AGENDA: DAY 1
WEDNESDAY, NOVEMBER 4, 2020
INVITATION-ONLY, CLOSED CCO ROUNDTABLE: 10:00 am – 12:20 pm
CHIEF COMPLIANCE OFFICER ROUNDTABLE
(Special Closed-Door Session, Invitation Only, Hosted by Pharmaceutical Compliance Forum)
10:00 am
Welcome & Introductions
Jeffrey M. Kawalek, MBA
Deputy Chief Compliance Officer, Jazz Pharmaceuticals, Inc., Chair, Pharmaceutical Compliance Forum (PCF), Philadelphia, PA
Deputy Chief Compliance Officer, Jazz Pharmaceuticals, Inc., Chair, Pharmaceutical Compliance Forum (PCF), Philadelphia, PA
Antitrust Admonition
John T. Bentivoglio, JD
Partner, Skadden Arps LLP, Former Special Counsel for Healthcare Fraud, and Chief Privacy Officer, US Department of Justice, Washington, DC
Partner, Skadden Arps LLP, Former Special Counsel for Healthcare Fraud, and Chief Privacy Officer, US Department of Justice, Washington, DC
10:10 am
Leveraging Artificial Intelligence (AI), Predictive Analytics and Other Technologies to Conduct Oversight and Enforcement
Renata Maziarz Miskell, MPS
Acting Chief Data and Analytics Officer, Office of Inspector General (OIG), US Department of Health and Human Services (HHS), Washington, DC
Acting Chief Data and Analytics Officer, Office of Inspector General (OIG), US Department of Health and Human Services (HHS), Washington, DC
As the Acting Chief Data and Analytics Officer for the Department of Health and Human Services (HHS), Office of Inspector General (OIG), Renata works to empower HHS OIG to use data proactively to protect the integrity of HHS programs as well as the health and welfare of the people they serve. In her role, Renata focuses on developing and implementing advanced analytics and artificial intelligence capabilities to support OIG in efficiently and effectively executing its oversight mission. Her prior roles have included a senior position in the private sector, directing the strategy for government financial reporting and compliance solutions, and serving as the acting Deputy Assistant Commissioner for Data at the U.S. Department of Treasury, Bureau of the Fiscal Service. Renata also played a key role in leading the government-wide implementation of the Digital Accountability and Transparency Act of 2014 (DATA Act) as well as the re-launch of USAspending.gov, using modern technology, cloud computing, and agile and user-centered development methodologies.
Joe Zimmerman
Vice President, Chief Compliance Officer & Privacy Officer, Ferring Pharmaceuticals, Inc., Parsippany, NJ (Moderator)
Vice President, Chief Compliance Officer & Privacy Officer, Ferring Pharmaceuticals, Inc., Parsippany, NJ (Moderator)
Joseph Zimmerman has over two decades of experience in the pharmaceutical industry in leadership roles of increasing responsibility in such areas as corporate compliance, privacy, leadership development, training, management, and sales. Since 2016 he has been with Ferring Pharmaceuticals, Inc., where he currently serves as Vice President, Chief Compliance & Privacy Officer, and Head of U.S. Government Affairs.
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, where he established the corporate function and managed the teams providing compliance support for numerous new product or indication approvals, branded drug launches, and through various M&A activity.
Mr. Zimmerman is a regular participant in government and industry Chief Compliance Officer roundtables, and periodically speaks to compliance professionals at industry conferences.
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, where he established the corporate function and managed the teams providing compliance support for numerous new product or indication approvals, branded drug launches, and through various M&A activity.
Mr. Zimmerman is a regular participant in government and industry Chief Compliance Officer roundtables, and periodically speaks to compliance professionals at industry conferences.
10:40 am
PhRMA and AdvaMed Update
Julie Ritchie Wagner, JD
Senior Assistant General Counsel, Pharmaceutical Research and Manufacturers of America (PhRMA); Former Senior Counsel, Office of Counsel to the Inspector General, US Department of Health and Human Services (HHS); Washington, DC
Senior Assistant General Counsel, Pharmaceutical Research and Manufacturers of America (PhRMA); Former Senior Counsel, Office of Counsel to the Inspector General, US Department of Health and Human Services (HHS); Washington, DC
Julie Wagner is Senior Assistant General Counsel at PhRMA with responsibility for shaping PhRMA advocacy and driving member consensus on issues related to enforcement, compliance, innovative contracting, and fraud & abuse matters. Prior to joining PhRMA, Julie was Senior Counsel at the HHS Office of Inspector General (OIG), serving as an Anti-Kickback Statute subject matter expert and advising the OIG, CMS, prosecutors, and industry on health care fraud and abuse matters.
