Agenda - Day 2 - Protected - 2017 Pharma Congress

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AGENDA: DAY 2
TUESDAY, NOVEMBER 7, 2017

7:00 am

Registration Opens: Continental Breakfast in Exhibit Hall

MORNING PLENARY SESSION

8:00 am

Co-chair Welcome and Introductions

Jeffrey M. Kawalek, MBA
Senior Director, Ethics & Compliance, North America, Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ (Co-chair)

Speaker Bio

Jeffrey Kawalek is a compliance professional with seventeen years of pharmaceutical experience with a focus on developing and implementing effective pharmaceutical compliance programs, mitigating risk, and advancing compliance with Company policy and Federal and state healthcare laws. Jeff is the Senior Director, Ethics and Compliance, North America for Ipsen Biopharmaceuticals, Inc. Previously, he worked at Novo Nordisk supporting the Chief Compliance Officer to set and accomplish the strategic objectives of the corporate compliance program. He contributed to the development of the compliance program and had responsibilities leading various functions including: Federal [Sunshine] Open Payments and state reporting, monitor and auditing, risk management, and components of the Corporate Integrity Agreement. He has also supported several global compliance initiatives. He holds a Bachelors Degree in Business Administration from The University of Delaware and an MBA from the Fox School of Business at Temple University.

Margaret Sparks, JD
Associate Vice President, North America Ethics and Business Integrity, Sanofi, US, Bridgewater, NJ (Co-chair)

8:15 am

FDA Keynote

Thomas W. Abrams, RPh, MBA
Director, Office of Prescription Drug Promotion, US 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.

Presentation Material (Acrobat)

8:45 am

Qui Tam Roundtable

Amy L. Easton, JD
Attorney at Law, Phillips & Cohen, LLP, Former Senior Trial Counsel, Department of Justice, Washington, DC

Speaker Bio

Amy Easton is an attorney in the Washington, DC office of the law firm of Phillips & Cohen LLP representing whistleblowers in False Claims Act cases. For twelve years prior to Phillips & Cohen she was Senior Trial Counsel with the Fraud Section of the Civil Division of the United States Department of Justice in Washington, DC. At DOJ she investigated and prosecuted civil False Claims Act cases across a broad sector of the health care industry.

Neil V. Getnick, JD
Managing Partner, Getnick & Getnick LLP; Former Assistant District Attorney, Manhattan District Attorneyís Office; New York, NY

Speaker Bio

Neil V. Getnick is the managing partner of Getnick & Getnick LLP, a New York City based law firm with a dedicated anti-fraud litigation, business integrity, and corporate monitoring practice. Mr. Getnick and his law firm have an active False Claims Act qui tam, IRS, SEC, and CFTC whistleblower practice. He and his firm have a won a series of groundbreaking cases including a $600 million civil recovery (as part of a $750 million global settlement) in a pharmaceutical manufacturing violations qui tam case, resulting in the highest award to a single whistleblower in U.S. history.

Robert Patten, JD
President and Chief Executive Officer, Taxpayers Against Fraud and TAF Education Fund; Former Assistant Attorney General and Managing Attorney, Medicaid Fraud Division, The Commonwealth of Massachusetts; Holliston, MA

Speaker Bio

Robert Patten is President and CEO of Taxpayers Against Fraud and the TAF Education Fund, a 501(c)(3)-501(c)(4) non-profit organization whose mission is to maintain the integrity and advance the effectiveness of whistleblower reward and private enforcement provisions in federal and state laws. Robert joined TAFEF after serving for 21 years as an Assistant Attorney General for the Commonwealth of Massachusetts, including 17 years in the Medicaid Fraud Control Unit, where he was responsible for the evaluation, investigation and litigation of civil and criminal health care fraud cases and the coordination of state-federal and multi-state investigations. He served from 2008 to 2017 as the co-chair of the Global Case Committee of the National Association of Medicaid Fraud Control Units.

Virginia ìGinnyî A. Gibson, JD
Partner, Hogan Lovells; Former First Assistant U.S. Attorney, Eastern District of Pennsylvania, US Department of Justice; Philadelphia, PA (Co-Moderator)

Speaker Bio

Virginia Gibson is a partner at Hogan Lovells in its Investigations and White Collar Defense group. She focuses on internal investigations, defense against government investigations, and criminal and civil False Claims Act litigation in the life sciences and health industries. A federal prosecutor for over 20 years in Philadelphia and Delaware, she served variously as First Assistant, Executive Assistant and Civil Chief and prosecuted some of the largest pharmaceutical and health care fraud cases to date.

Kathleen Meriwether
Partner/Principal, EY; Former Assistant United States Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia; PA (Co-Moderator)

Speaker Bio

Kathleen Meriwether is the Americas Leader of the Life Sciences team of Ernst & Youngís Fraud Investigation & Dispute Services practice. Kathleen specializes in assisting health sciences companies with fraud investigations (health care fraud and abuse, off label marketing, FCPA and other bribery and corruption) as well as global compliance assessments. Prior to her tenure with EY, Kathleen was an AUSA in the U.S. Attorneyís Office for the Eastern District of Pennsylvania, focusing on health care fraud. Before becoming an AUSA, Kathleen spent over 16 years with Bristol-Myers Squibb Company in a number of legal, regulatory affairs and compliance positions. Kathleen began her legal career as an associate with a national law firm based in Philadelphia.

9:30 am

Demonstrating the Value of the Compliance Organization

Kathleen M. Boozang, JD, LLM
Dean and Professor of Law, Seton Hall University School of Law, Newark, NJ

Speaker Bio

Kathleen Boozang has been Dean of Seton Hall Law since July 2015. Dean Boozang came to Seton Hall in 1990 as the founder of the Law Schoolís Center for Health & Pharmaceutical Law & Policy which has been ranked by US News as a top 20 program for two decades. Dean Boozang, together with others in this room, founded the Law Schoolís global compliance training program that this year was held in Buenos Aires for the first time, and will be in Warsaw for the first time in the Spring.

Michael Dusseau
Vice President, Compliance Operations, Allergan plc, New York, NY

Speaker Bio

Michael Dusseau is the Vice President, Compliance Operations with Allergan plc. In addition to his current role, he has held senior leadership positions in the Compliance Organizations of Schering-Plough, Merck, and Bayer 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 Shaw, JD
Vice President and Compliance Officer, US Pharmaceuticals, GlaxoSmithKline; Former Senior Counsel, Office of Inspector General, US Department of Health and Human Services; Former Member, PCF Executive Committee; Philadelphia, PA

Speaker Bio

Michael Shaw leads a values-based compliance program for GlaxoSmithKline (GSK) U.S. Pharmaceuticals and contributes compliance leadership to the global enterprise. Responsibilities have included overseeing GSKís global franchises, global monitoring program, enterprise risk strategy for commercial practices, and corporate integrity agreement. Previously, served as Global Head of Ethics & Compliance for Novartis Oncology, Deputy Compliance Officer for Novartis Pharmaceuticals Corporation, Director in PricewaterhouseCoopersí Global Pharmaceutical & Health Sciences Practice, Senior Counsel in the Office of Inspector General of the U.S. Department of Health and Human Services, and inhouse counsel for Olsten Health Services. International speaker on fraud and compliance issues. Quoted in numerous healthcare industry and compliance publications. Currently the Chair of the Chief Compliance Officer Committee of the Pharmaceutical Research & Manufacturers of America (PhRMA) and former Co-Chair in the Pharmaceutical Compliance Forum (PCF). Named Funniest Compliance Officer in America in 2011. Previously, served as an Adjunct Professor at Seton Hall School of Law teaching Healthcare Fraud & Abuse Law.

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

Speaker Bio

Erinn Hutchinson is a Partner in PwC’s Advisory Services Practice. Erinn has 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.

10:15 am

Break

MINI SUMMITS BLOCK A: 10:45 am ñ 11:45 am

(Choose one Mini Summit only)

Mini Summit I: Compliance Messaging: Using Behavioral Economics to Improve Messaging Stickiness

10:45 am

Welcome, Introductions, Discussions and Q&A

For those of you attending Mini Summit I: Compliance Messaging and Messaging Stickiness, the presenters will be giving away a special prize to a person in the audience.

To better execute compliance initiatives, we need to understand why, how, and when people choose a path that leads to either ethical behavior or compliance or regulatory violations. Behavioral psychology can shed light on how employees address questions of right, wrong, or grey, and better equip a company to design new and more effective compliance strategies which help lead employees at all levels to the right choices.

This panel will provide an introduction to behavioral psychology and economics, as well as how to use specific techniques to improve the retention of compliance messaging.

Brian Miller, MS, PhD Candidate
Senior Director of Compliance Training and Documentation, Otsuka Pharmaceutical Companies, Senior Manager of Learning Technologies, AstraZeneca; Former Associate Director Learning Design & Technology, Merck; Philadelphia, PA

Speaker Bio

Brian Miller has worked for nearly 25 years in corporate learning. He has worked in the fields of manufacturing, pharmaceutical clinical research, sales, and compliance. His roles have included trainer, instructional designer, e-learning developer, operations managers, and director of training and documentation. Mr. Miller has a MS in instructional technology systems and has worked in manufacturing, pharmaceutical clinical management, sales operations, and compliance.

Jon Smollen, MA, JD
Practice Professor of Law and Director, Center for Compliance and Ethics, Temple Law School; Former Executive Vice President and Chief Compliance Officer, Endo International; Philadelphia, PA

Speaker Bio

Jon Smollen is a Practice Professor of Law and Director of the Center for Compliance and Ethics at Temple Law School. Prior to his appointment at Temple Law School, Jon was Executive Vice President and Chief Compliance Officer for Endo International and was responsible for the companyís global compliance program. At Endo, Jon oversaw the resolution of a civil and criminal investigation of historic pharmaceutical marketing practices and negotiated and implemented Endoís Corporate Integrity Agreement with OIG and its Deferred Prosecution Agreement with the U.S. Department of Justice. Jon has also held legal and compliance leadership positions at Siemens Healthcare and Wyeth Pharmaceuticals. Prior to joining the private sector, Jon was an advisor to FTC Commissioner Thomas B. Leary and an attorney in the FTCís Bureau of Consumer Protection. He began his career in private practice in Washington, D.C and served as a judicial clerk for U.S. District Judge James P. Jones.

Mariann Snyder, CCEP
Global Compliance Communications Lead, AstraZeneca, Wilmington, DE

Speaker Bio

Mariann Snyder has a knack for simple messages. After almost two decades in litigation at AstraZeneca, helping many an employee witness clear the hurdles of legalese, she moved on to write policies in Compliance, simplifying from day one. Now, as AstraZeneca’s Global Compliance Communications Lead, she is responsible for the tone of our company Compliance function and loves seeing a “light come on” when a perfectly simple message gets through and sticks. A Certified Compliance & Ethics Professional, Mariann received her BA in Journalism from Harding University.

Yogesh Bahl, CPA, MBA
Managing Director, Alix Partners, New York, NY (Moderator)

Mini Summit II: HCP Engagement: The Road to Proactive Risk Management

10:45 am

Welcome, Introductions, Discussions and Q&A

The panelists will discuss how to proactively manage the risks associated with the engagement of HCPs to provide services for medical products manufacturers.

