A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
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Azita Ahmadi, B.S., received her Bachelor of Science in Biology from the University of the Pacific along with a certificate in Clinical Trial Design and Management from the University of Santa Cruz. She eventually earned her position as a senior Drug Safety Associate at InterMune Inc. Her professional experience has provided exposure to drug safety, drug development process, clinical monitoring processes, collaborative opportunities, compliance, training, data collection, source documentation, and validation. She recently developed a comprehensive narrative writing training program to help others acquire and practice the skills necessary for generating well-written case narratives for reporting to regulatory authorities. Azita is currently working toward her M.S. in Public Health Economics at the Johns Hopkins Bloomberg School of Public Health.
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Jerri Barden Perkins, M.D., spent eight years at FDA as a Medical Officer. She was an Acting Division Director for medical devices, involved in policy decisions in the Office of the Commissioner, and a Reviewing Medical Officer for drugs. She made recommendations to the FDA Commissioner on whether or not unsafe products should be recalled from the market. She also made recommendations on whether or not devices and drugs were safe and effective for the US market. Dr. Perkins has assisted both pharmaceutical and medical device industries with regulatory and clinical trials. She has given numerous presentations in the US and Europe, and was an invited speaker in China and India. She has published both research and articles regarding FDA issues such as, “How Does a Medical Officer Review an NDA Submission?” and “Tips on PMA Preparation/Presentation.” Dr. Perkins did her post-doctoral training at the National Institutes of Health, and received her M.D. degree from the Medical College of Virginia.
Meredith Brown-Tuttle, R.A.C., has held senior regulatory positions at Bay Area pharmaceutical companies and a full-service CRO. She has written and coordinated numerous drug and biologic submissions to US and international regulatory agencies, developed regulatory strategy for both device and drug companies, and conducted worldwide regulatory intelligence.
Elizabeth Buchanan, Ph.D. is Endowed Chair in Ethics and Director of the Center for Applied Ethics at the University of Wisconsin-Stout. She is a scholar in the fields of research ethics, information/communication technology ethics, and research methods. Her work is particularly focused on the intersections of research regulation, Internet or online venues and tools, and the subsequent ethical challenges that arise for researchers and research board reviewers. She is professionally active in Public Responsibility in Medicine and Research, the International Society for Ethics and Information Technology (Co-Director), and the Association of Internet Researchers. Elizabeth serves as an Associate Editor for the Journal of Research on Human Research Ethics (JERHRE), on the Editorial Board of Philosophy and Technology, and reviews for many other scholarly journals and granting agencies. Elizabeth is Vice-Chair of the UW Stout’s Institutional Review Board, and has served on both social science and medical school research ethics boards. She has presented her National Science Foundationfunded research on IRBs and Internet research to the Secretary’s Advisory Committee to the Office for Human Research Protections in 2010, 2012, and 2013. She has also presented at the OHRP Community Research Forums, and has done professional development work with many IRBs. She has been on the Faculty of the Public Responsibility in Medicine and Research roster since 2008, and has participated in pre-conference workshops and many didactic sessions at PRIM&R. As of 2012, she is a member of the PRIM&R Conference Planning Committee and a member of the American Association for the Advancement of Science Committee on Scientific Freedom and Responsibility. Elizabeth holds BA degrees in Philosophy and English from Rutgers University and her M.S. and Ph.D. from University of Wisconsin-Milwaukee.
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Linda Carter, R.N., B.S.N. has been working in clinical research for over 10 years. Her roles have included working as a study coordinator for investigator initiated trials, a clinical research associate for CRO, biomedical, and vaccine companies, as well as a clinical trial manager for international vaccine trials. Linda has provided training to her colleagues within the industry and clinical site personnel on protocols, EDC, IP management, and data listing review. She has also worked within the pharmaceutical industry as a training manager where she collaborated with subject matter experts to develop curricula that would engage participants, leverage best practices, meet regulatory requirements, address knowledge gaps, and support professional growth. Before working in clinical research, Linda began her career as a nurse in the United States Army Nurse Corp, followed by over ten years as a civilian nurse in critical care and in the emergency room. Linda applies her unique insight into the training needs of the teams that run and monitor clinical trials, drawing on her diverse experience, foundation for critical thinking, and practical understanding of the compliance issues found throughout clinical operations.
