Clinical Development Services

Team Experience

Our senior team members have a proven track record of identifying and implementing customized clinical development solutions with integrity and excellence.

• Selected Team Publications

Charles Chesson, Ph.D., Group Vice President, Clinical Research and Bioscience Group

 Dr. Chesson has more than 20 years of experience in health care research in operational settings, public health research, and industry pharmaceutical trials. Currently, at Social & Scientific Systems, he oversees operations of several complex biomedical research support contracts. Dr. Chesson previously served as project director for the Community Programs for Clinical Research on AIDS (CPCRA) Operations Center for the National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS). His experience includes the following:

• Served as chief operating officer and vice president of research for Immunity Care & Research; developed an international network of clinical research sites for the conduct of phase I-IV infectious disease clinical trials and oversaw operations of all research staff for compliance with SOPs, Good Clinical Practice (GCP), and Federal regulations. Responsible for strategic planning for site development and new therapeutic disease research contracting and development of both novel use and investigator-driven protocols
• Served as director of clinical trials coordination; monitored and implemented phase I, II, and III HIV clinical research trials and managed the research clinic for AIDS Research Alliance; implemented clinical trials, which involved developing case report forms, coordinating with the Institutional Review Board (IRB), coordinating site visits with study sponsors, overseeing the flow of laboratory data for the clinic, and overseeing analysis of research for internal studies

Jean T. Barbey, M.D., Medical Director

 Dr. Barbey has more than 20 years of experience as a practicing physician, teacher, and clinical researcher in academia and the CRO industry. At Social & Scientific Systems, he focuses on patient safety during the conduct of clinical studies  and the cardiac safety of compounds that are being tested in humans. His experience includes the following:

• U.S. Board Certified in internal medicine, cardiovascular disease, clinical pharmacology, and cardiac electrophysiology
• Previously medical director at Medifacts International (a top 3 commercial cardiac core laboratory); co-architect of WebHeart®, a global 24x7x365 cardiac safety and clinical data management system
• Former full-time faculty at Georgetown University: served as interim director, clinical pharmacology; assistant director, General Clinical Research Center (GCRC); director, clinical pharmacology research unit, Holter laboratory, and telemetry unit
• Senior advisor to FDA and pharmaceutical industry in the area of cardiac safety; past chair, Cardiovascular and Pulmonary Section, American Society for Clinical Pharmacology and Therapeutics (ASCPT)
  

 Kenneth White, Chief, Biomedical Informatics

  Mr. White has 15 years of experience in enterprise software design, specializing in clinical research and clinical trials data management systems. He has in-depth technical knowledge of high-performance Oracle Enterprise relational database design and complex mission-critical workflow and operations systems using Web-based technologies. He brings extensive experience with formal software systems development lifecycle approaches to implementing long-term production solutions. His experience includes the following:

• Serves as technical architect of SSS’ global clinical trials data management systems, supporting preclinical through Phase III development for biologics, devices, and drugs across all major therapeutic areas.
• Serves as lead designer for major systems upgrades for the largest HIV research network in the world, the AIDS Clinical Trials Group (ACTG) and the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT).
• Implemented Food and Drug Administration (FDA) validated systems standards, including 21 CFR-Part 11 and 820, and introduced global service availability for clinical research systems 24 hours a day, 7 days a week.
• Served as designer and lead engineer of WebHeart®, a global cardiac safety and clinical trials data management system. Maintained a constant presence (24 hours a day, 7 days a week) in more than 4,000 centers worldwide to conduct Phase I through IIIb trials (including thorough QT) for more than 50 leading pharmaceutical and biotechnology sponsors.

Center for Biostatistics and Clinical Data Management Staff

Hilda Maibach, M.S., Director, Center for Biostatistics and Clinical Data Management

 Ms. Maibach has more than 25 years of experience with a diverse portfolio of clients in all aspects of clinical and observational studies. At Social & Scientific Systems, she serves as the director for the Center for Biostatistics and Clinical Data Management, overseeing projects that focus on support for early phases of medical product development, data quality, and preclinical data analysis. Her experience includes the following:

• Clinical Trial Rescue consultant for industry-sponsored studies for early phase NIH studies as well as multicenter international studies
• Beginning in the late 1990s, partnered with investigators at Georgetown University Medical School, Department of Rheumatology, Immunology and Allergy, on multiple proteomic and genotyping investigations
• In 1998, founded ClinStats Data Group, a statistical and data management consulting firm, to support the biotechnology sector in preclinical and early phase drug development and biomarker development

