OUR EXPERTS
Nonclinical Safety
Meet some of the renowned scientists, physicians, and engineers who help BlueRidge clients achieve their most important life science goals.

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Marcie Wood, PhD
SENIOR VICE PRESIDENT, NONCLINICAL TOXICOLOGY & PRINCIPAL SCIENTIST
ToxStrategiesMy expertise includes developing nonclinical toxicology program technical and regulatory strategies to support advancement of therapeutic products into clinical trials and beyond. I have 20+ years of experience as a toxicologist, drug development professional, and former FDA leader, and I leverage this background to support clients with nonclinical challenges at all stages of drug development.
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Kristina Ulrich, PhD, ERT
SENIOR MANAGING SCIENTIST, DIRECTOR, NONCLINICAL TOXICOLOGY
ToxStrategiesI specialize in the design and implementation of nonclinical safety strategies to facilitate the advancement of novel therapeutics into clinical development and beyond. I have 20+ years of experience as a toxicologist/drug developer from a number of large pharmaceutical companies, as well being a former non-clinical assessor at MHRA. I leverage this expertise to enable my clients to make informed decisions about their safety challenges and to support streamlined progression of their programs.
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Kirsten Mease
SENIOR MANAGING SCIENTIST
ToxStrategiesI'm a Senior Managing Scientist at ToxStrategies with over 20 years of experience in pharmaceutical and biopharmaceutical drug development. My work focuses on nonclinical safety assessments, and I’ve had the opportunity to lead a wide range of toxicology studies across various species, routes of administration, and therapeutic areas. I collaborate closely with CROs around the world to ensure studies are well-designed, efficiently executed, and aligned with regulatory expectations. I also enjoy developing custom regulatory strategies and authoring the nonclinical sections of submissions for my clients for both U.S. and European health authorities.
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Tom Monticello, DVM, PhD, DACVPNew List Item
SENIOR CONSULTANT, NONCLINICAL TOXICOLOGY
ToxStrategiesI have been a scientific translational safety leader at major global pharmaceutical companies and have over 30 years of experience. As a board-certified veterinary pathologist, I have worked across therapeutic areas for small and large molecules, in addition to novel modalities (e.g., ADC, siRNA, BiTEs). I have proven success with Health Authority submissions across the developmental pipeline, from IND/CTAs to NDA/BLAs. I have also attained a successful professional network in translational safety sciences, serving as Past President of the Society of Toxicologic Pathology (STP), former Board of Director member for the International Consortium for Innovation and Quality in Pharmaceutical Research (IQ), and past Chair of the IQ DruSafe Leadership Group.
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Tim Robison, PhD, DABT
SENIOR CONSULTANT, NONCLINICAL TOXICOLOGY
ToxStrategiesI have 40 years of experience as a nonclinical toxicologist with 29 years at the US FDA as a Reviewer, Team Leader, and Supervisor working with multidisciplinary teams to support development of drugs for pulmonary, allergy, critical care, autoimmune, transplant, and viral (e.g., COVID) indications. My expertise includes evaluation of inhalation, oral, and parenteral toxicology studies, genetic toxicity studies with drug candidates and impurities, and extractables and leachables studies with devices used for pulmonary and autoimmune indications. In addition, I was co-chair of the CDER Genetic Toxicity Subcommittee for 25 years, and in this role, I provided recommendations on challenging genetic toxicology data. I leverage my extensive regulatory background to support nonclinical challenges at all stages of drug development for many different indications.
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Amy Kimzy, PhD, DABT
SENIOR MANAGING SCIENTIST, DIRECTOR NONCLINICAL TOXICOLOGY
ToxStrategiesI specialize in nonclinical toxicology development of large and small molecules across a variety of therapeutic routes including less common routes such as intrathecal and focus on providing clients with the expertise they need to maximize the potential of their drug candidates. I have 20+ years of experience in toxicology and drug discovery. I leverage this experience to help clients successfully advance their programs from target identification through IND- and market-enabling toxicology programs.
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Nate Collins, DVM, PhD, DACVP
SENIOR CONSULTANT, NONCLINICAL TOXICOLOGY
ToxStrategiesI am a clinical pathologist by training with 25 years’ experience in large pharma developing small and large molecules and novel modalities, including cell therapies, or oncology, immunology, CNS, infectious disease, and cardiovascular indications. I have led investigative toxicology, genetic toxicology, immunotoxicology, and biomarker discovery groups. The last 15 years of my career were spent overseeing nonclinical safety strategy for the portfolio of two pharma R&D organizations. I have made substantial contributions to the successful approval of 19 marketed drugs as well as numerous other development candidates, from preclinical through Phase 3 clinical development and post-marketing commitments. I leverage this experience as well as extensive health authority interactions to help clients solve challenging preclinical problems and progress their molecules.