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Mary Ellen Cosenza, PhD, DABT, ATS, ERT, RAC is a regulatory consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. She has extensive experience in product development planning, global registration strategy development, worldwide product registration in a variety of therapeutic areas and modalities, and successful FDA and global health authority interactions. In addition, she is recognized as an expert in preclinical development and is an American Board of Toxicology certified toxicologist. Click here to read Mary Ellen's bio. |
AREAS OF EXPERTISE
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NEWS & EVENTS
I am excited to announce that our book, Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals, is out and available! Additional information can be located on the Taylor & Francis Group website and Amazon.
Book Description
Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody–drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products, and therapeutic vaccines. Best practices are defined for efficient discovery research to facilitate a science-based, efficient, and predictive preclinical development program to ensure clinical efficacy and safety.
Key Features:
Editors:
Joy A. Cavagnaro and Mary Ellen Cosenza
Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody–drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products, and therapeutic vaccines. Best practices are defined for efficient discovery research to facilitate a science-based, efficient, and predictive preclinical development program to ensure clinical efficacy and safety.
Key Features:
- Defines best practices for leveraging of discovery research to facilitate a development program
- Includes general principles, animal models, biomarkers, preclinical toxicology testing paradigms, and practical applications
- Discusses rare diseases
- Discusses "What-Why-When-How" highlighting different considerations based upon product attributes.
- Includes special considerations for rare diseases
Editors:
Joy A. Cavagnaro and Mary Ellen Cosenza
805.469.9555
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