Brian Conner
Vice President, Head of Corporate Compliance, Strongbridge Biopharma plc, Trevose, PA

Speaker Bio

Brian Conner is currently the Vice President, Head of Corporate Compliance at Strongbridge Biopharma plc in the greater Philadelphia metro area. Brian is a seasoned compliance expert with over 20(+) years of progressive industry experience leading biotech/pharma healthcare compliance initiatives. Brian also possesses valuable experience in the areas of drug technology, drug devices, sales, marketing, technical operations, regulatory affairs, and quality operations.

Thomas M. Glavin, JD
Chief Compliance Officer, Olympus Corporation of the Americas; Former Vice President, US/Americas Compliance Officer, Shire; Center Valley, PA

Speaker Bio

Tom Glavin is an experienced pharmaceutical, biotechnology and medical device compliance professional and lawyer with a diverse background encompassing many facets of healthcare and corporate compliance, corporate ethics, sales and marketing law and practices, medical, research and development, and regulatory law. Tom serves as the Chief Compliance Officer at Olympus Corporation of the Americas (OCA) and is responsible for providing critical day-to-day compliance and ethics advice to senior management and all levels of Olympus employees and for leading the implementation and execution of OCAís Deferred Prosecution Agreements with DOJ and Corporate Integrity Agreement with OIG. Previously, Tom was the Compliance Officer for the Americas at Shire Pharmaceuticals. In that role he was responsible for the development, implementation and management of Shireís corporate compliance program in the U.S., Canada, and Latin America. Before Shire, Tom worked in Legal and Compliance positions at Sanofi and law firms in Philadelphia and Pittsburgh.

Daniel A. Kracov, JD
Partner and Head, FDA and Healthcare Practice, Arnold & Porter Kaye Scholer LLP, Washington, DC

Speaker Bio

Dan Kracov is a Partner and heads the FDA and Healthcare practice for Arnold & Porter Kaye Scholer. He assists clients, including start-up companies, trade associations, and large manufacturing companies, in negotiating the challenges relating to the development, approval and marketing of drugs, biologics, and medical devices. His experience in US Food and Drug Administration (FDA) strategic advice and crisis management has been recognized by Chambers, the Legal Times, and numerous other publications. Mr. Kracov regularly advises on regulatory strategies, product and compliance-related investigations, the development of regulatory corporate compliance programs, and due diligence in financings, mergers and acquisitions. He has a widely-recognized experience in biomedical product-related public policy matters, including Congressional investigations and FDA-related legislative strategies.

Michelle Murphy
Director Compliance, Regeneron Pharmaceuticals, Inc., Tarrytown, NY

Speaker Bio

Michelle Murphy is Director Compliance at Regeneron Pharmaceuticals, Inc. located in Tarrytown, NY. With over 12 years of life sciences sales experience, Michelle brings a unique perspective to the development of compliance training and overall communication strategy. She is also responsible for policy development and serves as the compliance lead for two marketed products and HCP engagement. Michelle believes a collaborative, proactive approach to compliance is how you successfully embed compliance within an organization. Michelle holds a Bachelor of Science degree from the University of Delaware.

Laura Skinner
Senior Manager, Life Sciences Regulatory and Operational Risk, Deloitte & Touche LLP, Austin, TX (Moderator)

Presentation Material (Acrobat)

Mini Summit III: Enforcement Trends, Risk Assessments and Best Practices for Patient Assistance and Reimbursement Support

10:45 am

Welcome, Introductions, Discussions and Q&A

The session is devoted to patient support services including enforcement trends, design, risk assessments, and oversight and management, with a primary focus on reimbursement support, copay assistance, free product assistance, and donations to charitable organizations.

Jennifer Chillas, JD
Senior Corporate Counsel, Bristol-Myers Squibb, Princeton, NJ

Speaker Bio

Jennifer Chillas is Senior Corporate Counsel at Bristol-Myers Squibb Company. Jennifer joined Bristol-Myers Squibb in 2005, providing legal support to its medical imaging business. She currently focuses her practice on digital marketing activities in the U.S. pharmaceuticals division. Prior to joining Bristol-Myers Squibb, Jennifer was an associate with Ropes & Gray in Boston, Massachusetts, where she counseled clients on a wide range of health care matters including privacy, fraud & abuse, and corporate transactions. Jennifer graduated, cum laude, from Boston University School of Law. Prior to law school, Jennifer was a pharmaceutical chemist.

Nereyda Garcia, JD
V.P., Global Heath, Ethics and Compliance, Alnylam Pharmaceuticals; Former Senior Director, Compliance, Biogen Idec; Boston, MA

Speaker Bio

Nereyda Garcia joined Alnylam in 2016 as VP, Global Head, Ethics and Compliance. Prior to joining Alnylam, she served as Compliance Officer at Biogen, leading the compliance programs for the US Commercial and the R&D/Medical groups. Prior to that, Nereyda was VP, Legal for PerkinElmer, leading the legal function for the companyís Life Sciences business unit, and Chief Ethics Officer for Haemonetics Corporation. Nereyda began her career in private litigation practice at Sherin and Lodgen LLP.

Laura G. Hoey, JD
Partner, Government Enforcement Group, Ropes & Gray LLP; Former Assistant US Attorney, US Attorneyís Office, Eastern District of Arkansas, US Department of Justice; Chicago, IL

Speaker Bio

Laura Hoey is a partner in the government enforcement practice at Ropes & Gray LLP in Chicago. She represents clients in the pharmaceutical, medical device, diagnostic laboratory, and dental industries as well as academic medical centers and medical professionals who are facing government investigations and Congressional inquiries. Laura conducts internal investigations in all types of government and regulatory compliance matters, including alleged improper marketing of pharmaceutical products and medical devices for uses for which they have not been approved by the FDA (off-label marketing) and other potential violations of the Food, Drug and Cosmetic Act; potential violations of whistleblower and anti-kickback statutes and of anti-corruption and anti-bribery statutes, including the U.S. Foreign Corrupt Practices Act; alleged health care fraud; and alleged violations of privacy and data security laws, including HIPAA. As a federal prosecutor, Laura prosecuted health care fraud, kick-back violations, Food, Drug and Cosmetic Act violations, document destruction and obstruction cases, and criminal HIPAA violations.

Casey J. Horton, CFE
Director, Healthcare and Life Sciences Disputes, Regulatory, Compliance and Investigations, Navigant Consulting, Chicago, IL (Moderator)

Speaker Bio

Casey J. Horton has over fifteen years of experience leading numerous risk, compliance and operational improvement projects, both in the US and across the globe. Casey brings Navigant clients a unique perspective and understanding of the regulatory and legal challenges facing both healthcare and life sciences companies. His practice focuses on performing compliance assessments and investigations and implementing effective and sustainable compliance solutions. Casey is a Director in Navigantís Global Healthcare and Life Sciences Disputes, Regulatory, Compliance & Investigations (ìHLS DRCIî) practice, where he brings deep experience and knowledge of compliance program development, Corporate Integrity Agreements (ìCIAsî), compliance and enterprise risk assessment execution, global monitoring initiatives, antibribery / anti-corruption issues, third-party due diligence review programs, patient services and assistance program reviews and financial and economic damage calculations.

Mini Summit IV: Managed Market Considerations for Hub and Specialty Pharmacy Arrangements

10:45 am

Welcome, Introductions, Discussions and Q&A

PBMís negotiate on behalf of the insurers to get the best price for medications from the manufacturers. A recent settlement (Novartis) and investigations (i.e., J&J, Merck, Endo) could involve incentive programs, discounts and other sales strategies the government may view as violations of the Anti-Kickback Statute and False Claims Act.

Terra Buckley, JD
Senior Director, US HCC, I&I Franchise, Global Compliance, Celgene Corporation, Summit, NJ

Speaker Bio

Terra Buckley has almost 20 years of experience in pharma and has held various roles in Sales, Marketing and Compliance. She has broad compliance experience that includes developing, implementing and managing compliance programs including policy development, training, auditing and monitoring, and transparency reporting. In her current role at Celgene she serves as the compliance advisor to the I&I franchise. In her prior roles she has worked in various therapeutic areas including primary care, neurology and oncology.

Greg Sherman, JD
Counsel III, Gilead Sciences, Foster City, CA

Speaker Bio

Greg Sherman serves in Gileadís Commercial Legal Department where he provides counsel on a wide variety of issues including trade and distribution, commercial contracting, patient access programs, government price reporting, government affairs, and investigations. Prior to joining Gilead, Greg was an associate at Sidley Austin LLP where he advised life science companies on healthcare fraud and abuse, reimbursement, and price reporting issues. Greg began his legal career at Hooper, Lundy & Bookman, PC where he advised institutional healthcare providers on compliance, Medicare and Medicaid reimbursement, licensing, and privacy issues.

Lisa Walkush
Principal, Advisory Services: National Life Sciences Sector Leader, Grant Thornton LLP, Philadelphia, PA

Speaker Bio

Ms. Walkush is Principal & National Life Sciences Leader for Grant Thronton. She has expertise in providing Business Transformation and Change Management, Operational Excellence, Compliance and Validation and Technology Consulting Services. Lisa has helped numerous clients in the life sciences industry successfully execute various business process and technology projects. Lisa has been working on business transformation programs in compliance, commercial and finance. Lisa also focuses on bringing change management methods and approaches to her clients. Lisa led SMART’s legal solutions practice which consults within-house legal counsel and law firms in the area of legal technologies and compliance program management. Under Lisaís guidance, the legal solutions practice helped several of the firm’s largest clients implement technology solutions for in-house legal counsel to manage their day-to-day activities more effectively and efficiently.

Seth Lundy, JD
Partner, King & Spalding, Washington, DC (Moderator)

Speaker Bio

Seth Lundy is Deputy Chair of the King & Spalding FDA & Life Sciences practice, resident in Washington, DC. Recognized as a national thought leader with over 20 years of industry experience, he focuses his practice on federal and state regulation of pharmaceutical, biotech, and medical device manufacturers, as well as on health care providers and suppliers. He regularly advises on corporate compliance, internal and external investigations, the Anti-Kickback Statute, the False Claims Act, the Food, Drug, and Cosmetic Act, the Sunshine Act, pricing, and Medicare and Medicaid coverage, coding and reimbursement.

Presentation Material (Acrobat)

Mini Summit V: Compliance and Ethics Considerations in R&D

10:45 am

Welcome, Introductions, Discussions and Q&A

This session will address:

Research Risk and R&D Personnel Interactions with HCPs
Best Practices in Managing Investigator Initiated Trials and Research Grant Requests
Interactions with IRBs and Informed Consent
Monitoring and Auditing Clinical Trial Interactions

David Cromley
Associate Vice President, Merck, Philadelphia, PA

Speaker Bio

David W. Cromley is the Division Compliance Officer (DCO) for Merck Research Laboratories (MRL). Previously, David was an attorney in the Regulatory, Commercial, and Merck Research Laboratories (MRL) group within the Office of General Counsel at Merck. David joined Merck in 1999, after serving as an associate at Morgan, Lewis & Bockius. David W. Cromley, Associate Vice President and MRL Division Compliance Officer, Global Compliance Organization, Merck David is the Division Compliance Officer (DCO) for Merck Research Laboratories (MRL). Previously, David was an attorney in the Regulatory, Commercial, and Merck Research Laboratories (MRL) group of the Office of General Counsel. David joined Merck in 1999, after serving as an associate at Morgan, Lewis & Bockius. David is a graduate from Brown University, where he received an AB in History, with honors, and was elected to membership in Phi Beta Kappa. David received his J.D. from the University of Virginia School of Law, where he served as Essays Editor on the Law Review. David served as Law Clerck to the Honorable Anthony J. Scirica of the United States Court of Appeals for the Third Circuit during the 1994-95 term.