Christopher L. White, JD
Chief Operating Officer & General Counsel, Advanced Medical Technology Association (AdvaMed), AdvaMed COVID Action Team Leader, Washington, DC
Chief Operating Officer & General Counsel, Advanced Medical Technology Association (AdvaMed), AdvaMed COVID Action Team Leader, Washington, DC
Christopher White is the Chief Operating Officer, General Counsel and Secretary of the Advanced Medical Technology Association (AdvaMed). Mr. White serves as the Association’s Chief Legal Officer and manages AdvaMed’s Legal Committee to develop and promote legal policy positions enhancing patient access to medical technology. Mr. White also leads the Association’s global working groups on legal policy and compliance, including over 1500 in-house medtech lawyers. He testified before state and federal legislative committees on priority legal policy issues, led the drafting team revising the AdvaMed Code, and led the multinational negotiating team to draft the Kuala Lumpur Principles, harmonizing industry Codes of Ethics in Asia. He has guest lectured at Northwestern, UPenn, Wharton, GWU School of Medicine and Health Sciences and is an Advisory Board Member to the GWU School of Medicine and Health Sciences. In March 2020, Mr. White was appointed the organization’s COVID-19 Action Team Leader, leading all COVID-19-related initiatives and policy. Additionally, he guided the organization to fully remote functioning upon the onset of the pandemic.
11:00 am
CCO Connection Program-Partner Experience
Dennis K. Barnes, JD CPA
Vice President, Global Governance, Risk & Compliance, Mayne Pharma; Former Vice President, Compliance & Risk Management, Global Compliance Officer, PAREXEL International; Raleigh-Durham, NC
Vice President, Global Governance, Risk & Compliance, Mayne Pharma; Former Vice President, Compliance & Risk Management, Global Compliance Officer, PAREXEL International; Raleigh-Durham, NC
Dennis Barnes is the VP, Global Governance, Risk & Compliance at Mayne Pharma headquartered in Raleigh, North Carolina. He is a licensed attorney and a Certified Public Accountant. Prior to joining Mayne Pharma, he served as the Global Compliance Officer of PAREXEL International, a global clinical research organization. Prior to that, he served in various capacities within global pharmaceutical companies and for several of the largest consulting firms in the world including KPMG and PwC.
Cynthia Cetani
Chief Integrity & Compliance Officer, Indivior; Former Group Integrity & Compliance, Head, Compliance Operations, Novartis International AG; Richmond, VA
Chief Integrity & Compliance Officer, Indivior; Former Group Integrity & Compliance, Head, Compliance Operations, Novartis International AG; Richmond, VA
Cindy was appointed as Chief Integrity & Compliance Officer for Indivior in October 2018. Cindy’s U.S. and global leadership spans multiple industries (Pharma, Life, Health). Prior to Indivior, Cindy held various roles across her 15 year career at Novartis (e.g., Chief Compliance Officer NPC and U.S. Country Compliance Head, Head of Compliance Operations, Group Integrity & Compliance in Basel, Switzerland). Before joining Novartis, Cindy was Director of Operations, Managed Markets at Pharmacia. Cindy is a Licensed Professional of Ethics & Compliance, and holds a Bachelor of Science, Commerce, Finance – Magna Cum Laude from Rider College, Lawrenceville, New Jersey.
11:10 am
Interview with an AUSA: The High-Risk Activity of Speaker Programs
Jake Lillywhite, JD
Assistant US Attorney, Civil Division, US Attorney’s Office, Southern District of New York, New York, NY
Assistant US Attorney, Civil Division, US Attorney’s Office, Southern District of New York, New York, NY
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)
Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice; Washington, DC (Moderator)
11:40 am
Interactive Roundtable Discussions
Roundtables will be pre-assigned and organized in groups of up to 20 participants
12:20 pm
Adjournment
MINI SUMMITS GROUP I: 10:00 am – 11:00 am
(During Congress broadcast, attendees may move among Mini Summits)
Mini Summit I: State-of-the-Art Compliance Training (in Dynamic Times)
“Uncertainty is the only certainty there is,” wrote the esteemed mathematician John Allen Paulos. Whether you fully agree with this statement or not, the fact is that we are living in a decidedly uncertain world. As compliance professionals we forge on, finding new answers as the business environment shifts almost daily. We find agile and creative approaches to compliance training to address both traditional and emerging risk areas.
This session shares a practical definition of “state of the art” and guidance for designing and developing compliance training that suits an evolving business environment of virtual work. The goals of this session are to:
- Share a practical framework for making training decisions.
- Share innovative approaches to optimize your compliance training for current and future use.
- Present creative approaches to tailor compliance training to your company’s culture to increase engagement and adoption.
10:00 am
Welcome, Introductions, Discussions and Q&A
Madelyn Archibald
Compliance Education and Training Manager, Merz Aesthetics, Raleigh, NC
Compliance Education and Training Manager, Merz Aesthetics, Raleigh, NC
Madelyn Archibald is the Brandon Hall Group’s 2020 Gold Excellence in Learning Winner for Best Advanced Compliance Training. She is the Compliance and Education Training Manager at Merz Aesthetic and received national recognition for her design of an escape room experience built upon compliance objectives. She was a speaker at the Global Pharmaceutical and Medical Summit in Boston this year, along with winning the Women in Compliance 2020 Award for “Most Impactful Compliance Training Programme”. She studied Criminal Justice at Campbell University, holds US Healthcare Compliance Certificate from Seton Hall, Training Certification I from Romar Learning Solutions, Cornerstone Core Specialist Certification. Madelyn is driven by her passion to empower others and lifelong learning.
