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Douglas E. Albrecht, B.S.N., C.C.R.A., has been in the clinical research industry for 20+ years, beginning his research career with the pharmaceutical industry, and for the last 17 years in the medical device industry. He has worked for large, small and start-up device manufacturers over the 17 years holding numerous positions from Clinical Coordinator to Clinical Project Manager to Manager of Clinical Affairs. Through it all Doug has helped develop and manage a number of large-scaled multi-center IDE trials leading to successful marketing applications for each. Since the year 2000, along with working full time for various companies, Doug has been a trainer for Barnett International, training in areas of clinical monitoring, clinical development and trial design, and managing and reporting adverse events.

Rob Andes currently serves as EVP of Engineering and Operations Core Concept, Inc., a software product and services company providing software solutions for pharmaceutical clinical trial management and analysis of studies as dynamic systems. Beginning in systems R&D, Mr. Andes has developed advanced technology solutions based on original work in artificial intelligence and cognitive engineering applied as software solutions. A technology leader and innovator, he has held positions as a key executive and lead team member of software applications companies, from successful start-ups to public companies. These postings have included the successful turnaround of a software unit at a Fortune 100 company and new technology developments in the medical field.  A member of the IEEE Systems, Man, and Cybernetics Society and the Association of Computing Machinery, he is a frequent speaker and has published multiple scientific and business publications, including journal articles and technical book chapters. Mr. Andes holds a B.S. in Applied Psychology and an M.S. in Industrial and Systems Engineering (Human-Machine Systems) from the Georgia Institute of Technology.
 

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Susan Bassion, Ph.D., has over 20 years of clinical, research and business management experience. She is currently an independent clinical research consultant and trainer. She has been Director of Clinical Operations and was responsible for the oversight of multiple Phase I-III projects across the therapeutic disciplines. She was also Director, Product Development and Regulatory Affairs. Her responsibilities included providing consultation on clinical drug development, including strategy, trial design and coordination of regulatory submissions.

 Meredith Brown-Tuttle, R.A.C. has held senior regulatory positions at Bay Area pharmaceutical companies and a full-service CRO. She has written and coordinated numerous drug and biologic submissions to US and international regulatory agencies, developed regulatory strategy for both device and drug companies, and conducted worldwide regulatory intelligence.
 

Majda Benhayoun, Ph.D. is currently Director of Program and Portfolio Management at Vertex Pharmaceuticals and has been working in drug development for the past 3 years. Prior to joining Vertex, Majda worked in Clinical Project Management for more than 15 years, with her first 11 years at Aventis Pharma, previously Rhone-Poulenc Rorer, and then 4 years at PAREXEL International where she held a position of Clinical Project Director. Majda has extensive experience in project management both strategic and operational in early and late stages of drug development in various therapeutic areas, some of them being CNS, inflammation, or immunology. As Clinical Program Manager, Majda has a broad experience in the concepts of clinical trials including planning and execution of clinical trials from single site Phase I to large and complex multinational Phase III trials concluding in NDA/MAA filing.

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 E. Carol Cox-McClave is the founder and Vice President of Intercoast Quality Assurance (IQA). Ms. Cox-McClave has extensive expertise in clinical research including clinical monitoring, quality assurance and Phase I research. She has worked in pharmaceutical research for over 20 years and in the quality assurance area for over 20 years. Ms. Cox-McClave has performed investigational site, sponsor-monitor, clinical report, submission, computer validation and systems audits. She has initiated and/or managed Quality Assurance departments for several major pharmaceutical companies. Ms. Cox-McClave holds a Masters degree in mathematics and computer science.

 Natalie Currie is an instructional designer, facilitator and founder of Natalie Currie, Clinical Research Consulting Inc. a learning and development organization dedicated to Academic Research Organizations, the Pharmaceutical and Biotechnology Industries and Clinical Research Organizations. Harnessing her 18 years of broad based clinical research experience Natalie is sought after as a speaker and facilitator in the United States and Canada. Natalie’s breadth of roles has spanned from Clinical Research Coordinator, Clinical Research Associate, Clinical Research Project Manager and management roles in Government and Health Economics. She has worked at the Addiction Research Foundation (now the Centre for Addiction and Mental Health [CAMH]) and Janssen-Ortho Inc. (a division of Johnson and Johnson) and has participated on international project teams for pivotal Phase III studies and led Canadian Phase IIIb-IV studies. Natalie holds an honors life science degree from the University of Toronto and is a member of the Society of Clinical Research Associates (SoCRA), the American and Canadian Societies of Training and Development (ASTD & CSTD), Toastmasters International and is on the organizing committee for the World Creativity and Innovation Week in Toronto.  Natalie designs and facilitates engaging, customized corporate and public workshops in the areas of clinical research study management, good clinical practice and communications all with visual thinking in mind.

