Life Science Compliance Update

Editorial Board

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Terry Chang MD, JD

Associate General Counsel and Director

Terry Chang is Associate General Counsel and Director, Legal & Medical Affairs for AdvaMed (Advanced Medical Technology Association). Mr. Chang holds his J.D. from the George Washington University Law School. He also obtained his Doctor of Medicine (M.D.) from Wayne State University School of Medicine and his Bachelor’s Degree in Economics from University of Michigan.Read More
AdvaMedLegal & Medical Affairs

Terry Chang is Associate General Counsel and Director, Legal & Medical Affairs for AdvaMed (Advanced Medical Technology Association).

Mr. Chang holds his J.D. from the George Washington University Law School. He also obtained his Doctor of Medicine (M.D.) from Wayne State University School of Medicine and his Bachelor’s Degree in Economics from University of Michigan.

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Ian Clark

Director of Corporate Training at BioMarin Pharmaceutical Inc.

Ian Clark currently serves as director of corporate training for BioMarin Pharmaceuticals. Prior to this Ian held a variety of roles, most recently as a consultant to the device industry. He also spent 15 years with Abbott Vascular. While at Abbott Vascular, Ian’s last role was Director, Medical Science, Professional Education and Government Transparency. In this capacity he directed U.S.…Read More

Ian Clark currently serves as director of corporate training for BioMarin Pharmaceuticals. Prior to this Ian held a variety of roles, most recently as a consultant to the device industry. He also spent 15 years with Abbott Vascular. While at Abbott Vascular, Ian’s last role was Director, Medical Science, Professional Education and Government Transparency. In this capacity he directed U.S. education grant strategies in line with internal stakeholders and compliance with external regulations. He also developed, implemented, and maintained multiple division-level government transparency policies and procedures aligned to Abbott Laboratories corporate initiatives. This role also was responsible for designing, developing, implementing and managing the expanded Medical Affairs Department.

Ian holds a BSc (honors) in Geography & Environmental Science from The Manchester Metropolitan University. He also became a Registered General Nurse at the Manchester Royal Infirmary School of Nursing.

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David Davidovic

President Path Forward, Former VP and Global Head Commercial Services, Roche and Genentech

David Davidovic is a part-time Senior Advisor to Polaris, while also serving as Founder of pathForward LLC, a San Francisco Bay area firm that provides pro-bono and revenue consulting, advisory and management support to nonprofit, as well as both established and start-up business ventures. pathForward is active in helping establish and grow businesses, currently focused in the digital health space.…Read More

David Davidovic is a part-time Senior Advisor to Polaris, while also serving as Founder of pathForward LLC, a San Francisco Bay area firm that provides pro-bono and revenue consulting, advisory and management support to nonprofit, as well as both established and start-up business ventures. pathForward is active in helping establish and grow businesses, currently focused in the digital health space.

Prior to these roles, Mr. Davidovic held a number of senior commercial roles with both Genentech/Roche and Merck & Co. In these roles, he most recently served as VP and Global Head, Commercial Services for Genentech/Roche.

Mr. Davidovic holds an MBA, Marketing & Information Systems, from McGill University. He also holds a BSc in Physiology from McGill.

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Marc Eigner

Senior Partner, Polaris

As a co-founder of Polaris Solutions and head of the technology practice, Marc Eigner is considered one of the founding fathers of pharmaceutical commercial-compliance technology and the leading expert this field, particularly in HCP/HCO spend automation and aggregate spend systems. He is a frequent lecturer and author on these topics. Under Marc’s direction, Polaris’ technology practice has grown from a core team to become the largest pharmaceutical compliance-focused technology group in the industry, implementing more than eighty spend management and aggregation systems worldwide.…Read More

As a co-founder of Polaris Solutions and head of the technology practice, Marc Eigner is considered one of the founding fathers of pharmaceutical commercial-compliance technology and the leading expert this field, particularly in HCP/HCO spend automation and aggregate spend systems. He is a frequent lecturer and author on these topics. Under Marc’s direction, Polaris’ technology practice has grown from a core team to become the largest pharmaceutical compliance-focused technology group in the industry, implementing more than eighty spend management and aggregation systems worldwide. Thanks to his leadership, Polaris continues to innovate, enlarging the scope of its technology practice and introducing a consistent stream of new products while delivering technology strategy expertise in support of Polaris Management Partners’ consulting practice.

