- Vice President, Healthcare Compliance Officer, Hyperion Therapeutics, Inc.
- Vice President, Chief Compliance Officer, Exelixis, Inc.
- Worldwide Compliance Director, Amgen Inc.
- University of San Diego, School of Law – J.D.
- University of Minnesota, Twin Cities – M.A.
- University of California, Los Angeles - B.A.
Hieu Le is the founder of Operational Compliance Solutions, a consulting firm focused on providing emerging biotech and life science companies with strategic compliance advice. He is an experienced senior business executive with over a decade of practice as a licensed attorney counseling some of the nation’s leading pharmaceutical companies.
Hieu previously served as, Vice President, Chief Compliance Officer of Exelixis, Inc. and Vice President of Healthcare Compliance at Hyperion Therapeutics, Inc. At both Exelixis and Hyperion, he was responsible for developing and implementing a corporate wide compliance program from the ground up, including establishing policies and procedures, developing and delivering training, monitoring and auditing company activities, and reviewing and providing counsel on company materials intended for promotions and scientific exchange.
Prior to joining Exelixis, Hieu was Corporate Counsel and Worldwide Compliance Director for Amgen, Inc. At Amgen, Hieu had responsibility as the Director for US domestic compliance and international compliance focusing on Asia and Latin America.
Hieu graduated from the University of San Diego School of Law. He earned a Masters in Counseling from the University of Minnesota, Twin Cities where he was a Justice Allen Page Scholar. He received a B.A. in Psychology from the University of California, Los Angeles.
Hieu is admitted to practice in California.
- Commercial Counsel, SRI International
- Transactional Attorney, Roku
- Legal Associate, Isolation Networks, Inc.
Hendson Lin is a Compliance Associate for Operational Compliance Solutions, a consulting firm focused on providing emerging biotech and life science companies with strategic compliance advice.
Hendson works to assist client companies with legal and regulatory compliance, policy formulation, employee monitoring, and investigation of employee misconduct.
Hendson is an experienced intellectual property and transactional attorney. He has experience drafting and negotiating a variety of complex commercial agreements ranging from patent licensing in robotics, pharmaceuticals, and software to music and content licensing. Hendson regularly works with a number of pharmaceutical companies and researchers throughout the United States and internationally in commercial services, research and development agreements, and material transfer agreements. Hendson also has a background in general civil litigation and corporate entity formation in California.
Hendson received his J.D. from UC Hastings College of the Law where he was a Senior Editor of the Hastings Business Law Journal and a member of the UC Hastings Trial Team. He received a B.A. in both Economics and Political Science from UC Davis.
Eric is the Head of Auditing and Transparency Reporting for Operational Compliance Solutions, a consulting firm focused on providing emerging biotech and life science companies with strategic compliance advice.
Eric is an experienced CPA that assists clients ensure compliance with federal and state regulations through aggregate spend system development and refinement, transparency reporting, compliance risk assurance, and monitoring and auditing.
Eric has worked as Senior Manager, Transparency Reporting & Analytics for INSYS Therapeutics, Inc where he served as the Subject Matter Expert on all transparency initiatives (federal Sunshine Act and state reporting obligations) and led the Speaker Programs department through restructuring policy and procedures, monitoring compliance, and creating spend analytics for efficiency and compliance. At INSYS, Eric also conducted spend audits to assist with extensive federal DOJ and state investigations.
Before joining INSYS, Eric was Manager, Compliance and Transparency at CIS by Deloitte. At CIS by Deloitte, Eric consulted over a dozen pharmaceutical and medical device companies through all aggregate spend related functions including system and policy development, spend monitoring and analytics, and government transparency reporting. Prior to entering the pharmaceutical industry, Eric served as an auditor at a national CPA firm.
Eric received his Bachelors of Science in Economics at the University of California, Berkeley. Shortly thereafter, Eric earned his California CPA.
- Senior Manager, Transparency Reporting & Analytics, INSYS Therapeutics
- Compliance Manager, Hyperion Therapeutics
- Manager, Compliance & Transparency, CIS by Deloitte
- University of California, Berkeley – B.S.
- Senior Director Law, Alexion Pharmaceuticals
- Worldwide Compliance Director and Senior Counsel, Amgen Inc. and Amgen Europe
- Corporate Counsel, Miltenyi Biotec
- Associate at law firm Taylor Wessing
- University of Wuerzburg, Germany
Thomas Gnielinski is a Compliance Consultant for Operational Compliance Solutions. He has more than 15 years of professional experience advising life science companies both in- and outside the US.
He most recently served as Senior Director Law at Alexion Pharmaceuticals in their International Headquarters in Switzerland, where he was the lead attorney for the company’s flagship ultra-rare disease drug outside the US. Thomas also was the responsible attorney for the affiliates in Germany, Austria, Switzerland, Central and Eastern Europe, Russia and the Middle East and provided extensive compliance advice to Senior Management at the International Headquarters.
Prior to Alexion Thomas was Senior Counsel and Director Compliance at Amgen, serving both at their worldwide Headquarters in the US and their International Headquarters in Switzerland. His main responsibilities were advising on Regulatory Promotion matters in the US and ex-US, healthcare compliance and competitor litigation in cases of non-compliant product promotion.
Thomas is admitted to practice law in Germany and California.
Ariel Mihic is a Marketing Associate for Operational Compliance Solutions, a consulting firm focused on providing emerging biotech and life science companies with strategic compliance advice. Ariel assists clients with commercial pull-through, from product launch, through line extensions, to mature brand transitions. She works with many companies to manage their promotional and access programs, generate Promotional Review Committee processes and efficiencies, build and manage speaker’s bureaus and launch broadcasts, develop and execute brand strategic and tactical plans, manage agencies, budgets, and vendors, develop Sales Training materials and workshops, create secondary audience strategy, tactics, and partnerships, support Access and Reimbursement programs and HUBs, provide Project Management support for large sales team meetings and events.
Ariel received her Doctorate of Pharmacy from the University of North Carolina at Chapel Hill.
- Marketing Consultant, Ariel Mihic Consulting
- Associate Director, Oncology Product Marketing, Genentech
- National Manager, Oncology Nurse Clinical Coordinators, Genentech
- Oncology Sales Representative, Novartis
- University of North Carolina at Chapel Hill, Pharm.D.
- Compliance Manager, ZS Pharma
- Compliance Manager, Biotech Compliance Consultants
- Middle Tennessee State University – Masters, Healthcare Informatics - Bachelors, Biology
Liz Brandon is a compliance consultant for Operational Compliance Solutions. As a consultant, Liz has experience with both large and small pharmaceutical companies conducting audits, consulting and developing solutions for transparency needs, and policy development and training.
Liz also serves as Compliance Manager for ZS Pharma, a subsidiary of AstraZeneca. At ZS Pharma, she is responsible for developing the corporate compliance program, including implementing policies, developing and delivering training and monitoring company activities. Liz is also responsible for implementing and administering software-based solutions for compliance processes such as grants management, review processes and learning management systems.
Prior to consulting for the pharmaceutical industry, Liz worked as a software developer and data engineer in the healthcare industry. Liz has extensive experience working with both hospital and pharmaceutical data and developing useful software, reports and dashboards for transparency and compliance reporting.
Liz earned a Masters degree in Healthcare Informatics and a BS in Biology from Middle Tennessee State University.