Agenda - Day 2 - 2018 Pharma Congress

Agenda Links: Preconferences/Day 1 | Day 3

AGENDA: DAY 2
THURSDAY, NOVEMBER 8, 2018

7:00 am

Registration Opens; Continental Breakfast in Exhibit Hall

BREAKFAST ROUNDTABLES

Breakfast Roundtable I: Adapting an Effective Compliance Program for a #TimesUp World

#MeToo and #TimesUp-related stories dominated the media in 2017 and 2018. The elements of an effective corporate compliance program are clearly critical to addressing risks associated with pharmaceutical and medical device company activities in research, sales and marketing. This panel will address how the elements of compliance programs can be extended to combat the risk associated with potential sexual and gender harassment in the workplace. The panel will discuss EEOC guidance, real world best practices for assessing corporate culture and combatting harassment, recent studies highlighting the incidence of harassment experienced by women in the academic sciences, and recommendations for changes to improve corporate culture in this important area.

7:15 am

Welcome, Introductions, Discussions and Q&A

Margaret Erin Rodgers-Schmidt, JD
Partner, Morgan Lewis & Bockius, Philadelphia, PA

Speaker Bio

Margaret Erin Rodgers-Schmidt is a Partner in Morgan Lewis’ white collar practice. Erin represents pharmaceutical manufacturers, medical device manufacturers, and healthcare clients in complex civil and criminal government investigations, internal investigations, and civil litigation. For these and other clients, Erin also conducts internal investigations and assessments related to sexual harassment and workplace culture. Erin regularly advises clients regarding the development and oversight of compliance programs and the negotiation, implementation, and monitoring of corporate integrity agreements. Erin co-leads Morgan Lewis’s healthcare industry initiative and supports the Morgan Lewis interdisciplinary team counseling clients on #MeToo-related matters and workplace culture.

Angela Schwartz, JD
Senior Manager, Fraud Investigations & Dispute Services, Life Sciences, EY, Philadelphia, PA

Speaker Bio

Angela J. Schwartz is a Senior Manager at Ernst & Young, LLP in the Forensic & Integrity Services practice. She has over 14 years of professional experience in investigations and compliance matters in the life sciences industry. Angela assists life sciences clients with compliance improvement projects, complex international bribery and corruption investigations, pre-acquisition compliance due diligence, the development and execution of monitoring programs, and third party assessments. Prior to joining EY, Angela was an associate at Morgan, Lewis & Bockius, LLP in the litigation group where she focused on government investigations and litigation in the life sciences industry.

Presentation Material (Acrobat)

Breakfast Roundtable II: The Impact of the Opioid Crisis on the Pharmaceutical Industry

John C. Richter, King & Spalding partner, will lead a breakfast roundtable discussion on the “The Impact of the Opioid Crisis on the Pharmaceutical Industry.” Richter, a former U.S. Attorney and Acting Assistant Attorney General for the Criminal Division will be joined by Rachel Honig, the First Assistant United States Attorney for the District of New Jersey.

The discussion will explore lessons for the pharmaceutical industry from the opioid crisis, including (1) the origins of the opioid crisis and its emergence as a major public health and policy issue and what other companies can learn from that history; (2) the methods, theories and techniques being pursued in the present investigations and cases and how those could be used in the future against non-opioid manufacturers; and (3) the compliance lessons that can be learned today by non-opioid manufacturers.

7:15 am

Welcome, Introductions, Discussions and Q&A

Rachael Honig, JD
First Assistant US Attorney, US Attorney’s Office for the District of New Jersey; Former Corporate Counsel, Litigation, Celgene, New York, NY

Speaker Bio

Rachael A. Honig is the First Assistant U.S. Attorney at the U.S. Attorney’s Office for the District of New Jersey. She rejoined the U.S. Attorney’s Office earlier this year after serving as Corporate Counsel, Litigation, at Celgene Corporation from 2016 to March 2018. At the U.S. Attorney’s Office, Ms. Honig previously served as Counsel to the U.S. Attorney (2013-2016); Deputy Chief of the Criminal Division (2010-2013); and an Assistant U.S. Attorney in the Criminal and Special Prosecutions Divisions (2003-2010). Prior to that, she was a Litigation Associate at Wilmer Cutler Pickering Hale & Dorr in Washington, D.C., and a judicial law clerk to the Hon. Mary M. Schroeder of the U.S. Court of Appeals for the Ninth Circuit.

John C. Richter
Partner, King & Spalding, Washington, DC (Moderator)

Speaker Bio

John Richter is a trial and investigations partner in the Special Matters and Investigations Practice Group, and represents and defends companies, Boards of Directors, Board committees, and individuals facing a variety of white-collar criminal and regulatory enforcement matters, parallel civil litigation, and internal corporate investigations. John previously served as the Acting Assistant Attorney General in charge of the Criminal Division at the U.S. Department of Justice and as the U.S. Attorney for the Western District of Oklahoma, having been nominated by President George W. Bush and confirmed by unanimous consent of the U.S. Senate.

Law360 named John “White-Collar MVP of the Year” in 2016. In 2017, he was recognized as one of the top 100 trial lawyers in America by Benchmark Litigation and as a Life Sciences Star for litigation by LMG Life Sciences. Also in 2017, John was elected to the Board of the National Association of Former United States Attorneys.

Presentation Material (Acrobat)

Breakfast Roundtable III: U.S. Leadership to Strengthen Ethical Business Practices Overseas: What Compliance Leaders Need to Know

The U.S. Department of Commerce, in partnership with leading industry bodies and hundreds of major health stakeholders, oversees the world’s largest public-private partnerships to strengthen ethical business practices in the medical device and pharmaceutical sectors. Spanning the Asia-Pacific and entire Western Hemisphere, these partnerships are recognized by Heads of State and Ministers. They have generated six national ethics agreements on four continents as well as facilitated a doubling in the number of industry association codes around the world, expanding high-standards to nearly 18,000 enterprises in these sectors alone. As these major initiatives continue to expand, compliance leaders in the United States with international responsibilities or interests can learn more about what to expect and future opportunities to directly contribute.

7:15 am

Welcome, Introductions, Discussions and Q&A

Andrew Blasi
Director, C&M International, Crowell & Moring, Former Pamela Harriman Foreign Service Fellow, US Embassy in London, Former Congressional Liaison, Australian Embassy and Foreign Affairs Subcommittee on Europe, US House of Representatives, Washington, DC

Speaker Bio

Andrew Blasi guides the development and management of large-scale international, multi-sectoral partnerships. This includes the facilitation of national agreements to strengthen ethical business practices within health systems around the world. Andrew also advises American business leaders on international trade and foreign policy matters in support of their engagement with U.S. government principals. Prior to joining C&M International in 2010, Andrew worked for the US-ASEAN Business Council in Washington. In 2008, Andrew served as the Pamela Harriman Foreign Service Fellow to Ambassador Robert Tuttle at the U.S. Embassy in London. Andrew has also worked in the Congressional Liaison Office of the Australian Embassy in Washington, D.C. and the U.S. House of Representatives Foreign Affairs Subcommittee on Europe. A native of South Florida, Andrew serves on the Board of Trustees for Florida House on Capitol Hill, a nonprofit, nonpartisan organization that serves as the state’s embassy in Washington, D.C.

Lynn Costa
Senior Policy Advisor for the Western Hemisphere, U.S. Department of Commerce, Washington, DC

Tricia Van Orden
Deputy Director, Trade Promotion Coordinating Committee Secretariat, International Trade Administration, US Department of Commerce, Washington, DC

Speaker Bio

Tricia Van Orden is Deputy Director of the Trade Promotion Coordinating Committee (TPCC) Secretariat at the International Trade Administration (ITA) within the U.S. Department of Commerce. In this role, she coordinates trade promotion strategies across 20 federal agencies and among states and localities to better assist and to improve the competitiveness of U.S. exporters.

Nancy Schwalje Travis, MIA
Vice President, International Compliance and Governance, AdvaMed, Former Deputy Director, Office of Economic Policy, Asia-Pacific Bureau, US Department of State, Washington, DC

Speaker Bio

As Vice President for International Compliance and Governance at the Advanced Medical Technology Association (AdvaMed), Nancy Schwalje Travis leads the association’s efforts to promote codes of ethics for the medical technology industry worldwide, focusing on Asia-Pacific, Latin America and Europe. She also addresses key issues related to association governance, including management of the Board of Directors. Ms. Travis has 20 years of international affairs and economics experience, with a particular focus on China trade issues. She worked on China and Taiwan’s World Trade Organization accession negotiations and has been involved in assessing compliance with WTO commitments. She was a leading voice in support of the Asia-Pacific Economic Cooperation (APEC) forum’s decision to promote codes of ethics for the medical device, pharmaceutical and construction industries and commit to regulatory harmonization for medical products. Throughout her career, she has received a number of exceptional performance awards and superior honor awards.

Russell Williams
Vice President, Government Relations and Public Affairs, Diabetes Canada, Patient Co-Chair, APEC Biopharmaceutical Working Group, Former President, Innovative Medicines Canada – Médicaments novateurs Canada, Ottawa, Canada

Speaker Bio

Russell Williams is the Vice-President, Government Relations and Public Policy at Diabetes Canada. He is the former President of Innovative Medicines Canada (formerly Rx&D), an influential association of over 50 pharmaceutical companies, a leading voice of the innovative life science sector in Canada. He worked with all governments at the Federal and Provincial levels, both at political and administrative levels, and he was involved in numerous task forces on pharmaceutical policy, and also participated in a number of key international coalitions focused on improving research, healthcare and ethics networks. Russell chaired the Code Compliance Network for the IFPMA, and serves as the primary private sector lead for the APEC biopharmaceutical ethics initiative. Prior to his appointment as President of Innovative Medicines Canada, Russell served as the Member of the Quebec National Assembly for the riding of Nelligan.

Chrisoula Nikidis
Canadian Head of Compliance and Ethics Solutions, IQVIA, Former Executive Director, Ethics and Compliance, Innovative Medicines Canada, Ottawa, Canada (Moderator)

Speaker Bio

Chrisoula Nikidis is the Canadian Head of Compliance and Ethics Solutions at IQVIA. A dedicated leader in the field of compliance, ethics, governance and stakeholder relations in the innovative medicines and life science sectors, Chrisoula’s successful career is highlighted by creative citizen mobilization, coalition-building and the development of ethical practices on a provincial, national and international level.

She has built a reputation as a trusted and respected leader of issues involving ethics and integrity both in the private and public sectors. She was previously the Executive Director, Ethics and Compliance for Innovative Medicines Canada.

Chrisoula has played a pivotal role in the advancement of compliance and ethics on the provincial, national and international level through her leadership in the Code of Ethical Practices as well as with her work with IFPMA and the APEC Biopharmaceutical Ethics Initiative.

Presentation Material (Acrobat)

8:00 am

Breakfast Roundtable Adjournment

MORNING PLENARY SESSION

8:00 am

Co-chair Welcome and Introductions

Jennifer McGee, JD
Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc., Rockville, MD (Co-chair)

Speaker Bio

Jennifer McGee has been Chief Compliance Officer at Otsuka Pharmaceutical Development & Commercialization since June 2015. She joined Otsuka in January 2011, overseeing compliance with the Corporate Integrity Agreement, implementation of the company’s Aggregate Spend solution and transparency reporting, and providing compliance support to the CardioRenal and Oncology franchises. Prior to joining Otsuka, Jennifer spent 7 ½ 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 still serves in the Army Reserves.

8:15 am

AUSA Roundtable

Charlene Keller Fullmer, JD
Assistant United States Attorney and Deputy Chief, Affirmative Litigation, United States Attorney’s Office, Eastern District of Pennsylvania, Philadelphia, PA

Speaker Bio

Assistant United States Attorney Charlene Keller Fullmer is the Deputy Chief for Affirmative Litigation in the Civil Division of the United States Attorney’s Office in the Eastern District of Pennsylvania, where she supervises and prosecutes health care and affirmative fraud matters. She led the Philadelphia civil prosecution team that investigated and resolved allegations of off-label promotion of the atypical antipsychotic drug Risperdal by Johnson and Johnson and its subsidiary Janssen Pharmaceuticals and served on the team that investigated and resolved allegations of off-label promotion and kickbacks by Pfizer, Inc.

Ms. Fullmer returned to the Justice Department in 2007 after six years in private practice at Duane Morris LLP in Philadelphia, where she litigated defensive matters. Prior to that time, she served as an Attorney Advisor in Washington, DC and Quantico, VA with the Federal Bureau of Investigation, Office of Professional Responsibility, the Bureau’s Internal Affairs.

Christopher B. Harwood, JD
Assistant US Attorney and Chief of the Civil Health Care Fraud Unit, US Attorney’s Office, Southern District of New York; Former Assistant US Attorney, US Attorney’s Office for the District of Columbia, US Department of Justice, New York, NY

Speaker Bio

Christopher Harwood joined the Civil Division of the U.S. Attorney’s Office for the Southern District of New York (“SDNY”) in January 2011. In October 2014, he was appointed as the Deputy Chief of the Office’s Civil Frauds Unit (“CiFU”), and in August 2016, he was appointed as the CoChief of the CiFU. Since joining the Office, he has focused his practice on affirmative fraud work, and has successfully pursued claims against numerous financial institutions, health care providers, and other recipients of federal funds. Prior to joining the SDNY, Mr. Harwood was an Assistant U.S. Attorney at the U.S. Attorney’s Office for the District of Columbia, as well as an associate at Cravath, Swaine & Moore LLP. He also served as a law clerk for the Hon. Norman H. Stahl of the U.S. Court of Appeals for the First Circuit, and the Hon. Joseph L. Tauro of the U.S. District Court for the District of Massachusetts.

Rachael Honig, JD
First Assistant US Attorney, US Attorney’s Office for the District of New Jersey; Former Corporate Counsel, Litigation, Celgene, New York, NY

Speaker Bio

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

Speaker Bio

John Bentivoglio is a partner at Skadden Arps in the life sciences enforcement and regulatory team in Washington, DC. Previously he served as Associate Deputy Attorney General and Special Counsel for Health Care Fraud at the U.S. Department of Justice.

