|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).|
|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.|
|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 became 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.|
|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.|
|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., ACRP-PM., P.M.P., has over 25 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.
Stacy Hoffman, B.S., M.C.R., has over 13 years of experience in clinical research. She began her career with a large phase 1 first-in-human CRO and has worked in a variety of roles including Clinical Project Administrator, Senior Start Up Specialist, Country Trials Manager and Start-Up Project Manager with a leading pharmaceutical company. Mrs. Hoffman has also managed multiple trials as a Project Manager from phases I-IV, including Early Oncology Phase 1 trials. Stacy brings clinical procedural experience from previous roles and has always been passionate about developing junior staff and others by using her experience to deliver trainings that are practical and engaging.
|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., 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.|
|Victoria Johnson, M.B.A., C.P.C. is a healthcare leader with over 15 years of clinical research billing and revenue cycle experience in both academic and corporate settings. Ms. Johnson’s specific experience in the financial management of clinical research, project management, revenue cycle management and technical/professional coding includes roles at the University of Texas MD Anderson Cancer Center as well as at number of healthcare systems and specialty practice settings. She has developed compliant research billing programs and throughout her career, she has demonstrated a strong ability to improve processes and create efficiencies within cross functional teams while reducing costs, increasing efficiency and improving profitability while maintaining compliance with applicable regulations. She is a certified professional coder with the American Academy of Professional Coders (AAPC) and also holds certifications in Claims and Insurance Follow Up with the Epic Certification group.|
|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
|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).|
Damien Mair, M.Sc., is an experienced data privacy and clinical research professional, with proven success in project management, process development/implementation and change management. He has 15 years of experience in the pharma industry (across various functions and levels of seniority within CROs), and 8 years of experience managing global teams and projects. Mr. Mair is a certified Data Protection Officer.
|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.|
|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.|
|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.|
|Denis R. Miller, M.D., earned his AB and MD degrees at Cornell University and completed his post-doctoral training at Children’s Hospital, Boston and Harvard Medical School. He has over 25 years of experience in academic medicine in pediatric hematology/oncology at Cornell, Memorial Sloan Kettering Cancer Center, and Northwestern University. Most of his clinical and laboratory research focused on hematologic malignances. He was a long-standing member and Vice Chairman of Children’s Cancer Group, a past president of the American Society of Pediatric Hematology/Oncology, and the Scientific Director of the Cancer Treatment Research Foundation. He has published over 300 peer-reviewed articles, chapters, books, and abstracts and was on the editorial boards of the British Journal of Hematology and American Journal of Clinical Oncology. Deny has 17 years of experience in industry and has worked for Roche, Aventis, and J&J PRD as well as at multiple CROs.|
|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.|
|Erika Moncada B.Sc., is a privacy professional skilled in data privacy, personal data protection, intercultural relations and clinical research. Her credo is that data privacy compliance is an enhancing and quality factor if taken deeply into account at the early stage of projects. She is DPO Certified from Maastricht University and the BSI Training Academy.|
|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.|
Tammy L. O’Dell, B.S., C.C.R.C., C.C.R.A., ACRP-PM has over 25 years of experience in clinical research, including 10 years of experience at a Site Management Organization (SMO) for pharmaceutical research (IND, Phase 2-4, multiple therapeutic indications) as well as her most current experience for the last 18 years at a medical device sponsor (IDE and Phase 2-4 post-market clinical follow-up). At the SMO, she served as a Certified Clinical Research Coordinator (CCRC) and moved in managerial roles. At the medical device sponsor her expertise includes direct communications and reporting to US and OUS regulatory bodies. Further, she has specialized in medical device monitoring and site training, project management, and protocol and case report form (CRF) creation and related clinical operations for recruitment and compliance. She also has experience with investigator site audits and support for US regulatory inspections, including CROs and external monitors for global studies. Ms. O’Dell has been published in peer-reviewed journals for medical device study outcomes and has had various abstracts and scientific exhibits presented at medical devices societies. She also holds the following ACRP certifications: Certified Clinical Research Coordinator, Certified Clinical Research Associate, and an ACRP-PM.
|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).|
|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).|
|Jennifer L. Stanford, R.N., M.S.N., has over 25 years of experience in the field of clinical research, which includes initiating four clinical trial departments across the country, within both an academic medical center and three community health systems. She specializes in efficient clinical trial start-up, trial management, training and consulting. The majority of her experience has been at the site level, where she has effectively managed trials in all therapeutic areas across all phases of clinical research, including industry sponsored, federally funded, and cooperative group trials. Her focus has been on FDA guided drug and device trials, in both out-patient and in-patient settings. Recently, the focus has been on rapid COVID-19 study start-ups within a large community health system, pediatric vaccine trials and OTC rapid antigen device trials.|
|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.|
|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.|
|Carl R. Torchio, B.S., has worked in the clinical research industry (pharma, biotech and contract research organizations (CROs) since 1984 in various capacities ranging from clinical research monitor to vice president. His therapeutic experience includes cardiovascular disease, infectious disease and 19 years in oncology research. His operational specialty is project management having co-developed courses in project management and co-authored several papers and abstracts on aspects of project management.|
|Susan Torchio, R.N., B.S.N., has over 20 years of clinical research experience. For the past 10, years she has been an instructor for Barnett International’s CRA and CRC course. Sue started her career in clinical research as a study coordinator at a busy family practice site that participated in multiple studies in a wide range of therapeutic areas including cardiology, infectious disease, and gastrointestinal. After two years as a coordinator, Sue joined a large CRO as a Clinical Research Associate, conducting a variety of late phase clinical programs. She has been at two other CROs in her career as a Project Manager working in infectious disease, trauma, endocrinology, and cardiology. She joined a BioPharma company in 1998 as a consultant and later a Project Manager in Medical Affairs. Medical Affairs was combined with Clinical Operations and she was promoted to a Senior Manager working in the CNS group. In 2005, her role changed and she is now heading up leading the Resourcing Group as an Associate Director within Clinical Operations. In this role she is responsible for working with a Function Outsource Provider to manage a field force of Regional Managers and Regional CRAs. In addition to her other responsibilities, Sue is also heading up the Pain Program in Clinical Operations. In this role she is in charge of various pain compounds and the studies that are conducted with them.|
|Lee Truax-Bellows, 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).|
|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.|
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.
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.
|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.|
|Shana Zink, B.S. 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.|