Cytel’s Nitin Patel Joins Colleagues from the FDA, PhRMA and ISPE to Expand Simulation Use in Clinical Research
Company CTO and Co-Founder reveals key role of simulation in design and implementation of adaptive trials
Cambridge, MA, USA - October 30, 2009 - Cytel Inc., a leading provider of clinical trial design and implementation services and specialized statistical software, today announced that Cytel Co-founder and CTO, Nitin Patel, Ph.D. is an invited expert speaker at both The Drug Information Association’s (DIA) FDA/PhRMA Modeling and Simulation in Drug Development: Quantitative Approaches for Decision Making, and the International Society for Pharmaceutical Engineering’s (ISPE) Annual Pharmaceutical Engineering Conference.
On October 28th Dr. Patel joins fellow experts from industry and key FDA statistical staff in Bethesda for presentations and discussions to further the use of simulation techniques in clinical research. He will present his most recent findings in the "Modeling and Simulation in Early Development" session.
Dr. Patel will also present on Wednesday, November 10th in San Diego, during the invited session: "The Key Role of Simulation in Planning Drug Supply for Adaptive Trials" at the annual ISPE meeting, the world's largest gathering of biopharmaceutical discovery, development and manufacturing engineers.
Regarding his role in these two innovative sessions, Dr. Patel remarked: “At Cytel, we’re seeing an intense interest in clinical trial simulations from both companies and regulators. Recent statistical and computational advances make it increasingly practical to accurately assess the statistical operating characteristics when planning a study. Trial design simulations are now proven to help sponsors optimize their trial designs. It turns out that the same statistical simulations are also applicable when tackling the difficult task of developing efficient plans for adaptive trial drug supply.”
The speaking engagements occur just months after Nitin Patel was named “Principal Investigator” for the Collaborative Research and Technology Agreement (CRADA) between Cytel and the FDA/CDRH division, overseers medical device and radiological health technologies.
About Cytel
Cytel Inc. is a leading provider of specialized statistical software and clinical trial design services for the biopharmaceutical, medical device, academic, and institutional research markets.
47 of the top 50 biopharmaceutical firms use Cytel software to design, simulate and analyze their clinical studies. Pioneers of the statistical and computational science of adaptive trials, Cytel and has designed more validated adaptive trials than any other service provider.
Cytel serves trial sponsors with innovative tools, training and consultation to increase the return on investment in clinical development.
For interview requests, or further information contact:
Michael Weitz
Marketing Director
617.661.2011
mike@cytel.com