Jeffrey Hagy
Associate Director, Corporate Compliance, Regeneron Pharmaceuticals, Inc., Tarrytown, NY
Associate Director, Corporate Compliance, Regeneron Pharmaceuticals, Inc., Tarrytown, NY
Arjun Rajaratnam, JD
President, Extrel Therapeutics, Inc.; Former, Chief Compliance Officer, Smith & Nephew; Raleigh, NC
President, Extrel Therapeutics, Inc.; Former, Chief Compliance Officer, Smith & Nephew; Raleigh, NC
Arjun has over 25 years in Corporate Compliance Programs and Enterprise Risk Management. His positons have included: Global Chief Compliance and Ethics Officer, Chief Risk Officer and Executive Committee member for Smith & Nephew, and Chief Compliance Officer for the US for GlaxoSmithKline. He has practiced law at Sidley & Austin, and in-house at predecessor companies to GlaxoSmithkline. Prior to being a lawyer, Arjun lead the environmental division for an engineering consulting firm. , Arjun was a founder and the first Co-Chair of the Pharmaceutical Compliance Forum, the leading organization for pharmaceutical compliance officers. He is involved in the local community as Adjunct Associate professor at the University of North Carolina at Chapel Hill, where he has given lectures on business ethics and compliance programs, and as a former member of the Board of Directors of the Friends of the Nasher Museum of Art at Duke University, and the Southern Documentary Fund.
Daniel O’Connor
Senior Vice President, PharmaCertify, New York, NY (Moderator)
Senior Vice President, PharmaCertify, New York, NY (Moderator)
Mini Summit II: Compliance Challenges with Digital Health Applications
A new health care consumer continues to emerge: Patients are better informed, and they want the ability to manage their health via tech-enabled solutions. Many life sciences organizations are exploring or expanding digital platforms—such as wellness applications and fitness trackers—to help meet these consumer demands. While these platforms present many benefits to patients, digital health assets introduce a new risk profile for life science companies.
Clarissa Crain, Deloitte Life Sciences, along with this expert panel will provide insights and actions to help you determine whether your assets are developed and deployed within the “guardrails” of this highly regulated industry.
10:00 am
Welcome, Introductions, Discussions and Q&A
Bill Aprea, JD
Former Executive Director, Senior Franchise and Compliance Counsel, JD; Celgene/Bristol-Myers Squibb; Chatham, NJ
Former Executive Director, Senior Franchise and Compliance Counsel, JD; Celgene/Bristol-Myers Squibb; Chatham, NJ
Bill Aprea’s experience as an attorney within the biopharmaceutical industry spans over 15 years with positions at multiple international innovator companies. Most recently, Bill served as Executive Director, Senior Franchise and Compliance Counsel at Bristol Myers Squibb following its acquisition of Celgene. Bill’s expertise includes FDA laws, regulations and guidance, anti-bribery and fraud and abuse and other laws, industry codes and guidelines. He began his career as a corporate and securities attorney in private law firm practice. He is a 1999 graduate of Rutgers School of Law in Newark, NJ.
Sergio Juan Abreu
Regional Compliance Officer, APAC, Merck Group; Former Regional Compliance Officer – LATAM, Merck Serono; Singapore
Regional Compliance Officer, APAC, Merck Group; Former Regional Compliance Officer – LATAM, Merck Serono; Singapore
Mr. Abreu is a lawyer specializing in Corporate Law with +13 years’ experience in the Compliance healthcare area.
Jami Vibbert, JD
Partner, Arnold & Porter, New York, NY
Partner, Arnold & Porter, New York, NY
Clarissa Crain
Senior Manager, Life Sciences Advisory, Deloitte; Former Analyst, Commercial Operations, Cephalon; Philadelphia, PA (Moderator)
Senior Manager, Life Sciences Advisory, Deloitte; Former Analyst, Commercial Operations, Cephalon; Philadelphia, PA (Moderator)
Mini Summit III: Key Considerations and Best Practices in Operationalizing Speaker Programs
- Adapting to monitoring in a virtual environment and navigating its operational challenges
- Evolving considerations of managing the speaker program lifecycle
- Discussion from recent enforcement actions and changes to programs and strategies as a result
10:00 am
Welcome, Introductions, Discussions and Q&A
Sergio Alegre, JD
Vice President, Global Compliance, Osmotica; Former Executive Director Compliance, Pacira; Bridgewater, NJ
Vice President, Global Compliance, Osmotica; Former Executive Director Compliance, Pacira; Bridgewater, NJ
Samantha Barrett Badlam, JD
Counsel, Litigation and Enforcement Group, Ropes & Gray, Washington, DC
Counsel, Litigation and Enforcement Group, Ropes & Gray, Washington, DC
Samantha Barrett Badlam is counsel in Ropes & Gray’s Litigation and Enforcement practice group. Samantha joined the firm in 2006, and her practice focuses in the area of white-collar defense in criminal and civil matters. Samantha has extensive experience in representing multinational companies and their executives in internal and government investigations of potential violations of the AKS, FDCA, FCA, and FCPA. She also dedicates a significant portion of her practice providing advice to clients on compliance matters, particularly in the life sciences and health care sector.
