Speakers – 10th Aggregate Spend and Open Payments Conference

Isha Arora
Independent Life Sciences Compliance Consultant, INGEN, LLC

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Isha Arora is a Chicago based independent consultant, focused on helping Life Science companies build out effective compliance programs through data and technology integration. Isha has many years of experience working in various stages of Life Sciences organizational growth, compliance program development, transparency data reporting, and operational strategic management. In previous roles she has helped companies build/launch their compliance analytics and monitoring programs. She received her bachelors in Finance and Healthcare Management from Northeastern University, and is passionate about the ever-changing compliance regulations, specifically the complexities around data reporting and development to support compliance programs.

Bernard Cooney
Assistant United States Attorney, District of New Jersey, U.S. DEPARTMENT OF JUSTICE

Charlene E. Davis, Esq.
Associate Vice President and Head of Healthcare Compliance North America, SUN PHARMACEUTICAL INDUSTRIES

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Charlene E. Davis, Esq. is Head of Healthcare Compliance North America at Sun Pharmaceutical Industries, Inc. Charlene leads the Healthcare Compliance North America (HCNA) group for Sun and certain affiliates and subsidiaries. In her role, she is responsible for the development and maintenance of Sun’s U.S. Comprehensive Compliance Program as well as its Medical, Legal, and Regulatory Review Program. Prior to Sun, Charlene was Senior Compliance Counsel for Otsuka America Pharmaceuticals, Inc. where she spent several years providing healthcare law guidance for device, digital, and neuroscience drug products. She also developed compliance-integrated sales force automation tools and led the development and maintenance of a North American contact center to support the handling of medical and pharmacovigilance inquiries and assist with related regulatory inspections. Prior to her in-house experience, Charlene practiced corporate defense litigation in Pennsylvania and New Jersey. She is an advisory board member for the Temple University Beasley School of Law Center for Compliance & Ethics and adjunct professor of law at Seton Hall University School of Law. Charlene holds a Juris Doctorate from Temple University Beasley School of Law and a Bachelor of Science in Applied Economics & Management from Cornell University.

Nicodemo Fiorentino, Esq.
Senior Manager, Compliance Operations and Transparency, SUN PHARMA

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Nicodemo Fiorentino, Esq. (licensed in State of New Jersey) currently serves as Senior Manager, Compliance Operations & Transparency for Sun Pharmaceutical Industries Inc. In this capacity, he is responsible for the collection, monitoring, auditing, and analyzing of aggregate spend data for reporting under the Physician Payment Sunshine Act and state disclosure laws, sample compliance, as well as partnering with various functional areas (e.g., Commercial Operations, IT, Marketing) to provide compliance direction related to the development of compliant technology solutions.

In addition to this role, Mr. Fiorentino is a Board Member of The Sharing Alliance (f.k.a. PDMA Alliance) and separately serves as an Associate Editor for and Board Member of Policy & Medicine’s Compliance Update, a monthly compliance publication designed for pharmaceutical, biotechnology, and device manufacturers. Previously, he worked for G&M Health, LLC, a health and life science advisory company, and provided comprehensive federal and state regulatory support to manufacturers, distributors, logistics providers, and contract sales organizations. He has also co-authored a law review article, “Drug Pricing – The Next Compliance Waterloo,” and contributed to Bloomberg BNA’s Pharmaceutical and Medical Device Law: Regulation of Research, Development, and Marketing (Second Edition).

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.

Daniel Font, CIIP-US, CIPM
Director, Compliance Investigations, Policy and Training, DAIICHI SANKYO

Bill Friedrich
Senior Manager, Compliance, HIKMA PHARMACEUTICALS

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My background covers almost 30 years with stints in FP&A, Financial Controls, Transparency and Compliance while working for Pfizer, Forest, and now Hikma sprinkled in with a period as an Aggregate Spend consultant helping companies navigate their federal & state transparency obligations.

I have focused on the Aggregate Spend & Compliance areas since 2009. Part of the group entrusted to build out one of the first in-house Pharma Transparency teams. As a consultant, I have been able to see the challenges of small and mid-sized companies versus those of Big Pharma.

Have worked in custom built and software supported programs so I understand the unique needs of each type of environment.

Kari K. Loeser
U.S. Healthcare Compliance Officer, RELYPSA

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Kari K. Loeser, Esq. is the U.S. Healthcare Compliance Officer and senior counsel for Relypsa, Inc. In this role, she advises client groups on legal and compliance matters pertaining to sales, marketing, corporate affairs, and promotional matters for the renal-cardiology portfolio, in addition to advising on legal and compliance matters for medical affairs including field medical, clinical/research, publications, and health economic outcomes research, and managed care and reimbursement activities. She oversees all compliance-related matters, including training, investigations, and also manages a team responsible for federal/state aggregate spend reporting (transparency) and compliance field monitoring.

Prior to Relypsa, Kari worked at Jazz Pharmaceuticals as senior counsel and also worked in medical affairs and healthcare compliance at Genentech, a member of the Roche Group. She has published various articles and a book chapter on E-Health and Ethics, and she has presented at various conferences, including the AHLA-HCCA Fraud and Abuse Conference. She currently authored an article in the International In-House Counsel Journal on client centricity, and authored a book chapter in CANCER POLICY: PHARMACEUTICAL SAFETY entitled “Anatomy of Risk Evaluation and Mitigation Strategies (REMS)” by Springer Publishing (Germany), published in early 2019. She is a licensed attorney, and is certified in Healthcare Compliance. She received her JD from DePaul University College of Law, and her BA with Honors from the University of Iowa.

