AGENDA: DAY 2
THURSDAY, NOVEMBER 5, 2020
MINI SUMMITS GROUP III 10:00 am – 11:00 am
(During Congress broadcast, attendees may move among Mini Summits)
Mini Summit IX: Managing Monitorships and Independent Review Organizations to Maximize Effectiveness
Monitorships and Independent Review Organizations are likely to continue in our industry. Our panel of experts will discuss the differences between these aspects of settlements and how to manage their effectiveness prior to, during, and after the settlement term. The topics discussed will include managing scope, communication, and escalation protocols, as well as how to better manage implementation of initiatives that yield a higher level of effectiveness.
10:00 am
Welcome, Introductions, Discussions and Q&A
Peter Agnoletto, CPA
Compliance Officer, Primary Care and Consumer Health Care, Sanofi; Former Chief Compliance Officer & Chief Audit Executive & ERM Leader, Par Pharma; Flemington, NJ
Compliance Officer, Primary Care and Consumer Health Care, Sanofi; Former Chief Compliance Officer & Chief Audit Executive & ERM Leader, Par Pharma; Flemington, NJ
Peter Agnoletto, is Compliance Officer, General Medicines and Consumer Healthcare, North America Ethics & Business Integrity at Sanofi. Prior to Sanofi Peter was the Chief Compliance Officer and Chief Audit Executive at Par Pharmaceuticals Companies, Inc. Peter is a Compliance and Financial executive with a demonstrated record of achievement in creating and implementing Governance Risk and Compliance frameworks and structures which protect companies’ interests while enabling them to achieve their growth objectives. Peter has over 20 years’ experience with multi-billion dollar international public companies and professional service organizations. Peter also has significant experience and expertise in Process Analysis and Redesign; Change and Program Management and Risk and Control Analysis. Peter also held management positions with Schering-Plough; PricewaterhouseCoopers; British Airways and Unilever.
John Seungjoo Rah, JD
Partner, DLA Piper, Washington, DC
Partner, DLA Piper, Washington, DC
Tara R. Shewchuk, JD, LLM
Chief Deputy Ethics and Compliance Officer, Medtronic Americas; Former Senior Director, Ethics and Compliance, AbbVie Former VP, Chief Compliance, Privacy & Security Officer Resurrection Health Care; Minneapolis, MN
Chief Deputy Ethics and Compliance Officer, Medtronic Americas; Former Senior Director, Ethics and Compliance, AbbVie Former VP, Chief Compliance, Privacy & Security Officer Resurrection Health Care; Minneapolis, MN
Tara Shewchuk is currently Chief Deputy Compliance Officer at Medtronic. Prior to her current role, Tara was VP, Ethics & Compliance for Medtronic’s Restorative Therapies Group (RTG), Sr. Compliance Director for Abbott’s Pharmaceutical Division, and VP, Compliance / Privacy & Security Officer for a Chicago IDN. She’s also held policy roles for several medical associations. From 2006-2016, Tara taught Bioethics and Health Care Compliance at Loyola University Chicago Law School and served as Thesis Advisor to LL.M. candidates. She has a J.D. from McGill, an LL.M. from Loyola and completed a Fellowship in Clinical Medical Ethics at University of Chicago.
Yogesh Bahl, CPA, MBA
Managing Director, AlixPartners, New York, NY (Moderator)
Managing Director, AlixPartners, New York, NY (Moderator)
Yogesh has 25 years of experience in compliance, operations, and investigations, with a focus in life sciences. Yogesh has conducted investigations, served as an expert in litigation, and has helped many companies implement strategies that are feasible, effective, and aligned with CCO and CFO priorities. Yogesh is focused on evolving compliance programs using the principles of behavioral psychology and behavioral economics. He has helped manage pre-IRO reviews, implementation of CIAs, investigations, data analytics, and third-party risks. Yogesh is passionate about women’s rights; he serves on the board of Womankind, an organization helping women and children survivors of gender-based violence.
Mini Summit X: Building Ethics and Integrity into the Foundation of Your Compliance Program
Join industry leaders as they discuss:
- Building corporate ethics and integrity vs. strict rules-based compliance programs
- How a principle-based approach impacts the roles of compliance and legal officers
- Best practices for empowering ethics leaders
- Views on how to maintain a culture of ethics and compliance in a remote environment.
10:00 am
Welcome, Introductions, Discussions and Q&A
Jennifer McGee, JD
Vice President and Global Chief Compliance Officer, Otsuka America Pharmaceutical; Former, PCF Co-chair; Rockville, MD
Vice President and Global Chief Compliance Officer, Otsuka America Pharmaceutical; Former, PCF Co-chair; Rockville, MD
Amy Pawloski
President, Strategic Versatility Former Global Compliance Operations Officer, Endo, Phoenixville, PA
President, Strategic Versatility Former Global Compliance Operations Officer, Endo, Phoenixville, PA
Amy Pawloski is President of Strategic Versatility LLC. She assists life sciences companies with all aspects of their Compliance programs from strategy to execution. She is also the General Manager of Helio Health’s novel PDR compliance data analytics tool. Prior to starting her consulting practice, Amy was the Global Compliance Operations Officer at Endo Pharmaceuticals. Prior to Endo, Amy spent 20 years at Bristol-Myers Squibb where she held multiple domestic and global Compliance leadership positions. Prior to her work in Compliance, she held prominent roles in Business Operations, Pricing & Reimbursement, and Finance. Amy began her career at PricewaterhouseCoopers in both the Audit and Consulting practices. Amy is a certified Compliance and Ethics Professional (CCEP), Project Management Professional (PMP), and Lean Six Sigma Green Belt.
Brad Powers, MS, JD
General Counsel and Chief Compliance Officer, Lumos Pharma; Former General Counsel and Chief Compliance Officer, NewLink Genetics; Des Moines, IA
General Counsel and Chief Compliance Officer, Lumos Pharma; Former General Counsel and Chief Compliance Officer, NewLink Genetics; Des Moines, IA
Brad Powers is General Counsel for Lumos Pharma – a clinical stage company with approximately 30 employees. Compliance at a small company provides the opportunity to emphasize direct employee interaction that is difficult to achieve in a larger organization while implementing appropriately sized solutions that can ease the rapid growth that comes with clinical success. Previously, Brad was General Counsel and Interim Director of Global Sales, Service and Marketing at Kinze Manufacturing and practiced IP litigation and licensing at McKee, Voorhees and Sease. In addition to his JD, Brad holds a master’s in Bioinformatics and Computational Biology.
Mona Peterson Rosow, JD, MPH
Senior Director, Global Office of Ethics & Compliance, Medtronic, Minneapolis, MI
Senior Director, Global Office of Ethics & Compliance, Medtronic, Minneapolis, MI
Mona Peterson Rosow is an 18+ year compliance leader whose experience spans the healthcare and medical device industry. She currently leads Medtronic’s global corporate compliance function and leads Medtronic’s compliance efforts in the areas of global trade compliance, anti-corruption, conflicts of interest, records information management, and ethical culture. She is passionate about working with her business partners on demystifying compliance to create organizations passionate about doing the right thing. Prior to Medtronic, Mona held a variety of legal and compliance positions at United Healthcare and Target and served as legal and compliance counsel at a boutique healthcare firm in Minneapolis.