Before joining Polaris, Marc worked for Andersen Consulting / Accenture and IBM.

Marc holds a BS and MS in Computer & Systems Engineering and an MBA focused on Technology Entrepreneurship, all from Rensselaer Polytechnic Institute. Marc has participated in several executive education programs at the Harvard Business School, including ‘Leading Professional Services Firms.’

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Nicodemo (Nico) Fiorentino JD

Senior Advisor, Research & Compliance G&M Health, LLC

Nicodemo (Nico) Fiorentino is Senior Advisor, Research & Compliance for G&M Health, LLC, a health and life-science service company offering compliance management services, computer validation, project management, audits & assessments, training and regulatory support services, located in Bridgewater, New Jersey. In that capacity, Mr. Fiorentino advises a diverse client base on federal and state laws and regulations, including proposed legislation, on matters such as distribution and supply chain security, aggregate spend, prescriptive authority, advertising and promotional labeling, and compliance issues impacting commercial CLIA laboratories and molecular diagnostic tests.…Read More

Nicodemo (Nico) Fiorentino is Senior Advisor, Research & Compliance for G&M Health, LLC, a health and life-science service company offering compliance management services, computer validation, project management, audits & assessments, training and regulatory support services, located in Bridgewater, New Jersey. In that capacity, Mr. Fiorentino advises a diverse client base on federal and state laws and regulations, including proposed legislation, on matters such as distribution and supply chain security, aggregate spend, prescriptive authority, advertising and promotional labeling, and compliance issues impacting commercial CLIA laboratories and molecular diagnostic tests.

Mr. Fiorentino received a bachelor’s degree, with honors, in History from Rowan University, Glassboro, New Jersey and a Juris Doctor (J.D.) from Rutgers University School of Law, Camden, New Jersey.

 

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Abraham Gitterman JD

Associate, Arnold and Porter

Abraham Gitterman is an Associate with Arnold & Porter.  His practice focuses on FDA and Healthcare regulatory, compliance, and fraud and abuse matters involving pharmaceuticals and medical devices. He regularly counsels clients on issues relating to compliant industry promotional and medical activities, including use of social media; mobile health applications; and clinical software; supply chain and track and trace matters, drug compounding, and continuing medical education (CME).…Read More

Abraham Gitterman is an Associate with Arnold & Porter.  His practice focuses on FDA and Healthcare regulatory, compliance, and fraud and abuse matters involving pharmaceuticals and medical devices. He regularly counsels clients on issues relating to compliant industry promotional and medical activities, including use of social media; mobile health applications; and clinical software; supply chain and track and trace matters, drug compounding, and continuing medical education (CME). Mr. Gitterman assists with extensive reviews of corporate compliance programs, both generally and pursuant to Corporate Integrity Agreements (CIAs) with OIG, for various life science companies and healthcare entities to ensure compliance with the Anti-Kickback Statute, the False Claims Act, and the Federal Food, Drug, and Cosmetic Act. Mr. Gitterman also has extensive experiencing counseling clients on the Physician Payments Sunshine Act.

Prior to joining the firm, Mr. Gitterman was a research associate at a national ACCME-accredited CME provider, where he assisted drafting medical education grant applications and evaluated various conflict of interest policies regarding physician relationships with manufacturers. Mr. Gitterman received a Health Law Certificate from the Law & Health Care Program at the University of Maryland Francis King Carey School of Law. During law school, Mr. Gitterman clerked with the US Department of Justice, Consumer Protection Branch; The Office of Counsel to the Inspector General for the Department of Health and Human Services (OCIG); and The FDA Office of Policy. Mr. Gitterman also founded the Health Law Regulatory & Compliance Competition.

