Robyn L. Phelps, MSc, PhD is a Toxicologist and Safety Pharmacologist with over 25 years of scientific and drug development experience. She has expertise in nonclinical pharmaceutical research and development, and has specialized skills in animal model development, cardiovascular and pulmonary safety pharmacology. Dr. Phelps has experience in all routes of administration including dermal and inhalation. Her study experience includes acute, subchronic and chronic toxicity, carcinogenicity and reproductive toxicology in multiple species. Dr. Phelps is an experienced manager who can provide both high level and study specific oversight. She is knowledgeable of domestic and international regulations and routinely interacts with regulatory authorities. She has authored nonclinical documents for national and international submissions as well as scientific manuscripts. Dr. Phelps serves as a corporate scientific advisor and is a member of the Roundtable of Toxicology Consultants.
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Kristen I. Livingston, MBA, is an accomplished Project Management professional, Alliance Manager, and Team Leader with over 25 years of pharmaceutical industry experience and demonstrated skill in managing global, cross-functional Teams culminating in regulatory submissions and approvals. Extensive knowledge of the drug development process from concept development and discovery through post-marketing and lifecycle management. Highly skilled in application of Project Management software (e.g. MSProject) and project budget management/oversight. Broad experience in supervising, mentoring and developing project managers, coordinators, and interns. Strengths include managing and leading high performance multidisciplinary project teams and co-development teams within a matrix environment, communication and influence management skills, flexibility, and building relationships that are the basis of successful partnerships and teamwork.
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For veterinary services or animal model development consultations, please contact PharmAdvance Consulting at rlphelps@usa.net.
John R. Decker, BSE, Electrical Engineering, Graduate Studies, Physiology, has extensive experience in Inhalation Technology including instrument and software development, and biologic testing. Mr. Decker is a well-recognized leader in the inhalation field who has dedicated a 40 year career to understanding the biological effects of environmental conditions on animals. His background includes generation and monitoring of inhaled pharmaceuticals, radionuclides, vapors and gases, smoke and chemical aerosols. He is an experienced program manager who has developed, constructed, installed and validated numerous regulatory-compliant automated systems for whole-body and nose-only inhalation exposure systems used by the National Toxicology Program, government, chemical industry, and pharmaceutical clients. In addition to the provision of program-specific engineering and monitoring services, Mr. Decker is an excellent staff trainer.
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Provides Consulting Services in Preformulation, Analytical and Pharmaceutical
Development; CMC Regulatory Strategy and Support, Compliance, and
Organizational and Managerial Effectiveness
www.rileyandrabel.com
Christopher M. Riley, PhD
(01) (408) 931-4480
criley@rileyandrabel.com
or:
Robyn L. Phelps, PhD
(01) (949) 293-1692
rlphelps@usa.net