Joseph Mack
Senior Compliance Counsel, BAYER

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Prior to joining Bayer, Joe Mack served for over nine years as an Assistant U.S. Attorney in the U.S. Attorney’s Office for the District of New Jersey. During his time at the U.S. Attorney’s Office, he served as Deputy Chief of the Health Care and Government Fraud Unit and Acting Chief of the General Crimes Unit. He has investigated and prosecuted corporate and individual defendants for violations of the federal anti-kickback statute, the Food, Drug, and Cosmetic Act, and tax crimes. Prior to working at the U.S. Attorney’s Office, he was an associate at White & Case LLP and Linklaters LLP.

Mr. Mack is a graduate, magna cum laude, of Pace University School of Law.

Heather McCollum, J.D., MHA, CCEP-I
Director, Compliance, SHIONOGI

Natalia Morozkina

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Natalia Morozkina is a compliance professional with 78 years of experience (the last three four of which were dedicated to the Pharmaceutical industry) responsible for financial transparency reporting (EFPIA, US Federal and State reporting), relationship management and overseeing the execution of all stakeholders driven/business focused Compliance and Ethics Risk Management strategic engagements. She supports a relentless focus on quality and excellence in business partners endeavors and provides valuable insights and risk assessments as well as input on how to mitigate risks to optimize partnership and business success.

She is passionate about yoga, the ancient art of achieving a healthy body and sound and powerful mind and has been practicing and teaching yoga for the past ten years as well.

Natalia obtained her bachelor’s degree in Economics & Interpreting, graduating summa cum laude from the Saint Petersburg State University of Economics and Finance (Saint-Petersburg, Russia) and considers pursuing a graduate degree in the fields of law or business management.

Sharon Muscato
Director, Transparency and Compliance Operations, ALEXION PHARMACEUTICALS

Bryan Stefanski
Compliance Director, SIEMENS HEALTHCARE

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BRYAN STEFANSKI is a Compliance Director at Siemens Healthineers in Malvern, Pennsylvania. Mr. Stefanski graduated with a Bachelor and Master’s Degree from Shippensburg University in Public Administration. He has almost 20 years of commercial compliance experience in the areas of healthcare insurance, pharmaceutical, and medical device. He is currently leading Siemens’ Healthineers U.S. Aggregate Spend team to prepare and comply with state and federal disclosure laws as well as the company’s global transparency efforts.

Bryan Stinehour
Product Manager, MEDISPEND

Thomas Sullivan

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President and founder of Rockpointe, a global medical education company which subsidiaries including accredited education provider Potomac Center for Medical Education and the popular Medical Education Exchange (MEDX) conferences.

Mr. Sullivan is the editor/author of the popular website Policy and Medicine (www.policymed.com) which covers important regulatory and compliance issues effecting the pharmaceutical and device industry. Tom has written extensively and featured as regular speaker on FDA regulations.

Publisher of Policy and Medicine Compliance Update a monthly publication dedicated to compliance professionals. He is also a regular contributor to Medical Marketing and Media and Medical Meetings.

Tom is also the founder of the CME Coalition, a lobbying and education organization to help guide policymakers on continuing medical education issues. And co-founder of the Association of Clinical Researchers and Educators with Thomas Stossel of Harvard and others to encourage physician industry collaboration.

Tom severs on the Maryland governors P-20 leadership council and has previously served on the NIH – NINDS working group to modernize clinical trials.

Prior to founding Rockpointe, Tom worked as a political consultant his clients included campaigns for US Senate, Governor, Congress, National Republican Congressional Campaign Committee, National Party of New Zealand, and the UK Conservative Party.

Sheea Sybblis

Robin Usi
Director, Division of Data and Informatics, Center for Program Integrity, CENTERS FOR MEDICARE & MEDICAID SERVICES

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Robin Usi is the Director for the Division of Data & Informatics (DDI), within the Data Sharing & Partnership Group of the CMS Center for Program Integrity. Robin is responsible for implementing and supporting the technologies, informatics and reporting for the Open Payments program and the Healthcare Fraud Prevention Partnership, a public-private partnership advancing the detection and prevention of healthcare fraud.
Prior to joining CMS, Robin worked in the Office of the Medicare Ombudsman where she led the planning, coordination, analysis, and research regarding policy and operations involving beneficiary access to and understanding of Medicare programs. Robin joined CMS in 2010.

Amy Valiante Ross
Vice President, Contracts and Compliance, CHIESI USA

Donna White
Vice President, Contracts and Compliance, CHIESI USA

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Donna White is the Vice President, Contracts and Compliance, at Chiesi USA, Inc. Starting in the pharmaceutical industry over 20 years ago as a sales representative, Donna has worked in most functional areas of the brand and generic, hospital, specialty and retail, sides of the business, with increasing responsibilities throughout. Currently, she leads a team that is dedicated to excellence in the areas of compliance, commercial contracting and contracting analytics, government programs, aggregate spend, and pricing for Chiesi USA.