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   Preconference Symposia (Optional; Choose one)
   Wednesday, October 21, 2015


PHARMA CONGRESS PRESENTATIONS
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7:30 a.m.



Congress Registration Opens










8:00 a.m.



Preconferences Commence (Choose one)




PRECONFERENCE I



REGULATORY CONCEPTS: BASIC PRINCIPLES




8:00 a.m.




Welcome and Overview

James Gibney
Senior Director of Compliance, Regeneron Pharmaceuticals; Former Director, Worldwide Programs and US Investigations - Corporate Compliance, Pfizer, Tarrytown, NY (Moderator)

    Speaker Bio

    Jim Gibney is Senior Director of Compliance. Jim and his team are responsible for leading efforts to enhance and manage all elements of an effective compliance program. Responsibilities include policy development, developing and delivering company-wide compliance training, Federal and State aggregate spend reporting, development and management of anti-bribery/anti-corruption program, executing a compliance communication strategy, and maintaining an internal monitoring program.

    Jim began his career at Pfizer in 1992 and has held various positions in sales, operations, and compliance.

    Jim served 9 years in the United States Naval Reserve and is a graduate of Rutgers University.










8:10 a.m.




INDs, NDAs and Drug Development

Natasha Leskovsek, RN, MPM, MBA, JD
Health Care and Life Sciences Regulatory Practice, Cooley, LLP, Washington DC

    Speaker Bio

    Natasha Leskovsek is an FDA regulatory partner in Cooley's Washington, DC office. Natasha advises regulated industry and its investors on strategic pathways to commercialization and pre- and postmarket compliance requirements. Prior to practicing law, Natasha worked as a clinical research nurse at NIH and in project management for a CRO. She received her J.D. from Georgetown University Law Center and BSN and MBA degrees from the University of Maryland. Natasha is a member of the Food and Drug Law Institute and the American Health Lawyers Association.
    Presentation Material (Acrobat)










8:40 a.m.




Scientific Exchange

Saul Helman, MD, MBA
Managing Director and Life Sciences Practice Leader, Navigant Consulting, Inc., Indianapolis, IN

    Speaker Bio

    Dr. Saul B. Helman has over two decades of healthcare and life sciences experience, both in management roles and consulting. Saul has significant international experience in healthcare, bio-pharmaceutical and medical device companies.

    Saul is a Managing Director at Navigant Consulting, Inc. and global practice leader for the Healthcare and Life Sciences Disputes, Regulatory, Compliance and Investigations practice, providing support in investigations, litigation, regulatory and compliance matters involving healthcare and life sciences companies. Applying his knowledge secured through working in international marketing and clinical development in industry, Saul has led projects involving expert witness testimony related to the life sciences industry, litigation support, cGMP and cGCP evaluations, regulatory support, compliance monitorships, compliance implementation and assessment and investigation support in both internal and external investigations, including off-label promotion, kick-backs, anti-bribery and anti-corruption.
    Presentation Material (Acrobat)










9:10 a.m.




Patient Safety: Pharmacovigilance and REMS

Dr. Seth B. Whitelaw
President and Chief Executive Officer, Whitelaw Compliance Group, LLC; Editor-in-Chief, Life Science Compliance Update, West Chester, PA

Presentation Material (Acrobat)










9:30 a.m.




Break







9:50 a.m.




Advertising and Promotion: HCPs and Consumers

Janet L. "Lucy" Rose, MBA
President, Lucy Rose and Associates, LLC; Former Director, DDMAC, FDA, Washington, DC

    Speaker Bio

    Ms. Rose is President of Lucy Rose and Associates, LLC, a life sciences regulatory consulting and training firm. For 12 years, she has consulted to, and provided training for, over 150 life sciences firms and their supporting companies. For 16 months during that period, Lucy served as the National Managing Director for Deloitte and Touche's Life Sciences Regulatory Practice.

    From 1995-97, Ms. Rose served as the Director of the Office of Training and Communications for the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration. There she designed and implemented programs to improve external communications with the pharmaceutical industry, health care professionals, and consumers.

    Ms. Rose led CDER's Division of Drug Marketing, Advertising and Communications (DDMAC) from 1993 to 1995. In this capacity, she was responsible for the regulatory oversight of all prescription drug advertising and marketing to U.S. health care professionals and consumers.










10:50 a.m.




Promotion to Payers and Government Price Reporting

John Shakow, Esq.
Partner, FDA and Life Sciences Practice, King & Spalding, Washington, DC

    Speaker Bio

    John Shakow, Partner, FDA & Life Sciences Practice Group, King & Spalding -- John Shakow is a nationally-recognized expert in all aspects of drug pricing and price reporting. He has counseled pharmaceutical and biotechnology clients on their rights and obligations under the Medicaid, Medicare, Federal Supply Schedule, 340B and TRICARE programs for almost twenty years. John regularly advises manufacturers on the spectrum of regulatory, commercial and litigation matters relating to pricing and government payor programs. He has extensive experience helping clients resolve commercial, strategic, organizational and other legal challenges while maintaining the integrity of their government pricing compliance efforts.
    Presentation Material (Acrobat)










11:30 a.m.




Preconference Adjournment; Lunch on your Own



PRECONFERENCE II



INNOVATIONS IN RISK ASSESSMENT, AUDITING AND MONITORING




8:00 a.m.




Welcome and Overview

David Stollman
Associate Director, Healthcare & Life Sciences Disputes, Regulatory, Compliance and Investigations, Navigant Consulting, Inc., Philadelphia, PA (Moderator)










8:10 a.m.




