliance and training programs and be ready to defend against any investigation or claim.

Contents & Contributors

Dissecting Recent Billion Dollar Off-Label Settlements
Mark J. Wanda, Senior Vice President, Legal Affairs andDeputy General Counsel, Sepracor Inc. (Marlborough, MA)
Arnold I. Friede, Counsel, McDermott Will & Emery (Washington, DC)
Christopher R. Hall, Partner, Saul Ewing LLP (Philadelphia, PA)
Peter S. Spivack, Partner, Hogan & Hartson LLP (Washington, DC)

Ensuring Compliance with the New FDA Guidance on Journal Reprints
Ann K. Rosen, Assistant General Counsel, Glaxo Smith Kline (Research Triangle Park, NC)
Mary Sullivan, Director, Advertising and Promotion, Drug Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. (Ridgefield, CT)

Enforcers’ Panel: Identifying Enforcement Trends
Joseph Trautwein, Assistant U.S. Attorney, District of Eastern Pennsylvania (Philadelphia, PA)

Retooling Your Compliance Program in the Wake of Recent Massive Settlements
Mitzi G. Cole, Division Counsel, Wyeth (Collegeville, PA)
Julie Kane, Vice President, Ethics and Compliance, Novartis Pharmaceuticals Corporation (East Hanover, N.J.)
Roger W. Louis, Senior VP, Healthcare and Regulatory Counsel and Chief Compliance Officer, Genzyme Corporation (Cambridge, MA)
Jennifer Bragg, Partner, King & Spalding LLP (Washington, DC)

Minimizing the Risk of the Sales Force Crossing the Line
Raymond J. Furey, Compliance Officer, OSI Pharmaceuticals (Melville, NY)
Abhi Gandhi, Commercial Compliance, Actelion Pharmaceuticals US (South San Francisco, CA)
Erik W. Snapp, Partner, Winston & Strawn LLP (Chicago, IL)

Effectively Using Multiple Communication Channels While Controlling Off-Label Risks

Debra S. Dunne, Partner, Stradley Ronon Stevens & Young, LLP (Philadelphia, PA)
Jennifer De Camara, Senior Counsel, Johnson & Johnson (New Brunswick, NJ)

Properly Framing the Role of MSLs to Avoid Promotional Pitfalls
Sheila Komara, Sr. Medical Science Liaison, Global Medical Affairs, Hospira, Inc. (Lake Forest, IL)
Curt Oltmans, Deputy General Counsel, Novo Nordisk Inc. (Princeton, NJ)

Knowing What to Do When You Receive a Subpoena: Responding Effectively to Off-Label Investigations and Qui Tam Suits
Laurence J. Freedman, Partner, Patton Boggs LLP (Washington, DC)
Daniel R. Margolis, Partner, Pillsbury Winthrop Shaw Pittman LLP (New York, NY)
Ina B. Scher, Partner, Davis & Gilbert LLP (New York, NY)

Assessing and Managing Risks in Product Liability Cases Based on Off-Label Uses
Atiba D. Adams, Assistant General Counsel, Pfizer Inc. (New York, NY)
Loren Brown, Partner, DLA Piper (New York, NY)
Mark C. Levy, Partner, Saul Ewing LLP (Philadelphia, PA)

Due Diligence: Uncovering Off-Label Red Flags When Engaging in M&A
Erik Eglite, D.P.M., J.D., Vice President, Chief Corporate Compliance Officer and Corporate Counsel,Ovation Pharmaceuticals, Inc. (Deerfield, IL)
Stephen Paul Mahinka, Partner, Morgan, Lewis & Bockius LLP (Washington, DC)

Minimizing Purchaser/Consumer Fraud Class Action Off-Label Liabilities
Mark S. Cheffo, Partner, Skadden Arps Slate Meagher & Flom LLP (New York, NY)
Judy L. Leone, Partner, Dechert LLP (Philadelphia, PA)
Allen P. Waxman, Partner, Kaye Scholer LLP (New York, NY)



