Roundtable Biographies - 102312

On October 23, 2012, Compliance Week and Deloitte presented an editorial roundtable at the Ritz Carlton Hotel in Philadelphia. The focus of the roundtable, which was moderated by Compliance Week Deputy Editor Joseph McCafferty, was on leveraging data management to enable compliance. Attendees' full biographies are below.

Christine Bachrach

Chief Compliance OfficerUniversity of Maryland Medical System

Christine Bachrach is the vice president and chief compliance officer for the University of Maryland Medical System. She is responsible for oversight of compliance across the system, including the development and implementation of new measures to improve the effectiveness of each hospital's regulatory compliance program. Previously, Bachrach was chief compliance officer for HealthSouth, a large provider of inpatient rehabilitation services. She established an enterprise methodology for regulatory compliance risk assessments, including integrating efforts from Sarbanes-Oxley requirements. She was also responsible for compliance audit, which included activities required by HealthSouth's Corporate Integrity Agreement. Prior to joining HealthSouth, she was a principal at Navigant Consulting, where she specialized in compliance program implementation, investigations, and financial operations for all types of healthcare organizations. At Arthur Andersen, Bachrach assisted clients with government investigations, multi-district commercial payer litigation support, and government-mandated Independent Review Organization activities. She started her career as an internal consultant for Kaiser Permanente in southern California.

Tracy Berns

VP, Chief Compliance & Regulatory CounselCovidien

Tracy Berns is vice president, chief compliance and regulatory counsel at Covidien, in charge of company compliance programs globally and responsible for working with the corporate quality and regulatory groups on regulatory matters. Covidien is global manufacturer of medical devices and supplies, diagnostic imaging agents, pharmaceuticals, and other healthcare products. Prior to joining Covidien, Berns worked with a number of medical device firms in regulatory and legal capacities, including C.R. Bard Inc., ABIOMED Inc., and Thermo Electron. In addition, Berns has served as a senior consultant with EXPERTech Associates and worked in private practice at law firms in Washington, D.C. specializing in FDA regulatory law.

Bret Bissey

SVP, Chief Ethics and Compliance OfficerUniversity of Medicine & Dentristry NJ

Bret Bissey is a nationally recognized professional in healthcare compliance with over 14 years of compliance-related experience. He joined UMDNJ in December 2010 and is responsible for managing the compliance and ethics program (40 FTEs and budget in excess of $5 million) of the largest public health sciences university in the United States to be in adherence with a rigorous five-year corporate integrity agreement with the Department of Health and Human Services Office of Inspector General which followed a two-year period of Federal Monitor oversight. He is the author of the Compliance Officer's Handbook, published in 2006, and has presented at 70+ industry conferences/meetings. Bissey was chief compliance & privacy officer at Deborah Heart and Lung Center for 9 years where he oversaw the successful adherence to the three-year (1999–2001) Corporate Integrity Agreement. Bissey is a Fellow of the American College of Healthcare Executives, the Health Care Compliance Association (Certified-CHC), Healthcare Financial Management Association, and the Ethics Officer Association. He is a past president (2001-2003) for Region 2 (NY, NJ, PR, and U.S. Virgin Islands) of the Health Care Compliance Association. He has also been in several senior-level management positions with consulting companies, academic medical centers, and in the clinical research industry.

Michael Clarke

VP, Ethics & Compliance Officer - AmericasActavis Inc.

Michael Clarke is the vice president, ethics & compliance officer-Americas for Actavis Inc., a global generic pharmaceutical manufacturer. As a member of senior management, he designs and manages the unit's healthcare compliance program, including developing policies and training, monitoring, and overseeing internal investigations. Previously, Clarke was vice president and compliance officer for EBI, which does business as Biomet Spine & Bone Healing Technologies, a business unit of Biomet Inc., a global orthopedic medical device company and also served as a compliance officer or ethics officer for the University of Medicine & Dentistry of New Jersey; Edison Schools and Medco Health Solutions. Before working in-house as a compliance professional, Clarke practiced corporate, civil, and criminal law as a litigation partner with the law firm of Drinker Biddle & Reath, as an associate at the law firms of Hannoch Weisman and Scarinci & Hollenbeck and as an assistant deputy public defender in Essex County, New Jersey. Clarke is the immediate past chair of the Business Law Section's Corporate Compliance Committee (from 2006 – 2010) and has been a panelist or moderator for numerous presentations on internal investigations or corporate compliance issues.

Dan Dunham

VP, Chief Compliance OfficerAptalis Pharma Inc.

Dan Dunham is vice president, chief compliance officer for Aptalis Pharma U.S. Inc., a specialty pharmaceutical company in northern New Jersey. Prior to joining Aptalis, Dunham served as vice president, chief compliance and privacy officer with Astellas U.S. in Deerfield, Illinois. Dunham got his start in compliance in the late 1990s at Warner-Lambert Company Inc., where he created the industry's first compliance department and program. Also at Warner-Lambert, he defended a criminal prosecution of the company in the GMP/GLP arena, helped the company address a manufacturing-focused civil consent decree, and defended one of the industry's first off-label promotion investigations. At Astellas, Dunham spearheaded the development of the company's global compliance function. Prior to joining the pharmaceutical industry, Dunham practiced law in New York. He also has worked in the Legal Departments of Pharmacia Corporation and Pfizer Inc.

David Hodgson

Partner, Enterprise Risk ServicesDeloitte & Touche LLP

David Hodgson is a partner and serves as Deloitte's global leader of enterprise risk services for life sciences. Hodgson's focus is on assisting organizations in improving their risk-management capabilities, by establishing and improving risk-management processes and by designing and implementing appropriate mechanisms to respond to high-priority risks. In this capacity, Hodgson has worked extensively with compliance functions. Hodgson specializes in the life sciences industry.