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 Anil D’Mello 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.

 David R. Dills is a consultant on technical and regulatory affairs and compliance to pharmaceutical, Class I, II, and III medical device, and biologics/biotech companies with an emphasis on establishing sustainable compliance and validation environments. Through his work, Mr. Dills has been affiliated within the FDA-regulated industry for more than nineteen years in the areas of QA, Quality Engineering, Validation, Regulatory Affairs/Compliance, and Corporate/Operations Management and employed on behalf of well-known, globally recognized manufacturers and service providers. Mr. Dills has authored and published numerous validation and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter.

Rakesh Dixit has a PhD in Toxicology-Biochemistry and is board certified in Toxicology from the American Board of Toxicology, Inc. since 1992. He conducted his pre-doctoral to post-doctoral training in biochemical mechanisms of toxicity, chemical carcinogenesis, and cancer chemoprevention at the University of Lucknow ( M.S.) Industrial Toxicology Research Center, India, and Case Western Reserve University, Ohio, USA, and the Medical College of Ohio, USA. Subsequently, he joined the faculty of University of Nebraska Medical Center, Eppley Institute for Cancer Research, and Allied Diseases in Omaha, NE. Dr. Dixit has over 20 years of experience in developing drugs with an extensive publication record. He spent 13 years at Merck and Co., Inc. at various senior level positions in the department of safety assessment. Dr. Dixit joined Johnson and Johnson as a Senior Director in Toxicology in 2005. He recently joined MedImmune, Inc. in Gaithersburg, Maryland as Senior Director and Head of Toxicology. Dr. Dixit is responsible for managing various drug development projects and biomarker projects.

 Ruth Dubinsky, M.S. O.D., founder of Clarity Consulting, Inc., works with pharmaceutical, biotech, device, and CRO clients, specializing in team dynamics. A former bench scientist, drug developer, and clinical researcher, she brings over 30 years of industry experience to her consulting practice. She understands the unique challenges and intense pressure on global, matrix pharma teams. Her work focuses on helping teams assess and recover from breakdowns, deal with inevitable conflict, make better, faster decisions – and accelerate their work. Teams walk away with clarity about what they can do differently – both behaviorally and operationally – that will have meaningful impact on moving their product through the pipeline. She co-led and co-authored a research study designed to identify specific behaviors and strategies of the highest performing drug development teams within J&J.

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 Lynne Eddy received her Ph.D. in Physiology and Biophysics from the University of Alabama at Birmingham. She has extensive experience in research and teaching in a university environment, having been a faculty member at Florida State University, the University of South Alabama College of Medicine, and the University of Southern California. She also has a broad base of experience in clinical research in both the pharmaceutical industry and in contract research organizations. She most recently was Director, Clinical Research Practices, at Alliance Pharmaceutical Corp. in San Diego and was responsible for assurance that clinical studies were being conducted in accordance with company, federal, and other agency guidelines and laws. She is currently serving as a consultant to the pharmaceutical and medical device industry in clinical research, compliance, and training and continues her teaching at UCSD Extension in several programs relating to clinical research where she has taught GCPs to over 1000 students over the past 10 years.

 Erica Elefant, R.N., B.S.N., M.S.W. has close to 15 years of clinical research experience and continues to work in the pharmaceutical industry. She has worked as a study coordinator, site monitor, and clinical research project manager in multiple therapeutic areas and phases of drug development. In addition to acquiring a strong clinical research knowledge base, Ms Elefant has obtained hands on experience writing clinical documents and SOPs. Ms. Elefant has worked as adjunct faculty at Drexel University and as a Clinical Trials Learning Manager where she has been responsible for developing and delivering trainings on various clinical research topics.

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Barbara S. Fant, Pharm.D., has over 18 years experience in pharmaceutical and medical device research and development. CRC is an independent consulting firm that provides clinical and regulatory support services to medical device and pharmaceutical companies to bring investigational products to market. CRC’s client base includes U.S. and international companies with a focus on start-up and incubator companies developing novel medical devices. CRC has successfully filed over 30 IDEs, pre-IDEs, 510(k)s, and PMAs with the FDA in the past four years. In addition to ophthalmics, therapeutic areas of expertise include imaging technologies and orthopedics. Dr. Fant is the principle regulatory consultant and owner of CRC. Prior to founding CRC, Dr. Fant spent several years directing and managing anti-infective clinical trials and pharmacokinetic studies with a major pharmaceutical company; established and directed a highly successful Phase I/Phase II academic-based clinical pharmacology research center at the University of Cincinnati; served as the vice chairperson and associate administrator for an independent institutional review board; and, was an assistant director for clinical research for a large contract research organization. Dr. Fant is recognized as an expert in FDA regulations pertaining to medical devices with extensive experience in developing ophthalmic medical devices. Dr. Fant also serves on the board of directors for Medennium, Inc., Salpingo Medical, and several charitable and philanthropic organizations in the Cincinnati, Ohio community. She holds a B.S. in Pharmacy from Ohio Northern University and a Doctor of Pharmacy degree from the University of Cincinnati Medical Center.