DOCUMENT TYPES: PPT PDF PPTX PPTM PRESENTATIONS AVAILABLE: 19

8:00
Registration and Continental Breakfast
9:00
Chairs' Opening Remarks
Ms. Mitzi G. Cole
Division Counsel
Wyeth Pharmaceuticals
Mr. Stuart Kim
Senior Regulatory Counsel‚ Pharmaceuticals
Covidien PLC
Dr. Mark I. Levy
Medical Director, Assistant Clinical Professor Psychiatry
UCSF
9:15
Dissecting Recent Billion Dollar Off-Label Settlements
Mark J. Wanda
Deputy General Counsel-Regulatory
Astellas US LLC
Arnold I. Friede, Esq.
Principal
Arnold I. Friede and Associates
1 file
How State Attorneys General Are Reshaping Pharmaceutical Marketing and Compliance
1.1 MB 8 pages Presentation
PPT - How State Attorneys General Are Reshaping Pharmaceutical Marketing and Compliance
Mr. Christopher R. Hall
Partner
Saul Ewing LLP (Philadelphia, PA)
Peter S. Spivack
Partner
Hogan Lovells US LLP
1 file
Dissecting Recent Billion Dollar Off-Label Settlements
1.3 MB 21 pages Presentation
PPT - Dissecting Recent Billion Dollar Off-Label Settlements
10:15
Morning Coffee Break
10:30
Ensuring Compliance with the New FDA Guidance on Journal Reprints
Ms. Ann K. Rosen
Assistant General Counsel
GlaxosmithKline
Ms. Mary Sullivan
Director of Ads and Promotions‚ Drug Regulatory Affairs
Boehringer-Ingelheim Pharmaceuticals‚ Inc.
1 file
Ensuring Compliance with the New FDA Guidance on Journal Reprints
517 KB 31 pages Presentation
PPT - Ensuring Compliance with the New FDA Guidance on Journal Reprints
11:15
Enforcers' Panel: Identifying Enforcement Trends
Mr. Randy S. Chartash
Chief‚ Economic Crime Section
United States Attorneys Office‚ Northern District of Georgia
Mr. Daniel R. Miller
Attorney
Berger & Montague‚ P.C.
Mr. Jeffrey Senger
Deputy Chief Counsel
Food and Drug Administration
Mr. Joseph Trautwein
Assistant U.S. Attorney
Office of the U.S. Attorney for the Eastern District of Pennsylvania
3 files
Settlement Agreement
1.2 MB 35 pages Presentation
PDF - Settlement Agreement
CORPORATE INTEGRITY AGREEMENT
3.4 MB 67 pages Presentation
PDF - CORPORATE INTEGRITY AGREEMENT
GOVERNMENT'S MEMORANDUM FOR ENTRY OF PLEA AND SENTENCING
2.5 MB 65 pages Presentation
PDF - GOVERNMENT'S MEMORANDUM FOR ENTRY OF PLEA AND SENTENCING
Holly Pierson