A few of his more recent engagements include: Assisted a global pharmaceutical company in identifying and prioritizing compliance risks and in performing procedures to help the company assess the operating effectiveness of compliance procedures. Assisted the chief compliance officer of a global pharmaceutical company in evaluating the organizational structure of the company's global compliance resources relative to leading practices and in identifying opportunities for improvement. Worked with a global pharmaceuticals company to design and implement a revised organizational model and supporting infrastructure for controls assurance across the enterprise. Assisted a large life sciences company in establishing an enterprise risk management function to assist the board and senior management in understanding the actions being taken to manage high-priority risks. Assisted the IT function of a global pharmaceutical company in developing and implementing a new security policy, developed in response to major changes to the company's systems. Led a team to assist a global pharmaceutical company in redesigning its procurement process to improve efficiency while continuing to appropriately manage risk.

Lisa Holt

Senior Director of ComplianceStryker Corp.

Lisa Holt is the senior director of compliance for Stryker Corp. overseeing all divisions in the United States. Stryker is one of the world's leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. Holt has been with Stryker in various roles since 2004. She managed Stryker Orthopedics' professional affairs organization dealing with HCP interactions during their Non-Prosecution Agreement with the Department of Justice. In this time, she guided processes and systems that have been implemented in all Stryker divisions around the world that control the selection and management of third-party consultants. She was awarded the 2001 PwC Award for Leadership in the Advancement of Ethics in the Medical Device and Diagnostics Industry.

Phil Munkacsy

Associate Director of Global ComplianceWatson Pharmaceuticals

Phil Munkacsy is the associate director of global compliance at Watson Pharmaceuticals and has over 30 years experience in pharmaceutical compliance programs relative to GMP, GCP, OIG, CIA, and PDMA regulations. Munkacsy's duties include direct responsibility for managing the Watson aggregate spend program, sales field monitoring program, implementation of fair market value program, and assistance with the Watson PDMA physician sampling program. From 2002 until 2011, he was the director of corporate compliance for Elan Pharmaceuticals where he assisted with the compliance activities related to the Elan Corporate Integrity Agreement, managed the field sales monitoring and GMP audit programs, and implemented an enterprise quality software system. Prior to Elan, Munkascy was the senior QA auditor for Carter-Wallace. There, he managed and executed the GMP vendor auditing program. Munkacsy is Health Care Compliance Association certified in healthcare compliance.

Helen Ong

Assistant General CounselPfizer

Helen Ong is assistant general counsel and the chief compliance counsel for Pfizer Inc.'s non-pharmaceutical businesses including consumer, nutrition, and animal health and also has responsibility for the Promotional Quality Assurance (PQA) group. Ong leads the compliance counsels who are dedicated to each of these business units and are responsible for establishing and maintaining the compliance infrastructure and developing risk mitigation strategies for their businesses. In addition, with respect to PQA, she leads the team that proactively monitors and analyzes U.S. promotional activities of Pfizer's field force to identify potential compliance signals and to support risk mitigation. Ong has been with Pfizer for over thirteen years and has provided strategic and commercial legal support to a number of businesses and platform groups within Pfizer during that time, including Pfizer's previous consumer healthcare operations, U.S. pharmaceuticals operations, worldwide business development and the established products business unit. Before joining Pfizer, she provided legal support to Schick-Wilkinson Sword at Warner-Lambert Co. and was an associate at the law firms of Simpson Thacher & Bartlett and Weil, Gotshal & Manges.

Mark Stehr

PartnerDeloitte & Touche LLP

Mark Stehr is a partner in Deloitte's life sciences practice with more than 26 years of public accounting experience, where he has served pharmaceutical, medical device, and consumer product companies in connection with sensitive matters relating to international investigations and third-party contract compliance in Europe, Middle East, Asia/Pacific, and The Americas. Stehr has led numerous client assignments involving financial and regulatory risks inside the global enterprise and throughout external business relationships with third-party relationships including: distributors, healthcare professionals and institutions, strategic alliance partners, licensees, contract research organizations, vendors, etc. He has significant experience in matters relating to FCPA, whistleblower allegations, financial fraud, product diversion, and other types of enterprise-wide risks. Stehr has also provided guidance at all stages of business transactions, from consulting on language in contract negotiations to strategy and advice during settlement discussions. Stehr has also served as an expert witness on various matters. His insights have been featured in a number of recent life sciences-focused publications, including a point of view on addressing risk and vulnerabilities related to strategic alliances with distributors and vendors, illegal price schemes, and inducements to purchase product. He also contributed to a Deloitte publication on navigating within increasingly stringent regulatory environments, particularly referencing third-party involvements.

Seth Whitelaw

Director, Enterprise Risk ServicesDeloitte & Touche LLP

Seth Whitelaw is a director in Deloitte's enterprise risk services group focusing on health sciences. He has more than 20 years of experience in the life sciences and healthcare industries in the areas of transparency, food and drug law, corporate governance, and compliance for medical devices, pharmaceutical sales and marketing, and pharmaceutical R&D. Whitelaw has served as the compliance officer for GlaxoSmithKline R&D, legal compliance officer, pharmaceuticals NA for SmithKline Beecham Pharmaceuticals, and senior attorney and compliance coordinator for C. R. Bard Inc. Whitelaw serves as the Deloitte & Touche advisory lead for transparency-related services. He recently authored “How Can FDA Improve Its Financial Disclosure Rules for Clinical Investigators in This New Era of Transparency?” for the FDLI Policy Forum in June 2011, and “Practicing Avoidance: Navigating Qui Tam and Consent Decrees” for Pharmaceutical Compliance Monitor in January 2012.