 Anna Filimonova, M.D., Ph.D., Associate Director GRO, CRA/GMBA, PAREXEL International (RUS) LLC, located in Moscow, Russia. Anna has MD degree and PhD in Paediatrics, Allergology & Immunology, was a university lecturer and consultant in Paediatrics for 4 years. Since 1998 Anna has been working for PAREXEL, first as CRA and than holding manager’s position in Clinical Operations in Russia. She has extensive experience in the pharmaceutical industry, her areas of expertise include clinical research and regulatory requirements in Russia, CIS and Eastern European countries.

 Gary B. Freeman, M.S., C.C.R.A., C.C.R.T., is President of The Freeman Group, a niche service provider of quality clinical monitoring, auditing, training, project management and consulting services internationally. He has personally worked in these areas with pharmaceutical, device, healthcare and contract research organizations for over 30 years. Mr. Freeman has been a credentialed clinical research trainer through ACRP since its inception in 2003.  Mr. Freeman holds a B.S. in Biology (pre-med program) from the University at Albany and an M.S. in Science Education from Russell Sage College. He has been actively involved in various clinical capacities for multiple therapeutic areas (Phase I-IV) for the following indications as well as devices:  allergy; anti-infective; cardiovascular; critical care; dental; dermatology; endocrinology; eye care; GI; imaging/diagnostics; immunology; infectious disease; oncology; organ transplant; OTC medications; psychiatric disorders, pulmonary; sleep disorders; and STDs. This experience includes pre-clinical laboratory work, data management, protocol writing and CRF design, clinical monitoring, clinical trial management, GCP auditing, developing and presenting clinical training programs, regulatory affairs management and overall responsibility for Clinical Operations in several settings, including presentations at FDA Advisory meetings. Mr. Freeman has also participated as a trainer for ACRP’s CRA and CRC Certification Exam Review courses and other clinical offerings and is an active instructor for several Drug and Device courses for Barnett International for public and on-site offerings. He lectures routinely worldwide and presents training workshops for drug and device companies, as well as investigator sites in addition to conducting GCP audits at investigational sites and vendors for pharmaceutical and device studies. Mr. Freeman is currently an active member of ACRP (Association of Clinical Research Professionals), DIA (Drug Information Association) and SQA (Society of Quality Assurance).

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 Albert A. Ghignone, M.S., R.A.C., is the CEO/President of AAG Incorporated. For more than 25 years, his professional focus has been in regulatory affairs, quality assurance, and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, and medical devices. He has been responsible for regulatory submissions, registrations, FDA liaison, and compliance activities. He also has expertise in the assessment of product and facilities for due diligence relative to FDA requirements. He lectures throughout the world on numerous FDA related matters. He is a member of the Regulatory Affairs Professional Society, which awarded him as 1984’s Professional of the Year. He has served the society as Vice President, President, and Chairman of the Board of Directors.

Diego Glancszpigel is an expert in designing and developing strategies for clinical trials in Latin America. He has been working for 14 years for the CRO Industry in Latin America and he is currently responsible for PAREXEL operations in Latin America. He regularly speaks at international conferences about Clinical Trials in Latin America and has expertise in study design, regulatory considerations, and cultural considerations.

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Yolanda Hall possesses a Masters in Regulatory Affairs and Health Policy. She currently holds the title of Director of Regulatory Affairs at Datafarm where she brings over 15 years of life science and healthcare regulatory experience to her position. Her primary responsibilities include supporting sponsors in implementing electronic submission filing strategies of all types to global regulatory bodies. She supervises the day to day activities of the Professional Services group which encompasses coordinating eCTD application and related software deployment, training and support. Additionally, she provides oversight for publishing, compilation tasks, and quality assurance compliancy for electronic submission procedures and processes.

 Elkan Halpern, Ph.D., is the chief statistician for the Department of Radiology and the Director of Statistics for the Decision Analysis and Technology Assessment Group, Massachusetts General Hospital. Formerly holding positions of Principal Statistician and Vice President, Dr. Halpern has had over 30 years of experience in all phases of clinical and statistical research for FDA submissions and post-marketing studies.