Christopher Corallo
Compliance Officer, North America, ConvaTec, Bridgewater, NJ
Compliance Officer, North America, ConvaTec, Bridgewater, NJ
Chris Corallo, Compliance Officer, North America: Chris is an industry professional with over 19 years of legal and compliance experience. Chris has driven the development and implementation of compliance programs, activities that include training and education, policy and procedures, HCP consultant management, transparency reporting, FMV and risk assessments, monitoring and auditing, 3P due diligence and investigations, for large and mid-sized medical device and pharmaceutical organizations. Chris is passionate about evolving a positive and approachable compliance culture, as well as collaborating with stakeholders to drive strategic business objectives in an ethical and compliant manner.
Ann-Marie Tejcek, MA
Senior Director, Chief Compliance Officer North America, Eli Lilly, Indianapolis, IL
Senior Director, Chief Compliance Officer North America, Eli Lilly, Indianapolis, IL
Ann-Marie Tejcek has been an employee with Eli Lilly and Company, a global innovation-based pharmaceutical company, for over 25 years. In 2017, Ann-Marie was asked to serve as the Chief Compliance Officer for the US and Canadian Affiliates supporting Medical, Marketing, Sales and capabilities functions. The mission of her team, and the broader compliance organization at Lily, is to integrate high performance with high integrity.
Emily C. Huebener, MA
Senior Manager, Health and Life Sciences Forensic & Integrity Services, EY, Chicago, IL (Moderator)
Senior Manager, Health and Life Sciences Forensic & Integrity Services, EY, Chicago, IL (Moderator)
Mini Summit IV: Privacy, GDPR and California Consumer Privacy Act – What’s Next
Join this panel of experts as they discuss latest developments to both domestic and international privacy laws including:
- Global Data Privacy Regulations
- Court of Justice of the European Union (CJEU) decision in Schrems II
- California Consumer Privacy Act (CCPA), Amendment to AB 713, and the California Privacy Rights Act (CPRA)
- HIPAA from a Business Associate perspective
- Operationalized privacy
- Upcoming state privacy laws and federal privacy law
10:00 am
Welcome, Introductions, Discussions and Q&A
Melia Arnett-Archie, JD
Senior Privacy & Data Protection Counsel, Stryker; Former Assistant State Attorney, Miami-Dade State Attorney’s Office; Fort Lauderdale, FL
Senior Privacy & Data Protection Counsel, Stryker; Former Assistant State Attorney, Miami-Dade State Attorney’s Office; Fort Lauderdale, FL
Nancy Libin, JD
Partner and Co-Chair, Privacy & Security and Technology Practice, Davis Wright Tremaine LLP; Former Chief Privacy and Civil Liberties Officer, US Department of Justice Counsel, Senator Joseph R. Biden, Jr., US Senate Judiciary Committee; Washington, DC
Partner and Co-Chair, Privacy & Security and Technology Practice, Davis Wright Tremaine LLP; Former Chief Privacy and Civil Liberties Officer, US Department of Justice Counsel, Senator Joseph R. Biden, Jr., US Senate Judiciary Committee; Washington, DC
Nancy Libin is a partner at Davis Wright Tremaine in Washington, D.C., where she co-chairs the Technology, Privacy & Security practice. Clients seek her counsel on legal and policy issues related to data privacy. She is the former chief privacy officer of the US Department of Justice, and was counsel to then-Senator Joe Biden on the Senate Judiciary Committee. She also served as counsel at the Center for Democracy & Technology, a public policy organization focused on Internet policy. She began her career as an associate at a large law firm in Washington, D.C., and is a graduate of Harvard University and Georgetown University Law Center.
Tim Robinson, JD, LLM
Chief Legal and Data Privacy Officer, MediSpend, Hampton Falls, NH
Chief Legal and Data Privacy Officer, MediSpend, Hampton Falls, NH
Mr. Robinson is the co-founder and Chief Legal and Privacy Officer for MediSpend. Over the last 20 years, Mr. Robinson has worked with numerous life science companies to develop and implement the necessary policies, procedures and systems to facilitate compliance with global healthcare laws. In addition, Mr. Robinson is responsible for the Company’s privacy program and ensures that MediSpend’s software solutions and operations satisfy all global privacy laws and regulations.