Sue Seferian
Health Care Compliance Officer, Johnson & Johnson, Titusville, NJ

Speaker Bio

Sue Seferian is the global R&D Health Care Compliance Officer for the Johnson & Johnson Pharmaceuticals Group. Sueís team is responsible for the implementation and maintenance of programs designed to ensure compliance with applicable regional/local health care fraud and abuse laws, anti-corruption and anti-bribery laws, advertising and promotion laws, privacy laws, codes of conduct and J&J company policies governing the R&D organizationís activities. Sue joined the Johnson & Johnson Law Department, where she provided legal support for the creation, implementation, and management of corporation-wide fraud and abuse and compliance programs. Sue later joined the World Wide Office of Health Care Compliance & Privacy and the Pharmaceuticals Group Health Care Compliance organization. Prior to joining Johnson & Johnson Sue worked at Reed Smith and other major law firms in the Philadelphia area, practicing health care law. Sue also clerked for the criminal division of the New Jersey Judiciary.

Michelle M. Shwery, MSc, MBA
Senior Advisor, Ethics and Compliance, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN

Speaker Bio

Michelle Shwery leads R&D compliance for Eli Lilly and Company. Previous leadership roles include Lillyís Enterprise Risk Management program and Global Clinical Operations / Medical Quality for South America, Asia, Africa and the Middle East, Australia, Canada, Mexico, Russia and Turkey. Shwery has led Early Drug Development Operations, Global Clinical Diagnostics and Global Medical Training. She began her career with Lilly Canada where she was responsible for Clinical Research, Customer Strategy and Service, Medical Information and Wholesaler/Pharmacy Accounts for the affiliate. She serves on Women United Steering Committee (UWCI) and is Past Board President of Dress For Success Indianapolis.

Seth B. Whitelaw, JD, LLM, SJD
President and Chief Executive Officer, Whitelaw Compliance Group, LLC; Editor, Life Science Compliance Update; Senior Fellow & Adjunct Professor, Life Sciences Compliance at Mitchell Hamline School of Law, West Chester, PA

Anup Kharode, MS, MBA
Partner, Pharmaceutical & Life Sciences R&D Advisory Services, PwC, Philadelphia, PA (Moderator)

Mini Summit VI: Compliance Program Effectiveness: Using Data Analytics to Tell the Story

10:45 am

Welcome, Introductions, Discussions and Q&A

This session will address:

Evolution of Compliance Programs, from OIGís Guidance in 2004 to date
Elements of Compliance Program
Available data and measures of effectiveness (KPIs, standards)
The rise in data availability
Compliance automation (Policies, Training, Field Observations, Risk Assessments)
Who is the audience: Compliance Dept, C-Suite
How best to communicate message, and when?

Christie Camelio
Vice President and US Healthcare Compliance Officer, Celgene Corporation, Summit, NJ

Speaker Bio

Christie Camelio joined Celgene in June, 2017 as Vice President and US Healthcare Compliance Officer where she is responsible for the design and implementation of the company’s US Compliance Program.She started her career in consumer products sales and marketing and then went to the agency side leading branding projects for consumer and pharmaceutical companies. In 2003, Christie joined Novartis Pharmaceuticals leading global branding projects. She then spent time in Novartis medical and commercial operations functions and led numerous transformation projects including the reimagining of the company governance structure resulting in streamlined decision making. Christie then led the Risk Management Oversight function which encompassed the risk assessment process, auditing and monitoring, investigations, data analytics, the HCP interactions and promotional material review process and the assessment of the company’s speaker programs.

Catherine Healy Kanzler, JD
Executive Director, Global Compliance Operations, Olympus, Center Valley, PA

Speaker Bio

Catherine Kanzler is Executive Director, Global Compliance Operations of Olympus Corporation of the Americas. She is responsible for building and harmonizing compliance programs throughout the Olympus Group worldwide. She manages the Company’s Corporate Integrity Agreement, and is a key contributor to the management of its Deferred Prosecution Agreements. Cathy was a leader in the design and implementation of the Company’s compliance monitoring, testing and data analytics programs, grants and distributor due diligence requirements, and Compliance, Grants and HIPAA governance committees. Prior to joining Olympus, she practiced law in New York, representing a range of clients in corporate and commercial litigation.

Daniel Spicehandler, JD
Director, Risk and Accountability, Novo Nordisk, New York, NY

Anthony Brennan, MBA
Senior Manager, Fraud Investigation & Dispute Services, EY; Former Senior Director, Governance, Metrics and Reporting, Health Care Compliance, Johnson & Johnson; Iselin, NJ (Co-Moderator)

Corey Dunbar
Senior Manager, Fraud Investigations & Dispute Services, EY, Iselin, NJ (Co-Moderator)

Speaker Bio

Corey Dunbar is a Senior Manager with Ernst & Youngís Fraud Investigation & Dispute Services (FIDS) practice. He specializes in data analytics pertaining to the detection of fraud, bribery, corruption, and other compliance risks occurring within accounting, financial, and communicational data. Corey has experience working with many Life Sciences companies in designing, developing and implementing compliance monitoring solutions and platforms. Corey also has extensive experience helping his clients understand where data analytics can be best utilized and what types of procedures and protocols should accompany the use of such analytics.

Mini Summit VII: International Organization for Standardization (ISO) 37001: A New Era of Anti-bribery/Anti-corruption (ABAC) Compliance

10:45 am

Welcome, Introductions, Discussions and Q&A

Multinational companies within the pharma and med device industry are well-aware of the risks of bribery and corruption. Compliance departments of these companies continuously look for ways to enhance their anti-corruption program and controls. This session will explore the latest standard called ISO 37001. The International Organization for Standardization published ISO 37001 in October 2016 in the hopes to set up a globally recognized standard in establishing a robust anti-corruption management system. Through this new standard, for the first time ever, companies can now certify their anti-corruption program. This panel of anti-corruption experts will discuss the background of ISO 37001, its potential impact within companies and surmise the regulators view of ISO 37001.

Michael K. Loucks, JD
Partner, Skadden Arps LLP; Former Acting United States Attorney, District of Massachusetts, US Department of Justice; Washington, DC

Speaker Bio

Michael Loucks is an experienced trial and appellate attorney whose practice focuses on internal investigations and government enforcement matters in the U.S. and abroad, and on false claims act litigation in federal and state courts. He is a Partner at Skadden Arps LLP. Prior to joining Skadden, Mr. Loucks served as acting U.S. attorney and first assistant U.S. attorney for the District of Massachusetts. He repeatedly has been selected for inclusion in Chambers USA: and The Best Lawyers in America.

Paul J. Peterson, CPA, CIA, CFE, CFF
Senior Manager, Forensic Advisory Services, Grant Thornton, Alexandria, VA

Speaker Bio

Paul Peterson joined Grant Thornton in 2010 and has more than 18 years of experience as an auditor, forensic accountant and investigator and focuses his practice on advising companies on global fraud and anticorruption matters. He is a US-trained, internationally experienced fraud examiner who has worked with general counsel, internal audit, compliance departments, management, and audit committees on fraud issues including investigations, fraud and corruption risk assessments, compliance due diligence and developing and enhancing anti-corruption compliance programs. Throughout his career, Peterson spent multiple years overseas and most recently spent three years living in China helping multinational corporations navigate fraud matters.

Presentation Material (Acrobat)

Louis Ramos, JD
Partner, DLA Piper; Former Assistant General Counsel, Compliance Division, Pfizer; Former Assistant US Attorney, US Attorneyís Office, District of Columbia; Washington, DC

Speaker Bio

Lou Ramos is a partner with DLA Piper whose practice focuses on white collar litigation, government and internal investigations, and compliance counseling. Louís experience includes leading investigations and counseling clients on matters involving the FCPA, the UK Bribery Act, the False Claims Act, off-label promotion, anti-kickback statutes, and research and manufacturing issues. He has led investigations in the United States and around the world. Prior to joining DLA Piper, Lou was an Assistant General Counsel with Pfizerís Compliance Division, and he served as an Assistant U.S. Attorney in the District of Columbia.

William P. Olsen
Principal, Practice Leader, Corporate Compliance, Forensic Advisory Services, Grant Thornton LLP, Arlington, VA (Moderator)

Speaker Bio

Bill Olsen is a Principal and national practice leader for the Corporate Compliance practice of Grant Thornton LLPís Forensic Advisory Services. Bill is a former member of the special prosecutions section of the New Jersey attorney generalís office and was the global security manager for a Fortune 500 company. He was with a Big 5 Accounting firm prior to joining Grant Thornton. Bill authored The Anti-Corruption Handbook and is a frequent speaker on global corruption matters. He was named one of the Top 25 Consultants of 2012 by Consulting magazine and also the National Law Journals top 50 Trailblazers and Pioneers of 2014.

11:45 am

Networking Luncheon

OPTIONAL LUNCHEON MINI SUMMITS 11:55 am ñ 12:55 pm

(Choose one Mini Summit only)

Luncheon Mini Summit VIII: FDA Regulation and Cutting Edge Technology – What Pharmaceutical and Medical Device Companies Should Know

This session will address:

Digital Health Product Regulation by FDA
FDAís Regulatory Approach for Regenerative Medicine
What FDA regulatory controls with which companies must comply?
FDA initiatives for regenerative medicine–what should industry expect?
Update on FDA regulatory environment after 21st Century Cures and FDARA.

11:55 am

Welcome, Introductions, Discussions and Q&A

Virginia Beakes-Read, JD
Executive Director/Special Counsel, Regulatory Strategy and Law, Eisai Inc., Washington DC

Speaker Bio

Ginny Beakes-Read is Executive Director/Special Counsel, Regulatory Strategy and Law at Eisai, Inc. Ginny is a member of Eisaiís Global Regulatory Affairs and Legal Departments. She works with the Development, Commercial, Public Policy, Government Affairs, and other departments on a variety of regulatory, legal, and policy matters. Her internal work at Eisai focuses on FDA regulatory law matters, from research, development, application submission and review, supply chain, to commercial regulatory issues. Ginny also helps to influence the regulatory environment in areas of interest for the company. She successfully led the companyís efforts to change the law governing DEA and FDA scheduling of new molecular entities as Controlled Substances.

