Instructor Biographies - Barnett Educational Services

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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.

	Beth Dean Casey, R.N., B.S., has over 25 years of experience in academic and private practice clinical research in the capacity of Director of Clinical Trials, Research Nurse Manager, Research Nurse Coordinator, and Clinical Trials Administrator. In addition, she has worked in the pharmaceutical industry in the capacity of Global Project Manager, Safety and Pharmacovigilance, and Clinical Research Associate roles. Her experience spans multiple disciplines to include: Oncology, Infectious Disease/HIV/AIDS, Transplant, Neurology, Neurosurgery, Cardiovascular and Nephrology extending to NIH, Industry, Investigator-initiated, Biologics/Biosimilars, Vaccine and Device trials. She developed the operations/SOPs, Research Nurse Coordinator training, and Regulatory Oversight for seven years within the UAB Neuro-Oncology/Comprehensive Cancer Center programs. She conducted multiple trials in GBM brain tumor to include antiangiogenics, vaccine, and oncolyzing viruses with multi-disciplinary roles and interaction across the Bone Marrow Transplant unit, Institutional Biosafety Committee; Project Review Panels, Vaccine panels; and the Cell lab for autologous vaccine trials. More recently she has worked with new compounds in both breast and ovarian cancer and monitoring sites through FDA inspection readiness for the NDA of a recently approved product. Ms. Casey has published and lectured on site quality, research nurse coordinator competencies, and regulatory compliance during the last decade.

	Nikki Christison, B.S., C.C.R.A.,T.I.A.C.R. 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.

	Philip Cola, Ph.D., is a research administrator and practitioner scholar with over 25 years of experience in the fiscal, legal, scientific and ethical reviews of research. He was the Vice President for Research and Technology Management at University Hospitals Cleveland Medical Center for the past 21 years where he oversaw the Institutional Review Board, clinical research compliance, grants administration, research finance and clinical research education and training. He holds appointments as an Associate Professor of Management and as an Adjunct Assistant Professor of Medicine at Case Western Reserve University (CWRU) where he teaches qualitative and quantitative research methods and leadership. Presently, he also directs the regulatory knowledge and support core of the CTSA grant at CWRU. Phil holds a Ph.D. in Management from the Weatherhead School of Management at CWRU and a Master’s Degree in Experimental Psychology and Research Method and Design from Cleveland State University. His research interests include the responsible conduct of research, factors influencing success of physician scientists in academic medical centers, the translational science paradigm and nonprofit organizations.

	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.

	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.

	Kelli J. Deiaco, Ph.D., is a licensed psychologist who brings over 20 years of experience working in behavioral health and higher education. She received a Ph.D. from Temple University’s APA accredited Counseling Psychology program where her research focused on coping and self-concept in women and trauma and narrative therapy. She completed a pre-doctoral internship in Rehabilitation Psychology and a post-doctoral residency in Health Psychology with a focus on Cognitive-Behavioral Interventions. Dr. Deiaco earned a master’s degree from Columbia University in Developmental Psychology. Most recently she completed specialized training from the Search Inside Yourself Leadership Institute in Mindfulness-Based Emotional Intelligence. She currently teaches for DeSales University and develops and implements customized seminars in the areas of mindful leadership and workplace wellness.

	Holly Deiaco-Smith, M.S.Ed., 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.

	Sharon Donatucci is an experienced drug safety professional. In addition to the training she does with Barnett, she also serves as a consultant for Pharmacovigilance activities. Previously, Ms. Donatucci served as the Chief Pharmacovigilance Science Officer for Ashfield Pharmacovigilance (formerly Drug Safety Alliance). She also held the position of Vice President of PV Operations at Ashfield. In that role, she was responsible for overseeing APV’s case management function and ensuring that resources were properly allocated for optimal operating capacity and effective, efficient delivery of services. A member of DSA since its inception in 2000, Ms. Donatucci previously served as Senior Director of Training and Quality Control, overseeing the quality aspects of case processing in order to identify training needs and ensure client satisfaction. She also managed all aspects of DSA’s employee development training program, facilitating classes for new hires and audit compliance courses for all employees and developed the company’s Drug Safety Case Manager Certification Program. Prior to her training role, she served as a Drug Safety Associate and Project Manager for DSA.

