BN.com Gift Guide

Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials / Edition 1

Hardcover (Print)
Used and New from Other Sellers
Used and New from Other Sellers
from $150.14
Usually ships in 1-2 business days
(Save 21%)
Other sellers (Hardcover)
  • All (5) from $150.14   
  • New (4) from $150.14   
  • Used (1) from $158.39   

Overview

"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 production
  • Discusses the principles of ICH S6 and their implementation in the U.S., Europe, and Japan
  • Covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals
  • Addresses 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 biopharmaceuticals
  • Covers transitioning from preclinical development to clinical trials
This is a hands-on, straightforward reference for professionals involved in preclinical drug development, including scientists, toxicologists, project managers, consultants, and regulatory personnel.
Read More Show Less

Editorial Reviews

From the Publisher
"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)
Read More Show Less

Product Details

  • ISBN-13: 9780470108840
  • Publisher: Wiley
  • Publication date: 7/28/2008
  • Edition number: 1
  • Pages: 1072
  • Product dimensions: 6.50 (w) x 9.40 (h) x 2.00 (d)

Meet the Author

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.

Read More Show Less

Table of Contents

FOREWORD (Joy A. Cavagnaro, PhD, DABT, RAC, and Anthony D. Dayan, LLB, MD, FRCP, FRCPath, FFOM, FFPM, FIBiol).

ACKNOWLEDGMENTS.

CONTRIBUTORS.

PART I: BACKGROUND.

1. Biopharmaceuticals: Defi nition and Regulation (Lincoln 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 (Patricia D. Williams, PhD (Summit Drug Development Services)).

PART II: PRINCIPLES OF PRECLINICAL DEVELOPMENT.

3. The Principles of ICH S6 and the Case-by-Case Approach (Joy A. Cavagnaro, PhD, DABT, RAC (Access BIO)).

4. Implementation of ICH S6: EU Perspective (Peter 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 (Takahiro Nakazawa, PhD (Eli Lilly Japan)).

6. Implementation of ICH S6: US Perspective (Mary Ellen Cosenza, PhD, MS, DABT, RAC (Amgen)).

PART III: CURRENT PRACTICES IN PRECLINICAL DEVELOPMENT.

7. Comparison of Preclinical Development Programs for Small Molecules (Drugs/Pharmaceuticals) and Large Molecules (Biologics/Biopharmaceuticals): Studies, Timing, Materials, and Costs (Christopher Horvath, DVM, MS, DACVP (Archemix Corp.)).

8. Demonstration of Comparability of a Licensed Product after a Manufacturing Change (Richard M. Lewis, PhD (Access BIO)).

PART IV: SELECTION OF RELEVANT SPECIES.

9. Selection of Relevant Species (Meena 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 (William 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 (Jennifer 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 (Martin 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 (Johan te Koppele, PhD (TNO Quality of Life) and Renger Witkamp, PhD (Wageningen University, The Netherlands)).

PART V: SAFETY/TOXICITY ENDPOINTS.

14. Safety Pharmacology: Similarities and Differences between Small Molecules and Novel Biopharmaceuticals (Edward W. Bernton, MD (Pathway Pharmacology)).

15. Genetic Toxicity Testing of Biopharmaceuticals (David Jacobson-Kram, PhD, DABT, and Hanan Ghantous, PhD, DABT (FDA)).

16. General Toxicity Testing and Immunotoxicity Testing for Biopharmaceuticals (Jeanine L. Bussiere, PhD, DABT (Amgen)).

17. Reproductive Toxicity Testing for Biopharmaceuticals (Pauline L. Martin, PhD (Centocor Research and Development Inc.)).

18. Reproductive/Developmental Toxicity Assessment of Biopharmaceuticals in Nonhuman Primates (Gerhard 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 (Joy A. Cavagnaro, PhD, DABT, RAC (Access BIO)).

20. Immunogenicity of Therapeutic Proteins and the Assessment of Risk (Huub Schellekens, MD, PhD (Utrecht University), and Wim Jiskoot, PhD (Leiden University)).

21. Assessment of Autoimmunity and Hypersensitivity (Jacques Descotes, MD, PharmD, PhD, and Thierry Vial, MD (Poison Centere and Pharmacovigilance Unit, Lyon, France)).

PART VI: SPECIFIC CONSIDERATIONS BASED ON PRODUCT CLASS.

22. Current Practices in the Preclinical Safety Assessment of Peptides (Shawn M. Heidel, DVM, PhD, and Todd J. Page, PhD (Eli Lilly)).

23. Enzyme Replacement Therapies (Laura Andrews, PhD, DABT (Genzyme), and Michael O’Callaghan, DVM, PhD, MRCVS (Genzyme)).

24. Toxicology of Oligonucleotide Therapeutics and Understanding the Relevance of the Toxicities (Arthur A. Levin, PhD, DABT (Biotech & Pharmaceutical Consulting), and Scott P. Henry, PhD, DABT (Isis)).

25. Preclinical Saxfety Evaluation of Biological Oncology Drugs (Theresa Reynolds, BA, DABT (Genentech)).

26. Preclinical Safety Evaluation of Monoclonal Antibodies (George Treacy, MS, and Pauline Martin, PhD (Centocor Research and Development)).

