Parexel has expanded its early phase drug development capabilities with a dedicated unit to provide biopharmaceutical companies with support for proof-of-concept studies. The new unit integrates capabilities in regulatory strategies, drug development, and clinical pharmacology. Proof-of-concept studies are mainly used in targeted patient populations and are designed to demonstrate early signals of a product's efficacy. The goal of these studies is to help avoid costly late stage clinical development failures.
   
"As the biopharmaceutical industry explores new development paradigms to bring safe and effective treatments to market more efficiently, companies are conducting a growing number of complex and rigorous proof-of-concept studies. Providing clients with integrated, early phase development strategies and expertise gives them the ability to support early identification and selection of the most promising compounds," said Herman Scholtz, M.D., corporate vice president, Early Drug Development, Parexel.
   
A dedicated team will provide clients with the required scientific, therapeutic, and regulatory services to design and implement these studies for new drug entities across a range of therapeutic indications. This team offers solutions including the use of biomarkers and adaptive trial designs, which are supported by biostatistical and eClinical technology capabilities. Relevant technologies include Interactive Voice and Web Response Systems (IVRS/IWRS) to randomize patients and track drug inventory, as well as EDC to provide rapid access to study data.
   
The proof-of-concept service offering provides the company's SuperSites capabilities together with a global network of investigator and academic sites to help accelerate patient recruitment. The SuperSites solutions use the company's hospital-based Clinical Pharmacology Research Units, drawing on recruitment specialists and relationships with local, hospital-based physicians as well as on-site call centers and database capabilities.  

Tris Pharma has completed the expansion of its research and manufacturing facility in South Brunswick, NJ. The expansion provides 15,000 sq. ft. of additional space to the facility and is FDA-compliant with cGMP. It allows for additional commercial-scale equipment and a new, larger warehouse with a high-speed packaging area.  
   
"These recent events show that the company is on a steady and stable path as charted," says Ketan Mehta, chief executive officer and founder of Tris Pharma. "FDA's assurance of our facilities and the recent investment in our capabilities mean we have ample infrastructure with which to leverage our pipeline of drug delivery technologies and services."

Ronald Shoup has been named executive director of Pharma Services, AIT Laboratories. Mr. Shoup was the former co-founder and chief scientific officer of West Lafayette, IN-based Bioanalytical Systems, Inc. (BASi).

"Ron brings 30 years of leadership, entrepreneurship, and scientific expertise to AIT as we look to expand our facility to meet the growing needs of the Pharma industry," said AIT president and chief executive officer, Michael A. Evans, Ph.D.

AIT supports clinical trials through its current drug analysis services and plans to offer regulated bioanalytical services for preclinical development in the future. AIT develops, validates, and performs mass spectrometry analysis in support of new drug development.

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