9:00 am

FCPA Enforcement Update

Leslie Backschies, MA
Supervisor Special Agent and Unit Chief, International Corruption Unit, Federal Bureau of Investigation, Los Angeles, CA

Speaker Bio

Supervisory Special Agent Backschies supervises the Los Angeles International Corruption Squad for the FBI, which includes satellite offices in Houston Texas, Miami Florida, San Francisco California, and New Orleans Lousiana. In 2012, SSA Backschies was selected for the FBI’s International Operations Division (IOD) Americas Unit, where she was stationed in South America. In this capacity, Supervisory Special Agent Backschies was the Program Manager over the FBI’s offices in Brasilia, Mexico City, Bogota, Caracas, Santiago and San Salvador. In that role, Agent Backschies supervised many of the high profile investigations that have been conducted by the FBI, in collaboration with partners in law enforcement in Latin America. SSA Backschies joined the FBI in 1998 where she served in the FBI’s National Security Division. She has 20 years’ experience with the FBI.

Jacob Elberg, JD
Assistant US Attorney, US Attorney’s Office, District of New Jersey, US Department of Justice, Newark, NJ

Speaker Bio

Jake Elberg is an Assistant U.S. Attorney with the U.S. Attorney’s Office for the District of New Jersey, where he has supervised and directed the Office’s criminal and civil healthcare matters, including investigations and prosecutions of fraud against health insurance plans, kickback schemes, violations of the Food, Drug & Cosmetic Act, and the diversion of prescription drugs, as well as health care-related actions under the False Claims Act and investigations and prosecutions relating to the Foreign Corrupt Practices Act. Jake is also an Adjunct Professor at Seton Hall Law School. Jake attended Dartmouth College and Harvard Law School.

Tarek Helou, JD
Assistant Chief, FCPA Unit, Fraud Section, Criminal Division, US Department of Justice, Washington, DC

Speaker Bio

Tarek Helou is an Assistant Chief in the U.S. Department of Justice’s Foreign Corrupt Practices Act Unit. He has worked in the FCPA Unit since 2012. As an Assistant Chief, Tarek supervises other attorneys who work with law enforcement agents to prosecute and investigate violations of the FCPA and related criminal laws. He was an Assistant U.S. Attorney in San Francisco from 2007 to 2012, where he prosecuted cases involving drug trafficking, firearms offenses, racketeering, money laundering, tax violations, child exploitation, fraud, and immigration offenses. From 2001 to 2007, Tarek was an associate at Orrick, Herrington, and Sutcliffe in Silicon Valley and San Francisco.

Cheryl J. Scarboro, JD
Partner, Simpson Thacher & Bartlett; Former Chief, Foreign Corrupt Practices Act Unit, Enforcement Division, US Securities and Exchange Commission, Washington, DC

Speaker Bio

Cheryl Scarboro is a Partner in the Washington, D.C. office of Simpson Thacher & Bartlett LLP. Formerly the first Chief of the SEC’s FCPA Unit, she represents corporations, financial institutions and individuals in SEC and other regulatory enforcement proceedings. Cheryl conducts internal investigations and counsels clients on FCPA compliance programs, SEC reporting, disclosure and corporate governance requirements. She was recognized as one the “25 Most Influential Women in Securities Law” by Law360, is consistently listed in the “Top 250 Women in Litigation” by Benchmark Litigation, and was named to the “Enforcement 40” by the Securities Enforcement Forum. Cheryl is a member of the Board of Visitors of Duke University School of Law.

Gary F. Giampetruzzi, JD
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY, USA (Moderator)

Speaker Bio

Gary Giampetruzzi is a partner in the Investigations and White-Collar practice in the Litigation Department at Paul Hastings, based in the firm’s New York office. Mr. Giampetruzzi routinely advises clients on day-to-day compliance matters, and represents corporations in high-profile federal and state investigations, including those involving federal and state False Claims Act (qui tam suits), State Attorney General consumer protection statutes, the Foreign Corrupt Practices Act (“FCPA”), and oversees other complex civil and criminal litigation matters. While his practice cuts across numerous sectors, Mr. Giampetruzzi possesses particularly deep experience in the life sciences sector, representing many of the world’s most prominent biotech, pharmaceutical, and medical device companies.

Prior to joining Paul Hastings, Mr. Giampetruzzi most recently served as Vice President, Assistant General Counsel and Head of Government Investigations at Pfizer Inc. He was previously a Deputy Compliance Officer responsible for international compliance investigations and programs.

9:45 am

Qui Tam Roundtable

Zachary A. Cunha, JD
Assistant US Attorney and Chief, Civil Division, US Attorney’s Office, District of Rhode Island, US Department of Justice; Former AUSA, District of Massachusetts and Eastern District of New York, Providence, RI

Speaker Bio

Zachary A. Cunha is Chief of the Civil Division in the U.S. Attorney’s Office for the District of Rhode Island. During his nearly fourteen-year career with DOJ, Mr. Cunha has served in three U.S. Attorney’s Offices, including the Eastern District of New York and the District of Massachusetts, where he headed that office’s Affirmative Litigation Unit and was responsible for litigating and supervising a number of nationally significant health care fraud investigations. In 2010, Mr. Cunha was recognized with the Attorney General’s Award for Exceptional Service, the Department of Justice’s highest honor, for his work on the prosecution team in United States v. Pfizer. Mr. Cunha is a graduate of Brown University and the George Washington University Law School.

Suzanne E. Durrell, JD
Managing Member, Whistleblower Law Collaborative, LLC, Taxpayers Against Fraud Education Fund, 2017 Whistleblower Lawyer of the Year, Boston, MA

Speaker Bio

Suzanne E. Durrell is a Managing Member of the Whistleblower Law Collaborative LLC in Boston which she founded with Robert M. Thomas, Jr. She and Mr. Thomas were named the 2017 Whistleblower Lawyers of the Year by the non-profit public interest organization Taxpayers Against Fraud Education Fund for “an extraordinarily successful year in careers devoted to fighting fraud.” Together they have successfully represented relators in many cases including ones against Mylan, Amgen, Forest, Elan, Eisai, WellCare, Amedisys, and Pfizer. Ms. Durrell served as an Assistant U.S. Attorney and as Deputy Chief, and then Chief, Civil Division, U. S. Attorney’s Office, Boston, supervising and prosecuting False Claims Act cases from 1989 to 2002. She also served as Deputy Associate Attorney General at the Department of Justice in Washington, D.C. She received the Attorney General’s Award for Exceptional Service, the most prestigious recognition bestowed by the Department.

Colette G. Matzzie, JD
Partner, Phillips & Cohen LLP, Former Civil Appellate Staff and Trial Attorney, Tobacco Litigation Team, US Department of Justice, Washington, DC

Speaker Bio

Colette Matzzie is a partner at whistleblower law firm Phillips & Cohen LLP. She represents whistleblowers in a wide variety of qui tam cases brought under the federal False Claims Act and similar state false claims laws. Her practice includes pursuing fraud cases that involve healthcare fraud, defense contractor fraud, and government procurement fraud, as well as other types of wrongdoing. She represented a whistleblower in a landmark EHR that settled in June 2017 for $155 million. Other major whistleblowers cases she has brought include ones against Verizon Communications ($96.5 million settlement) and pharma company Boehringer Ingelheim ($95 million). Ms. Matzzie has been named one of the “500 Leading Lawyers in America” by Lawdragon magazine six consecutive years for her work representing whistleblowers. Prior to joining Phillips & Cohen, Ms. Matzzie served on the Civil Appellate staff of the US Department of Justice for five years.

Silvija A. Strikis, JD
Partner, Kellogg, Hansen, Todd, Figel & Frederick; Former Law Clerk, Justice Sandra Day O’Connor, US Supreme Court, Washington, DC

Speaker Bio

Kellogg Hansen partner Silvija Strikis has extensive experience in False Claims Act matters, representing both relators and defendants, including litigation of FCA cases to judgment and on appeal. Before becoming a lawyer, she practiced as a Certified Public Accountant. She served as a Bristow Fellow (attorney) in the Office of the Solicitor General of the United States, and as a law clerk to the Honorable Harry T. Edwards, then Chief Judge of the United States Court of Appeals for the D.C. Circuit and the Honorable Sandra Day O’Connor of the Supreme Court of the United States.

Kathleen Meriwether, JD
Americas Leader – Life Science, Forensic & Integrity Services, EY, Former Assistant United States Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA (Moderator)

Speaker Bio

Kathleen Meriwether is the Americas Leader of the Health Sciences team of Ernst & Young’s Forensic & Integrity Services practice. Kathleen specializes in assisting health sciences companies with governmental and internal investigations, global risk and compliance assessments and regulatory compliance analyses. Prior to her tenure with EY, Kathleen was an Assistant United States Attorney in the U.S. Attorney’s 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. Kathleen began her legal career as an associate with a national law firm based in Philadelphia.

10:30 am

Break

MINI SUMMITS BLOCK A: 11:00 am – 12:00 pm

(Choose one Mini Summit only)

Mini Summit I: Fostering a Culture of Ethics and Compliance beyond just Laws and Regulations

Join our panel of experts as they discuss how fostering an ethical culture in an organizations goes beyond “Tone at the Top”. Our panel will discuss how leaders need to be authentic and live their organization’s values to establish Tone at the Top. Hear how you can leverage the Power of Storytelling to shift from a culture of command and control to one of accountability and quality. Our experts will also share how components of compliance are being included in performance management, and how they have recognized and rewarded people whose behaviors reflect their organization’s values.

11:00 am

Welcome, Introductions, Discussions and Q&A

Thomas Beimers, JD
Partner, Hogan Lovells; Former Senior Counsel, Office of Counsel to the Inspector General, US DHHS; Former Special Assistant United States Attorney, US Attorney’s Office, Eastern District of Michigan, Minneapolis, MN and Washington, DC

Speaker Bio

Tom Beimers is a partner in the health care practice at Hogan Lovells US LLP. Tom was previously senior counsel with the Department of Health and Human Services’ Office of the Inspector General, where he was a member of the Pharma Team. In that capacity, Tom investigated False Claims Act and other fraud matters and negotiated and monitored corporate integrity agreements. From 2008 to 2010, he served as Special Assistant United States Attorney in Detroit, prosecuting criminal health care fraud cases as part of the Justice Department’s Medicare Fraud Strike Force. Since returning to private practice in 2012, Tom has assisted clients responding to False Claims Act investigations and has provided advice and counsel regarding fraud and abuse issues.

Stephanie J. Meltzer, JD
Vice President and Assistant General Counsel, Innovative Health, Pfizer, Former Assistant United States Attorney, United States Attorney’s Office, District of Columbia, US Department of Justice, New York, NY

Speaker Bio

Stephanie Meltzer, a Vice President, Assistant General Counsel, is a member of Pfizer’s Compliance Division Leadership Team, having served multiple roles of seniority within the Division including overseeing Pfizer’s global Anti-Corruption Program Office, its Mergers and Acquisitions compliance function, and responsibility for supporting teams focused on access and reimbursement. She currently serves as the Chief Compliance Counsel for Pfizer’s Innovative Health business and manages proactive compliance support for various developed and emerging market regions. Stephanie is a former federal prosecutor and partner at a major international law firm, as well as member of the Annual Bar Associations’ White Collar Crime Conference Planning Committee.

Lori Queisser
Senior Vice President and Global Chief Compliance Officer, Teva; Former Senior Vice President Global Compliance and Business Practices, Schering-Plough; Former Vice President, Chief Compliance Officer, Eli Lilly, Horsham, PA

Speaker Bio

Lori Queisser joined Teva Pharmaceuticals in June of 2015 in the key role of Senior Vice President and Global Chief Compliance Officer. She reports directly to the CEO. In this role, Lori is responsible for leading the organization’s compliance efforts globally, and setting the strategy for the implementation of compliance programs across the business. She will also engage the organization in promoting a culture of compliance, based on our values and Code of Conduct. Lori brings significant, diverse, global experience in the Compliance and Pharmaceutical industry to the Teva team. She has held senior roles in Eli Lilly and Schering Plough before consulting in the field as both President/Owner of Queisser and Associates and as a Principal at KPMG. Most recently, she was employed at DePuy Synthes, a Johnson and Johnson Company, as their Healthcare Compliance Officer. Lori is a Past Chair of the Pharmaceutical Compliance Forum.

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

Speaker Bio

Professor Smollen teaches Introduction to Compliance and serves as the Director of the Center for Compliance and Ethics. He also serves as the co-editor of the Law School’s Compliance & Risk Management e-journal. Prior to joining Temple Law, Professor Smollen was Executive Vice President and Chief Compliance Officer for Endo International. He previously served as Vice President and Chief Compliance Officer for Siemens Healthcare U.S and in a number of leadership positions at Wyeth Pharmaceuticals, including Chief Privacy Officer and Senior Counsel on regulatory issues. Prior to joining the private sector, Professor Smollen was an advisor to FTC Commissioner Thomas B. Leary and an attorney in the FTC’s Bureau of Consumer Protection. He began his legal career at Squire, Sanders, and Dempsey in Washington, D.C and served as a judicial clerk for U.S. District Judge James P. Jones. He served on the Board of the International Pharmaceutical Privacy Consortium from 2003-2006.

Lisa Walkush, EMTM
Partner, Advisory Services and National Life Sciences Sector Leader, Grant Thornton, LLP, Philadelphia, PA (Moderator)

Speaker Bio

Lisa Walkush is a Principal in Grant Thornton’s Advisory Practice, as well as the National Sector Leader for the Life Sciences industry. Lisa has expertise in providing Business Transformation and Change Management, Operational Excellence, Compliance and Validation and Technology Consulting Services.

Mini Summit II: What’s Old is New Again: Global Compliance Function Harmonization is Needed Now more than Ever

Join the panel of experts, from varying viewpoints within the industry, as we explore trends in the global view and role of compliance:

Trends in global markets driving critical compliance considerations
Governance structures including global view to risk prioritization, standards, and control requirements
Operating and resource model to meet global complexities

11:00 am

Welcome, Introductions, Discussions and Q&A

Scott Bass, JD
Partner and Head, Global Life Sciences Team, Sidley Austin LLP, New York, NY

Speaker Bio

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

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

Robert A. Ladd, JD
Vice President, Global Head Integrity & Compliance, Oncology, Novartis; Former, General Counsel, GE Healthcare Partners; East Hanover, NJ

Speaker Bio

Robert Ladd is the Global Head of Integrity & Compliance for Novartis Oncology, responsible for advising the business on compliance risk, the strategic design and implementation of the Oncology integrity and compliance program, and supporting the company’s mission. In this role, he is a member of the Oncology Executive Committee (OEC) and the Compliance Leadership Team (CLT). Robert has worked throughout his career in investment banking and healthcare. He joined Novartis in October 2017 and previously served as the General Counsel for GE Healthcare Partners. He has held senior commercial and transactional legal and leadership roles in compliance of increasing responsibility at GE Healthcare and Pfizer; Robert was previously a Vice President at Goldman Sachs. Prior to entering corporate law, Robert worked as an associate at Brown & Wood and Latham and Watkins in New York City; he began his legal career as a transactional attorney representing investment banks.