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Toby Ann Holetz

Compliance Officer, Biogen

Toby Ann Holetz graduated with a degree in Business Management and is currently employed by Quintiles Inc.  Toby has been with Quintiles for more than 16 years and has experience in CRM system implementation, balanced scorecards, strategy map creation and communications.  Toby served as the Sarbanes-Oxley Control owner for all global Clinical Revenue for more than 5 years and is currently the Compliance Officer at Biogen. …Read More

Toby Ann Holetz graduated with a degree in Business Management and is currently employed by Quintiles Inc.  Toby has been with Quintiles for more than 16 years and has experience in CRM system implementation, balanced scorecards, strategy map creation and communications.  Toby served as the Sarbanes-Oxley Control owner for all global Clinical Revenue for more than 5 years and is currently the Compliance Officer at Biogen.  Within her current role Toby is responsible for working directly with customers to deliver on requirements, manage internal resources and systems, develop processes to accurately document and capture data for global reporting, and manage the communication and training plans.

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John Kamp JD, PhD

Executive Director Coalition for Healthcare Communications

John Kamp, PhD, JD, is Executive Director of the Coalition of Healthcare Communications (CHC), whose members include trade associations and individuals representing medical public relations, advertising, publishing and medical education companies. The CHC is located in New York City and focuses on the role of professional communication in the delivery of efficient and effective healthcare in America.…Read More

John Kamp, PhD, JD, is Executive Director of the Coalition of Healthcare Communications (CHC), whose members include trade associations and individuals representing medical public relations, advertising, publishing and medical education companies. The CHC is located in New York City and focuses on the role of professional communication in the delivery of efficient and effective healthcare in America.

Dr. Kamp’s doctorate is in Journalism, from the University of Iowa, and he is co-editor of book series soon to be published by FDA News.

Dr. Kamp is Of Counsel to Wiley, Rein, & Fielding and is a leading advocate of First Amendment and marketing issues throughout the government, including the Federal Trade Commission, Food and Drug Administration, Department of Commerce and the White House. He served the Federal Communications Commission (FCC) for 9 years as Senior Legal and Policy Advisor to three Chairmen, head of the Office of Congressional and Public Affairs, and Inspector General. From 1989 to 2000 he was Senior Vice President of the American Association of Advertising Agencies, Washington Office. He was appointed to the Federal Trade Commission Advisory Committee on Privacy Access and Security (2000) and has been admitted to the District of Columbia Bar and the Supreme Court of the United States.

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Meryl Katz JD

ACA Auditor, Independence Blue Cross

Meryl Katz currently serves as an ACA Auditor for Independence Blue Cross in Philadelphia.   Prior to joining Independence Blue Cross she spent more than three years as an Enterprise Regulatory Affairs Analyst for AmeriHealth Caritas.   Earlier in her career Ms. Katz served as a Staff Attorney for AIDS Law Project of Pennsylvania and as a Law Clerk to the Honorable Colleen A.…Read More

Meryl Katz currently serves as an ACA Auditor for Independence Blue Cross in Philadelphia.   Prior to joining Independence Blue Cross she spent more than three years as an Enterprise Regulatory Affairs Analyst for AmeriHealth Caritas.   Earlier in her career Ms. Katz served as a Staff Attorney for AIDS Law Project of Pennsylvania and as a Law Clerk to the Honorable Colleen A. Maier in the New Jersey Judiciary.

Ms. Katz holds a J.D. from Drexel University School of Law, and a B.A. in Theatre/Theatre Arts management from the University of Maryland Baltimore County.

