Faculty – 8th Aggregate Spend and Sunshine Act Conference

Ishita Arora
Compliance Manager, HORIZON PHARMA PLC

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Ishita Arora is currently Chicago based Compliance Manager at Horizon Pharma. A native to Houston, TX, Ishita proceeded to Northeastern University Boston where she received a BA in Finance and Health Sciences. After working in Big Pharma for slightly over two years, she moved over to Horizon Pharma where the entrepreneurial attitude allows her to be creative with her role. Ishita is passionate about learning the ever changing compliance regulations, specifically the complexities around transparency aggregate spend reporting, and is intrigued with the development of big data to support compliance.

She enjoys working in the Biopharma industry as it allows her to play her strengths in business while also being able to see a direct impact on the lives of patients. In her spare time she likes to travel and stay active.

Melissa Blaco
Director, Compliance Reporting, REGENERON PHARMACEUTICALS

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Melissa Blaco is a Director in the Compliance Department at Regeneron Pharmaceuticals, Inc. focusing on the company’s transparency reporting efforts. Melissa earned a B.S. in accounting at the State University of New York, College at Oneonta and is a licensed CPA in the State of New York. Melissa spent several years working in public accounting in the New York and Boston area before entering the biotechnology accounting field, specializing in SEC reporting. She joined Regeneron’s accounting department in 2008 and transitioned into compliance in 2011.

Gretchen Reyes Cseplo
Compliance Officer, US, Canada and Global Compliance Operations, CONVATEC

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Gretchen is currently the Compliance Officer, U.S., Canada and Global Operations at ConvaTec; a global medical products and technologies company, with leading market positions in ostomy care, wound therapeutics, continence and critical care, and infusion devices.

During her tenure at ConvaTec, she has held a number of compliance roles, and has been directly responsible for all global compliance training, employee communications, and the implementation of compliance and anti-bribery programs in high-risk LATAM markets and U.S. transparency/aggregate spend reporting. She is also a proactive business partner to C-level members and all leadership levels within the organization.

She enjoys presenting live sessions on a variety of professional subjects, including employee engagement, ethics and compliance tone; U.S. transparency/disclosure operations; and anti-bribery/corruption prevention in Latin America.

Gretchen is a member of the AdvaMed State Affairs and Sunshine Implementation Working group. She has a bachelor’s degree in psychology from Rider University and a master’s of arts in higher education administration from Rowan University. She has been an Alumnus of the Seton Hall School of Law’s Healthcare Compliance Certification Program since 2010.

On a personal note, Gretchen is married; a mother of two boys; fluent in her native language, Spanish, and is expanding her Portuguese.

Derek Devgun, Senior Legal Specialist, Mergers and Acquisitions, MEDTRONIC

Derek Devgun
Legal Director, Restorative Therapies Group, MEDTRONIC

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Derek Devgun is a lawyer in the M&A legal group at Medtronic in Minneapolis, where he handles acquisitions, divestitures, equity and debt investments, joint ventures and related matters for Medtronic across the world. In 2015, he also completed a 6 month secondment for Medtronic in Mumbai, India, where he served as interim head of an 8-person legal and compliance group. Derek has law degrees from the University of Birmingham (LL.B. with Honors, 1990) and from the University of Iowa (J.D. Order of the Coif, 1993). He is admitted to practice law in Minnesota and as a solicitor in England and Wales. He has been with Medtronic for almost 9 years, and prior to going in-house he was in private practice in the Minneapolis-St. Paul area. Derek is a regular speaker and has authored numerous publications, mostly on subjects relating to international business law.

Michael Hunn, Quality Project Manager, Compliance, DRAEGER MEDICAL

Michael Hunn
QA Project and Compliance Manager, DRAEGER MEDICAL

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Michael joined the medical device industry in 1990 and holds more than 25 years of medical device experience. In 1990, he joined Dräger in Telford, PA as a Senior Quality Engineer and worked on various quality control techniques for the manufacturing of anesthesia delivery systems. Over the years he has leveraged Lean ideas, tools and techniques to increase both efficacy and efficiency in the quality assurance and quality management (process improvement initiatives, CAPA management, root cause analysis, procedural document developments and management review) arenas. In addition to his responsibilities for the quality management system, Michael added compliance management to his resume in 2010. Reporting to the Chief Compliance Officer, he represents the company as the prime central compliance contact regarding planning, coordination and implementation of healthcare compliance program activities. He works with employees and managers from sales, marketing, legal, compliance, and R&D and third parties such as suppliers and consultants to ensure corporate compliance with US and state healthcare compliance laws, rules and regulations and compliance with applicable industry guidelines and standards.

Michael holds a master’s degree in organization and management from LaSalle University from Philadelphia, PA as well as a bachelor’s degree in mechanical engineering from Drexel University in Philadelphia, PA.

Leo Otero
Senior Manager, US Payment Transparency, PFIZER

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Leo Otero is a currently a Sr. Manager on Pfizer’s U.S. Payment Transparency Team. He began his Pfizer career in 2001 working directly with the Vice President of the company, and has experience in various positions during his 16 years at Pfizer. His experiences include working in both finance and compliance positions on the Medical and Marketing side. In 2010, he was one of the original members of Pfizer’s US Payment Transparency team, and has worked on Healthcare Professional Transparency Sunshine Act disclosures initiative since the team’s inception. His responsibilities include managing the disclosure for non-clinical payments for Pfizer’s general ledger source, SAP, as well as the management of external funding payments made to outside organizations, including sponsorships, exhibits, fellowships, preceptorships and medical education grants. His responsibilities also include assisting with the EFFPIA global initiatives and collaborating with internal and external stakeholders on improving processes which mitigate HCP disclosure risk while implementing automated processes. Leo has a B.A from Queens College University and an MBA in Communications from Fordham University in New York City.

