Advisory Board

In line with our commitment to continuous improvement, the GW Regulatory Affairs program formed a permanent Advisory Board to provide guidance on the program's direction and to assist students in achieving their academic and professional objectives. Hailing from highly respected organizations across the industry, the Advisory Board will provide information on industry practices by participating in some strategic thinking and direction-setting for the program. Additionally, members will provide input to the Regulatory Affairs program curriculum to ensure that it effectively incorporates essential skills that meet current business needs and industry standards.

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Robie Aridi

Former VP of Operations for Lansinoh Laboratories

Bio

Robie Aridi served as Vice President of Operations for Lansinoh Laboratories, a manufacturer of OTC drugs, medical devices, cosmetics and other consumer products. Over the years, Mr. Aridi has held several key positions in small and large multinational organizations. His expertise is in key verticals, including FDA-regulated products, consumer packaged goods, high tech, and alternative energy. Robie earned the degree of Master of Science in Business Administration from The Johns Hopkins University.  In addition, Robie holds several professional designations, including:  Certified Professional in Supply Management (CPSM), Certified Purchasing Manager (C.P.M., Lifetime Certification), and Certified in Production and Inventory Management (CPIM).

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Aomesh Bhatt

Regulatory and Medical Affairs Director, Europe
Reckitt Benckiser Group

Bio

Aomesh Bhatt serves as the Director of Medical and Regulatory Affairs, Europe for Reckitt Benckiser. In his role, Dr. Bhatt assumes overall country-level research and development regulatory and medical affairs leadership for the European business and manages staff across multiple European countries. At Reckitt, Dr. Bhatt also leads development and registration of new products, maintenance of existing products and compliance of all products in the OTC medicines, medical devices, food supplements, cosmetics, biocides and household goods areas. In addition to interfacing with a range of authorities—including the FDA, EMA and MHRA— on regulatory competence in scientific meetings, he is also a member of the Global R&D Regulatory and Medical Affairs Leadership Team. He has also served as Director of Medical and Regulatory Affairs for North Europe and North America, as well as UK Medical Director, during his time at Reckitt Benckiser.

Prior to his current role, Dr. Bhatt served as Global Director of Medical Sciences for Ferring Pharmaceuticals in St Prex, Switzerland. In this position, he led the global medical strategy, life cycle management and therapeutic areas for inflammatory bowel disease, esophageal varices, pediatric growth, osteoarthritis and sepsis. Dr. Bhatt was also responsible for global product launches, and the development and review of clinical documentation for scientific advice and submissions to national regulatory authorities. Dr. Bhatt has also served as European Senior Medical Adviser for Procter and Gamble Pharmaceuticals, UK, as well as in general medical practice as a sessional general practitioner, general practice registrar, senior house officer, and business and service manager in a variety of specialties across the UK.

Since 2012, Dr. Bhatt has also served as a Technology Appraisal Committee D Member for the UK’s National Institute for Health and Clinical Excellence (NICE), which recommends whether a new or existing health technology or drug should be used in the National Health Service (NHS).

He received his Diploma in Pharmaceutical Medicine from the University of Cardiff, his M.B.A. from the Warwick Business School, and his M.B. and B.S. from London Hospital Medical College, University of London.

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Marlene Bobka

President
FOI Services, Inc.

Bio

Marlene Bobka serves as the Senior Vice-President at FOI Services, Inc. In this role, she is responsible for functions that facilitate access to FDA records acquired using the Freedom of Information Act, and producing teleconferences that interpret FDA regulations, actions and expectations.

Ms. Bobka is a widely published author and speaks frequently on topics that give insight into finding and using fugitive drug, device and biologic regulatory information. She has addressed audiences worldwide for organizations including the Drug Information Association, the Regulatory Affairs Professional Association, the Special Libraries Association, the American Chemical Society, the Association of Food and Drug Officials and many others.

Before joining FOI, Ms. Bobka taught online searching strategy; conducted extensive medical, chemical, and government literature research; and designed and documented databases at Bibliographic Retrieval Services and the National Cancer Institute. She holds a B.S. in biology and chemistry and an M.L.S. with a concentration in biomedical information structure. As an undergraduate student, Ms. Bobka was awarded an AAAS research grant, and as a graduate student, she was inducted into the information science honor society, Beta Phi Mu.

Bobka has held elected office in multiple professional societies, has been named a “Thought Leader” by Pharmaceutical Executive, and was included in a listing of 100 Influential Device Executives in the publication, Medical Device & Diagnostic Industry.  She has served as a guest lecturer, adjunct faculty member and Advisory Board member for graduate programs in Library and Information Sciences and FDA Regulatory Affairs.

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Joe Bocchino

Senior Associate Dean for Health Sciences
Associate Professor of Clinical Research and Leadership
George Washington University

Bio

Dr Joseph (Joe) 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. Dr. Bocchino teaches in the School of Medicine and Health Sciences and in the Graduate School of Education and Human Development. He continues to conduct research and write, presenting his work in international academic forums.