Nikki Christison, B.S., C.C.R.A. has worked extensively with both sponsors and CROs as a Study Coordinator, CRA, Project Manager, Auditor, and Director of Clinical Operations over the past 18 years, and has published articles in both The Monitor and The Journal of Clinical Research Best Practices on Risk Based Monitoring, Operational Advisory Boards, Study Feasibility, and CRO Relationship Management. Nikki has conducted hundreds of study visits and developed and facilitated training in multiple international venues. Nikki is an experienced speaker and has presented and conducted workshops at Association of Clinical Research Professionals (ACRP) Global Conferences, MAGI, Cambridge Healthtech Institute, iBIG, and Outsourcing Clinical Trials (OCT), and teaches seminars for Barnett International and ACRP.
Karen Chu, Ph.D., has been working in Asia Pacific clinical research for last eight years. Karen Chu started in the industry with the Medical Affairs and then extended her management role to Regulatory Affairs, Data Management, Statistical Analysis, and lastly to Clinical Operations in the last six years. She has extensive experience with clinical trials in countries such as China, South Korea, Taiwan, and Singapore, and is very familiar with the regulatory landscape of the Asia Pacific region. Karen’s current role is to manage the Global Portfolio Directors and Project Leaders in the Asia Pacific region and has the overall accountability for the business relationships and the delivery of services to the customers in the region.
Irina Colligon is a pharmaceutical industry consultant with primary focus on compliance and process design. Prior to becoming a consultant, Irina worked in academic research as well as medical device (diagnostics) and pharmaceutical R&D. Her experience and background include developing diagnostic test kits, drug metabolism, pharmacokinetics, and bioanalysis, as well as international regulations, quality management, computer and laboratory equipment validation and implementation, records management, and laboratory safety. She has authored, co-authored, and presented on these topics at various meetings, workshops, and in several publications. Irina is a member of the SQA and MARSQA. Irina holds a Bachelor of Arts in Biology degree from the University of Pennsylvania and a Six Sigma Green Belt certification from Drexel University’s Goodwin College.
Dr. Leylén Colmegna, has studied Medicine at the University of Rosario, Argentina. Dr. Colmegna has more than 10 years of experience in clinical research. She has worked at an Investigative Site, and has held several positions at CROs and in the pharmaceutical industry. Since 2010, as CEO and COO of her Argentinabased regional CRO, she provides leadership of local management teams across all operations units (Medical, Clinical, Data Management, Regulatory Affairs, Pharmacovigilance, and Marketing).
Natalie Currie, B.Sc., is an instructional designer, facilitator, and learning and development consultant dedicated to academic research organizations, the pharmaceutical and biotechnology industries, and clinical research organizations. Harnessing her 18 years of broad-based clinical research experience, Natalie is sought after as a speaker and facilitator in the United States and Canada. Natalie’s breadth of roles has spanned from Clinical Research Coordinator, Clinical Research Associate, Clinical Research Project Manager, and management roles in Government and Health Economics. She worked at the Addiction Research Foundation (now the Centre for Addiction and Mental Health [CAMH]) and Janssen-Ortho Inc. (a division of Johnson and Johnson), participated on international project teams for pivotal Phase III studies, and led Canadian Phase IIIb-IV studies. Natalie holds an honors life science degree from the University of Toronto and is a member of the Society of Clinical Research Associates (SoCRA), the American and Canadian Societies of Training and Development (ASTD & CSTD), Toastmasters International, and is on the organizing committee for the World Creativity and Innovation Week in Toronto. Natalie designs and facilitates engaging, customized corporate and public workshops in the areas of clinical research study management, good clinical practice, and communications, all with visual thinking in mind.
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Anil D’Mello, Ph.D. is a Professor of Pharmaceutical Sciences at the Philadelphia College of Pharmacy at the University of the Sciences in Philadelphia. He has over 18 years experience in teaching Pharmacokinetics to Pharm.D. and Ph.D. students. Anil is the recipient of the Lindback Award for Distinguished Teaching and is listed in Who’s Who Among America’s Teachers. He has conducted Biopharmaceutics and Pharmacokinetics training courses at different pharmaceutical companies including Merck, Boehringer-Ingelheim, and Cephalon. His research examines the role of the maternal nutritional environment during pregnancy and lactation on the development of physiological systems in the offspring. He has numerous publications in peer reviewed journals in the area of pharmacokinetics, drug metabolism, and endocrinology. Anil is a member of the steering committee of the Delaware Valley Drug Metabolism Discussion Group.
Holly DeIaco-Smith, M.S., brings over seventeen years of management consulting experience to her clients, helping them change to be more successful. Holly’s tenure in Big 4 consulting, including Accenture and IBM Global Services, grounded her with a foundation of best methodologies, leading practices, and outstanding client experience. It was these experiences that inspired and compelled her to found a management consulting organization serving the agriculture, education, financial services, pharmaceutical, and retail industries. Holly’s experience includes strategic planning, process improvement, benchmarking for leading practices, organizational improvement, learning design and development, and change management. Given the critical need today for organizations to develop a talented workforce, Holly has helped her clients define and improve their learning strategies. Holly’s unique collaborative approach of truly partnering with her clients and her strong focus on change management enable her to provide excellent service and results.