Beth D. Harper, B.S., M.B.A., Beth is the Chief Clinical Officer of Centerphase Solutions, Inc., whose mission is to deliver timely and predictable clinical trials.  Previously Beth was President of Clinical Performance Partners, Inc., a clinical research consulting firm specializing in enrollment and site performance management.  In addition to her 25+ years of clinical research experience, she is an Adjunct Assistant Professor at the George Washington University who has published and presented extensively in the areas of study feasibility, site selection, patient recruitment and protocol optimization.  Beth received her B. S. in Occupational Therapy from the University of Wisconsin and an M.B.A. from the University of Texas.

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Steve Jolley is Principal of SJ Pharma Consulting and has 23 years of experience in drug safety & pharmacovigilance. He is a specialist in global safety compliance and signal detection and has worked with over 50 clients in the US, Europe and Japan. Steve is a regular speaker at international industry events including DIA and MHRA, and a featured speaker with the FDA at DIA conferences and webinars on auditing, signaling and data mining.

Kenny Jones holds a degree in nursing, business administration, a master’s degree in business management and is currently completing work on his doctorate degree in clinical psychology. He started working in the pharmaceutical industry in 1988. He worked in several roles that allowed him experiences to include good manufacturing practices, good clinical practices, monitoring, auditing, clinical project management, and many others. He has worked on national and global, phase 11 and III, adult and pediatric studies, in the areas of neuro/psyche and infectious diseases. In 2005 Kenny began work in the Medical Device industry developing and managing clinical research studies in the endovascular and drug eluting stents environment.

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 Sidney Kahn, Ph.D., professional credentials include MB, ChB (Cape Town), Ph.D. (London),  FRCPath (Chemical Pathology), and MFPM. His academic career spanned 17 years in clinical laboratory medicine and basic research in neuroimmunology in the UK and USA. He spent the next 13 years at Bristol-Myers Squibb and Johnson & Johnson managing drug safety groups responsible for safety assessment of medicinal products throughout their lifecycle before establishing Pharmacovigilance & Risk Management Inc. in 2002. Throughout his industry career, he was actively involved in US and global activities to enhance pharmacovigilance, risk assessment, and risk management, including PhRMA representation to ICH on MedDRA EWGs (M1, MedDRA MSSO Technical Evaluation Panel, Points to Consider), the U.S. National Coordinating Council for Medication Error Reporting and Prevention, the PhRMA/FDA Electronic Regulatory Submissions Task Force, and the ICH Post-Marketing EWG. He was a member of the CIOMS-VI WG, a MedDRA MSSO Blue Ribbon Panel, and the HL7 SPL Implementation Workgroup. Dr. Kahn is a frequent presenter at conferences and workshops in the USA and Europe on all aspects of pharmacovigilance, risk management, and labelling.

 Hillary Kimes, R.N., M.S.N., C.C.R.A., C.C.R.C., has over 15 years experience as a CRA and CRC within the US, Europe, and Asia. Her clinical expertise is in cardiology, interventional cardiology, neurology, ED/trauma, and oncology. Her experience includes the development and conduct of clinical team, CRA, and investigator training focusing on implementing GCP compliant clinical research in the United States, Hong Kong, Singapore, and Beijing. She has conducted QA audits within the US and Asia and developed quality improvement, site-based systems. Hillary currently monitors and provides training for drug and device studies to teams utilizing EDC for global clinical trials. Hillary is best known for her signature work on the development of “The Golden Rules of Monitoring” and focus on improving site performance.

 Piotr Kolataj, M.D., practiced clinical medicine (internal medicine and dialysis) in Warsaw, Poland for more than 10 years. Dr. Kolataj graduated from Warsaw Medical School and became board certified in internal medicine in 1992. The same year, while continuing his work as a hospital clinician, he joined PAREXEL International in its endeavors to develop the CRO industry in Poland and the CEE region. In 1995 Dr. Kolataj was appointed to the position of Country Manager of PAREXEL’s fast-growing Polish office. In 1998 Dr. Kolataj co-founded the Polish GCP Association and served several years as a board member, and President from 2000-2002. As a result of his successes in expanding the company’s structure and growing the number of international clinical trials coming into the CEE region, Dr. Piotr was appointed PAREXEL’s Director of Clinical Operations-Eastern European Region in 2002 where he has responsibility for countries such as Russia, the Ukraine, the Baltic’s,  Poland and Georgia. In 2003 he achieved a master degree in business administration from French Institute of Management in Warsaw. Besides his management work at the PAREXEL, Piotr is a regular speaker on international meetings and seminars promoting clinical trials in emerging regions especially CEE by sharing his own experience and observations on developing clinical trials.

