Our Team

Donna is Founder and President 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

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. Kristi brings an extensive background in regulatory affairs in the pharmaceutical and biotech industries. 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

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 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

Katharine brings a combination of pharmaceutical and CRO experience and leads RPI’s strategic consulting efforts in Europe. Her range of therapeutic area knowledge spans oncology, rheumatology, women’s health, respiratory, CNS, and dermatology. In addition to this, Katharine has experience with preparing and leading teams through face-to-face meetings with PDCO, MHRA, INFAMED, PGWP, and innovation task force meetings at EMA. Additionally, Katharine has authored Orphan Drug Designation applications and various regulatory documents in support of product submissions in Europe. She is a regular attendee of TOPRA meetings in the UK and has conducted training and webinars on various regulatory topics. Katharine holds a BSc (Honors) in Pharmacology from Sheffield University and an MSc Regulatory Affairs from the University of Wales, Cardiff.

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 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

Brian is Director of Medical & Regulatory Writing at RPI. Brian brings significant experience in Medical and Regulatory Writing, including authoring and reviewing documents for regulatory submissions (INDs, NDAs, BLAs, and MAAs) and medical communications. Prior to RPI, Brian was a Principal Medical Writer for several large pharma/biopharma sponsors, including Onyx, Astellas, Merrimack, Merck, and Otsuka Pharmaceuticals, where he specialized in a broad range of therapeutic areas including but not limited to Oncology, Immunology/Rheumatology, Neurological Disorders, Infectious Diseases, Cardiovascular Diseases, Diabetes and Metabolism, Blood Disorders, Respiratory, Transplantation and Cell Therapy, and Rare Diseases. Before entering the pharma/biopharma industry, Brian was a professor and independent research scientist at the University of Miami School of Medicine for 10 years where he conducted research on Stem Cells and Neurodevelopment. Brian has a Ph.D. in Cellular and Integrative Neurosciences from the University of Florida (Gainesville) and completed fellowships in Molecular Genetics and Genomics at the Howard Hughes Medical Institute.

Cathy is highly experienced in Global Quality Systems with considerable U.S. and International experience within the Pharmaceutical, Biotech, Medical Devices and Combination Product environment. Cathy has experience across therapeutic areas, including ophthalmology, respiratory, neurology, and oncology phase I – IV clinical development through commercialization. Prior to joining RPI, Cathy has had various quality and compliance roles throughout her career in consulting roles as well as providing quality management oversight for companies such as EyePoint Pharmaceuticals, Teva Pharmaceuticals, and MAP Pharmaceuticals. Cathy holds a BS in Clinical Science with a Minor in Chemistry from San Francisco State University.

Sameena is a strategic thought leader in drug development, alliance, project, and portfolio management. Sameena has broad experience in management of projects at all stages of drug development – as early as target selection to pre-IND through to NDA/ MAA submissions and commercial planning. She has led large, cross-functional teams in global alliances with Amgen, Otsuka, Genentech, Novartis, Onyx, and AstraZeneca with particular interest in optimization of the drug development and alliance management process in small and midsized companies. Sameena holds a Bachelor of Pharmacy from the University of Bradford and has a Ph.D. in Pharmaceutics from the University of Nottingham.

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 brings her extensive background from working in Regulatory Affairs and Clinical Operations and has consulted 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