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Jacqueline K. Earabino, R.N., B.S.N. has has been involved in clinical research since college where she majored in Biology and Environmental Science, earning a dual Bachelor’s degree. She then went on to work for three years at Johns Hopkins School of Medicine. In this role she assisted with ongoing pre-clinical research in the department of Anesthesiology and Critical Care Medicine, afterwards earning a B.S.N. in nursing from Johns Hopkins. Therapeutic areas of expertise include medical/surgical, women’s health, pediatrics/pediatric trauma, infectious disease, internal medicine, and oncology. She has also worked as a research nurse at Duke Cancer Center and Cancer Center of NC. Jackie has worked as a CRA at several CROs including PPD, Quintiles, Novella, and Trio Clinical Research. She is currently working as a consultant, having started her own company in 2007. For the past two years she has held roles as a global trial manager on two oncology studies. This experience has included multiple trips to provide monitoring support, as well as to train project teams and clinical study sites in the UK and EU. She also has experience working in pharmacovigilance and clinical data management for a large CRO. Jackie’s wide range of background,education, and experience both as a nurse, CRA, and project manager make her a valuable clinical research resource. She continues to work in project management and training.
Christina Eberhart, B.S., has over 13 years of clinical research experience, contributing in such roles as director of clinical operations, director of quality assurance, manager of quality assurance, clinical research associate, and as the principle of an investigator trial network. Christina has conducted quality control monitoring and auditing for sponsors and CROs. She has contributed to the development of on-boarding and training systems for clinical research departments, academic medical centers, and the division of acquired immunodeficiency syndrome (DAIDS) within the National Institutes of Health (NIH). Christina is a national speaker on several clinical research topics for the Association of Clinical Research Professionals (ACRP), Drug Information Association (DIA), Society of Clinical Research Associates (SoCRA), and MAGI. She is a member of ACRP and ASQ. She is a member of the bioresearch central advisory board, and is past-president for the Greater Kansas City Chapter of ACRP.
Barbara Elashoff, M.S., is focuses her consulting services on clinical trial data monitoring. Previously, Barbara was the Director of Biostatistics at Myraqa, a regulatory consulting company specializing in the design and analysis of clinical trials and diagnostic studies. She was also a statistical reviewer at the FDA in the Division of Pulmonary and Allergy Drug Products. Barbara received a Master’s degree in Biostatistics from Harvard University.
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Anna Filimonova, M.D., Ph.D., has extensive experience in the pharmaceutical industry, with a focused expertise on clinical research and regulatory requirements in Russia, the Commonwealth of Independent States (CIS), and Eastern European countries. Anna has an M.D. degree and Ph.D. in Paediatrics, Allergology and Immunology, and was a university lecturer and consultant in paediatrics for four years. Anna began her clinical research career as a CRA, and now holds a manager’s position in Clinical Operations in Russia for a major CRO.
Daniel J Filoramo, RN, B.S., is a successful pharmaceutical professional with over 18 years of diversified clinical research experience. Daniel’s experience encompasses multiple roles in all phases of drug development and marketing. He has been employed with a large pharmaceutical company for the past 10 years as a Sr. Clinical Scientist in the department of Early Clinical Translational Research. In this capacity, he has had the opportunity to author protocols and clinical study reports, and monitor and manage operations for Phase I and Pharmacology studies. Daniel is also responsible for the overall operational management of early assets. With his strong clinical research background, he is instrumental with process improvement activities, authoring of Standard Operating Procedures, and providing training on various clinical research topics. In addition, Daniel’s experience spans across multiple therapeutic areas such as Anti-Infectives, Cardiovascular, Immunology, Metabolic, and the Neurosciences.
