• Introduction
• 29 min
  1. General introduction to non-clinical toxicity testing of pharmaceuticals

  • Dr. Andrea Weir
• 14 min
  2. Overview of nonclinical safety assessment

  • Dr. Claudette L. Fuller
• 12 min
  3. Biological safety testing: supporting medical device combination products

  • Dr. Christine L. Lanning
• 34 min
  4. Regulatory guidance on toxicity testing of pharmaceuticals: ICH

  • Dr. John Kapeghian
• 48 min
  5. Toxicology testing standards: good laboratory practices and the institutional animal care committee

  • Dr. Peter Thomas
• Basics of Non-clinical Toxicity Testing
• 20 min
  6. Acute, subchronic, and chronic toxicity testing

  • Mr. Gregory Ruppert
• 56 min
  7. Safety pharmacology in human pharmaceutical development

  • Dr. R. Dusty Sarazan
• 42 min
  8. Genetic toxicology

  • Dr. Roderick Todd Bunch
• 48 min
  9. Reproductive and developmental toxicology

  • Dr. Alan Hoberman
• 48 min
  10. Juvenile toxicity testing

  • Dr. Alan Hoberman
  • Dr. Elise Lewis
• 43 min
  11. Pharmacokinetics, toxicokinetics and safety margins

  • Dr. Mark Rogge
• 48 min
  12. Toxicity testing of impurities and metabolites

  • Dr. Kurt Black
• Organ System Toxicity Testing
• 38 min
  13. Drug induced liver injury: a clinical perspective

  • Prof. Victor Navarro
• 62 min
  14. Toxicology of the kidney

  • Prof. Lawrence Lash
• 58 min
  15. Toxicology of the cardiovascular system

  • Dr. Peter Siegl
• 67 min
  16. Toxicology of the immune system

  • Dr. Leigh Ann Burns Naas
• 59 min
  17. Toxicology of the developing immune system

  • Dr. Leigh Ann Burns Naas
• 43 min
  18. Hematology interpretation for toxicity studies

  • Dr. Nancy Everds
• New Methods for Assessing Toxicity
• 45 min
  19. Introduction to toxicogenomics and example case studies

  • Dr. Cindy Afshari
• Special Cases for Toxicity Testing
• 46 min
  20. Preclinical safety evaluation of biopharmaceuticals: science-based approach of facilitating clinical trials

  • Dr. Joy Cavagnaro
• 32 min
  21. Approaches to nonclinical vaccine development

  • Dr. Lisa Plitnick
• 54 min
  22. Toxicity testing of oncology drugs: unraveling the last 15 years of progress

  • Dr. Krishna Allamneni
• Archived Lectures *These may not cover the latest advances in the field
• 56 min
  23. Cellular and molecular toxicology

  • Dr. Dominic Williams
• 31 min
  24. Overview of non-clinical safety assessment in drug development

  • Dr. Danuta Herzyk
• 42 min
  25. Evaluation of the adult nervous system in preclinical studies

  • Dr. Mark Butt
• 56 min
  26. Non-clinical development of pharmaceuticals using engineered animal models

  • Dr. Brad Bolon
• 22 min
  27. Reproductive and developmental toxicology

  • Dr. Alan Hoberman
  • Dr. Elise Lewis
• 13 min
  28. Non-clinical toxicity testing for vaccines

  • Dr. Lisa Plitnick
• 36 min
  29. Toxicity testing for oncology drugs

  • Dr. Theresa Reynolds
  • Dr. Krishna Allamneni

Printable Handouts

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Navigable Slide Index

1. Introduction
2. Disclaimer
3. Presentation objectives
4. Overall cancer incidence in US, 1975-2007
5. Cancer survivors in the US, 1971-2007
6. Special considerations for oncology drugs (1)
7. Special considerations - why
8. Regulatory guidance: oncology drug development
9. Special considerations for oncology drugs (2)
10. List of special considerations
11. Special considerations: phase 1
12. Special considerations: treatment extension
13. Special considerations: small therapeutic index
14. Special considerations: timing and duration
15. Impact on the toxicology program
16. Objectives of toxicity testing
17. Impact: phase 1
18. Impact: treatment extension
19. Early extension of treatment
20. Impact: small therapeutic index
21. Value of a PD marker in oncology
22. Activity, efficacy and toxicity, value of a PD marker
23. Value of a PD marker: rituxan
24. Value of a PD marker: avastin
25. Safety evaluation for small and large molecules
26. Toxicity evaluation for small and large molecules
27. How do small molecules differ from biologics?
28. Differences in drug development plans
29. Preclinical drivers for small molecules
30. Lead optimization scheme
31. Challenges specific to small molecules
32. Cytotoxic vs. non-cytotoxic oncology drugs
33. More on targeted inhibitors
34. Toxicology plan for small molecules
35. Oncology drug failures
36. Current regulatory guidance
37. Regulatory guidance: oncology drug development
38. Specific regulatory guidance for oncology drugs
39. IND-enabling toxicology program
40. Selecting phase 1 starting dose - example
41. NDA-enabling toxicology program
42. Non-clinical testing for drug combinations
43. Regulatory guidance impurities
44. The ICH S9 initiative - introduction
45. ICH S9 - start dose
46. ICH S9 - duration of chronic toxicity studies
47. ICH S9 - reproductive toxicology
48. Acknowledgements

Topics Covered

• Special considerations for the development of oncology drugs and impact on design of toxicology programs
• Key similarities and differences in small molecule and large molecule toxicology programs
• Value of PD marker in drug development
• Current regulatory guidance for oncology products

Links

Series:

• Non-Clinical Testing for Toxicity of Pharmaceuticals

Categories:

• Cancer
• Pharmaceutical Sciences

Therapeutic Areas:

• Oncology

Talk Citation

Publication History

• Published on July 30, 2009
• Archived on February 29, 2024

Financial Disclosures

• Dr. Theresa Reynolds has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
• There are no financial/commercial matters to disclose.