 Robert L. Kunka, Ph.D. is an acclaimed scientist who has a long history of getting drug approvals quickly. Bob has contributed to the development of 27 pharmaceutical products in a seven therapeutic areas including Advair, Flovent, Flonase, Retrovir, Valtrex, Imitrex, Combovir, Zofran, Maxaquin, and Calan. His expertise on international product development teams produced submissions with successful clinical pharmacology strategies, sound matrix management of individual study teams, and effective interactions with regulatory agencies leading to successful IND/aNDA/sNDA/NDA approvals. Prior to starting a career as a consultant, Bob’s experience in drug development stems from 24 years in the pharmaceutical industry at GlaxoSmithKline (GSK), Chugai-Upjohn, and GD Searle. Prior to this, he was Assistant Professor in the Pharmaceutics Department at the University of Pittsburgh School of Pharmacy where he taught graduate and undergraduate courses in pharmacokinetics and pharmacy posology. He also served on the Technical Advisory Committee for the Pennsylvania Generic Drug Formulary. Bob earned his Ph.D. in Pharmacokinetics at the University of North Carolina (UNC) at Chapel Hill and Bachelor of Science in pharmacy at the University of Illinois at the Medical Center in Chicago. While at UNC, he was honored to be named the American Foundation for Pharmaceutical Education Charles J Lynn and Syndor Barksdale Penick Memorial Fellow. Since then he has authored over 75 publications and presentations at international scientific meetings, serves as a reviewer for the Journal of Clinical Pharmacology, and received a number of scientific awards including GSK Silver and Gold Recognition Awards, the Glaxo Medical Operations Outstanding Service Award, and the GD Searle Special Unit Award.

Doreen W Lechner, Ph.D. began her career in the pharmaceutical industry at Wyeth-Ayerst in pre-clinical drug metabolism and then moved onto Schering-Plough Corporation's Drug Safety Group and eventually moved into the Regulatory Affairs arena. She continued her career at Bristol-Myers Squibb as an Associate Director of Regulatory Affairs. In these positions Doreen was exposed to a variety of regulatory challenges including comprehensive management of FDA submissions, identification of safety issues, development of safety programs for Rx to OTC switches, and preparations for advisory committee meetings.

Dr. Lechner moved to Sentrx in 1999 and has been part of the team for the past 11 years, assuming several positions in the areas of Adverse Event Management and Quality Standards. She has over 30 years of pharmaceutical industry experience, with a strong focus on Regulatory Compliance and Adverse Event Operations. She has been an instrumental part in creating the Sentrx internal infrastructure surrounding regulatory compliance and quality standards. Through Dr. Lechner's hard work and instruction, Sentrx has successfully "passed" every regulatory agency and client inspection/audit ever performed of our facility. In addition to keeping Sentrx compliant, Dr. Lechner  is a member of the Executive Leadership team and leads the Client Account Group team which is responsible for delivering pharmacovigilance expertise to our clients.

Dr. Lechner received her PhD in Pharmacology from the School of Biomedical Sciences at The University of Medicine and Dentistry of New Jersey.  

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 Anne McDonough, M.P.H., C.C.R.A., M.I.C.R., has over 15 years 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 scientist, 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, medical devices, and vaccines) in a variety of therapeutic areas. She also currently chairs the exam committee for the EU and ICH CCRA exams (Association of Clinical Research Professionals).

Christopher Metzler, D.P.M., has extensive experience in global pharmacovigilance and drug information systems compliance and auditing. He is responsible for the Sentrx regulated document system; process improvement initiatives; and responses to client, health authority and business partner audits. Prior to joining Sentrx, Dr. Metzler was Audit Manager for Wyeth Pharmaceuticals’ Global Business Compliance group. There he was responsible for auditing headquarters, affiliates, and business partners for pharmacovigilance, privacy, labeling and medical information practices against international laws and regulations and company policies and procedures. During his tenure, he audited more than 200 drug safety SOPs and maintained an excellent level of understanding of current global pharmacovigilance legislation and guidance.  Dr. Metzler also spent nearly five years with Schering-Plough Corporation, holding positions of increasing responsibility in Drug Safety Surveillance Compliance, Operations and Training. As Senior Global Drug Information Services Compliance Manager, Dr. Metzler oversaw audits, standard operating procedure (SOP) development and compliance, training and medical inquiry support.  Prior to entering the pharmaceutical industry, Dr. Metzler was a pharmacist and a practicing podiatrist. He graduated from Rutgers College of Pharmacy in 1984 and from New York College of Podiatric Medicine in 1989. He holds NJ licenses for Podiatry and for Pharmacy, and he is certified by the American Board of Podiatric Orthopedics.