Naji Younes, Ph. D., Principal Scientist

Dr. Younes brings more than 20 years of biostatistical experience to SSS. Most recently, he worked on the Epidemiology of Diabetes Intervention and Complications (EDIC) study, where he served as a statistician. At SSS, Dr. Younes serves as a senior subject matter expert in the development of sophisticated systems to manage Phase I-IV trial data. He also has a major role in the creation of new state-of-the-art global data coordinating centers. His past experience includes the following:

• Deputy director of statistics and data management for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Type 1 diabetes TrialNet Network
• Principal investigator and statistician for the Women's Angiographic Vitamins and Estrogen Trial

Cora MacPherson, Ph.D., Principal Scientist

Dr. MacPherson has more than 20 years of experience in multi-site clinical trial design, management, and analysis. Her experience includes the following:

• For ClinStats Data Group, as director of biostatistics, collaborated with medical researchers in the design, conduct, and analysis of multicenter clinical trials for drug development programs; presented interim safety and efficacy results to sponsors and FDA; and prepared final analysis of study results for FDA submission and the publication of abstracts and manuscripts
• Served as an assistant research professor of statistics and of epidemiology and biostatistics at the George Washington University Biostatistics Center; consulted with medical researchers in the design, conduct, and analysis of clinical trials; focused on the NICHD-funded Maternal Fetal Medicine Units network (MFMU), directing design, conduct, and analysis of multicenter clinical trials; and managed and monitored ongoing trials, including data quality assurance
• Coauthored more than 25 peer-reviewed publications
• Served as a biostatistician at CIBA-Geigy Pharmaceuticals Corporation
• Member of the Data and Safety Monitoring Boards for three NIH-funded clinical trials
• Analyzed results from clinical trials and wrote statistical reports for New Drug Applications; acted as a statistical consultant to clinical research staff; participated in the design of phase I-IV clinical trials; developed statistical analysis plans for trials

Dana Dooley, M.A., Data Manager

Ms. Dooley has more than 10 years of experience working with adverse events data and clinical research data. Her responsibilities and experience include the following:

• Manages facilitation of the smooth flow of data between acquisition and SAS analysis
• Trains new staff in working with and in data systems
• Responsible for the integrity and completeness of data, including verification, integrity, and standardization of safety data
• Maintains data accountability and traceability as well as managing editing systems; works closely with statisticians and programmers to ensure data collection and management are conducted with the statistical analysis in mind
• Served as a research assistant in both industry- and government-sponsored studies while at the Psychotic Disorders Clinic at Massachusetts General Hospital, the New England/Tufts Medical Center, the North Suffolk Mental Health Association, and the University of Massachusetts Medical Center

Center for Clinical Operations Staff

John M. Adams, Pharm.D., Director, Center for Clinical Operations

 Dr. Adams has more than 15 years of clinical research experience in a variety of settings. At Social & Scientific Systems, he serves as the director of the Center for Clinical Operations and is responsible for clinical trials oversight, clinical development consulting activities, and clinical interactions with regulatory agencies. His experience includes the following:

• Former research assistant professor at the University of Buffalo and research associate in the Laboratory for Antiviral Research in Buffalo, NY
• Supervised clinical studies and provided clinical pharmacology/clinical development consulting services at PharmaResearch Corporation, a global clinical development services organization
• Served as post-approval clinical lead for Hepsera® and clinical research scientist at Gilead Sciences; at Roche, 2 years of medical affairs experience interacting directly with experts in the treatment of viral hepatitis and HBV/HCV/HIV infection
• Wrote or provided scientific input into dozens of clinical protocols, clinical study reports, medical/scientific abstracts, manuscripts, and clinical development plans

