图书简介
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 th
Chapter 1.1 Case-By-Case Approach: Historical Perspective Joy Cavagnaro Chapter 1.2 Selection of Relevant Animal Models/Species D. Blasnet, M. Di Piazza and E. Musvasva Chapter 1.3 Dose Extrapolation to Humans for Novel Biologics John T. Sullivan Chapter 1.4 READY, AIM, FIRE! The Importance of Strategic Drug Development Plans Patricia D. Williams Chapter 1.5 Global Regulatory Expectations and Interactions Mary Ellen Consenza Chapter 2.1 \"Key Considerations in the Chemistry, Manufacturing and Controls (CMC) of BioPharmaceuticals\" Sara McKenzie and Ed Branson Chapter 2.2 Preclinical Toxicology Testing Paradigms Joy Cavagnaro Chapter 2.3 Inhalation Delivery of Biologics Stephanie F. Greene and Gregory L. Finch Chapter 2.4.1 Nonclinical Considerations for Biopharmaceutical Comparability Assessment Christopher E. Ellis and Melanie T. Hartsough Chapter 2.4.2 Immunogenicity of Therapeutic Proteins Steven J. Swanson Chapter 2.4.3 Testing for Off-Target Binding Diana M. Norden and Benjamin J. Doranz Chapter 2.4.4 Reproductive, Developmental, & Juvenile Toxicity Assessments and Practical Applications Christopher J Bowman and Gerhard F. Weinbauer Chapter 2.4.5 Biosimilar Products - A Review of Past and Current Regulatory Approval Standards for Preclinical Safety Studies A. Kimzey, K. Mease, B. Mounho-Zamora, *M. Wood Chapter 2.4.6 Nonclinical Safety Strategy for Combinations of Biopharmaceuticals or Biopharmaceutical with Small Molecular Weight Compound Maggie Dempster and Helen G. Haggerty Chapter 2.4.7 Due Diligence Regulatory and Preclinical focus Janet Nokleby Chapter 2.5 Regulatory Toxicology for Biopharmaceuticals: Preparing for Pre-IND Interactions and Avoiding IND Pitfalls for Oncology and Non-Oncology Products Janice Lansita, Andrew McDougal, Jane Sohn and Shawna Weis Chapter 2.6 Outsourcing and Monitoring Preclinical Studies Including GLP Considerations P. Mookherjee Chapter 3.1 Nonclinical Development of Peptides and Therapeutic Proteins Melanie T. Hartsough Chapter 3.2 Antibodies (Abs) and Related Products Containing Complementarity Determining Regions (CDRs) Michael W. Leach Chapter 3.3 Nonclinical Safety Evaluation of Therapies for Rare Diseases K. McKeever and T. MacLachlan Chapter 3.4 Development of Antibody Drug Conjugates Stanley A. Roberts, Simon Chivers, Anu Connor, Hadi Falahatpisheh, Magali Guffroy, Anthony J. Lee, Lise I. Loberg, Colin Phipps, Sherry L. Ralston, Melissa M. Schutten, Nicola J. Stagg, Jay Tibbitts Chapter 3.5 Preventive and Therapeutic Vaccines S.D. Klas and D.L. Novicki Chapter 3.6 Understanding the Nonclinical Safety Consdierations for Therapeutic Oligonucleotides Patrik Andersson, Cathaline den Besten, Scott P. Henry, Arthur A. Levin Chapter 3.7 Cellular-based Therapies Ellen G. Feigal, Mary Ellen Cosenza Chapter 3.8 Considerations in the Preclinical Development of Gene Therapy Products Joy Cavagnaro Chapter 3.9 Genome-Editing Technologies Kathleen Meyer-Tamaki Chapter 4.1 Nonclinical Development of Anti-Cancer Biotherapeutics Marque Todd, Cris Kamperschroer, Jonathan Heyen, Rafael Ponce and Timothy MacLachlan Chapter 4.2 Non-Clinical Safety Evaluation of Immunomodulatory Biological Therapeutics for the Treatment of Immune-Mediated Diseases Frank R. Brennan Chapter 4.3 Nonclinical Safety Program Considerations for Biologic Therapeutics for Neurodegenerative Conditions D.N. Hovland, Jr., B.B. Smith and C.W. Chen Chapter 4.4 Nonclinical Development of Biologics for Infectious Diseases B.B. Smith
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