David J. Ludlow, JD
Partner, Sidley Austin LLP, Washington, DC (Moderator)
Partner, Sidley Austin LLP, Washington, DC (Moderator)
David Ludlow is a partner in Sidley Austin’s Washington, D.C. Office. He has extensive experience representing pharmaceutical, medical device, and other life sciences companies and individuals in government enforcement actions, litigation, and internal investigations. David regularly counsels companies on their corporate compliance programs and helps companies conduct program reviews, risk assessments, and employee training.
Mini Summit XI: Annual Medical Device Roundtable
Join Chris White, Chief Operating Officer & General Counsel, ADVAMed, for an update on AdvaMed’s Code and Ethics & Compliance Leaders from Medical Device Industry to discuss:
- COVID Considerations
- Compliance Program Management with Diverse Businesses
- Medical Device Asset Management
- DPA/CIA Lessons Learned
- Enforcement Trends
10:00 am
Welcome, Introductions, Discussions and Q&A
Thomas M. Glavin, JD
Chief Compliance Officer for the Americas, Olympus Corporation of the Americas; Former Vice President, US/Americas Compliance Officer, Shire; Center Valley, PA
Chief Compliance Officer for the Americas, Olympus Corporation of the Americas; Former Vice President, US/Americas Compliance Officer, Shire; Center Valley, PA
Tom Glavin is an experienced pharmaceutical, biotechnology and medical device compliance professional and lawyer with a diverse background encompassing many facets of healthcare and corporate compliance, corporate ethics, sales and marketing law and practices, medical, research and development, and regulatory law. Tom has extensive experience implementing compliance and ethics programs. Tom has served as Chief Compliance Officer at Olympus Corporation of the Americas since September 2016, where he has been responsible for leading the Compliance Program and function, including the implementation and execution of Integrity agreements with the OIG and DOJ. From 2005-2015, Tom was the Compliance Officer for the Americas at Shire Pharmaceuticals. Before Shire, Tom worked in Legal and Compliance positions at Sanofi (previously Aventis and Rhone-Poulenc Rorer), and at law firms in Philadelphia and Pittsburgh.
Jonathan Glazier, MBA, JD
Head of Legal Compliance, Philips North America; Former Senior Director of Corporate Compliance and Privacy Officer, Fresenius Medical Care North America; Andover, MA
Head of Legal Compliance, Philips North America; Former Senior Director of Corporate Compliance and Privacy Officer, Fresenius Medical Care North America; Andover, MA
Mr. Glazier currently leads the Legal Compliance function in North America for Philips, a health technology company. Jonathan also leads the healthcare compliance domain globally. Prior to Philips, Jonathan was the Senior Director of Corporate Compliance, Privacy and Information Security Officer for Fresenius Medical Care North America, the dialysis and infusion products and services company.
Keith Korenchuk, MPH, JD
Vice President and Chief Compliance Officer, DH Diagnostics, a Danaher Company, Chevy Chase, MD
Vice President and Chief Compliance Officer, DH Diagnostics, a Danaher Company, Chevy Chase, MD
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.
Emily F. Hodge, JD
Partner, Choate, Hall & Stewart Former Special Assistant District Attorney, Suffolk County, Boston Municipal Court, Boston, MA (Moderator)
Partner, Choate, Hall & Stewart Former Special Assistant District Attorney, Suffolk County, Boston Municipal Court, Boston, MA (Moderator)
Emily Hodge has over ten years of experience representing individuals and life sciences companies in government and internal investigations and providing compliance advice to companies that are navigating a challenging and nuanced enforcement environment. Ms. Hodge is also experienced in complex civil litigation and has defended a number of clients in civil qui tam actions. Ms. Hodge’s analytical skills, knowledge of the industry, and leadership make her a valued contributor in complex investigations and a trusted advisor in times of critical decision-making for her clients.
Mini Summit XII: Update on Pharma CIAs, including changes to OIG’s Model CIA Template and Insights on Agency Priorities from Recent CIA Negotiations
- Overview of recent Corporate Integrity Agreements (CIAs), including changes to OIGs template
- Agency insights on priorities from recent CIA negotiations
10:00 am
Welcome, Introductions, Discussions and Q&A
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.
Elizabeth Jobes, JD
Global Chief Compliance Officer Amryt Pharma; Former Senior Vice President, Chief Compliance Officer North America at EMD Serono Inc.; Former Head of Corporate Compliance and Legal Counsel Company, Spark Therapeutics, Inc.; Cambridge, MA
Global Chief Compliance Officer Amryt Pharma; Former Senior Vice President, Chief Compliance Officer North America at EMD Serono Inc.; Former Head of Corporate Compliance and Legal Counsel Company, Spark Therapeutics, Inc.; Cambridge, MA
Thomas Beimers, JD
Partner, Hogan Lovells Former Senior Counsel, Office of Counsel, HHS Inspector General; Former Special Assistant United States Attorney, US Attorney’s Office, Eastern District of Michigan; Minneapolis, MN and Washington, DC (Moderator)
Partner, Hogan Lovells Former Senior Counsel, Office of Counsel, HHS Inspector General; Former Special Assistant United States Attorney, US Attorney’s Office, Eastern District of Michigan; Minneapolis, MN and Washington, DC (Moderator)
Mini Summit XIII: Drug Promotion from the Living Room: Navigating Interactions with HCPs and Addressing Compliance Concerns during a Pandemic
Ethics & Compliance professionals are responsible for ensuring that all interactions with Health Care Professionals (“HCPs”) adhere to legal and regulatory requirements, even when a government-mandated lockdown is in place. This panel will provide strategies and best practices to address challenges that companies face when maintaining compliance controls around virtual interactions with HCPs in the era of COVID-19. This discussion will focus primarily on the following activities: conducting virtual speaker programs, advisory boards, HCP consulting arrangements, and HCP details and monitoring efforts related to same.
10:00 am
Welcome, Introductions, Discussions and Q&A
Punkaj T. Amin, MS, MBA
Compliance Officer – US Wound Management, Office of Ethics and Compliance (OEC), Smith & Nephew, Fort Worth, TX
Compliance Officer – US Wound Management, Office of Ethics and Compliance (OEC), Smith & Nephew, Fort Worth, TX
Punkaj Amin has 15+ years professional experience as a consultant (PwC) and Compliance Officer in both the pharmaceutical and medical device industries (Grifols and Smith+Nephew).
Rore Middleton, JD
Senior Director, Compliance and Privacy, Blueprint Medicines; Former Director, US Compliance and Ethics, Alexion Pharmaceuticals, Inc.; Cambridge, MA
Senior Director, Compliance and Privacy, Blueprint Medicines; Former Director, US Compliance and Ethics, Alexion Pharmaceuticals, Inc.; Cambridge, MA
Rore is the Senior Director, Compliance and Privacy responsible for implementing the US compliance program at Blueprint Medicines. Prior to Blueprint, Rore worked in compliance at Alexion Pharmaceuticals and Purdue Pharma. After graduating from Howard University, Rore got her JD from the University of Texas and practiced civil litigation for several years before moving from Texas to the East Coast. Rore is mom to three amazing daughters, Waverly, Dylann, and Sydney. In her free time, Rore loves working out, practicing yoga, and ticking places off her travel bucket list.
Ben Kaye-Smith
Senior Vice President Ethics, Risk & Compliance, Novartis Gene Therapies; Former Global Head Integrity & Compliance Risk Review & Prevention, Novartis; Switzerland
Senior Vice President Ethics, Risk & Compliance, Novartis Gene Therapies; Former Global Head Integrity & Compliance Risk Review & Prevention, Novartis; Switzerland
Thomas Goimarac, MBA, CHFP
Managing Consultant, Berkeley Research Group, LLC (BRG), Phoenix, AZ (Co-Moderator)
Managing Consultant, Berkeley Research Group, LLC (BRG), Phoenix, AZ (Co-Moderator)
Briannon Irwin, JD
Senior Managing Consultant, Berkeley Research Group (BRG); Former Judicial Law Clerk, The Supreme Court of Pennsylvania; Washington, DC (Co-Moderator)
Senior Managing Consultant, Berkeley Research Group (BRG); Former Judicial Law Clerk, The Supreme Court of Pennsylvania; Washington, DC (Co-Moderator)
Briannon Irwin is a Senior Managing Consultant at Berkeley Research Group (BRG). During her tenure at BRG, Ms. Irwin has conducted multiple compliance assessments related to investigations by the U.S. Department of Justice, the Department of Health and Human Services Office of Inspector General, the Environmental Protection Agency, and other governmental bodies. She has provided substantial support in the remediation of compliance concerns relating to operational aspects of compliance program development, management, and oversight, including compliance program design, implementation, and evaluation measures. Ms. Irwin has evaluated the state of compliance programs of various entities in the life sciences industry, ranging from regional wholesale pharmacy distributors to international pharmaceutical and medical device companies. She has also tracked the improvements made to a large medical device company’s compliance program in the context of an investigation initiated by the U.S. Department of Justice.
Mini Summit XIV: Changing Dynamics of State Price Transparency and Reporting Requirements
An emerging issue across the healthcare delivery system is the pressure to lower prescription drug prices. In the absence of a federal program, state governments are adopting drug price transparency laws that require companies to disclose specific strategic and commercial pricing information. The growth in the number of state governments adopting price transparency laws is similar to the way spend transparency rolled out across the country over a decade ago and create an intricate and varied regulatory environment, as the complexity of the laws differ between jurisdictions. This session will discuss these and other key issues, including:
- How are companies operationalizing compliance with these price transparency laws?
- Are some states harder to comply with than others?
- What is the role of compliance in the context of drug price transparency?
- How are companies handling enforcement issues or communications with state regulators?
10:00 am
Welcome, Introductions, Discussions and Q&A
Yvonne Clark, JD
Corporate Compliance Counsel, Spark Therapeutics Former Commercial Counsel, Merck, Philadelphia, PA
Corporate Compliance Counsel, Spark Therapeutics Former Commercial Counsel, Merck, Philadelphia, PA
Yvonne Clark is an attorney with 17 years of experience advising and defending companies in the pharmaceutical, biotech and device industries. Ms. Clark serves as Corporate Compliance Counsel at Spark Therapeutics, a Philadelphia-based gene therapy company. She previously worked as an attorney at Merck Sharp & Dohme Corporation, and supported Merck’s U.S. Commercial Division on a variety of legal and compliance matters. Before working as an in-house attorney, Ms. Clark was in private practice at the law firms of Pepper Hamilton LLP and Dechert LLP.
Kristin M. Mykulak, JD
Assistant General Counsel, Litigation & Compliance, Dr. Reddy’s Laboratories, Princeton, NJ
Assistant General Counsel, Litigation & Compliance, Dr. Reddy’s Laboratories, Princeton, NJ
Kristin Mykulak has 13 years of legal and compliance experience in private practice and serving as in-house counsel for Dr. Reddy’s Laboratories, Inc. While in private practice, Kristin provided compliance counseling and strategic legal representation to pharmaceutical and healthcare companies. At Dr. Reddy’s, Kristin manages the US litigation portfolio and leads the compliance team in the US, Canada and LatAm, providing compliance advice to the branded specialty, generic and over-the-counter pharmaceutical businesses, custom pharmaceutical services business, and active pharmaceutical ingredient supply business.
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.
John Patrick Oroho, JD
Executive Vice President and Chief Strategy Officer, Porzio Life Sciences, LLC Principal, Porzio, Bromberg & Newman, Morristown, NJ (Moderator)
Executive Vice President and Chief Strategy Officer, Porzio Life Sciences, LLC Principal, Porzio, Bromberg & Newman, Morristown, NJ (Moderator)
11:00 am
Transition Break
MINI SUMMITS GROUP IV 11:15 am – 12:15 pm
(During Congress broadcast, attendees may move among Mini Summits)
Mini Summit XV: Compliance Challenges and Opportunities for Emerging Life Sciences Organizations
Join industry leaders as they share insights and actions to help navigate the unique compliance-related challenges and opportunities that come with working at emerging life sciences organizations. Topics to be discussed include resourcing considerations (e.g., compliance department budgets, use of internal vs external resources), embedding compliance within the organization, and the importance of practical compliance advice.
11:15 am
Welcome, Introductions, Discussions and Q&A
Samantha Barrett Badlam, JD
Counsel, Litigation and Enforcement Group, Ropes & Gray, Washington, DC
Counsel, Litigation and Enforcement Group, Ropes & Gray, Washington, DC
Joseph Calarco
Vice President, Compliance, Nabriva Therapeutics; Former Chief Compliance Officer, NEOS Therapeutics; Former Director, Compliance & Ethics, US Operations, Bristol-Myers Squibb; Lansdale, PA
Vice President, Compliance, Nabriva Therapeutics; Former Chief Compliance Officer, NEOS Therapeutics; Former Director, Compliance & Ethics, US Operations, Bristol-Myers Squibb; Lansdale, PA
Eric Siegel, MBA, JD
Vice President, Head of Compliance US, Idorsia Pharmaceuticals US; Former Chief Compliance Officer, Jazz Pharmaceuticals; Former Senior Investigator, Office of the Inspector General, City of Philadelphia; Philadelphia, PA
Vice President, Head of Compliance US, Idorsia Pharmaceuticals US; Former Chief Compliance Officer, Jazz Pharmaceuticals; Former Senior Investigator, Office of the Inspector General, City of Philadelphia; Philadelphia, PA
Eric is an attorney and compliance professional with more than twenty-five years of experience in the life sciences industry. He currently serves as Vice President, Head of Compliance US for Idorsia Pharmaceuticals US Inc. in Radnor, Pennsylvania. Prior to joining Idorsia, Eric served as Vice President and Chief Compliance Officer for Jazz Pharmaceuticals in Philadelphia, Pennsylvania. Before that, he held the roles of Executive Vice President, General Counsel as well as Chief Compliance Officer for Incyte Corporation, a global biopharmaceutical company located in Wilmington, Delaware. Earlier in his career, Eric served in senior management Legal and Compliance roles for EMD Serono, Solstice Neurosciences and Cephalon. He began his career in the pharmaceutical industry at GlaxoSmithKline.
Amy Yuda, MSJ, CCEP, CHC, CQA
Compliance Manager, bioMerieux; Former Compliance Officer, PolarityTE; Former Compliance Officer, US WorldMeds; Salt Lake City, UT
Compliance Manager, bioMerieux; Former Compliance Officer, PolarityTE; Former Compliance Officer, US WorldMeds; Salt Lake City, UT
Amy has spent over 15 years in Compliance and Quality Assurance, leading organizations through inspections and investigations. She was the former Compliance Officer at US WorldMeds, Solstice Neurosciences, and HEMA Biologics from 2016 to 2019, and the former Compliance Officer at PolarityTE from 2019 to 2020. Amy has her Masters of Jurisprudence (MSJ) in Pharmaceutical and Medical Device Law & Compliance from Seton Hall University. She is a Certified Compliance & Ethics Professional (CCEP), Certified in Healthcare Compliance (CHC), and a Certified Quality Auditor (CQA).
Russell Rose, JD
Senior Manager, Deloitte & Touche, LLP, Dallas, TX (Moderator)
Senior Manager, Deloitte & Touche, LLP, Dallas, TX (Moderator)
Mini Summit XVI: Keeping a Pulse on Social Media Communication, Including Promotion of Products Across Borders
Despite the proliferation of electronic and social media communication platforms, the legal and regulatory regime governing these activities has failed to evolve. Pharmaceutical and device companies struggle to apply old rules and standards in order to remain compliant. The COVID-19 environment, which has pushed more activities online, has intensified the need for creative and effective regulatory and compliance strategies to manage risk. This panel will provide insights and updates on how companies are navigating these issues from a regulatory and compliance perspective, including best practices for engaging in online communications while remaining compliant.
11:15 am
Welcome, Introductions, Discussions and Q&A
Catherine Healy Kanzler
Executive Director, Global Compliance Operations Olympus Corporation of the Americas, Center Valley, PA
Executive Director, Global Compliance Operations Olympus Corporation of the Americas, Center Valley, PA
Catherine Kanzler is Head of Global Compliance Operations for Olympus Corporation. She is responsible to continuously improve and harmonize Olympus Group compliance programs, gain efficiencies where needed, and nurture the Company’s culture of integrity. Recently, she led the implementations of the Olympus Global Code of Conduct, and the Company’s Integrity Line for compliance reporting and case management. She also managed the Company’s Corporate Integrity Agreement and was a key contributor to the management of its Deferred Prosecution Agreements. Prior to joining Olympus, she practiced law in New York, representing a range of clients in corporate and commercial litigation.
Jonathon L. Kellerman
Executive Advisor, Office of Ethics & Compliance, Abbvie; Former Executive Vice President, Global Chief Compliance Officer, Allergan, Former Partner, PwC; Madison, NJ
Executive Advisor, Office of Ethics & Compliance, Abbvie; Former Executive Vice President, Global Chief Compliance Officer, Allergan, Former Partner, PwC; Madison, NJ
Jonathon Kellerman is a global compliance leader with an exceptional record of innovation, operational improvement and business protection/enablement in the pharmaceutical, life sciences and health care industries. As Executive Vice President, Chief Global Compliance Officer at Allergan Jonathon built a risk management and compliance function that bought a singular focus on ethics and accountability across a $16B pharmaceutical and medical aesthetics company that had //doubled// in size through rapid acquisitions. A member of the Executive Leadership Team, Jonathon had broad strategic and operational influence across the company, including $200M in M&A transactions and integrations. He also serves on the Board of Directors of the Allergan Foundation. Jonathon joined Allergan after 18 years at PwC (and Coopers & Lybrand). Becoming a Partner in 2005, he pivoted to launch and co-lead the global Pharmaceutical & Life Sciences compliance practice, which grew to $200M in revenue from local, regional and global clients, including most of the top 20 global pharmaceutical and medical device companies.
Kirt Kraeuter, MGA
Senior Director, Corporate Compliance, Moderna; Former European Compliance Director, Otsuka; Former, Executive Director, Worldwide Compliance Committee & Monitoring, Bristol-Myers Squibb; Yardley, PA
Senior Director, Corporate Compliance, Moderna; Former European Compliance Director, Otsuka; Former, Executive Director, Worldwide Compliance Committee & Monitoring, Bristol-Myers Squibb; Yardley, PA
Kirt is a compliance professional focused on the use of analytics to both embed compliance culture and demonstrate the effectiveness of compliance programs. He leverages over 25 years of life sciences experience to help companies design compliance programs to optimize business outcomes. His work has spanned multiple geographies, including Europe, the US, China, Australia, Canada, Brazil, Mexico and numerous other countries. Kirt is a passionate advocate for the biopharmaceutical industry, with past roles supporting industry associations such as IFPMA and EFPIA.
Donna White, CCEP Vice President, Compliance, Chiesi, USA, Cary, NC
Donna White, CCEP Vice President, Compliance, Chiesi, USA, Cary, NC
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.
Gary C. Messplay, JD
Partner, FDA and Life Sciences, King & Spalding, Washington, DC
Partner, FDA and Life Sciences, King & Spalding, Washington, DC
Mini Summit XVII: Compliance Risk Assessment Key Insights and Alignment to Enterprise Risk Management
Establishing a Risk Assessment Strategy
- What are the key considerations when establishing a risk management strategy?
- What tools or processes have been most beneficial to conducting risk assessments or managing your overall risk management program?
- How have you found success in partnering with the business and/or leadership to ensure compliance priorities are built into the overall enterprise risk management strategy?
Executing a Risk Assessment Strategy
- How do you identify key risk indicators? What influences how these indicators are weighted or prioritized?
- How do you derive insights when there’s either too much or too little data available?
- How often should companies be conducting risk assessments? Is there a way to tailor the year to year approach to be more pointed based on previous year outcomes?
Incorporating Automation, AI & Machine Learning to Proactively Identify Compliance Risk
- How are you currently leveraging digital capabilities to gain further insights?
- How do you see the inclusion of AI and machine learning transforming compliance / risk management practices?
11:15 am
Welcome, Introductions, Discussions and Q&A
Christie Camelio
Chief Compliance, Ethics & Risk Management Officer, TG Therapeutics, New York, NY
Chief Compliance, Ethics & Risk Management Officer, TG Therapeutics, New York, NY
Ms. Camelio is currently Chief Compliance, Ethics, and Risk Management Officer at TG Therapeutics. She has over 20 years of industry experience including implementing, guiding, and constructing proactive healthcare compliance, corporate compliance, and enterprise risk management strategies and programs for some of the world’s most successful pharmaceutical and biotechnology companies. She holds a B.A. in Psychology from Tulane University, a Healthcare Compliance Certification from Seton Hall, Risk Management for Corporate Directors and Business Finance Certifications from Harvard Business School, a Leading Global Projects Project Management Certification from Thunderbird School of Global Management, and a LEAN Six Sigma Black Belt Certification.
Keith Korenchuk, MPH, JD
Vice President and Chief Compliance Officer, DH Diagnostics, a Danaher Company, Chevy Chase, MD
Vice President and Chief Compliance Officer, DH Diagnostics, a Danaher Company, Chevy Chase, MD
Kristin Rand, JD, MA
Head, Corporate Compliance and Global Risk Officer, Moderna, Boston, MA
Head, Corporate Compliance and Global Risk Officer, Moderna, Boston, MA
Kristin Rand has over two decades of experience in the pharma/biotech industry. In her current position as Head of Corporate Compliance and Global Risk Officer at Moderna, she oversees the corporate compliance, risk, internal audit and privacy programs. Prior to Moderna, Kristin held the position of Vice President and Compliance Officer at Seattle Genetics, where she was accountable for the company’s Compliance Program. Her past experience includes compliance and medical affairs roles at Genentech and Wyeth Pharmaceuticals, as well as serving as General Counsel to a medical communications and education company. She attained a Bachelor of Science degree in Diagnostic Genetic Sciences, Juris Doctorate degree, and Master of Arts degree in industrial-organizational psychology.
Mona Peterson Rosow, JD, MPH
Sr. Director, Global Office of Ethics & Compliance, Medtronic, Minneapolis, MI
Sr. Director, Global Office of Ethics & Compliance, Medtronic, Minneapolis, MI
Mona Peterson Rosow is an 18+ year compliance leader whose experience spans the healthcare and medical device industry. She currently leads Medtronic’s global corporate compliance function and leads Medtronic’s compliance efforts in the areas of global trade compliance, anti-corruption, conflicts of interest, records information management, and ethical culture. She is passionate about working with her business partners on demystifying compliance to create organizations passionate about doing the right thing. Prior to Medtronic, Mona held a variety of legal and compliance positions at United Healthcare and Target and served as legal and compliance counsel at a boutique healthcare firm in Minneapolis.
Emily Cunningham
Associate Principal, Compliance Consulting, IQVIA, New York, NY (Moderator)
Associate Principal, Compliance Consulting, IQVIA, New York, NY (Moderator)
Mini Summit XVIII: Government Enforcement Trends
Join this panel of state regulators, federal prosecutors, and other experts as they discuss recent enforcement trends including the following:
- Investigations and settlements involving electronic health records
- How the government is investigating and prosecuting companies and individuals for Covid-19 related conduct
- The latest updates from DOJ’s Consumer Protection Branch
- Ongoing scrutiny of independent and manufacturer patient assistance programs
11:15 am
Welcome, Introductions, Discussions and Q&A
Jacob T. Elberg, JD
Associate Professor of Law, Seton Hall Law School Former Chief, Health Care & Government Fraud Unit and Assistant US Attorney, US Attorney’s Office, District of New Jersey, US Department of Justice, Newark, NJ
Associate Professor of Law, Seton Hall Law School Former Chief, Health Care & Government Fraud Unit and Assistant US Attorney, US Attorney’s Office, District of New Jersey, US Department of Justice, Newark, NJ
Professor Elberg teaches in the areas of Health Law, Health Care Fraud and Abuse, Evidence, and Data Analytics. His areas of interest include corporate crime and compliance, the role of various actors in the enforcement of health care fraud laws and regulations, and criminal justice policy.
Prior to joining Seton Hall Law School, Professor Elberg served for 11 years as an Assistant U.S. Attorney at the U.S. Attorney’s Office for the District of New Jersey. As Chief of the Office’s Health Care & Government Fraud Unit for five years, Professor Elberg led one of the largest and most impactful health care units in the country.
After graduating law school, Professor Elberg clerked for the Honorable Nancy Gertner, United States District Court for the District of Massachusetts, and then practiced law as an associate at the firm of Dwyer & Collora LLP (now Hogan Lovells) in Boston. , where his areas of practice included white collar criminal defense, internal corporate investigations, and general commercial litigation. He is a member of the Massachusetts, New Jersey, and New York Bars.
David Lazarus, JD
Assistant United States Attorney and Unit Chief US Attorney’s Office, District of Massachusetts US Department of Justice; Former Assistant District Attorney Bronx District Attorney’s Office; Boston, MA
Assistant United States Attorney and Unit Chief US Attorney’s Office, District of Massachusetts US Department of Justice; Former Assistant District Attorney Bronx District Attorney’s Office; Boston, MA
Clint Narver, JD
Assistant Director of the Consumer Protection Branch US Department of Justice; Former Associate Chief Counsel US Food and Drug Administration; Washington, DC
Assistant Director of the Consumer Protection Branch US Department of Justice; Former Associate Chief Counsel US Food and Drug Administration; Washington, DC
Mr. Narver is an Assistant Director at the United States Department of Justice, Consumer Protection Branch, where his work focuses on criminal law enforcement relating to the Federal Food, Drug, & Cosmetic Act. Previously, Mr. Narver served as an Associate Chief Counsel with the FDA’s Office of the Chief Counsel. He is a graduate of the University of Pennsylvania Law School and the University of California at Berkeley.
James Sheehan, JD
Chief, Charities Bureau at Attorney General of New York; Former Chief Integrity Officer, Executive Deputy Commissioner, City of New York Human Resources Administration; Former NY Medicaid Inspector General; Former Associate United States Attorney, US Attorney’s Office for the Eastern District of Pennsylvania; New York, NY
Chief, Charities Bureau at Attorney General of New York; Former Chief Integrity Officer, Executive Deputy Commissioner, City of New York Human Resources Administration; Former NY Medicaid Inspector General; Former Associate United States Attorney, US Attorney’s Office for the Eastern District of Pennsylvania; New York, NY
James Sheehan is the Chief of the New York Attorney General’s Charities Bureau, which oversees compliance and regulation of the nation’s largest Charities sector.
Prior to this role, he was the New York City Human Resources Administration’s first Chief Integrity Officer, overseeing audit, investigations, and data analysis for the nation’s largest social services agency. From 2007 to 2011, he was New York’s first Medicaid Inspector General, overseeing the country’s first mandatory compliance program, and New York’s’ leading role in health care data analytics.
Prior to his New York public service roles, Mr. Sheehan was an Assistant and Associate US Attorney in the Eastern District of Pennsylvania, where he developed a nationally recognized program working with whistleblowers under the False Claims Act.
Prior to this role, he was the New York City Human Resources Administration’s first Chief Integrity Officer, overseeing audit, investigations, and data analysis for the nation’s largest social services agency. From 2007 to 2011, he was New York’s first Medicaid Inspector General, overseeing the country’s first mandatory compliance program, and New York’s’ leading role in health care data analytics.
Prior to his New York public service roles, Mr. Sheehan was an Assistant and Associate US Attorney in the Eastern District of Pennsylvania, where he developed a nationally recognized program working with whistleblowers under the False Claims Act.
Melissa Tearney, JD
Partner and Co-chair, Litigation Department, Choate, Hall & Stewart, Boston, MA (Moderator)
Partner and Co-chair, Litigation Department, Choate, Hall & Stewart, Boston, MA (Moderator)
Melissa Tearney is Co-Chair of Choate’s Litigation Department. She has nearly 30 years of experience defending companies in government investigations, directing internal investigations, and advising international companies in implementation of compliance measures and programs. Melissa’s subject matter and industry expertise and strategic thinking make her a highly trusted advisor for clients in high-stakes matters.
Mini Summit XIX: Best Practices of Conducting Investigations
Industry Ethics & Compliance leads begin the discussion defining “Internal Investigations” and the approach to conducting these and those triggered by a government inquiry, involving ex-US investigations, or considerations for the medical device industry. The panel will also discuss the following aspects of investigations including:
- Culture / Psychology of Internal Investigations
- Balancing the Reality/Practicality of Internal Investigations
- Stakeholder Engagement
- Root Cause Analysis
11:15 am
Welcome, Introductions, Discussions and Q&A
Yogesh Bahl, CPA, MBA
Managing Director, AlixPartners, New York, NY
Managing Director, AlixPartners, New York, NY
Yogesh has 25 years of experience in compliance, operations, and investigations, with a focus in life sciences. Yogesh has conducted investigations, served as an expert in litigation, and has helped many companies implement strategies that are feasible, effective, and aligned with CCO and CFO priorities. Yogesh is focused on evolving compliance programs using the principles of behavioral psychology and behavioral economics. He has helped manage pre-IRO reviews, implementation of CIAs, investigations, data analytics, and third-party risks. Yogesh is passionate about women’s rights; he serves on the board of Womankind, an organization helping women and children survivors of gender-based violence.
Margaret Feltz, MA, JD
Vice President, Ethics & Compliance, Purdue Pharma; Former Compliance Counsel, Boehringer Ingelheim; Stamford, CT
Vice President, Ethics & Compliance, Purdue Pharma; Former Compliance Counsel, Boehringer Ingelheim; Stamford, CT
Maggie is Vice President, Ethics & Compliance and is responsible for managing the ethics and compliance program for Purdue Pharma L.P. Purdue Pharma is a member company of a global network of independent associated companies which are engaged in the research, development, production, and marketing of prescription and over-the-counter medicines and healthcare products. Distinguished by our pioneering research, products, and medical programs directed toward alleviating pain, Purdue Pharma is an industry leader in pain medication research and abuse-deterrent technology. Maggie has extensive experience in all facets of ethics and compliance, and in her role at Purdue has responsibility for leadership and strategic direction of Purdue’s comprehensive ethics and compliance program. She has led multi-disciplinary teams and accomplished successful implementation of a corporate integrity agreement, including frequent engagement with Purdue’s federal government monitor. Prior to joining Purdue, Maggie served as Compliance Counsel at Boehringer Ingelheim Pharmaceuticals, Inc. and practiced health care law at McDermott, Will & Emery.
Daryl Kreml, JD
Vice President and Chief Compliance Officer, Sage Therapeutics; Former Head, US Compliance & Global Program Management, Biogen Former Director & Sen Managing Counsel, Int’l Compliance, Boston Scientific; Cambridge, MA
Vice President and Chief Compliance Officer, Sage Therapeutics; Former Head, US Compliance & Global Program Management, Biogen Former Director & Sen Managing Counsel, Int’l Compliance, Boston Scientific; Cambridge, MA
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 and 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 US 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.
Craig Moran, JD
Senior Investigations Counsel, Stryker, Mahwah, NJ
Senior Investigations Counsel, Stryker, Mahwah, NJ
Craig is Senior Investigations Counsel at Stryker Corporation where he leads a global team responsible for handling significant investigations impacting the corporation and identifying and responding to risks to by developing enhancements to the investigation procedures. Previously, Craig was Divisional Counsel for Stryker’s Trauma & Extremities Division where he provided advice for all legal issues related to the division including providing counsel to ensure robust and effective compliance with global laws and regulations. Craig previously spent 12 years in private practice representing individual and corporate clients in connection with a broad range of complex litigation and white-collar criminal matters.
Kevin Ryan, MS, JD
Vice President, Chief Compliance Officer, ACADIA; Former Director, Ethics & Compliance, Novo Nordisk; San Diego, CA
Vice President, Chief Compliance Officer, ACADIA; Former Director, Ethics & Compliance, Novo Nordisk; San Diego, CA
Sarah diFrancesca, JD
Partner, Dinsmore & Shohl LLP, Cincinnati, OH (Moderator)
Partner, Dinsmore & Shohl LLP, Cincinnati, OH (Moderator)
Sarah diFrancesca is co-chair of the Life Sciences practices at Dinsmore & Shohl LLP. Sarah’s practice focuses on complex health care litigation, investigations, regulatory compliance, and fraud and abuse relevant to clinical-stage and commercial pharmaceutical, biotechnology, and medical device companies and clinical laboratories. Her experience includes defending health care and life sciences companies and individuals in criminal and civil False Claims Act investigations regarding complex government theories of health care fraud, false claims, misbranding, off-label promotion and kickbacks. This includes negotiating and implementing settlements and corporate integrity agreements, and advising clients on regulatory self-disclosures. Sarah also advises companies on the Anti-Kickback Statute, fraud and abuse laws, FDA and regulatory compliance matters, transparency laws, and industry codes of conduct.
Mini Summit XX: Patient Services Compliance Survey (Year 4) Update
- Review of the results of Patient Services Compliance Benchmarking Survey.
- Considerations for where patient services activities reside in your company, the types of activities they are conducting, and the compliance challenges surrounding patient interactions.
- Usage of patient data and the associated risks with data privacy.
11:15 am
Welcome, Introductions, Discussions and Q&A
Stefanie A. Doebler, JD
Of Counsel and Co-chair, Health Care Practice Group, Covington & Burling LLP; Washington, DC
Of Counsel and Co-chair, Health Care Practice Group, Covington & Burling LLP; Washington, DC
Andrea L. Kocharyan, JD
Vice President, Legal and US Chief Compliance Officer, Zealand US; Former Vice President, Head of Legal Affairs, Sumitomo Dainippon Pharma Oncology; Former Vice President, US General Counsel and Compliance Officer, EVO Biologics; Cambridge, MA
Vice President, Legal and US Chief Compliance Officer, Zealand US; Former Vice President, Head of Legal Affairs, Sumitomo Dainippon Pharma Oncology; Former Vice President, US General Counsel and Compliance Officer, EVO Biologics; Cambridge, MA
Andrea is the Head of Legal, and US Chief Compliance Officer for Zealand Pharma US, Inc., a US based subsidiary of Zealand Pharma A/S, located in Copenhagen, Denmark. In this role, Andrea provides legal and compliance counsel for Zealand Pharma U.S. and serves as a strategic advisor and member of the US Leadership team, with responsibility for designing, building, implementing and managing Zealand Pharma US’s ethics and compliance programs.
Chapman Richardson
Global Head, Data Consumerization, Sanofi; Former Executive Director, Global Next Generation Digital, Novartis; Bridgewater, NJ
Global Head, Data Consumerization, Sanofi; Former Executive Director, Global Next Generation Digital, Novartis; Bridgewater, NJ
Chapman is the Global Head of Data Consumerization at Sanofi and is all about extracting value from enterprise data assets. His current responsibilities include defining the overall EIM Strategy for Sanofi with strategic imperatives around Master Data and Metadata Management, Data Quality, and Data Governance with an emphasis on customer/patient engagement. Prior to joining Sanofi, Chapman was at Novartis for over 10 years mostly serving in global transformational roles in the areas of CRM, Digital Marketing, and Patient Services. He most recently translated his digital engagement experiences into value for personalized medicine in the revolutionary CAR-T therapeutic space. He began his career in consulting with Accenture, IQVIA, and CapGemini where he leveraged design thinking to bring innovation to life for his clients. Chapman is a graduate from Rutgers University with degrees in Engineering and Economics.
Manny Tzavlakis
Managing Partner, Helio Health Group, Editorial Board, Policy & Medicine Compliance Update (formerly LSCU), Morristown, NJ (Moderator)
Managing Partner, Helio Health Group, Editorial Board, Policy & Medicine Compliance Update (formerly LSCU), Morristown, NJ (Moderator)
12:15 pm
Transition Break
DAY II PLENARY SESSION
1:00 pm
Co-chair Welcome and Introductions
1:15 pm
Equity, Diversity and Inclusion
Edie Stringfellow, MA
Director, Diversity & Inclusion, Massachusetts Biotechnology Council (MassBio), Cambridge, MA
Director, Diversity & Inclusion, Massachusetts Biotechnology Council (MassBio), Cambridge, MA
1:45 pm
Implementing, Equity, Diversity, and Inclusion Roundtable
Michael R. Clarke, JD, CCEP
Vice President, Global Chief Compliance Officer, ConvaTec; Former Vice President, Corporate Compliance, Indivior; Bridgewater NJ
Vice President, Global Chief Compliance Officer, ConvaTec; Former Vice President, Corporate Compliance, Indivior; Bridgewater NJ
Michael Clarke is the Global Chief Compliance officer for ConvaTec, Inc., a global medical technology company. In his over 17 years as a senior compliance leader, Mr. Clarke has created or managed global ethics & compliance programs, by educating employees and third parties on compliance policies and procedures; monitoring HCP interactions by sales, marketing and medical affairs employees; conducting and overseeing third party due diligence efforts; counseling on OFAC requirements; overseeing internal investigations; and implementing corruption, fraud and bribery risk mitigation processes. He has been a panelist or moderator for numerous ethics & compliance presentations on creating and managing global ethics & compliance programs, including presenting at the Seton Hall Law School Healthcare Compliance Certification Program. He became a Certified Compliance and Ethics Professional in December 2018.
Sujata Dayal
Vice President & Global Chief Compliance Officer, Medline Industries; Former Vice President Health Care Compliance and Privacy, Pharmaceuticals, Johnson & Johnson; Chicago, IL
Vice President & Global Chief Compliance Officer, Medline Industries; Former Vice President Health Care Compliance and Privacy, Pharmaceuticals, Johnson & Johnson; Chicago, IL
Jill Fallows Macaluso, JD
Corporate Vice President, Chief Ethics, Compliance and Privacy Officer, Novo Nordisk, Princeton, NJ
Corporate Vice President, Chief Ethics, Compliance and Privacy Officer, Novo Nordisk, Princeton, NJ
Jill Fallows Macaluso Esq., RN, is the Corporate Vice President and Chief Ethics, Compliance & Privacy Officer for Novo Nordisk Inc. She has led the US Compliance Program since being appointed Chief Compliance Officer in September 2015, and her role has since expanded to include responsibility for the company’s privacy program. Ms. Fallows Macaluso is responsible for leading a modern and effective Ethics, Compliance & Privacy Program that enables business success and meets evolving government expectations.
With 20 years of industry experience, Ms. Fallows Macaluso has evolved the Ethics, Compliance & Privacy Program to focus on proactive business partnership. She firmly believes that culture is critical to an organization’s success and is committed to fostering a shared commitment to ethics, integrity, and trust throughout Novo Nordisk.
Ms. Fallows Macaluso joined Novo Nordisk in 2003. Previously, Ms. Fallows Macaluso was with the General Corporate and Healthcare practice of Day Pitney, LLP.
Robert A. Ladd, JD
Vice President, Global Head Integrity & Compliance, Novartis, Oncology; Former General Counsel, GE Healthcare; Former Senior Corporate Counsel, Pfizer; New York, NY
Vice President, Global Head Integrity & Compliance, Novartis, Oncology; Former General Counsel, GE Healthcare; Former Senior Corporate Counsel, Pfizer; New York, NY
Latarsha Stewart, MS, JD
Vice President, Head of Compliance, Servier Pharmaceuticals; Former Head of Compliance, Global Oncology Business Unit, Takeda Oncology; Boston, MA
Vice President, Head of Compliance, Servier Pharmaceuticals; Former Head of Compliance, Global Oncology Business Unit, Takeda Oncology; Boston, MA
Latarsha Stewart is Head of Compliance at Servier Pharmaceuticals and responsible for the implementation and ongoing enhancement of a comprehensive and effective U.S. ethics and compliance program. During her career, Latarsha has implemented practical compliance policies and procedures, conducted internal auditing, monitoring and investigations and executed innovative training on a range of healthcare compliance topics. Previously Latarsha was Head of Compliance for the Takeda Global Oncology Business Unit. She earned her Bachelor of Science in Communication from Cornell University, a Juris Doctor and Master of Science degree from Boston University, and is also a member of the New York Bar.
Yogesh Bahl, CPA, MBA
Managing Director, AlixPartners New York, NY (Moderator)
Managing Director, AlixPartners New York, NY (Moderator)
Yogesh has 25 years of experience in compliance, operations, and investigations, with a focus in life sciences. Yogesh has conducted investigations, served as an expert in litigation, and has helped many companies implement strategies that are feasible, effective, and aligned with CCO and CFO priorities. Yogesh is focused on evolving compliance programs using the principles of behavioral psychology and behavioral economics. He has helped manage pre-IRO reviews, implementation of CIAs, investigations, data analytics, and third-party risks. Yogesh is passionate about women’s rights; he serves on the board of Womankind, an organization helping women and children survivors of gender-based violence.
2:30 pm
Visit Exhibit Hall
3:00 pm
US DOJ and US SEC Update on FCPA Enforcement
Craig Carpenito, JD
United States Attorney, US Attorney’s Office, District of New Jersey; Former Senior Counsel, Northeast Regional Office, US Securities and Exchange Commission; Newark, NJ
United States Attorney, US Attorney’s Office, District of New Jersey; Former Senior Counsel, Northeast Regional Office, US Securities and Exchange Commission; Newark, NJ
Craig Carpenito is the U.S. Attorney for the District of New Jersey. As U.S. Attorney, he is responsible for overseeing all federal criminal prosecutions and the litigation of all civil matters in New Jersey in which the federal government has an interest. Mr. Carpenito supervises a staff of approximately 130 attorneys and 110 support personnel in Newark, Camden, and Trenton. Prior to being sworn in as U.S. Attorney on Jan. 4, 2018, Mr. Carpenito was previously a partner at Alston & Bird LLP, where he was a co-chair of the firm’s Litigation and Trial Practice Group and its Government and Internal Investigations Team. He served in the U.S. Attorney’s Office for the District of New Jersey from 2003 to 2008. Prior to his initial tenure in the U.S. Attorney’s Office, Mr. Carpenito was Senior Counsel in the Securities and Exchange Commission’s Division of Enforcement, New York Regional Office.
Robert I. Dodge, JD
Assistant Director, FCPA Unit, US Securities & Exchange Commission; Former Assistant US Attorney, US Attorney’s Office, Western District of Michigan; Former Assistant Section Chief, Environmental Defense Section, US Department of Justice; Washington, DC
Assistant Director, FCPA Unit, US Securities & Exchange Commission; Former Assistant US Attorney, US Attorney’s Office, Western District of Michigan; Former Assistant Section Chief, Environmental Defense Section, US Department of Justice; Washington, DC
David Last, JD
Assistant Chief, FCPA Unit, Fraud Section, Criminal Division, US Department of Justice, Washington, DC
Assistant Chief, FCPA Unit, Fraud Section, Criminal Division, US Department of Justice, Washington, DC
Gary F. Giampetruzzi, Esq.
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer; New York, NY (Moderator)
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer; New York, NY (Moderator)
Gary Giampetruzzi is a partner in the Litigation Department of Paul Hastings, is the Global Chair of the Life Sciences Department, one of the Vice-Chairs of the Investigations and White Collar Department, and an active member of the Paul Hastings Litigation Diversity Working Group. Mr. Giampetruzzi routinely advises clients on day-to-day compliance matters, 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, and the Foreign Corrupt Practices Act (“FCPA”), and oversees other complex civil and criminal litigation matters. While his practice cuts across numerous sectors, including defense, energy, and private equity, 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, he 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.
3:45 pm
Advanced Patient Engagement Strategies
Ann E. Beasley, JD
Director, Life Sciences, Governance, Risk & Compliance, Guidehouse; Former Senior Vice President, Chief Compliance Officer, Biogen; Boston, MA
Director, Life Sciences, Governance, Risk & Compliance, Guidehouse; Former Senior Vice President, Chief Compliance Officer, Biogen; Boston, MA
Nereyda Garcia, JD
Compliance Head, Rare Disease and Rare Blood Disorder, Sanofi; Former Global Head, Ethics and Compliance, Alnylam; Former Sr. Director, Compliance, Biogen Idec; Boston, MA
Compliance Head, Rare Disease and Rare Blood Disorder, Sanofi; Former Global Head, Ethics and Compliance, Alnylam; Former Sr. Director, Compliance, Biogen Idec; Boston, MA
Nereyda joined Sanofi in December 2019. Prior to that, she was Global Head of Ethics & Compliance at Alnylam Pharmaceuticals where she oversaw the implementation of a commercial-stage global compliance program. Nereyda was also Privacy Officer at Alnylam. She joined Alnylam from Biogen where she held senior roles leading compliance for the US business as well as global R&D and Medical Affairs. She previously served in senior legal roles at PerkinElmer and Haemonetics, where she also led the compliance program as Chief Ethics Officer. Nereyda began her legal career as a litigation attorney in Boston.
Casey J. Horton, CFE
Director, Life Sciences, Governance, Risk & Compliance, Guidehouse, Chicago, IL (Moderator)
Director, Life Sciences, Governance, Risk & Compliance, Guidehouse, Chicago, IL (Moderator)
4:30 pm
Annual Chief Compliance Officer Fireside Chat
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.
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
Nancy A. Grygiel, JD
Senior Vice President, Chief Compliance Officer, Amgen; Former VP Compliance, Corporate & International, Allergan; Former Senior Director Global Compliance, Mylan; Newbury Park, CA
Senior Vice President, Chief Compliance Officer, Amgen; Former VP Compliance, Corporate & International, Allergan; Former Senior Director Global Compliance, Mylan; Newbury Park, CA
Nancy Grygiel serves as senior vice president and chief compliance officer, responsible for Amgen’s global privacy, trade and compliance organization. Nancy joined Amgen in 2015, and was vice president of compliance, responsible for overseeing Amgen’s healthcare and anti-corruption compliance programs in all markets. In addition, Nancy has been accountable for reporting status and effectiveness of the Program; its elements, and ongoing activities to Amgen’s CEO operating teams, and to the company’s Corporate Responsibility and Compliance Committee (CRCC), on an ongoing basis. Prior to joining Amgen, Nancy served as vice president, compliance, at Allergan. Prior to Allergan, Nancy held positions of increasing responsibility at Mylan Pharmaceuticals, responsible for developing and establishing the company’s export controls and international compliance program, as a result of the company’s rapid global expansion in 2007. Earlier in her career, Nancy worked in the legal field with a focus on international laws; transnational business transactions, export-control laws, as well as in-house legal roles within the telecommunications industry in her home country, Argentina.
John Knighton, JD
Chief Compliance Officer, TherapeuticsMD; Former Vice President, Head of Global Compliance, Orexigen Therapeutics; Boca Raton, FL
Chief Compliance Officer, TherapeuticsMD; Former Vice President, Head of Global Compliance, Orexigen Therapeutics; Boca Raton, FL
Tara R. Shewchuk, JD, LLM
Chief Deputy Ethics and Compliance Officer, Medtronic; Former Senior Director, Ethics and Compliance, Abbott (now AbbVie); Former VP, Chief Compliance, Privacy & Security Officer, Resurrection Health Care (now Ascension/AMITA); Minneapolis, MN
Chief Deputy Ethics and Compliance Officer, Medtronic; Former Senior Director, Ethics and Compliance, Abbott (now AbbVie); Former VP, Chief Compliance, Privacy & Security Officer, Resurrection Health Care (now Ascension/AMITA); Minneapolis, MN
Tara Shewchuk is currently Chief Deputy Compliance Officer at Medtronic. Prior to her current role, Tara was VP, Ethics & Compliance for Medtronic’s Restorative Therapies Group (RTG), Sr. Compliance Director for Abbott’s Pharmaceutical Division, and VP, Compliance / Privacy & Security Officer for a Chicago IDN. She’s also held policy roles for several medical associations. From 2006-2016, Tara taught Bioethics and Health Care Compliance at Loyola University Chicago Law School and served as Thesis Advisor to LL.M. candidates. She has a J.D. from McGill, an LL.M. from Loyola and completed a Fellowship in Clinical Medical Ethics at University of Chicago.
Tom Gregory, MBA
Global & US Leader, Health & Life Sciences, Forensic & Integrity Services, EY, Atlanta, GA (Moderator)
Global & US Leader, Health & Life Sciences, Forensic & Integrity Services, EY, Atlanta, GA (Moderator)
Tom Gregory is a partner at Ernst & Young and the Global Sector Leader for Health and Life Sciences within the firm’s Forensic & Integrity Services practice. He leads a diverse team advising senior executives, boards and their outside counsel on complex investigations and related compliance matters. His experience includes a focus on the False Claims Act, Anti-Kickback Statute, FCPA and local law equivalents. Tom is a CPA and Chartered Financial Analyst.
5:45 pm
DAY II ADJOURNMENT
(All Day II sessions available on demand.)