Melissa Murphy, MBA
Senior Compliance Specialist, Office of Ethics and Compliance, Medtronic, Minneapolis, MN

Speaker Bio

Melissa Murphy is a compliance professional in the medical device industry with additional experience in finance and IT roles. She has been involved in and led global projects and programs throughout her tenure at Medtronic.

Clarissa Crain
Senior Manager, Life Sciences Advisory, Deloitte, Philadelphia, PA (Co-moderator)

Laura (Munns) Skinner, MBA
Senior Manager, Life Sciences Advisory, Deloitte, Austin, TX (Co-moderator)

Speaker Bio

Laura Skinner has 25 years of experience serving the global life sciences and healthcare industries. She is a strategic, detail-oriented finance and operations professional with acknowledged experience in leading sales and marketing compliance, financial management, operational consolidation and process improvement engagements. Laura specializes in developing compliance policies, procedures and frameworks for the processes and practices related to healthcare professional engagement, fair market value services, risk management, and auditing and monitoring globally.

Presentation Material (Acrobat)

Mini Summit III: Third Party Lifecycle Management

Life Science companies continue to work with a large number of third parties including HCPs, HCOs, Sales and Distribution third parties and other vendors. Working with third parties brings significant opportunity and scale, but also substantial strategic, operational, financial, legal, compliance and reputational risks. This panel of experts will discuss in depth the complexity of third party ecosystems and the importance of a structured methodology to assess and act upon risks associated with third party interactions making third party risk management a critical aspect of any governance, risk and compliance programs.

11:00 am

Welcome, Introductions, Discussions and Q&A

Anthony Alvizu, CPA, EnCE, CFE
Managing Director, Global Risk and Investigations Practice (GRIP), FTI Consulting, Chicago, IL

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, fraud, computer and other types of investigations in countries across the globe. Over the past seven 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 co-developed his firm’s anti-corruption compliance software solution that continuously manages third-party risk and due diligence.

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

Speaker Bio

As a Partner at Arnold & Porter, LLP, Keith Korenchuk 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.

Since 2001, 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.

Alex Ganz, JD
Senior Manager of Compliance, Aegerion Pharmaceuticals; Former Compliance Manager, Shire and Vertex, Boston, MA

Speaker Bio

Alex Ganz: After helping shape the global compliance function at Vertex Pharmaceuticals, he was brought on at Shire to stabilize compliance operations during the Baxalta merger. Alex was most recently lured out of consulting by Aegerion Pharmaceuticals, were he handles US compliance, DPA, and CIA obligations.

Aneta Nastaj, MS
Training Manager, Corporate Research and Investigations, South Quay, London, UK

Speaker Bio

Aneta Nastaj is a Training Manager at CRI Group’s Anti-Bribery and Anti-Corruption (ABAC®) Centre of Excellence. In her role, Aneta designs in-house and client training events on anti-bribery and risk management system standards and delivers them in EMEA region to auditors, assessors, and compliance officers. With experience in on-site investigations in Europe, Aneta has expertise in third-party risk management.

Chrisoula Nikidis
Canadian Head of Compliance and Ethics Solutions, IQVIA; Former Executive Director, Ethics and Compliance, Innovative Medicines Canada; Former Industry Co-Chair Designate, APEC Biopharmaceutical Working Group on Ethics, Ottawa, Canada (Moderator)

Speaker Bio

Mini Summit IV: Annual Medical Device Compliance Roundtable

11:00 am

Welcome, Introductions, Discussions and Q&A

Focus on key compliance issues impacting the Medical Device Industry and an actionable plan on how to address these issues within your organization.

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

Speaker Bio

Jonathan P. Glazier is Senior Legal Counsel, Legal Compliance at Philips Electronics North America Corporation. In his role, Jonathan leads the legal compliance function at Philips focusing on healthcare compliance concerns and serves as the Company’s Ethics Officer.

Previously, Jonathan was Senior Director of Corporate Compliance, Privacy and Information Security Officer at Fresenius Medical Care North America of Waltham, MA. In that role and in his prior roles at the German headquartered dialysis and infusion products and services company, Jonathan developed significant legal compliance experience on health care and non-health care related matters.

Marc Levine
Director of Compliance, Insightec; Former Compliance Officer, Stryker Corporation; Former Business Conduct Specialist, MAKO Surgical, Fort Lauderdale, FL

Speaker Bio

Marc Levine has nearly 13 years experience in medical device compliance, working with start-ups and fortune 500 companies alike, and has become a recognized expert in the field. Marc started his career with Mako Surgical Corp., a Fort Lauderdale-based orthopedics company where he established and led a best-in-class compliance program. Following Stryker Corp.’s acquisition of Mako in 2013, Marc served as Compliance Officer at Stryker for 4 and a half years. He now serves as Director of Compliance at INSIGHTEC, a high-tech Israeli-based medical device company. Marc received an Anti-bribery Specialist Accreditation from Trace International.

David Ryan, JD
Vice President and Chief Compliance Officer, Epizyme; Former Vice President, Associate General Counsel and Chief Compliance Officer, Haemonetics; Former Vice President of Legal Affairs, Associate General Counsel and Chief Compliance Officer, AMAG Pharmaceuticals, Boston, MA

Speaker Bio

David M. Ryan is VP and Chief Compliance Officer at Epizyme, Inc., a clinical-stage oncology biotech, where he is responsible for establishing the company’s strategy for global compliance. Before joining Epizyme, he was VP, Associate General Counsel, and Chief Compliance Officer at Haemonetics Corp., a medical device company. Prior to that, he was a partner at the law firm of Nixon Peabody LLP, where he spent fifteen years as a litigator focusing on white collar criminal matters.

Speaker Bio

Jean McKiernan, MBA
Director, PwC, Chicago, IL (Moderator)

Presentation Material (Acrobat)

Mini Summit V: Dissecting Recent CIAs and Review of Draft Model CIA

Panelists will analyze recent pharma and device CIAs for new provisions that reflect the OIG’s evolving views on what compliance controls are effective and discuss a Model CIA that would improve the efficiency and effectiveness of OIG-mandated compliance controls.

11:00 am

Welcome, Introductions, Discussions and Q&A

Regina G. Cavaliere, JD
Principal, Regulatory Enforcement and Compliance, Life Sciences Sector, KPMG LLP; Former Vice President and Chief Compliance Officer, Otsuka America, Short Hills, NJ

Speaker Bio

Regina Cavaliere is a Principal in KPMG’s Advisory practice in Short Hills, NJ. As a former CCO for a life sciences company, Regina brings firsthand knowledge of the risks facing life sciences companies and perspectives on how to enhance the effectiveness and efficiency of compliance programs through innovation. She has over 24 years of experience with the life sciences industry (both pharmaceutical and medical device) having represented clients in product liability litigation as outside counsel and having worked in industry for over 17 years in legal and compliance roles.

Jennifer McGee, JD
Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc., Rockville, MD

Speaker Bio

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

Speaker Bio

Presentation Material (Acrobat)

Mini Summit VI: Advanced Strategies to Measure Effectiveness, Monitor and Report on Compliance Programs

Hear from a distinguished panel of industry peers, academic leaders and strategic advisors on how to measure the effectiveness of your compliance program. The panel will discuss the most recent research on compliance effectiveness, strategies to measure compliance effectiveness and best practices for communicating these measures to your Board and wider organization.

11:00 am

Welcome, Introductions, Discussions and Q&A

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

Speaker Bio

Wendy C. 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. Ms. Goldstein 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.

Patricia J. Harned, PhD
Chief Executive Officer, ECI (Ethics and Compliance Initiative); Former President, Ethics Resource Center; Former Member, Standing Advisory Group, Public Company Accounting Oversight Board, Washington, DC

Speaker Bio

Patricia Harned is Chief Executive Officer of the Ethics & Compliance Initiative (ECI). The mission of the ECI is to empower organizations to build and sustain high quality ethics & compliance programs. Dr. Harned speaks and writes frequently as an expert on ethical leadership, ethics in the workplace, corporate governance, and global integrity. She chaired the ECI’s Blue Ribbon Panel on High-Quality Ethics & Compliance Programs, which established a new industry standard for E&C efforts in organizations. She serves on the board of the U.S. Center for SafeSport, and she is a Special Advisor to the International Association of Independent Corporate Monitors.

Presentation Material (Acrobat)

Perri Pomper, JD
Director of Compliance, Clinical Genomics; Former Director, Ethics and Compliance Strategy & Education, Novo Nordisk, New York, NY

Speaker Bio

Perri Pomper is the Director of Compliance for Clinical Genomics Inc. a medical device and clinical diagnostic company focused on colorectal cancer screening and diagnosis. In her role she oversees the development and implementation for the US and Australia compliance program.

Prior to Clinical Genomics Inc. Perri was a Director for Ethics and Compliance at Novo Nordisk Inc. where she was responsible for building the short and long-term strategy for the compliance program – she was also responsible for all training and communication plans with a focus on proactive partnership and building a culture of integrity. Previously Perri was a Legal Consultant with Polaris Management Partners.

Perri received a Juris Doctorate from Touro Law School and a B.A. in Psychology from the State University of New York at Albany.

Eugene F. Soltes, MBA, PhD
Jakurski Family Associate Professor of Business Administration, Harvard Business School; Author, Why They Do It: Inside the Mind of the White-Collar Criminal, Cambridge, MA

Speaker Bio

Eugene Soltes is the Jakurski Family Associate Professor of Business Administration at Harvard Business School where his research focuses on corporate misconduct and fraud, and how organizations design cultures and compliance systems to confront these challenges. Professor Soltes’ work on corporate misconduct and fraud culminated in the book “Why They Do It: Inside the Mind of the White-Collar Criminal,” which was described by Kirkus Reviews as “a groundbreaking study” on white-collar criminality. Professor Soltes is a popular keynote speaker and frequently advises firms about their compliance programs and training. He is regularly invited to speak to regulators, including the Department of Justice, Securities and Exchange Commission, United States Treasury, and the Federal Bureau of Investigation.

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Kiley Smith Kelly, MBA
Partner, Forensic & Integrity Services, EY, Philadelphia, PA (Moderator)

Speaker Bio

Kiley Smith Kelly is a Principal in EY’s Fraud Investigation & Dispute Services practice. Kiley leads global bribery and corruption investigations and compliance assessments in the life sciences industry, with a focus on regulatory compliance in the pharmaceutical, biotechnology and medical device areas. Kiley has extensive experience in assessing clients’ processes, controls and the management of compliance and regulatory risks, with a concentration in sales, marketing and medical affairs activities. She helps clients assess high-risk activities in the industry including, interacting with healthcare professionals, payments to healthcare organizations, as well as engaging third party intermediaries to act on the company’s behalf. Kiley works with clients to develop, implement and evaluate global compliance auditing and monitoring programs, including the strategic use of data analytics and technology platforms. She has worked with multinational life sciences companies to develop targeted metrics and dashboards to monitor compliance risk.

Mini Summit VII: Compliance 3.0: Managing Promotional Programs, Relationships with Patient Advocacy Groups and New Entrants into the Marketplace

Join your colleagues in this interactive discussion on the evolution of the compliance office from “Compliance 1.0 to 3.0”. The commercial compliance profession is now over 25 years old. While the demands have changed as the commercial model has become more complex, many of the concerns have stayed the same. Will Compliance 3.0 require a different kind of compliance office, and how will this transition change the skill needs for compliance professionals?

11:00 am

Welcome, Introductions, Discussions and Q&A

Terra Buckley, JD
Executive Director, US HCC Business Advisory Center of Excellence, Celgene, Former Head, US Compliance, Helsinn, Former Director, Ethics & Compliance, North America, Ipsen, Summit, NJ

Speaker Bio

Terra Buckley is currently Executive Director and head of the Business Advisory Center of Excellence within Celgene’s US Healthcare Compliance function. She joined Celgene one year ago as a Senior Director advising both the I&I Franchise and Market Access. Terra has 20 years of industry experience with various roles in Sales, Marketing and Compliance, and has spent the last eight years in various compliance roles with increasing responsibility, most recently as the head of US Compliance for Helsinn Therapeutics.

Michael R. Clarke, JD
Vice President, Corporate Compliance, Indivior Inc., Richmond, VA

Speaker Bio

Michael R. Clarke is the Vice President, Corporate Compliance for Indivior Inc. He is responsible for managing the global compliance program for Indivior across its business operations in the North American, European, Middle East, African, China and Pacific Rim regions. Previously, Mr. Clarke was V.P., Ethics & Compliance – Americas for Actavis plc, and Vice President and Compliance Officer for EBI, LLC, d/b/a Biomet Spine & Bone Healing Technologies. He also served in an ethics & compliance officer role for the University of Medicine & Dentistry of New Jersey; Edison Schools and Medco Health Solutions. Before working in-house as a compliance professional, Mr. Clarke practiced corporate, civil and criminal law as a litigation partner with the law firm of Drinker Biddle & Reath LLP, as an associate at the law firms of Hannoch Weisman and Scarinci & Hollenbeck and as an Assistant Deputy Public Defender in Essex County, New Jersey.

Kelly N. “Nikki” Reeves, MPA, JD
Partner, King & Spalding LLP, Washington, DC

Speaker Bio

Nikki Reeves is a partner in King & Spalding’s 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.

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

Speaker Bio

Dr. Whitelaw has more than 25 years of industry experience in the life sciences and health care sectors. A former compliance officer for both pharmaceutical (GSK) and medical device companies (C.R. Bard, Inc. and Misonix), he is a licensed food and drug attorney, with a doctorate in Health Law. He also is former Food and Drug Law Institute (FDLI) fellow and interned in the FDA’s Office of Chief Counsel. In addition to running his own consulting firm, Dr. Whitelaw is Senior Fellow & Adjunct Professor, Life Sciences Compliance at Mitchell Hamline School of Law and Editor for the Policy & Medicine Compliance Update.

Darren R. Jones
Partner, Global Compliance Consulting Leader, Polaris Management, New York, NY (Moderator)

Presentation Material (Acrobat)

12:00 pm

Networking Luncheon and Mini Summits Block B

MINI SUMMITS BLOCK B: 12:15 pm – 1:15 pm

(Choose one Mini Summit only)

Mini Summit VIII: Open Payments: Where Does the Sun Shine Now?

