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Selected MSHS in Regulatory Affairs Faculty Profile

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Learn from Experts in Regulatory Affairs

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Learn from experts in the field with ties to major agencies that are influential to the shaping of regulatory policy. Engage with experienced Regulatory Affairs leaders within a contemporary curriculum developed with the strategic insight of our program’s Advisory Board that includes members of agencies such as the Food and Drug Administration (FDA).

 

Daniela Drago, Ph.D.

Director, Clinical & Translational Research and
Regulatory Affairs Programs,
Assistant Professor

Dr. Daniela Drago is an internationally recognized global regulatory affairs expert. Prior to joining academia, she worked in the pharmaceutical and medical device industry. She has held senior positions in global regulatory and medical affairs at F. Hoffman-La Roche, Vifor Pharma, Reckitt Benckiser and Bausch & Lomb.

Dr. Drago has substantial know-how on regulatory strategic and operational activities for a wide range of product categories, ranging from prescription-only to over the counter (OTC) drugs, medical devices, cosmetics, and other regulated fast moving consumer goods.

She is a frequent lecturer at international courses and workshops, has published numerous articles and serves on the board of directors of the Association of Graduate Regulatory Educators. Dr. Drago received her Ph.D. in Chemistry from the Swiss Federal Institute of Technology (ETH Zurich).

 

Joseph Bocchino, Ed.D., MBA

Senior Associate Dean for Health Sciences,
Associate Professor

Dr. Joseph Bocchino has served as an executive within the pharmaceutical, healthcare and hospitality industries and has held board positions within the private and public sectors. His corporate experiences have included: hospital assignments; assignments in both the U.S. domestic markets and global markets; responsibilities in pharmaceutical clinical research, manufacturing and marketing environments; medical device development and manufacturing; and oversight responsibilities for regulatory affairs and product registrations. He has extensive merger and acquisition experience in the evaluation and integration stages, focusing on the valuation and retention of human leadership capital during corporate transactions.

 

Joan Butler, Ed.D.

Program Director for Clinical Research Administration,
Assistant Professor of Clinical Research and Leadership

Dr. Joan Butler has over 25 years’ experience in drug development and has held executive, project management, regulatory and clinical research positions within the pharmaceutical industry. Dr. Butler was chosen as the industry project manager representative loaned to FDA’s Office of the Commissioner to aid the implementation of the ‘team based managed review process’ within the Centers for Drugs and Biologics for PDUFA implementation for which she received special recognition.

Dr. Butler has taught at the George Washington University since 2008.  During this time, she continues to serve as the Director, Clinical Research Administration Programs.  Dr. Butler has taught several courses within the graduate Clinical Research Administration program, and has focused on evaluating and updating the curricula in both the undergraduate and graduate programs.

 

Shayesteh Fuerst-Ladani, MS, MBA

Adjunct Instructor of Clinical Research and Leadership

Professor Shayesteh Fuerst-Ladani is the Managing Director and founder of SFL Regulatory Affairs & Scientific Communication Ltd. She has longstanding experience in formulating global regulatory strategy for development and approval of healthcare products. She held several management positions within the pharma, biotech and medical device sectors before founding SFL. She has been involved in reviewing and assessing the impact of European and US legislation, such as the Cell & Tissue Directive, the Advanced Therapy Medicinal Products Regulation, the Orphan Medicinal Product Regulation and reviewing requirements impacting Drug & Device Combination Products, Personalized Medicine and Health Technology Assessment (HTA).

Professor Fuerst-Ladani received her MSc in Microbiology from the University of Vienna, Austria and an MBA from the Open University Business School, Milton Keynes, UK. She is an active member of EuropaBio (European biotech trade association) acting as Chair of the combination products working group. She is member of the advisory council Europe at DIA (Drug Information Association) and has served on the program committee of the Euromeeting from 2011-2014. Professor Fuerst-Ladani is a frequently invited speaker about regulatory affairs at international conferences and meetings.

 

Kenneth Garrison, MBA

Adjunct Instructor of Clinical Research and Leadership

Professor Kenneth Garrison has had a multi-faceted career highlighted by three distinct phases: corporate finance, small business ownership and nonprofit management. He is the CEO of the Strategic and Competitive Intelligence Professionals (SCIP) based in Alexandria, Virginia. SCIP is a nonprofit membership organization that conducts educational seminars and training conferences on four continents. Members are located in 70 countries and are generally employed by multinational corporations. He manages SCIP operations and works closely with the Board of Directors to establish goals and objectives –inclusive of developing strategic plans for the society.

Previously, Professor Garrison served as President of the Federation of Credit and Financial Professionals, a nonprofit organization that provides services to commercial credit, collection, risk and financial managers. Concurrently, he served as the Executive Vice President of Smyth Group Services, a technology-based organization providing credit information sharing within a competitive environment. Earlier in his career, he served as President of Finance Credit and International Business (FCIB), owned and operated a commercial printing business, and worked in the corporate world, on the treasurer's staff at Reynolds Metals Company.

 

Nancy Singer

Adjunct Assistant Professor of Clinical Research and Leadership

Professor Nancy Singer founded Compliance-Alliance LLC to specialize in the professional development for FDA and industry employees in the medical device and drug industries. Previously she served as AdvaMed’s Special Counsel for FDA compliance and enforcement matters. In her role as Special Counsel, Professor Singer represented the industry on the working group that conceived and validated the procedures for the Quality System Inspection Technique (QSIT). While working on QSIT, she received Vice President Gore’s Reinventing Government Hammer Award and the FDA Commissioner’s Special Citation. Professor Singer began her career as an attorney with the United States Department of Justice where she did litigation for the Food and Drug Administration. Subsequently she was a partner at the law firm of Kleinfeld Kaplan and Becker. Professor Singer received her BS from Cornell University and JD and LLM degrees from New York University Law School. She is a retired commander in the United States Naval Reserve.

 

Islam Younis, Ph.D.

Adjunct Assistant Professor of Clinical Research and Leadership

Dr. Islam Younis is a Team Leader in the Office of Clinical Pharmacology at the U.S. Food and Drug Administration and is also an adjunct assistant professor at the GW School of Medicine and Health Sciences. Dr. Islam Younis holds a Master of Science and a Doctorate in Pharmaceutical Sciences from West Virginia University in addition to three Graduate Certificates in Public Health, Drug Development and Regulatory Sciences and Pharmacoepidemiology from Georgetown University, University of California at San Francisco and University of Pennsylvania, respectively.

In his full-time job, Dr. Younis helps making regulatory and drug development decisions pertinent to clinical pharmacology and clinical trials design. He has a wide and diverse experience in regulatory sciences and clinical pharmacology. He has published 13 peer reviewed papers, 10 conference abstracts and two book chapters and presented in national and international meetings. His current research focuses on leveraging prior knowledge toward optimizing clinical trials and improving drug development efficiency.