Clinical Pharmacology Study Group was established in 1989 in Worcester,
Massachusetts by Doctor Birbara and Mary Coughlin, RN. Both have been
involved in clinical trials since 1975 and wanted to create a dedicated
research center to become involved with the newest medications in the field
of rheumatology. In the early years, we worked with the traditional
anti-inflammatory medications (NSAIDs) in conjunction with stomach protecting
agents to find a way to administer NSAIDs more safely and with less GI
irritation. In the mid 1990's, when the COX II inhibitor medications were
being developed, our group grew rapidly in order to keep up with the studies
we were asked to do. CPSG was excited to be part of the testing for
Celebrex, Vioxx, Bextra, and other COX II inhibitors. In the late 1990's,
we entered the era of biologicals for the treatment of rheumatoid arthritis
(RA) These past few years have been the most exciting since we have been
able to witness first hand the tremendous efficacy and improvements in
quality of life of our patients.
We are continuing to expand work with biologicals in the areas of rheumatoid arthritis, psoriasis, psoriatic arthritis and Chrohn's disease. We are also participating in many new trials for fibromyalgia, osteoarthritis, osteoporosis, gout, and lower back pain.
CLINICAL PHARMACOLOGY STAFF
Charles Birbara, MD is a practicing rheumatologist in Worcester, MA. He is a graduate of Harvard College and received his medical degree from McGill University, following which he did a rheumatology fellowship at Northwestern University in Chicago. He is currently an Associate Professor of Medicine at the University of Massachusetts Medical School. Dr. Birbara has been involved in clinical research trials since 1975 and has been the Medical Director of Clinical Pharmacology Study Group (CPSG) since 1989.
Dr. Birbara has served as Principal Investigator for over 500 clinical research protocols, the majority of which have been in the areas of rheumatoid arthritis, osteoarthritis and pain. More recently, CPSG has focused its involvement with targeted biologic therapies to treat all forms of systemic inflammatory diseases, including rheumatoid arthritis, psoriasis and psoriatic arthritis, Crohn’s disease, and inflammatory and degenerative diseases of the spine. Dr. Birbara has authored or co-authored numerous manuscripts published peer reviewed journals. He is a fellow member of the American College of Rheumatology.
Nassif F. Maalouli, MD, is the Assistant Medical Director at Clinical Pharmacology study group. He has been a Sub-Investigator since 2000. During this time he has participated in over 300 clinical trials/protocols for various Arthritic conditions, including Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis, Low Back pain, Psoriasis, Psoriatic Arthritis, Fibromyalgia, Gout, Diabetes and Crohn's disease.
His clinical interests include treatments with Biologic drugs and Stem Cells therapy in Rheumatology, Dermatology and Immunology.
Mary Coughlin, RN, has been working in Clinical Trials since 1975. A graduate of Regis College with a BA in psychology, Anna Maria College with a MA in psychology, and Worcester State College with a BS in nursing, she has been working at Clinical Pharmacology Study Group since 1989. She has been involved in over 500 trials with CPSG, serving as the primary coordinator. Mary has experience administering all of the new biologic medications. She serves on the Nursing Advisory Board for Abbott, Bristol Myers Squibb, Roche, and UCB, and travels extensively to teach other nurses how to administer the new biologic medications. She is an Adjunct Faculty Member at the Mass College of Pharmacy and Allied Health Sciences, a member of the Rheumatology Nurse’s Association, Member of Signa Theta Tau Nursing Honor Society, Member of the Associates of Clinical Pharmacology, and a Member of the Allied Health Professionals for the Arthritis Foundation.
John Kelly, MD is a Medical Consultant working with CPSG. He is a graduate of Tulane University, received his MD from Tulane Medical School and completed his residency at Worcester City Hospital. Dr. Kelly has a large Internal Medicine practice located in Worcester and he serves as a staff physician at both Saint Vincent Hospital and UMass/Memorial Hospital both in Worcester. He is board certified in internal medicine and in geriatric medicine.
Sheela M Kumar, MD has been a Sub-Investigator with CPSG since 2001 and has participated in hundreds of studies in this time. Dr. Kumar received her MD from the Mysore Medical College in India in 1980, and received a Master's Degree in Public Health from the University of Massachusetts Medical Center in 1994
Joan M Greaney, RN, has been a Study Coordinator with the CPSG since 2005. She has been a registered nurse since 1972, receiving her degree from the Worcester City Hospital School of Nursing. Prior to joining the CPSG, she was employed as a research nurse for many years at the Fallon Clinic.
Amanda Popoloski, Pharm. D, R.Ph is the 1st year Pharmacy Fellow, joining CPSG in July 2009. She is working as both Investigational Pharmacist and Study Coordinator. She received her Pharm. D from the Massachusetts College of Pharmacy in Boston in June, 2009. Amanda is also an Adjunct Professor of Pharmacy Practice co-coordinating a class on clinical trials at the Massachusetts College of Pharmacy in Worcester. Her clinical interests include stem cell therapy, rheumatology and immunology. She is a member of ASHP, APhA and MPhA.
Mary Binder-OConnell has been Administrative Assistant and Study Coordinator for CPSG since 2003. She is a 2002 Graduate of Salters College and a Nationally Certified Medical Assistant (CMA-AAMA). She is responsible for administrative duties in over 30 current trials. She compiles and submits Site Status Reports to multiple Regulatory Agencies. She is trained in ECG administration, electronic data entry, and recertification in CPR. She currently serves her fifth year as CEU officer and Executive Board Member of the Worcester Chapter of the American Association of Medical Assistants.
Angela Fleming, CMA, has been the Laboratory and Data manager since 2005. Angela is a 2002 graduate of The Salter College. Angela's duties include full phlebotomy, all lab specimen handling and transportation. Fully trained in diagnostic specimen handling and shipping. IATA certified. EKG's, Medical transcription and Data entry management. Documentation on AE's. Familiararity with all aspects of clinical trails. Experienced in a vast variety of data capture systems. 1572 documentations. Certified in Microsoft Word, Access, and Excel. CPR and Advanced Life Saving Certified.