September 13, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Cambridge, Mass. – Cytel, a biometrics clinical research organization (CRO) and clinical trial software provider, is opening a new office in King of Prussia, Penn., and hiring more than 100 biostatisticians, statistical programmers and data managers.
The new site will add significant capacity to its already global team with a goal of meeting the growing demand for biometrics-focused clinical research activities. The hiring is expected to begin immediately and end at the end of the year across sites in the U.S., Europe and India.
The new office in Pennsylvania is located at 2200 Renaissance Boulevard, and include an onsite cafeteria, gym and day care center.
“King of Prussia is a hub for clinical biometrics expertise, and our office is ideally located to support the biopharmaceutical and medical device companies in the mid-Atlantic region,” said Irving Dark, Cytel’s senior vice president of Clinical Research Services, in a statement. “This site will also serve as the center for our rapidly expanding Quantitative Pharmacology and Pharmacometrics business unit.”
In July, the company’s president, Cyrus Mehta, also Adjunct Professor of Biostatistics at Harvard School of Public Health, and Deepak Bhatt,executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital Heart and Vascular Center, and professor of Medicine, Harvard Medical School, co-authored a paper published in the New England Journal of Medicine. The paper was titled “Adaptive Designs for Clinical Trials,” and notes that adaptive design has been proposed to increase the efficiency of randomized clinical trials while potentially cutting costs.
The article notes that, “Adaptive designs for exploratory clinical trials deal mainly with finding safe and effective doses or with dose-response modeling. The emphasis is on strategies that will assign a larger proportion of the participants to treatment groups that are performing well, reduce the number of participants in treatment group that are performing poorly, and investigate a dose range that is larger than ranges in corresponding trials with nonadaptive designs, in order to select effective doses for the confirmatory stage of investigation.”
In April 2017, Cytel was recognized, with its work with TRACON Pharmaceuticals , as the Most Innovative Trial Design 2017 at the second annual Clinical and Research Excellence (CARE) Awards. CARE Awards celebrate excellence across the global clinical research enterprise and are managed by Informa’s Pharma Intelligence.
Cytel’s biostatistics experts teamed with TRACON to create what is called a groundbreaking adaptive trial, a Phase III trial of TRC105 and Pazopanib versus Pazopanib alone in patients with advanced AngioSarcoma. The trial received a Special Protocol Assessment from the U.S. Food and Drug Administration (FDA) and analyzed TRC105 safety and efficacy data in real-time to evaluate the final study sample size and treatment population.
In a statement, Cytel’s chief human resources officer, Cary Morrill, said of today’s announcement, “Cytel is able to attract the best talent in the industry thanks to a reputation for offering employees meaningful work in a collaborative and positive environment. We look forward to welcoming new hires to our team over the coming months.”