Incorporating Effective Record Reviews In Your Auditing & Monitoring Plan

Chris Castro, CCEP
Associate Director, Healthcare and Life Sciences Disputes, Regulatory, Compliance and Investigations, Navigant Consulting, Inc., Phoenix, AZ

    Speaker Bio

    Chris Castro is an Associate Director in Navigant's Healthcare & Life Sciences Disputes, Regulatory, Compliance, and Investigations practice. He has over a two decades of life sciences experience encompassing, sales as a representative and district manager, brand and field training, compliance and management and has served clients ranging from large Fortune 500 public companies to middle market privately held companies. Chris has provided support in investigations, litigation and compliance integration matters involving life sciences, device, and lab testing companies.
    Presentation Material (Acrobat)










8:50 a.m.




Enhancing Sales Performance through Field Based Monitoring

Kerry Clem
Senior Vice President, Sales, Acorda Therapeutics, Ardsley, NY

    Speaker Bio

    Kerry Clem has been the head of Sales at Acorda since January 2011. In his role, Mr. Clem is responsible for the Sales Force, Sales Training, Market Development, and Promotional Operations.

    Before joining Acorda, Mr. Clem was Vice President of Sales at Allos Therapeutics, Inc. where he built the organization's inaugural sales force to launch their first commercially available product. Mr. Clem also served as Vice President of Sales and Marketing at Solstice Neurosciences, Inc., which included overseeing the European commercial business. Mr. Clem has over 18 years of sales and marketing experience in the areas of neurology, oncology, movement disorders, cardiology, anesthesiology and pain. Over the span of his career he has been involved in the development of commercial organizations and multiple product launches.






Wendy Heckelman, PhD
President and Founder, WLH Consulting, Inc., Fort Lauderdale, FL

    Speaker Bio

    Dr. Wendy Heckelman leverages her twenty-five years of experience and expertise in compliance, cultural transformation, change management, and strategic implementation to address complex business performance challenges. She uses a rigorous and scientific lens to diagnose business performance issues, challenges, and opportunities for organizational effectiveness. Wendy leads a team of experienced consultants who develop clear recommendations and custom solutions for each client engagement.

    Dr. Heckelman has also patented a unique compliance process utilizing software to minimize once commonplace compliance errors. Her distinct approach has garnered a number of clients seeking to maximize the efforts of both their sales and compliance teams.
    Presentation Material (Acrobat)










9:30 a.m.




Break







9:45 a.m.




Getting Ahead of the Game -- Utilizing Data and Other Operational Indicators to Identify Potential Compliance Issues Early

Gary Keilty
Managing Director, FTI, Washington, DC

    Speaker Bio

    Gary Keilty is a Managing Director with FTI Consulting's National Health Solutions practice and is based in Washington, D.C. Gary has over twenty five years experience as a management consultant and specializes in providing financial, investigative, operational and industry expertise assistance to Life Sciences companies, healthcare providers and health law firms. Gary's areas of expertise includes assisting clients and their outside counsel during large government investigation and commercial litigation cases, assisting clients with regulatory compliance assessments and compliance program development and providing Independent Review Organization services.






Daniel L. Dovdavany, Esq.
Assistant General Counsel North America Litigation & Investigations, Sanofi US, Bridgewater, NJ

    Speaker Bio

    Dan DOVDAVANY is Assistant General Counsel, North America Litigation & Investigations, at Sanofi U.S. in Bridgewater, NJ. At Sanofi, Dan manages government investigations, qui tam litigation and health care compliance internal investigations. Prior to joining Sanofi, Dan worked at an international law firm representing health care companies in product liability, antitrust and commercial litigation. Dan graduated from the Benjamin N. Cardozo School of Law in 2000 and is admitted to the New York, New Jersey, District of Columbia and Massachusetts State Bars.
    Presentation Material (Acrobat)










10:30 a.m.




Building a Compliance Data Analytics Capability

Amy Pawloski, CPA, CCEP
Head of US Compliance & Ethics Monitoring and Data Analytics, Bristol-Myers Squibb, Plainsboro, NJ

    Speaker Bio

    Amy is the Head of U.S. Compliance & Ethics Monitoring & Data Analytics for Bristol-Myers Squibb Company (BMS). She has responsibility for overseeing BMS's U.S. compliance monitoring program and, most recently, has been appointed to lead the development of a data analytics program. Amy has been with BMS since 1999 and has held various analytical and strategic roles of increasing responsibility in finance, project management, pricing & reimbursement, and operations. Prior to her current role, she was the project manager responsible for the U.S. Pharmaceuticals' business implementation of the company's Corporate Integrity Agreement. Prior to joining BMS, Amy was a Manager in the Audit and Business Assurance practice as well as the Consulting practice at PricewaterhouseCoopers in Philadelphia. She received a BS, cum laude, from Villanova University School of Business. She was a CPA and is currently a certified Project Management Professional (PMP), Lean Six Sigma Green Belt, and Certified Compliance and Ethics Professional (CCEP).
    Presentation Material (Acrobat)










11:00 a.m.




