Sergio Alegre, Vice President, Global Compliance, Osmotica/Vertical Pharmaceuticals

Sergio Alegre is the Vice President of Global Compliance for Osmotica Pharmaceuticals and its subsidiaries, Vertical Pharmaceuticals and Trigen Labs. He previously served as Executive Director of Pacira Pharmaceuticals, where he implemented and oversaw its Compliance Program. In addition, he spent seven years as Vice President of Mergers and Acquisitions for Realogy Corporation following a time in private practice at a law firm located in New York City. He holds a B.A. from Rutgers University and a J.D. from Fordham University School of Law.

 

Don DeSmet, Manager of Sample Operations – Cold Chain, Sanofi & Sharing Alliance Board Member

Don DeSmet is responsible for cold chain equipment deployment, cold chain field monitoring and field compliance to cold chain requirements. Previously Don was Manager of Accountability for Bayer Healthcare for 17 years and was responsible for all aspects of PDMA compliance, Sample Vendor Partner Management, and Bayer’s Sample Send program. Don has served on the Sharing Alliance board for 14 years, and has held the positions of both President and Vice President. Prior to Bayer, Don spent 25 years in various senior logistics and warehouse operations positions for both Pharma and consumer goods organizations. Don also owned a contract packaging concern for 5 years. Don holds a BA in Materials and Logistics Management from Michigan State University.

 

Nicodemo Fiorentino, Senior Manager, Compliance Operations & Transparency, Sun Pharmaceuticals Industries, Inc. & Sharing Alliance Board Member

Nicodemo Fiorentino, Esq. (licensed in the State of New Jersey) currently serves as Senior Manager, Compliance Operations & Transparency for Sun Pharmaceuticals 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 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.

 

Judy Fox, Director of Compliance Services, QPharma, Inc. & Sharing Alliance Board Member

Judy is the Director of Compliance Services at QPharma, Inc. where her responsibilities include ensuring compliance concerns and requirements are addressed by clients. She assists clients in developing and assessing Commercial Corporate Compliance program policies, procedures and codes of conduct and serves as an advisor on commercial compliance risks. Judy is a Subject Matter Expert in federal and state compliance, transparency reporting and sample accountability regulations, and has participated in numerous industry presentations. She is an appointed board member of the Alliance, and has worked with the team for seven years.

 

Alan G. Minsk, Partner, Arnall Golden Gregory & Sharing Alliance Legal Counsel

Alan G. Minsk is a Partner and Chair of the Food & Drug Practice Team of Arnall Golden Gregory LLP. Alan advises pharmaceutical, medical device, and food companies on all legal and regulatory matters relating to the U.S. Food and Drug Administration, and certain matters concerning the U.S. Department of Agriculture, the Federal Trade Commission, the Drug Enforcement Administration, the Bureau of Alcohol, Tobacco and Firearms, and the Consumer Product Safety Commission. He counsels clients and has spoken and written on a wide variety of FDA-related issues, including regulatory strategies and life cycle management, combination products, FDA enforcement, FDA inspections, corporate compliance, market exclusivity, product promotion and advertising, product liability, clinical trials and imports and exports. He serves on several Editorial Advisory Boards and the Sharing Alliance as the General Counsel. He is a graduate of Brandeis University and Georgetown University Law Center.

 

John E. Nause, Vice President, Ethics and Compliance, G&M Health, LLC

John Nause is currently Vice President, Ethics and Compliance at G&M Health, LLC, a compliance consulting company for the healthcare industry. Before joining G & M, John was the North America Head of Corporate Ethics and Compliance at Dr. Reddy’s Laboratories, Inc., where he supported the generic business as well as the branded subsidiary Promius Pharma, LLC. Before joining Dr. Reddy’s, John worked for Watson Pharmaceuticals, Inc. managing the department responsible for Government Contracts and Government Pricing programs, and before that he worked at Johnson and Johnson Health Care Systems Inc. where he negotiated and managed Federal Supply Schedule Contracts for J&J’s pharma and medical device/diagnostic operating companies. Before that, John was a sales representative in Philadelphia for Diagnostic Imaging Inc., a subsidiary of PSS World Medical, which was a national distributor of radiology equipment, supplies, and services.

 

Kelly Pryslak, Sr. Manager, Sample Compliance & SAFE Fleet, Janssen Pharmaceuticals, Inc. & Sharing Alliance Vice President

Kelly Pryslak has extensive PDMA Sample Compliance experience. She is currently the Sr. Manager of Sample Compliance & SAFE Fleet at Janssen Pharmaceuticals, Inc. in Titusville, NJ. Kelly provides leadership in maintaining the highest quality compliance, providing guidance to supported sales forces and business partners as well as ensuring internal policies and procedures meet Federal PDMA, State, Corporate and CIA requirements. Kelly began her career with Janssen Pharmaceuticals in 1999 in Trade Relations and joined Samples Management Department as an Analyst in 2002. Kelly’s broad knowledge in PDMA compliance is the result of serving in roles of increasing responsibilities and leadership, gaining experience required to become the department head in 2014. Kelly holds a B.S. degree in Business Administration with a concentration in Marketing from Montclair State University.

 

Margaret Rossini, Director, Corporate Compliance Monitoring and Risk, Sandoz, Inc.

Margaret Rossini is Director, Corporate Compliance Monitoring and Risk at Sandoz Inc.  Margaret is responsible for monitoring, reporting and risk assessments of commercial, medical and external facing activities, events, and payments based on policy requirements and risk profile.  She also oversees transparency aggregation processes that enable annual Federal and State reporting in compliance with Open Payments and state law requirements. Margaret has over 15 years’ experience in the pharmaceutical industry, and has worked in compliance related roles in this industry for over 10 years.  Margaret holds a Bachelor of Arts in International Relations and a Masters of Science in Information Systems.

 

Deb Segura, Executive Director, The Sharing Alliance™

Deb Segura is the Executive Director of the Sharing Alliance, and has over 25 years of experience in the pharmaceutical industry. She has dedicated herself to providing valuable compliance information to Alliance members and industry. The Sharing Alliance is a not for profit organization founded in 1989 with a mission to improve the pharmaceutical industry’s understanding of the Prescription Drug Marketing Act (PDMA) and related sample compliance regulations. Prior to taking the position of Executive Director, Deb’s career included various management positions at Kos Pharmaceutical (now Abbott), Novo Nordisk, and Bristol Myers Squibb. Her primary focus was sample compliance, education and training, and sample investigations.

January 31, 2019

8:30am - 3:00pm

$399.00 per person

Novartis Pharmaceuticals Corporation

One Health Plaza

Building 438 Auditorium

East Hanover, NJ 07936-1080

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Speaker Bios