Gary B. Freeman, M.S., C.C.R.A., provides quality clinical monitoring, auditing, training, project management, and consulting services internationally. He has personally worked in these areas with pharmaceutical, device, healthcare, and contract research organizations for over 30 years. Mr. Freeman has been a credentialed clinical research trainer through ACRP since its inception in 2003. Mr. Freeman holds a B.S. in Biology (pre-med program) from the University at Albany and an M.S. in Science Education from Russell Sage College. He has been actively involved in various clinical capacities for multiple therapeutic areas (Phase I-IV) for the following indications, as well as devices: allergy, anti-infective, cardiovascular, critical care, dental, dermatology, endocrinology, eye care, GI, imaging/diagnostics, immunology, infectious disease, oncology, organ transplant, OTC medications, psychiatric disorders, pulmonary, sleep disorders, and STDs. This experience includes pre-clinical laboratory work, data management, protocol writing and CRF design, clinical monitoring, clinical trial management, GCP auditing, developing and presenting clinical training programs, regulatory affairs management and overall responsibility for clinical operations in several settings, including presentations at FDA Advisory meetings. Mr. Freeman has also participated as a trainer for ACRP’s CRA and CRC Certification Exam Review courses and other clinical offerings, and is an active instructor for several drug and device courses for Barnett International for public and on-site offerings. He lectures routinely worldwide and presents training workshops for drug and device companies, as well as investigator sites. He also conducts GCP audits at investigational sites and vendors for pharmaceutical and device studies. Mr. Freeman is currently an active member of ACRP (Association of Clinical Research Professionals), DIA (Drug Information Association) and SQA (Society of Quality Assurance).
Joy Frestedt, Ph.D., C.C.T.I., R.A.C., F.R.A.P.S., has over 30 years of experience, and provides clinical, regulatory, and quality affairs consulting services to the pharmaceutical, medical device, and food industries. She recently served as interim Regulatory Director at the University of Minnesota Academic Health Center and as a member of the Allina IRB. She previously held key positions at Ortho Biotech, Medtronic, Mayo Clinical Trial Services, AstraZeneca, and Orphan Medical. She holds a B.A. from Knox College and a Ph.D. in pathobiology from the University of Minnesota Medical School. Dr. Frestedt is a member of American Society of Clinical Oncology (ASCO), American Association of Pharmaceutical Scientists (AAPS), Association of Clinical Research Professionals (ACRP), and Society of Clinical Research Associates (SoCRA), and is a Fellow of Regulatory Affairs Professionals Society (RAPS). Dr. Frestedt was honored in 2011 as one of the “100 Most Inspiring People in the Life Sciences Industry” by PharmaVOICE and one of the top 25 “Industry Leaders,” a “Women in Business Award” by the Minneapolis/St. Paul Business Journal.
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Glenda Guest, C.C.R.A., RQAP-GCP, specializes in medical device monitoring and project management, auditing and training on U.S.-regulated research, Quality Systems and Good Clinical Practices in clinical research settings. With her extensive background in a clinical CRO environment, she has developed a unique perspective, not only of the regulatory requirements for product development and market approval, but also the insights from collaboration with multiple sponsor companies’ varying approaches in meeting those requirements. Ms. Guest has had the opportunity to work with large and small manufacturers in both the premarket approval and 510(k) realms. She is an active member of the MedTech Association, as well as the Association of Clinical Research Professionals (ACRP), Model Agreements & Guidelines International (MAGI), and the Society of Quality Assurance (SQA). She has been an ACRP Certified Clinical Research Associate status since April of 2002 and an SQA Registered Quality Assurance Professional – Good Clinical Practices since April 2007
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Elkan Halpern, Ph.D., is the chief statistician for the Department of Radiology and the Director of Statistics for the Decision Analysis and Technology Assessment Group, Massachusetts General Hospital. Formerly holding positions of Principal Statistician and Vice President, Dr. Halpern has had over 30 years of experience in all phases of clinical and statistical research for FDA submissions and post-marketing studies.
Beth D. Harper, B.S., M.B.A., has extensive clinical research consulting experience, focused on the delivery of timely and predictable clinical trials, and enrollment and site performance management. Previously, Beth was President of Clinical Performance Partners, Inc., a clinical research consulting firm specializing in enrollment and site performance management. In addition to her 25+ years of clinical research experience, she is an Adjunct Assistant Professor at the George Washington University, and has published and presented extensively in the areas of study feasibility, site selection, patient recruitment, and protocol optimization. Beth received her B. S. in Occupational Therapy from the University of Wisconsin, and an M.B.A. from the University of Texas.
Bart Harvey, M.D., Ph.D., M.Ed., is a Public Health Physician-Epidemiologist and Associate Professor in the University of Toronto’s Dalla Lana School of Public Health where he teaches courses in public health, epidemiology, and statistics. He has been the principal or co-author of nearly 50 peer-reviewed publications, and has presented invited and peer-reviewed papers at national and international professional conferences. In addition, Bart has authored a self-study text, Statistics for Medical Writers and Editors (2009) and was the lead editor of The Research Guide: A Primer for Residents, Other Health Trainees and Practitioners (2011). He is a Fellow of the American College of Preventive Medicine (ACPM) and the American Medical Writers Association (AMWA). Bart was the recipient of the Eric Martin Award for Excellence in Medical Writing in 2011 and an AMWA Book Award for The Research Guide in 2012. Bart also serves as an investigating coroner in Toronto.