	Donna W. Dorozinsky, R.N., M.S.N., C.C.R.C., has over 25 years of experience in study operations that includes clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management. She spent 15 years at SmithKline Beecham in early development and in 2005 founded DWD & Associates, Inc., which has most recently become Just in Time GCP. She has led the implementation of eSource and electronic Trial Master File solutions, and has expertise in clinical validation of these systems. She recently served as chair of the revisions to Zone 4 of the TMF Reference Model. Donna has presented numerous training programs in topics of GCP compliance, Quality Management Systems, and TMF Management and is a dynamic educator.

	Carol Fedor, N.D., R.N., C.C.R.C., began her 25-year career in clinical research as a Clinical Research Coordinator (CRC). Eventually, as Director of the Human Research Protection Program at University Hospitals Cleveland Medical Center, she was responsible for the administrative oversight, leadership of policy and procedure implementation, and programmatic development for the Institutional Review Board and the Research Compliance and Education Offices within the Center for Clinical Research and Technology. Her passion for the training of research professionals inspired her to develop a nationally recognized clinical research education curriculum and to mentor to CRCs internationally. She conducted a survey, with Dr. Philip A. Cola, on the role of the CRC which ultimately led to the publication of a series of articles and served as the Senior Editor for a book entitled “Responsible Research: A Guide for Coordinators”. Carol has a Nursing Doctorate (N.D.) from Frances Payne Bolton School of Nursing, Case Western Reserve University and a Bachelor of Arts in Anthropology from Case Western Reserve University, Cleveland, Ohio.

	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. 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.P.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.

	Karen L. Gilbert, B.S., C.C.R.A. has worked in the clinical research industry since 1994 monitoring pharmaceutical and medical device trials, managing an investigational site, and serving as a global study manager. Her experience also includes two years serving as Clinical Trainer & Curriculum Manager with Barnett Educational Services. Karen’s training courses and presentations have been delivered internationally to industry clients and at global professional conferences. She has co-authored two articles published in the clinical research industry journal, Clinical Researcher (formerly The Monitor). Ms. Gilbert received her certification as a Certified Clinical Research Associate (CCRA) through the Association of Clinical Research Professionals (ACRP) in 2005 and remains active in this organization.

	Celeste M. Gonzalez, RQAP-GCP, C.C.R.P., is a Clinical quality assurance expert with broad experience in the interpretation and application of US and foreign regulations, guidances, directives, and guidelines as applied to the conduct of pharmaceutical, medical device, and animal health clinical trials. She is well-experienced in the development of Clinical Quality Systems and has been responsible for the leadership of high performing quality and compliance teams. Some specific accomplishments include the completion of over 300 clinical investigator site audits of Phase I, II, III, IV, IDE and 510k studies, she completed over 75 vendor audits including contract research organizations (CROs), and she has developed quality systems for and brought contract research organizations (and related studies) into full GCP compliance within a 9-month period. In addition to numerous industry presentations and publications, Celeste is also a member of the ISO 14155: 2011 sub-committee on ICH E6 (R2) harmonization.

	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.

	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.

	Debbie Harper, B.Sc., P.M.P., is a highly skilled Consultant and Trainer with broad and extensive knowledge (>20 years) of the global clinical research industry, covering all phases of drug development, in multiple therapeutic areas. She has a wealth of expertise in the development and execution of operational strategy, including serving as a VP of Operations for a large CRO. Ms. Harper has demonstrated abilities in leadership excellence, training design and delivery, early clinical development, process improvement and strategic initiatives. She is Project Management certified through PMI and possesses significant experience developing and delivering gold standard customized project management and clinical research related training courses for project leads and clinical operations.

