Camargo's Ruth E. Stevens Leads Open Forum At AAPS Annual Meeting
Camargo Pharmaceutical Services, a full-service clinical research organization (CRO) specializing in end-to-end drug development through the 505(b)(2) process, exhibited at the 2010 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting, which took place in New Orleans, Louisiana, November 14-18. Camargo Executive Vice President and Chief Scientific Officer Ruth E. Stevens, Ph.D., MBA, was selected to participate in a regulatory open forum where she presented on the topic, "Enhancing the Development Pipeline: Strategies for Repurposing, Fixed-Dose Combinations, 505(b)(2) Filings and Patent Protection."
Dr. Stevens presented the current regulatory requirements, as well as the clinical, nonclinical and CMC expectations. She discussed many significant changes the pharma industry has undergone in response to the looming patent cliff of several blockbuster drugs and fierce generic competition. These changes have caused an increased emphasis on life cycle management, focusing on saving development costs and increasing revenue from current drugs on the market. Dr. Stevens covered strategies from the discovery perspective, such as repurposing an approved drug and development candidate selection for future fixed-dose combinations, stating such candidates may be suitable for the 505(b)(2) approach for regulatory filing. Dr. Stevens presented alongside other companies and the open forum concluded with a panel discussion for participants to ask questions.
"I was extremely honored when approached by AAPS to present at the Annual Meeting," stated Dr. Stevens. "This is a strong meeting for the pharmaceutical industry and it is a compliment to have Camargo recognized for its research and expertise within the 505(b)(2) regulatory arena."
Camargo is focused on global drug development through the 505(b)(2) process and provides a full spectrum of services from discovery through each phase of clinical development.
About Camargo Pharmaceutical Services
Camargo Pharmaceutical Services is a full-service CRO for the continuum of drug development. With more than 150 FDA approvals, Camargo works with companies to develop comprehensive programs, managing every facet of the plan from formulation and testing the drug product, conducting clinical studies and FDA application submissions.
SOURCE: Camargo Pharmaceutical Services