Update and Operational Advice on Sunshine Act Expansion signed By President Trump to include APRNs and PAs as Covered Recipients;
Update on Monetary Restrictions Impacting Interactions with New Jersey Physicians;
Review and Analysis of Chicago and Philadelphia Sales Representative Licensure/Registration Requirements and its Impact on HCP Interactions;
Review & Analysis of Pricing Disclosures/Transparency Laws sweeping the Country; and
Analysis of Canadian Transparency Laws and the growing trend of O-US Transparency Reporting Obligations.

12:15 pm

Welcome, Introductions, Discussions and Q&A

Brian A. Bohnenkamp, MHA, JD
Partner, FDA and Life Sciences Practice, King & Spalding LLP, Washington, DC

Speaker Bio

Brian Bohnenkamp is a Partner in the FDA & Life Sciences Practice Group in King & Spalding’s Washington, D.C. office. He specializes in regulatory and compliance matters relating to drug, biotechnology and medical device companies. Brian has extensive experience counseling manufacturers on fraud and abuse laws, industry codes of conduct, federal and state transparency laws and regulations, state and local gift bans, compliance program laws and sales representative licensing requirements, as well as government ethics restrictions.

Brian provides counsel to companies on a variety of laws and regulations administered and enforced by FDA, OIG, DOJ, and CMS, as well as by state attorneys general, boards of pharmacy, departments of health, and similar administrative and enforcement authorities.

He provides counsel to the Ad Hoc Sunshine and State Law Compliance Group, a coalition of pharmaceutical, biotechnology and medical device manufacturers.

Christine N. Bradshaw, JD
Vice President, Porzio Life Sciences, LLC; Principal, Porzio, Bromberg & Newman PC, Morristown, NJ

Speaker Bio

Chrissy Bradshaw is a Vice President for Porzio Life Sciences, LLC. In her role, Ms. Bradshaw oversees the development, implementation and support of Porzio AggregateSpendID, the company’s automated tool for the collection and reporting of payments to healthcare professionals (HCPs) and healthcare organizations (HCOs). She serves as a primary point of contact for new customers, analyzes customer reporting requirements, and directs system design and implementations. Ms. Bradshaw is also a principal with Porzio, Bromberg & Newman P.C. and a co-chair of the firm’s Life Sciences Compliance and Regulatory Counseling Department. She served as a judicial clerk for the Honorable Gail L. Menyuk of the New Jersey Tax Court during the 2006-2007 term. Ms. Bradshaw was the Publications Editor of the American University Journal of Gender, Social Policy & the Law at American University’s Washington College of Law.

Alex Ganz, JD
Senior Manager of Compliance, Aegerion Pharmaceuticals; Former Compliance Manager, Shire and Vertex, Boston, MA

Speaker Bio

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 Oroho is 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), Antikickback 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. Mr. Oroho has an extensive pharmaceutical regulatory and compliance background. He spent three years as General Counsel for Integrated Pharma Technologies and Computer Systems Services & Consulting, Inc.

Mini Summit IX: Interactions with Specialty Pharmacy

The discussion begins with background information regarding the nature and role of specialty pharmacies, as well as some of the risks that are inherent in pharmaceutical manufacturer and specialty pharmacy relationships, including an understanding of the cornerstone legal issues, e.g., FCA, AKS, HIPAA, AE Reporting, and Price Reporting issues. Panelists will share the compliance professional’s role in developing the infrastructure to minimize risks assumed by the contract and evolving risks. The session will conclude with select case studies.

12:15 pm

Welcome, Introductions, Discussions and Q&A

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

Speaker Bio

Yogesh Bahl is a managing director at AlixPartners, where he leads the life sciences practice for the firm’s Financial Advisory Services group. Yogesh assists clients by specializing in strategy, finance, and operations risk management by applying his more than 20 years of cross-industry experience. His finance, accounting, and statistics foundation helps companies manage investigations, corporate transactions, analysis of revenues, and evaluation of supply chain integrity. He has significant experience in managing strategic alliances, accounting issues, intellectual property, and fraud and corruption. He serves as an expert during corporate disputes to evaluate liability and calculate damages. Yogesh’s dispute consulting experience includes evaluating industry practice and liability, calculating lost profits, evaluating reasonable royalty rates, analyzing postclosing financial statements, and performing financial analyses to facilitate negotiations.

Craig Clesson, JD, CIPP/US
Assistant General Counsel and Global Privacy Officer, Syneos Health; Former Vice President and Ethics and Compliance Officer, Aegerion; Boston, MA

Speaker Bio

Craig Clesson is the current Global Privacy Officer at Syneos Health, which was recently formed by the combination of INC Research and inVentiv Health. He manages a global team of privacy professionals, and for the first time in his career is not at a company implementing a CIA. Craig’s prior roles include Vice President of Ethics & Compliance at Aegerion Pharmaceuticals, which signed a DPA for HIPAA, a distinction of being a pharma industry first; and Director of Compliance at Amgen.

Sarah diFrancesca, JD
Partner, Health Care and Life Sciences Regulatory Practice, Cooley, LLP, New York, NY

Speaker Bio

Sarah diFrancesca is a partner in Cooley’s Health Care Regulatory and Life Sciences practice. Sarah’s practice includes advising life sciences and health care companies on fraud and abuse, compliance and regulatory matters, and industry guidance. Sarah represents companies in connection with government investigations, inquiries, settlements and voluntary disclosures. Sarah also conducts internal compliance reviews and investigations and advises Boards of Directors, compliance committees and senior management on internal investigations and compliance-related matters.

Richard Liner, JD
Senior Counsel, Compliance and Investigations, Bayer, Whippany, NJ

Speaker Bio

Richard Liner is Senior Compliance Counsel for Bayer’s pharmaceuticals Division. He advises on a broad spectrum of complex fraud and abuse and compliance issues, including anti-kickback, anti-corruption, off-label promotion and HIPAA privacy. He routinely works on the development of policies, procedures and guidance for the Bayer pharmaceutical business and manages both external and internal compliance investigations. Richard joined Bayer in 2009 after spending six years at the law firm Arent Fox in Washington, D.C., where he counseled and defended manufacturer and healthcare provider clients on a variety of fraud and abuse and regulatory matters.

Katherine Norris, MPA
Director, Berkeley Research Group; Former Senior Director, Compliance and Integrity Programs, NSF Health Sciences; Former Director, Corporate Compliance, Spectranetics; Former Manager, Corporate Compliance, King, Washington, DC (Moderator)

Presentation Material (Acrobat)

Mini Summit X: Is your Board of Directors Bored of your Compliance Dashboards?

This mini summit session will discuss the important role BODs provide for an effective compliance program. Listen to experienced compliance and board members discuss how compliance must be incorporated into BOD meeting agendas, how to be effective with limited time, how to educate BOD members on the importance of compliance and other compliance related topics.

12:15 pm

Welcome, Introductions, Discussions and Q&A

Thomas Costa, JD
Member, US Board of Directors, Sanofi; Former Vice President, US Compliance and Ethics, Bristol-Myers Squibb, Washington, DC

Speaker Bio

Thomas E. Costa is a pharmaceutical compliance consultant with over 38 years of experience in the pharma/bio industry.

Sarah A. Franklin, JD
Partner, Covington & Burling LLP; Former Attorney, Federal Trade Commission, Washington, DC

Speaker Bio

Sarah Franklin is vice-chair of Covington’s 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.

In addition to her life sciences practice, Ms. Franklin conducts sensitive internal investigations for a range of clients on issues including securities violations, government contracting, and anti-bribery/anti-corruption. Prior to entering private practice, Ms. Franklin investigated and prosecuted consumer protection violations for the Federal Trade Commission.

Jennifer McGee, JD
Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc., Rockville, MD

Speaker Bio

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

Presentation Material (Acrobat)

Mini Summit XI: Next Generation Data Analytics

Using data for proactive risk management. Focus on driving innovation based on the use of predictive analytics, leveraging analytics to identify risks, and managing risks in a proactive manner. The use of multidata source information to develop correlations to derive insights; thereby, advancing and transforming the function to include automated business rules to proactively manage up.

12:15 pm

Welcome, Introductions, Discussions and Q&A

Michael Dusseau
Vice President, Compliance Operations, Allergan; Former Vice President, Compliance, Bayer; Former Divisional Compliance Officer, Merck, Madison, NJ

Speaker Bio

Michael Dusseau has held senior leadership roles in the Compliance Organizations of Schering-Plough, Merck, Bayer and Allergan with broad responsibilities including the negotiation, implementation and operation of Corporate Integrity Agreements, compliance training and privacy programs, analytics monitoring, transparency, hotlines and compliance investigations. Michael has experience in Rx, Device and Consumer segments of the business and the design and implementation of compliance organizations and programs in the US and globally. With over 30 years of experience in the pharmaceutical industry Mike has held positions in sales, sales operations, information technology and compliance.

Kellie Fidler, MBA, PMP
Director, Global Compliance Risk Mitigation and Monitoring Strategy, Bristol-Myers Squibb, Princeton Pike, NJ

Speaker Bio

Kellie Fidler is the Lead, Global Risk Mitigation & Monitoring Strategy at Bristol-Myers Squibb (BMS), where she collaborates with business partners and Global Compliance in markets to design and deliver an analytics framework. Before becoming part of the Compliance organization, Kellie held various positions within the US Commercial Operations teams. Prior to BMS, she worked for several software companies, including IBM.

Virginia “Ginny” A. Gibson, JD
Partner, Hogan Lovells LLP; Former First Assistant US Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA

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 trial lawyer for 30 years, and at Hogan Lovells for nearly 20, she has defended clients under federal and state scrutiny and found solutions to legal issues and regulatory uncertainty while advancing business objectives. Because Ginny was a federal prosecutor for over 20 years, and the First Assistant U.S. Attorney and Civil Chief in two federal districts, she knows the language to engage with the enforcement team to get results. She defends clients against federal and state investigations, working in tandem with clients to achieve declinations or dismissal while counseling on compliant improvements that defuse the government’s concerns.

Bryan Timer, MA
Business Analytics, Director, Data Analytics and Transparency, Merck, North Wales, PA

Speaker Bio

Bryan Timer is the Director of US Data Analytics and Transparency at Merck. In his current role, Bryan supports Merck’s 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 Merck’s compliance program and assists with developing and growing the group’s 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.

Jeffrey Rosenbaum, MBA
Partner and Co-founder, Dovetail Consulting Group, LLC; Former Senior Vice President, Chief Compliance and Risk Officer, Shire; Former Vice President, Chief Compliance Officer, Vertex Pharmaceuticals; Former Executive Director, Global Head, Ethics and Compliance, Novartis Oncology, Boston, MA (Moderator)

Speaker Bio

Jeff Rosenbaum is a co-founder and partner at Dovetail Consulting Group. Jeff brings a unique approach to his client engagements—coupling deep real-world experience with structured consulting discipline to provide pragmatic and realistic solutions for pharmaceutical and biotechnology companies. Before founding Dovetail Consulting Group, Jeff was the Chief Compliance and Risk Officer at Shire. He was responsible for the company’s Global Compliance and Risk Management function, including Corporate and Healthcare Compliance; Privacy; Employee, Health, and Safety (EHS); Corporate Security; and Enterprise Risk Management (ERM). Prior to joining Shire, Jeff was responsible for developing, implementing, and monitoring global compliance programs, first at Novartis Oncology as the Global Head of Ethics & Compliance, and then at Vertex Pharmaceuticals, where he was the Chief Compliance Officer. Earlier in his career, Jeff was a Director in Global Pharmaceutical Advisory Practice at PricewaterhouseCoopers. Jeff began his career in the pharmaceutical industry at Wyeth Pharmaceuticals.

Mini Summit XII: The Fine Line of Promotion with Medical Professionals: Avoiding White Coat Marketing

This panel will discuss compliance strategies to mitigate perceived risks with Medical colleagues interactions with HCPs/HCEs.

12:15 pm

Welcome, Introductions, Discussions and Q&A

Kellie Branson Combs, JD
Partner, Ropes & Gray LLP, Washington, DC

Speaker Bio

Kellie Combs is Partner in the Life Sciences group at Ropes & Gray LLP, where she provides legal and strategic advice to medical product manufacturers on a broad range of regulatory issues. 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.

Pamela Lonzer, MSJ
Associate Director, Medical Operations, Compliance and Controls, Alexion; Former Associate Director-US Medical Advisor, Global Compliance and Risk Management, Shire; Former Associate Director, Research and Development-Global Compliance, Astellas, Chicago, IL

Speaker Bio

Pamela Lonzer, MJ Pamela Lonzer is a conscientious and forward-thinking healthcare professional with twenty years of clinical and pharmaceutical experience. She has held various leadership roles in Compliance supporting various global and domestic research & development (R&D), medical affairs and commercial clients.

Margaret Sparks, JD
Associate Vice President, North America Ethics and Business Integrity, Sanofi US, Bridgewater, NJ

Speaker Bio

Margaret Sparks has been with Sanofi US or its predecessor company since November 2001, when she joined the Aventis Pharmaceuticals Legal Department, supporting the Respiratory franchise. Margaret moved to the Compliance team in 2007, and now supports a variety of business groups and compliance functions. Prior to Sanofi US, Margaret was part of the Litigation group at Patterson, Belknap, Webb & Tyler, LLP in New York.

Ravi Tayi, MD, MPH
Chief Medical Officer, US Ferring Pharmaceuticals; Former Vice President, Global Medical Affairs, Mallinckrodt; Former Vice President, Medical Affairs and Clinical Development, Cubist/Optimer; Former Vice President and Chief Medical Officer, Global Medical Affairs and Clinical Development, Archimedes, New York, NY

Speaker Bio

Ravi Tayi is a performance and results oriented strategic professional with 15+ years of diverse experience, including US & Global pharmaceutical industry experience in direct and matrix organizations with knowledge and expertise in all functions within Global Medical Affairs and Clinical Development. He has expertise in drug, device and drug/device combinations with extensive experience in launching drugs and devices in multiple therapy areas. He is currently the Chief Medical Officer at Ferring US where he is responsible for all aspects of medical strategy, development and execution with in Ferring.

Ravi’s previous experience includes senior level management positions at Mallinckrodt Pharmaceutivals as Vice President, Global Medical Affairs, VP, Clinical Development and Biometrics at Ikaria, Inc. and VP, Medical Affairs and Clinical Development at Cubist/Optimer Pharmaceuticals. He is a Leadership Board Member of the Arthritis Foundation.