Catherine Williams. JD
Director & Privacy Counsel, Privacy Office Novo Nordisk, Plainsboro, NJ
Director & Privacy Counsel, Privacy Office Novo Nordisk, Plainsboro, NJ
Adam Greene, JD, MPH
Partner and Co-chair, Health Information & HIPAA Practice, Davis Wright Tremaine LLP; Former Senior Health Information Technology and Privacy Specialist, Office for Civil Rights, HHS; Washington, DC (Moderator)
Partner and Co-chair, Health Information & HIPAA Practice, Davis Wright Tremaine LLP; Former Senior Health Information Technology and Privacy Specialist, Office for Civil Rights, HHS; Washington, DC (Moderator)
Adam Greene specializes in health information privacy and security laws, using his experience as a former regulator to help clients understand how they can permissibly leverage their health data, bring their information security programs into compliance with the HIPAA Security Rule, and respond to potential breach incidents. He works with healthcare providers, health plans, cloud services providers, health IT companies, and financial institutions to navigate HIPAA and the patchwork of other federal and state health information laws. His work ranges from applying health information laws to new technologies, such as AI and machine learning, to working with organizations to analyze complex privacy and security incidents involving health data under federal and state breach notification laws. Before joining DWT, Adam worked on HIPAA and the HITECH Act at the U.S. Department of Health and Human Services in its Office of General Counsel and Office for Civil Rights. He drafted and negotiated the first HIPAA financial settlement agreements on behalf of the government, and assisted with implementing the HITECH Act and drafting the first HIPAA Breach Notification Rule.
11:00 am
Transition Break
MINI SUMMITS GROUP II: 11:15 am – 12:15 pm
(During Congress broadcast, attendees may move among Mini Summits)
Mini Summit V: Third Party Management Beyond Due Diligence: Selecting, Integrating and Managing Third Parties throughout the Relationship Lifecycle
Topics to be discussed:
- Who owns 3rd party due diligence in your organization?
- Describe the balance of driving growth and sales vs. risk tolerance faced with your Channel Partners?
- How do you select and screen your Channel Partners?
- Do you conduct any live monitoring of your Channel Partners?
- How has COVID-19 affected your 3rd party due diligence program?
11:15 am
Welcome, Introductions, Discussions and Q&A
Ethan Gumpert
Global Ethics, Compliance and Governance, Advanced Medical Technology Association (AdvaMed), Washington, DC
Global Ethics, Compliance and Governance, Advanced Medical Technology Association (AdvaMed), Washington, DC
Ethan Gumpert manages the global ethics, compliance and governance portfolio at AdvaMed. Previous to AdvaMed, Ethan held various roles in lobbying, policy research, securities analysis and international business development. Ethan earned his BA in International Relations and Minor in Entrepreneurship from the American University in Washington, DC.
Patrick Mooty, JD
Executive Director, Compliance & Ethics, Sumitomo Dainippon Pharma America, Marlborough, MA
Executive Director, Compliance & Ethics, Sumitomo Dainippon Pharma America, Marlborough, MA
Patrick Mooty leads the team that provides healthcare compliance and transparency reporting services to affiliates of Sumitomo Dainippon Pharma Group, including Sunovion Pharmaceuticals and SDP Oncology. Prior to joining Sunovion in 2016, Patrick was Global Compliance Officer for HeartWare (now Medtronic), where he guided R&D and promotional efforts related to HeartWare’s ventricular assist device, which was approved in 56 countries. Prior to joining HeartWare in 2011, Patrick was Senior Director of Ethics and Compliance at Fresenius Medical Care, the world’s largest provider of dialysis products and services. Patrick led compliance efforts for the US medical devices business and established the compliance program for Fresenius’ new Renal Pharmaceuticals entity. Prior to joining Fresenius in 2004, Patrick was an attorney specializing in regulatory compliance and taxation matters. He is a graduate of the University of Pennsylvania Carey Law School and Dartmouth College.
Gina Nese
Chief Compliance Officer Advanced Sterilization Products (Fortive/ASP), Everett, WA
Chief Compliance Officer Advanced Sterilization Products (Fortive/ASP), Everett, WA
Patricia Petit, MBA
Compliance Officer, Latin America and Canada, Olympus Corporation of the Americas; Former Latin America Compliance and Legal Manager, GE Healthcare; Miami, FL
Compliance Officer, Latin America and Canada, Olympus Corporation of the Americas; Former Latin America Compliance and Legal Manager, GE Healthcare; Miami, FL
Patricia Petit is the Compliance Officer for Latin America and Canada for Olympus Corporation of the Americas, where she oversees Olympus compliance program for her region. Prior to joining Olympus, Patricia worked for GE Healthcare, most recently as Latin America Legal and Compliance Manager. Prior to joining GE Healthcare, Patricia worked for a Brazilian law firm. Throughout her career, Patricia had a particular focus on third party management. Patricia holds a law degree from Pontificia Universidade Catolica de Sao Paulo (PUC-SP) and obtained her MBA from Fundacao Getulio Vargas (FGV-SP) in Brazil.