Effective Field Monitoring Essentials to Consider when Working with Sales, Marketing and Medical Teams

Scot Steinheiser, CHC, CCEP
Managing Partner and Founder, Commercial Compliance Consulting, SCS Compliance Group LLC, Mundelein, IL

    Speaker Bio

    With over 30 years of life sciences experience, Scot leverages his training and award-winning sales background to partner and facilitate key compliance initiatives with his clients. In 2005 he was recruited to the compliance team at Astellas Pharma US, Inc. (Fujisawa) and led the development and delivery of all corporate compliance training programs while also serving as an advisor and investigator across therapeutic areas. Scot founded SCS Compliance Group LLC in 2012. Scot's firm is focuses-on compliance field ride-along audits, speaker program and advisory board monitoring, and compliance training development/deployment.






Gary Mendelsohn
Assistant Director, Corporate Compliance for Oncology, Astellas, Greer, SC

    Speaker Bio

    Gary has over 25 years experience in the pharmaceutical industry as a Compliance Officer, Trainer Medical Science Liaison, and Sales Representative. Gary's current position in Compliance involves annual product risk assessments, development and execution of a field monitoring plan, development and delivery of compliance training, and general compliance guidance on appropriate interactions with healthcare providers. Gary also has developed a strong expertise in Speaker Programs, Sponsorships and joint Medical/Commercial Interactions.
    Presentation Material (Acrobat)










11:30 a.m.




Preconference Adjournment; Lunch on your Own



PRECONFERENCE III



ADVANCED ISSUES IN DOMESTIC AND GLOBAL TRANSPARENCY AND ANALYTICS: TAKING THE DATA TO THE NEXT LEVEL




8:00 a.m.




Welcome and Overview

Edward Glynn, MBA
Principal, Ernst & Young LLP, New York, NY (Moderator)










8:10 a.m.




Exploring the Analytics Maturity Model: Capitalizing on your Investment in Aggregate Spend

Corey Dunbar, CFE
Senior Manager, Fraud Investigations & Dispute Services, Ernst & Young LLP, New York, NY

    Speaker Bio

    Corey Dunbar is a Senior Manager with Ernst & Young's Fraud Investigation & Dispute Services (FIDS) practice. He specializes in data analytics pertaining to the detection of fraud, bribery, corruption, and compliance risks occurring within accounting, financial, and communicational data. Corey has experience working with Fortune 100 Life Sciences companies in designing, developing and implementing compliance monitoring solutions as well as analytical approaches to conducting audit related activities. Corey has also led large, global investigations including matters related to the Foreign Corrupt Practices Act and the UK Bribery Act.
    Presentation Material (Acrobat)










8:50 a.m.




Linking Aggregate Spend Data with Other Data Sources to Identify Compliance Trends, Learn about your Competitors and Provide Strategic Insights to the Business

Andy Bender, MS, MBA
President and Founder, Polaris, New York, NY

    Speaker Bio

    Andy Bender is Polaris' founder. As a hands-on executive, Andy has been involved in a wide variety of compliance-related engagements for pharmaceutical and device manufacturers, ranging from policy development and process automation to organizational change. His expertise ranges from the sales and marketing to medical and clinical departments of the client organization. Andy is still involved in many of Polaris' client assignments, and has personally led many FMV, auditing and monitoring projects, as well as numerous international transparency reporting and HCP/O implementations.

    Polaris has over 110 pharmaceutical and med device clients and employs a staff of more than 250, including five healthcare law attorneys. Polaris has offices in New York, Amsterdam, San Francisco, Paris and Boston.
    Presentation Material (Acrobat)










9:30 a.m.




Break







9:50 a.m.




Advanced Analytics: The Art of the Possible in Providing Value-Added Insights to the Business

Samir Hans, MS
Principal, Deloitte, Washington, DC

    Speaker Bio

    Samir Hans is a Principal in the Regulatory, Forensics Advisory Market Segment in Deloitte Advisory. Samir helps lead the Analytics Insight business competency. He also leads the analytics practice in the Forensics Investigation Market Offering. His area of focus principally involves Rare Event Modeling (REM), which is a practice area dedicated to helping clients generate value from their data through the detection of faint signals. He has led REM engagements in a number of domains, including fraud and compliance, quality and safety recall, and program integrity, in both the commercial and public sectors. Over the past several years, he had led a number of important strategic firm initiatives, including the acquisition of a large electronic discovery business, technology vendor alliances, and scaling new market offerings. Beginning his career as a software developer in the Silicon Valley, he brings that same sense of entrepreneurship with advanced technologies into his practice each day.










10:30 a.m.




Using Company-specific and Open Payments Data to Ensure Accuracy and Gain Insights

Terrell Sweat, MBA
Compliance Director, Actelion Pharmaceuticals, South San Francisco, CA






Jonathan Wilkenfeld, MBA
President, Potomac River Partners, Vienna, VA

Presentation Material (Acrobat)










11:00 a.m.




Growing and Integrating Global Transparency Analytics

Nadeem "Ned" Mumtaz, MBA, MIS
Practice Leader and Associate Partner, Streebo Inc., Princeton, NJ






Dr. Seth B. Whitelaw
President and Chief Executive Officer, Whitelaw Compliance Group, LLC; Editor-in-Chief, Life Science Compliance Update, West Chester, PA

Presentation Material (Acrobat)










11:30 a.m.




Preconference Adjournment; Lunch on your Own



PRECONFERENCE IV



ADVANCED GLOBAL COMPLIANCES ISSUES




8:00 a.m.