Jennifer Vondee, MPH
Manager, Pharmaceutical and Life Sciences Risk Consulting, PwC, Durham, NC (Moderator)

Speaker Bio

Jennifer Vondee has over 12 years of experience advising global pharmaceutical and medical device companies on building and implementing corporate ethics and compliance programs. Jennifer’s expertise is focused on advising compliance organizations on strategic and pragmatic solutions to address complex risks across commercial and global medical affairs activities as well as enhancements to compliance programs as defined by U.S. and international laws, regulations and industry ethics and compliance standards. Jennifer has significant experience leading projects focused on integration of compliance programs, strategy and governance structure for life science mergers and acquisitions including advising business stakeholders across commercial operations, global medical affairs, and research and development on harmonization recommendations and compliance considerations.

Mini Summit XIII: Market Access Compliance Considerations

In a fast evolving area, how do Compliance Professionals approach risk management of this ever expanding topic in their organizations? How do they work with functional colleagues, such as legal – and how do they keep oversight of interconnected risks, yet separately executed activities.? We’ll explore these challenges against the backdrop of new, related FDA guidance on payer interactions.

12:15 pm

Welcome, Introductions, Discussions and Q&A

Meenakshi Datta, JD
Partner and Global Co-leader, Healthcare Practice, Sidley Austin LLP, Chicago, IL

Speaker Bio

Meena Datta is global co-leader of the Sidley’s Healthcare practice and member of the global Life Sciences team, manages key strategic matters for life sciences and healthcare companies throughout the world. Meena specializes in all areas of health care regulatory law for pharmaceutical and medical device manufacturers, including the Anti-Kickback Statute, government pricing and state pricing transparency laws, the Sunshine Act, health care reform, and HIPAA and data privacy and security. Her particular areas of focus include patient support programs, market access, and government pricing. She routinely works with General Counsels, Compliance Officers, and their departments to develop and implement effective compliance programs. Meena serves as outside counsel to a wide range of healthcare clients, including emerging and established biopharmaceutical, medtech, and big data companies.

Daryl Kreml, JD
Vice President and Chief Compliance Officer, SageTherapeutics; Former Head, US Compliance and Global Program Management, Biogen; Former Director and Senior Managing Counsel, International Compliance, Boston Scientific, Boston, MA

Speaker Bio

Daryl Kreml is a Compliance leader whose career spans government, law firm, and in-house roles. Following his graduation from Harvard Law School, Daryl joined the Central Intelligence Agency. He then spent more than eight years in the Compliance & Enforcement Practice Group of a leading law firm, working from its offices in Washington, DC and London. His in-house Compliance roles have included Head of International Compliance at Boston Scientific and Head of U.S. Compliance at Biogen. He is currently the Chief Compliance Officer at Sage Therapeutics, helping to shape a global culture of Compliance right from the start.

Jodi Lindsey, JD
Senior Director and Head of US Healthcare Compliance, Alkermes; Former Associate Director, Commercial Compliance, Biogen, Boston, MA

Speaker Bio

Jodi Lindsey is an experienced health care and life sciences attorney with broad expertise in pharmaceutical advertising, regulatory and compliance matters. She is the Senior Director, Head of US Healthcare Compliance for Alkermes where she manages the company-wide healthcare compliance program and provides legal support to Medical Affair and Patient Engagement organizations. Her specialties include compliance with Food, Drug & Cosmetic Act and FDA guidance, federal and state anti-kickback prohibitions, PhRMA Code, and federal and state privacy laws.

Ann E. Beasley, JD
Director, Life Sciences, Governance, Risk & Compliance, Navigant, Former Senior Vice President, Chief Compliance Officer, Biogen, Boston, MA (Moderator)

Speaker Bio

Ann Beasley is Director, Life Sciences Regulatory & Compliance with Navigant Consulting, Inc. She has extensive experience as an in-house Compliance Officer in building, managing and optimizing corporate compliance programs in life sciences companies. Ann brings an understanding of the issues clients’ face in implementing all the elements of an effective compliance program across global biotech, pharmaceutical, and device companies’ international operations. This includes a deep understanding of anti-bribery and anti-corruption (domestic and international), conflicts of interest, and regulatory matters as they manifest in daily operations and which require practical risk management controls. Selected experience in developing and managing corporate compliance programs include: developing integrated risk assessments, developing investigations protocols, policy and procedure written standard development, facilitating courses at INSEAD and co-chair and panel member of multiple Pharmaceutical Compliance Congresses (PCF).

1:15 pm

Transition Break

MINI SUMMITS BLOCK C: 1:30 pm – 2:30 pm

(Choose one Mini Summit only)

Mini Summit XIV: Global Documentation Framework: Practical Strategies for Implementing an Effective Document Framework for Global Policies and Procedures

In this session, we present practical strategies for implementing an effective document framework for global policies and procedures. While implementing policies and procedures on a local level is relatively straightforward, structuring and unifying them across global organizations is a challenge facing many compliance leaders today. Companies must balance the need to communicate geographic and organization-specific requirements while avoiding complexity pitfalls that render them ineffective for practical use.

1:30 pm

Welcome, Introductions, Discussions and Q&A

Susan P. Novak
Director, Corporate Policies Global Compliance, Celgene Corporation; Former Director of Compliance, Sandoz; Summit, NJ

Speaker Bio

Susan Novak is the Director, Global Compliance Corporate Policies with Celgene Corporation. Previously, she was the Director of Compliance at Sandoz. Susan has more than 15 years of compliance experience in the pharmaceutical industry and a proven record of minimizing risk by developing, implementing, and sustaining robust global and domestic compliance programs. Her expertise is in driving change and positioning compliance as a business partner by employing a collaborative approach.

Adam Oakley
Director, Potomac River Partners, Arlington, VA

Speaker Bio

Adam Oakley joined Potomac River Partners in 2011. Adam has worked with a variety of life science organizations and possesses a comprehensive compliance background. He has managed a diverse set of documentation projects, including creating documentation frameworks, developing policies, procedures, and compliance manuals, performing gap analyses, and implementing and managing CIA obligations. Adam also brings expertise to producing a broad spectrum of training courses and providing auditing and monitoring services. Prior to joining Potomac, Adam worked on the Communications & Compliance team at Flagstar Bancorp.

Jonathan Wilkenfeld, MBA
Partner, Potomac River Partners, Washington, DC (Moderator)

Speaker Bio

Jon Wilkenfeld is a leader in healthcare compliance and has been consulting in the field since 2002. He is an established subject matter expert on compliance topics, including aggregate spend and state law reporting, compliance auditing and monitoring, and drafting of compliance policies.

At Potomac River Partners, Jon has had the opportunity to work with a wide range of clients such as Top 5 global pharmaceutical companies, mid-sized pharmaceutical and device firms, early-stage biotech organizations, and organizations that support life science companies such as contract sales forces and meeting logistics suppliers. He has authored articles published in Rx Compliance Report, Pharmaceutical Executive, and Compliance Today and is a frequent speaker and moderator at industry conferences.

Prior to launching Potomac, Jon was a Senior Manager at Polaris Management Partners and a Strategy Consultant with Accenture.

Presentation Material (Acrobat)

Mini Summit XV: R&D: Hidden Risks beyond Clinical Trial Recruitment, including FMV, Invoicing

Traditionally, compliance programs have placed a keen emphasis on commercial risks. Yet risks abound earlier in a compound or product’s life cycle. This session will explore some of the hidden risks associated with clinical trial recruitment and the corresponding interactions with healthcare professionals, institutions, and patients along with possible controls and approaches to mitigate these risks.

1:30 pm

Welcome, Introductions, Discussions and Q&A

Dennis K. Barnes, JD, MBA, CPA
Vice President, Global Governance, Risk and Compliance, Mayne Pharma; Former Vice President, Compliance and Risk Management, Global Compliance Officer, PAREXEL; Former Senior Director, North America Compliance, sanofi-aventis, Raleigh-Durham, NC

Speaker Bio

Dennis Barnes is the Vice President, Global Governance, Risk & Compliance for Mayne Pharma. He is responsible for the development and implementation of the Global Enterprise Risk Management Program, the development and implementation of the Global Anti-Competition/Anti-Trust Compliance Program, and the development and implementation of the Global Anti-Bribery/Anti-Corruption Compliance Program. He is also responsible for the establishment of a Global Internal Audit function.

He was previously Vice President, Compliance & Risk Management, Global Compliance Officer for Parexel International Corp., Senior Director, North America Compliance for Sanofi-aventis, Director, Compliance, Disputes & Investigations – Life Sciences at Navigant Consulting ad Director, Pharamceutical Advisory at KPMG, LLP

Seth H. Lundy, JD
Partner, King & Spalding, Washington, DC

Speaker Bio

Seth H. Lundy is deputy chair of the King & Spalding FDA & Life Sciences Practice group, resident in Washington DC. 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 healthcare providers and suppliers. He advises on corporate compliance, the Anti-Kickback Statute, the False Claims Acts, the Sunshine Act, the Stark Law, the Food, Drug & Cosmetic Act, pricing and discounting matters, and Medicare and Medicaid billing, coding and reimbursement.

Gregory S. Moss, JD
Senior Vice President, Deputy General Counsel, Kadmon Corporation, New York, NY

Speaker Bio

Mr. Moss serves as Senior Vice President and Deputy General Counsel to Kadmon Holdings, Inc. In this role, he is responsible for the development and implementation of legal and compliance programs and for a broad range of corporate and general legal and compliance matters. Mr. Moss serves as Deputy Chairman of Kadmon’s Internal Compliance Committee and is a member of its promotional review committees. Prior to joining Kadmon, Mr. Moss represented, and provided advice to, financial services providers, insurers, banks, pharmaceutical and medical device companies, corporations, small and medium sized businesses and individuals on a broad range of complex matters as a member of the Corporate Risk team at one of Australia’s leading law firms. Mr. Moss also serves on the Board of Directors of MeiraGTx Holdings plc and Vitls, Inc.

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

Speaker Bio

Sue Seferian is the global R&D Health Care Compliance Officer for the Janssen Pharmaceuticals Research & Development Group, within Johnson & Johnson. Sue’s 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 organization’s activities.

Sue joined the Johnson & Johnson Law Department in 1999, where she provided legal support for the creation, implementation, and management of corporation-wide fraud and abuse and compliance programs. Prior to Johnson & Johnson, she worked for the World Wide Office of Health Care Compliance & Privacy (WWOHCC & P), the Pharmaceuticals Group Health Care Compliance organization, Reed Smith and other major law firms in the Philadelphia area. Sue also clerked for the criminal division of the New Jersey Judiciary.

Regina G. Cavaliere, JD
Principal, Regulatory Enforcement and Compliance, Life Sciences Sector, KPMG LLP; Former Vice President and Chief Compliance Officer, Otsuka America Short Hills, NJ (Moderator)

Speaker Bio

Presentation Material (Acrobat)

Mini Summit XVI: Compliance Considerations for Small to Mid-size Pharma and Device Companies

Building successful compliance programs at small to mid-sized pharma and device programs is not just about learning how to do more with less. These companies require a different approach to compliance and the business partners. Learn from a panel of industry experts who have mastered using their compliance resource and company size to their advantage.

1:30 pm

Welcome, Introductions, Discussions and Q&A

Joseph Calarco, MSS
Chief Compliance Officer, Neos Therapeutics, Inc.; Former Director, Compliance and Ethics, US Operations, Bristol-Myers Squibb; Former Director, Corporate Compliance, Shire, Philadelphia, PA

Speaker Bio

Joseph Calarco has 24 years’ experience in Pharmaceuticals. He is currently the Chief Compliance Officer at Neos Therapeutics. His responsibilities include: Compliance Program direction and oversight, Business partnership and support, Risk assessment activities, Implementation of policies and procedures, Education and training, and Monitoring, auditing and investigations. Previously, he was the Director of U.S. Compliance Operations at BristolMyers Squibb and Director of Monitoring and Investigations at Shire Pharmaceuticals.

Speaker Bio

Tara McCarthy, JD
Partner, Dovetail Consulting Group, Former Senior Vice President, GC and Secretary at Chiasma, Former Vice President of Commercial Law at Vertex, Boston, MA

Eric Baim, JD
Managing Director, Dovetail Consulting Group, LLC; Former Vice President, Head of US Compliance, Shire, Boston, MA (Moderator)

Speaker Bio

Eric Baim is a Managing Director at Dovetail Consulting Group. At Dovetail, Eric advises clinical stage, pre-launch and commercial biotech, pharma, and medical device companies in the strategy, design, build and assessment of compliance and risk management functions. In addition to helping create and execute solutions across the range of compliance program needs, Eric also helps companies create compliance frameworks to support their core and innovative business offerings. Eric has over 18 years of experience in the field. Before joining Dovetail, Eric was the Vice President and Head of Compliance U.S. for Shire and, prior to that, he held a number of global and U.S. ethics and compliance roles at Novartis. Eric began his fraud and abuse and compliance-counseling career at various law firms in Washington, DC.

Mini Summit XVII: Compliance Issues Associated with PBM Relationships

PBMs play an integral role in access to and distribution of pharmaceutical products. This session will explore the relationships between pharmaceutical manufacturers and PBMs, potential compliance challenges associated with those relationships, and practical strategies for managing those challenges.

1:30 pm

Welcome, Introductions, Discussions and Q&A

Eliza L. Andonova, JD
Counsel, Hogan Lovells, Washington, DC

Speaker Bio

Eliza Andonova is Counsel at the Washington, D.C. office of Hogan Lovells. For over a decade she has counseled healthcare companies on the complex laws that regulate the healthcare industry. She helps clients establish and continually improve their compliance programs so they can focus on providing life sustaining and life improving treatments.

Eliza’s focus is on federal and state anti-kickback statutes, civil monetary penalties law, and false claims laws. She advises drug and device manufacturers and direct healthcare providers on such issues as discount and rebate arrangements, consultant and speaker arrangements, product support services and patient assistance programs.

After law school, Eliza served as a law clerk to the Honorable James H. Michael, Jr. of the US District Court for the Western District of Virginia. She is a member of the American Health Lawyers’ Association.