Mohammad Ovais

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Mohammad Ovais is the Founder & CEO at qordata and has spent a decade building analytical solutions and applications for Fortune 1000 companies. Prior to this, he served as the Managing Partner/Co-Founder at Streebo. With a Bachelor in Computer Science from Rice University and EMP from MIT, he serves on the board of Entrepreneur Organization as Strategic Alliances Chair.

Michael O’Connor
Senior Director, Global Head Compliance and Ethics Operations, ALEXION PHARMACEUTICALS, INC.

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Mike is a big picture, strategic thinker and creative problem-solver with a talent for understanding complex situations, implementing solutions and achieving results. He has more than 18 years of international experience in the pharmaceutical industry, at leading consulting firms and internally, with a focus on compliance. Mike has been building organizations and leading teams throughout his career with a key focus on delivering business results. Mike is currently at Alexion, where he is the Global Head of Compliance Operations and leverages his technology background to drive a data-based approach to implementing and sustaining compliance capabilities.

Amie Phillips Pablo
Associate Director, Government Reporting, NOVO NORDISK

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Amie Phillips Pablo, Associate Director, Government Reporting, is responsible for overseeing and managing NNI’s compliance with applicable government laws and regulations, including direct responsibility for the processes, policy and procedures designed to ensure compliance with the NNI government reporting requirements (e.g. Aggregate Spend, Corporate Integrity Agreement (CIA), Risk Evaluation and Mitigation Strategy (REMS), etc.). Additionally, she is responsible for the associated reporting and/or obligations associated with these requirements. Prior to joining NNI in 2012, Ms. Phillips Pablo worked with the Fraud Investigation and Dispute Services practice of Ernst & Young. She holds a Bachelor of Science in Industrial/Organizational Psychology from High Point University.

Michael Pace
Director of Life Sciences, CONCUR

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Mike Pace joined Concur in 2012 and is the Director of Concur’s U.S. Life Sciences Market. The primary focus for Mike and his team is to help companies deploy innovative solutions, which simplify spend management, easily capture data for regulatory reporting, and ultimately achieve the perfect business trip. Mike is a graduate of Cornell University with over 11 years of sales and leadership experience in the Finance and HR technology industries.

Helen Park
Manager, US Payment Transparency, PFIZER

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Helen Park is currently a Manager on Pfizer’s US Payment Transparency Team. She has a B.S. in accounting from the School of Management at Binghamton University and started her journey at Pfizer in 2005, working in the Financial Disclosure Team, where she was responsible for tracking and managing financial interests of the clinical investigators and reporting it accordingly to the regulation to the FDA. She also has experience working in the Medical Education Group as a grant manager, where she reviewed all Medical Education grants requests for compliance, policies and alignment with our Clinical Area goals. She has been in her current role in US Transparency since 2013 and her main focus for the sunshine act reporting is managing the end-to-end process on Dispute resolution and tracking the deltas for each CMS submission. She also manages the speaker operations data and supports the research data.

Jason Reese
Transparency Analyst, Ethics and Compliance, ASTELLAS

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Jason Reese is a Transparency Analyst at Astellas US, LLC in Northbrook, IL. He manages data collection from third-party vendors and internal sources for US-based Astellas entities, and assists with State and Federal transparency reporting. Jason also provides Transparency training to “new hires” at Astellas. Prior to joining the Transparency team, Jason provided project management support to Astellas Global Marketing Strategy and Medical Affairs teams. Before he joined Astellas in 2007, Jason worked in account management, field sales, and compliance functions in other industries.

Danny Smout
Senior Solutions Consultant, CONCUR

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Danny Smout joined Concur back in 2015 as a Senior Solutions Consultant, focusing on Concurs Life Sciences Market on the East Coast. His experience spans over 15 years in Travel and Expense management within the Life Science industry, working for various companies in various roles globally. The role of a Solution Consultant at Concur is to not only support the sales organization as a product specialist, but to partner with clients to help understand business needs and requirements, and discuss best practices and product application.

Avi Spira, Chief Compliance Officer, CANTEL MEDICAL

Avi Spira
Chief Compliance, Risk and Privacy Officer, FUJIFILM HOLDINGS AMERICA CORPORATION

Richard Velardi
Compliance Manager, Transparency and Reporting, SUN PHARMA

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Rich Velardi is the Compliance Manager, Transparency and Reporting for Sun Pharmaceutical Industries Incorporated and its subsidiary organizations, which include Ranbaxy Laboratories, Taro Pharmaceutical Industries, DUSA Pharmaceuticals, Inc., InSite Vision Incorporated, and Sun Pharma Advanced Research Company. He is responsible for the development of the transparency and reporting program across all of the organizations. He works with members of sales, commercial operations, R&D, legal and compliance to ensure corporate compliance with all state and federal transparency regulations. He is the primary contact for all reporting activity within the organizations.

Rich holds a bachelor’s degree in political science from Fairleigh Dickinson University in Florham Park, NJ as well as a Juris Doctorate from Western New England School of Law in Springfield, MA.

Donna White
Vice President, Contracts and Compliance, CHIESI USA, INC.

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

Ben Yao
Director, Transparency, ASTELLAS

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Ben is a compliance professional who has specialized in the development and execution of transparency reporting programs for the last seven years. Over the course of that time, Ben has worked with more than a dozen pharmaceutical and medical device companies on transparency-related activities, including open payments and state report development, architecture design, and data analytics. As the Director of Transparency for Astellas Pharmaceuticals, Ben is accountable for Astellas’ US transparency program, including the design and development of analytics that can be used by internal stakeholders for a variety of activities. Ben received his undergraduate degree from the University of Illinois, Urbana-Champaign and his MBA from Emory’s Goizueta Business School.