 Miguel Montalvo has over 22 years of experience and, as part of his current role within AAC Consulting Group, Inc., he provides specialized compliance-focused consulting and management of validation projects for customers around the world. Before joining AAC in 1999, Mr. Montalvo held positions of increasing responsibility in the areas of Validation, Technical Services and Quality Operations in companies such as Millipore Corporation, Raytheon Engineers and Constructors, Mova Pharmaceutical Corp., Bristol-Myers Squibb, and Baxter Healthcare Corporation. He has managed the validation efforts for several facilities under start-ups and major renovations with processes including bulk API’s, solid-dosage, parenterals, topicals, liquids, and medical devices for customers in the pharmaceutical and biotechnology segments.  He holds an MBA and a BS in Chemical Engineering from Rensselaer Polytechnic Institute. His expertise includes areas such as Process and Cleaning Validation, Use of Statistics in different applications, Facility and Equipment Qualification with focus on Sterile Operations, and Validation of Sterilization/Depyrogenation Processes. He has been a speaker at validation and quality related conferences around the world for such groups as IIR, IVT, and Barnett International and his articles/papers have been published in the American Pharmaceutical Review and the Journal of Validation Technology publications. He is a member of the Journal of Validation Technology editorial board.

 Eric Morfin, M.B.A., P.M.P., is a partner with Critical Skills Inc. whose mission is to increase organizational effectiveness through the establishment of Superior Thinking Skills as a company’s most sustainable competitive advantage. Critical Skills Inc. primary focus is in applying project management best practices to the Pharmaceutical / Biotech / Life Sciences industries. Eric Morfin, PMP, has been a project manager since 1987. A sought after speaker on the subject of Project Management, Portfolio Management and Resource Management at North American and European symposiums and conferences, Mr. Morfin has been published many times in PM Magazines and Pharmaceutical publications. Currently co-author of several Project Management in Pharmaceuticals books, Mr. Morfin is an active member of several professional societies and has developed several unique seminars on Project Management in Drug Development such as “Project Management in Discovery and Preclinical” and “Project Management for Global Clinical Trials”. He is the Chair of the PM Norcal PharmaLIG and the Chair of the PMI Pharmaceutical SIG (www.pharmasig.org).  He has consulted with clients in a variety of industry settings throughout North America, Europe and Asia. He has worked with the World Bank, Merck Frost, Hewlett Packard, GlaxoSmithKline, Aventis, Novartis, Bristol Myers-Squibb, and Astrazeneca to name only a few. Prior to partnering with Chiron, Mr. Morfin managed for 10 years the project management practice of a worldwide training and consulting organization headquartered in the USA. Previously, he worked with a leading consulting group in the strategic field. In Europe, besides managing his own computer firm, dealing in digital animation, he created and managed an entire new division for Apple Computer. Mr. Morfin is bilingual in French and English, has traveled extensively in Europe and Asia, earned his M.B.A. in International Business in San Francisco. He currently lives in San Francisco with his wife and daughter.

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John J. Needham is the Chief Operating Officer of Patient Recruitment Strategy, LLC, a consulting firm focused on global strategies for patient recruitment, enrollment, compliance, adherence, and retention. The firm advises pharmaceutical drug development, biotech, medical device, and contract support organizations. Prior to establishing this organization, John was the head of Global Patient Recruitment Strategies for Phase II and III trials at Johnson and Johnson Pharmaceutical Research and Development, LLC. John has held senior leadership positions within the healthcare industry at Acurian, Alliance Health Information, PatientQuest, Telerx Marketing, TeleSpectrum Worldwide, and PharmaKinetics Laboratories.

Elizabeth Ronk Nelson, M.P.H., has over 20 years of experience in medical and clinical research. During her career, she has managed clinical trial site operations as a clinical research program coordinator and researcher and has served as an IRB Quality Assurance Specialist and a Senior (GCP) Auditor, Trainer, and Compliance Director. Her professional areas of specialization include fraud detection and prevention; mock FDA audits; customized, audit finding-specific, risk-based training; independent GCP quality systems and compliance audits; SOP and training program development and gap analysis; corrective and preventative action (CAPA) and quality systems improvement plans for GCP; customized skill-based training for clinical research professionals; clinical investigator site and IRB development and quality improvement (QI) plans; vendor audits/assessments; and site selection/qualification assessments. Ms. Nelson has extensive experience in investigating and pursuing suspect clinical data cases and has worked professionally with industry and government representatives to pursue legal actions for severe noncompliance cases.

