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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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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 Foundation-funded 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 MS and PhD 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, clinical research associate for a CRO, biomedical and vaccine’s company as well as working as a clinical trial manager for international vaccine trials. Linda has provided training to her colleagues within the industry as well as to clinical site personnel on protocols, EDC, IP management, and data listing review. Linda has also worked within the pharmaceutical industry as a training manager where she worked with subject matter experts to develop curricula that would engage participants and 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 where she worked in critical care and the emergency room. This background gave her a foundation for critical thinking and affords her the lexicon to interact knowledgably across therapeutic areas in clinical research. Linda’s nursing and pharmaceutical industry experience gives her unique insight into the training needs of the teams that run and monitor clinical trials as well as a practical understanding of the compliance issues found throughout clinical operations. Linda strives to bring practical application and relevance to her trainings by sharing her experiences working in the industry.
Eric Chojnicki, Ph.D., M.B.A., currently holds the position of Director, CMC Project Management and Technical Affairs for Global Pharmaceutical Sciences at Allergan, Inc. and is responsible for CMC portfolio and project management processes, practices and infrastructure.Previously he was a CMC Team Leader and provided strategic leadership of two CMC teams each developing a novel biologic. As Senior Director Life Sciences at SmartAnalyst he worked as a strategy consultant providing leadership on projects for clients to facilitate strategic decisions in therapeutic areas of Oncology, Immune Modulators and Anti-Infective Agents and on bio-marker driven development strategies. He also built a strong specialty practice consulting oncommercial development and entry strategies for emerging markets and strategies for development of Bio-Similar and “Bio-Better” products. During his 20 year career he has held line management and cross-functional management positions at companies such as Tanox (Genentech), Bristol-Myers Squibb, Amgen, Inc. and others. He has published, holds patents and lead development efforts for small molecule, protein based, peptide, live cell, gene based therapeutics and vaccines. Dr. Chojnicki has a B.A. with duel majors in Biology and Chemistry from Washington & Jefferson, College. M.S and Ph.D. Degrees in Genetics & Developmental Biology from West Virginia University where he performed some of the initial scientific research to elucidate the biological function of TGF-beta. This work produced the first commercially sold diagnostic antibodies that recognized TGF-beta. He received an MBA in Pharmaceutical Management from Fairleigh Dickinson University and is an Adjunct Professor in the Department of Pharmaceutical Management at the Silberman College of Business at Fairleigh Dickinson University. He consults at the Lakenau Institute of Medical Research on research strategy and commercial development of the institute's technologies. In addition to his academic credential, Dr. Chojnicki holds certifications as a PMP from the Project Management Institute and as a Six Sigma Black Belt from Villanova University.
Nikki Christison, B.S., C.C.R.A. has been working in the industry for over 18 years as a study coordinator, regional CRA, and managing her own research company consulting as an auditor, monitor, project manager, trainer, and regulatory specialist. Ms. Christison has consulted with multiple sponsors and CROs in developing sites, generating corrective action plans and educating CRAs, Managers, Clinicians and Site Staff on industry best practices and GCPs in a number of webinars and live workshops. She has extensive experience developing and presenting on a variety of industry topics and is passionate about the educational process.
Barton Cobert, M.D., F.AC.P., F.A.C.G., is an expert on drug safety and pharmacovigilance, and author of the textbook Cobert’s Manual of Drug Safety and Pharmacovigilance – 2nd edition, used in training courses on drug safety and pharmacovigilance. He is also co-author of Drug Safety Data with Dr. Michael Klepper, and Pharmacovigilance from A-Z.Dr. Cobert has extensive experience in drug safety, clinical research, regulatory affairs, risk management, compliance, mock inspections/audits, data management, data monitoring committees, and informatics in drug safety and clinical trials. He is a frequent presenter and instructor/trainer at Drug Safety Meetings, Drug Information Association (DIA), PERI, Uppsala Monitoring Centre, Temple University, and the University of Montréal, Health Canada, the Chinese FDA, and others. He was one of the founding members of the International Conference on Harmonisation (ICH) starting in 1989. He has worked on several ICH Working Groups and co-chaired the PSUR update group. He has also had numerous safety articles published in referred journals. Dr. Cobert was previously Global Head of Drug Safety at Schering Plough (1992-2003) and Global Head of Safety at Novartis Consumer (2006-2007), and held senior positions at Forest Laboratories, Hoechst Roussel Pharmaceuticals (now Sanofi-Aventis), Ives Laboratories, and Medidata Solutions. Dr. Cobert is a graduate of the New York University School of Medicine where he also did his training in Internal Medicine and Gastroenterology. He also did a post-doctoral fellowship in hepatology at Hopital Beaujon/INSERM in Paris, France. He is board certified in Internal Medicine and Gastroenterology. He is on staff at the NY University School of Medicine and the Rutgers/University of Medicine and Dentistry of NJ where he is an Adjunct Associate Professor. His consulting firm is actively engaged in drug safety, clinical research, IT, risk management, audits and inspections, compliance/quality, and data safety management boards.