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Maureen J. Lloyd

Director, Life Sciences Governance, Risk Management, & Compliance PwC

Maureen Lloyd is a Director in PwC's Life Sciences Governance, Risk management, and Compliance practice.  She specializes in working with clients in the pharmaceutical & biotech industries, directing innovative strategies in Medical Affairs, External Medical Communications, R&D, Transparency, and Compliance. In her current role, Maureen leverages her industry experiences, including her leadership of Publications, Independent Investigator Sponsored Research, Independent Medical Education, External Funding and Transparency/Aggregate Spend.…Read More

Maureen Lloyd is a Director in PwC’s Life Sciences Governance, Risk management, and Compliance practice.  She specializes in working with clients in the pharmaceutical & biotech industries, directing innovative strategies in Medical Affairs, External Medical Communications, R&D, Transparency, and Compliance. In her current role, Maureen leverages her industry experiences, including her leadership of Publications, Independent Investigator Sponsored Research, Independent Medical Education, External Funding and Transparency/Aggregate Spend.

Prior to joining PwC, Maureen held various consulting roles and served as Executive Director Pfizer Medical – External Medical Communications.

She holds a BSc Medical Sciences, Medical Biochemistry from University of Bradford.

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Kari K. Loeser JD

Senior Director & Senior Compliance Counsel, Jazz Pharmaceuticals

Kari Loeser currently serves as Senior Counsel with Jazz Pharmaceuticals.  She began her legal career with a private firm, then moved to the American Medical Association as a Policy Analyst, before becoming an Investigator with the U.S. Department of Health & Human Services.  In 2007 she joined Genentech as a Senior Compliance Manager.  She left Genentech in 2012 to join Jazz Pharmaceuticals in her current role.…Read More

Kari Loeser currently serves as Senior Counsel with Jazz Pharmaceuticals.  She began her legal career with a private firm, then moved to the American Medical Association as a Policy Analyst, before becoming an Investigator with the U.S. Department of Health & Human Services.  In 2007 she joined Genentech as a Senior Compliance Manager.  She left Genentech in 2012 to join Jazz Pharmaceuticals in her current role.

Ms. Loeser received her J.D. in Health Law from DePaul University College of Law.  She also holds a B.A. in Political Science and Religion (honors) from the University of Iowa.

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Chad Morin

Director, Compliance Operations at ARIAD Pharmaceuticals

Chad Morin is Director, Compliance Operations at ARIAD Pharmaceuticals, where he is responsible for the development, implementation and continual refinement of ARIAD’s Healthcare Compliance Program. This includes the formation and enhancement of all policies, procedures, and applicable training & communications to support a global program, establishment of an audit/monitoring program, and identification of risks & issues relating to healthcare compliance and the aggregate spend transparency program.…Read More

Chad Morin is Director, Compliance Operations at ARIAD Pharmaceuticals, where he is responsible for the development, implementation and continual refinement of ARIAD’s Healthcare Compliance Program. This includes the formation and enhancement of all policies, procedures, and applicable training & communications to support a global program, establishment of an audit/monitoring program, and identification of risks & issues relating to healthcare compliance and the aggregate spend transparency program.

Prior to joining ARIAD, Chad was Associate Director, Global Compliance at Cubist Pharmaceuticals (now a wholly owned subsidiary of Merck & Co., Inc.), where he was responsible for enterprise wide oversight of the aggregate spend, audit/monitoring, and training & communications programs. This included the enterprise plan for global reporting, data integrity policies and practices, processes, training, technology and all associated deliverables.  While at Cubist, Chad led development and implementation of policies and processes for global expansion through Europe, Canada, and Australia

Chad began his life sciences career in Compliance Operations at Boston Scientific.  He is a graduate of The Citadel, a veteran of the U.S. Navy, and a certified Project Management Professional (PMP).