David Nettleton is a 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation consultant involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. Services include compliance related to product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.  He has completed more than 180 mission critical software implementation projects involving: medical devices, blood bank, clinical trial, corrective action, document control, electronic data capture, Excel spreadsheets, laboratory instruments, laboratory information management (LIMS), manufacturing, enterprise resource planning, toxicology systems, and VMWare. His latest book is “Risk Based Software Validation - Ten easy Steps” which provides fill-in-the-blank templates for completing a COTS software validation project.

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 Marcellina N. Oparaoji, Ed.D., B.S.N., R.N., C.C.R.P., As a study coordinator, clinical research Monitor, Project Manager, Training Director and clinical research administrator, Marcellina has been involved in clinical trial management; trial coordination; site monitoring; project management and coordination; budget development; training of other clinical personnel, orientation and site management, with pharmaceutical industry experience, CROs and academic settings. Dr. Oparaoji has extensive background in Curriculum development and course delivery of multi-disciplined learning experiences, to small, large and diverse customer groups and cross-functional teams. She has also been both an academic and clinical consultant in different settings. As a Vice President of Nursing/Science Education, she managed a Practical Nursing School with a large number of adult students and staff. She has also served as a science and language teacher. She holds a Masters degree in Training and Development, a Doctorate in Educational Leadership and Policies, and degrees in Nursing, Teaching, Foreign Language and Finance/Banking and several certificates in clinical research practice, management (AMA) and training. She is an active member of  Professional organizations like SOCRA, etc and also the Association of Training and Development (ASTD). She is a Certified clinical research professional (CCRP).  Currently, Marcellina is the Associate Director, Clinical Research Management and Training for Clinical Research Group, at Drexel University College of Medicine, Philadelphia, PA.

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 Graciela Rácaro has more than 8 years of experience in Drug Development between Non Clinical and Clinical Research working for the Pharma industry, PAREXEL and a multinational Biotech company. Her experience in therapeutic areas includes dermatology, reproductive health, endocrine/metabolism, cystic fibrosis, neurology, cardiovascular, bone diseases and anesthesia. Phase experience in Phase II-IV trials.  For the last 5 years she has been in charge of the implementation of the studies in Latin America within all what this may imply (i.e. running the importation and storing of drugs, proposing sites and Investigators for new studies, managing study related financial issues and resources, etc.). Furthermore, she has also supervised Local Authorities submissions for study approvals in several Latin-American countries, including Argentina, Brazil, Chile, Mexico, Uruguay and Venezuela, having always a special concern to follow all Local, FDA and EMEA regulations. Experience in clinical trials monitoring, site evaluation and initiation, data collection and quality control review of data collected at trial sites to ensure compliance with multiple protocols, FDA/EMEA regulations and GCP guidelines. Experience as Primary CRA with responsibility for managing and training CRAs team. Experience as Project Manager in Latin-American stand alone projects and Regional Project Manager for global projects. Experience as Line Manager for CRAs, Clinical Operations Managers and Regulatory staff, coaching and mentoring of new CRAs, training and mentoring of New Managers and EDC Super User in Latin-America.  Graciela Rácaro also has a strong experience on external/internal audits as well as local and international (FDA) inspections, all of them with successful results.

Denise G. Redkar-Brown began her career as a Medical Technologist working in a hospital laboratory environment. She made the transition to the pharmaceutical industry and after more than 20 years she has held positions in basic and clinical research. She is published in the European Journal of Pharmacology for her work in Pharmacology while at AstraZeneca and was recently published in the Good Clinical Practices Journal in 2008. Denise has contributed to the successful submissions for Accolate® (the first leukotriene antagonist for asthma therapy) and Seroquel® (Serotonin receptor compound for treatment of Schizophrenia and bi-polar disorder). Denise also worked at Dupont Pharma (Immunology), Knoll (Humira®), and Sanofi (vaccines), and at present she is the Associate Director of Scientific Affairs, Data Management for Cetero Research in Fargo, North Dakota. Denise has been an Instructor for Barnett International/Cambridge Healthtech Institute for 11 years specializing in Clinical Data Management delivering training programs and interactive webinars for multiple clients in the pharmaceutical and biotech industry.