Welcome and Overview

Nathaniel B. Edmonds, Esq.
Partner, Paul Hastings; Former Assistant Chief, Foreign Corrupt Practices Act Unit, Fraud Section, Criminal Division, US Department of Justice, Washington, DC (Moderator)

    Speaker Bio

    Nathaniel Edmonds is a partner in the Litigation Department of Paul Hastings based in the firm's Washington, D.C. office. As a former Assistant Chief of the Foreign Corrupt Practices Act (FCPA) Unit of the Fraud Section in the Criminal Division of the Department of Justice (DOJ), Mr. Edmonds assisted in the supervision of all FCPA cases in the United States and oversaw the investigation and prosecution of companies, business executives, and others for making improper payments to foreign officials in international business transactions. Mr. Edmonds also assisted in the drafting of A Resource Guide to the U.S. Foreign Corrupt Practices Act, published in November 2012 by the DOJ and the Securities and Exchange Commission (SEC), available at http://www.justice.gov/criminal/fraud/fcpa/guide.pdf.

    Mr. Edmonds advises companies on regulatory compliance matters around the world, including FCPA and anticorruption investigations, risk assessments and due diligence, as well as developing and overseeing anticorruption compliance programs. Mr. Edmonds also assists companies in determining the scope of potential liability stemming from improper payments and how to best respond to potential enforcement actions by U.S. and foreign law enforcement authorities.
    Presentation Material (Acrobat)










8:10 a.m.




Doing Business in China in 2016

Scott Bass
Global Life Sciences Head, Sidley Austin LLP, Washington, DC

    Speaker Bio

    SCOTT BASS heads the firm's global Life Sciences team, coordinating pharmaceutical, medical device, food and dietary supplement matters in the United States, Europe and Asia. He is ranked internationally among the top authorities on FDA-related enforcement and regulatory issues, and has led audits and investigations involving off-label promotion, pharmacovigilance, PDMA, GMP, and fraud and abuse issues, as well as DEA and FTC matters. Scott has also acted as an expert on an EU Commission panel, an advisor on new China drug and device legislation, and as an advisor on an FDA dietary supplement website.

    Scott has represented such companies as Bayer, Genentech, Colgate Palmolive, Allergan, Novartis, Cargill, Herbalife and Roche in a number of regulatory or enforcement matters.










8:40 a.m.




Is Brazil the Next Hot Spot?

Henrique Frizzo
Partner, Life Sciences and Public Law, Trench, Rossi e Watanabe, A Baker McKenzie Affiliate, São Paulo, Brazil

    Speaker Bio

    Henrique Krüger Frizzo is graduated from Universidade de São Paulo with a degree in Law in 2003. LL.M in State and Governmental Affairs at Escola de Formação de Governantes, associated with Universidade de São Paulo in 2004. Extension Course on Public-Private Partnerships (PPPs) at Escola Superior do Ministério Público de São Paulo - 2005. Specialization in "Contracts with the Public Administration", at Fundação Getulio Vargas -- 2007.

    His area of expertise is Public Law, Government Affairs and Regulatory, with focus on consultancy matters. Mr. Frizzo is recognized by Chambers & Partners as a leading lawyer in Public Law and Regulatory. He is a speaker in events related to compliance in contracts with the government and regulatory.
    Presentation Material (Acrobat)










9:10 a.m.




Managing Compliance Risks Presented by Pharma Suppliers and Vendors: Beyond QRM and GMP

Traci Coughlan, Esq.
Principal, Advisory Services, The Red Flag Group, Berlin, MD

Presentation Material (Acrobat)










9:40 a.m.




Break







10:00 a.m.




Applying Analytics to Compliance Programs Resulting in Informed Business Decisions

Joseph Coniker, GMP
Principal, National Practice Leader, Business Analytics, Grant Thornton, Philadelphia, PA

    Speaker Bio

    Joseph Coniker is a Principal in Grant Thornton LLP and national practice leader for Business Analytics. Coniker has over 20 years of professional experience, including 15 years focused on Oracle, Siebel and Hyperion based technologies. Projects that Coniker influenced have resulted in more than $1 billion in working capital improvements.

    Coniker is a member of the AICPA, and Oracle Customer Advisory Council. He is a published author on data analytics matters, and frequent speaker at regional and national events, including Oracle Open World, and guest speaker at the doctoral program on technology and warehousing at Robert Morris University, and finance programs at the University of Richmond.
    Presentation Material (Acrobat)










10:30 a.m.




Monitoring and Auditing of Third Parties

Jeff Antoon
Director Internal Audit, Johnson & Johnson, New Brunswick, NJ

    Speaker Bio

    Jeff Antoon, Director Internal Audit, joined Johnson & Johnson in June 1987 as an Auditor.

    As Director of Corporate Internal Audit's Audit Services Group, Jeff is responsible for worldwide audits in the areas of Foreign Corrupt Practices Act, and Sensitive Issue (fraud) reviews.

    Jeff has delivered presentations at various Johnson & Johnson and industry conferences. His external presentations include the Institute of Internal Auditors, Association of Corporate Counsels, the Center for Business Intelligence, the American Conference Institute, c5, exl pharma, American Leaders, Q1 Productions, Marcus Evans, and The Economist.

    Prior to joining Johnson & Johnson, Jeff worked for two years each at PricewaterhouseCoopers and Engelhard Corporation. He has a Bachelors degree in Accounting from Villanova University, and a Masters in Business Administration from the University of Maryland. Jeff is a Certified Public Accountant.
    Presentation Material (Acrobat)










11:00 a.m.




