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News

Clinsys expands clinical trial development services

Clinsys Clinical Research : 10 April, 2008  (Company News)
Clinsys Clinical Research has introduced its Therapeutically-aligned Program Strategists (TPS), an innovative concept for the evaluation and execution of clinical trials.
The TPS teams are comprised of highly skilled and experienced professionals with defined therapeutic expertise who evaluate, create and execute all sponsor projects, from clinical development plans and clinical trial design through protocol finalisation, leading to successful trial conduct.

Each TPS team consists of MDs, PhDs and a clinical operations program director with expertise in a specific therapeutic area. These strategists apply a research-oriented approach to clinical trial strategy, design and execution to either deliver a comprehensive clinical development plan or protocol, or review and critique client synopses and protocols. The TPS team also provides analysis of the competitive environment, the current standards of care and market potential. TPS services extend to design and implementation of generic and bioavailability/bioequivalence (BA/BE) trials.

'Our TPS team concept enables clients to leverage our therapeutic expertise in the way that is most beneficial to their drug development and clinical trial programmes,' said David E Williams, chief executive officer of Clinsys. 'Regardless of whether our TPS teams are engaged from start to finish or if they are brought in to evaluate existing project components, what they deliver is the best possible trial design, clinical development plan and market positioning.'

To facilitate the development, growth and success of the TPS teams, Clinsys has called on Linda Patricia Miller, MD, and promoted her to vice president, clinical development, and chief scientific officer. With more than 25 years of Phase I-IV clinical trial experience and 10 years of pharmaceutical experience, she will select appropriate team members and provide strategic medical and scientific guidance throughout all phases of project/programme planning and execution to ensure cohesive, consistent delivery of TPS services. Dr Miller trained at Memorial Sloan-Kettering Cancer Center in the design and conduct of new agent trials.

The TPS teams are supported by Chris Gregory, PhD, senior director, clinical development, and Nermina Nakas, MD, MPH, director, clinical development. Dr Gregory brings more than 15 years of biotechnology/pharmaceutical and academic experience, with special attention to Alzheimer disease, Parkinson disease and multiple sclerosis. Dr Nakas applies more than 22 years of clinical, academic and industry research experience in multiple therapeutic areas, with specific emphasis on respiratory disease, dermatology and paediatrics. Joining Drs Gregory and Nakas in clinical development is Daniel Wood, PhD, senior clinical research scientist. Dr Wood develops and prepares clinical trial synopses and protocols for designated therapeutic areas.

Recently, John Oh, MD, MBA, joined Clinsys as director, clinical development. He will develop the TPS pain, stroke, traumatic brain injury and spinal cord injury programmes, drawing on his experience directing programmes in neurorehabilitative medicine and physical medicine and rehabilitation. Prior to joining Clinsys, Dr Oh served as director, medical affairs, for a global CRO. He also assisted with development of a commercialisation plan for SBIR and NIH grants for a functional MRI analysis and data management system at several start-up companies. Dr Oh, who received his MD from Temple University and his MBA from Duke University, served as the residency programme director and an investigator for clinical trials at the University of North Carolina School of Medicine.
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