RIC Leadership
The REMS Industry Consortium is led by a Board of Directors representing the six founding companies. These are forward-looking organizations committed to coalescing the REMS professional community in the service of patient safety and REMS innovation.
RIC Board of Directors
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Kevin Holman, MBA, RAC, RIC Board Member & Chairperson Kevin Holman, MBA, RAC leads the REMS & Risk Management Center of Excellence at Johnson & Johnson Innovative Medicine where he built and leads a team of risk management experts to oversee the design, implementation, management, and assessment of risk management programs in the U.S. and North America. Throughout his career, Kevin has contributed to nearly half of the currently-approved shared REMS programs and dozens of single-product REMS programs across various therapeutic areas. Kevin holds a Master of Business Administration degree from Webster University, a Bachelor of Science degree in Biological Sciences from Southern Illinois University ‒ Edwardsville, and a Regulatory Affairs Certification (US-RAC) from the Regulatory Affairs Professional Society. |
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Stephanie Streib, MBA, RIC Board Member & Secretary and Best Practices Working Group Co-lead Stephanie feels fortunate to have contributed to the development and operations of numerous and varied REMS programs over the past 12 years, including the Ambrisentan REMS, Clozapine REMS, and the Pomalidomide REMS, to name a few. Stephanie is currently an Associate Director of Risk Management, US and Canada at Jazz Pharmaceuticals, where she oversees technology initiatives for the XYWAV and XYREM REMS. Prior to Jazz Pharmaceuticals, Stephanie’s experience includes working on multiple shared REMS programs at Mylan Pharmaceuticals and United BioSource. She also worked in the Customer Relations department at Mylan Pharmaceuticals as an account manager. Stephanie is passionate about communication, collaboration and education about REMS within an organization. Stephanie holds a B.S. in Business Administration and Marketing from West Virginia University, and an MBA with a focus in Cybersecurity from Fairmont State University. |
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Kishore Gopu, MS, MBA, RIC Board Member & Vice Chairperson Kishore Gopu, M.S., MBA, Senior Director, REMS Operations has been with Teva since 2007 and has served in many departments including Regulatory Affairs, Commercial Operations, Patient Solutions, Market Access, and Pharmacovigilance. Since joining Teva, Kishore has built the REMS department from the ground up and has been leading it for the last nine years. Prior to Teva, he worked/consulted for many large corporations, including Wyeth and Johnson & Johnson, for six years. He was involved in the development and implementation of over a half dozen shared REMS programs including the iPLEDGE®, TIRF REMS, Opioid REMS, and Clozapine REMS to name a few, and continues to be responsible for the oversight of Teva’s REMS portfolio. Kishore holds a M.S. from the University of South Carolina and a MBA from Fairleigh Dickinson University. |
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Kal Elhoregy, RPh, PA, RIC Board Member & Treasurer Kal Elhoregy, R. PH, PA, is an accomplished healthcare industry executive with 25+ years’ experience focused on implementation of Risk Minimization Programs, Quality Management Systems, Pharmacovigilance Compliance, Quality Risk Management, Audits and Inspection Readiness for companies within the pharmaceutical industry. In his current role as a Director, Risk Evaluation and Mitigation Strategy (REMS), Regulatory Affairs Clinical at Amneal Pharmaceuticals, he manages all REMS activities for multiple programs including operations and development of new programs and ensures the entity’s full compliance with the regulatory requirement and risk management standards and guidelines. Kal received his Bachelor of Science, Accounting from the Faculty of Commerce, Ain Shams University and his Bachelor of Science of Pharmacy from Arnold & Marie Schwartz College of Pharmacy, Long Island University, Brooklyn, NY. |
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Michael Cheung, DHSc, MS, RIC Board Member Michael Cheung, DHSc, MS is currently the Senior Director of REMS Strategy and Submissions at Bristol Myers Squibb where he leads a team focused on establishing the U.S. elements of the company's risk management strategies to support their expanding and evolving portfolio. With over 19 years of biopharmaceutical industry experience spanning risk management, pharmacovigilance, medical affairs, and clinical research roles, Michael leans on his broad experience to ensure patient safety. Michael holds a Doctor of Health Sciences degree from A.T. Still University, a Master's degree in Regulatory Affairs from Northeastern University, and a Bachelor's degree in Kinesiology from San Diego State University. |
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Ron Selders, RIC Board Member
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