J. Mark Farrar, MSJ, CPA, CFE, CFF, CIPP/US
Partner, Life Sciences Governance, Risk Management and Compliance, Guidehouse; Former Interim Chief Global Compliance Officer, Beckman Coulter; Atlanta, GA (Moderator)
Partner, Life Sciences Governance, Risk Management and Compliance, Guidehouse; Former Interim Chief Global Compliance Officer, Beckman Coulter; Atlanta, GA (Moderator)
Mini Summit VI: Regulatory Updates for Compliance and Legal Professionals
FDA regulatory oversight and enforcement has never been so front and center as it is currently in the COVID-19 environment. Biopharma and medical devices companies work diligently to navigate and adhere to their regulatory compliance obligations, stay abreast of changes in the laws, regulations and guidance and promptly address any enforcement issues that may arise. This panel will draw insights and updates from attorneys who work in the FDA regulatory space including an in-house attorney from a biopharmaceutical company, focusing on FDA priorities and the compliance and enforcement environment and the impact and potential impact on the industry.
11:15 am
Welcome, Introductions, Discussions and Q&A
Shelby Buettner, JD
Associate Chief Counsel, Office of the Chief Counsel Food and Drug Administration, Washington, DC
Associate Chief Counsel, Office of the Chief Counsel Food and Drug Administration, Washington, DC
Lauren Miller, JD
Corporate Counsel, Otsuka Pharmaceutical Company; Former Regulatory Counsel, Office of Prescription Drug Promotion, FDA, Washington, DC
Corporate Counsel, Otsuka Pharmaceutical Company; Former Regulatory Counsel, Office of Prescription Drug Promotion, FDA, Washington, DC
Khelin N. Aiken, JD
Partner, Baker & McKenzie LLP; Former Regulatory Counsel, Center for Drug Evaluation and Research US Food and Drug Administration (FDA); Washington, DC (Co-moderator)
Partner, Baker & McKenzie LLP; Former Regulatory Counsel, Center for Drug Evaluation and Research US Food and Drug Administration (FDA); Washington, DC (Co-moderator)
Veleka Peeples-Dyer, JD
Partner and Chair, North America Food and Drug Administration (FDA) Practice Group, Baker & McKenzie LLP, Washington, DC (Co-moderator)
Partner and Chair, North America Food and Drug Administration (FDA) Practice Group, Baker & McKenzie LLP, Washington, DC (Co-moderator)
Mini Summit VII: Best Practices in Operationalizing Updates to the Sunshine Law
- What does the expansion of the CR definition mean to your operations (e.g., policies, training, systematic changes)?
- How do the new categories of Nature of Payment impact your data collection or reporting and are any more or less relevant to your business?
- Device identifier requirements and the impact to your company, data collection requirements and resources needed to operationalize.
- Beyond the changes, how has the pandemic impacted reporting (e.g., schedule/timeline)?
- Preemption and what the new rules mean for state/local reporting?
11:15 am
Welcome, Introductions, Discussions and Q&A
Susan K. Hibbard
Associate Director, Transparency Office of Ethics & Compliance, Boehringer Ingelheim, Ridgefield, CT
Associate Director, Transparency Office of Ethics & Compliance, Boehringer Ingelheim, Ridgefield, CT
Heather McCollum, JD, MHA, CCEP-I
Senior Director, Compliance, Shionogi, Florham Park, NJ
Senior Director, Compliance, Shionogi, Florham Park, NJ
Kristine Mueller, JD, LLM
Global Compliance Operations Manager, North America, Arthrex, Naples, FL
Global Compliance Operations Manager, North America, Arthrex, Naples, FL
Christine N. Bradshaw, JD
Vice President, Porzio Life Sciences, LLC Principal, Porzio, Bromberg & Newman PC, New York, NY (Moderator)
Vice President, Porzio Life Sciences, LLC Principal, Porzio, Bromberg & Newman PC, New York, NY (Moderator)
Mini Summit VIII: Compliance Considerations for Rare and Ultra Rare Drugs
Join the discussion on key compliance considerations for rare and ultra-rare products related to the following areas:
- Disease State Education
- Patient Interactions
- HCP Engagement
- Medical/Commercial Interactions
11:15 pm
Welcome, Introductions, Discussions and Q&A
Terra Buckley, JD
Vice President, Head of Global Compliance, Mesoblast Limited; Former Executive Director, Head of the Business Advisory Center of Excellence, US Healthcare Compliance, Celgene; New York, NY
Vice President, Head of Global Compliance, Mesoblast Limited; Former Executive Director, Head of the Business Advisory Center of Excellence, US Healthcare Compliance, Celgene; New York, NY
Terra has 10 years of experience building and managing compliance programs for companies ranging from start-ups to mid-sized biotech and pharma. Her expertise includes managing the unique risks associated with rare and ultra-rare diseases. Prior to moving into compliance, she spent twelve years in various commercial roles including sales, sales management and marketing. Terra has her JD in Health Law and Compliance from Seton Hall Law School. She is currently the Head of Compliance for Mesoblast, an innovative cellular medicines company.