Presentation Material (Acrobat)

Chia-Feng Lu, JD
Associate, Baker McKenzie, Washington, DC (Moderator)

Speaker Bio

Chia-Feng Lu assists clients in developing strategies for research and development, regulatory compliance, market access, and business development and licensing. He has extensive experience in formulating compliance strategies and devising compliance programs, and has overseen the implementation of the global compliance structure in more than 70 jurisdictions during his secondment with a multinational pharmaceutical company. In his current capacity, he serves as a leading compliance counsel to a flagship biotech company in Asia, and to one of the largest specialty pharmas in the world. Prior to joining the Firm, he worked at a multinational pharmaceutical company and a consulting firm. Chia-Feng also holds appointments as an adjunct academic of the Faculty of Medicine at Kyoto University, and the School of Pharmacy at Kitasato University in Japan.

Presentation Material (Acrobat)

Luncheon Mini Summit IX: Pricing Considerations (Mylan Epipen, Marathon Pharmaceuticals, et al)

11:55 am

Welcome, Introductions, Discussions and Q&A

This session will focus on companies undergoing congressional investigations into their drug pricing as well as 340B, oversight of Federal Programs and the drug pricing crisis.

John D. Shakow, JD
Partner, King & Spalding LLP, Washington, DC

Speaker Bio

John Shakow is a Partner with King & Spalding. He 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.

Andrew T. Clark, MBA
Partner/Principal, EY, Washington DC (Moderator)

Speaker Bio

Andrew Clark is a Principal with Ernst & Young in its Fraud Investigation & Dispute Services practice where he specializes in the Life Science industry. Specifically, Andrew has spent much of his career assisting companies under Corporate Integrity Agreements with the US government, both in the capacity as leading efforts as an Independent Review Organization, as well as advising compliance, legal and business function executives on leading compliance practices. Additionally, Andrew has performed numerous investigations and assessments related to the Foreign Corrupt Practices Act and other anti-bribery and anti-corruption efforts.

Presentation Material (Acrobat)

Luncheon Mini Summit X: Rescheduled. See Mini Summit XXV

Luncheon Mini Summit XI: Innovation and Compliance: They are not Mutually Exclusive

11:55 am

Welcome, Introductions, Discussions and Q&A

Learn how organizations have been able to navigate the continued pressures of cutting costs, addressing regulation, while improving quality and innovating. Discussion will include experience from the panelist on innovation, including use of cloud technology, and compliance, including the impact of culture.

Tom Costa, JD
Pharmaceutical Consultant, Aventis Board of Directors; Former Vice President, US Compliance & Ethics, Bristol-Myers Squibb; Washington, DC

Speaker Bio

Thomas Costa has over 35 years of senior legal and compliance experience in the Pharmaceutical and Medical Device fields. He spent 28 years with Bristol-Myers Squibb in Princeton and London before retiring in October 2014. He is presently a Compliance Consultant and works with the Sanofi Compliance Team and the Aventis Board.

Gary Del Vecchio
Health Care Compliance Officer Cardiovascular & Metabolism and Puerto Rico, The Janssen Pharmaceutical Companies of Johnson & Johnson; Former, Executive Director, US Pharmaceutical Compliance & Ethics, Bristol-Myers Squibb; Titusville, NJ

Speaker Bio

Gary Del Vecchio is currently working at Janssen Pharmaceuticals as the Healthcare Compliance Officer, Cardiovascular & Metabolism and Puerto Rico. Prior to joining Janssen, Gary spent 29 years at Bristol-Myers Squibb, 13 in their Compliance and Ethics Group, last serving as Executive Director, Compliance and Ethics. His earlier experience included roles within manufacturing operations, quality control and assurance, global manufacturing supply chain, sales learning and development, compliance and ethics program development, CIA implementation and oversight and Healthcare Compliance investigations. Gary is a former Co-Chair of the Pharmaceutical Compliance Forum (PCF).

Wendy C. Goldstein, JD
Partner, Health Care and Life Sciences Regulatory Practice, Cooley, LLP, New York, NY

Speaker Bio

Wendy Goldstein is a member of the Cooley business department and leads the firm’s Health Care & Life Sciences Regulatory practice. Ms. Goldstein concentrates in healthcare fraud and abuse and government health care program matters relevant to manufacturers, payors and other ancillary providers in the health care life sciences space. She also represents those entities that invest in such concerns. She serves on the board of directors of several non-profit health care associations, and educational institutions. She also is actively involved in pro bono activities relating to the pediatric oncology research and other health care education and access initiatives. Ms. Goldstein has been ranked by Chambers USA as one of America’s leading lawyers for health care (2008 to 2017). She was selected for inclusion in The Best Lawyers in America (2013-2017) and in New York Super Lawyers – Metro (2006 to 2017).

Joseph Coniker
Principal, Enterprise Performance Management (EPM) Analytics, Grant Thornton LLP, Raleigh, NC (Moderator)

Speaker Bio

Joseph Coniker is a Principal at Grant Thornton and national practice leader for EPM Analytics, focused on enabling cloud solutions. He has over 22 years of experience, specializing in digital applications, data modernization, and data governance. Coniker is a graduate from New York University and Harvard Business School, and recent participant in the big data and analytics program and University of North Carolina.

MINI SUMMITS BLOCK B 1:00 pm ñ 2:00 pm

(Choose one Mini Summit only)

Mini Summit XII: Third Party Risk Management/Due Diligence Update

1:00 pm

Welcome, Introductions, Discussions and Q&A

Third party risk management is no longer nascent. Organizations have had time to implement programs, processes and procedures, take stock, and benchmark. Many are in the process of updating/upgrading their programs (e.g., we are seeing organizations switch or replace their third party risk management/DD software/platforms). But struggles, challenges and concerns remain.

Panelists will venture to address some of these struggles, challenges and concerns as well as discuss fundamental third party risk management topics such as third party risk ranking, ongoing monitoring, and third party ABAC training.

Kenneth Borgerding, JD
Vice President, Chief Compliance Officer, Lundbeck; Deerfield, IL

Speaker Bio

Prior to his current position, Mr. Borgerding was Associate General Counsel for Regulatory and Compliance at Lundbeck; Senior Regulatory Counsel at Takeda Pharmaceutical North America; Life Sciences Associate at K&L Gates in Washington, DC; and Regulatory Counsel at CDER in the FDA. He also served in the US Army Judge Advocate Generalís Corps from 1995-2001 & 2003 assigned to the elite 82nd Airborne Division. He also served two tours in the Middle East.

Katherine (Katie) Norris, MPA
Director, Corporate Compliance & Risk Management, BRG; Former Director, Corporate Compliance, Spectranetics; Washington, DC

Speaker Bio

Katherine (Katie) Norris is a Director with Berkeley Research Group, Inc. She has 15 years of experience in corporate governance and compliance in the pharmaceutical, medical device, over-the-counter consumer products, and cosmetics industries. She has focused primarily on support during investigation and resolution of government investigations and compliance with enforcement actions. Her experience includes the development, execution, and management of compliance programs intended to fulfill the obligations of two corporate integrity agreements, a pretrial diversion agreement, and a non-prosecution agreement. Ms. Norris has performed substantial internal investigations and supported extensive federal investigations with the U.S. Department of Justice, Health and Human Services Office of Inspector General, Securities and Exchange Commission, Federal Trade Commission, Department of Education, and National Institutes of Health. Previously, she was Senior Director, Compliance and Integrity Programs for NSF Health Sciences; Director, Corporate Compliance with The Spectranetics Corporation and Manager of Corporate Compliance for King Pharmaceuticals, Inc.

Mona M. Patel, JD
Partner, Covington & Burling LLP, Washington DC

Speaker Bio

Mona Patel has extensive experience representing clients in large scale federal and state investigations brought by enforcement authorities, related qui tam or follow-on consumer protection litigation, internal investigations and compliance matters. She advises clients in the life sciences, defense, technology and manufacturing industries on a wide variety of white collar matters. As a partner in the White Collar Defense & Investigations practice, Ms. Patel advises clients on a broad range of compliance issues arising under federal and state healthcare laws and regulations and under the Foreign Corrupt Practices Act and other anti-bribery laws. She provides counsel and tailored training to companies developing, evaluating or strengthening their anti-corruption compliance programs and controls and investigations protocols, and routinely provides strategic due diligence advice on proposed corporate transactions, joint ventures and other engagements.

Anthony L. Alvizu
Managing Director, Global Risk & Investigations Practice, FTI Consulting, Chicago, IL (Moderator)

Speaker Bio

Tony Alvizu is a Managing Director at FTI Consulting and is based in Chicago. He has almost 30 years of experience assisting companies, boards and their counsel conduct corruption, financial, accounting, computer, corruption and other types of investigations in countries across the globe. Over the past six years Mr. Alvizu has been exclusively focused on proactive, monitoring and reactive anti-corruption, investigation and compliance matters with a focus on third-party risk management and due diligence. Mr. Alvizu helped develop an anti-corruption compliance solution that continuously manages third-party risk and due diligence.

Mini Summit XIII: Global Compliance in the Transactional Context: Due Diligence, Integration and Post-Transaction Steps

1:00 pm

Welcome, Introductions, Discussions and Q&A

There are many compliance challenges for health care and life sciences companies in todayís active merger environment. This wide-ranging presentation will cover such topics as:

Appropriate pre-acquisition due diligence;
ìDay 1î requirements
Scoping and conducting risk assessments post-closing; and
Challenges of compliance program integration, including how to best build an integrated global compliance program following an acquisition or merger transaction.

Alison Fethke, JD
Counsel, Ropes & Gray LLP; Former Division Counsel, Legal, Regulatory and Compliance, AbbVie; Chicago, IL

Speaker Bio

Alison Fethke is a Counsel in the Health Care Group at Ropes & Gray, located in Chicago. Alison focuses her practice on fraud and abuse, FDA and general compliance matters for drug and device manufacturers. Alison also spent 8 years as in-house counsel at a major pharmaceutical company and a disease management company, before returning to Ropes & Gray in 2013.

Tracy Strong, JD
Vice President, International Compliance Officer, Laboratory Corporation of America, Burlington, NC

Speaker Bio

Tracy Strong is Vice President, International Compliance Officer and compliance counsel for LabCorp. Tracy is responsible for managing LabCorp’s global compliance program, including anti-bribery/anticorruption, trade sanctions, global data privacy and anti-human trafficking compliance, across LabCorp’s drug development and clinical diagnostic testing business segments. Prior to LabCorp, Tracy was an associate at Jones Day San Francisco focusing on commercial litigation.

Daniel A. Kracov, JD
Partner and Head, FDA and Healthcare Practice, Arnold & Porter Kaye Scholer LLP, Washington, DC

Speaker Bio

Gildas Durand
Partner/Principal, Fraud Investigation and Internal Audit, EY, Miami, FL (Moderator)

Presentation Material (Acrobat)

Mini Summit XIV: Hands on Learning: Managing an Internal Investigation under a CIA, DPA and a Data Analytics Failure

1:00 pm

Welcome, Introductions, Discussions and Q&A

Managing internal investigations on their own can be a challenge; however, managing an internal investigation when the company is under a CIA, managing a DPA, and handling a data analytics failure by a third party reaches a new layer of complexity.

