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- Introduction
-
2. Overview of nonclinical safety assessment
- Dr. Claudette L. Fuller
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3. Biological safety testing: supporting medical device combination products
- Dr. Christine L. Lanning
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4. Regulatory guidance on toxicity testing of pharmaceuticals: ICH
- Dr. John Kapeghian
- Basics of Non-clinical Toxicity Testing
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6. Acute, subchronic, and chronic toxicity testing
- Mr. Gregory Ruppert
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7. Safety pharmacology in human pharmaceutical development
- Dr. R. Dusty Sarazan
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8. Genetic toxicology
- Dr. Roderick Todd Bunch
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9. Reproductive and developmental toxicology
- Dr. Alan Hoberman
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10. Juvenile toxicity testing
- Dr. Alan Hoberman
- Dr. Elise Lewis
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11. Pharmacokinetics, toxicokinetics and safety margins
- Dr. Mark Rogge
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12. Toxicity testing of impurities and metabolites
- Dr. Kurt Black
- Organ System Toxicity Testing
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13. Drug induced liver injury: a clinical perspective
- Prof. Victor Navarro
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14. Toxicology of the kidney
- Prof. Lawrence Lash
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15. Toxicology of the cardiovascular system
- Dr. Peter Siegl
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16. Toxicology of the immune system
- Dr. Leigh Ann Burns Naas
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17. Toxicology of the developing immune system
- Dr. Leigh Ann Burns Naas
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18. Hematology interpretation for toxicity studies
- Dr. Nancy Everds
- New Methods for Assessing Toxicity
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19. Introduction to toxicogenomics and example case studies
- Dr. Cindy Afshari
- Special Cases for Toxicity Testing
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21. Approaches to nonclinical vaccine development
- Dr. Lisa Plitnick
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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
-
23. Cellular and molecular toxicology
- Dr. Dominic Williams
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24. Overview of non-clinical safety assessment in drug development
- Dr. Danuta Herzyk
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27. Reproductive and developmental toxicology
- Dr. Alan Hoberman
- Dr. Elise Lewis
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28. Non-clinical toxicity testing for vaccines
- Dr. Lisa Plitnick
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29. Toxicity testing for oncology drugs
- Dr. Theresa Reynolds
- Dr. Krishna Allamneni
Printable Handouts
Navigable Slide Index
- Introduction
- 2009 to today
- Current objectives
- Relevant talks
- Novel therapeutic modalities of oncology drugs
- Five pillars of cancer treatment
- What are novel modalities of cancer therapy?
- Novel modalities: antibody drug conjugates
- Unique safety concerns with ADCs
- Nonclinical safety testing considerations for ADCs
- Bispecific T-cell engagers (BiTEs)
- Nonclinical safety testing of bispecific antibodies
- BiTE molecule case studies
- Cancer vaccines
- Nonclinical safety assessment considerations for cancer vaccines
- Therapies engaging or mimicking T-cells
- Nonclinical safety considerations for cell therapy products
- Nonclinical safety testing for cell-based oncology products
- Novel modalities of oncology drugs gene therapy
- Unique considerations during nonclinical assessment of gene therapy/editing therapeutics
- Current clinical trials with gene-editing for cancer treatment
- Novel modalities of oncology drugs: oligonucleotides
- Novel mechanisms of oncology therapeutics
- Targeted inhibitors and precision oncology
- Tyrosine Kinase Inhibitors (TKIs)
- Limitations of TKIs
- Immuno-oncology drugs
- Immuno-oncology as a novel MOA (1)
- Immuno-oncology as a novel MOA (2)
- Approved immuno-oncology agents
- Nonclinical safety considerations for IO agents
- Targeted Protein Degradation (TPD)
- Challenges and considerations of TPD
- Regulatory landscape last 15 years
- FDA Oncology Drug Development Overview
- The ICH S9 guidance for industry
- Relevant guidance since 2009
- Details of updates to key guidances
- FDA guidances and publications related to pediatric drug development
- Pediatric assessments
- Guidance documents for small molecules drugs and well-characterized biologics
- Guidelines in developing immune-targeting cancer pharmaceuticals
- Guidance documents for cell and gene therapy products with regards to toxicology
- Drug metabolite(s) safety testing for oncology drugs
- Industry trends
- Scarcity of nonhuman primates (NHPs) for pharmaceutical research
- Growth and consolidation of CROs nonclinical safety testing
- Conclusions
- Thank you
Topics Covered
- Novel therapeutic modalities
- Antibody-drug conjugates
- Safety considerations
- Bispecific T-cell engagers (BiTEs)
- Cancer vaccines
- Gene therapy
- Novel mechanisms
- Tyrosine Kinase Inhibitors (TKIs)
- Targeted Protein Degradation (TPD)
- ICH S9 guidance
- Nonhuman primates
Links
Series:
Categories:
Therapeutic Areas:
External Links
- Slide 12: Bispecific Antibody Development Programs Guidance for Industry
- Slide 16: Non-clinical Models for Safety Assessment of Immuno-oncology Product
- Slide 19: How Gene Therapy Can Cure or Treat Diseases
- Slide 21: ClinicalTrials.gov Identifier: NCT03057912 A Safety and Efficacy Study of TALEN and CRISPR/Cas9 in the Treatment of HPV-related Cervical Intraepithelial Neoplasia I.
