CAMBRIDGE, Mass.–(BUSINESS WIRE)–PROMETRIKA, LLC has announced that it has expanded its strategic regulatory consulting services under the leadership of Aileen Ryan, MS, Senior Regulatory Advisor, who has been providing regulatory consulting services to PROMETRIKA’s client companies on a part-time basis for the past 2 years has now joined the company on a full-time basis. Ms. Ryan brings to this position over 40 years of diverse experience in pharmaceutical regulatory affairs, including regulatory strategy, submission preparation (IND/NDA/BLA/MAA), and health authority interactions. Her experience spans submissions in the US, Canada, EU, and Japan. Other leadership roles have included supervision of clinical quality assurance, medical writing, and safety functions.
At PROMETRIKA, Ms. Ryan will spearhead regulatory affairs activities and will be available to provide its sponsors with strategic consulting and regulatory support from the pre-IND phase through marketing application preparation and approval, and continuing with life-cycle management. Ms. Ryan will also be providing the regulatory perspective to PROMETRIKA’s Clinical Operations, Pharmacovigilance, Biostatistics, and Medical Writing functions, which will further enhance PROMETRIKA’s delivery of best-in-class services.
“Aileen’s experience and approach are a natural fit for our company,” commented Miganush Stepanians, President & CEO. “As a leader in regulatory affairs, she has always excelled at translating business and scientific objectives by providing regulatory support and guidance to clinical plans, ensuring high levels of quality and efficiency. This approach is one of the many reasons I am excited to have her join our leadership team.”
Prior to joining PROMETRIKA, Ms. Ryan’s leadership roles have included Head of Regulatory Affairs and Compliance at the Ludwig Institute for Cancer Research, Vice President of Regulatory Affairs at Allos Therapeutics, Ophtherion, and Vion Pharmaceuticals, and Head of Global Regulatory Strategy for Oncology at Bayer Pharmaceuticals. Her work has covered drugs, biologics, and devices across a wide range of therapeutic areas. Recent areas of focus have centered on oncology, particularly early phase studies of immunotherapy treatments.
“I am eager to bring my years of experience to PROMETRIKA and its clients,” said Ms. Ryan “I am equally as enthusiastic to be part of an organization that sees the value in a collaborative team approach to clinical trials, and look forward to working with the entire team.”
Ms. Ryan received her Bachelor of Science degree in Biochemistry from the University Massachusetts at Amherst and a Master’s of Science in Basic Medical Sciences from New York Medical College.
About PROMETRIKA, LLC – www.prometrika.com
Founded in 2003 and based in Cambridge, Massachusetts, PROMETRIKA is a unique Clinical Research Organization (CRO), utilizing a collaborative approach to clinical development and execution with a close‑knit, highly‑experienced senior leadership team involved in all phases of trials. PROMETRIKA’s services include complete clinical operations and clinical trial management, data management, pharmacovigilance, biostatistics and programming, medical writing, and regulatory submissions.