During this session, the panelists will discuss the key considerations in managing the expectations of regulators, the companyís Board, and the IRO. Also, the panelists will discuss the importance of managing the companyís data when outsourcing data management to a vendor. In this age of outsourcing key functions to third parties, companies need to stay close when operations are working so that they are better able to manage the risks when the outsourced operations fail.

John Seungjoo Rah, JD
Partner, DLA Piper, Washington, DC

Speaker Bio

John Rah advises pharmaceutical and medical device manufacturers, healthcare providers and suppliers and managed healthcare organizations on corporate compliance program development and operations designed to mitigate the risk of fraud and abuse. John counsels clients on investigations and informal inquiries by the US Department of Justice (DOJ) and the US Department of Health and Human Services Office of Inspector General (OIG). His work also includes conducting internal investigations for health care companies involving potential violations of relevant policies and procedures designed to ensure compliance with the anti-kickback, Food Drug and Cosmetics Act . John also has a deep background in negotiating and implementing Corporate Integrity Agreements (CIAs), Deferred Prosecution Agreements (DPAs), and state consent decrees, and regularly interacts with the OIG and other relevant agencies in connection with these integrity agreements.

Jane H. Yoon, JD
Of Counsel, Litigation Department, Paul Hastings; Former Assistant United States Attorney, Health Care and Government Fraud Unit, US Attorneyís Office for the District of New Jersey, US Department of Justice; New York, NY

Yogesh Bahl, CPA, MBA
Managing Director, Alix Partners, New York, NY (Moderator)

Mini Summit XV: Recent FDA Guidance Document Manufacturer Communications

1:00 pm

Welcome, Introductions, Discussions and Q&A

The panelist will discuss considerations for the application of recent guidance documents. Planned discussion topics will include:

Dissemination of ìon-labelî versus ìoff-labelî information ñ who can compliantly say what when?
Is the difference between promotional and non-promotional communication really clear?
Has FDAís viewpoint on First Amendment rights changed?
Should we anticipate any potential enforcement consequences?

Kathryn Pryze, CCEP
Compliance Director, AstraZeneca, Wilmington, DE

Speaker Bio

Ms. Pryze is currently providing compliance support to the US business at AstraZeneca. She focuses primarily on providing creative results-oriented business solutions to the functional areas of Medical Affairs and Corporate Affairs. Kathryn is a Certified Compliance & Ethics Professional that has spent the past seven years supporting AstraZenecaís US and Global teams in the area of compliance. Practicing the ëGreat 8í she has lead various projects and been accountable for identifying risk areas, conducting monitoring programs, assisting in the development and delivery of training materials, helping establish the use of analytics, and conducting investigations.

Donna White, CCEP
Vice President, Contracts & Compliance, Chiesi USA, Inc.; Former Senior Director, Contracts and Compliance, Cornerstone Therapeutics; Cary, NC

Kellie B. Combs, JD
Partner, Ropes & Gray, Washington, DC

Speaker Bio

Kellie Combs is a Partner in the Life Sciences group at Ropes & Gray LLP, where she provides legal and strategic advice to pharmaceutical, biotechnology, and medical device manufacturers on a broad range of issues under the Food, Drug, and Cosmetic Act and the Public Health Service Act. She serves as co-counsel to the Medical Information Working Group, represented Pacira in its litigation against FDA, and has extensive experience handling matters implicating FDA promotional rules and the First Amendment. Kellie also routinely advises clients on lifecycle management, regulation of clinical research, and post-approval compliance. In addition, she conducts regulatory due diligence in connection with transactions involving life sciences clients and advises on government investigations of FDA-regulated companies.

Liisa Eisenlohr, PhD, MBA
Associate Director, Navigant; Former Senior Director, Global Medical Information, Clovis Oncology; Former Clinical Scientist, Genentech; San Francisco, CA (Moderator)

Speaker Bio

Liisa Eisenlohr, PhD, MBA, is an Associate Director at Navigant Consulting with over 20 years of experience in the life sciences industry. Liisa has spent the past ten years in various global roles in medical affairs and clinical development at biopharmaceutical companies in the San Francisco Bay Area. Prior to this, she worked in the tissue banking/ medical device and bioreagents industries where she established and managed marketing, scientific communications, and clinical operations departments. Liisaís broad skill set includes experience in various areas of medical affairs, regulatory affairs, compliance, and clinical trial management. Liisa holds a certification in Pharmaceutical and Medical Device Law and Compliance from the Seton Hall University School of Law.

Presentation Material (Acrobat)

Mini Summit XVI: Compliance Considerations for Small and Mid-Sized Pharma and Medical Device Companies

1:00 pm

Welcome, Introductions, Discussions and Q&A

This session will focus on compliance considerations for small to mid-sized pharmaceutical and medical device organizations, such as:

Resources (Budget, HR, Role of other Functions)
Risk Assessments
Training: In-Person Virtual, Computer-based?
Investigations: budget and constraints
Auditing and monitoring
Enforcement Actions from recent settlements?
Compliance Assessments
International Growth

Sergio Alegre, JD
Vice President, Global Compliance, Osmotica Pharmaceutical Corp.; Former Executive Director Compliance, Pacira Pharmaceuticals, Inc.; New York, NY

Speaker Bio

Sergio Alegre is the Vice President, Global Compliance for Osmotica Pharmaceutical. In this position, Sergio is principally responsible for the development and implementation of the companyís compliance program on a global basis. He also serves as a member of the Company’s Executive Committee. Sergio has over 15 years of compliance and legal experience both inside and outside of the pharmaceutical industry. He holds a JD from Fordham University School of Law and a Bachelor’s Degree from Rutgers University.

Holly Kramen, JD
Former Vice President, Global Compliance Officer, Circassia, Washington, DC

Speaker Bio

Holly Kramen is most recently VP, Global Compliance Officer for Circassia Pharmaceuticals, a UK-firm specializing in respiratory diagnostics and treatment. She is an experienced compliance leader addressing challenges and innovating practices while building Legal and Compliance programs in companies of all sizes and therapeutic focuses, from the ground up. Her previous in-house positions include Pfizer, Gilead and Given Imaging. Among her accomplishments, she created and co-authored the first pharmaceutical compliance manual and built the first US aggregate spend system. She has also held external leadership roles at Porzio, Bromberg, Newman, Porzio Life Sciences, PwC and in her own private practice.

Jennifer Sanfilippo, JD
Vice President, Commercial Integrity Counsel, The Medicines Company, Parsippany, NJ

Speaker Bio

Jennifer Sanfilippo, is Vice President, Commercial Integrity Counsel at The Medicines Company, a global pharmaceutical company focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace. In this role, Ms. Sanfilippo is responsible for implementing the companyís legal and compliance goals in the areas of marketing and promotion, healthcare professional interactions, fraud and abuse, anti-corruption and commercial contracting on a global basis. Ms. Sanfilippo also serves as chair of The Medicine Companyís promotional review committee, where she oversees the legal and compliance review of promotional materials and related activities. Previously, Ms. Sanfilippo was a member of the Life Sciences Compliance, Commercialization and Regulatory Counseling team at Porzio, Bromberg & Newman, where she counseled pharmaceutical, medical device, and biotechnology companies on a variety of regulatory and compliance-related issues.

John Patrick Oroho, JD
Executive Vice President, and Chief Strategy Officer, Porzio Life Sciences, LLC; Principal, Porzio, Bromberg & Newman PC, Morristown, NJ (Moderator)

Speaker Bio

John Patrick Oroho is the Executive Vice President and Chief Strategy Officer of Porzio Life Sciences, LLC. He meets regularly with companies to identify sales and marketing issues and to propose solutions that streamline their practices in meeting compliance requirements of all 50 states and the District of Columbia. Mr. Oroho is also a principal of the law firm, Porzio, Bromberg & Newman P.C., and practices in the Life Sciences Compliance and Commercialization Department. He concentrates his law practice in regulatory compliance with respect to the Prescription Drug Marketing Act (PDMA), Anti≠kickback statute, False Claim Act, and Medicare and Medicaid fraud and abuse. Mr. Oroho previously served as Senior Vice President and General Counsel for the PDMA Alliance, a national trade association focused on sample distribution and pharmaceutical marketing and sales compliance. Mr. Oroho also served as General Counsel for Integrated Pharma Technologies and Computer Systems Services & Consulting, Inc.

Mini Summit XVII: Advanced Issues in Global Compliance

1:00 pm

Welcome, Introductions, Discussions and Q&A

The panel will address a variety of advanced issues involving global compliance. Among other things, the panelists will discuss best practices for globalizing core compliance functions, including staffing, risk assessments, auditing and monitoring, and investigations. The panel will also focus on developing a global auditing and monitoring program and some of the considerations and challenges associated with that subject.

Nereyda Garcia, JD
V.P., Global Heath, Ethics and Compliance, Alnylam Pharmaceuticals; Former Senior Director, Compliance, Biogen Idec; Boston, MA

Speaker Bio

Keith M. Korenchuk, JD, MPH
Partner, Arnold & Porter LLP, Washington, DC

Speaker Bio

Keith Korenchuk is a Partner with Arnold & Porter. In this role he counsels and advises global companies on regulatory and compliance matters worldwide, with a focus on compliance program effectiveness, compliance program implementation, operations and evaluation, and related regulatory counseling and advice. He works in a wide variety of industries and sectors including consumer products, electronics, energy, financial services, life sciences, medical device, pharmaceutical, and technology. Mr. Korenchuk has been included in The Best Lawyers in America. He has developed, led, and implemented “hands-on” educational and healthcare programs that provide pharmaceuticals and healthcare services, teachers, school supplies, library resources, and computers to indigenous communities in South America for the past 12 years.

Jonathan Levy, JD
Corporate Compliance Lead, Spark Therapeutics; Former Associate Director of Compliance and Ethics, US Pharmaceuticals, Bristol-Myers Squibb; Philadelphia, PA

Speaker Bio

Jonathan Levy is the Corporate Compliance Lead, Commercial for Spark Therapeutics, Inc. He is a lawyer who has worked as a federal prosecutor, in state government as an auditor of public contracts, as a counselor to businesses and individualsí private practice, and most recently as a compliance professional in pharma and biotech. He believes compliance guidance articulated in policies and training that explain the “why” behind the guidance, drives not only compliant behavior, but shows the value-add of having compliance at the table as a business partner.

Meghan Naas, MA
Senior Finance Manager, Compliance, TESARO, Inc., Waltham, MA

Speaker Bio

Meghan Naas works for TESARO, an oncology-focused biopharmaceutical company based in Waltham, MA, where she focuses on Anti-Bribery/Corruption, Aggregate Spend, sits on the Grant and IST review Committees, performs field rides and other compliance reviews, administers the 401(k) Plan and acts as the compliance representative for the Medical Department. Prior to TESARO, Meghan worked for an Investment Advisor with $10B in assets under management as the Director of Compliance, Risk and Special Projects, and previous to that she worked for a broker/dealer in various capacities including risk management, audit, and project management.

