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Translational Medicine : Optimizing Preclinical Safety Evaluation of Biopharmaceuticals by Mary Ellen Cosenza (2024, Trade Paperback)
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About this product
Product Identifiers
PublisherTaylor & Francis Group
ISBN-100367644452
ISBN-139780367644451
eBay Product ID (ePID)20075301773
Product Key Features
SubjectPharmacy, General, Pharmacology, Chemistry / General
Subject AreaScience, Medical
LanguageEnglish
Publication Year2024
FormatTrade Paperback
Publication NameTranslational Medicine : Optimizing Preclinical Safety Evaluation of Biopharmaceuticals
AuthorMary Ellen Cosenza
TypeTextbook
Number of Pages542 Pages
Dimensions
Item Length11 in
Item Weight51.9 Oz
Item Width8.2 in
Additional Product Features
Intended AudienceCollege Audience
Table Of Content1.1 Case-By-Case Approach: Historical Perspective 1.2 Selection of Relevant Animal Models/Species 1.3 Dose Extrapolation to Humans for Novel Biologics 1.4 READY, AIM, FIRE! The Importance of Strategic Drug Development Plans 1.5 Global Regulatory Expectations and Interactions 2.1 "Key Considerations in the Chemistry, Manufacturing and Controls (CMC) of BioPharmaceuticals" 2.2 Preclinical Toxicology Testing Paradigms 2.3 Inhalation Delivery of Biologics 2.4.1 Nonclinical Considerations for Biopharmaceutical Comparability Assessment 2.4.2 Immunogenicity of Therapeutic Proteins 2.4.3 Testing for Off-Target Binding 2.4.4 Reproductive, Developmental, & Juvenile Toxicity Assessments and Practical Applications 2.4.5 Biosimilar Products -- A Review of Past and Current Regulatory Approval Standards for Preclinical Safety Studies 2.4.6 Nonclinical Safety Strategy for Combinations of Biopharmaceuticals or Biopharmaceutical with Small Molecular Weight Compound 2.4.7 Due Diligence Regulatory and Preclinical focus 2.5 Regulatory Toxicology for Biopharmaceuticals: Preparing for Pre-IND Interactions and Avoiding IND Pitfalls for Oncology and Non-Oncology Products 2.6 Outsourcing and Monitoring Preclinical Studies Including GLP Considerations 3.1 Nonclinical Development of Peptides and Therapeutic Proteins 3.2 Antibodies (Abs) and Related Products Containing Complementarity Determining Regions (CDRs) 3.3 Nonclinical Safety Evaluation of Therapies for Rare Diseases 3.4 Development of Antibody Drug Conjugates 3.5 Preventive and Therapeutic Vaccines 3.6 Understanding the Nonclinical Safety Considerations for Therapeutic Oligonucleotides 3.7 Cellular-based Therapies 3.8 Considerations in the Preclinical Development of Gene Therapy Products 3.9 Genome-Editing Technologies 4.1 Nonclinical Development of Anti-Cancer Biotherapeutics 4.2 Non-Clinical Safety Evaluation of Immunomodulatory Biological Therapeutics for the Treatment of Immune-Mediated Diseases 4.3 Nonclinical Safety Program Considerations for Biologic Therapeutics for Neurodegenerative Conditions 4.4 Nonclinical Development of Biologics for Infectious Diseases
Dewey Decimal610.72
Dewey Edition23
IllustratedYes
LC Classification NumberR852.T7 2024
SynopsisTranslational Medicine 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., 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 About the Editors Joy A. Cavagnaro is an internationally recognized expert in preclinical development and regulatory strategy with an emphasis on genetic medicines.. Her 40-year career spans academia, government (FDA), and the CRO and biotech industries. She was awarded the 2019 Arnold J Lehman Award from the Society of Toxicology for introducing the concept of science-based, case-by-case approach to preclinical safety evaluation, which became the foundation of ICH S6. She currently serves on scientific advisory boards for advocacy groups and companies and consults and lectures in the area of preclinical development of novel therapies. Mary Ellen Cosenza is a regulatory toxicology consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. She has held leadership position in both the American College of Toxicology (ACT) and the International Union of Toxicology (IUTOX) and is also an adjunct assistant professor at the University of Southern California where she teaches graduate-level courses in toxicology and regulation of biologics.
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