Application of Attorney-Client Privilege in the Context of Internal Cross-Border Bribery Investigations

Vivian Robinson, Esq.
Queen's Counsel, Partner, McGuireWoods; Former General Counsel of the UK Serious Fraud Office; Former Head QEB Hollis Whiteman Chambers, Recorder of the Crown Court and Former Treasurer of Inner Temple, London, UK

    Speaker Bio

    Vivian Robinson QC became a barrister in 1967 and practised at the English criminal bar for over forty years. He was appointed Queen's Counsel in 1986, became Head of QEB Hollis Whiteman Chambers in 2006 and served as Treasurer of Inner Temple in 2009.

    In 2009 he left the practising bar to take up appointment as first General Counsel at the Serious Fraud Office. In this capacity he played a prominent role in the development of the SFO's enforcement strategy on the UK Bribery Act 2010 and was the SFO's principal liaison with the business community on this subject.

    In 2011 he joined US law firm McGuireWoods, becoming a member of the firm's Government, Regulatory and Criminal Investigation team. He advises clients on compliance and white collar crime issues, both in the UK and internationally.

    He is a co-author of "The FCPA and UK Bribery Act -- A Ready Reference for Business and Lawyers".










11:30 a.m.




Preconference Adjournment; Lunch on your Own




    Day I
    Wednesday, October 21, 2015









OPENING PLENARY SESSION




1:00 p.m.




Welcome and Introduction: PCF Co-Chairs

Matthew D'Ambrosio, JD, MBA
Senior Vice President, Chief Compliance and Ethics Officer, Sunovion Pharmaceuticals, Inc., Marlborough, MA (Co-chair)

    Speaker Bio

    Matthew D'Ambrosio is currently Senior Vice President, Chief Compliance and Ethics Officer at Sunovion Pharmaceuticals Inc.

    Prior to joining Sunovion, Mr. D'Ambrosio served as Vice President, U.S. Legal Affairs and Chief Compliance Officer at Prostrakan, Inc.

    Previously, Mr. D'Ambrosio served as Chief Compliance Officer for Reliant Pharmaceuticals, Inc., one of the country's largest privately-held pharmaceutical companies which was acquired by GSK in 2007. He began his career with Johnson & Johnson where he headed compliance programs in each of J&J's three core sectors: Pharmaceuticals, Medical Device & Diagnostics and Consumer Products

    Mr. D'Ambrosio was previously adjunct faculty at Seton Hall Law in the Health Law Program.






Gary Del Vecchio
Executive Director, US Pharmaceutical Compliance and Ethics, Bristol-Myers Squibb Company, Plainsboro, NJ (Co-chair)

    Speaker Bio

    Mr. Del Vecchio has been with Bristol-Myers Squibb for 26 years. His experience includes roles within manufacturing operations, quality control and assurance, global manufacturing supply chain, systems implementation, education and training, and compliance and ethics program development and support. Gary has been a member of the US Pharmaceuticals Compliance and Ethics department for 10 years and currently holds the position of Executive Director, USP Compliance and Ethics. In this role he provides compliance and ethics leadership to the Sales, Marketing, Medical, Access and Global Commercialization organizations along with managing the US Compliance and Ethics investigations team. His initial compliance role focused primarily on the creation and implementation of the company's comprehensive US Compliance and Ethics education and training program. Gary is currently serving as a Co-Chair of the Pharmaceutical Compliance Forum, a coalition of senior compliance professionals and legal counsel from approximately 65 of the largest research-based pharmaceutical manufacturers. The PCF was founded in 1999 by compliance professionals from the pharmaceutical industry to promote effective corporate compliance and ethics programs.






James Gibney
Senior Director of Compliance, Regeneron Pharmaceuticals; Former Director, Worldwide Programs and US Investigations - Corporate Compliance, Pfizer, Tarrytown, NY (Co-chair)

    Speaker Bio

    Jim Gibney is Senior Director of Compliance. Jim and his team are responsible for leading efforts to enhance and manage all elements of an effective compliance program. Responsibilities include policy development, developing and delivering company-wide compliance training, Federal and State aggregate spend reporting, development and management of anti-bribery/anti-corruption program, executing a compliance communication strategy, and maintaining an internal monitoring program.

    Jim began his career at Pfizer in 1992 and has held various positions in sales, operations, and compliance.

    Jim served 9 years in the United States Naval Reserve and is a graduate of Rutgers University.






Elizabeth V. Jobes, Esq.
Head of Corporate Compliance and Legal Counsel, Spark Therapeutics, Philadelphia, PA (Co-chair)






Glenna Shen, JD, MBT
Executive Director, Worldwide Compliance and Business Ethics, Amgen Inc., Thousand Oaks, CA (Co-chair)

    Speaker Bio

    Glenna Shen is Executive Director, Compliance with responsibility for the US Business and Global Functions at Amgen. Ms. Shen joined Amgen in 2000, and has held various positions in the Law Department and with Worldwide Compliance and Business Ethics, most recently heading up the Compliance function at Onyx Pharmaceuticals, and Amgen subsidiary. Ms. Shen obtained her Bachelor of Arts degree in Biology from the University of Miami and her Juris Doctor and Master of Business Taxation from the University of Southern California.










1:15 p.m.