Mark P. Graves, JD, MBA
Senior Vice President and Chief Compliance Officer, MiMedx Group; Former Senior Director, Office of Ethics and Compliance, Abbott Laboratories; Former Deputy Ethics & Compliance Officer, Takeda Pharmaceuticals; Marietta, GA
Senior Vice President and Chief Compliance Officer, MiMedx Group; Former Senior Director, Office of Ethics and Compliance, Abbott Laboratories; Former Deputy Ethics & Compliance Officer, Takeda Pharmaceuticals; Marietta, GA
Mr. Graves joined MiMedx in July 2018 and brings more than 20 years of pharmaceutical and biotech industry experience to the Company, ranging from compliance and sales management to government affairs. He most recently was the U.S. leader for the global Patient Experience & Value function in the neurology division of UCB, Inc., a biopharmaceutical company. From 2011 to 2015, he was UCB’s Deputy Compliance Officer involved in all aspects of compliance including the implementation and management of the company’s corporate integrity agreement. Prior to that, Graves was Senior Director in the Office of Ethics and Compliance for the Pharmaceutical Products Division of Abbott Laboratories, as well as Deputy Ethics & Compliance Officer for Takeda Pharmaceuticals North America, Inc. and TAP Pharmaceutical Products, Inc. Prior to his pharmaceutical and biotech career, he practiced labor and employment law.
Gregory S. Moss, LLB
Executive Vice President, General Counsel and Corporate Secretary, Chief Compliance Officer, Kadmon Holdings, New York, NY
Executive Vice President, General Counsel and Corporate Secretary, Chief Compliance Officer, Kadmon Holdings, New York, NY
Mr. Moss was appointed Executive Vice President, General Counsel and Corporate Secretary of Kadmon in 2019. Mr. Moss also serves as Kadmon’s Chief Compliance Officer. Mr. Moss joined Kadmon in 2012 and from 2015 until August 2019, served as its Senior Vice President, Deputy General Counsel. Prior to joining the Company, Mr. Moss worked as a solicitor in the Corporate Risk practice group of one of Australia’s leading law firms and at a boutique legal practice and hedge fund in New York City. Mr. Moss holds a Bachelor of Arts and Bachelor of Laws (BA/LLB) from Macquarie University, Sydney, Australia.
Jennifer Santos, JD
Senior Director, R&D Business Partner, Office of Business Integrity & Ethics, Vertex Pharmaceuticals, Boston, MA
Senior Director, R&D Business Partner, Office of Business Integrity & Ethics, Vertex Pharmaceuticals, Boston, MA
Jennifer Santos is a Senior Director in the Office of Business Integrity & Ethics at Vertex Pharmaceuticals in Boston. She serves as a compliance business partner for the Global Research & Development teams as well as Regulatory Affairs, Quality Assurance and Business Development.
BJ D’Avella, MBA
Leader, Life Sciences Consulting Group, Paul Hastings, New York, NY (Moderator)
Leader, Life Sciences Consulting Group, Paul Hastings, New York, NY (Moderator)
BJ D’Avella is the leader of Paul Hastings’ Life Sciences Consulting Group. For nearly 20 years, BJ has worked with Life Sciences clients to lead Legal and Compliance program design and delivery efforts. He has deep experience in risk management designs related to patient services, sales and marketing, medical affairs, and clinical operations, and has specialized in all key Legal and Compliance areas: program charters and operating models, organizational designs and staffing, written standard architectures and written standards, training and communications, risk assessment processes, and monitoring and auditing programs. Throughout his career, he has supported his clients along the CIA-IRO continuum, from CIA readiness through implementation and IRO-related work. He has deep experience in the conduct of Fair Market Value (FMV) assessments, and has led the creation and development of technology-enabled compliance services.
12:15 pm
Transition Break
OPENING PLENARY SESSION
1:00 pm
Welcome and Introduction: PCF Co-Chairs
Indrani Franchini, JD
Executive Vice President Chief Compliance Officer, Alexion Pharmaceuticals, New York, NY
Executive Vice President Chief Compliance Officer, Alexion Pharmaceuticals, New York, NY
Jeffrey M. Kawalek, MBA
Deputy Chief Compliance Officer, Jazz Pharmaceuticals, Inc., Chair, Pharmaceutical Compliance Forum (PCF), Philadelphia, PA
Deputy Chief Compliance Officer, Jazz Pharmaceuticals, Inc., Chair, Pharmaceutical Compliance Forum (PCF), Philadelphia, PA
Margaret Sparks, JD
Head of Compliance, Vaccines, North America Ethics and Business Integrity, Sanofi Bridgewater, NJ
Head of Compliance, Vaccines, North America Ethics and Business Integrity, Sanofi Bridgewater, NJ
Ann Marie Tejcek
Senior Director, Chief Compliance Officer North America, Eli Lilly, Indianapolis, IN
Senior Director, Chief Compliance Officer North America, Eli Lilly, Indianapolis, IN
Ann-Marie Tejcek has been an employee with Eli Lilly and Company, a global innovation-based pharmaceutical company, for over 25 years. In 2017, Ann-Marie was asked to serve as the Chief Compliance Officer for the US and Canadian Affiliates supporting Medical, Marketing, Sales and capabilities functions. The mission of her team, and the broader compliance organization at Lily, is to integrate high performance with high integrity.