Janet Ellen Holwell, C.C.R.C., C.C.R.A., is an independent consultant specializing in maximizing excellence in GCP quality, compliance, and training for both sites and industry. She works contractually with sponsors, CROs, academic medical centers, and site investigators and their personnel to provide training in the clinical research process, specializing in ICH GCP compliance and quality oversight. Janet began her career as a clinical research coordinator in academia over 30 years ago. Prior to transitioning to industry, she managed a clinical pharmacology unit at Columbia Presbyterian Medical Center in New York City, overseeing all operations. She was an instructor in GCP and helped develop the first GCP program in an academic institution. She was an invited lecturer for Columbia University School of Nursing’s postgraduate Course for Clinical Research Coordinators. Prior to her position in quality management with Pfizer, she held positions as a clinical research associate, site selection specialist, study manager with oversight of vendor CRAs, and trainer for several pharmaceutical companies. Janet has been an active member of the Association of Clinical Research Professionals (ACRP) since 1992, having served on the board of trustees, North American Council, and various forums. She is a founding member, past president, and presently an active board member of the New York Metropolitan Chapter of ACRP. She is also an approved trainer for the ACRP Certification Examination Prep Course and Fundamentals in Clinical Research.
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Treena Jackson, M.S., C.Q.A., R.A.C., C.S.S.G.B. is a consultant providing global quality auditing, regulatory, process improvement, and training services with a focus on GCP and GLP. She is also currently the GCP expert on staff at a major CRO, and teaches as an adjunct professor at Campbell University in the Clinical Research Program. At Campbell University, Treena has taught in the undergraduate and graduate degree programs for Clinical Research. She has been in the pharmaceutical industry for over 14 years working for a major pharmaceutical company, a small biotech, and a CRO prior to working as a consultant. She has also travelled to over 10 different countries for audits, including vendor audits, for causeaudits, process improvements, and routine site audits. Treena has her MS degree in Regulatory Affairs and Quality Assurance from Temple University and a BS degree in Laboratory Animal Science. She has been teaching and training on a College and University level since 2004 and has also spoken at several programs for American Society of Quality (ASQ) as well as other organizations. Treena is also very active on the board of directors for NC Society of Quality Assurance.
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Marina Malikova, Ph.D., M.S., M.A., C.C.R.A., has over 10 years of experience in the clinical research field. She has managed Phase I-IV studies involving investigational drugs, devices, and biologics. She has worked on industry-sponsored and investigator-initiated trials in the fields of vascular surgery, neurosurgery, cancer diagnostics, and interventional radiology. In her current role, she is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, strategic planning, and macro-management of research programs. She provides guidance and oversight to all clinical research personnel, and advises faculty/staff on protocol and informed consent writing; assists with applications and submissions; and ensures compliance. She also provides oversight for data user agreements; cost coverage analysis and budgets development; and contracts and licensing for clinical research. Dr. Malikova has a Ph.D. in Biochemistry, a Master’s Degree in Clinical Investigation, and Project Management Certification from Boston University. She has seven years of teaching experience, and has developed several clinical research related courses. She is a member of Association for Clinical Research Professionals (ACRP), Drug Information Association (DIA), Regulatory Affairs Professionals Society (RAPS), and European Society of Radiology (ESR).
Anne McDonough, M.P.H., C.C.R.A., M.I.C.R., C.Sci., has over 16 years of experience in a variety of roles in clinical research. Ms. McDonough started her career working in investigational sites for HIV trials, spent over 10 years working in the American and European divisions of an international CRO, and is currently a freelance clinical research consultant based in London providing monitoring, project management, clinical science, medical writing, and training services. She has broad international experience in a full range of clinical trials (Phases I to IV, pharmaceuticals, biotechnology products, diagnostics, devices, and vaccines) and in a variety of therapeutic areas. She also currently serves on the exam committee for the CCRA exam (Association of Clinical Research Professionals) and is past chair of the European exam committee.
