Time Response Modeling in Rheumatoid Arthritis and Other Autoimmune Indications

With large sales and high medical need in this category, in recent years, there has been increasing interest on the part of biopharma in developing new, more effective compounds including biologics and biosimilars. With competition rising, it is critical to more efficiently design your clinical trials so as to accelerate cycle times and speed your products to patients in need.

Well designed time response models can be valuable tools in achieving these objectives. These models have been shown to be predictive of trial outcomes and can also be used to:

• Help design clinical trials
• Compare a new drug to existing therapies
• Examine the effects of time and endpoints on power and sample size
• Support endpoint selection

In this webinar, the presenters will discuss time response modeling for Rheumatoid Arthritis (RA) and similar indications based on a number of biologic agents that they have studied. The webinar is intended to help drug developers:

• Optimize trial designs
• Review innovative trial design features and operating characteristics such as adaptive designs
• Investigate novel analysis methodologies to better achieve objectives
• Improve the probability of more efficiently and successfully developing new RA treatments

Speakers

Russell Reeve, PhD, Senior Biostatistics Director, Center for Statistics in Drug Development, Quintiles

Dr. Reeve supports Model-Based Drug Development (MBDD) at Quintiles in areas including disease progression models and client-specific statistical research. He also leads Quintiles’ biosimilars biostatistics group and consults with clients on development and trial design strategies. He holds leadership and other roles on a variety of Boards including: Quintiles Adaptive Trial Board, Innovation MBDD Advisory Board, NCSU College of Science Foundation Board of Directors, George Mason University’s Statistics Department Advisory Board.

Dr. Reeve has published on a variety of topics including CATD and population modelling. He holds a patent in the field of metabolomics and has been a leader in adaptive trial design and execution. Prior to joining Quintiles, Dr. Reeve was responsible for the scientific development of Pharsight’s modeling and simulation software and worked on a number of biologics agents and vaccines, such as interferon-a, vaccines for HCV, HPV, and influenza, as well as in vitro diagnostics based on ligand-binding and bDNA technologies.

Dr. Reeve earned his B.S. in Mathematics from Utah State University, M.S. in Operations Research from Rensselaer Polytechnic Institute, and Ph.D. in Statistics from Virginia Polytechnic Institute and State University. Dr. Reeve has taught graduate statistics courses at University of Rochester and Memphis State University, and has previously been adjunct in Clinical Research at Campbell University.

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Niti Goel, MD, Senior Medical Director & Global Head, Rheumatology Center of Excellence, Quintiles

Dr. Goel advises customers on drug development pathways in rheumatologic and immunologic diseases, including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthropathy, systemic lupus erythematosus, gout, osteoarthritis and other related conditions. She also provides therapeutic and medical regulatory strategy expertise, including novel trial designs for development programs.

Board Certified in Rheumatology, Dr. Goel has almost 20 years of academic and Pharmaceutical industry experience in clinical development and medical affairs. She has extensive expertise designing and conducting clinical trials and development programs across several rheumatologic diseases –from early to late phase and regulatory approvals. Her expertise also includes disease scales training development, patient-reported outcomes, clinical trial equipoise, biosimilars, and lifecycle planning. She has published on a variety of topics and is an active member of OMERACT.

Dr. Goel received her MD from Jefferson Medical College of Thomas Jefferson University in Philadephia, PA and completed her internship and residency in internal medicine and fellowship in rheumatology at Duke University Medical Center in Durham, NC. Prior to entering the Pharmaceutical industry, Dr. Goel was an Assistant Professor of Medicine in the Division of Rheumatology at the University of Texas Medical Branch, in Galveston. In this role, she was active in patient care, co-developed rheumatology curricula for medical students, residents and fellows, and was an Investigator for multiple clinical drug studies and NIH clinical epidemiologic studies in systemic lupus erythematosus (LUMINA) and scleroderma (GENISOS). Dr. Goel is currently an Adjunct Assistant Professor of Medicine in the Division of Rheumatology at Duke University School of Medicine.

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