27. Immunomodulatory Biopharmaceuticals and Risk of Neoplasia (Peter 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 (Stanley A. Roberts, PhD, DABT, Gary Woodnutt, PhD, and Curt W. Bradshaw, PhD (CovX Research, LLC)).

29. Preclinical Safety Evaluation of Immunotoxins (Jennifer G. Brown, PhD, Joycelyn Entwistle, PhD, Nick Glover, PhD, and Glen C. MacDonald, PhD (Viventia Biotech, Inc)).

30. Preclinical Safety Evaluation of Blood Products (Richard M. Lewis, PhD (Access BIO)).

31. Preclinical Safety Evaluation of Viral Vaccines (A. Marguerite Dempster, PhD, DABT, and Richard Haworth, FRCPath, DPhil (GlaxoSmithKline)).

32. Preclinical Safety Evaluation of Biopharmaceuticals (Mercedes A. Serabian, MS, DABT, and Ying Huang, PhD (FDA)).

33. Considerations in Design of Preclinical Safety Evaluation Programs to Support Human Cell-Based Therapies (Joy A. Cavagnaro, PhD, DABT, RAC (Access BIO)).

34. Preclinical Safety Evaluation of Biopharmaceuticals: Combination Products (Biologic/Device) (Bruce Babbitt, PhD, and Barry Sall (Parexel Consulting)).

35. Tissue Engineered Products: Preclinical Development of Neo-Organs (Timothy A. Bertram, DVM, PhD, and Manuel Jayo, DVM, PhD (Tengion)).

PART VII: PRECLINICAL STUDY DESIGN, IMPLEMENTATION, AND ANALYSIS.

36. GLP Requirements and Current Practices (Tanya Scharton-Kersten (Novartis)).

37. Preclinical Safety Study Design Templates and Estimated Costs (Gary W. Wolfe, PhD, DABT (Summit Drug Development Services)).

38. Practical Considerations in the Design of Preclinical Safety Assessments for Biopharmaceuticals (Damon R. Demady, PhD (Knopp Neurosciences)).

39. Survey of Preclinical Toxicology Programs for Approved Biopharmaceuticals (Anita Marie O’Connor, PhD (Anita O’Connor Consulting, LLC)).

PART VIII: TRANSITIONING FROM PRECLINICAL DEVELOPMENT TO CLINICAL TRIALS.

40. Science and Judgment in Establishing a Safe Starting Dose for First-in-Human Trials of Biopharmaceuticals (Jennifer Visich, PhD (Genentech), and Rafael Ponce, PhD, DABT (Zymogenetics)).

PART IX: AFTERWORD.

A Retrospective (Anthony D. Dayan, LLB, MD, FRCP, FRCPath, FFOM, FFPM, FIBiol).

INDEX.

Read More Show Less

Customer Reviews

Be the first to write a review
( 0 )
Rating Distribution

5 Star

(0)

4 Star

(0)

3 Star

(0)

2 Star

(0)

1 Star

(0)

Your Rating:

Your Name: Create a Pen Name or

Barnes & Noble.com Review Rules

Our reader reviews allow you to share your comments on titles you liked, or didn't, with others. By submitting an online review, you are representing to Barnes & Noble.com that all information contained in your review is original and accurate in all respects, and that the submission of such content by you and the posting of such content by Barnes & Noble.com does not and will not violate the rights of any third party. Please follow the rules below to help ensure that your review can be posted.

Reviews by Our Customers Under the Age of 13

We highly value and respect everyone's opinion concerning the titles we offer. However, we cannot allow persons under the age of 13 to have accounts at BN.com or to post customer reviews. Please see our Terms of Use for more details.

What to exclude from your review:

Please do not write about reviews, commentary, or information posted on the product page. If you see any errors in the information on the product page, please send us an email.

Reviews should not contain any of the following:

  • - HTML tags, profanity, obscenities, vulgarities, or comments that defame anyone
  • - Time-sensitive information such as tour dates, signings, lectures, etc.
  • - Single-word reviews. Other people will read your review to discover why you liked or didn't like the title. Be descriptive.
  • - Comments focusing on the author or that may ruin the ending for others
  • - Phone numbers, addresses, URLs
  • - Pricing and availability information or alternative ordering information
  • - Advertisements or commercial solicitation

Reminder:

  • - By submitting a review, you grant to Barnes & Noble.com and its sublicensees the royalty-free, perpetual, irrevocable right and license to use the review in accordance with the Barnes & Noble.com Terms of Use.
  • - Barnes & Noble.com reserves the right not to post any review -- particularly those that do not follow the terms and conditions of these Rules. Barnes & Noble.com also reserves the right to remove any review at any time without notice.
  • - See Terms of Use for other conditions and disclaimers.
Search for Products You'd Like to Recommend

Recommend other products that relate to your review. Just search for them below and share!

Create a Pen Name

Your Pen Name is your unique identity on BN.com. It will appear on the reviews you write and other website activities. Your Pen Name cannot be edited, changed or deleted once submitted.

 
Your Pen Name can be any combination of alphanumeric characters (plus - and _), and must be at least two characters long.

Continue Anonymously

    If you find inappropriate content, please report it to Barnes & Noble
    Why is this product inappropriate?
    Comments (optional)