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Paul C. Brooks

Senior Vice President, Healthcare Solutions
BSI Group

Bio

Paul Brooks serves as the Senior Vice President Healthcare Solutions, at BSI.

Mr. Brooks qualified as an electro-mechanical technician engineer at BSI Testing Laboratories from 1981 to 1987. In 1987, he moved into BSI Product Certification and BSI Quality Assurance Registration as a Senior Certification Officer responsible for certification of products and registration of quality management systems to BS 5750 (UK predecessor of ISO 9000).

In 1993 Mr. Brooks joined BSI Inc., the US subsidiary of BSI, as the local expert on CE Marking under the Medical Devices Directive. During his six years with BSI Inc., he worked with more than 400 U.S. medical device manufacturers that were selecting a notified body and beginning the CE Marking process for complying with European regulations. Mr. Brooks also took the lead on programs to raise awareness of the new European CE Marking regulatory approach in North America. In 1996, Brooks was called upon to present and provide input on the FDA Modernization Act 1997, particularly regarding the possible use, role and acceptance of third-party conformity assessment in U.S. regulatory requirements.

Mr. Brooks returned to London 1998 to be Head of Notified Body for BSI’s Medical Devices Group, and was regularly involved in European Medical Devices Notified Bodies meetings and technical groups, interacting with UK Competent Authority, trade / industry groups and in Brussels at Notified Body meetings with the European Commission.

He relocated back to BSI’s Washington, D.C. office in 2001 and is now responsible for leading BSI activities in the medical devices regulatory sector, including EU Notified Body, EU/U.S. Conformity Assessment Body, Health Canada /SCC CMDCAS accreditation, and U.S. FDA recognition. He is also responsible for supporting understanding by BSI’s North American medical device manufacturer customers of Australian, Asian and South American regulatory programs that recognize or take account of third-party conformity assessment, including Australia, Japan and new emerging regulations in Asia.

Mr. Brooks is a long-standing member, and for six years Board Member (Chairman of the Board 2013), of the Regulatory Affairs Professional Society (RAPS) and a member of American Society for Quality (ASQ) – Biomedical Division. He routinely presents and trains at sessions organized by both of these societies as well as the Association for the Advancement of Medical Instrumentation (AAMI), AdvaMed and other focused meetings. He was invited in Spring 2007 to join an International Accreditation Forum (IAF) Working Group to explore the wider acceptance of accredited ISO 13485 certification as a basis for helping to meet regulatory requirements for emerging regulations around the world.

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Chris Cain

VP, Clinical and Regulatory Affairs
Corindus Vascular Robotics

Bio

Chris Cain has 20 years of clinical and regulatory affairs experience within the medical device industry. Currently, Chris is Vice President Clinical and Regulatory Affairs at Corindus Vascular Robotics. His responsibilities cover all aspects of clinical research and regulatory. Chris is a member of the American Association of Clinical Research Professional, the Regulatory Affairs Professionals Society, and the Society of Clinical Research Associates. He received his B.S. in nursing from the University of Central Missouri and his M.B.A. from University of Missouri Kansas City. He is a Medical Device Interest Group Board Member – ACRP.

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David E. Chadwick

Director, Regulatory Affairs, Regulatory Science
Cook, Inc.

Bio

David Chadwick serves as the Director, Regulatory Affairs, Regulatory Science for Cook, Inc. In this role, he provides high-level regulatory and clinical advice on pre- and post-market safety, quality, performance, testing, compliance and marketing issues pertaining to the manufacture and supply of medical devices globally. Dr. Chadwick first joined Cook, Inc. as a regulatory scientist in 2006, and took on his current position in 2010.

In his regulatory affairs experience, he has been responsible for product registration, compliance and product complaints, and has served as his company’s regulatory and clinical focus person for post-market activities and customer feedback. Dr. Chadwick has also functioned as an internal auditor within the Quality System and an external auditor for vendor qualification, and has served as his company’s management representative for the Quality System. The scope of his experience includes the product areas of dermatology, in vitro diagnostics, urology, cardiology, drug delivery, electrosurgery, cardiovascular stents and catheters. His main focus is medical devices and combination products, but his experience also expands into drug regulation and submission.

Dr. Chadwick graduated with a B.S. in Biology from Albright College, and graduated with a Ph.D. in Anatomy and Cell Biology from the School of Medicine, University of Pittsburgh. He also has the RAC certification from the Regulatory Affairs Professionals Society (RAPS), where he has been recognized as a Fellow.

Association of Food & Drug Officials

Joe Corby

Executive Director
Association of Food & Drug Officials (AFDO)

Bio

Joseph Corby worked for the New York State Department of Agriculture and Markets for 37 years retiring in 2008 as the Director of the Division of Food Safety and Inspection. He is currently the Executive Director of the Association of Food & Drug Officials (AFDO), and he serves on the Board of Directors for the International Food Protection Training Institute (IFPTI) and the Partnership for Food Safety Education (PFSE). He is also an Instructor for IFPTI, Louisiana State University, and the University of Tennessee. He has been an outspoken advocate for the advancement of a nationally integrated food safety system and continues to work with numerous groups and associations in support of this cause.

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Tricia DeSantis

Vice President, Global Regulatory Affairs
Johnson & Johnson Consumer Companies

Bio

Tricia DeSantis serves as Vice President, Global Regulatory Affairs for Johnson & Johnson Consumer Companies. She is currently (September 2013) the leader of the Global Regulatory Affairs Organization for the J&J Consumer Sector. As such, she provides strategic leadership to the global organization consisting of 300 regulatory professionals located around the world. The team is responsible for driving regulatory strategy and execution as well as operational excellence. She is a leader and/or member of several leadership teams across J&J, including the Medical and Regulatory Sciences Leadership Team, the Consumer GRA Leadership Team, the J&J Regulatory Policy Council and the J&J Consumer Policy Council.

Prior to this role, Ms. DeSantis was Vice President and Head, Global Regulatory Policy and Intelligence Team for Janssen Global Regulatory Affairs, J&J.  In this position, she lead the Global Regulatory Policy and Intelligence (GRPI) team within Janssen Global Regulatory Affairs, which is made up of 25 colleagues across six global locations that drive regulatory policy, intelligence, information, and knowledge management across J&J Pharmaceuticals. In addition, Ms. DeSantis served as the GRA lead to the North America Commercial Organization and was a member of the NA Management Board. She was also a member of the Janssen GRA Senior Leadership Team. Prior to her work at Janssen, she was the Vice President, GRA, Regulatory Support Services, Strategic Policy and Support, and led a global department responsible for submissions, archiving, as well as policy, intelligence, information, and knowledge management. She joined J&J in 2001 and has held various positions of increasing responsibility, including FDA Liaison. 

Prior to joining J&J, she served as a Director of Regulatory Affairs, FDA Liaison for Novartis Pharmaceutical Corporation from October 2000 to October 2001.

Ms. DeSantis spent 15 years at the U.S. Food and Drug Administration. She was the Drug Review Program Director for the Center for Drug Evaluation and Research at the FDA from 1994-2000. Her main focus was to provide regulatory, scientific, and policy advice and assistance to the Center and Deputy Center Director concerning matters pertaining to the quality, safety and effectiveness of all drug products for human use. In 1997, she was recruited back to FDA as the Supervisory Project Manager of the Division of Anti-Infective Drug Products Division. Early in her career, DeSantis worked in CBER within the Office of Gene and Cell Therapy, conducting bench research in the biologic modifiers program in support of IND/BLA reviews.

Before her tenure at the FDA, Ms. DeSantis’ professional experience included serving as a patent examiner at the U.S. Patent and Trademark Office, Department of Commerce. As a patent examiner in the Biotechnology Unit, she was responsible for granting U.S. Patents in the monoclonal antibody, hybridization, immunoassay, and genetic engineering arenas. In addition, she worked for several years as a microbiologist at the National Cancer Institute, National Institutes of Health. Her main research interest involved the development of human monoclonal antibodies to Chronic Lymphocytic Leukemia and T-cell Lymphoma Viruses, in addition to anti-idiotypic and carcinogen DNA-adduct monoclonal antibodies.

Ms. DeSantis holds a Bachelor of Sciences in microbiology from the University of Maryland, College Park, Maryland.

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Bob Darius

Head Quality Advocacy Liaison
Audit & Risk Management
GSK Vaccines

Bio

Bob Darius is currently serving as Head Quality Advocacy Liaison in GSK Vaccines. Previously, he served as the Vice President of the Quality Unit for the North American & Dresden, Germany Vaccines sites in GSK, with oversight of the Quality Assurance, Quality Control, and Validation Compliance teams. These sites manufacture Influenza Vaccines, Adjuvants, and other Vaccine products approved in Europe and Asia. Bob was a Senior Consultant at Biologics Consulting Group, then started Radius Biotechnology, LLC in 2005.

Between 1990 and 2005, served in the FDA Center for Biologics Evaluation & Research as a Microbiologist, Senior CMC / BLA reviewer, Lead Inspector and Trainer, Branch Chief, and Senior Advisor to the Center Director for Counter Bioterrorism Products. Bob has regulated, consulted on, and managed the full range of biological products and has gained experience with technical manufacturing approaches, validation, and remediation. He has lead diverse teams to qualify facilities and gain multiple regulatory approvals of sites both as a consultant and within GSK Vaccines and is an active speaker and writer within industry groups to help advance regulatory and quality knowledge, and continuous learning.

Bob graduated from George Mason University in Biology, and completed graduate work in Biotechnology at John Hopkins University.