 Barry Renaud is the founder and President of Quality Assurance Systems, Inc. (QAS). Since 1990, he and his firm have served more than 160 biomedical research companies, law firms, and research institutions worldwide and have performed investigational site, sponsor-monitor, database, clinical report, submission, Computer System Validation, computer systems, process, and other types of audits. Mr. Renaud has also provided discovery and expert testimony in court cases and has served as an Application Integrity Policy consultant. In addition, he often provides Quality System consulting, which includes the development of Quality Management Systems and Standard Operating Procedures and their supporting documentation. Before founding QAS, he directed Clinical Quality Assurance departments at a major pharmaceutical company and a Contract Research Organization.

 Lily Romero, P.A., C.C.R.C., has over thirty years experience in clinical research. Her experience includes positions as Director of Global Development Training at Elan Pharmaceuticals, an Associate Director of Clinical Operations at Quintiles, Inc., and a Clinical Research Coordinator and Research Administrator at the Allergy & Asthma Medical Group and Research Center, A P.C. in San Diego, CA. She has worked on Phase I - IV clinical trials including pediatric studies. She was an instructor for and assisted in the development of an investigator GCP training workshop for the American Academy of Pharmaceutical Physicians. She is on the Advisory Board and an instructor for the Clinical Trials Design and Management certificate program at the University of California at San Diego (UCSD) Extension. Currently, she is a member of the Academy Board for the Associates of Clinical Research Professionals (ACRP).

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 Sandra “SAM” Sather, M.S., B.S.N., C.C.R.C., C.C.R.A., has over 25 years of clinical training and research experience. SAM is a clinical research consultant with a specialization in Human Performance Improvement (HPI). Her medical and science training started in nursing where she received a Bachelor of Science in Nursing in 1983 and practiced nursing for over 10 years, intensive care to community health nursing, with much of the job in a training role. As a nurse, SAM also served as a clinical research coordinator (CRC) for intensive care cardiovascular trials. Soon after her work as a CRC, she made the transition to full time in the research industry. SAMs experience in the industry includes work for and with CROs, sponsors and research sites of drug and device studies. In 2007, she completed her Master in Science in Education with a specialization in Training and Performance Improvement.  SAM Sather is currently the vice-president of Clinical Pathways, a consulting team out of North Carolina that provides training, monitoring, auditing and other services for clients in the clinical research drug and device industry. She is dual certified by ACRP and is the chair for the CCRA Exam Committee. SAM is a frequent speaker at industry conferences and has authored over 50 courses for clinical research training programs.

 Jennifer Stanford, R.N., M.S.N., is the Corporate Director of the Clinical Research Department for Valley Health located in Winchester, VA. She opened this office in September 2004, which serves all physicians within the Valley Health System and the surrounding outpatient private practices. She is also responsible for the oversight of the Institutional Review Board at the medical center. Previously, Ms. Stanford was the Executive Director of Cardiopulmonary Research Science and Technology Institute (CRSTI) in Dallas, a non-profit research organization which focused on cardiology and cardiac surgery trials. Prior to her work at CRSTI, Jennifer started the Clinical Trials Office at The University of Texas Southwestern Medical Center in 1997 and was able to build a comprehensive, successful office.

David M. Stier, M.D., is President of EUREKA RESEARCH, which provides study design and data analysis for outcomes studies, clinical trials, and patient registry programs. Prior to founding EUREKA RESEARCH, Dr. Stier was Vice President with The Lewin Group, an international health policy and research consulting firm. Dr. Stier has worked closely with pharmaceutical, biotechnology, and medical device company executives to create research platforms that blend clinical medical research, health outcomes research, and product commercialization objectives into comprehensive research programs executed during the peri-launch and post-product-launch periods.

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Susan Torchio, R.N., B.S.N., has over 20 years of Clinical Research experience. For the past 10 years she has been an instructor for Barnett International’s CRA and CRC course. Sue started her career in Clinical Research as a study coordinator at a busy family practice site that participated in multiple studies in a wide range of therapeutic areas including Cardiology, Infectious Disease, and Gastrointestinal. After 2 years as a coordinator, Sue joined a large CRO as a Clinical Research Associate - conducting a variety of late phase clinical programs. She has been at two other CROs in her career as a Project Manager working in Infectious Disease, Trauma, Endocrinology and Cardiology. She joined a BioPharma company in 1998, as a consultant and later a Project Manager in Medical Affairs. Medical Affairs was combined with Clinical Operations and she was promoted to a Senior Manager working in the CNS group. In 2005, her role changed and she is now heading up leading the Resourcing Group as an Associate Director within Clinical Operation. In this role she is responsible for working with a Function Outsource Provider to manage a field force of Regional Managers and Regional CRAs. In addition to her other responsibilities, Sue is also heading up the Pain Program in Clinical Operations. In this role she is in charge of various pain compounds and the studies that are conducted with them.