	Marla Hoelle, B.S.N., R.N., C.C.R.A., P.M.P., is a Clinical Training Manager for Barnett International. She has over 20 years of experience in clinical research. Marla began her career in clinical research as a study coordinator for an academic medical center, followed by working in a private physician group conducting clinical research. She continued her career path in clinical research working as a CRA and Project Manager. She has served as a clinical project manager for pharmaceutical and medical device trials managing all operational aspects of clinical trial activities from study start-up to FDA submission. In the projects she has managed, she has led a team of research professionals including CRAs, biostatisticians, data managers, regulatory, medical writers, safety, and vendors. She has a passion for the development and mentoring of study coordinators, CRAs, clinical project managers. Marla brings her experience and lessons learned from the various clinical trial projects she has managed to the trainings she delivers. Areas of therapeutic experience include: Cardiovascular, Infectious Diseases, Oncology, Orthopaedics, and Women’s Health.

	Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P., 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.

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.

Tamar Kagan, M.Ed, PCC partners with leaders and teams committed to growing their leadership capacity and impact. She has extensive experience with clients from the private, non-profit, and public sectors, and has worked with clients from a variety of industries including healthcare, education, finance, communications, marketing/sales, and media. Tamar is warm and inclusive with a talent for balancing practical outcomes for people and the environments in which they work and live. Tamar holds the International Coach Federation’s Professional Certified Coach designation. She is an Adler Certified Professional Coach, and also completed the Organization and Relationship Systems (ORSC) coaching program. Tamar completed her Master of Education in adult education with a focus on workplace, learning and change from the Ontario Institute for Studies in Education at U of T, and has a certificate in applied mindfulness meditation from the University of Toronto School of Continuing Studies. Finally, Tamar is a certified practitioner of the Leadership Circle Profile and the EQ-i 2.0 assessment.

Susan M. Leister, M.B.A., Ph.D., CQA, CSSBB, has over 19 years of experience covering the pharmaceutical, medical device, and clinical arena, including extensive working knowledge of GCP, cGMP, GLP, ICH E6 GCP, HSP, and 45CFR46. She has managed various inspections including: ISO, CE Mark, Health Canada, EMA, DEA, Maryland Board of Pharmacy, and FDA. Dr. Leister provides QM oversight to multiple government and commercial clients. She currently oversees a QA auditing team comprised of 13 FTEs who verify monitoring performance and internal audits with a global reach, conduct quality trend analysis including analysis of reports and associated data, and provides recommendations and quality consultative services. She is experienced in managing NIH drug repository and stability lab for domestic and international clinical trials and is skilled in developing plans for resolutions to deviations and CAPAs, analyzing QA/QC results, and recommending process improvements with 6 Σ. In the past five years, Dr. Leister has overseen more than 500 quality audits with a 100% on-time delivery metric for audit reports and has managed review of ~approximately 175 clinical quality management plans for clinical research sites with a 100% on-time delivery.

	Marina Malikova, Ph.D., MSci, MA, C.C.R.A., RAC, has over twelve years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics, and has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology. Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance. Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.

	Angie Maurer, R.N., B.S.N., M.B.A., C.C.R.A., has spent over 20 years in healthcare and 16 years in the drug development and medical device industries spanning biopharmaceutical, diagnostic, medical device, and CRO organizations. Currently, Angie is a co-founder and CEO of an innovative clinical trial software solutions company that addresses clinical trial challenges. Angie has spent the last 11 years as a global Clinical Research consultant working with various companies from small start-ups to large companies providing expertise in Quality Risk Management (program and software development), process development and improvement, drug/device development programs, clinical trial management, and QA clinical audits. Angie has a clinical and business background holding a Bachelor’s in Science Nursing, Masters in Business Administration, a certificate in Lean Six Sigma, and a CCRA certificate through ACRP. She is also a speaker at various clinical research conferences across the United States and is on the editorial board for Clinicalleader.com. Angie enhances her expertise through continuing education as an active member of Association of Clinical Research Professionals (ACRP) and Watermark (a senior executive’s women’s organization).

	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.