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Daniela Drago

Program Director for Regulatory Affairs Program
Program Director for Clinical & Translational Research
Assistant Professor of Clinical Research and Leadership

Bio

Dr. Daniela Drago has served within the pharmaceutical industry, where she has held various positions in the regulatory arena over the last 10 years. In her career Dr. Drago acquired extensive experience in global regulatory affairs, a broad knowledge of product regulations and significant expertise in managing and directing global regulatory teams. Dr. Drago has been working for companies ranging in size from start-ups to Fortune 100. She gained substantial know-how on strategic regulatory and operational activities for a wide range of product categories, ranging from prescription-only to over the counter (OTC) drugs, medical devices, cosmetics, nutritional and other regulated fast moving consumer goods. She has been leading and managing several pharmaceutical products to successful marketing approvals within US, Europe and other countries including emerging markets.

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Surendra Gokhale

Head, Clinical Trials Regulatory Management Group
Global Drug Regulatory Affairs
F. Hoffmann-La Roche Ltd.

Bio

Surendra Gokhale currently serves as Senior Group Manager in Global Regulatory Affairs at Roche in Basel, Switzerland. In his role, Dr. Gokhale leads the Clinical Trials regulatory management group. Finding the alignment between different regional regulatory aspects in the EU, United States, Asia and Latin American countries, as well as global development plans, is the main focus of his work. As part of Roche Global Regulatory Affairs since 2008, Dr. Gokhale is Roche’s representative on the Regulatory Affairs group (ERLC), and EU Clinical Trials subgroup of the European Pharmaceutical Association (EFPIA). He also represents Roche in the IFPMA Regulatory Group (RPTS), as well as the ICH M5 subgroup.

After joining Roche as a researcher in 1990, Dr. Gokhale moved into regulatory affairs in 1995, and worked as a European partner and a global regulatory leader on several projects in various therapeutic areas before taking over the group manager position in the Global Regulatory Department from 2001 to 2002.

He has extensive experience with EU procedures and has interfaced with the EU rapporeturs, CHMP members, and EMA, and has participated in meetings with other health authorities worldwide.

Dr. Gokhale received his Ph.D. in synthesis of biologically active compounds from the University of Poona in Pune, India, and his Post-doctorate in nucleotide and nucleoside chemistry from the University of Konstanz Germany. He received his M.Sc. from the University of Poona in 1980.

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Scott Huie

Vice President, Corporate & Product Compliance
Valeritas, Inc.

Bio

Scott Huie serves as the Vice President for Corporate and Product Compliance at Valeritas, a company that is committed to developing and commercializing innovative treatment solutions that contribute to clinical and humanistic outcomes for patients, with an initial focus on the treatment of Type 2 diabetes. He has more than 33 years of experience in medical device, pharmaceutical and combination products.  Prior to serving in his current role, Mr. Huie served as the Vice President for Operations and Regulatory Affairs. He has written, compiled and received clearance on all of the regulatory submissions made by the company.

During his career, he has held roles in product/process development and engineering, operations, materials, facilities, regulatory, quality, compliance and complaint handling. Prior to joining Valeritas, he served as the Vice President for Operations at Fusion Medical Technologies, which was acquired by Baxter Healthcare Corporation, developing and commercializing a unique hemostatic agent used in surgeries. He has also held positions at Aradigm, Cygnus Therapeutic Systems, Ciba-Geigy and 3M Corporation specializing in alternative drug delivery technologies including transdermal, buccal and aerosol delivery of pharmaceutical products. Mr. Huie received his B.S. in chemical engineering from Rensselaer Polytechnic Institute.

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Tara Kambeitz

Global Marketing Manager
UL LLC, Health Sciences Division

Bio

Tara Kambeitz serves as a global marketing manager for UL’s Life & Health Business Unit, overseeing global marketing strategy and execution for both the Health Sciences and Water divisions.

In Ms. Kambeitz’s 14-year career with UL, she has been involved in several areas of the conformity assessment business, primarily working with the medical device industry.  She has worked in evaluating products to standards, business development, acquisition due diligence and integration, marketing, sales, account management, and customer service.  Her training includes specialized work in regulatory affairs, ISO management systems including ISO 9000, ISO 13485, TL 9000, TS 16949, and ISO 14000, in vitro diagnostics directive, and holds an external RABQSA accredited certificate for the ISO 13485 Lead Auditing Course.

Ms. Kambeitz co-authored an article on Japan’s Pharmaceutical Affairs Law published in the January 2008 MD&DI. She earned her Bachelor of Science degree in biological sciences from the University of California, Davis and Master of Business Administration from Portland State University. 

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Kazem Kazempour

President and CEO
Amarex Clinical Research

Bio

Kazem Kazempour, Ph.D., is the co-founder, president, and CEO of Amarex Clinical Research, a full-service contract research organization providing services to the pharmaceutical, biotech and device communities.

