Instructor Biographies

Clinical Research Subject Matter Experts: Biographies

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z


	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 20 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).

	Sonja Cooper, Ph.D, M.B.A., has 20+ years of experience in clinical research and the pharmaceutical industry. She has extensive working knowledge of clinical research trials inclusive of procurement, program management, study start-up, recruitment tactics and challenges, clinical trial management, employee retention strategies, and audit processes. Dr. Cooper is well versed in building and fostering key relationships that lead to performance improvements, DEI initiatives, and constructing strategic alliances. She has held roles as Sr. Clinical Operations Manager, Project Manager, Trial Manager, Lead CRA, and CRA. Dr. Cooper serves as an expert in creating clinical monitoring processes such as monitoring evaluation programs, CRA oversight programs, central monitoring (risk-based) departments, role specific competencies learning sessions, and CPA-CRA-CTM step ladder promotion programs. Additionally, she serves as a mentor for Morehouse School of Medicine - Clinical Trials Office and has worked in higher education as an administrator and professor for 8 years.

	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 25 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. 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.

	Holly J. 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.

	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.

Misha Eliasziw, Ph.D., is a biostatistician who has over 30 years of experience in the design, management, and analysis of clinical trials and longitudinal cohort studies. Dr. Eliasziw has applied her skills to a wide spectrum of research areas, including acute and secondary prevention of stroke, multiple sclerosis, advanced brain imaging, cancer biomarkers, prevention of substance use among adolescents, reduction of traffic-related air pollution through filtration, prenatal nutrition, and prevention of obesity among children with autism spectrum disorder and intellectual disabilities. She has published over 250 peer-reviewed articles, and paralleling her research efforts, Dr. Eliasziw has taught biostatistics to graduate students, postgraduate medical education trainees, healthcare professionals, and clinical faculty. In recognition of her exemplary teaching abilities, she has received several teaching awards. Currently, she is an Associate Professor in the Department of Public Health and Community Medicine at Tufts University in Boston, Massachusetts. Dr. Eliasziw graduated from the University of Western Ontario with a doctorate in Epidemiology and Biostatistics and completed her post-doctoral training in biostatistics at Harvard University.

Joy Frestedt, Ph.D., C.P.I., R.A.C., F.R.A.P.S., F.A.C.R.P., has over 40 years of experience in clinical research, regulatory negotiation, quality system development and business leadership in the pharmaceutical, medical device, and food industries. She has experience running clinical trials, conducting laboratory analyses and assisting firms with strategic decisions involving clinical research programs, regulatory strategies and quality system management to compete globally. Dr. Frestedt has served as Regulatory Director at the University of Minnesota Academic Health Center, as a member of the Allina IRB and 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), Society of Clinical Research Associates (SoCRA), and is a Fellow of Regulatory Affairs Professionals Society (RAPS) and Association of Clinical Research Professionals (ACRP). Author of FDA Warning Letters about Food Products: How to Avoid or Respond to Citations (Elsevier, 2017) and Warning Letters: 2016 Reference Guide (Barnett International, 2016), 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.



	Debbie Harper, B.Sc., P.M.P., is a seasoned leader with extensive business and operational experience in the global R&D life sciences sector, encompassing all phases of clinical development. With a proven track record in managing and executing complex, high-impact strategic projects, she excels at driving change and navigating complex business environments to overcome challenges. Her expertise spans a broad spectrum of areas, including early-stage development, advanced therapy development, ICH Good Clinical Practice (GCP), GxP regulations, project and quality management, and the development and delivery of training courses. She is a certified Project Management Professional (PMP) and an IAOCR Qualified Clinical Research Trainer (a qualification which further underscores her commitment to excellence in the field). Debbie is a senior training consultant and subject matter expert for Barnett International (since 2017) and develops and delivers GxP-related training courses e.g., Risk Based Quality Management, Clinical Project Management (basic and advanced), ICH GCP webinars and e-learning.

	Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P., specializes in maximizing excellence in GCP quality, compliance, and training for both sites and industry. She works with domestic and international clients to provide training and mentoring in the clinical research process, specializing in ICH-GCP compliance and quality oversight. She prepares clients for inspections/ audits as well as helps them write effective CAPAs and SOPs, develop quality plans and create internal QA processes. She began her career as a clinical research coordinator in academia over 35 years ago. She has held positions as a clinical research associate, site selection specialist, study manager with oversight of vendor CRAs, clinical operations quality management and trainer for several pharmaceutical companies. She is a fellow and dual-certified by the ACRP. Ms. Holwell 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.

	Treena Jackson, M.S., M.A., C.Q.A., R.A.C., C.S.S.G.B. provides global quality auditing, regulatory, process improvement, and training services with a focus on GCP and GLP. She has taught as an adjunct professor at both Campbell University and Durham Technical College in the Clinical Research Programs. At Campbell University, Treena taught in the undergraduate and graduate degree programs for Clinical Research and developed an online class on Pharmaceutical Compliance and QA. She has worked in the pharmaceutical industry for over 20 years working for a major pharmaceutical company, a small biotech, and CROs 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, a MA degree in Christian Education and a BS degree in Laboratory Animal Science. She is currently working on her PhD in Organizational Leadership. Treena 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), Regulatory Affairs Professional Society (RAPS), Society of Quality Assurance (SQA) as well as other organizations. Treena is also an author who has contributed to several regulatory affairs textbooks.

	Indu Kayarat is an experienced drug safety professional with over 12 years of pharmacovigilance, project management, business development and people management. Indu currently is employed as Associate Director with a leading global provider of clinical research services in their Aggregate Report Department. Her primary responsibilities involve project management, client interface, quality review of periodic reports, mentoring, training and contributing to leadership initiatives and innovations. She has also been involved in automation, preparing SOPs/guidance documents and process updates within her domain. She is also involved in people management and mainly responsible for performance of direct reports (quality, compliance, productivity, profitability, and utilization to name few). Indu has an undergraduate degree in Biotechnology and a postgraduate degree in Pharmaceutical Management.

	Laura Kelly, B.S., is a clinical research professional with over 25 years of experience focused on Clinical Operations. Ms. Kelly’s expertise includes leading/building teams and oversight of domestic and global clinical trials across multiple therapeutic areas. She started her career as a Study Coordinator at a cancer center. Since that time Ms. Kelly has worked as a CRA, Clinical Operations Clinical Trainer, Line Manager, Regional Manager of Clinical Operations, Associate Director and Director of Clinical Operations at several organizations. Ms. Kelly has worked for a CRO, large pharma/biotech and small start-up companies. She has experience in Phases I-IV clinical trials, including first in human studies. Ms. Kelly’s tenure in the industry includes extensive study start-up as well as post-marketing experience.

	Vanessa Laroche, B.S., C.I.P., CQA, C.C.R.P., is a clinical research professional with over 20 years of experience specializing in the management and regulatory oversight of domestic and international clinical trials in multiple therapeutic areas. She has advanced knowledge of federal regulations, ICH GxP guidelines and ethical codes governing the protection of human subjects. Ms. Laroche has many years of hands-on experience with conducting internal and external audits of suppliers/vendors and Investigator site visits, as well as evaluating Quality Management Systems and leading process improvement initiatives. She has served in many roles, including: Clinical Research Coordinator; CRA; Clinical Program & Operations Manager managing over 70 Phase II-IV investigational drug and medical device trials; Compliance Officer for the IRB oncology board at a prestigious academic medical center; and Clinical QA Manager at a large CRO and mid-size biotech company.

	Andy Lawton has extensive experience in computing, statistics, data management, RDE/RDC, system design, Risk Based Approach in both CSV and clinical trials. He currently works with a variety of companies and institutions on the implementation of ICH E6 R2, ICH E8, QMS/QbD and Risk Based Monitoring. Previously, Andy held the position of Global Head of Clinical Data Management at Boehringer Ingelheim where he also held positions of increasing responsibility during his 32 years with BI. Andy was a Founding Committee Member of ACDM, Member of TransCelerate RBM work stream and a Member of EFPIA WG on Data Transparency. His most notable publications is the paper with Dr. Alistair Ross on GP Audit - throughout 80's and 90's this was the most quoted paper in the BMJ, and he won “best author of the year 2015 and 2016” from the DIA, for the TransCelerate papers on SDV and Central Monitoring in the TIRS Journal.