Keynote: OIG Update

Mary E. Riordan, Esq.
Senior Counsel, Office of Counsel to the Inspector General, Office of Inspector General, Department of Health and Human Services, Washington, DC

    Speaker Bio

    Mary Riordan is a Senior Counsel in the Office Inspector General (OIG) for the U.S. Department of Health and Human Services. She primarily handles cases brought under the federal False Claims Act involving alleged fraud against the Medicare and Medicaid programs, and she focuses on matters involving drug and device manufacturers. She has represented the OIG in the negotiation of numerous settlements and Corporate Integrity Agreements with such providers. She was a co-author of the OIG's 2003 Compliance Program Guidance for Pharmaceutical Manufacturers and a co-organizer of the OIG's February 2012 Pharmaceutical Compliance Roundtable. In addition, Ms. Riordan handles prescription drug and device related issues associated with recent legislation, including the 2010 Affordable Care Act.
    Presentation Material (Acrobat)






Introduction by Matthew D'Ambrosio, JD, MBA
Senior Vice President, Chief Compliance and Ethics Officer, Sunovion Pharmaceuticals, Inc., Marlborough, MA (Co-chair)

    Speaker Bio

    Matthew D'Ambrosio is currently Senior Vice President, Chief Compliance and Ethics Officer at Sunovion Pharmaceuticals Inc.

    Prior to joining Sunovion, Mr. D'Ambrosio served as Vice President, U.S. Legal Affairs and Chief Compliance Officer at Prostrakan, Inc.

    Previously, Mr. D'Ambrosio served as Chief Compliance Officer for Reliant Pharmaceuticals, Inc., one of the country's largest privately-held pharmaceutical companies which was acquired by GSK in 2007. He began his career with Johnson & Johnson where he headed compliance programs in each of J&J's three core sectors: Pharmaceuticals, Medical Device & Diagnostics and Consumer Products

    Mr. D'Ambrosio was previously adjunct faculty at Seton Hall Law in the Health Law Program.










2:00 p.m.




AUSA Panel

Charlene Keller Fullmer, Esq.
Assistant United States Attorney, US Attorney's Office, Eastern District of Pennsylvania, Philadelphia, PA

    Speaker Bio

    Assistant United States Attorney Charlene Keller Fullmer is the Deputy Chief for Affirmative Litigation in the Civil Division of the United States Attorney's Office in the Eastern District of Pennsylvania, where she supervises and prosecutes health care and affirmative fraud matters. She led the Philadelphia civil prosecution team that investigated and resolved allegations of off-label promotion of the atypical antipsychotic drug Risperdal by Johnson and Johnson and its subsidiary Janssen Pharmaceuticals, which resulted in a $2.2 billion global settlement with the Department of Justice, the largest paid for a single drug. In 2009, she served on the team that investigated and resolved allegations of off-label promotion and kickbacks by Pfizer, Inc. The $2.3 billion civil and criminal resolution was at the time the largest health care fraud settlement in the history of the Department of Justice. For her efforts in these matters, she was the recipient of the 2014 Attorney General's Award for Fraud Prevention, an Award of Commendation from the Assistant Attorney General for the Civil Division, Tony West, and the 2014 National Health Care Anti-Fraud Association's Investigation of the Year. In October 2010, Attorney General Eric Holder presented her with the Attorney General Award for Exceptional Service, the Department of Justice's highest commendation.

    Ms. Fullmer returned to the Justice Department in 2007 after six years in private practice at Duane Morris LLP in Philadelphia, where she litigated defensive matters, including False Claims Act, health care, white collar, antitrust, and insurance coverage litigation. Prior to that time, she served as an Attorney Advisor in Washington, DC and Quantico, VA with the Federal Bureau of Investigation, Office of Professional Responsibility, the Bureau's Internal Affairs.

    She is a 1993 graduate of Lehigh University, cum laude, and a 1996 graduate of Temple University School of Law, cum laude, where she served on the Law Review.






Jeffrey Steger
Assistant Director, Consumer Protection Branch, Civil Division, U.S. Department of Justice, Washington, DC

    Speaker Bio

    Jeffrey Steger is an Assistant Director in the Consumer Protection Branch, Civil Division, United States Department of Justice. His responsibilities include civil and criminal enforcement of the Federal Food, Drug, and Cosmetic Act. Mr. Steger started with the Department of Justice in 1994, following a clerkship for Judge Jane Roth on the United States Court of Appeals for the Third Circuit. Mr. Steger worked for the United States Senate Committee on Governmental Affairs from 1986 to 1993. As a trial attorney for the Consumer Protection Branch, Mr. Steger has litigated a broad range of civil and criminal cases on behalf of the United States, including cases brought under the Food, Drug, and Cosmetic Act as well as prosecutions of investment and financial fraud. He received his BA in economics from Brandeis University and his JD from Georgetown University.






Kristen Williams, Esq.
Assistant United States Attorney, US Attorney's Office, Los Angeles, CA






John T. Bentivoglio, Esq.
Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice, Washington, DC (Moderator)

    Speaker Bio

    John Bentivoglio represents pharmaceutical, medical device and biotechnology manufacturers criminal, civil, and administrative enforcement actions by the U.S. Department of Justice, state Attorneys General, and other agencies. He has negotiated successful resolutions of such matters for Allergan, Calloway Laboratories, Jazz Pharmaceuticals, Merck & Co., Otsuka Pharmaceuticals, and Serono, among others. He also has counseled more than a dozen companies on the negotiation and implementation of Corporate Integrity Agreements. In addition to assisting companies in enforcement actions, he regularly advises clients on compliance program issues and on federal and state anti-kickback and false claims statutes, FDA advertising and promotional rules, and Medicare and Medicaid regulatory issues.