Brian Sharkey, JD
Principal, Porzio, Bromberg & Newman, PC, Morristown, NJ (Moderator)

Mini Summit XVIII: Effective and Balanced Monitoring Program based on Risk

1:00 pm

Welcome, Introductions, Discussions and Q&A

This session will be an open forum to discuss monitoring activities based on risk. The process of how companies identify risk to incorporate into monitoring programs (and any best practices), common and emerging risks, and how to establish and monitor activities for compliance with policies and regulations.

Sarah A. Franklin, JD
Partner, Covington & Burling, LLP, Washington, DC

Speaker Bio

Sarah Franklin is vice chair of Covingtonís Life Sciences Litigation and Investigations practice group. Ms. Franklin has defended numerous criminal and civil enforcement actions covering a broad range of health care compliance issues, including fraud and abuse, advertising and promotion, price reporting, and manufacturing. She also draws on her enforcement experience and industry knowledge to conduct internal investigations and regularly advises pharmaceutical, biotech, and medical device companies on mitigating risks and implementing compliance programs.

Beth Richardson
Director, Compliance, Horizon Pharma, Inc.; Former Compliance Director, CVS Health; Lake Forest, IL

Speaker Bio

Beth Richardson is a Chicago area based Compliance Director at Horizon Pharma. She has worked with pharmaceutical companies for the past 15 years to build, redesign, and enhance compliance programs. Her career originally started in consulting followed by TAP, Takeda, and CVS Health. Beth enjoys the entrepreneurial aspects of building compliance programs while also evolving with the ever changing regulatory environment.

Brian Van Hoy
Vice President, Compliance, G & M Health LLC; Former Director, Ethics and Compliance, Eli Lilly; Bridgewater, NJ (Moderator)

Speaker Bio

Brian Van Hoy is the Vice President of Compliance at G&M Health. He is an Ethics and Compliance Professional with extensive experience in the pharmaceutical and device industries. Prior to joining G&M, Brian held a position as Director of Ethics and Compliance for Eli Lilly. He has more than 30 years of experience within the healthcare industry across multiple functions and services. These areas include the establishment of an effective compliance program for new pharmaceutical and device companies and identifying opportunities to improve existing programs for established companies. In addition to compliance, Brian is experienced in sales, marketing, medical, regulatory and quality. Brian has served as President of the PDMA alliance and is a certified Compliance and Ethics Professional. He graduated from Purdue University having obtained a degree in Pharmacy.

Presentation Material (Acrobat)

2:00 pm

Transition Break

MINI SUMMITS BLOCK C 2:15 pm ñ 3:15 pm

(Choose one Mini Summit only)

Mini Summit XIX: Focus Clinical/R&D FMV, Monitoring, & Contracting Considerations

2:15 pm

Welcome, Introductions, Discussions and Q&A

Outsourcing of traditional pharmaceutical company functions, such as pharmacovigilance (PV).
— The role of Safety Data Exchange Agreements, and what to include in those documents.
— Sources of Risk.
Industry support of investigator-initiated studies ñ potential risks and proposed steps to mitigate that risk.
Fair market value assessments for research services Phase IV and Outcomes Research
New compliance risk areas for consideration, e.g.
— Clinicaltrials.gov, a new frontier of HHS enforcement activity?
— Potential misconduct related to ìright to tryî laws and expanded access
— Value Based Contracting
— Enforcement trends

Robert F. Church, JD
Partner, Hogan Lovells US LLP; Former Associate General Counsel, Amgen; Former Associate Chief Counsel, FDA; Los Angeles, CA

Speaker Bio

Robert Church is a partner in the FDA practice group at Hogan Lovells. Rob previously served as an Associate Chief Counsel at the Food and Drug Administration and in senior positions at Amgen Inc. Rob has an in-depth understanding of the regulatory requirements and operational details of clinical trials, new drug approvals, and the commercialization of pharmaceutical products. Rob also helps clients draft and negotiate regulatory agreements, including Safety Data Exchange Agreements, Manufacturing Quality Agreements, and all forms of agreements used in clinical trials. He also assists clients with the assessment of opportunities in the life sciences markets.

Jonathan Levy, JD
Corporate Compliance Lead, Spark Therapeutics; Former Associate Director of Compliance and Ethics, US Pharmaceuticals, Bristol-Myers Squibb; Philadelphia, PA

Speaker Bio

Mark A. DeWyngaert, MBA, PhD
Managing Director, Life Sciences Regulatory and Operational Risk, Deloitte & Touche LLP, New York, NY (Co-Moderator)

Oliver Steck
Principal, Life Sciences Regulatory and Operational Risk, Deloitte & Touche LLP, New York, NY (Co-Moderator)

Speaker Bio

Oliver Steck is a Principal in Deloitte & Toucheís Regulatory & Operational Risk Advisory practice and is leading the Regulatory and Patient Safety Risk Advisory group. He has over 20 years experience as a management consultant in the life science industry and helped global clients to optimize their organizations and processes in respect of regulatory information management, audits and compliance related issues, regulatory intelligence, drug safety and overall risk and quality management. Oliver lived and worked in Europe, Asia and the Americas.

Presentation Material (Acrobat)

Mini Summit XX: The Next Generation of Aggregate Spend Solutions, including Data Collection and Adjudication Challenges, Integration with Compliance Controls, and Monitoring and Global Challenges

2:15 pm

Welcome, Introductions, Discussions and Q&A

In this session, the panelists will discuss the evolution of the challenges to aggregate spend law compliance and how systems have matured since the early days of the federal Sunshine law enactment. In addition, the current landscape of CMS enforcement and how that has impacted (or not impacted) change will be discussed. Finally, they will address compliance with global aggregate spend laws, in particular, monitoring new developments, determining when applicable to your company, who is responsible for compliance, and how to operationalize capturing data and reporting.

Michael OíConnor, MS
Independent Consultant; Former Executive Director, Global Head, Boehringer Ingelheim; Former Senior Director, Global Head Compliance and Ethics Operations, Alexion Pharmaceuticals, Inc., New York, NY

Speaker Bio

Mike O’Connor is a consistent big picture, strategic thinker and creative problem solver with a talent for understanding complex situations, implementing solutions, and achieving results. He has over 18 years of international experience assisting clients in the Pharmaceutical industry with addressing business issues in areas such as Corporate Compliance, eDiscovery, Sales and Marketing Optimization, Regulatory Compliance, Document/records Management, Master Data Management and Information Management. Mike also has over 15 years of experience building and managing project teams throughout project life cycles, including business assessments, advisory, vendor selection, and realization with a key focus on delivering business results. Mike is currently at Alexion where he is the Global Head of Compliance Operations.

Kelly N. ìNikkiî Reeves, MPA, JD
Partner, King & Spalding LLP, Washington, DC

Speaker Bio

Nikki Reeves is a partner in King & Spaldingís FDA & Life Sciences Practice Group in Washington, D.C. She counsels pharmaceutical, biotechnology, and medical device companies on FDA and healthcare regulatory compliance matters, including product advertising/promotion, clinical trial regulation, quality system regulation/good manufacturing practices, FDA enforcement actions, and federal healthcare compliance programs. Nikki is an expert on state transparency laws targeting the pharmaceutical and device industries and the federal Physician Payment Sunshine provisions enacted as part of the Affordable Care Act and implemented by CMS. She leads the K&S Ad Hoc Sunshine and State Law Compliance Group, a coalition of pharmaceutical and medical device manufacturers that she advises on these state and federal transparency/disclosure laws. She also leads the K&S International Marketing and Disclosure Compliance Group, a separate coalition of pharmaceutical manufacturers, on the growing area of global transparency/disclosure laws and industry codes of conduct applicable to the pharma and medical device industry.

Darren R. Jones, CIA
Managing Partner, Polaris Management Partners, New York, NY (Moderator)

Presentation Material (Acrobat)

Mini Summit XXI: Cyber Security for Pharma and Medical Device Companies

2:15 pm

Welcome, Introductions, Discussions and Q&A

Discussion of the risk landscape for the Life Science industry from a law enforcement and private counsel experienced in cyber incident response. This will focus on what types of intrusions are occurring and who are behind them. The session concludes with planned for an incident response before it ever occurs.

Thomas G.A. Brown, JD
Managing Director, Global Practice Leader ñ Cyber Security & Investigations, Berkeley Research Group; Former AUSA, U.S. Attorneyís Office for the Southern District of New York; New York, NY

Speaker Bio

Tom Brown is a Managing Director and Global Leader of Berkeley Research Groupís Cyber Security and Investigations practice. Mr. Brown specializes in helping clients manage cyber risk, respond to cyber incidents, remediate vulnerabilities, and address post-incident regulatory inquiries and litigation. Prior to joining BRG, Mr. Brown served for 12 years as an Assistant United States Attorney in the U.S. Attorneyís Office for the Southern District of New York, where he supervised the Complex Frauds and Cyber Crime Unit. As a federal prosecutor, Mr. Brown supervised and led a broad range of complex, cross-border cyber investigations. They include Silk Road, a $1.2 billion underground drug website, the prolific ìhacktivistî groups Anonymous and LulzSec, and the hack of NASDAQ. Mr. Brown is a recipient of the FBI Directorís Award for Outstanding Cyber Investigation and was named ìProsecutor of the Yearî by the Federal Law Enforcement Foundation in 2011.

Jodi G. Daniel, MPH, JD
Partner, Crowell & Morings, Washington DC

Speaker Bio

Jodi Daniel is a partner in Crowell & Moring’s Washington, D.C. office and a member of the firm’s Health Care Group. She leads the Digital Health Practice and provides strategic advice to clients navigating the legal and regulatory environments related to technology in the health care sector to help them achieve their business goals. Jodi was the founding director of the Office of Policy in the Office of the National Coordinator for Health Information Technology (ONC), U.S. Department of Health and Human Services (HHS) for a decade after serving in the Office of the General Counsel at HHS for five years. At HHS, Jodi helped spearhead important changes in health information privacy and health information technology to improve health care for consumers nationwide. She was also one of the key drafters of the original Health Insurance Portability and Accountability Act (HIPAA) Privacy Rules and Enforcement Rules and developed the Nationwide Privacy and Security Framework for Electronic Exchange of Health Information.

Justin Herring, JD
Assistant United States Attorney, United States Attorneyís Office, District of New Jersey, US Department of Justice, Newark, NJ

Speaker Bio

Justin Herring is an Assistant United States Attorney in the District of New Jersey, where he is the Cyber Crimes Coordinator. He is a member of the Economic Crimes Unit and prosecutes cyber crimes, securities fraud, and other financial crimes. He was previously an Assistant United States Attorney in the District of Maryland, where he was also the Cyber Crimes Coordinator. Before becoming a federal prosecutor, he worked at Gibson, Dunn, & Crutcher, LLP, and clerked for Chief Judge Danny J. Boggs of the United States Court of Appeals for the Sixth Circuit. He received a J.D. with honors from the University of Chicago Law School.

Megan Reiss, LLM, PhD
Senior National Security Fellow, R Street Institute, Washington DC

Speaker Bio

Megan Reiss is senior national security fellow with the R Street Institute, where she writes about cybersecurity and other pressing national security issues. Megan joined R Street in September 2017 from Office of U.S. Sen. Ben Sasse, R-Neb., for whom she was also a senior national security fellow. Before that, she was co-manager of the William P. Clements Jr. Papers Project, a collaboration between the University of Texas at Austinís Clements Center for National Security and its Briscoe Center for American History.

