Our Team

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Donna Kato

Founder and CEO

Donna is Founder and CEO of RPI and has spent her career in the pharmaceuticals industry, specializing in regulatory affairs for the last 30 years. Donna started her career at Syntex in discovery research and later joined its worldwide regulatory affairs department. After Syntex, Donna led regulatory affairs at Acologix and Celtrix before founding RPI in 1995. Under Donna’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 active as an instructor in the University of California Berkeley Extension Certificate Program in Regulatory Affairs. Donna holds a B.S. degree in biochemistry from the University of California, Davis and an M.B.A. from Santa Clara University

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Kristi Miller

Ph.D., Head of Regulatory Affairs

Kristi leads a diverse, cross-functional team of regulatory affairs professionals at RPI in developing and implementing 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, Kristi was the Director of Global Regulatory Affairs at Phamacyclics and previously spent 10 years at Genentech in the area of regulatory affairs, providing regulatory leadership and executed strategy for products across development (pre-IND through post-marketing), including indications in asthma and ophthalmology. Kristi holds a B.S. degree in Genetic Engineering from Cedar Crest College and a Ph.D. in Tumor Cell Biology from Northwestern University

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Elizabeth Narciso

Head of Regulatory Operations

Elizabeth is Head of Regulatory Operations at RPI where she leads a team of regulatory operations professionals in preparing and submitting regulatory documentation on behalf of clients to the FDA and other health authorities. Elizabeth has spent her career in Regulatory Operations and integrated Regulatory Affairs, with over 17 years of experience in a variety of roles as research associate, regulatory associate, documentation specialist, publisher, and in developing and maintaining systems and procedures. Prior to joining RPI, Elizabeth held roles at Genitope, PDL Biopharma, CV Therapeutics, Matrix Pharmaceutical, and Theravance. Elizabeth holds a B.S. degree in Biology with an emphasis in Microbiology from San Francisco State University

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Laura Kilgore

RAC, Chemistry, Manufacturing, and Controls (CMC)

Laura leads regulatory CMC at RPI and specializes in providing strategic input, project management, and technical writing support for the development of agency meeting requests, original applications (IND, NDA) and briefing documents. Laura has nearly 20 years of experience in the pharmaceuticals industry with extensive experience in providing regulatory CMC and quality leadership for development products supporting marketing approvals, as well as in life cycle 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, Laura spent six years at Actavis Laboratories and over 10 years at Nektar Therapeutics in regulatory affairs and quality assurance. Laura holds a B.S. degree in Chemistry, Magna Cum Laude, from Auburn University and is RAC-US certified

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Ann Leonard

Ph.D., RAC, Associate Director, Medical Device,
In vitro Diagnostics, and Drug/Device Combinations

Ann leads medical device, in vitro diagnostic and drug/device combination work at RPI, supporting cross-functional drug and device development teams working toward key milestones and regulatory deliverables in the U.S., Canada, EU, and Asia. With over 15 years of experience in regulatory affairs supporting the development of drug, device, biotechnology, in vitro diagnostic and ‘combination’ products for multiple indications and patient populations, Ann is able to assist development teams with regulatory strategy, product development plans, GxP compliance solutions, and regulatory submission preparation including authoring and maintenance of drug and device regulatory applications (i.e. IND, CTA, NDA, BLA, MAA, IDE, 510(k), Technical Files and PMA). Prior to joining RPI, Ann previously held positions at both small and large companies providing innovative healthcare solutions such as Inovio Pharmaceuticals, Alere, Genentech, InvivoScribe Technologies and Abbott Vascular. Ann holds a B.S. degree in Biology from Boston University and a doctorate in Biology and certificate in Regulatory Science from the University of California San Diego

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Maria Crump

Head of eTMF Services

Maria leads a team that provides the services and solutions to facilitate management of data and documents for clinical trial including quality oversight continuously throughout the lifecycle of the study on behalf of clients. Maria has over 20 years working in Regulatory Affairs and Clinical Operations. She has been an independent consultant for many years and worked with numerous small biotech as well as major pharmaceutical companies. Maria has played a pivotal role in supporting MAA and NDA applications as well as an EMA inspection. Maria holds a B.S. degree in Ornamental Horticulture from California Polytechnic, San Luis Obispo and an MBA from University of San Francisco

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