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Karen Wolfe-Kerker has over 35 years of experience in healthcare, including over 30 years in the pharmaceutical drug, biologic and medical device industry in areas such as diabetes and endocrinology, metabolism, oncology, cardiovascular, pulmonary renal, CNS and medical imaging. She specializes currently in FDA and other Regulatory Authority communications, regulatory operations, Common Technical Document (CTD) structure and compliance, regulatory document development, electronic submissions, FDA Meeting Requests, Meeting Background Information submissions, managing formal meetings and representing companies located outside the US as a US Agent for FDA communications.
Karen has been a Regulatory Consultant for more than 24 years, functioning in a variety of positions including Vice President, Regulatory Affairs; Director of Regulatory; Director of Regulatory and Clinical Affairs; Sr. Manager of Regulatory and Clinical Affairs; Project Manager; Regulatory Consultant, Quality Assurance Consultant and Manager of Clinical Research for contract corporate clients, Contract Research Organizations (CROs) and Fortune 500 International Pharmaceutical and Medical Device Companies.
She has facilitated or led the development and submission of several New Drug Applications (NDAs), Biologic License Applications (BLAs), and Premarket Approval Applications (PMAs), leading to marketing clearances. Additionally, Karen has facilitated and/or led the development and submission of more than 35 Investigational New Drug (IND) applications, more than 200 IND amendment, update and report submissions including Annual Reports, IND/IDE Safety Reports, DSURs, Special Protocol Assessments, Requests for Pediatric Waiver/Deferral, Priority Review, Breakthrough Therapy Designation, Fast Track Status, Accelerated Approval Requests, Proprietary Name Review and Combination Product Designation Requests. She has also managed several Investigational Device Exemption (IDE) Applications and submissions for significant risk medical devices. In several roles, Karen managed and supervised regulatory affairs and quality assurance activities and staff for clients, including corporate regulatory and good clinical practice (GCP) compliance assessment. Outside the US, Karen has performed regulatory consulting and facilitated submissions associated with regulatory authorities in several countries, including Canada, the EU, Australia, Chile and S. Korea.
Prior to entering the pharmaceutical and medical device industry, for ten years Karen had in-hospital patient care experience in respiratory therapy, cardiology and diagnostic cardiac and medical ultrasound imaging.
Karen has an MS in Health Sciences with an emphasis in Clinical Leadership and Management and a BS in Clinical Research Administration, both from The George Washington University, Washington, DC. She had undergraduate training in Respiratory Therapy from St. Louis Community College and Cardiac Ultrasound Training from St. Luke’s Hospital, St. Louis, MO.
Karen is certified in U.S. Regulatory Affairs (RAC) by the Regulatory Affairs Professional Society and is Certified as a Clinical Research Associate (CCRA) by the American Society of Clinical Research Professionals. She also maintains active status as a Registered Diagnostic Cardiac Sonographer (adult echocardiography) from the American Registry of Diagnostic Medical Sonographers.