    Mr. Bentivoglio previously served as associate deputy attorney general and special counsel for health care fraud at the DOJ, was a special assistant to the assistant attorney general, Criminal Division and served as a professional staff member to Sen. Joseph R. Biden Jr., chairman, Committee on the Judiciary.

    He serves on the board of directors of the Children's Law Center in D.C., and co-chairs the guardian ad litem pro bono team in Skadden's D.C. office.










2:45 p.m.




FBI's New Focus on FCPA Investigations

Jeffrey S. Sallet
National Chief of Public Corruption and Civil Rights, Federal Bureau of Investigation, Washington, DC

    Speaker Bio

    Jeffrey S. Sallet is the Section Chief (SC) of the Public Corruption and Civil Rights Section of the Criminal Investigative Division within the Federal Bureau of Investigations (FBI). In this capacity, he has oversight and responsibility over all Public Corruption, Civil Rights, International Human Rights, Foreign Corrupt Practices Act (FCPA), Antitrust, International Money Laundering and Threat Finance investigations FBI wide. SC Sallet has spearheaded several new FCPA initiatives to include: overseas deployments of Agents and Analysts using a newly developed corruption matrix, forging new strategic private sector relationships, advancing internal FBI FCPA training geared toward a proactive shift utilizing sophisticated techniques and implementing a unique corruption global intelligence collection platform.






Introduction by Kris Curry, MBA
Principal, Fraud Investigation & Dispute Services, Ernst & Young LLP; Former Vice President, Health Care Compliance, Pharmaceuticals Group, Johnson & Johnson, Philadelphia, PA

    Speaker Bio

    Kris Curry is a Principal with Ernst & Young's Fraud Investigation & Dispute Services practice. Kris specializes in assisting health sciences companies with global risk and compliance assessments and analyses. Kris works closely with management teams and chief compliance officers to identify enforcement risks, determine potential vulnerabilities and recommend solutions from business and operational perspectives. Kris also assists clients in fraud investigations, compliance inquires and in strategizing responses to government subpoenas and other inquiries.

    Kris is a compliance and regulatory professional with more than 20 years of life science experience. Prior joining EY, Kris was the Vice President and Chief Compliance Officer for the Pharmaceutical Sector of Johnson & Johnson. As the CCO she was responsible for the development and implementation of a comprehensive global compliance program. She has first-hand experience managing and responding to government investigations, including the negotiating of settlements agreements.

    Kris brings deep, relevant experience in health care and life sciences, and she is a frequent lecturer at industry events. Her significant regulatory and compliance experience includes such diverse areas such as promotional compliance, research and development, sales and marketing practices, including off-label, fraud and abuse, government pricing and relationships with third parties.










3:15 p.m.



Break










3:45 p.m.




Keynote: FDA-OPDP Update

Thomas W. Abrams, RPh, MBA
Director, Division of Drug Marketing, Advertising and Communications, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, Silver Spring, MD

    Speaker Bio

    Thomas Abrams is the Director of the Office of Prescription Drug Promotion (formerly the Division of Drug Marketing, Advertising, and Communications (DDMAC)), Food and Drug Administration. Mr. Abrams has held the positions of Acting Director, Acting Deputy Director, and Branch Chief in DDMAC. He joined FDA as a reviewer in DDMAC where he was primarily responsible for reviewing promotional material for cardiovascular products. Prior to joining FDA, Mr. Abrams worked in pharmaceutical sales and marketing for Merck and Company. Mr. Abrams received his B.S. degree in pharmacy from the School of Pharmacy, Rutgers University and his M.B.A. degree from Rutgers School of Business.
    Presentation Material (Acrobat)






Introduction by Janet L. "Lucy" Rose, MBA
President, Lucy Rose and Associates, LLC; Former Director, DDMAC, FDA, Washington, DC

    Speaker Bio

    Ms. Rose is President of Lucy Rose and Associates, LLC, a life sciences regulatory consulting and training firm. For 12 years, she has consulted to, and provided training for, over 150 life sciences firms and their supporting companies. For 16 months during that period, Lucy served as the National Managing Director for Deloitte and Touche's Life Sciences Regulatory Practice.

    From 1995-97, Ms. Rose served as the Director of the Office of Training and Communications for the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration. There she designed and implemented programs to improve external communications with the pharmaceutical industry, health care professionals, and consumers.

    Ms. Rose led CDER's Division of Drug Marketing, Advertising and Communications (DDMAC) from 1993 to 1995. In this capacity, she was responsible for the regulatory oversight of all prescription drug advertising and marketing to U.S. health care professionals and consumers.










4:15 p.m.




Chief Compliance Officer Roundtable: Now that the CIA is Completed, How is the Ethics and Compliance Program Evolving?

Melissa S. Barnes, Esq.
Chief Ethics and Compliance Officer, Eli Lilly and Company, Indianapolis, IN

    Speaker Bio

    Melissa Stapleton Barnes became senior vice president, enterprise risk management, and chief ethics and compliance officer for Eli Lilly and Company in January 2013. She also serves as a member of the company's executive committee.

    Prior to taking this role, Melissa was vice president and deputy general counsel, global litigation and specialty legal. Since joining Lilly in 1994, she has held a variety of legal and business roles, including general counsel for Lilly Diabetes and Lilly Oncology, managed market segment leader for national accounts, and Six Sigma black belt.

    Melissa earned a Bachelor of Science degree with highest distinction from Purdue University and a law degree from Harvard Law School. Prior to joining Lilly, Melissa was a litigator at the law firm of Baker & Daniels in Indianapolis.