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.
Karen Chu, Ph.D., has been working in Asia Pacific clinical research for last 8 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 6 years. She has extensive experience with clinical trials in countries as, China, S. Korea, Taiwan, Singapore ... etc and 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.
Dr. Leylén Colmegna, has studies 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 the CRO and Pharmaceutical Industry. During 2010, she founded LAT Research, a Regional CRO with headquarter in Argentina and operates in Latin America. Dr. Colmegna is acting as CEO and COO. She is responsible for the leadership of local management teams across all operations units. (Medical; Clinical; Data Management, Regulatory Affairs, Pharmacovigilance & Marketing)
Natalie Currie 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 has 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) and has 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 those experiences that inspired and compelled her to found a management consulting organization serving 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 strong focus on change management enables her to provide excellent service and results.
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Jacqueline K. Earabino, R.N., B.S.N. has been involved in clinical research world since college where she majored in Biology and Environmental Science, earning a dual bachelors degree. She then went on to work for 3 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 BSN 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 CRO’s 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 2 years she has held roles as a global trial manager on 2 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., is a manager in the advisory services practice of Ernst & Young LLP. She 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 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 Institute 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.
Erica Elefant, R.N., B.S.N., M.S.W. has close to 15 years of clinical research experience and continues to work in the pharmaceutical industry. She has worked as a study coordinator, site monitor, and clinical research project manager in multiple therapeutic areas and phases of drug development. In addition to acquiring a strong clinical research knowledge base, Ms Elefant has obtained hands on experience writing clinical documents and SOPs. Ms. Elefant has worked as adjunct faculty at Drexel University and as a Clinical Trials Learning Manager where she has been responsible for developing and delivering trainings on various clinical research topics.
Barbara Elashoff, M.S., is the CEO of Patient Profiles, a software company focusing 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., Associate Director GRO, CRA/GMBA, PAREXEL International (RUS) LLC, located in Moscow, Russia. Anna has MD degree and PhD in Paediatrics, Allergology & Immunology, was a university lecturer and consultant in Paediatrics for 4 years. Since 1998 Anna has been working for PAREXEL, first as CRA and than holding manager’s position in Clinical Operations in Russia. She has extensive experience in the pharmaceutical industry, her areas of expertise include clinical research and regulatory requirements in Russia, CIS and Eastern European countries.
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. Daniel 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, monitor and manage operations for Phase I and Pharmacology studies. He is also responsible for the overall operational management of early assets. With his strong clinical research background, Daniel 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 in addition to conducting 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., is President and CEO of Frestedt Incorporated, a company providing clinical, regulatory, and quality affairs services. Dr. Frestedt has over 30 years of experience in 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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Albert A. Ghignone, M.S., R.A.C., has had a professional focus has been on regulatory affairs, quality assurance, and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, and medical devices. He has been responsible for regulatory submissions, registrations, FDA liaison, and compliance activities. He also has expertise in the assessment of product and facilities for due diligence relative to FDA requirements. He lectures throughout the world on numerous FDA related matters. He is a member of the Regulatory Affairs Professional Society, which awarded him as 1984’s Professional of the Year. He has served the society as Vice President, President, and Chairman of the Board of Directors.
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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 who 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. She 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 post-graduate 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 RTI-HS located in Durham, NC 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 pharma 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 cause-audits, 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.
Steve Jolley is a subject matter expert in all areas of global safety compliance and signal detection, and is a frequent speaker at leading industry events. Steve has 27 years' experience in drug safety and pharmacovigilance, and has worked with over 100 clients in the US, Europe, Japan, and India. He holds degrees in mathematics and computer science from Cambridge University, England. Steve is a featured speaker with FDA and MHRA at conferences and webinars on auditing, signaling, and data mining. He is a member of DIA's training faculty, and is an instructor for DIA's Clinical Safety and Pharmacovigilance Certificate Program. In 2010 Steve was elected as chairman of the DIA's Clinical Safety and Pharmacovigilance steering committee for North America. Steve began his career in the pharmaceutical industry in 1985 when he founded DLB Systems, a supplier of computer systems for clinical trials and adverse event reporting to many of the leading life science companies worldwide. DLB was acquired by eResearch Technologies in 1997; since then Steve has worked as an independent consultant.
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Robert L. Kunka, Ph.D. is an accomplished and respected scientist who contributed to the development of 28 pharmaceutical products in eight therapeutic areas. His expertise on international product development teams produced submissions with successful clinical strategies, sound matrix management of individual study teams, and effective interactions with regulatory agencies leading to successful IND, aNDA, and NDA approvals. Prior to starting his current career as a consultant, Bob’s experience in drug development stems from 24 years in the pharmaceutical industry at GlaxoSmithKline (GSK), Chugai-Upjohn, and GD Searle. During his time at GSK, he served as secretary of the protocol review committee and chairman of the Bio Task Force that mentored young scientists during the development process. At Searle he made presentations for generic products at state formularies and reviewed potential licensing candidates. Prior to this, he was Assistant Professor at the University of Pittsburgh School of Pharmacy where he taught graduate and undergraduate courses in pharmacokinetics. He also served on the Technical Advisory Committee for the Pennsylvania Generic Drug Formulary. Bob earned his Ph.D. in Pharmacokinetics at the University of North Carolina (UNC) at Chapel Hill and Bachelor of Science in pharmacy at the University of Illinois at the Medical Center in Chicago. While at UNC, he was honored to be named the American Foundation for Pharmaceutical Education Charles J Lynn and Syndor Barksdale Penick Memorial Fellow. Since then he has authored over 75 publications and presentations at international scientific meetings, serves as a reviewer for the Journal of Clinical Pharmacology, and received a number of scientific awards including GSK Silver and Gold Recognition Awards, the Glaxo Medical Operations Outstanding Service Award, and the GD Searle Special Unit Award. Bob will be presenting at the 2014 World Congress of Basic and Clinical Pharmacology meeting in Cape Town, South Africa on July 17 as a member of a program entitled The Changing Face of Pediatric Drug Development. The title of his talk is Pediatric Drug Development from the Sponsor’s Perspective and Bridging to Relevant Data.
Tim Krupa, M.S., M.B.A. is a proven leader who assists companies with their clinical development. Tim has a wealth of experience in pharmaceutical development with Big Pharma and the CRO industry. He began his career with Eli Lilly and Company where he led teams in Clinical Operations, Clinical Data Management, Medical Writing, and World Wide Regulatory Affairs. Recently, he served as Executive Director, Project Management at Quintiles, Inc. where he led teams in Project Management and Clinical Operations and gained an intimate knowledge of the Biotech industry. As a difference maker, one of Tim’s key strengths is that he is a leader who builds engaged teams that execute and deliver as promised.
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Anne McDonough, M.P.H., C.C.R.A., M.I.C.R., 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 instructorled 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 PM Magazines and Pharmaceutical publications. Currently 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. Prior to partnering with Chiron, Mr. Morfin managed for 10 years 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, 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) ASQ Certified Manager of Quality/Organizational Excellence. Ms. Morris provides GMP, GCP, GPvP, and QMS expertise to the pharmaceutical and medical device industries. With 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, desigining, and implementing information management systems. This expertise draws on project experience from a wide range of industris: pharmaceutical R&D, pharmaceutical finance, pharmaceutical informatics, systems biology research, material sciences, banking, and national scurity. His current focus is on the development and commericalization 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 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 recently 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®), and Sanofi (vaccines), and at present she is the Associate Director of Scientific Affairs, Data Management for Cetero Research in Fargo, North Dakota. Denise has been an Instructor for Barnett International/Cambridge Healthtech Institute for 11 years specializing in Clinical Data Management delivering training programs and interactive webinars for multiple clients in the pharmaceutical and biotech industry.
Lily Romero, P.A., C.C.R.C., has over thirty years 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., and a Clinical Research Coordinator and Research Administrator at the Allergy & Asthma Medical Group and Research Center, 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 is a partner at the law firm of Burns & Levinson LLP in Boston, MA. He specializes in representing 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 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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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 2 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 Operation. 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.
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Cheryl Vitow is a medical writer and clinical management consultant with 25+ years in the pharmaceutical,biotechnology, and device industry. 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 started and 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, Ms. Westbrook serves as the Quality Assurance Manager for the Americas at INC Research in Raleigh, NC, and 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.