	Mary Mills, R.N., C.C.R.A., has over 25 years of experience in the pharmaceutical industry. Prior to beginning her “official” career in research, she gained extensive experience as an R.N., in the intensive care units at The Regional Medical Center in Memphis, a teaching hospital, where research was widely conducted. Since 1987, Mary has worked with biotech and pharmaceutical companies as a nursing consultant and educator. She has extensive experience as a Clinical Project Manager, Clinical Research Coordinator and Study Coordinator in a variety of clinical trial settings covering a wide-range of clinical therapies. In recent years, she has been involved as a Project Manager for one of the largest international risk-based clinical trials. Mary also works with federally funded trials where a risk-based approach to monitoring is practiced and is currently working on an International RBM Workgroup. Mary maintains her nursing licensure and has dedicated many hours as a nurse consultant, educator and preceptor for numerous clinical specialties. She is an active member of DIA (Drug Information Association) and ACRP (Association of Clinical Research Professionals) and spends many hours annually participating in continuing education activities in the areas of clinical trials and nursing. Mary is an industry expert on risk-based approaches/risk-based monitoring whereby she is a sought after speaker at industry conferences on these topics. Additionally, Mary has presented at the FDA-CTTI QbD meetings as a member of the Boehringer-Ingelheim team presenting their risk-based approaches to clinical trials.

	Jarrard Mitchell, M.B.A., CQA, is a Certified Quality Auditor (CQA) and serves as a Quality Assurance Manager and operational leader with over 15 years of Pharmaceutical and Clinical Research Organization (CRO) experience. He has global audit experience and broad therapeutic indications including but not limited to: HIV, MRSA, Organ Transplantation, Oncology, Ebola, various medical devices, and Drugs of Abuse trials. He has regulatory inspection experience with both the FDA and EMA. He is an expert in leading process improvement activities and Corrective Action and Preventive Action (CAPA) investigations. Mr. Mitchell is well versed on complex clinical trial regulations and guidelines of the Food and Drug Administration (FDA), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), International Conference on Harmonisation (ICH), Good Clinical Practice (GCP), Human Subject Protection (HSP), European Medicines Agency (EMA), College of American Pathologists (CAP), and Clinical Laboratory Improvements Amendments (CLIA). Mr. Mitchell has an established record of identifying potential noncompliance and formulating practical solutions. He has proven success in developing QA programs with performance improvements that proactively increase quality and compliance.

	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.

	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.

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 preventive 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.

	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).

	Caroline Ritchie, Ph.D., M.B.A., is a regulatory medical writer and scientific publication professional with experience in both the pharmaceutical and medical device industries. She has led major regulatory submissions in the fields of oncology, autoimmune disorders, and rare genetic diseases. After working for several companies, including Covidien, Medtronic, and Ariad Pharmaceuticals, Caroline started her own scientific consulting and medical writing business. Caroline is passionate about contributing to the development of life-saving therapeutics and enjoys mentoring scientists and medical writers.

	Robert Romanchuk, B.S.H.S., CIP, C.C.R.C., C.C.R.C.P., is a seasoned clinical research professional with experience in both research operations and human subjects protections. Currently serving as a vice-chair for a prominent independent IRB, his IRB experience includes management of a local IRB in a community hospital, site visits for independent IRBs, and membership on three local IRBs at different periods during his career. He is familiar with the conduct of research due to a 15-year tenure at a large community hospital system with 13 hospitals and 450 physician practice in a multistate footprint. During that time he oversaw and led the growth of research from a single site within this organization to a fully functional, centralized research operation serving the entire system with central contract negotiation, uniform clinical trial billing practices, CTMS and EMR. He is a frequent speaker at national and international venues and is passionate about human subjects protections.

	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).

	Michelle Rothstein, PCC, CPCC, is a leadership and communications coach and has coached with leaders and teams from across North America and the UK. She has worked with both private sector and notfor-profit executives and their employees to help them gain greater alignment with both personal and team goals. Michelle is a faculty member of Studio Y, a fellowship program for young innovators at the MaRS Discovery District in Toronto. She also holds the designation of Professional Certified Coach from the ICF, is a certified Professional Co-Active Coach, and is a certified practitioner of the Leadership Circle Assessment Tool. Michelle has also completed training with Organization and Relationship Systems Coaching (ORSC) and Group Coaching with Jennifer Britton of Potentials Realized. Michelle’s authentic, bold, and humorous approach both challenges and champions clients to advance their performance and enhance their fulfillment. Working with Michelle, clients quickly experience her infectious energy and ability to deliver the compassionate kicks forward that have made her a powerful coach and trusted confidant. She connects deeply with clients to create a safe space that is ripe for creativity and authentic engagement to develop and execute a resonant and sustainable action plan.