Louis Grue, Deputy Director, Center for Clinical Operations

 Mr. Grue has extensive knowledge and experience in the biopharmaceutical industry, having spent more than 16 years as a clinical coordinator, regional clinical research associate (CRA), CRA field trainer, and CRA manager. As the global corporate training manager and assistant director for staff training and development, he was responsible for the development, implementation, and evaluation of staff training at the corporate level for all international locations for a large global contract research organization (CRO). Mr. Grue’s clinical experience has included emergency psychiatry, rheumatology, infectious disease, and HIV/AIDS. He worked for the Johns Hopkins University School of Medicine, Division of Infectious Disease, as an HIV/AIDS research nurse program coordinator. He was a senior clinical monitor for the National Institute of Allergy and Infectious Diseases (NIAID) AIDS Clinical Trials Group (ACTG) and a regional CRA for PharmaResearch Corporation. As CRA field trainer at PharmaResearch, he coordinated inhouse and field training for the clinical research monitoring program. His clinical research experience includes Phase I through Phase IV pediatric and adult clinical trials. He is a registered nurse (RN) and a certified clinical research associate (CCRA). His experience includes the following:

• Provided ongoing assessment of the overall management and performance of the domestic Community Programs for Clinical Research on AIDS (CPCRA) research units. Developed and coordinated the units’ corrective action plans and training based on reports from the data management center and findings from the monitoring group. 
• Coordinated inhouse and field clinical training of the monitoring program and PharmaResearch’s Pharmatrace™ system, a clinical trials management database. 
• Served as project leader for the evaluation of the HIV TherapyEdge™ service, a secure, Web-based clinical decision support system that is used to assist health care providers in optimizing therapeutic regimen selection and clinical management of patients with complex, chronic diseases.

Lysa Triantafillou, B.A., Director, Regulatory and Quality Management Systems

 Ms. Triantafillou has nearly 15 years of experience in clinical research and quality assurance/regulatory compliance roles. At SSS, she serves as the director of regulatory and quality management systems, and is responsible for ensuring compliance with all regulatory statutes and performance of high quality work for clinical drug studies. Her experience includes the following:

• Served as director, quality assurance and regulatory compliance, at Copernicus Group IRB
• For the preceding 8 years, held quality assurance positions at global contract research organizations, including global director of quality assurance
• Recognized by the American Society for Quality as a certified quality auditor; participates in the Association of Clinical Research Professionals (ACRP), American Society for Quality (ASQ), Society for Quality Assurance (SQA) and its North Carolina chapter (NCCSQA), British Association for Research Quality Assurance (BARQA), North Carolina Regulatory Affairs Forum (NCRAF), and the Triangle PEERS (Part 11 Electronic Records and Signatures) Group
• Regularly invited to present to a variety of professional organizations

Philip Pieper, B.S.N., R.N., Associate Director, Clinical Operations

 Mr. Pieper has nearly 20 years of clinical and therapeutic experience in infectious diseases (HIV, HIV vaccines, hepatitis B, hepatitis C), oncology (bladder, prostate, lymphoma, multiple myeloma), cardiology (hypertension, cardiac care), and other areas. He is Social & Scientific Systems’ associate director for clinical operations, responsible for monitoring sites that are performing clinical drug studies and reviewing records for accuracy, ensuring that the data are of the highest quality and that study protocols are being followed. His other responsibilities and experience include the following:

• Provides strategic leadership, organization, training, and ongoing evaluation and support of the Center for Clinical Operations
• Assures compliance with Good Clinical Practices (GCPs), ICH, the group’s standard operating procedures, and corporate and client policies and procedures
• Serves as a source of scientific and therapeutic expertise for clinical staff
• Experience as a senior clinical operations manager, project manager, clinical research associate, and clinical research nurse/study coordinator

Phyllis Fliederbaum, Senior Clinical Program Manager

 Ms. Fliederbaum has more than 20 years of varied clinical research experience, including global project manager, clinical research associate, data coordinator, and health research analyst. She serves as Social & Scientific Systems’ senior clinical program manager and is responsible for program management activities, providing clinical input into the integrated information management systems upgrade, and formulating standard operating procedures. She has worked with domestic and international staff on the IMPAACT project, implementing annual site evaluations of integral community participation as well as site quality assurance, both functions of the Clinical Operations Center. Her other experience includes the following:

• Responsible for clinical protocol and CRF design, CRA/staff training, and study management from site recruitment through final clinical study report
• Coordinated a global pivotal registration trial that resulted in approval of Viread® for the treatment of HIV infection
• Led studies from protocol writing to final submission, in both public and industry settings, for pediatric/adult HIV, metabolic diseases, autoimmune diseases, hepatitis B, and novel treatments for hepatitis C.