On Sunday, April 20th 2025, starting 8:30am GMT, there will be maintenance work that will involve the website being unavailable during parts of the day. We apologize for any inconvenience this may cause and appreciate your understanding.
- Introduction
-
29 min
-
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
- 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
-
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
-
56 min
-
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
Navigable Slide Index
- Introduction
- Disclaimer
- Presentation objectives
- Overall cancer incidence in US, 1975-2007
- Cancer survivors in the US, 1971-2007
- Special considerations for oncology drugs (1)
- Special considerations - why
- Regulatory guidance: oncology drug development
- Special considerations for oncology drugs (2)
- List of special considerations
- Special considerations: phase 1
- Special considerations: treatment extension
- Special considerations: small therapeutic index
- Special considerations: timing and duration
- Impact on the toxicology program
- Objectives of toxicity testing
- Impact: phase 1
- Impact: treatment extension
- Early extension of treatment
- Impact: small therapeutic index
- Value of a PD marker in oncology
- Activity, efficacy and toxicity, value of a PD marker
- Value of a PD marker: rituxan
- Value of a PD marker: avastin
- Safety evaluation for small and large molecules
- Toxicity evaluation for small and large molecules
- How do small molecules differ from biologics?
- Differences in drug development plans
- Preclinical drivers for small molecules
- Lead optimization scheme
- Challenges specific to small molecules
- Cytotoxic vs. non-cytotoxic oncology drugs
- More on targeted inhibitors
- Toxicology plan for small molecules
- Oncology drug failures
- Current regulatory guidance
- Regulatory guidance: oncology drug development
- Specific regulatory guidance for oncology drugs
- IND-enabling toxicology program
- Selecting phase 1 starting dose - example
- NDA-enabling toxicology program
- Non-clinical testing for drug combinations
- Regulatory guidance impurities
- The ICH S9 initiative - introduction
- ICH S9 - start dose
- ICH S9 - duration of chronic toxicity studies
- ICH S9 - reproductive toxicology
- 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:
Categories:
Therapeutic Areas:
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 19, 2025, from https://doi.org/10.69645/BNXM3097.Export Citation (RIS)
Publication History
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.