	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).

	Stella Stergiopoulos, M.S., M.P.H., manages multi-sponsored and grant funded research projects at Tufts CSDD. She has experience conducting research on pharmaceutical industry practices and trends affecting pharmacovigilance, nonclinical drug development, pharmaceutical outsourcing practices, cycle time metrics, resource management, and protocol design. She has also been a speaker at conferences and has published articles in peer-reviewed and trade journals. Prior to joining Tufts CSDD, Ms. Stergiopoulos was a research associate at The Brattle Group and a researcher at Massachusetts General Hospital. She holds a BA from Brandeis University, and an MS and MPH from Tufts University.

	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 preventive 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.

	Suzi Tran, M.B.A., CMQ/OE, CQA, CSQE, is an experienced Quality Assurance Manager with over 25 years of experience in developing and implementing quality management systems for various federal and private clients. She is a Certified Quality Auditor who has performed internal and external audits using criteria from ISO, ICH, and CFR requirements.

	Lee Truax-Bellows, FNP, C.C.R.A., RQAP-GCP, TIACR, 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).

	David Vanscoy. B.S. , has over 30 years’ experience in the pharmaceutical and biotech industries in vaccines, diagnostics, solid oral dosage forms, cell culture, and medical devices. He has held positions in Quality Assurance, Quality Control, Manufacturing, Research, and Product Development in both large and small companies. His experience includes sterile manufacturing, environmental monitoring and validation. He has conducted hundreds of audits, both domestically and internationally, involving manufacturing facilities and laboratories. He holds a Microbiology degree from the University of Maryland at College Park.

	Mary L. Veazie, M.B.A., CPA, CHC, CHRC, is a Certified Public Accountant with over 15 years of experience in clinical research finance. Collectively, she has over 25 years of financial and auditing experience. She developed and directed a clinical research finance office for a large academic medical center. She is certified in Healthcare Research Compliance and Healthcare Compliance. Ms. Veazie’s skill set includes full comprehension of the clinical research billing process and its impact on an organization’s clinic operations and revenue cycle.

Tabitha Westbrook, M.A., LPCA, CCTP RQAP-GCP, has more than 20 years of experience in the pharmaceutical industry, 15 of which have been in Clinical Quality Assurance. Ms. Westbrook has both conducted and provided training on such topics as clinical quality auditing processes, process audits, vendor audits and vendor management, investigator site audits (both routine and for cause), hosting sponsor audits and regulatory inspections, standard operating procedure (SOP) creation and maintenance, identifying and managing protocol deviations, root cause analysis, and corrective and preventive actions. She also teaches courses on conflict management and resolution and leveraging emotional intelligence in the workplace. Her teaching style is interactive and interpersonal, using real-world scenarios to bring the information to life and help learners generalize information across their various roles and jobs. Ms. Westbrook also provides mentoring to newer members of industry.

Linda Yancey, R.N., C.C.R.A., is a clinical research professional with a history of orchestrating successful multi-institutional academic clinical research consortiums and strategic pharmaceutical collaborations designed to decrease clinical trial activation timelines and reduce financial operating associated costs. She has substantive leadership experience and a strong background in healthcare with over 20 years serving in varied progressive roles. In her role at UT MD Anderson Cancer Center, she has led numerous teams and has provided research operational oversight for 150 clinical trials (first in man, phase i -iii protocols, immune-modulating agents) with over 3,000 enrolled patients representing contractual awards over $60 million. Under her leadership, the rate of clinical research patient reimbursement increased from 25% to 81% during the fiscal year and she developed a centralized infrastructure that led to increased clinical trial revenues. Linda holds Bachelor of Science degrees in both business and nursing. She is a certified Clinical Research Associate and has an extensive background which includes mass tort legal nurse consulting, auditing/monitoring per GCP/FDA regulations, FDA site inspections, clinical trial management system development, clinical research billing compliance, project management, and pharmaceutical strategic alliances.