He started his career in statistics by working at the Genetics Institute (1975) and published his first article on genetics in 1979. His experience in the industry and FDA has allowed him to understand biometrics, quality assurance/quality control from both a sponsor's perspective, as the provider of the data, and from a regulatory perspective as the reviewer of the data. Mr. Kazempour has worked in many therapeutic areas including vaccines, anti-infectives, anti-virals, AIDS, and cardiovascular, as well as devices, and has been a key contributor in the approval of these drugs/devices. Additionally, he has established, presented, and participated in many Data Safety Monitoring Boards (DSMB).

During his more than 30 years of experience in biomedical research, Mr. Kazempour has conducted research activities with the National Institutes of Health (NIH), the pharmaceutical industry and universities. While at the Food and Drug Administration (FDA) as a statistical reviewer, he received several awards for innovative problem solving and teamwork. During his tenure at the FDA, Mr. Kazempour also worked as a senior staff fellow and as a mathematical statistician responsible for supervising and conducting independent statistical analyses of clinical trials and reviewing statistical sections of submitted protocols and statistical analyses.

Mr. Kazempour has been recognized many times by the FDA for his contributions in the drug approval process. He has been active in the biomedical research community throughout his career as an organizer, a panel discussion member, and presenter at national and international meetings. He has made presentations to FDA, and FDA advisory committees on more than 30 different drugs. He is also a widely published author, having written articles, book chapters, and technical reports.

While serving as Global Biometrics Senior Director for an international pharmaceutical company, Mr. Kazempour was responsible for the global standardization of biostatistical, scientific programming, and data management procedures. He also implemented ICH guidelines and validated the programs for all biometrics offices. Additionally, he prepared and presented the biometrical aspects of study designs of Investigational New Drug Applications (IND), New Drug Application (NDA), PLA, and supplements to regulatory agencies in the United States and Europe.

Iowa Department of Inspections and Appeals

Steven Mandernach

Bureau Chief
Iowa Department of Inspections and Appeals Food and Consumer Safety

Bio

Steven Mandernach is the Bureau Chief for the Iowa Department of Inspections and Appeals Food and Consumer Safety Bureau. Mandernach is currently President-elect of the Association of Food and Drug Officials and co-chair of the Association’s Laws and Regulations committee. He has served as the chair for the Manufactured Food Regulatory Program Alliance. He is past president of the Mid-Continental Association of Food and Drug Officials.

Mandernach has a Juris Doctorate from Drake University Law School. He is currently pursuing a Master’s of Science in Food Safety from Michigan State University.

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Elizabeth Mathew

Regulatory Affairs Leader
GE Healthcare Services

Bio

Elizabeth Mathew currently serves as Regulatory Affairs Leaders at GE Healthcare Services. In her role, she works closely with regulatory, engineering, marketing, legal and other professionals within the company to develop and implement programs and processes for regulatory affairs compliance within the service business. Ms. Mathews is also responsible for identifying regulatory trends and their implications for GE Healthcare, and developing and implementing effective regulatory strategies to meet business objectives. In her position, she has gained expertise in regulations and importation laws related to used, refurbished, fully refurbished, and remanufactured medical devices.

She started her career at GE in 2000 as an electrical engineer, and in 2006 began specializing in global safety and performance standards for medical devices to ensure ever-evolving regulations were incorporated into product development. In 2008, Ms. Mathew became a post-market regulatory affairs leader, wherein she evaluated and investigated complains and reported adverse events to the regulatory agency. She has expertise in registering medical devices in Canada, Brazil, Venezuela, Mexico, Argentina, EU countries, China, Taiwan, Hong King, The Republic of Korea, Japan, Singapore, Thailand, Australia and New Zealand.  Ms. Mathews has been in her current role at since 2011.

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Michael C. Morton

Vice President for Global Regulatory Affairs
Medtronic, Inc.

Bio

Michael C. Morton is Vice President for Global Regulatory Affairs, at Medtronic, Inc.  Michael is responsible for public health policy advocacy and for internal regulatory policy within corporate regulatory affairs.

Michael has more than 25 years of experience in the medical device industry, including quality, clinical, and regulatory affairs. Before joining Medtronic, Inc., Michael worked with CarboMedics, Inc., W.L. Gore and Associates, Alcon Labs, and Sorin Group.

Michael has been recognized as a Fellow of the Regulatory Affairs Professional Association (RAPS). He is active in industry groups, including the Advanced Medical Technology Association (AdvaMed). He chairs the AdvaMed PMA Working Group, co-chairs the Pediatric Devices Working Group, and is a member of the Heart Valve Task Force. Michael represented industry within Study Group 1 (Premarket) of the Global Harmonization Task Force. He served as the industry representative to the FDA Circulatory System Devices Advisory Panel from 2001 to 2005.

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Marcia Nusgart

Executive Director
Alliance of Wound Care Stakeholders

Bio

Marcia Nusgart R.Ph. is the founder and Executive Director of the Alliance of Wound Care Stakeholders (“Alliance”) a non-profit interprofessional association for clinical organizations whose members treat patients with wounds. It addresses regulatory and legislative issues impacting wound care. She also serves as Executive Director for the Coalition of Wound Care Manufacturers (“Coalition”) and President of Nusgart Consulting LLC.

