Leadership

Sameena Sharif is a strategic thought leader in drug development, alliance, project, and portfolio management. She has broad experience in managing projects at all stages of drug development — from the target selection and pre-investigational new drug stages through new drug application/marketing authorization application submissions and commercial planning. She has led large, cross-functional teams in global alliances with Amgen, Otsuka, Genentech, Novartis, Onyx, and AstraZeneca, with a particular interest in optimization of the drug development and alliance management process in small and midsize companies. She holds a Bachelor of Pharmacy from the University of Bradford and has a Ph.D. in pharmaceutics from the University of Nottingham.

Donna Kato is RPI's founder and strategic advisor and has spent her career in the pharmaceuticals industry, specializing in regulatory affairs for the last 30 years. She started her career at Syntex in discovery research and later joined its worldwide regulatory affairs department. After Syntex, she led regulatory affairs at Acologix and Celtrix before founding RPI in 1995. Under Ms. Kato’s leadership, RPI has grown to a full-service regulatory affairs consultancy assisting hundreds of clients with product development worldwide. As part of her support for the regulatory affairs community, Donna has been an instructor in the Extension Certificate Program in Regulatory Affairs at the University of California, Berkeley. She holds a B.S. in biochemistry from the University of California, Davis, and an MBA from Santa Clara University.

With an extensive background in regulatory affairs in the pharmaceutical and biotech industries, Kristi Miller leads a diverse, cross-functional team of regulatory affairs professionals. Together, they develop and implement global regulatory strategy in conjunction with clients across all stages of development and diverse therapeutic areas, including neurology, immunology, and oncology. Prior to joining RPI, Dr. Miller was the director of global regulatory affairs at Pharmacyclics. Before that, she spent 10 years at Genentech in the area of regulatory affairs, providing regulatory leadership and executing strategy for products across development from the pre-investigational new drug stage through post-marketing, including indications for asthma and ophthalmology. She holds a B.S. in genetic engineering from Cedar Crest College and a Ph.D. in tumor cell biology from Northwestern University.

Linda McBride began her career in the pharmaceutical industry more than 30 years ago as a research pharmacist with Novartis Consumer Health. She subsequently held regulatory positions of increasing responsibility at Enturia, Cogentus, and Gilead Sciences. Her therapeutic area expertise includes analgesia, antiseptics, cardiovascular, dermatology, infectious disease, neurology, oncology, and pulmonology, and she has dealt with small molecules, biologics, combination products, and over-the-counter products. Ms. McBride has a B.S. in pharmacy, is a registered pharmacist, and has earned Regulatory Affairs Certification for the United States.

Elizabeth Narciso leads a team of regulatory operations professionals in preparing and submitting regulatory documentation on behalf of clients to the Food and Drug Administration and other health authorities. She has spent her career in regulatory operations and has integrated regulatory affairs in a variety of roles, including research associate, regulatory associate, documentation specialist, and publisher. Additionally, she has experience developing and maintaining systems and procedures. Prior to joining RPI, Ms. Narciso held roles at Genitope, PDL Biopharma, CV Therapeutics, Matrix Pharmaceutical, and Theravance. She holds a B.S. in biology with an emphasis in microbiology from San Francisco State University.

Laura Kilgore leads regulatory affairs for chemistry, manufacturing, and controls. Additionally, she specializes in providing strategic input, project management, and technical writing support for the development of agency meeting requests, original investigational new drug applications and new drug applications, and briefing documents. Ms. Kilgore has extensive experience in providing regulatory chemistry, manufacturing, and controls and quality leadership for development products supporting marketing approvals, as well as in lifecycle management for a broad range of marketed products across pharmaceutical, biologic, and medical device products, including solid oral dosage forms, topicals, transdermals, combination products, biosimilars, and devices. Prior to joining RPI, she spent six years at Actavis Laboratories and over 10 years at Nektar Therapeutics in regulatory affairs and quality assurance. Ms. Kilgore holds a B.S. in chemistry, magna cum laude, from Auburn University and has Regulatory Affairs Certification for the United States.