- Slide 21: ClinicalTrials.gov Identifier: NCT04035434 A Safety and Efficacy Study Evaluating CTX110 in Subjects with Relapsed or Refractory B-Cell Malignancies (CARBON)
- Slide 21: ClinicalTrials.gov Identifier: NCT04244656 A Safety and Efficacy Study Evaluating CTX120 in Subjects with Relapsed or Refractory Multiple Myeloma
- Slide 21: ClinicalTrials.gov Identifier: NCT04037566 CRISPR (HPK1) Edited CD19-specific CAR-T Cells (XYF19 CAR-T Cells) for CD19+ Leukemia or Lymphoma
- Slide 25: ACCR FDA Approvals in Oncology: July-September 2023
- Slide 35: FDA Oncology Drug Development Overview – Past to Present
- Slide 37: ICH Safety Guidelines
- Slide 38: Scientific Insights: ICH S6 (R1) - Preclinical Safety of Biopharmaceuticals
- Slide 39: S11 nonclinical safety testing in support of development of pediatric pharmaceuticals
- Slide 44: FDA Safety Testing of Drug Metabolites
Talk Citation
Allamneni, K. (2024, February 29). Toxicity testing of oncology drugs: unraveling the last 15 years of progress [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved October 14, 2024, from https://doi.org/10.69645/FPBB9675.Export Citation (RIS)
Publication History
Financial Disclosures
- There are no financial/commercial matters to disclose.
A selection of talks on Oncology
Transcript
Please wait while the transcript is being prepared...
0:00
Welcome to the 'Toxicity
Testing of Oncology Drugs:
Unraveling the Last 15
Years of Progress'.
My name is Krishna Allamneni
and I'm a board
certified toxicologist,
currently working as a
chief development officer
for an oncology start-up.
Across more than two decades,
building and leading
pre-clinical
development departments in
the pharmaceutical
industry, I've gained
extensive experience in
strategically evaluating
benefit/risk profiles for
diverse therapeutic modalities,
including small and
large molecules
in a range of therapeutic
areas such as oncology,
hematology, CNS,
infectious diseases,
autoimmune conditions,
diabetes, and liver metabolism.
This presentation is an overview
of the last 15 years of
progress in the
nonclinical safety testing
of oncology drugs.
0:50
In our previous talk in 2009,
we described the unique
considerations for
oncology drug
development and how
these considerations
shape the design,
scope, and timing of
the toxicology studies
that were conducted
for cancer drugs.
In addition, we focused on
pharmacodynamic markers
that were emerging as
game changers for oncology
drug development.
We went through the
similarities and
differences in safety
and toxicology testing,
comparing and contrasting
the programs that were
developed for small molecules
versus large molecules.
The ICH S9 guidance had just
come out and we introduced
that as a nonclinical
safety assessment guideline
on oncology therapeutic
development.
We also shared the
existing publications by
De George and the guidance
on the preclinical evaluation by
EMEA along with ICH M3 that
defined the timeline for
various nonclinical
safety studies.
Since that 2009 presentation,
there has been a
tremendous progress
in the field of oncology
drug development
in terms of modalities and
mechanisms of cancer drugs,
as well as guidances that
help sponsors developing
cancer drugs.
Consequently, although
not much has changed in
the standard parameters to
be tested in
nonclinical toxicology,
certain exemptions or
additional parameters are
added given the evolution
of our understanding.
In the 1980s, cancer
drug approvals
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