Kirsten Morasco brings over seventeen years of life sciences industry experience to her clients. She began her career in the pharmaceutical industry where she led teams that brought new products to market, managed global projects, and implemented training for new and existing employees. As a consultant, she has assisted her clients with change, process improvement, and meeting compliance standards and requirements. She is skilled in managing global process improvement/harmonization engagements dedicated to developing and implementing management solutions that enhance the speed and efficiency of clients’ processes and enable the implementation of these processes among employees. In particular, Ms. Morasco has developed document management processes for companies implementing a document management system in a compliance environment; developed managed, and implemented controlled documents, including Standard Operating Procedures (SOPs) and Business Practices to ensure compliance with federal and state regulations; developed and delivered instructor-led training for pharmaceutical staff with regards to clinical trial procedures and monitoring; developed and conducted instructor-led Standard Operating Procedures training for pharmaceutical staff; developed educational materials and seminars for the marketing department and administrative staff of a pharmaceutical company; and worked with instructional designers to ensure development and delivery of instructor-led SOP training for a large pharmaceutical company.
Eric Morfin, M.B.A., P.M.P., has been a project manager since 1987. A sought after speaker on the subject of project management, portfolio management, and resource management at North American and European symposiums and conferences, Mr. Morfin has been published many times in project management magazines and pharmaceutical publications. Currently the co-author of several project management in pharmaceuticals books, Mr. Morfin is an active member of several professional societies and has developed several unique seminars on project management in drug development, such as “Project Management in Discovery and Preclinical” and “Project Management for Global Clinical Trials.” He has consulted with clients in a variety of industry settings throughout North America, Europe, and Asia. He has worked with the World Bank, Merck Frost, Hewlett Packard, GlaxoSmithKline, Aventis, Novartis, Bristol Myers-Squibb, and AstraZeneca to name only a few. For 10 years, Mr. Morfin managed the project management practice of a worldwide training and consulting organization headquartered in the USA. Previously, he worked with a leading consulting group in the strategic field. In Europe, besides managing his own computer firm dealing in digital animation, he created and managed an entire new division for Apple Computer. Mr. Morfin is bilingual in French and English, has traveled extensively in Europe and Asia, and earned his M.B.A. in International Business in San Francisco. He currently lives in San Francisco with his wife and daughter.
Jeanne Morris B.S. MT (ASCP), is an ASQ Certified Manager of Quality/Organizational Excellence. Ms. Morris provides GMP, GCP, GPvP, and QMS expertise to the pharmaceutical and medical device industries. She has over 20 years of experience in regulated industry, including 15 years with the United States Food and Drug Administration. Her expertise includes risk assessment and mitigation, regulatory readiness support and mock inspections, process improvement project management, and procedure review and training. Prior to consulting, Ms. Morris held varied leadership positions at Takeda Global Research and Development, Inc., most recently as Director GxP Compliance, where she ensured drug development activities were conducted in compliance with regulations, guidance, and standards. While working for the FDA, Ms. Morris conducted over 300 inspections in the United States and internationally. She was a member of FDA’s national training cadre, and recipient of the prestigious FDA Commissioner’s Award of Merit.
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Elizabeth Ronk Nelson, M.P.H., has over 20 years of experience in medical and clinical research. During her career, she has managed clinical trial site operations as a clinical research program coordinator and researcher, and has served as an IRB Quality Assurance Specialist and a Senior (GCP) Auditor, Trainer, and Compliance Director. Her professional areas of specialization include fraud detection and prevention; mock FDA audits; customized, audit finding-specific, risk-based training; independent GCP quality systems and compliance audits; SOP and training program development and gap analysis; corrective and preventative action (CAPA) and quality systems improvement plans for GCP; customized skill-based training for clinical research professionals; clinical investigator site and IRB development and quality improvement (QI) plans; vendor audits assessments; and site selection qualification assessments. Ms. Nelson has extensive experience in investigating and pursuing suspect clinical data cases and has worked professionally with industry and government representatives to pursue legal actions for severe noncompliance cases.
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Randy Ramin-Wright, M.Sc., is a Program Manager and QRM Consultant with more than 20 years of experience in IT consulting, modeling, designing, and implementing information management systems. This expertise draws on project experience from a wide range of industries: pharmaceutical R&D, pharmaceutical finance, pharmaceutical informatics, systems biology research, material sciences, banking, and national security. His current focus is on the development and commercialization of Quality Risk Management products and services, and the development of industry standard risk metrics to help pharmaceutical companies optimize the use of their drug development resources. Randy has an M.Sc. in Physics and B.Sc. in Astro-Physics from Michigan State University.
