Kimberley Cummings, PhD, RAC

Kimberley is a Director of SciLucent, leading the Clinical Development & Regulatory Affairs Practice, which provides clinical, regulatory, management, and business support to the healthcare products industry worldwide.  She is an experienced regulatory affairs professional, working with interdisciplinary teams guiding drugs, biologics, and medical devices through the clinical and regulatory processes towards marketing approval.  Kimberley has experience developing and implementing scientific and regulatory strategies for both the U.S. and EU regulatory agencies.  She has successfully prepared and managed regulatory submissions focusing on agency meeting packages, Exploratory INDs, INDs, NDAs, BLAs, ANDAs, and ongoing reports necessary to support these applications.  She has a demonstrated ability in the client achievement of FDA programs such as special protocol assessment, fast track, breakthrough therapy, priority review, and accelerated approval.  Kimberley has significant experience in orphan designation requests, the design of clinical trials to support orphan indications, and the lifecycle management of approved products with orphan drug status.  Kimberley earned her Ph.D. in Biomedical Sciences with a specialization in Pathology from the Medical College of Ohio and a B.S. in Forensic Chemistry from Ohio University.  She maintains Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS).