Preclinical Safety Evaluation of Biopharmaceuticals

A Science-Based Approach to Facilitating Clinical Trials

Inbunden, Engelska, 2008

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"The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies."—From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials: Includes an overview of biopharmaceuticals with information on regulation and methods of productionDiscusses the principles of ICH S6 and their implementation in the U.S., Europe, and JapanCovers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticalsAddresses all aspects of the preclinical evaluation process, including: the selection of relevant species; safety/toxicity endpoints; specific considerations based upon class; and practical considerations in the design, implementation, and analysis of biopharmaceuticalsCovers transitioning from preclinical development to clinical trialsThis is a hands-on, straightforward reference for professionals involved in preclinical drug development, including scientists, toxicologists, project managers, consultants, and regulatory personnel.

Produktinformation

Utgivningsdatum2008-08-22
Mått165 x 241 x 61 mm
Vikt1 647 g
FormatInbunden
SpråkEngelska
Antal sidor1 072
FörlagJohn Wiley & Sons Inc
ISBN9780470108840

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Joy A. Cavagnaro, PhD, is the President of Access BIO, a consultancy specializing in science-based regulatory strategies and product development services. She has over twenty-five years of experience in biotech spanning academia, the CRO and biotech industries, and government. During her tenure at the FDA, Dr. Cavagnaro served as rapporteur for ICH S6. She is founder and past chair of the BIO Preclinical Safety Expert Group (BioSafe) and was the U.S. BIO Representative to the 2006 ABPI/BIA Early Stage Clinical Trials Taskforce.Dr. Cavagnaro is currently North American Chair of the Drug Information Association–Biotech SIAC and Chair of the Clinical and Regulatory Affairs Committee of the American Society of Gene Therapy. She serves on a number of scientific advisory boards and lectures internationally in the area of preclinical development of novel therapies.