	Susan M. Leister, M.B.A., Ph.D., CQA, CSSBB, has over 20 years of experience covering the pharmaceutical, medical device, and clinical arena, including extensive working knowledge of GCP, cGMP, GLP, ICH E6 GCP, and HSP. She has managed various inspections including ISO, CE Mark, Health Canada, MHRA, EMA, DEA, Maryland Board of Pharmacy, and FDA. Dr. Leister provides QM oversight to multiple government and commercial clients from large pharma to the small biotech startup. She currently oversees a QA auditing team comprised of ~ 20 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. Dr. Leister is seasoned in mock inspections and overall inspection readiness.

	Marina Malikova, Ph.D., MSci, MA, C.C.R.A., RAC, has over 17 years of experience in the clinical research field, with 8 years’ experience on executive level. She has managed Phase I – IV studies involving investigational drugs, devices, biologics and combination products. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology. Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She has a strong background in biomedical sciences and has completed her postdoctoral fellowship in the field of cell signaling and cell migration. She also holds a Master’s Degree in Clinical Investigation, Certification in Project Management from Boston University and dual board certified in Regulatory Affairs (RAC) for pharmaceutical products and medical devices by Regulatory Affairs Professionals Society (RAPS). She also holds professional certification in Clinical Safety and Pharmacovigilance by Drug Information Association (DIA).



	Jim Markley, assists clients in the management of their TMFs and maintaining oversight throughout the life of their studies. He has worked in the clinical research industry for the past eight years and has applied his ICH-GCP knowledge at a clinical site, large CRO, and in support of several sponsors. He has experience helping clients prepare for and manage FDA, EMA, MHRA and PMDA inspections.

	Heather Marshall, M.S.N., B.S.N., R.N., has over 20 years of research experience in the pharmaceutical and medical device arena focused on global Clinical Research in various roles and therapeutic areas including cardiovascular, CT surgery, neurology, and orthopedic surgery. As the Director of Clinical Affairs for a leading medical device company, Heather is leading numerous clinical studies, ensuring compliance with regulatory standards and advancing innovations in orthopedics. Prior to this role Mrs. Marshall led a safety team for a medical device CRO working with Medical Monitors, Data Safety Monitoring Boards, and Clinical Events Committees. In addition to her professional accomplishments, she is an experienced educator, having taught continuing education courses for cardiac nurses. Her commitment to education and her ability to convey complex concepts in an accessible manner make her an exceptional instructor for our research training programs. Participants can look forward to gaining insights from her vast experience and leadership in clinical research and medical device development. Mrs. Marshall holds an M.S.N in Nursing Leadership and Administration from the University of Phoenix.

	Shelley Marti, M.S.N., P.M.P., has extensive background in global pharmaceutical corporations with proven expertise in GCP and GCLP standards, worldwide health authority regulations, and quality assurance/compliance systems. Shelley has leveraged deep operational knowledge of drug development to empower and drive performance with cross-functional teams, ensuring companies achieve strategic goals while maintaining high-level quality/efficiency through strategic target setting, focus on execution and creating strong collaborations with stakeholders at all levels. Shelley is inclusive, practical, organized and a solution-oriented contributor known for leading by example with a positive ‘can-do’ attitude. Areas of expertise include: Quality, Audit Plan Strategies (Risk Based), Quality Agreements / Oversight Plans, Global Quality Project Leadership, Lead & Manage Quality Governance Frameworks, Quality Dashboard Development & Execution, Inspection Readiness Efforts, Investigation & Management of Quality Events, Onboarding & Training Strategies (Internal / External) and Quality Insight Analysis.

	Shelia Russell McCullers, M.S., D.M., is a Quality Assurance Manager with 30 years of scientific experience including quality assurance, regulatory compliance, clinical research, auditing, biotechnology quality control, safety monitoring, biomedical diagnostic testing and training. Dr. McCullers has conducted audits and hosted several successful inspections including internal inspections, EMA, CLIA and FDA. While serving in the military, she researched toxins that were potential biological weapons, and she was a member of the Human Use Committee in support of clinical trials at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). She has conducted research on the health effects and trends of tobacco use for NCI. As a Clinical Research Information Specialist, she prepared IND Annual Reports for submission to the FDA on behalf of the NCI. While researching sepsis, Dr. McCullers discovered a novel antibody to an adhesion molecule. She has completed training in Quality Assurance, GMP, GLP, GDP and GCP including the Protection of Human Research Subjects courses. While working as a Quality Manager, Dr. McCullers maintained a Key Performance Indicator score of greater than 90% for each quarter, and she submitted Medical Incident Reports, health department notifications, deviations and CAPAs with 100% on-time delivery.





	Linda Patricia Miller, M.D., has more than 20 years of experience in industry where she worked with Organon and Eisai as Director of Clinical Development, with Clinsys as VP of Clinical Development and Chief Scientific Officer, and PPD as Executive Director for Global Product Development. She served as Editorial Coordinator for the classic textbook, Blood Disease in Infants and Children. Dr. Miller received her MS and MD degrees from Rutgers University and completed her residency in pediatrics at New York Hospital-Cornell Medical Center. Her primary area of research and many of her publications are the design and conduct of new agent studies and early phase drug development.



	Kirsten Morasco, B.S., 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.

	Heather Murphy R.N., M.B.A., CQA is a Senior Pharmacovigilance expert with 23 years of experience with Drug Safety and Pharmacovigilance. Heather's career highlights included the development and implementation of Drug Safety and Pharmacovigilance departments at various small to mid-sized Pharmaceutical companies , the strategic and tactical implementation of global Pharmacovigilance systems for Pharmaceutical companies in preparation for global product launch, the completion of 220+ Pharmacovigilance audits (REMS, for cause, qualification, requalification, business partner, license partner, CRO, specialty pharmacy, and warehouse/supply/distribution vendors) and is the author of the book A Guide to Pharmacovigilance Audits in the USA (SpringerNature 2024).

	Danny Nasmyth-Miller, B.A. (Hons), M.B.A., began his career in clinical research in 1996, as a Clinical Research Associate (CRA). From CRA, he moved into project management (PM), leading global projects (phases I, II, III) and a 416-person Project Planning and Support department at a global CRO. In his roles, he oversaw the management of projects around the globe as a Vice President and Executive President. He continues to lead global projects for clients across pharma, biotech and device companies. Danny holds a degree in business studies and a Masters in Business Administration (MBA), and passed his PMP certification from the Project Management Institute (PMI) in 2005. In 2023 he was awarded City & Guilds level 3 teacher and training certificate. Danny is passionate about sharing his Project Management experience and in helping the next generation of PMs to deliver successful clinical research project management.

	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, leads Barnett’s Data Management training initiatives. She also consults and conducts audits for the Data Management, Biostatistics and Medical Writing disciplines. In addition to consulting on projects using real world data (RWD), she has also established a successful Clinical Data Management department at a CRO. Ms. Redkar-Brown is past chair of the Educational Committee and past Board member for the Society of Clinical Data Management (SCDM). She is published in the European Journal of Pharmacology for her work in pharmacology while at AstraZeneca and was also published in the Good Clinical Practices Journal. She is a contributing author of the Good Clinical Practice Question and Answer Guide, (Barnett International, 2017, 2018, 2020, 2022, 2024) and is co-author of the chapter on Selecting an EDC Application in the Good Clinical Data Management Practices (GCDMP) published by the Society of Clinical Data Management.

	Robert Romanchuk, B.S.H.S., CIP, 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).

	Nazma M. Rosado, MAOL, P.M.P., CPLP, 6σ, CMQ/OE has over 27 years of experience in the Biopharma industry having worked with companies such as Pfizer, Medimmune, Genentech, Astellas, EMD Serono/Merck KGaA, Janssen, Alexion, CuraGen, and various consulting companies. Ms. Rosado was involved with TransCelerate Biopharma, Inc. for 2 years and served as a Co-Lead for the Change Management Council and as the Change Champion for Astellas Pharma. She has been a Program Manager, Project Manager, Study Manager, and CRA before her move to leadership positions. She is an Adjunct Professor at Suffolk University Law School where she teaches a course on Pharmaceutical Development. She also teaches at MassBioEd’s Apprenticeship program. Ms. Rosado has a B.A. in Neuroscience and a B.A. in Psychology from Colgate University and an M.A. in Organizational Leadership from Gonzaga University.