William J. Hughes, Jr., JD, LLM
Principal, Porzio, Bromberg & Newman, PC; Assistant US Attorney and Trial Attorney, US Department of Justice, Morristown, NJ (Moderator)

Presentation Material (Acrobat)

Mini Summit XXII: Modernizing Compliance: Pulling Critical Levers to Improve Effectiveness

2:15 pm

Welcome, Introductions, Discussions and Q&A

Modern compliance organizations are risk intelligent, efficient, and deliver through business partnership and enablement. In this session, leveraging the diverse backgrounds and expertise of the panelists and their respective company experiences, we will discuss how pulling the critical levers of people, process, technology and analytics is changing the way companies manage risk and helping to improve overall compliance effectiveness.

Jill Fallows-Macaluso, JD
Chief Compliance Officer and Vice President, Novo-Nordisk, Princeton, NJ

Speaker Bio

As Chief Compliance Officer and Vice President for Novo Nordisk Inc., Jill Fallows Macaluso Esq., RN is charged with developing, operating, and overseeing an effective healthcare compliance program within the United States. Prior to joining the Compliance Department in 2012, Ms. Fallows Macaluso was Sr. Corporate Counsel in the Novo Nordisk Inc., Legal Department for nine years. Previously, Ms. Fallows Macaluso was with the General Corporate and Healthcare practice of Day Pitney, LLP. She holds a Bachelor of Science in Nursing from the University of Pennsylvania and a Juris Doctorate from Rutgers University School of Law.

Lindsay Havern, JD
Vice President and Assistant General Counsel, Pfizer, New York, NY

Speaker Bio

Lindsay Havern is the Chief Compliance Counsel for Pfizerís Global Compliance Risk Assessment, Systems and Reporting. She also manages Compliance Governance for the Executive Compliance Committee and the Regulatory and Compliance Committee of the Board. Her team executes the Companyís compliance risk assessment to enable early identification of emerging compliance risks based on predictive analytics and other quantitative and qualitative inputs. Previously, Lindsay served as the Chief Compliance Counsel for the Global Innovative Pharma, Oncology and Consumer businesses. She also has overseen the Companyís proactive and programmatic compliance activities. Prior to joining Pfizer, she was a partner at DLA Piper LLP.

Ann-Marie Tejcek, MA
Senior Director Ethics & Compliance, USA/Canada, Eli Lilly and Company, Indianapolis, IN

Speaker Bio

Ann-Marie Tejcek has been an employee with Eli Lilly and Company for over 24 years. Ann-Marie served as the Chief Compliance Officer for the US and Canadian Affiliates supporting Medical, Marketing and Sales activities. The mission of her team, and the broader compliance organization at Lilly, is to integrate high performance with high integrity. Ann-Marie began her career at Lilly in San Diego, California where she held numerous roles in Sales, Human Resources, and in Managed Care. Ann-Marie has led the launches of three different products in the United States for Lilly, was a Neuroscience National Senior Sales Director, Regional Medical Leader for Integrated Health Systems, and various other US and Global leadership roles in Sales, Marketing and Medical across the organization during her tenure.

Bryan Timer
Director, Data Analytics & Transparency, Merck, Allentown, PA

Speaker Bio

Bryan Timer is the Director of US Data Analytics and Transparency at Merck. In his current role, Bryan supports Merckís existing analytics efforts in the US and remains an integral part in ensuring the program is continuously evolving to meet internal and external demands. Bryan is looked at as an advisor for various other groups within Merckís compliance program and assists with developing and growing the groupís analytical capabilities. Prior to joining Merck, Bryan spent seven years as a consultant for two software companies which focused on providing software solutions to clients in the Consumer Packaged Goods industry as well as small and medium sized pharmaceutical companies.

Clarissa Crain
Senior Manager, Life Sciences Regulatory and Operational Risk, Deloitte & Touche LLP, Philadelphia, PA (Co-Moderator)

Jack Tanselle, MBA
Managing Director, Life Sciences Regulatory and Operational Risk, Deloitte & Touche LLP, Indianapolis, IN (Co-Moderator)

Presentation Material (Acrobat)

Mini Summit XXIII: Optimizing Data Collection for Use in Risk Assessments, Monitoring, and Auditing

2:15 pm

Welcome, Introductions, Discussions and Q&A

This session will focus on optimizing data collection for use in risk Assessments, monitoring, and auditing.

Stefanie A. Doebler, JD, MPH, MA
Of Counsel, Covington & Burling LLP, Washington, DC

Speaker Bio

Stefanie Doebler is of counsel in Covington & Burlingís health care and food and drug practice groups. Her practice focuses on health care compliance matters for pharmaceutical and medical device clients. She provides advice related to advertising and promotion, fraud and abuse, state law compliance and reporting regulations, interactions with health care professionals, clinical trial conduct and results disclosure, supply chain management, Medicaid price reporting, and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices.

Chris Fletchall, MBA
Senior Director, Ethics and Compliance, Global Operations, Eli Lilly and Company, Indianapolis, IN

Speaker Bio

Chris Fletchall is currently a Senior Director for Eli Lilly and Companyís Ethics and Compliance organization. He is leads Lillyís Ethics and Compliance Global Operations function. This function is responsible for many of the operational aspects of implementing Eli Lillyís global compliance program. Previously, he has been part of Lilly USAís compliance program in a variety of roles. Chris started his career with Eli Lilly and Company as a Pharmaceutical Sales Representative. He has had a variety of experiences with Lilly including a Business Analyst role supporting Lillyís Managed Markets team, a Human Resources role, and a Regional Account Manager role supervising Account Managers who have responsibility for cultivating relationships with large Federal Healthcare accounts.

Amy Pawloski
Global Lead, Compliance Risk Mitigation and Monitoring Strategy, Bristol-Myers Squibb, Philadelphia, PA

Speaker Bio

Amy Pawloski is the Global Lead, Risk Mitigation & Monitoring Strategy for BristolMyers Squibb (BMS). She is responsible for developing the strategy for a coordinated global risk-based monitoring program focusing heavily on data analytics. Prior to taking this role, Amy was the Head of U.S. Compliance & Ethics Monitoring & Data Analytics and oversaw the company’s U.S. compliance monitoring program. This included responsibility for the development and implementation of the U.S. compliance data analytics program. Prior to her roles in Compliance, she was a project manager responsible for the entire U.S. Pharmaceuticalsí business implementation of the companyís Corporate Integrity Agreement (CIA) in addition to holding roles in Commercial Business Operations, Government Pricing, and Finance. 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.

Katherine Buckley, MBA
Principal, Pharmaceutical and Life Sciences Advisory Practice, PwC, Philadelphia, PA (Moderator)

Mini Summit XXIV: The Evolution of Compliance Programs and Lessons Learned from Recent Rulings

2:15 pm

Welcome, Introductions, Discussions and Q&A

This session will focus on how compliance programs have evolved through the years. What is the difference between ethics and compliance, and what is expected of the business as the first line of defense? In addition, the panelists will share lessons learned from recent rulings, such as Wells Fargo.

Raymond A. Bonner, JD
Partner and Chair, Food, Drug and Medical Device Compliance and Enforcement Practice, Sidley Austin LLP; Former Assistant US Attorney, US Attorneyís Office, District of Maryland; Washington, DC

Speaker Bio

Raymond Bonner leads the firmís Food, Drug and Medical Device Compliance and Enforcement practice and is a member of the firmís Executive Committee. He concentrates his practice on representing life science companies in connection with government investigations, enforcement proceedings and litigation. These investigations and related enforcement matters involve a range of matters including clinical studies, marketing practices, pricing and reimbursement, product safety and reporting, good manufacturing practices (GMP), quality system regulation (QSR), and HACCP. Prior to joining Sidley, Mr. Bonner served as an Assistant United States Attorney in the District of Maryland for six years, where he prosecuted pharmaceutical application and GMP cases and litigated other FDA-related cases. Throughout his tenure as a prosecutor, he counseled FDA and its Special Prosecution Staff investigating the healthcare industry. Mr. Bonner is the recipient of the FDAís Harvey W. Wiley Medical and Commissionerís special citation.

Margaret K. Feltz, MA, JD
Vice President, Chief Compliance Officer, Ethics and Compliance, Purdue Pharma LP; Former Member, PCF Executive Committee; Stamford, CT

Jonathan Glazier, JD, MBA
Senior Legal Counsel, US Compliance Lead, Philips Electronics North America; Former Senior Director of Corporate Compliance and Privacy Officer, Fresenius Medical Care North America; Andover, MA

Gary Keilty
Managing Director, FTI Consulting, Tampa, FL (Moderator)

Speaker Bio

Gary Keilty is a Managing Director with FTI Consulting and has over 25 years experience providing consulting services to Life Sciences companies and Healthcare Providers. Gary’s consulting experience includes assisting clients with litigation and government investigation support, regulatory compliance program assessments, compliance program development and IRO services. Gary has significant knowledge of current federal investigative and enforcement initiatives and targeting and audit methodologies used by various State and Federal agencies.

Presentation Material (Acrobat)

Mini Summit XXV: The Winding Path to the Patient: Balancing Risks in Patient and Product Support

2:15 pm

Welcome, Introductions, Discussions and Q&A

The legal backdrop and operational considerations related to patient assistance programs (e.g., drug assistance programs, co-pay and coupon cards, hub services) and independent charity support.

Meenakshi Datta, JD
Partner, Sidley Austin LLP, Chicago, IL

Speaker Bio

Meena Datta is a trusted advisor among publicly traded and privately held life sciences companies. Meena focuses on strategic and regulatory counseling on all aspects of healthcare law that impact pharmaceutical, medical device, clinical diagnostic laboratories, and healthcare and digital health companies, including healthcare reform; fraud and abuse, particularly the Federal Anti-Kickback Statute; pharmaceutical government price reporting obligations; federal healthcare program coverage and reimbursement issues; healthcare compliance programs, including drafting policies and procedures, counseling on implementation issues, and conducting audits and internal reviews; managed care contracting; HIPAA and HITECH implementation and compliance; and federal and state transparency and reporting laws, including the Sunshine Act and similar state laws.