Katherine Chaurette, JD
Senior Director, Assistant General Counsel, Regeneron Pharmaceuticals, Inc.; Former Vice President Legal, Head of Health Law, Regulatory, Market Access, Marketed and Launched Products, Sanofi, Boston, MA

Speaker Bio

Kathy Chaurette has 18 years’ experience advising biopharmaceutical companies, focusing extensively on market access, patient support, and health care coverage and reimbursement. Kathy has particular expertise in advising on arrangements with specialty pharmacies, distributors, PBMs, GPOs, health plans and health care providers; developing patient support programs; assessing pricing strategies, including value-based opportunities; complying with government pricing programs such as the Medicaid rebate program, 340B pricing, and Medicare ASP reporting; and advising on pre-approval communications in compliance with FDA guidance.

Richard Liner, JD
Senior Counsel, Compliance and Investigations, Bayer, Whippany, NJ

Speaker Bio

Eileen Erdos
Principal, Forensic and Integrity Services, EY, Chicago, IL (Moderator)

Presentation Material (Acrobat)

Mini Summit XVIII: Risk Assessments and Mitigation Plans: Best Practices and Lessons Learned

An important part of an effective compliance program is risk assessment and mitigation. Our panel will discuss the importance of a repeatable methodology for identifying and prioritizing risk activities, including outputs that inform a compliance plan and stand up to OIG scrutiny. Discussion topics include:

Communicating with business stakeholders about risk.
Best practices from risk assessments across company sizes, therapeutic areas, and geographies.
Creating a feedback loop to inform future risk assessments and mitigation plans.
Reacting to unforeseen risks between assessments.

1:30 pm

Welcome, Introductions, Discussions and Q&A

Christie Camelio
Vice President and US Healthcare Compliance Officer, Celgene; Former Head of Risk Management, Novartis Pharmaceuticals, Summit, NJ

Speaker Bio

Christie Camelio is Vice President, Deputy Chief Compliance Officer at Celgene with responsibility for leading the US Healthcare Compliance Program as well as Corporate Compliance Functions such as Investigations, Spend Transparency, Third Party Due Diligence and Corporate Policies.

She started her career in sales and marketing before joining Novartis in 2003. In her 14 years at Novartis she held roles in Medical and Commercial Operations and led numerous organization transformation projects. She then joined Novartis Compliance to lead the Risk Management function which encompassed the risk assessment process, auditing and monitoring, investigations, data analytics, HCP interactions and promotional material review process.

Gary Del Vecchio
Health Care Compliance Officer, Cardiovascular and Metabolism, The Janssen Pharmaceutical Companies of Johnson & Johnson; Former Executive Director, US Pharmaceutical Compliance and Ethics, Bristol-Myers Squibb; Former PCF Co-chair, New York, NY

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).

Francisco Ribeiro
Senior Director & Head of US Compliance, Tesaro, Inc.; Former Senior Director, Corporate Compliance, Biogen; Former Senior Director, Corporate Compliance, International Markets, Sandoz, A Novartis Company; Former Senior Manager, Compliance Operations, LatAm, Johnson & Johnson, Boston, MA

Speaker Bio

Francisco (Cisco) Ribeiro leads the US Compliance program at TESARO, an oncology-focused biopharmaceutical company headquartered in Waltham, MA. He has close to 15 years of professional experience, 10 years being in compliance roles in a combination big pharma and biotech companies. Prior to TESARO, he worked for Sarepta Therapeutics, Biogen, Novartis, and Johnson & Johnson in US, international, and global roles, building, managing, and improving compliance programs. He is a lawyer by background admitted to the bar in Brazil.

Kamleh J. Nicola, LLB
Partner, Baker & McKenzie LLP, Toronto, Canada

Speaker Bio

Kamleh Nicola, a partner with Baker & McKenzie LLP in Toronto, specializes in intellectual property, with an emphasis on disputes within the life sciences’ industry. Kamleh also advises clients on the regulatory aspects of pharmaceuticals and medical devices, including strategic advice related to product approval and launch, marketing, labelling, compliance and pricing. Kamleh’s commitment to excellence in client service was recognized by Baker & McKenzie’s Global IP Group when she was twice the recipient of an award for being “Passionately Client Driven”.

Christian A. Dingler
Managing Consultant, Navigant Consulting, Richmond, VA (Co-Moderator)

J. Mark Farrar, CPA, CFE, CFF
Managing Director, Navigant; Former Interim Global Chief Compliance Officer, Beckman Coulter, Atlanta, GA, USA (Co-Moderator)

Speaker Bio

J. Mark Farrar is a Managing Director at Navigant Consulting, Inc. and the global practice leader of the Life Sciences Governance, Risk Management and Compliance practice. He advises clients globally on complex issues such as white collar crime, off-label allegations, FCPA matters, False Claims Act damages, violations of the Anti-Kickback Statute, compliance program development, global transparency, privacy and GDPR issues, risk assessments, and various auditing and monitoring assessments. Mark served as the interim global CCO for a multi-billion medtech company. Mark also serves as the IRO for a number of companies under a CIA. Mark is a CPA licensed in Georgia, a Certified Fraud Examiner and Certified in Financial Forensics.

Presentation Material (Acrobat)

Mini Summit XIX: “All in Compliance” — Aligning with Your Business Partners

Join our panel of experts as they discuss leveraging and aligning business partners to bring compliance forward. In an age of increasing regulation, organizations need to be compliant from the ground up. Rather than merely enforcing policy, the role of a business partners can help align the business and compliance by providing guidance for business leaders so they make informed decisions and mitigate risks within the organization. Our panel will discuss topics such as compliance governance structures, leveraging business partners as change agents, and effective skillsets for business partners to develop.

1:30 pm

Welcome, Introductions, Discussions and Q&A

Craig Chiulli, MBA
Group Product Director, Metabolic Franchise, Johnson & Johnson, Titusville, NJ

Speaker Bio

Craig Chiulli is a senior leader in marketing and sales with 20-plus years of experience in the Pharmaceutical industry. He is passionate about cross functional partnerships, creating a strong culture and fostering collaboration. He has extensive experience working within compliance guidance and structure in several multinational companies, including some under CIAs.

Jill Dailey, MBA, JD
Vice President and Chief Compliance Officer, Incyte; Former Assistant General Counsel, Asia Pacific Compliance Lead, Pfizer; Former Head, US Ethics and Compliance, Novartis, New York, NY

Speaker Bio

Jill Dailey has spent 19 years as a legal and compliance professional in the pharmaceutical industry, having worked at both large and mid-sized companies prior to joining Incyte Corp as the Chief Compliance Officer in 2016. She has a diverse range of pharmaceutical experience in compliance, transactions, manufacturing and product support in both the innovative and generic pharmaceutical space. Incyte is a global, mid-sized biotech focused on immunotherapy with a presence in the US, Europe and Japan. Prior to joining Incyte, Jill was the Asia Pacific Regional Compliance Lead at Pfizer, and prior to that served as the Compliance Lead for the Pfizer’s Global Established Pharma business in North America.

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 of Ropes & Gray and focuses her practice on legal and regulatory matters in the health care and life sciences industries. She provides advice on a wide range of issues, including fraud and abuse and FDA regulatory matters and compliance program development and support. Alison works with pharmaceutical and medical device companies on a wide range of sales, marketing, medical and research and development issues both domestically and globally, and also advises with respect to government investigations stemming from alleged violations of U.S. federal healthcare program laws and the FCPA

Ravi Tayi, MD, MPH
Chief Medical Officer, US, Ferring Pharmaceuticals; Former Vice President, Global Medical Affairs, Mallinckrodt; Former Vice President, Medical Affairs and Clinical Development, Cubist/Optimer; Former Vice President and Chief Medical Officer, Global Medical Affairs and Clinical Development, Archimedes, New York, NY

Speaker Bio

Joe Zimmerman
Vice President and Chief Compliance Officer US, Ferring Pharmaceuticals, Parsippany, NJ

Speaker Bio

Joseph Zimmerman has over two decades of experience in the pharmaceutical industry in leadership roles of increasing responsibility in such areas as corporate compliance, leadership development, training, management, and sales. He has held his current position at Ferring since 2016. Prior to Ferring, Mr. Zimmerman operated a health care compliance and business operations consulting company. Until late 2015, he served as Senior Vice President and Chief Compliance Officer for two multi-billion dollar publicly traded companies: Actavis (now Allergan) and Forest Laboratories (acquired by Actavis). He held the position of Global Chief Compliance Officer for Forest starting in 2004.

Lisa Walkush, EMTM
Partner, Advisory Services and National Life Sciences Sector Leader, Grant Thornton, LLP, Philadelphia, PA (Moderator)

Speaker Bio

Mini Summit XX: Giving in the Era of Prosecutorial Scrutiny: Navigating the Murky Waters of Patient Programs and Interactions with Patients and Patient Organizations, including Patient Services Compliance Survey Update

Program participants — including the head of the civil division of one of the busiest qui tam dockets in the country and a former AUSA/current defense counsel — will discuss the DOJ’s recent developments with respect to patient assistance programs (PAPs) and the government’s targeting of pharmaceutical companies who give to PAPs.

1:30 pm

Welcome, Introductions, Discussions and Q&A

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

Speaker Bio

Jonathan Levy is the Corporate Compliance Counsel 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 individuals’ 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.

Jason P. Mehta, JD
Partner, Bradley Arant Boult Cummings LLP; Former Assistant United States Attorney, US Attorney’s Office for the Middle District of Florida, US Department of Justice, Tampa, FL

Speaker Bio

Jason Mehta is currently a partner at Bradley Arant Boult Cummings, advising companies and individuals on a wide variety of healthcare compliance practices. Jason is a former federal prosecutor who personally recovered nearly a quarter of a billion dollars and was recognized with the “Director’s Award,” one of the highest honors given to DOJ employees.

Sarah Whipple, JD
Senior Corporate and Compliance Counsel, Akebia Therapeutics, Inc.; Former Vice President, Global Compliance and Privacy Officer, Aegerion; Former Chief Compliance Officer and Associate General Counsel, AMAG, Boston, MA

Speaker Bio

Sarah Whipple is the Senior Corporate and Compliance Counsel for Akebia Therapeutics Inc. She is a experienced health care and life sciences attorney with broad expertise in pharmaceutical and medical device advertising, regulatory and compliance matters.

Sarah’s specialties include compliance with Food, Drug & Cosmetic Act and FDA guidance, federal and state anti-kickback prohibitions, PhRMA Code, AdvaMed Code, and federal and state privacy laws.

Her previous experience includes senior leadership positions at Aegerion Pharmaceuticals, AMAG Pharmaceuticals, Inspiration Biopharmaceuticals, Inc., and Biogen Idec.

Minna Bak, MBA
Senior Manager, Helio Health Group, New York, NY (Moderator)

Speaker Bio

Minna Bak has over 10 years of providing strategic and management consulting services to life science companies. She has assisted pharmaceutical, medical device and biotechnology companies with operational excellence in medical affairs, clinical and commercial operations, and in compliance to HCP and patient interaction and disclosure regulations.

Presentation Material (Acrobat)

2:30 pm

Transition Break

MINI SUMMITS BLOCK D: 2:45 pm – 3:45 pm

(Choose one Mini Summit only)

Mini Summit XXI: Compliance Considerations for “Evolved” Pharmaceutical Product, including Gene Therapy and Ultra Rare Disease Products

Determine specific compliance challenges for gene therapy and rare disease focused organizations, with a focus on topics such as interactions with HCPs, unique testing models, various reimbursement strategies, etc.
Understand the unique touch points with patients and the challenges associated with patient interaction, patient privacy, and patient support services
Examine and address compliance considerations when conducting pre-approval discussions and disease state awareness discussions

2:45 pm

Welcome, Introductions, Discussions and Q&A

Chuck Bell, JD, BSN
President, Arete Resources, Inc.; Former Compliance Officer, Kedrion Biopharma Inc.; Former Interim Compliance Officer, Insmed Inc.; New York, NY

Andrew Furlow, JD
Senior Associate, Hogan Lovells US LLP, New York, NY

Speaker Bio

As a Senior Associate at Hogan Lovells, Andrew Furlow is a trusted adviser to providers, drug and device manufacturers, and other key players in the healthcare industry. He works with healthcare companies to shape and respond to new and strategically important legislation, saving crucial time and resources.

Andrew is an authority on topics such as the Open Payments disclosure law, the branded prescription drug fee, and Medicare value-based payment programs. Previously, he clerked for the Honorable David F. Hamilton on the United States Court of Appeals for the Seventh Circuit and the US District Court for the Southern District of Indiana. Andrew served as an Executive Editor on the Harvard Law Review while earning his degree at Harvard Law School. He was a “Rising Star, Health Care award recipient by the Washington, D.C. Super Lawyers for 2017-18.

Elizabeth Jobes, JD
Head of Corporate Compliance and Legal Counsel, Spark Therapeutics, Inc.; Former Senior Vice President and Chief Compliance Officer, Auxilium; Former Chief, Repeat Offender Unit, Philadelphia District Attorney’s Office, Philadelphia, PA

Speaker Bio

Elizabeth Jobes Head of Corporate Compliance and Legal Counsel, Spark Therapeutics, Inc. She is responsible for the creation and implementation of a strategically driven compliance program. Prior to joining Spark, Liz was Senior Vice President, Chief Compliance Officer at Auxilium Pharmaceuticals, Inc., Vice President, Chief Compliance Officer for Adolor Corporation and Senior Director, Global Compliance at Cephalon, Inc. Before joining Cephalon, Liz was a prosecutor for the City of Philadelphia for 15 years. She tried over 200 jury trials, participated in grand jury investigations, and was Chief of the Repeat Violent Offenders Unit.

Ali Lyons
Director, Ethics and Compliance, Aegerion Pharmaceuticals; Former Operations Lead, Ethics and Compliance, Eli Lilly and Company, Cambridge, MA

Speaker Bio

Ali Lyons currently serves as the Director, Ethics and Compliance, at Aegerion Pharmaceuticals. In this role, Ms. Lyons functions as the Business Partner and Compliance Lead for all U.S. activities and initiatives. Before joining Aegerion, Ms. Lyons worked at Eli Lilly and Company in a variety of roles from Specialty Sales, Leadership Training, and most recently, in the Ethics and Compliance Department as the Operations Lead across all business units (Oncology, Diabetes, Cardiovascular, Immunology and Neuroscience) for the U.S. Affiliate. Prior to her time at Lilly, Ms. Lyons served as the Product and Brand Manager of Liquid Handling and Molecular Technologies at Eppendorf North America.