As Executive Director of the Alliance and the Coalition, she is viewed as a highly visible, respected and credible source of industry information for the Centers for Medicare and Medicaid Services and their contractors, Food and Drug Administration and the Agency for Healthcare Research and Quality as she advocates for appropriate public policy processes. As the Alliance’s Executive Director, she organized its efforts in writing the article, “Consensus Principles for Wound Care Research Obtained Using a Delphi Process (Wound Repair and Regeneration May/June 2012), submitted wound care quality measures to the Centers for Medicare and Medicaid Services (CMS) and tackled issues relating to coverage, coding and payment for wound care procedures and products.

Ms. Nusgart is an industry leader in providing comprehensive strategies to medical device and pharmaceutical manufacturers regarding coding, coverage and reimbursement issues under Medicare and Medicaid. Her accomplishments range from advocating successfully, in her coalition capacity, for CMS to modernize the HCPCS coding process to make it more timely, transparent and understandable for manufacturers; to, in her consulting role, obtaining new HCPCS codes along with appropriate coverage and payment for manufacturers' products.

She is highly regarded in the wound care industry through her numerous published articles and is a highly sought after speaker, appearing at various conferences such as the Symposium on Advanced Wound Care Conferences, European Wound Management Association, World Union of Wound Healing Societies, American College of Tissue Healing and Wound Repair, American Professional Wound Care Association, MEDTRADE shows, FDA and NIH Meetings, and the Medical Device Manufacturers Association Reimbursement Conferences. She has received numerous honors ranging from the 2011 Distinguished Alumni award by the Ohio State University College of Pharmacy to the AAWC Leadership Award to the designation of Master from APWCA, both honoring key opinion leaders who have made significant contributions impacting wound care.

Ms. Nusgart founded her own business, Nusgart Consulting LLC, in 1998. Prior to that she worked in two associations-- the Advanced Medical Technology Association (AdvaMed) and the National Community Pharmacy Association. She has also served in senior positions for Super X Drugs (now CVS) and worked for Merck. She holds a Bachelors of Science in Pharmacy from the Ohio State University. She currently serves on the Boards for four distinct organizations: Women Business Leaders of the U.S. Healthcare Industry Foundation, the Ohio State University College of Pharmacy, Kestrel Wound Care Wound Source and Premier Homecare.

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Magdalena Pabón

Training Specialist
FDA's Center for Food Safety and Applied Nutrition’s (CFSAN’s) Staff College

Bio

Magdalena Pabón is a training specialist at the Food and Drug Aministration’s (FDA) Center for Food Safety and Applied Nutrition’s (CFSAN’s) Staff College. In this position, she assists in the development and coordination of courses offered by the college. She also advises the CFSAN staff and managers regarding the use of competencies and Individual Development Plans (IDPs). Currently, she is in charge of the Center’s Communication Program. Ms.  Pabón is certified in creating team development plans and organizational development tools. She is in the process of becoming certified as an instructor for a “Crucial Conversations” course. Ms. Pabón was nominated for the well regarded “FDA Supervisory Potential” course. She is currently part of the Health and Human Services Internal Coach Bootcamp Pilot. Prior to working at CFSAN’s Staff College, Ms. Pabón worked as an Equal Employment Opportunity Specialist for CFSAN, a Personnel Management Specialist at FDA, and as a Pharmaceutical Sales Consultant in industry.

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Mitzi Perdue

Corresponding Editor
GEN: Genetic Engineering and Biotechnology News

Bio

Mitzi Perdue holds degrees from Harvard University and George Washington University, is a past president of the 35,000 member American Agri-Women and was one of the U.S. Delegates to the United Nations Conference on Women in Nairobi. She currently writes for the Academy of Women’s Health, and GEN, Genetic Engineering & Biotechnology News.

Most recently, she’s authored Tough Man, Tender Chicken, Business and Life Lessons from Frank Perdue, and I Didn't Bargain for This, her story of growing up as a hotel heiress. She also programmed a computer app, B Healthy U, designed to help people track the interactions of lifestyle factors that influence their energy, sleep, hunger, mood, and ability to handle stress. In addition to being a programmer and software developer, Mitzi is also an artist and designer of EveningEggs™ handbags.

In addition, Mitzi is the author of I the I Want to EggScape™ Book, A Quick Guide To Successful Media Appearances, and six cookbooks, including The Farmers' Cookbook series and the Perdue Chicken Cookbook. She is also the author of more than 1600 newspaper and magazine articles on food, agriculture, the environment, philanthropy, biotechnology, genetic engineering, and women's health.

She was a syndicated columnist for 22 years, and her weekly environmental columns were distributed first by California’s Capitol News and later, by Scripps Howard News Service, to roughly 420 newspapers. For two years she was a Commissioner on the National Commission on Libraries and Information Science.