    In 2012, Melissa was recognized by the Healthcare Businesswomen's Association as a "Rising Star," and in 2015 was recognized by Ethisphere as an "Attorney Who Matters."






Michael B. Dusseau
Vice President, Compliance Operations, Allergan plc; Former Vice President, Compliance, Bayer, Parsippany, NJ

    Speaker Bio

    Michael has held senior leadership roles in the Compliance Organizations of Schering­ Plough, Merck, Bayer and Allergan with broad responsibilities including the negotiation, implementation and operation of Corporate Integrity Agreements, global compliance training and privacy programs, monitoring, transparency, hotlines and compliance investigations. Michael has experience in both the Rx and Consumer segments of the business and in the design and implementation of compliance organizations and programs.

    With over 30 years of experience in the pharmaceutical industry Mike has held positions in sales, sales operations, information technology and compliance.

    Michael holds a bachelor's degree in science from California State University, Long Beach.






Tricia Glover
Vice President, North America Chief Compliance Officer, Teva Pharmaceuticals, Kansas City, MO






Lawrence P. Platkin
Vice President and Head, U.S. Compliance Center of Excellence, Bayer Corporation, Whippany, NJ

    Speaker Bio

    Larry Platkin is currently Vice President and head of the Compliance Center of Excellence for Bayer Corporation. He was named Vice President and Compliance Officer of Bayer HealthCare in June, 2008, responsible for the implementation of BHC's 2008 Corporate Integrity Agreement, as well as compliance strategy, development of policies and procedures, investigations, communications and training. Prior to that, he held positions in the Bayer Law and Patents Department, counseling the pharmaceuticals business (and its predecessor, Berlex Laboratories, Inc.). Prior to that, he held positions in the Legal Departments of Ciba-Geigy Corporation and American Home Products Corp. Larry was in private practice in Newark, NJ prior to that. He is a graduate of Rutgers College, New Brunswick, NJ and Rutgers University School of Law, Newark, NJ.






Trudy Tan, CPA
Vice President Compliance North America, AstraZeneca, Wilmington, DE






Erinn Hutchinson
Partner, Advisory Services, PwC, Philadelphia, PA (Moderator)

    Speaker Bio

    Erinn Hutchinson is a Partner in PwC's Pharmaceutical and Life Sciences Practice, based in Shanghai. Erinn has fifteen years of experience providing business advisory services to pharmaceutical and medical device companies in the areas of compliance , risk management, and performance improvement. Her expertise includes providing comprehensive risk assessment services on a broad range of health care and pharmaceutical operational issues including corporate compliance, monitoring and auditing, corporate integrity agreements, commercial regulations, reimbursement, anti-bribery, and due diligence for mergers and acquisitions. In addition to extensive experience in the U.S. and China, Erinn has performed compliance assessment reviews in Brazil, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Italy, Mexico, Poland, Portugal, Russia, and the Ukraine.










5:00 p.m.




Panel: FCPA Anticorruption: Examining a Hypothetical Case from All Sides: DOJ, SEC, and CCO

Jeffrey H. Knox, Esq.
Partner, Simpson Thacher & Bartlett LLP; Former Chief, Fraud Section, Criminal Division, US Department of Justice, Washington, DC






Cheryl J. Scarboro, Esq.
Partner, Simpson Thacher & Bartlett LLP; Former Chief, FCPA Unit, US Securities and Exchange Commission, Washington, DC

    Speaker Bio

    Cheryl Scarboro is a Partner in the Washington, D.C. office of Simpson Thacher & Bartlett LLP. She represents corporations, financial institutions and individuals in SEC and other regulatory enforcement proceedings. Cheryl joined the Firm following a 19-year tenure at the Securities and Exchange Commission, most recently as the first Chief of the SEC's FCPA Unit in the Division of Enforcement. She is recognized by Benchmark Litigation as one of the "Top 250 Women in Litigation" in the U.S. and is consistently recommended by The Legal 500 in white collar. Cheryl is a member of the Board of Visitors of Duke University School of Law.






Ashley Watson, Esq.
Senior Vice President, Chief Ethics & Compliance Officer, Merck & Co, Inc.; Former Counsel, Chief Ethics and Compliance Officer, Hewlett-Packard, Philadelphia, PA






Gary Giampetruzzi, Esq.
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., Washington, DC (Moderator)

    Speaker Bio

    Gary F. Giampetruzzi is one of the most recognized anti-corruption/FCPA compliance and enforcement attorneys and thought leaders, and highly regarded by peers, life science industry insiders, and regulators for his strategic thinking and insight into compliance program, internal investigations and government enforcement issues. Mr. Giampetruzzi has extensive experience with all facets of the anti-corruption and FCPA and U.S. healthcare landscapes. He has been a leader in this growing area of practice for the past 15 years, having led the development of cutting edge compliance programs and measures, conducted and overseen hundreds of internal investigations, and been on the ground in more than 40 markets worldwide (including Asia, North Africa, Europe, the Middle East and Latin America). A recent addition to Paul Hastings Investigations and White Collar practice in February 2014, Mr. Giampetruzzi spent 13 years at Pfizer Inc. as its Vice President, Assistant General Counsel and Head of Government Investigations, and earlier on served as Pfizer's Deputy Compliance Officer, where he was also responsible for international compliance investigations and the implementation and maintenance of compliance programs throughout the company's international operations, with a particular focus on emerging markets.
    Presentation Material (Acrobat)










5:45 p.m.



Adjournment and Networking Reception




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