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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

Reynolds, T. and Allamneni, K. (2009, July 30). Toxicity testing for oncology drugs [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved April 15, 2025, from https://doi.org/10.69645/BNXM3097.
Export Citation (RIS)

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.