Mitzi also produced and hosted more than 400 half hour interview shows, Mitzi's Country Magazine on KXTV, the CBS affiliate in Sacramento, California. In addition, she hosted and produced more than 300 editions of Mitzi's Country Comments, which was syndicated to 76 stations. Her radio series, Tips from the Farmer to You, was broadcast weekly for two years on the Coast to Coast Radio Network.

Today Mitzi also serves on the boards of the Institute of International Education, the Cal Ripken, Sr. Foundation, and also the Advisory Board of the Rosalind Franklin Society.

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Nicole Petty

Director, Human Resources
Stryker Instruments

Bio

Nicole Petty serves as the Director of Human Resources at Stryker Instruments. Her responsibilities cover all aspects of Learning & Development, Wellbeing, and Community Engagement.  Her team enhances the total employee experience by providing impactful opportunities for personal and professional growth and wellbeing. Ms. Petty has been a speaker at several medical device conferences sharing her Learning and Development expertise in the areas of curriculum development, learning needs analysis, and instructional design process. She also serves as an active member in a Learning Forum where she collaborates with learning leaders from other FDA regulated companies.

Prior to her current role, Ms. Petty served as the Regulatory Affairs Manager at Stryker Instruments. During her 10 years in Regulatory Affairs, she acquired extensive experience in global product submissions, product complaints, regulatory reporting, internal and external audits, and field actions. She became RAC certified in 2002 and co-authored a chapter in the Fundamentals of Canadian Regulatory Affairs book. Nicole holds a BA in Business Administration from Kansas State University.

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Amra Racic

Principal Regulatory Affairs Policy and Advocacy
Medtronic

Bio

Amra is a Principal Regulatory Affairs Policy and Advocacy Specialist at Medtronic’s corporate office in Minneapolis, MN. She has been in the Healthcare industry for over 17 years, most of those spent with the Medtronic Regulatory group focusing on a variety of US FDA and international submissions for high and low risk medical devices, as well as Invitro Diagnostics. Prior to Medtronic, she has also worked on Regulatory projects at Bayer AG and also had responsibility for Patient care management at a local hospital in Minneapolis.

As a Principal Regulatory Affairs Policy and Advocacy Specialist, Amra has responsibility for implementing and establishing regulatory policies across the strategic business units and geographies to ensure that Medtronic has adequate policies to operate in accordance with global requirements. In her position, she is also responsible for partnering with others within the Corporate Regulatory Affairs Department to maintain a scalable and sustainable program for Regulatory Advocacy. In this role, Amra works across Geographies and Business Units, and across functions, to establish advocacy positions that are supportive of Medtronic, their patients, and stakeholders.

Amra holds a BS in Business Administration and an MBA with Management Focus from Walden University in Minneapolis.

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Susan Rolih

Executive Vice President, Regulatory and Quality Systems
Meridian Bioscience Corporation

Bio

Susan Rolih serves as the Executive Vice President, Regulatory and Quality Systems for Meridian Bioscience Corporation. She has more than 25 years of experience in the in vitro diagnostic device (IVDD) industry. Since joining Meridian Bioscience, she has been responsible for the regulatory and quality units of Meridian’s diagnostic and Life Science affiliates in the United States and Europe. She has extensive experience in due diligence assessments, design controls, quality auditing, process development, regulatory submissions and product training for both the IVDD and blood products industries.

Ms. Rolih earned her Bachelor of Science Degree from Arizona State University and her Master of Science Degree from the University of Cincinnati. She has authored numerous journal articles on blood group serology and has served as an editor for several reference books. She has also served as instructor and advisory board member for medical laboratory specialist programs at the University of Cincinnati and Georgia State University.

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Nancy Singer

Founder
Compliance Alliance LLC

Bio

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, Professor Singer 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 B.S. from Cornell University , and J.D. and LL.M. degrees from New York University Law School. She is a retired commander in the United States Naval Reserve.

John C. Villforth

U.S. Public Health Service (Retired)

Bio

RADM John Villforth is a graduate of Pennsylvania State University, where he received a graduate degree in sanitary engineering.  He obtained a second M.S. in physics from Vanderbilt University and conducted radiation research at Oak Ridge National Laboratory.  He spent more than seven years in the U.S. Air Force involved with various radiological health and engineering issues, serving as the director of the USAF’s only radiological health laboratory.

In 1961, he was commissioned in the U. S. Public Health Service (USPHS) and joined the radiological health program. In 1969, he became the Director of the Bureau of Radiological Health (BRH), and continued in that capacity when BRH was transferred to the Food and Drug Administration (FDA) in 1982. In 1972, he was promoted to Rear Admiral.