Denise G. Redkar-Brown, MT, began her career as a Medical Technologist working in a hospital laboratory environment. She made the transition to the pharmaceutical industry, and after more than 20 years she has held positions in basic and clinical research. She is published in the European Journal of Pharmacology for her work in pharmacology while at AstraZeneca, and was published in the Good Clinical Practices Journal in 2008. Denise has contributed to the successful submissions for Accolate® (the first leukotriene antagonist for asthma therapy) and Seroquel® (Serotonin receptor compound for treatment of Schizophrenia and bi-polar disorder). Denise also worked at Dupont Pharma (Immunology), Knoll (Humira®), Sanofi (vaccines), and as Associate Director of Scientific Affairs, Data Management for Cetero Research, and is serving as a member of the Board of Trustees for the Society of Clinical Data Management (SCDM).
Lily Romero, P.A., C.C.R.C., has over 30 years of experience in clinical research. Her experience includes positions as Director of Global Development Training at Elan Pharmaceuticals, an Associate Director of Clinical Operations at Quintiles, Inc., a Clinical Research Coordinator and Research Administrator at the Allergy & Asthma Medical Group and Research Center, and a P.C. in San Diego, CA. She has worked on Phase I-IV clinical trials including pediatric studies. She was an instructor for and assisted in the development of an investigator GCP training workshop for the American Academy of Pharmaceutical Physicians. She is on the Advisory Board and an instructor for the Clinical Trials Design and Management certificate program at the University of California at San Diego (UCSD) Extension. Currently, she is a member of the Academy Board for the Associates of Clinical Research Professionals (ACRP).
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John Serio, J.D., represents pharmaceutical, biotechnology, nutraceutical, and medical device companies, particularly as to patent prosecution, licensing, and litigation matters. Mr. Serio also has extensive expertise in food and drug law involving pharmaceuticals and medical devices. He advises companies on a wide variety of regulatory issues, including the national and international conduct of clinical studies, manufacturing, the preparation and filing of regulatory documents, compliance with FDA regulations, and FDA enforcement matters. Mr. Serio is a recognized expert on direct to consumer advertising of pharmaceuticals. As a licensed pharmacist and a registered patent attorney, Mr. Serio has a multilateral understanding of complex scientific principles and drug development within the pharmaceutical industry. He is an accredited speaker with the American College of Pharmaceutical Education and regularly speaks and writes on pharmaceutical issues. Mr. Serio received his undergraduate degree at the University of Rhode Island College of Pharmacy, and his law degree from Western New England School of Law. His recent publications include State-by-State Clinical Trial Requirements Reference Guide, Barnett Educational Services, 2012; “Pharma and Social Media: The Leaders and Followers,” A FirstWord Market Intelligence Report (August 2009); and “Connecting with Patients, Overcoming Uncertainty,” Regulatory Issues in Social Media for Pharmaceutical Marketers (2008).
Jackie Stader, COT, C.C.R.C., provides independent quality research training, monitoring, auditing, medical writing, and project management consultation services. In addition, her drug and medical device experience with both sponsors/CROs and sites has enabled her to place needed focus on rescue and risk-based training, including SOP development and improved GCP. Jackie is also a sought-after international trainer and speaker, with many publications to her credit. She ties in her lengthy experience as a Clinical Research Coordinator and Certified Ophthalmic Technician to her training and lecturing topics. She provides independent quality research training, monitoring, auditing, medical writing, and project management consultation services. In addition, her drug and medical device experience with both sponsors/CROs and site has enabled Jackie to place needed focus on rescue and risk-based training, including SOP development and improved GCP. Jackie is also a sought-after international trainer and speaker, with many publications to her credit. Jackie ties in her lengthy experience as a Clinical Research Coordinator and Certified Ophthalmic Technician to her training and lecturing topics.
David M. Stier, M.D., provides study design and data analysis for outcomes studies, clinical trials, and patient registry programs. Prior to his consulting work, Dr. Stier was Vice President with The Lewin Group, an international health policy and research consulting firm. Dr. Stier has worked closely with pharmaceutical, biotechnology, and medical device company executives to create research platforms that blend clinical medical research, health outcomes research, and product commercialization objectives into comprehensive research programs executed during the peri-launch and post-product-launch periods.
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Vaska Tone is an internationally respected professional in clinical research and quality assurance (QA) with wide ranging experience in varying GxP auditing, training, standard operating procedures (SOPs), and corrective and preventative actions (CAPA) consultancy gained through increasing positions of responsibility in the pharmaceutical and CRO industries. She has 25 years of experience in clinical development for the pharmaceutical, biotechnology, and device industries, including extensive experience in GCP quality assurance including support for pharmacovigilance. She has directly managed staff and quality deliverables ensuring oversight and effective communications of audit findings to allow for appropriate CAPA and any necessary SOP development. She is a Society of Quality Assurance (SQA) committee member, and a pre-test writer for the RQAPGCP annual certification test. She is a participant on developing comprehensive auditing standards within QA Societies, namely joint projects with RQA, SQA, and JSQA. She is an American Society of Quality certified auditor with experience in lean-sigma standards, and a guest lecturer at the University of Southern California (USC) School of Pharmacy.