Marci Juneau, MBA
Partner, Helio Health Group, Atlanta, GA (Moderator)

Speaker Bio

Marci Juneau is a seasoned management consultant specializing in advising life science companies. Her focus is on Compliance, process optimization, and reporting and regulatory risks related to their operations, Aggregate Spend/Disclosure, Patient Services Support, sales and marketing activities, medical affairs, clinical trials, and R&D. Marci has extensive experience in providing pharmaceutical, medical devise and biotechnology companies with effective advise on program implementation, operational excellence, change management, data analytics, compliance adherence, and risk mitigation. Prior to Helio, Marci was Director at Huron Consulting Group’s Life Sciences Practice. Marci worked for Ernst & Young’s Fraud and Investigation focusing in Healthcare.

Presentation Material (Acrobat)

Mini Summit XXII: Best Practice in HCP/HCO Management to Reduce Compliance Risk and Enhance Efficiency

Discuss emerging trends in how to manage your companies HCP/HCO interactions across the globe
Hear about best practices in developing and implementing efficient HCP/HCO management processes
Receive an overview of risks across small to large life sciences companies and how best to mitigate and reduce exposure

2:45 pm

Welcome, Introductions, Discussions and Q&A

Sharon R. Delshad, JD
Director, Compliance and Legal Affairs, Nalpropion Pharmaceuticals, Inc.; Former Director, Compliance and Legal Affairs, Orexigen Therapeutics, San Diego, CA

Speaker Bio

Sharon Delshad is the Director of Compliance and Legal Affairs at Nalpropion Pharmaceuticals, where she is responsible for compliance strategy and operations as well as helping to build the new Company. In July 2018, Nalpropion purchased the assets of Orexigen Therapeutics, where Sharon and her colleagues worked to commercial a company then see it through the due diligence period of an asset sale. Sharon developed her career in life sciences by working on patent infringement cases and by providing compliance support to life science companies of all sizes as a consultant at PwC and EY.

Melanie Fagan
HCP Engagement Lead, Medical Affairs Compliance, GlaxoSmithKline, Philadelphia, PA

Speaker Bio

As Lead, External Expert Engagement, US Medical Affairs Governance and Compliance for GlaxoSmithKline, Melanie Fagan is the lead for contractual healthcare professional and external expert engagement in the US. Melanie supports the GSK and ViiV organizations for governance and controls related to contractual HCP engagements for Speakers, Advisors, and Consultants in the Commercial, Payer, Vaccines, and Research & Development areas. As the HCP Engagement lead, Melanie leads a team which supports HCP engagement compliance for the US and global engagements. Her team interfaces US and global activity owners to provide efficient and compliant centralized management of HCP engagement activities. Melanie has 10 years’ experience at GSK, with prior roles at AstraZeneca and start up biotech.

Jeffrey M. Kawalek, MBA
Senior Director, Ethics and Compliance, North America, Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ

Speaker Bio

Jeffrey Kawalek is a compliance professional with nearly 20 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 & Compliance North America for Ipsen. He oversees, maintains and enhances the U.S. Ethics & Compliance Program. He executes on various aspects of the U.S. Ethics & Compliance program including: policies, training, communications, monitoring, investigations and risk management. Previously he was Director, Compliance at Novo Nordisk where he supported the Chief Compliance Officer to set and accomplish the strategic objectives of the corporate compliance program. He also provides tactical compliance support to the Oncology, Neurology, and endocrinology brand and field teams as well as U.S. Medical/HEOR, Value & Access, and Transparency Operations. He collaborates with the Global Ethics & Compliance team on global compliance initiatives.

Dennis McCloskey, JD
Compliance Officer, Olympus Corporation of the Americas; Former Assistant District Attorney, Homicide Unit, Philadelphia District Attorney’s Office, Philadelphia, PA

Speaker Bio

Dennis McCloskey, is a Compliance Officer at Olympus Corporation of the Americas (OCA). He is responsible for oversight of all aspects of the Company’s compliance program at seven Olympus subsidiaries throughout the United States and Canada. Dennis also oversees the Company’s internal compliance investigations function and is a member of OCA’s Internal Investigations Committee and Health Care Grants Committee. Dennis participates in management of the Company’s Corporate Integrity Agreement and its Deferred Prosecution Agreements. Prior to joining Olympus, Dennis was an Assistant District Attorney in the Philadelphia District Attorney’s Office where he was assigned to the Homicide and Major Trial Units.

Mark Scallon, MHA
Senior Principal, Polaris, IQVIA Global Compliance, Richmond, VA (Moderator)

Speaker Bio

Mark Scallon has 20 years of experience advising life sciences companies on compliance matters. Mark helps lead Polaris’ management consulting division and has extensive experience working with clients to transform their compliance function, with particular expertise in compliance program development, monitoring, audits, risk assessments, global spend transparency, privacy and FCPA/ABAC matters.

Mini Summit XXIII: Compliance Considerations in Value-based Contracting

Value-based contracting (VBC) has demonstrated potential to drive improved outcomes and greater efficiency in healthcare delivery. However, there are potential statutory impediments to such contracts, including the federal Anti-Kickback Statute and Medicaid price-reporting rules.

The panel will explore value-based contracting opportunities and risks, including discussions on

The various types (taxonomy) of value-based contracts
Trends in volumes and outcomes of VBC contracts
The OIG’s Request for Information regarding the Anti-Kickback Statute and Beneficiary Inducements CMP
The role of the Engagement Specialist for in-process auditing of such contracts
Policy changes that can open the door for more effective value-based contracting

Participants will gain knowledge and insight into the potential for VBC and hear from experts on current experience and leading practice.

2:45 pm

Welcome, Introductions, Discussions and Q&A

Jennifer Barbre, MBS
Executive Director, Compliance, Spectrum Pharmaceuticals, Inc.; Former Director, Compliance and Ethics Program, Avanir; Former Director, Commercial Compliance, Boehringer Ingelheim, Irvine, CA

Speaker Bio

Jennifer Barbre is currently the Executive Director of Compliance at Spectrum Pharmaceuticals in Irvine, CA. She has held various Compliance and Quality positions at Avanir, Boehringer Ingelheim, Johnson & Johnson and Wyeth (now Pfizer) throughout per career.

William Connelly, JD
Senior Counsel, Amgen; Former Staff Attorney, US DHHS, Washington, DC

Speaker Bio

William Connelly is Senior Counsel for Amgen in their Washington, DC office. He supports Amgen’s government affairs and policy teams. He also advises on access support programs for several Amgen products. Bill previously was a partner at a national law firm and an attorney with the Office of the General Counsel of the U.S. Department of Health and Human Services.

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

Speaker Bio

Josh T. O’Harra, MS, JD
Assistant General Counsel, Eli Lilly and Company; Former Sr. Associate, King & Spalding, Washington, DC

Speaker Bio

Josh O’Harra is an Assistant General Counsel at Eli Lilly and Company and is responsible for advising a diversified, research-based biopharmaceutical manufacturer on all matters pertaining to state and federal healthcare programs, commercial contracting and US government pricing.

Prior to joining Lilly, he was a Senior Associate at King & Spalding where he represented and counseled Fortune 500 biopharmaceutical companies in connection with various healthcare industry issues, including legal compliance with government price reporting laws, Federal Supply Schedule (FSS) contracting provisions, commercial contracting, healthcare fraud and abuse laws, and FDA regulations.

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 policy. In that role, Ms. Wagner provides legal counsel on PhRMA’s advocacy related to value-based contracting, the federal Anti-Kickback Statute, the physician payment Sunshine Act, and other priority policy issues. Prior to joining PhRMA, Ms. Wagner served in the U.S. Department of Health & Human Services Office of Inspector General (OIG) where she worked in the Industry Guidance Branch as an Anti-Kickback Statute subject matter expert, drafting industry guidance and advising the OIG and prosecutors on fraud and abuse issues.

Patterson Shafer
Managing Director, Health Care and Life Sciences, Grant Thornton, Stamford, CT (Moderator)

Handout Material (Acrobat)

Mini Summit XXIV: Evolving Risks and Opportunities related to Medical Affairs, e.g. Professional Medical Education, Digital Information, etc.

The Pharmaceutical and Medical Device Industry is rapidly pivoting to be patient-centric and quickly assess vast volumes of data from numerous sources to assist physician and patients make informed decisions. To meet these challenges companies are upgrading and expanding their medical affairs teams. Medical affairs is best positioned to generate and present critical scientific knowledge to the key stakeholders. Especially as the industry focuses more on specialty products and rare diseases, medical affairs is best positioned to holistically pull together scientific and clinically relevant results regarding patient outcomes, relevant health economics, patient safety at all stages of the product life cycle. The rapid growth of proactive and deeper relationships with not only prescribers but also the broader patient/patient advocacy community also leads to new areas of risk. These risks include privacy, data security, transparency, value based care, bias in publications, charitable giving and reimbursement support to name a few. There exists a tension among these trends. Customer-facing and proactive informational efforts can look commercial in nature. As medical affairs teams align more with the commercial sectors, this could potentially undermine the benefit of medical affairs’ independent perspective and judgment.

2:45 pm

Welcome, Introductions, Discussions and Q&A

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

Speaker Bio

Stefanie Doebler is of counsel in the health care and food and drug practice groups at Covington & Burling, LLP. 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.

Stephanie Macholtz, JD, MBA
Director, Compliance and Ethics, Global Medical Affairs and Business Development, Alexion Pharmaceuticals, Inc.; Former Compliance Officer, Biogen; Former Associate Director, Compliance, R&D, Eisai, Boston, MA

Speaker Bio

Stephanie Macholtz is currently Director, Compliance & Ethics, Global Medical Affairs and Business Development at Alexion Pharmaceuticals in Boston, MA. She has been a Compliance professional in the pharmaceutical and biotech industry for over ten years supporting global R&D, Medical, and commercial functions. Prior to her career in Compliance, Stephanie oversaw the conduct of several multinational clinical trials.

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

Speaker Bio

With over 20 years in the pharmaceutical industry, Donna White has worked with branded and generic products; retail, hospital and specialty products; and, many functional areas within her companies, including Compliance, Legal, Commercial, Business Development and Analytics. Her current responsibilities as Vice President, Compliance & Contracts with Chiesi USA, Inc. include Corporate Compliance, Pricing, Aggregate Spend and Government Programs, amongst other oversight responsibilities and participation in various committees.

BJ D’Avella, MBA
Senior Manager, Life Sciences Advisory, Deloitte & Touche LLP, Parsippany, NJ (Co-moderator)

Speaker Bio

BJ D’Avella is a Senior Manager extensive experience assisting global life science companies with program delivery related to compliance and regulatory risks inherent to sales and marketing activities, market access, medical affairs, and clinical operations. BJ has led the creation and development of technology-enabled services for our clients and dataenabled monitoring program execution and reporting tools. BJ has specialized in leading complex projects related to Commercial, Medical, and R&D operations and compliance, especially within the areas of Commercial/Market Access Compliance Program Design and Management, Patient Services Compliance, Clinical Program Management (including RWE study execution), Monitoring Program design and execution, Corporate Integrity Agreement (CIA) support, and Fair Market Value (FMV) assessments.

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

Speaker Bio

Dr. DeWyngaert trained as a molecular biologist and has been actively involved in both research and business development roles for the past 30 years. He has provided operational, clinical, managerial, consulting, and litigation services to various segments of the health care industry. He specializes in assisting pharmaceutical manufacturers, biotechnology, and medical device companies with identifying and mitigating regulatory risks, valuing intellectual property and litigation support.

Presentation Material (Acrobat)

Mini Summit XXV: Biopharma Product in Crisis: An Interactive Case Study in Effective Crisis Management

A life sciences company facing a product safety/integrity crisis must address simultaneous, urgent regulatory, compliance, litigation, congressional, media and public policy issues, and its responses in each area must be carefully framed and executed. This session is an interactive case study based on a hypothetical product crisis that gradually unfolds in stages. After each set of events unfurls, the moderator will lead the panel through a discussion of the issues raised and the strategies and responses that should be considered. Attendees will be encouraged to participate with suggestions, questions or critiques based on their experience. Our panel includes individuals with a range of expertise, including compliance, product liability, FDA regulatory, criminal defense, and media matters.

2:45 pm

Welcome, Introductions, Discussions and Q&A

Mahnu V. Davar, JD
Partner, Arnold & Porter Kaye Scholer LLP; Lecturer, University of Pennsylvania Law School; Fellow, Salzburg Global Seminar, Washington, DC

Speaker Bio

Mahnu Davar is Partner at Arnold & Porter. His practice focuses on assisting FDA-regulated entities with complex regulatory and compliance matters. He has represented early stage medical technology companies, clinical labs, major academic research institutions, and some of the largest multinational drug and device companies in the oncology, ophthalmology, pain, and diabetes care spaces. Mr. Davar has developed and led training programs for legal, compliance, and business functions in Europe and Asia and has developed a keen understanding of compliance risk areas, having completed two lengthy industry secondments. Mr. Davar routinely counsels clients on the regulatory and compliance aspects of promotional launch campaigns, clinical research, educational grants and charitable giving, manufacturing and supply chain, deal diligence, and other mission-critical activities. Mr. Davar is a lecturer at the University of Pennsylvania Law School, a Fellow of the Salzburg Global Seminar, and a former Fulbright Scholar to India.

Paul Fishman, JD
Partner and Head, Crisis Management and Strategic Response Team, Arnold & Porter LLP; Former United States Attorney, District of New Jersey, Washington, DC

Speaker Bio

Paul Fishman heads Arnold & Porter’s Crisis Management and Strategic Response team and is a member of the firm’s White Collar Defense, Commercial Litigation, Securities Enforcement, and Appellate practices. As the United States Attorney for the District of New Jersey, he was responsible for all criminal and civil matters in which the federal government was involved. Mr. Fishman also served in national level leadership positions with the Department of Justice. Appointed by both Attorneys General Eric Holder and Loretta Lynch to the Attorney General’s Advisory Committee (AGAC) of US Attorneys, Mr. Fishman served as the Chair of that committee. Immediately prior to serving as US Attorney, Mr. Fishman was in private practice for 12 years. He is a Distinguished Fellow at Seton Hall Law School; co-chaired Governor Phil Murphy’s Transition Committee on Law and Justice; and serves on the Board of the New Jersey Institute for Social Justice.

