Dr. Karen Brown has more than 20 years of experience in pharmaceutical development. She has worked in all stages of drug development, from target discovery through regulatory submission, although she does consider the IND-enabling and early clinical development stages her “sweet spot.” Her broad background has given her unique insights into the kinds of challenges that can arise at each stage of the development process. She loves working with clients to evaluate their asset development programs, identify key scientific/clinical and regulatory risks, and create streamlined development plans structured around data-driven go/no go decision points that utilize modeling and simulation to get the maximum information from the data.
Dr. Brown started out in the pharmaceutical industry doing target discovery and pre-clinical DMPK work as a bench scientist. She then moved into translational medicine and clinical pharmacology, where she has worked as a clinical scientist, study leader, project team representative, global project team leader, and group head. She has experience from Phase 1 to 4 in the cardiovascular, metabolism, neuroscience, inflammation, immunology, and infectious disease therapeutic areas, and has designed and conducted both standard Phase 1 studies, including single and multiple-ascending dose, ADME, relative bioavailability, bioequivalence and drug-drug interaction studies, as well as a variety of pharmacodynamic proof of mechanism studies. She has participated in numerous regulatory meetings as well as IND and global CTD filings. In her later years in the industry, Dr. Brown developed a focus on partnered projects and has worked with small companies to design studies and development plans, identify and address key risks, and engage with regulators.
During her career, Dr. Brown has developed strong collaboration skills that have enabled her to be an effective leader and partner in multi-cultural settings. She has served as a mentor for many years and enjoys learning from others and sharing her experience to help others succeed.
Dr. Brown holds a PhD in pharmacology from the University of Pennsylvania, a Masters’ degree in biochemistry from the University of California Berkeley, and a Bachelors’ degree in molecular biology from Princeton University.