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John A. Murphy JD

Assistant General Counsel, PhRMA

John Murphy is the Assistant General Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA), a trade association representing innovative biopharmaceutical research and discovery companies.  Mr. Murphy’s responsibilities include serving as legal advisor to the Organization’s state advocacy, government relations, and policy sections, as well as coordinating legal and advocacy policy on the Organization’s health reform initiatives.…Read More

John Murphy is the Assistant General Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA), a trade association representing innovative biopharmaceutical research and discovery companies.  Mr. Murphy’s responsibilities include serving as legal advisor to the Organization’s state advocacy, government relations, and policy sections, as well as coordinating legal and advocacy policy on the Organization’s health reform initiatives.

Prior to joining PhRMA, Mr. Murphy served several years as the Senior Director of State Health Policy and Government Affairs with the Biotechnology Industry Organization, a trade association representing innovative biotechnology companies both in the US and abroad.  Murphy began his legal career as an associate in the healthcare and government investigations practices of Hogan Lovells, LLP.

Mr. Murphy speaks regularly on issues related to the biopharmaceutical industry, both legal and policy related, and also more broadly on health reform issues impacting the US market.

Mr. Murphy is a graduate of the Catholic University of America Columbus School of Law and Villanova University.

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John Patrick Oroho JD

Partner, Porzio

John Patrick Oroho is a principal of Porzio, Bromberg & Newman in the Life Sciences Compliance, Commercialization and Regulatory Counseling Department. His practice is concentrated in the areas of regulatory compliance with respect to Aggregate Spend, Physician Payment Sunshine Act, the Prescription Drug Marketing Act (“PDMA”), Antikickback Statute, False Claims Act, and Medicare and Medicaid fraud and abuse.…Read More

John Patrick Oroho is a principal of Porzio, Bromberg & Newman in the Life Sciences Compliance, Commercialization and Regulatory Counseling Department. His practice is concentrated in the areas of regulatory compliance with respect to Aggregate Spend, Physician Payment Sunshine Act, the Prescription Drug Marketing Act (“PDMA”), Antikickback Statute, False Claims Act, and Medicare and Medicaid fraud and abuse.

Mr. Oroho is a noted expert on pharmaceutical compliance, specifically OIG and state compliance with Sales and Marketing and product distribution. He has written and lectured extensively on these, as well as other life science compliance issues. He has worked with companies under Corporate Integrity Agreements to ensure their compliance with the standards established for pharmaceutical marketing and sales. Mr. Oroho previously served as Senior Vice President and General Counsel for the PDMA Alliance, a national trade association focused on sample distribution and pharmaceutical marketing and sales compliance. Mr. Oroho has been responsible for the development of Aggregate Spend systems and PDMA-compliant sample tracking systems.

Mr. Oroho is also Executive Vice President and Chief Strategy Officer of Porzio Life Sciences, LLC, a wholly owned subsidiary of the law firm. He meets regularly with companies to identify sales and marketing issues and to propose solutions that streamline their understanding of acceptable practices and conduct in meeting compliance requirements of all 50 states and the District of Columbia.

Mr.Oroho obtained his J.D. from the University of Notre Dame School of Law, and completed his B.S., with honors, at the United States Merchant Marine Academy.

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Kristin Rand JD, MA

Executive Director, Compliance & Associate General Counsel, Seattle Genetics, Inc.

Kristin Rand has more than 15 years of experience in the pharma/biopharma industry. In her current position as Executive Director of Compliance & Associate General Counsel at Seattle Genetics she oversees the company’s Compliance Program and commercial, insurance and employment legal matters. 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.…Read More

Kristin Rand has more than 15 years of experience in the pharma/biopharma industry. In her current position as Executive Director of Compliance & Associate General Counsel at Seattle Genetics she oversees the company’s Compliance Program and commercial, insurance and employment legal matters. 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.

Ms. Rand obtained a B.S. degree in Diagnostic Genetic Sciences from University of Connecticut and completed her J.D. at Quinnipiac University School of Law.  She also holds an M.A. degree in industrial-organizational psychology from Northcentral University.

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Marc J. Scheineson Esq

Partner, Life Sciences, Alston & Bird LLP

Marc Scheineson is a partner in the Washington, D.C., office of Alston & Bird LLP, where he heads the firm’s Food and Drug Law Practice. He advises companies on a wide range of issues, including product approvals, marketing, clinical studies and enforcement. Previously, he served as the associate commissioner for legislative affairs of the Food and Drug Administration.…Read More

Marc Scheineson is a partner in the Washington, D.C., office of Alston & Bird LLP, where he heads the firm’s Food and Drug Law Practice. He advises companies on a wide range of issues, including product approvals, marketing, clinical studies and enforcement. Previously, he served as the associate commissioner for legislative affairs of the Food and Drug Administration. He was involved there in many agency innovations, including prescription drug user fees, debarment, medical device amendments and nutritional labeling. He was also counsel to the ranking member of the Health Subcommittee of the House of Representatives Committee on Ways and Means, and a senior vice president of Ketchum Communications. Mr. Scheineson is also experienced with the application of the OIG anti-kickback statute, HIPAA privacy rules, patent term exclusivity, institutional review board regulation, human research protection, scientific misconduct, technology transfer and licensing, advertising and promotion law, ACCME accreditation, and advises on the FDA regulatory aspects of corporate acquisitions.

Mr. Scheineson received an LL.M. degree from the Georgetown University Law Center, and his B.A. and J.D. degrees from the University of Cincinnati and its College of Law.

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Paul J. Silver

Managing Director & Practice Leader, Huron Life Sciences

Paul J. Silver has 26 years of experience in the pharmaceutical, medical device, and consumer products industry, specializing in compliance and regulatory matters. Paul regularly works with in-house legal counsel, corporate compliance officers, senior operations professionals and outside legal counsel that support these professionals. Paul has provided expert testimony on behalf of pharmaceutical companies in litigation matters involving sales and marketing practices.…Read More

Paul J. Silver has 26 years of experience in the pharmaceutical, medical device, and consumer products industry, specializing in compliance and regulatory matters. Paul regularly works with in-house legal counsel, corporate compliance officers, senior operations professionals and outside legal counsel that support these professionals. Paul has provided expert testimony on behalf of pharmaceutical companies in litigation matters involving sales and marketing practices.

Mr. Silver holds a B.S. degree in Finance & Marketing from the University of Alabama.

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David Vulcano LCSW, MBA, CIP, RAC

AVP & Responsible Executive for Clinical Research, Healthcare Corporation of America

David Vulcano is a well-known leader in the clinical research industry through numerous publications, presentations and contributions.  Among other things he is currently the Responsible Executive for Clinical Research at HCA, the largest private healthcare provider in the United States and operations globally. He is and has been in many industry leader roles both in the United States and globally, including Chair of the Board of Trustees for the Association of Clinical Research Professionals (ACRP). …Read More

David Vulcano is a well-known leader in the clinical research industry through numerous publications, presentations and contributions.  Among other things he is currently the Responsible Executive for Clinical Research at HCA, the largest private healthcare provider in the United States and operations globally. He is and has been in many industry leader roles both in the United States and globally, including Chair of the Board of Trustees for the Association of Clinical Research Professionals (ACRP).  His contributions to the research industry are numerous, with the most recent recognitions including the 2012 Special Recognition Award by the Regulatory Affairs Professional Society, the 2012 Best Practice in Human Subject Protection by the Health Improvement Institute and named one of the Top 100 leaders in the Health IT Community in 2012 by the HealthTech Council (through his leadership to assure the ethical conduct of clinical research with “big data” in healthcare). He has been an expert witness in the clinical trials arena and is also a member of the Nashville Chapter of the Angel Capital Group where he participates in deal screening, due diligence, entrepreneur mentoring and takes the occasional board seat in startup companies

Mr. Vulcano holds three degrees:  an MBA, an MSW, and a B.S. degree in Psychology/Philosophy, all from Louisiana State University.

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