PHILADELPHIA, PA – April 22, 2013 –– ERT, a leading global provider of high-quality patient safety and efficacy endpoint data collection solutions for use in clinical drug development, today announced the successful conclusion of its sixth annual conference, PROFICIENCY 2013: Maximizing Product Value with Optimized Endpoints. Conducted in Fort Lauderdale, FL, the conference focused on how biopharmaceutical developers can meet the increasingly complex challenges of developing and bringing new medical products to market and addressing the needs of various stakeholders throughout the product lifecycle.
During the two-day conference, a faculty of international regulatory, scientific, and industry experts led strategic and practical discussions pertaining to the collection of high-quality patient safety and efficacy data, concentrating on the use of Clinical Outcome Assessments (COA) – including Patient, Clinician, and Observer Reported Outcomes (PRO, ClinRO, and ObsRO). The conference concluded with an interactive, mock FDA Advisory Committee session, where attendees experienced firsthand the challenges and opportunities that face biopharmaceutical developers as they articulate the importance of safety and efficacy endpoints to the regulatory community.
PROFICIENCY attendees represent a wide variety of international biopharmaceutical companies and hold mid- to senior management positions in clinical operations, regulatory, health economics outcomes research (HEOR), and data management. In post-conference surveys, the majority of attendees indicated that they chose to participate in the conference because they are planning, or expect to be planning a study that involves the collection of COA data and that they need to keep up to date on regulatory changes regarding the collection of COA.
A vice president of clinical operations for an emerging pharmaceutical company commented, “By attending PROFICIENCY I was able to take a step back and think more strategically about the use of PROs in the lifecycle of product development. We have an early stage compound where PROs are going to be very important…What I learned at PROFICIENCY will be very applicable as we plan the development of this program."
“Considering the growing interest in COAs for clinical research and their regulatory and commercialization implications, it’s no surprise that so many biopharmaceutical researchers are eager to learn how they can optimize this important data throughout the product lifecycle,” said Dr. Jean Paty, ERT’s Chief Scientist and Regulatory Expert, Outcomes. “We’re extremely pleased with the success of the conference and the discussions that emerged as a result of the dynamic group of faculty and attendees.”
Select content from this year’s annual conference will be delivered during a series of 1-day regional conference hosted by ERT throughout the U.S., Europe, and Japan beginning September 2013. For information on dates, locations, and program agenda, please visit www.ert.com/resources/seminars/proficiency-regional-conferences.
ERT (www.ert.com) is a leading provider of high-quality patient safety and efficacy endpoint data collection solutions for use in clinical drug development. ERT delivers a combination of technology, services, and consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process throughout the product lifecycle. ERT delivers the most widely deployed solutions in centralized cardiac safety, respiratory services, suicidal risk assessment and Clinical Outcome Assessments (COA) – which includes patient, clinician, and observer reported outcomes. By efficiently integrating these solutions through a system built upon a scientific and regulatory foundation, ERT collects, analyzes, and delivers safety and efficacy data critical to the approval, labeling and reimbursement of pharmaceutical products. ERT is a global organization with headquarters in Philadelphia, PA and offices throughout the U.S., U.K., Japan, and Germany.