Foreword xiJoy A. Cavagnaro, PhD, DABT, RAC, and Anthony D. Dayan, LLB, MD, FRCP, FRCPath, FFOM, FFPM, FIBiolAcknowledgments xixContributors xxi Part I Background 11. Biopharmaceuticals: Definition and Regulation 3Lincoln Tsang, PhD, FRSC, FIBiol, FRPharmS (Arnold and Porter, London, UK), and Nathan Cortez (Southern Methodist University)2. Methods of Production of Biopharmaceutical Products and Assessment of Environmental Impact 21Patricia D. Williams, PhD (Summit Drug Development Services)Part II Principles of Preclinical Development 433. The Principles of ICH S6 and the Case-by-Case Approach 45Joy A. Cavagnaro, PhD, DABT, RAC (Access BIO)4. Implementation of ICH S6: EU Perspective 67Peter R. Ryle, PhD, DipRCPath (Tox), FRCPath (PR BioServices), and David J. Snodin, PhD, FRSC, MChemA, MSc (Parexel Consulting)5. Implementation of ICH S6: Japanese Perspective 93Takahiro Nakazawa, PhD (Eli Lilly Japan)6. Implementation of ICH S6: US Perspective 111Mary Ellen Cosenza, PhD, MS, DABT, RAC (Amgen)Part III Current Practices in Preclinical Development 1237. Comparison of Preclinical Development Programs for Small Molecules (Drugs/Pharmaceuticals) and Large Molecules (Biologics/Biopharmaceuticals): Studies, Timing, Materials, and Costs 125Christopher Horvath, DVM, MS, DACVP (Archemix Corp.)8. Demonstration of Comparability of a Licensed Product after a Manufacturing Change 161Richard M. Lewis, PhD (Access BIO)Part IV Selection of Relevant Species 1799. Selection of Relevant Species 181Meena Subramanyam, PhD, Nicola Rinaldi, PhD, Elisabeth Mertsching, PhD, and David Hutto, PhD, DVM (Biogen Idec)10. Tissue Cross-Reactivity Studies for Monoclonal Antibodies: Predictive Value and Use for Selection of Relevant Animal Species for Toxicity Testing 207William C. Hall, VMD, PhD, DACVP (Hall Consulting Inc.), Shari A. Price-Schiavi, PhD, DABT (Charles River Laboratories—PAI), Joan Wicks, DVM, PhD, DACVP (Charles River Laboratories—PAI), and Jennifer L. Rojko, DVM, PhD, DACVP (Charles River Laboratories—PAI)11. Physiologic IgG Biodistribution, Transport, and Clearance: Implications for Monoclonal Antibody Products 241Jennifer L. Rojko, DVM, PhD, DACVP, and Shari Price-Schiavi, PhD, DABT (Charles River Laboratories—PAI)12. The Role of Pharmacokinetics and Pharmacodynamics in Selecting a Relevant Species 277Martin D. Green, PhD (FDA), and Melanie Hartsough, PhD (Biologics Consulting Group, Inc.)13. Use of Animal Models of Disease in the Preclinical Safety Evaluation of Biopharmaceuticals 293Johan te Koppele, PhD (TNO Quality of Life) and Renger Witkamp, PhD (Wageningen University, The Netherlands)Part V Safety/toxicity Endpoints 30914. Safety Pharmacology: Similarities and Differences between Small Molecules and Novel Biopharmaceuticals 311Edward W. Bernton, MD (Pathway Pharmacology)15. Genetic Toxicology Testing of Biopharmaceuticals 337David Jacobson-Kram, PhD, DABT, and Hanan Ghantous, PhD, Dabt (fda)16. General Toxicity Testing and Immunotoxicity Testing for Biopharmaceuticals 343Jeanine L. Bussiere, PhD, DABT (Amgen)17. Reproductive Toxicity Testing for Biopharmaceuticals 357Pauline L. Martin, PhD (Centocor Research and Development Inc.)18. Reproductive/Developmental Toxicity Assessment of Biopharmaceuticals in Nonhuman Primates 379Gerhard F. Weinbauer, PhD, Werner Frings, PhD, Antje Fuchs, PhD, Michael Niehaus, PhD, and Ingrid Osterburg (Covance, Germany)19. Preclinical Evaluation of Cancer Hazard and Risk of Biopharmaceuticals 399Joy A. Cavagnaro, PhD, DABT, RAC (Access BIO)20. Immunogenicity of Therapeutic Proteins and the Assessment of Risk 475Huub Schellekens, MD, PhD (Utrecht University), and Wim Jiskoot, PhD (Leiden University)21. Assessment of Autoimmunity and Hypersensitivity 487Jacques Descotes, md, PharmD, PhD, and Thierry Vial, md(Poison Centere and Pharmacovigilance Unit, Lyon, France)Part VI Specific Considerations Based on Product Class 49922. Current Practices in the Preclinical Safety Assessment of Peptides 501Shawn M. Heidel, DVM, PhD, and Todd J. Page, PhD (Eli Lilly)23. Enzyme Replacement Therapies 517Laura Andrews, PhD, DABT (Genzyme), and Michael O’Callaghan, DVM, PhD, MRCVS (Genzyme)24. Toxicology of Oligonucleotide Therapeutics and Understanding the Relevance of the Toxicities 537Arthur A. Levin, PhD, DABT (Biotech & Pharmaceutical Consulting), and Scott P. Henry, PhD, DABT (Isis)25. Preclinical Safety Evaluation of Biological Oncology Drugs 575Theresa Reynolds, BA, DABT (Genentech)26. Preclinical Safety Evaluation of Monoclonal Antibodies 587George Treacy, MS, and Pauline Martin, PhD (CentocorResearch and Development)27. Immunomodulatory Biopharmaceuticals and Risk of Neoplasia 601Peter J. Bugelski, PhD, FRCPath, Clifford Sachs, PhD, DABT, Joel Cornacoff, DVM, PhD, DABT, Pauline Martin, PhD, and George Treacy, MS (Centocor Research and Development)28. Strategy Considerations for Developing the Preclinical Safety Testing Programs for Protein Scaffold Therapeutics 633Stanley A. Roberts, PhD, DABT, Gary Woodnutt, PhD, and Curt W. Bradshaw, PhD (CovX Research, LLC)29. Preclinical Safety Evaluation of Immunotoxins 649Jennifer G. Brown, PhD, Joycelyn Entwistle, PhD, Nick Glover, PhD, and Glen C. MacDonald, PhD (Viventia Biotech, Inc)30. Preclinical Safety Evaluation of Blood Products 669Richard M. Lewis, PhD (Access BIO)31. Preclinical Safety Evaluation of Viral Vaccines 683A. Marguerite Dempster, PhD, DABT, and Richard Haworth, FRCPath, DPhil (GlaxoSmithKline)32. Preclinical Safety Evaluation of Biopharmaceuticals 713Mercedes A. Serabian, MS, DABT, and Ying Huang, PhD (FDA)33. Considerations in Design of Preclinical Safety Evaluation Programs to Support Human Cell-Based Therapies 749Joy A. Cavagnaro, PhD, DABT, RAC (Access BIO)34. Preclinical Safety Evaluation of Biopharmaceuticals: Combination Products (Biologic/Device) 783Bruce Babbitt, PhD, and Barry Sall (Parexel Consulting)35. Tissue Engineered Products: Preclinical Development of Neo-Organs 799Timothy A. Bertram, DVM, PhD, and Manuel Jayo, DVM, PhD (Tengion)Part VII Preclinical Study Design, Implementation, and Analysis 82736. GLP Requirements and Current Practices 829Tanya Scharton-Kersten (Novartis)37. Preclinical Safety Study Design Templates and Estimated Costs 851Gary W. Wolfe, PhD, DABT (Summit Drug Development Services)38. Practical Considerations in the Design of Preclinical Safety Assessments for Biopharmaceuticals 913Damon R. Demady, PhD (Knopp Neurosciences)39. Survey of Preclinical Toxicology Programs for Approved Biopharmaceuticals 931Anita Marie O’Connor, PhD (Anita O’Connor Consulting, LLC)Part VIII Transitioning From Preclinical Development to Clinical Trials 96940. Science and Judgment in Establishing a Safe Starting Dose for First-in-Human Trials of Biopharmaceuticals 971Jennifer Visich, PhD (Genentech), and Rafael Ponce, PhD, DABT (Zymogenetics)Part IX Afterword 985A Retrospective 987Anthony D. Dayan, LLB, MD, FRCP, FRCPath, FFOM, FFPM, FIBiolIndex 999

"For scientists who are intimately involved with biopharmaceutical development, a copy of the book for their personal library is mandatory. Those who may not be intimately involved in biopharmaceutical development but may have an interest in the progress of a biotherapeutic agent will find this book a valuable resource and a reminder for the need of evaluating the safety of biotherapeutics by looking at each biopharmaceutical on a case-by-case approach." (International Journal of Toxicology, March/April 2009)