	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).

	Barbara Tomasi, Ph.D., CIPPE, CIPM, DPO, DP is an experienced privacy professional with a demonstrated history of working in the pharmaceuticals industry. Skilled in Data Privacy, Personal Data Protection, Intercultural Relations, Privacy Law, Clinical Research, and Clinical Trials, her credo is that Data Privacy compliance is an enhancing and quality factor if taken deeply into account at the early stage of projects.

	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.

	Mary L. Veazie, M.B.A., CPA, CHC, CHRC, is a Certified Public Accountant with over 16 years of experience in clinical research finance. Collectively, she has over 30 years of financial and auditing experience. She established 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, auditing of health system’s clinical research billing program, and its impact on an organization’s clinic operations and revenue cycle. She is a professional coach, an author and serves on the board of directs of several non-profit organizations.

	Maria Veleva, M.D., has over 20 years of experience in the global R&D life sciences sector, covering all phases of clinical development across various geographies. Her expertise spans early-stage clinical development, project and quality management, ICH GCP, GxP regulations, and the design and delivery of training programs. A certified Lean Six Sigma professional, Maria is a sought-after trainer and speaker, having presented at numerous international conferences and authored several publications on clinical research and quality management. She has also been actively mentoring professionals for over 10 years, supporting career development and knowledge sharing within the industry. Maria serves as Chair of the Consultant Special Interest Group of the Research Quality Association (RQA), Co-Chair of the Quality Working Party of the European Forum for Good Clinical Practice (EFGCP) and is a member of the Society of Quality Assurance (SQA).

	Elizabeth Weeks-Rowe, LVN, C.C.R.A., has twenty-three years of diverse clinical research experience, having worked as a study coordinator, CRA, CRA Trainer and CRA Manager. Her experience as a CRA includes phase 1-4 studies, and studies in the areas of oncology, neurology, vaccines, endocrinology, critical care, women’s health, dermatology and some ophthalmology. She gained specific expertise in site evaluation and investigational models by spending 11 years on a dedicated pre study evaluation visit team for a large CRO. She has a passion for coaching/development and has worked as a dedicated CRA evaluator, conducting monitoring sign off visits on new CRAs and performance monitoring assessment visits on experienced CRAs to ensure quality in monitoring. She has developed CRA training content and delivered classroom and field training to new and experienced CRAs and has a passion for coaching and development. Ms. Weeks-Rowe has also authored several publications on the CRA role and has written >50 articles/blogs for various clinical research publications, such as ACRP, Centerwatch, Pharmatimes, Clinical Leader and the Journal of Best Research Practices, and authored a monthly clinical research column entitled “Pulse on Study Conduct” about life as a traveling CRA.



	Laura Wiggins, M.B.A., has over 20 years of experience in the clinical research and marketing industries. Her earlier work included patient recruitment, media planning and buying, participant outreach, business development and medical writing within the Phase 1 and multi-site CRO space. Laura currently coordinates TMF management activities and works with clients to analyze, develop and implement processes that support business use of electronic clinical systems to ensure TMF quality and completeness. Laura has a passion for organization and collaboration with her colleagues and clients to achieve results.

Shana Zink, B.S., C.C.R.A. has over 25 years of research experience in the pharmaceutical and medical device arena with the past 15 years focused on global Clinical Research in various therapeutic areas including cardiovascular, orthopedic surgery, bariatric, oncology and plastic surgery. From 2013-2018, Shana was Vice President of Clinical Affairs at AtriCure, Inc., an innovative leader in the treatment of atrial fibrillation. Prior to AtriCure, she held positions with a variety of responsibilities including Quality Assurance and Clinical Affairs at J&J, Proctor & Gamble and Searle Pharmaceuticals (a Monsanto Company). Ms. Zink holds a B.S. in Biological Sciences from Northern Illinois University and obtained a certificate in Project Management from Boston University Corporate Education Center.