Susan Torchio, R.N., B.S.N., has over 20 years of clinical research experience. For the past 10, years she has been an instructor for Barnett International’s CRA and CRC course. Sue started her career in clinical research as a study coordinator at a busy family practice site that participated in multiple studies in a wide range of therapeutic areas including cardiology, infectious disease, and gastrointestinal. After two years as a coordinator, Sue joined a large CRO as a Clinical Research Associate, conducting a variety of late phase clinical programs. She has been at two other CROs in her career as a Project Manager working in infectious disease, trauma, endocrinology, and cardiology. She joined a BioPharma company in 1998 as a consultant and later a Project Manager in Medical Affairs. Medical Affairs was combined with Clinical Operations and she was promoted to a Senior Manager working in the CNS group. In 2005, her role changed and she is now heading up leading the Resourcing Group as an Associate Director within Clinical Operations. In this role she is responsible for working with a Function Outsource Provider to manage a field force of Regional Managers and Regional CRAs. In addition to her other responsibilities, Sue is also heading up the Pain Program in Clinical Operations. In this role she is in charge of various pain compounds and the studies that are conducted with them.
Lee Truax-Bellows, M.S., FNP, C.C.R.A., RQAP-GCP, has an extensive background in the pharmaceutical and medical device industries, having worked for both industry and a CRO as a Monitor, Medical Communications Associate, Project Manager, Senior Quality Auditor, Senior Trainer, and Regulatory and SOP Consultant. Lee has been involved in regulated research the past 25 years and currently specializes in product development, GCP auditing and SOP development and training on regulated research and Good Clinical Practice. She is an active member of the Association of Clinical Research Professionals (ACRP), New York State MedTech Association and Society of Quality Assurance (SQA). Lee is ACRP certified as a Certified Clinical Research Associate (CCRA) and registered through SQA as a Registered Quality Assurance Professional in Good Clinical Practices (RQAP-GCP).
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Cheryl Vitow is a medical writer and clinical management consultant with over 25 years in the pharmaceutical, biotechnology, and device industries. She has a degree in Medical Technology, Biochemistry (Rutgers), and her Masters work is in Clinical Pharmacology (Jefferson). She began her career as a bench chemist. She has been involved in the design, conduct, and reporting of clinical studies from Phase 1 through Phase 4 and has worked for Johnson and Johnson, Aventis, Squibb (before BMS), Eisai, Lippincott, and many others. She has run a successful medical writing and clinical project management consulting firm for 15 years.
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Tabitha Westbrook, RQAP-GCP, has nearly 17 years experience in the pharmaceutical industry, 12 of which have been in quality assurance. Currently, as the Quality Assurance Manager for the Americas of a major CRO, Ms. Westbrook oversees most types of audits and regulatory inspections. Ms. Westbrook received her undergraduate degree in Psychology from North Carolina Central University and is currently seeking her Master’s degree in Professional Counseling from Liberty University. Tabitha is passionate about people living full and authentic lives including in the workplace, and speaks regularly on such topics.
Liz Wool, R.N., B.S.N., C.C.R.A., CMT, has 35 years’ experience in healthcare, including 24 years in the clinical research industry, holding positions as a Research Nurse, CRA, Study Manager, Compliance-Quality Management, and Training. She is a dynamic, engaging, and internationally sought after consultant, speaker, and trainer with specializations in training, operations-compliance-quality, quality management, risk management, supplier-vendor management, and quality oversight. Notably, Liz supports organizations with their organizational training gap analyses and inspection responses (CAPAs) for the employee training framework, role-based training, and on-boarding programs. Liz volunteers her time to professional non-profit organizations (DIA, ACRP) at both the global and local levels, and serves as faculty for both organizations. She has also been a faculty member for ACRP, teaching the CRA and CRC Certification Exam Review Courses. Liz has held positions as a Research Nurse at Johns Hopkins Hospital in Baltimore, Maryland, CRA, CRA manager, study manager, senior manager, West Coast Learning and Development, Head, Clinical Research Training, as well as director-level positions in Clinical Compliance and Clinical Operations. This experience has been obtained through positions at Gilead, Quintiles, Johnson and Johnson Pharmaceutical Research and Development, Scios, and The Henry M. Jackson Foundation. Liz’s multiple certifications include Master Trainer, Instructional Designer, and Clinical Research Associate.