Pierson LLC
Moderator:Mr. Thomas M. Gallagher
Partner
Pepper Hamilton LLP
12:30
Networking Luncheon for Speakers and Delegates
13:45
Retooling Your Compliance Program in the Wake of Recent Massive Settlements
Ms. Mitzi G. Cole
Division Counsel
Wyeth Pharmaceuticals
Ms. Julie Kane
Vice President‚ Ethics & Compliance
Novartis Pharmaceuticals Corporation
Mr. Roger W. Louis
Senior VP‚ Healthcare and Regulatory Counsel‚ and Chief Compliance Officer
Genzyme Corporation
Ms. Jennifer Bragg
Partner
King & Spalding LLP
1 file
Retooling Your Compliance Program in the Wake of Recent Massive Settlements
53 KB 22 pages Presentation
PPT - Retooling Your Compliance Program in the Wake of Recent Massive Settlements
15:00
Afternoon Coffee Break
15:15
Minimizing the Risk of the Sales Force Crossing the Line
Mr. Raymond J. Furey
Compliance Officer
OSI Pharmaceuticals
Mr. Abhi Gandhi
Commercial Compliance
Actelion Pharmaceuticals US
Mr. Erik W. Snapp
Partner
Winston & Strawn LLP
1 file
Minimizing the Risk of the Sales Force Crossing the Line
493 KB 32 pages Presentation
PPT - Minimizing the Risk of the Sales Force Crossing the Line
16:15
Effectively Using Multiple Communication Channels While Controlling Off-Label Risks
Debra S. Dunne, R.Ph., Esq.
Partner
Shook, Hardy & Bacon LLP
1 file
Effectively Using Multiple Communication Channels
213 KB 23 pages Presentation
PPT - Effectively Using Multiple Communication Channels
Jennifer M. De Camara
Assistant General Counsel
Johnson & Johnson (Titusville, NJ)
1 file
Effectively Using Multiple Communication Channels While Controlling Off-Label Risks
271.5 KB 20 pages Presentation
PPT - Effectively Using Multiple Communication Channels While Controlling Off-Label Risks
17:00
Conference Adjourns
8:00
Continental Breakfast
8:45
Co-Chairs' Opening Remarks
9:00
Properly Framing the Role of MSLs to Avoid Promotional Pitfalls
Ms. Sheila Komara
Sr. Medical Science Liaison‚ Global Medical Affairs
Hospira‚ Inc.
1 file
Properly Framing the Role of MSLs to Avoid Promotional Pitfalls
291 KB 17 pages Presentation
PPT - Properly Framing the Role of MSLs to Avoid Promotional Pitfalls
Mr. Curt Oltmans
Deputy General Counsel
Novonordisk
1 file
Framing Role of MSLs to Acoid Promotional Pitfalls
252 KB 10 pages Presentation
PPT - Framing Role of MSLs to Acoid Promotional Pitfalls
9:45
Morning Coffee Break
10:00
Knowing What to Do When You Receive a Subpoena: Responding Effectively to Off-Label Investigations and Qui Tam Suits
Mr. Laurence J. Freedman
Partner
Patton Boggs LLP
Mr. Daniel R. Margolis
Partner
Pillsbury Winthrop Shaw Pittman LLP
Ms. Ina B. Scher
Partner
Davis & Gilbert LLP
1 file
Responding Effectively to Off-Label Investigations and Qui Tam Suits
671.5 KB 14 pages Presentation
PPT - Responding Effectively to Off-Label Investigations and Qui Tam Suits
11:00
Assessing and Managing Risks in Product Liability Cases Based on Off-Label Uses
Mr. Atiba D. Adams
Assistant General Counsel
Pfizer Inc.
Loren H. Brown
Partner and Co-Chair, US Litigation Group
DLA Piper
Dr. Mark I. Levy
Medical Director, Assistant Clinical Professor Psychiatry
UCSF
1 file
ASSESSING AND MANAGING RISKS IN PRODUCT LIABILITY CASES BASED ON OFF-LABEL USE
283.3 KB 65 pages Presentation
PPTX - ASSESSING AND MANAGING RISKS IN PRODUCT LIABILITY CASES BASED ON OFF-LABEL USE
12:00
Networking Luncheon for Speakers and Delegates
13:15
Due Diligence: Uncovering Off-Label Red Flags When Engaging in M&A
Mr. Erik Eglite
V.P.‚ Chief Compliance Officer & Corporate Counsel
Lundbeck Inc.
1 file
Due Diligence-Uncovering Off-Label Red Flags
110.8 KB 21 pages Presentation
PPTM - Due Diligence-Uncovering Off-Label Red Flags
Mr. Stephen Paul Mahinka
Partner
Morgan‚ Lewis & Bockius LLP
1 file
Detecting Off-Label Promotion Issues That Can Derail a Life Sciences M&A
614.5 KB 27 pages Presentation
PPT - Detecting Off-Label Promotion Issues That Can Derail a Life Sciences M&A
14:00
Minimizing Purchaser/Consumer Fraud Class Action Off-Label Liabilities
Mark S. Cheffo
Partner
Skadden‚ Arps‚ Slate‚ Meagher & Flom LLP
1 file
Recent Developments in Off-Label Promotion Litigation
143 KB 12 pages Presentation
PPT - Recent Developments in Off-Label Promotion Litigation
Ms. Judy L. Leone
Partner
Dechert LLP
1 file
DISCOVERY ISSUES IN OFF-LABEL LITIGATION
163 KB 15 pages Presentation
PPT - DISCOVERY ISSUES IN OFF-LABEL LITIGATION
Mr. Allen P. Waxman
Partner
Kaye Scholer LLP
1 file
Minimizing Purchaser/Consumer Fraud Class Action Off-Label Liabilities
816 KB 12 pages Presentation
PPT - Minimizing Purchaser/Consumer Fraud Class Action Off-Label Liabilities
15:00
Conference Concludes