Joe Mack, JD
Senior Compliance Counsel, Bayer; Former Assistant United States Attorney and Deputy Chief, Health Care and Government Fraud Unit, US Attorney’s Office, District of New Jersey, New York, NY

Speaker Bio

Joe Mack is currently Senior Compliance Counsel at Bayer U.S. LLC. In that role, Joe is responsible for identifying and mitigating compliance risks and conducting internal investigations. Prior to joining Bayer, Joe worked for over nine years as an Assistant United States Attorney in the U.S. Attorney’s Office for the District of New Jersey. During his time at the U.S. Attorney’s Office, Joe served as the Deputy Chief of the Health Care and Government Fraud Unit and the Acting Chief of the General Crimes Unit. He has investigated and prosecuted individuals for violations of the federal anti-kickback statute, the Food, Drug, and Cosmetic Act, and tax crimes.

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

Speaker Bio

Ann-Marie Tejcek has been an employee at Eli Lilly for over 25 years. She has served in various US and Global leadership roles in Sales, Marketing and Medical across the organizations during her tenure. Ann-Marie currently serves as the lead Compliance Officer for the US and Canadian Affiliates supporting the promotional and medical activities for those teams. The mission of her team, along with the broader E&C organization at Lilly, is to integrate high performance with high integrity.

Daniel A. Kracov, JD
Partner, Arnold & Porter Kaye Scholer LLP, Washington, DC (Moderator)

Presentation Material (Acrobat)

Mini Summit XXVI: Privacy and Cybersecurity Compliance Update, including GDPR Compliance

This panel will discuss practical problems pharmaceutical companies face when implementing a data privacy and cybersecurity compliance program. Companies must keep track of multiple regulatory requirements, both in the U.S. and under the E.U. GDPR. This requires legal, management, and technical expertise. How can compliance officers begin to manage this enormous task?

2:45 pm

Welcome, Introductions, Discussions and Q&A

Kate Heinzelman, JD
Counsel, Sidley Austin LLP; Former Deputy General Counsel, US Department of Health and Human Services; Former Special Assistant and Associate Counsel to President Barack Obama, Washington, DC

Speaker Bio

Kate Heinzelman is a member of the Privacy and Cybersecurity, Healthcare, and Commercial Litigation groups at Sidley Austin. Her practice focuses on enforcement and regulatory matters in privacy/cybersecurity and healthcare. Before joining Sidley, Kate was Deputy General Counsel at the Department of Health & Human Services. Before joining the Department of Health & Human Services, Kate worked in the White House Counsel’s Office as Special Assistant and Associate Counsel to President Barack Obama. In this role, she advised the President and his Administration on crisis response, national security, privacy and technology, energy, and environmental matters. Kate also served as Counsel to the Assistant Attorney General for National Security at the Department of Justice. Kate served as a law clerk to Chief Justice John G. Roberts, Jr. on the U.S. Supreme Court and Judge Merrick Garland on the U.S. Court of Appeals for the D.C. Circuit.

Adam Greene, JD, MPH
Partner and Co-chair, Health Information and HIPAA Practice, Davis Wright Tremaine LLP, Former Senior Health Information Technology and Privacy Specialist, Office for Civil Rights, DHHS, Washington, DC

Speaker Bio

Adam Greene is a partner in the Washington, D.C. office of Davis Wright Tremaine and co-chair of its Health Information Group. Adam primarily counsels health care providers, technology companies, and financial institutions on compliance with health information privacy, security, and breach notification rules. Previously, Adam was a regulator at the U.S. Department of Health and Human Services, where he played a fundamental role in administering and enforcing the HIPAA rules. At HHS, Adam was responsible for determining how HIPAA rules apply to new and emerging health information technologies and was instrumental in the development of the current HIPAA enforcement process.

Agatha O’Malley, MStPH, JD
Privacy Officer and Senior Counsel, Otsuka Pharmaceuticals (US); Former Director- Head of Privacy, Shire, Philadelphia, PA

Speaker Bio

Agatha O’Malley is an experienced Privacy Professional who has held positions both in the pharmaceutical and professional services industries. She is currently working for Otsuka Pharmaceuticals as their Global Data Protection Officer.

David W. Opderbeck, JD
Professor of Law, Seton Hall University Law School; Counsel, Gibbons PC, Newark, NJ (Moderator)

Mini Summit XXVII: The Compliance Training Revolution

Listen as panelists share their perspective on the following:

Micro learning to pull through
Nudge learning (Reminders)
CIA changes – Training Plan vs. Required Time
The use of Real-Life scenarios to drive “What’s in it for Me”
Just in time learning (using off the shelf materials to address “hot topics”)
Primary risk areas covered by training programs – Anti-Bribery, Conflicts of Interest, Meal Limits and Spending, etc.
Reducing overall exposure to Risk
Training delivery to employees – Live, e-learning, self-directed or a combination of these delivery methods
Measuring Effective Training Programs – Assessments/Attestations and Collection of data analytics
Multiple language options for International employees

2:45 pm

Welcome, Introductions, Discussions and Q&A

Julianne Brierley
Director, Head of Compliance Learning, Novartis, New York, NY

Speaker Bio

Julianne Brierley: With 26 years in the pharma industry, 9 with Upjohn and 17 with Novartis, I have witnessed the sweeping changes caused by increased regulation. I have spent the majority of my pharma career on the commercial side with 16 years in sales, 2+ years in marketing and 6+ years in training. My move to compliance learning is a chance to use the experience I have to help our associates focus on making good decisions, empowered with the confidence to know what is right and not just what is legal.

Vickie L. McCormick
Vice President, Janssen US Commercial Health Care Compliance and CIA Operations, Johnson & Johnson; Former Chief Compliance Officer, St. Jude Medical, Titusville, NJ

Speaker Bio

Vickie McCormick has been with Johnson & Johnson since 2008 and is currently VP, Janssen U.S. Commercial Health Care Compliance & CIA Operations. Previously, Vickie was VP, Health Care Compliance for the DePuy Synthes companies of Johnson & Johnson. Before joining Johnson & Johnson, Vickie was Chief Compliance officer for St. Jude Medical. Before that she was Special Counsel with Halleland, Lewis, Nilan, and Johnson, specializing in health care law and consulting. During this time, Vickie worked extensively with Medtronic on HIPAA Privacy implementation and Anti-Kickback Statute compliance matters and was acting Chief Compliance Officer for Medtronic Spinal and Biologics. Prior to Halleland, she was the Corporate Integrity Officer for UnitedHealth Group for and in-house counsel for various segments of UnitedHealth Group’s business.

Chad Londeree
Healthcare Industry Group Leader, SAI Global, Richmond, VA (Moderator)

Speaker Bio

Chad Londeree has over 16 years of operations and sales experience in regulatory compliance with the life sciences industry. He currently manages the Integrated Risk Management solution for SAI Global by assisting clients in getting a holistic and integrated view of risk. Prior to that he was an Account Executive for Cegedim specializing in Transparency Reporting and CRM. He also served as Director of Reconciliation and State Services for BuzzeoPDMA (now IQVIA).

Presentation Material (Acrobat)

3:45 pm

Transition Break

CLOSING PLENARY SESSION

4:10 pm

Welcome and Introductions

Margaret Sparks, JD
Associate Vice President, North America Ethics and Business Integrity, Sanofi US, Bridgewater, NJ

Speaker Bio

4:15 pm

Keynote

Sally Q. Yates, JD
Partner, King and Spalding; Former Acting Attorney General; Former Deputy Attorney General; Former US Attorney; Former Assistant US Attorney, US Attorney’s Officer, Northern District of Georgia, US Department of Justice, Washington, DC

Speaker Bio

Former Deputy Attorney General Sally Yates is a partner in King & Spalding’s Special Matters & Government Investigations practice, twice named by Law360 as “White Collar Practice Group of the Year.” Sally’s deep experience, leadership and wide-ranging background provide clients with strong, independent judgment in difficult times. Known for her lifelong, nonpartisan focus on public corruption, Sally is recognized worldwide for her integrity and credibility. A Fellow of the American College of Trial Attorneys, she specializes in independent investigations for public and private organizations and boards.

4:45 pm

Patient Support Programs, including Reimbursement Support and Co-payment Waivers, Roundtable

Laura G. Hoey, JD
Co-leader, Government Enforcement and White Collar Group, Health Care and Life Sciences Industry Group, Ropes & Gray, LLP, Chicago, IL

Gregg Shapiro, JD
Assistant US Attorney, US Attorney’s Office, District of Massachusetts, US Department of Justice, Boston, MA

Speaker Bio

Gregg Shapiro has been an Assistant United States Attorney in the District of Massachusetts since 2005 and is currently Chief of the Affirmative Civil Enforcement Unit. His work primarily involves health care fraud, including kickbacks and Medicare and Medicaid price reporting violations. Prior to joining the United States Attorney’s Office, Gregg worked in private practice and in the Consumer Protection Bureau of the Federal Trade Commission.

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

Speaker Bio

Erinn Hutchinson joined PwC in 2003 and became a Partner in 2012. She provides 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.

Erinn is a leader of PwC’s Health Industries Advisory Academy, which develops consulting skills, industry expertise and leadership in new Associates. Prior to PwC, Erinn was a consultant Navigant, providing litigation and dispute support for the healthcare industry.

In addition to extensive experience in the U.S. and China, Erinn has performed compliance assessment reviews in Brazil, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Italy, Mexico, Poland, Portugal, Russia, and the Ukraine.

5:30 pm

Recent Developments in Pharmaceutical and Medical Device Pricing and Cost Containment

Susan Dentzer
President and Chief Executive Officer, NEHI (The Network for Excellence in Health Innovation); Analyst on Health Policy, The NewsHour; Former Editor, Health Affairs, Washington, DC

Speaker Bio

Susan Dentzer is President and Chief Executive Officer of the NEHI, the Network for Excellence in Health Innovation, a nonprofit, nonpartisan organization composed of nearly 100 stakeholder organizations from across all key sectors of health and health care. NEHI’s mission is to advance innovations that improve health, enhance the quality of health care, and achieve greater value for the money spent. With offices in Washington, DC, and Boston, Massachusetts, NEHI conducts independent, objective research and thought leadership to accelerate these innovations and bring about changes within health care and public policy. One of the nation’s most respected health and health policy thought leaders and journalists, and a frequent speaker and commentator on television and radio, Dentzer previously served as editor-in-chief of the journal Health Affairs and as the on-air Health Correspondent for the PBS NewsHour. She is an elected member of the National Academy of Medicine.

Presentation Material (Acrobat)

6:00 pm

Closing Comments and Adjournment

Jeffrey M. Kawalek, MBA
Senior Director, Ethics and Compliance, North America, Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ

Speaker Bio

Agenda Links: Preconferences/Day 1 | Day 3

AGENDA: DAY 2THURSDAY, NOVEMBER 8, 2018

7:00 am

Registration Opens; Continental Breakfast in Exhibit Hall

BREAKFAST ROUNDTABLES

Breakfast Roundtable I: Adapting an Effective Compliance Program for a #TimesUp World

7:15 am

Breakfast Roundtable II: The Impact of the Opioid Crisis on the Pharmaceutical Industry

7:15 am

Breakfast Roundtable III: U.S. Leadership to Strengthen Ethical Business Practices Overseas: What Compliance Leaders Need to Know

7:15 am

8:00 am

Breakfast Roundtable Adjournment

MORNING PLENARY SESSION

8:00 am

Co-chair Welcome and Introductions

8:15 am

AUSA Roundtable

9:00 am

FCPA Enforcement Update

9:45 am

Qui Tam Roundtable

10:30 am

Break

MINI SUMMITS BLOCK A: 11:00 am – 12:00 pm

Mini Summit I: Fostering a Culture of Ethics and Compliance beyond just Laws and Regulations

11:00 am

Mini Summit II: What’s Old is New Again: Global Compliance Function Harmonization is Needed Now more than Ever

11:00 am

Mini Summit III: Third Party Lifecycle Management

11:00 am

Mini Summit IV: Annual Medical Device Compliance Roundtable

11:00 am

Mini Summit V: Dissecting Recent CIAs and Review of Draft Model CIA

11:00 am

Mini Summit VI: Advanced Strategies to Measure Effectiveness, Monitor and Report on Compliance Programs

11:00 am

Mini Summit VII: Compliance 3.0: Managing Promotional Programs, Relationships with Patient Advocacy Groups and New Entrants into the Marketplace

11:00 am

12:00 pm

Networking Luncheon and Mini Summits Block B

MINI SUMMITS BLOCK B: 12:15 pm – 1:15 pm

Mini Summit VIII: Open Payments: Where Does the Sun Shine Now?

12:15 pm

Mini Summit IX: Interactions with Specialty Pharmacy

12:15 pm

Mini Summit X: Is your Board of Directors Bored of your Compliance Dashboards?

12:15 pm

Mini Summit XI: Next Generation Data Analytics

12:15 pm

Mini Summit XII: The Fine Line of Promotion with Medical Professionals: Avoiding White Coat Marketing

12:15 pm

Mini Summit XIII: Market Access Compliance Considerations

12:15 pm

1:15 pm

Transition Break

MINI SUMMITS BLOCK C: 1:30 pm – 2:30 pm

Mini Summit XIV: Global Documentation Framework: Practical Strategies for Implementing an Effective Document Framework for Global Policies and Procedures

1:30 pm

Mini Summit XV: R&D: Hidden Risks beyond Clinical Trial Recruitment, including FMV, Invoicing

1:30 pm

Mini Summit XVI: Compliance Considerations for Small to Mid-size Pharma and Device Companies

1:30 pm

Mini Summit XVII: Compliance Issues Associated with PBM Relationships

1:30 pm

Mini Summit XVIII: Risk Assessments and Mitigation Plans: Best Practices and Lessons Learned

1:30 pm

Mini Summit XIX: “All in Compliance” — Aligning with Your Business Partners

1:30 pm

Mini Summit XX: Giving in the Era of Prosecutorial Scrutiny: Navigating the Murky Waters of Patient Programs and Interactions with Patients and Patient Organizations, including Patient Services Compliance Survey Update

1:30 pm

2:30 pm

Transition Break

MINI SUMMITS BLOCK D: 2:45 pm – 3:45 pm

Mini Summit XXI: Compliance Considerations for “Evolved” Pharmaceutical Product, including Gene Therapy and Ultra Rare Disease Products

2:45 pm

Mini Summit XXII: Best Practice in HCP/HCO Management to Reduce Compliance Risk and Enhance Efficiency

2:45 pm

Mini Summit XXIII: Compliance Considerations in Value-based Contracting

2:45 pm

Mini Summit XXIV: Evolving Risks and Opportunities related to Medical Affairs, e.g. Professional Medical Education, Digital Information, etc.

AGENDA: DAY 2
THURSDAY, NOVEMBER 8, 2018