Donna White, CCEP
Vice President, Compliance, Chiesi, USA, Cary, NC
Vice President, Compliance, Chiesi, USA, Cary, NC
Donna White is the Vice President, Compliance, for Chiesi USA, Inc., Chiesi Global Rare Disease, and Chiesi Canada Corporation. During her long tenure in the pharmaceutical industry, Donna has worked in most functional areas, supporting multiple therapeutic classes in the hospital, retail, specialty, rare disease, brand and generic spaces. Currently, she, along with her team, oversees Corporate Compliance, State Price Transparency, Government Programs, Aggregate Spend, PDMA, and Fair Market Value with other responsibilities throughout the organization. At Chiesi, Donna chairs the Compliance Committee and the Pricing Committee. She also serves on the Pharmaceutical Compliance Forum’s Leadership Team as a Member Co-Chair.
Joe Zimmerman
Vice President, Chief Compliance Officer & Privacy Officer, Ferring Pharmaceuticals, Inc., Parsippany, NJ
Vice President, Chief Compliance Officer & Privacy Officer, Ferring Pharmaceuticals, Inc., Parsippany, NJ
Joseph Zimmerman has over two decades of experience in the pharmaceutical industry in leadership roles of increasing responsibility in such areas as corporate compliance, privacy, leadership development, training, management, and sales. Since 2016 he has been with Ferring Pharmaceuticals, Inc., where he currently serves as Vice President, Chief Compliance & Privacy Officer, and Head of U.S. Government Affairs.
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, where he established the corporate function and managed the teams providing compliance support for numerous new product or indication approvals, branded drug launches, and through various M&A activity.
Mr. Zimmerman is a regular participant in government and industry Chief Compliance Officer roundtables, and periodically speaks to compliance professionals at industry conferences.
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, where he established the corporate function and managed the teams providing compliance support for numerous new product or indication approvals, branded drug launches, and through various M&A activity.
Mr. Zimmerman is a regular participant in government and industry Chief Compliance Officer roundtables, and periodically speaks to compliance professionals at industry conferences.
Antitrust Admonition
John T. Bentivoglio, JD
Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer US Department of Justice; Washington, DC
Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer US Department of Justice; Washington, DC
1:15 pm
Keynote: OIG Update
Gregory E. Demske, JD
Chief Counsel to the Inspector General Office of Inspector General US Department of Health and Human Service, Washington, DC
Chief Counsel to the Inspector General Office of Inspector General US Department of Health and Human Service, Washington, DC
Mary E. Riordan, JD
Senior Counsel, Office of Counsel to the Inspector General Office of Inspector General US Department of Health and Human Services, Washington, DC
Senior Counsel, Office of Counsel to the Inspector General Office of Inspector General US Department of Health and Human Services, Washington, DC
2:15 pm
US DOJ Keynote
Gustav W. Eyler, JD
Director, Consumer Protection Branch Civil Division, US Department of Justice, Washington, DC
Director, Consumer Protection Branch Civil Division, US Department of Justice, Washington, DC
Andy Mao, JD
Deputy Director, Fraud Section, Civil Division, Elder Justice Initiative Coordinator, US Department of Justice, Washington, DC
Deputy Director, Fraud Section, Civil Division, Elder Justice Initiative Coordinator, US Department of Justice, Washington, DC
Gejaa T. Gobena, JD
Partner, Hogan Lovells; Former Deputy Chief, Fraud Section, Criminal Division; Former Trial Attorney, Civil Division, Fraud Section US Department of Justice; Washington, DC (Moderator)
Partner, Hogan Lovells; Former Deputy Chief, Fraud Section, Criminal Division; Former Trial Attorney, Civil Division, Fraud Section US Department of Justice; Washington, DC (Moderator)
3:00 pm
Visit Exhibit Hall
3:30 pm
FDA Keynote
Catherine (Katie) Gray, PharmD
Acting Director, Office of Prescription Drug Promotion US Food and Drug Administration, Silver Spring, MD
Acting Director, Office of Prescription Drug Promotion US Food and Drug Administration, Silver Spring, MD
Catherine Gray leads the Office of Prescription Drug Promotion (OPDP) at the FDA. Her diverse team of professionals focuses on the challenging and evolving policy and operational issues pertaining to the promotion of prescription drugs. She oversees policy development, social science research, regulatory counseling, compliance activities, stakeholder engagement, and operational support to the office as it realizes its mission to protect the public health. Her over twenty years of experience include roles in clinical pharmacy and the pharmaceutical industry.
4:00 pm
DAY I ADJOURNMENT