While at the BRH, Mr. Villforth helped develop a national regulatory radiation protection program for machine-produced radiation under the authority of the Radiation Control for Health and Safety Act of 1968.  He also placed a high premium on education of the professions and the public regarding awareness of potential radiation risks for both ionizing radiation (x-rays) and non-ionizing radiation (lasers and microwaves).  When the nuclear accident at Three Mile Island occurred, he was designated by the Secretary of DHEW (now DHHS) as the coordinator of the Department’s emergency response team.  In 1982, the FDA’s radiation and medical device bureaus were merged into the Center for Devices and Radiological Health (CDRH), and Mr. Villforth was named the director. From 1984 to 1990, the Surgeon General appointed him to the additional duty of USPHS Chief Engineer.  He retired from the Commissioned Corps of the USPHS in 1990 and immediately after retirement  was elected president of the educational, non-profit organization, The Food and Drug Law Institute, and served in that capacity until retiring again in 2001. He has served on six corporate boards and several non-profit board and advisory committees since his retirement.

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Michael Viscido

Corporate Director, Quality Systems & Services
Ikaria, Inc.

Bio

Mr. Michael Viscido is currently the Corporate Director, Quality Systems and Services for Ikaria, Inc. In this role, he is responsible for leading the development and implementation of global quality systems and training and for the operational quality support of Ikaria’s North American Regional Service Centers.

Mr. Viscido holds an M.S. in Engineering Management, is a senior member of the American Society for Quality (ASQ), holds four ASQ Certifications (CQA, CQE, CRE, CQM) and is RAPS RAC-US certified. He has more than 20 years of experience in the practice of Quality Assurance in the Medical Device and Pharmaceutical Industries.

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Christopher L. White, Esq.

Senior Executive Vice President, General Counsel and Secretary
Advanced Medical Technology Association (AdvaMed)

Bio

Christopher L. White, Esq. is Senior Executive Vice President, General Counsel and Secretary of the Advanced Medical Technology Association (AdvaMed).

Mr. White serves as the Association’s Chief Legal Officer and manages AdvaMed’s Legal Committee to develop and promote legal policy positions enhancing patient access to medical technology. Mr. White also leads the Association’s global working groups on legal policy and compliance. He testified before state and federal legislative committees on priority legal policy issues; led the drafting team revising the AdvaMed Code; and led the multinational negotiating team to draft the Kuala Lumpur Principles, harmonizing industry Codes of Ethics in Asia.

He serves as a frequent speaker and author on industry legal and compliance issues. As Chief Legal Officer, he also manages the Association’s HR, governance, and provides counsel on contract, corporate, tax exemption, and legislative and regulatory matters.

Mr. White is a graduate of Wake Forest University where he studied cell biology, and Catholic University Law School.

He is an avid sailor, cyclist and beekeeper.

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Robert E Yocher

Senior Vice President, Regulatory Affairs
Heartware International Inc.

Bio

Bob Yocher is currently the Senior Vice President of Regulatory Affairs at HeartWare International Inc. of Framingham, Massachusetts. Previously he was the Vice President, Regulatory Affairs and Corporate Quality Compliance, Genzyme Corporation, Cambridge, Massachusetts. 

Bob holds a B.A. in Microbiology and Biochemistry from the University of Connecticut and a Masters Degree in Health Science in Public Health Microbiology and Epidemiology from the School of Allied Health, Quinnipiac University. He is Regulatory Affairs Certified and is a Certified Quality Engineer (E-8448) and Certified Quality Auditor (US001168). Bob was elected a Fellow of the Regulatory Affairs Professional Society in 2008 and a Senior Member of the American Society of Quality in 2005.  He brings over 46 years of experience in the medical products business. Bob has held many senior executive management positions in QA, Regulatory Affairs, Clinical Affairs and Marketing. 

Bob was an adjunct faculty for Health Product Regulation at Regis College Graduate School of Nursing and a guest lecturer at the Mass. School of Pharmacy and Northeastern University from 2002-2012.  He was also on Regis college graduate school advisory board from 2002 -2014. 

He has participated as a working group member on the Secretary's Advisory Committee on Genetic Testing (SACGT) and was the Working Group chair for AdvaMed's IVD Task Force on Genetics and BIO's working group on Research Tools and Molecular Diagnostics.  He has been an active member of many professional organizations including Regulatory Affairs Professionals Society, The American Society for Quality / Biomedical Division, AdvaMed, PhRMA, NEMA, MassMedic and the American Clinical Laboratory Association.

Bob was the Boston Chapter Chair for RAPS 2008-2010, and the Fellows Chair at RAPS 2009-2011.  Bob has been a member of the Board of Directors for RAPS since 2010. He has also published many professional articles including “Regulatory Considerations for Promotional Material of Medical Products on the Internet”, in the Journal of Commercial Biotechnology, (Vol.7, Number 2, October 2000) and " HIPAA and Data Privacy", in Focus, The official Journal of Regulatory Affairs Professionals Society (March, 2002) and the “The RAPS Fellow” in Focus The official Journal of Regulatory Affairs Professionals Society (April, 2010).