BJ DíAvella
Senior Manager, Life Sciences Regulatory and Operational Risk, Deloitte & Touche LLP, Atlanta, GA (Moderator)

Presentation Material (Acrobat)

3:15 pm

Networking Break

CLOSING PLENARY SESSION

3:45 pm

Co-Chair Welcome and Introductions

Jennifer McGee, JD
Chief Compliance Officer, Otsuka Pharmaceuticals, Inc., Princeton, NJ (Co-chair)

Speaker Bio

Jennifer McGee is Vice President and Chief Compliance Officer at Otsuka America Pharmaceutical, Inc. She joined Otsuka in January 2011 as Senior Compliance Counsel, overseeing compliance with the Corporate Integrity Agreement, implementation of the companyís Aggregate Spend solution and transparency reporting, and providing compliance support to the CardioRenal and Oncology franchises. Prior to joining Otsuka, Jennifer spent 7 Ω years as a litigation attorney in the White Collar Group at the Washington, D.C. office of Shook, Hardy & Bacon, focused on the representation of pharmaceutical and medical device manufacturers in government investigations. Jennifer also served on active duty in the US Army for more than 13 years, trying more than 70 felony cases, and recently retired from the Army Reserves

Keynote: The Role of Behavioral Economics in Ethics and Compliance

Jim Sheehan, JD
Chief, Charities Bureau at Attorney General of New York; Chief Integrity Officer, Executive Deputy Commissioner, City of New York Human Resources Administration; Medicaid Inspector General, New York Office of the Medicaid Inspector General; Former Associate United States Attorney, US Attorneyís Office for the Eastern District of Pennsylvania; New York, NY

Speaker Bio

Mr. Sheehan was appointed by New York Attorney General Eric Schneiderman in January 2014 as the new chief of the Charities Bureau, the division of the New York Attorney General’s office that supervises charitable organizations. The Charities Bureau is responsible for enforcement activities, trust regulation, oversight and public outreach for over 90,000 New York nonprofits whose employees make up the largest nonprofit sector in this country. Previously, Mr. Sheehan served as York’s first Chief Integrity Office of the Human Resources Administration (HRA), the nation’s largest social services agency with over 14,000 employees. Mr. Sheehan previously served as first New York State Medicaid Inspector General from 2007 through 2011, and pioneered the use of data analysis tools to identify improper claims in the nation’s most generous Medicaid program. He had been the Associate U.S. Attorney for Civil Programs in the Eastern District of Pennsylvania (Philadelphia).

4:15 pm

Interview regarding PhRMA Priorities and Policy Initiatives

Jim Stansel, JD
General Counsel, PhRMA, Washington, DC

Speaker Bio

Jim Stansel is General Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA), where he is responsible for leading a team of lawyers in supporting PhRMAís policy, advocacy and science priorities and in the development of sound legal policies impacting the pharmaceutical industry. Jim previously served as Acting General Counsel, Deputy General Counsel and Health Policy Counselor to the Secretary of the U.S. Department of Health & Human Services. He also was previously a partner and co-head of Sidley Austin LLPís Global Life Sciences Team.

Ann E. Beasley, JD
Director, Navigant Consulting; Former Senior Vice President, Chief Compliance Officer, Biogen; Boston, MA (Moderator)

Speaker Bio

Ann is a Director at Navigant Consulting, Inc., in the Healthcare and Life Sciences Disputes, Regulatory, Compliance and Investigations practice. She has over 17 years of in-house healthcare and life sciences experience for companies in pharmaceutical, biologics, vaccine, device and genetic testing. She has practiced in both legal and compliance departments and just prior to joining Navigant, was the Chief Compliance Officer and Senior Vice President at Biogen. Ann has significant international experience having built and led global compliance programs for major pharmaceutical and biotechnology companies, including developing the organizational infrastructure of the function and the individual skill development of compliance professionals. Ann has specific legal and regulatory expertise in advertising and promotion, kick-backs, anti-bribery and anti-corruption, grants and charitable contributions, conflicts of interest, healthcare practitioner fee for service arrangements, spend transparency, Phase IV clinical trial processes, Investigator Initiated Studies, issues related to medical affairs practices including advising on field interactions, publication processes and use, and secondary research.

4:45 pm

Brief Overview of the Policy and Politics of Pharma Pricing

Tom Hubbard, MPP
Vice President of Policy Research, NEHI (The Network for Excellence in Health Innovation); Former Executive Assistant for Economic Affairs, US Senator John Kerry; Former Deputy Director of Development, Massachusetts Governor Michael Dukakis; Cambridge, MA

Speaker Bio

As NEHI Vice President of Policy Research, Tom Hubbard manages ongoing projects on value-based contracting for biopharmaceuticals in the U.S. He also manages recurring NEHI projects on medication management and adherence, Real World Evidence, and comparative effectiveness policy. NEHI is a national non-profit, nonpartisan organization comprised of stakeholders from across all key sectors of U.S. health and health care.

Presentation Material (Acrobat)

5:00 pm

View from the Marketplace: Rewarding Results: Moving Forward for Value-Based Contracting for Biopharmaceuticals

Jim Clement, MHA
Executive Director, Cost of Care and Supply Chain Strategy, Aetna; Former National Account Manager, PBMs and Specialty Pharmacy, Genentech, Inc.; Former Director, Pharmaceutical Contracting, Express Scripts, Inc.; Hartford, CT

Speaker Bio

Jim Clement currently serves as Executive Director for Aetna Pharmacy Management and is responsible for transforming the financing of the pharmacy benefit and leading Aetna’s enterprise relationships with pharmaceutical manufacturers. Jim maintains administrative oversight for PBM strategy, actuarial services, network administration, client pricing, analytics and vendor management in addition to his focus on innovative contracting models that help drive value-based care. Prior to joining Aetna, Mr. Clement worked at Genentech in channel and distribution management focusing on the PBM and Specialty Pharmacy segments and forming payer contracting and negotiating strategies. Prior to Genentech, Mr. Clement was the Director of Pharmaceutical Contracting at Express Scripts.

David Hartenbaum, MD, MBA
Executive Director, Account Management, Merck, Philadelphia, PA

Speaker Bio

David Hartenbaum is currently Executive Director for PBM and National Accounts within Merck’s US Integrated Account Management group. His team is also responsible for all regional health plan contracting as well as Fee for Service Medicaid contracting. David has 13 years of Managed Markets experience at Merck and the Merck/Schering-Plough joint venture.

Dorothy Hoffman, MPP
Director, Healthcare Transformation and Policy Partnerships, Eli Lilly and Company, Indianapolis, IN

Speaker Bio

Dorothy Hoffman, M.P.P., is the Director of Healthcare Transformation and Policy Partnerships. In this role, Dorothy develops partnerships to solve healthcare system and policy challenges. She launched the companyís policy partnership with Anthem advocating for the implementation of novel value-based payment and communication arrangements in the U.S. In her career at Lilly, Dorothy has held positions in Corporate Affairs of increasing responsibility at the Company Headquarters in Indianapolis, Indiana and in affiliate offices in Belgium and the United Kingdom. More recently, Dorothy was the Head of U.S. Health Policy. In this role she provided advice to business and scientific executives on how legislative and regulatory changes will impact the development and commercialization of Lillyís innovative medicines portfolio. Previsously, Dorothy worked at the International Chamber of Commerce in Paris, France, where her work focused on the role of international trading agreements and the impact on access to medicines in developing countries.

Julie Ritchie Wagner, JD
Assistant General Counsel, PhRMA; Former Senior Counsel, Office of Counsel to the Inspector General, US Department of Health and Human Services; Washington, DC

Speaker Bio

Julie Wagner is Assistant General Counsel at PhRMA with responsibility for compliance, and enforcement matters. Prior to joining PhRMA, Julie served in the Office of the Inspector General at the U.S. Department of Health & Human Services where she worked in the Industry Guidance Branch as an Anti-kickback Statute subject matter expert, advising on fraud and abuse issues.

Speaker Bio

AGENDA: DAY 2TUESDAY, NOVEMBER 7, 2017

7:00 am

Registration Opens: Continental Breakfast in Exhibit Hall

MORNING PLENARY SESSION

8:00 am

Co-chair Welcome and Introductions

8:15 am

FDA Keynote

8:45 am

Qui Tam Roundtable

9:30 am

Demonstrating the Value of the Compliance Organization

10:15 am

Break

MINI SUMMITS BLOCK A: 10:45 am ñ 11:45 am

Mini Summit I: Compliance Messaging: Using Behavioral Economics to Improve Messaging Stickiness

10:45 am

Mini Summit II: HCP Engagement: The Road to Proactive Risk Management

10:45 am

Mini Summit III: Enforcement Trends, Risk Assessments and Best Practices for Patient Assistance and Reimbursement Support

10:45 am

Mini Summit IV: Managed Market Considerations for Hub and Specialty Pharmacy Arrangements

10:45 am

Mini Summit V: Compliance and Ethics Considerations in R&D

10:45 am

Mini Summit VI: Compliance Program Effectiveness: Using Data Analytics to Tell the Story

10:45 am

Mini Summit VII: International Organization for Standardization (ISO) 37001: A New Era of Anti-bribery/Anti-corruption (ABAC) Compliance

10:45 am

11:45 am

Networking Luncheon

OPTIONAL LUNCHEON MINI SUMMITS 11:55 am ñ 12:55 pm

Luncheon Mini Summit VIII: FDA Regulation and Cutting Edge Technology – What Pharmaceutical and Medical Device Companies Should Know

11:55 am

Luncheon Mini Summit IX: Pricing Considerations (Mylan Epipen, Marathon Pharmaceuticals, et al)

11:55 am

Luncheon Mini Summit X: Rescheduled. See Mini Summit XXV

Luncheon Mini Summit XI: Innovation and Compliance: They are not Mutually Exclusive

11:55 am

MINI SUMMITS BLOCK B 1:00 pm ñ 2:00 pm

Mini Summit XII: Third Party Risk Management/Due Diligence Update

1:00 pm

Mini Summit XIII: Global Compliance in the Transactional Context: Due Diligence, Integration and Post-Transaction Steps

1:00 pm

Mini Summit XIV: Hands on Learning: Managing an Internal Investigation under a CIA, DPA and a Data Analytics Failure

1:00 pm

Mini Summit XV: Recent FDA Guidance Document Manufacturer Communications

1:00 pm

Mini Summit XVI: Compliance Considerations for Small and Mid-Sized Pharma and Medical Device Companies

1:00 pm

Mini Summit XVII: Advanced Issues in Global Compliance

1:00 pm

Mini Summit XVIII: Effective and Balanced Monitoring Program based on Risk

1:00 pm

2:00 pm

Transition Break

MINI SUMMITS BLOCK C 2:15 pm ñ 3:15 pm

Mini Summit XIX: Focus Clinical/R&D FMV, Monitoring, & Contracting Considerations

2:15 pm

Mini Summit XX: The Next Generation of Aggregate Spend Solutions, including Data Collection and Adjudication Challenges, Integration with Compliance Controls, and Monitoring and Global Challenges

2:15 pm

Mini Summit XXI: Cyber Security for Pharma and Medical Device Companies

2:15 pm

Mini Summit XXII: Modernizing Compliance: Pulling Critical Levers to Improve Effectiveness

2:15 pm

Mini Summit XXIII: Optimizing Data Collection for Use in Risk Assessments, Monitoring, and Auditing

2:15 pm

Mini Summit XXIV: The Evolution of Compliance Programs and Lessons Learned from Recent Rulings

2:15 pm

Mini Summit XXV: The Winding Path to the Patient: Balancing Risks in Patient and Product Support

2:15 pm

3:15 pm

Networking Break

CLOSING PLENARY SESSION

3:45 pm

Co-Chair Welcome and Introductions

Keynote: The Role of Behavioral Economics in Ethics and Compliance

4:15 pm

Interview regarding PhRMA Priorities and Policy Initiatives

4:45 pm

AGENDA: DAY 2
TUESDAY, NOVEMBER 7, 2017