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- Introduction
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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
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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
- Brief biography
- Outline
- The value of vaccines
- A brief history of pathogens and vaccines
- Smallpox and the beginning of vaccines
- How vaccines work: the response to vaccination
- How vaccines work: the response to a pathogen
- Herd immunity
- Common types of vaccines
- Manufacturing vaccines
- Testing conducted prior to vaccine release
- Importance of vaccination
- Vaccines and autism: the MMR vaccine
- Importance of vaccination: measles and mumps
- Importance of vaccination: hepatitis A and rubella
- Current regulatory guidelines
- Nonclinical safety evaluation of vaccines
- Nonclinical vaccine regulatory guidelines (1)
- Nonclinical vaccine regulatory guidelines (2)
- FDA’s guideline on COVID-19 vaccines
- Key considerations for nonclinical toxicology studies
- Different patient populations for different vaccines
- Support of special populations in clinical studies
- Considerations in the design of toxicity studies
- Appropriate animal model
- Vaccine formulation considerations
- Selection of dose and route of administration
- Routine toxicity studies for vaccines
- Exploratory immunogenicity study (1)
- GLP repeat-dose toxicity studies (1)
- IND-enabling GLP repeat-dose toxicity studies
- Developmental and Reproductive Toxicity (DART) study (1)
- Additional toxicity studies that may be required
- Expected findings in nonclinical toxicity studies
- Example 1: Adult prophylactic vaccine
- Exploratory immunogenicity study (2)
- GLP repeat-dose toxicity study (2)
- Developmental and Reproductive Toxicity (DART) study (2)
- Example 2: Prophylactic vaccine with a novel adjuvant
- Exploratory immunogenicity study (3)
- GLP repeat-dose toxicity study (3)
- Developmental and Reproductive Toxicity (DART) study (3)
- Additional studies for vaccines with a novel adjuvant
- Conclusions
- Thank you
Topics Covered
- Brief history of vaccination
- How vaccines work
- The importance of vaccination
- Current regulatory guidelines for vaccines
- Considerations in the design of toxicity studies
- Routine toxicity studies for vaccines
- Nonclinical toxicity testing strategies
Links
Series:
Categories:
Therapeutic Areas:
External Links
- Timeline of the history of vaccines
- How vaccines work
- Further information on the concept of herd immunity
- Further information on the common types of vaccines
- Further information on how vaccines are made
- Further information about the history of vaccination and disease outbreaks
- Guidance for the development and licensure of vaccines to prevent COVID-19
Talk Citation
Plitnick, L. (2021, June 29). Approaches to nonclinical vaccine development [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved October 14, 2024, from https://doi.org/10.69645/ZHFL9347.Export Citation (RIS)
Publication History
Financial Disclosures
- There are no commercial/financial matters to disclose.
A selection of talks on Pharmaceutical Sciences
Transcript
Please wait while the transcript is being prepared...
0:00
Hello, this presentation will provide an overview of
the approaches for non-clinical vaccine development.
0:08
My name is Lisa Plitnick and I work for Merck.
I've been at Merck for 19 years and I am
the Therapeutic Area Leader for Vaccines in the Department of Nonclinical Safety.
I've also included here my email address,
in case you have follow-up questions for the presentation.
0:25
I'd like to start with an overview of vaccines and vaccination,
followed by a review of the current regulatory guidelines for non-clinical evaluation of vaccines.
I'll discuss considerations in the design of non-clinical toxicity studies, and go over some routine study designs.
I'll then provide examples of the testing strategies for
a typical prophylactic vaccine, and a prophylactic vaccine with a novel adjuvant.
0:50
To put into perspective the value of vaccines and vaccination,
vaccination is on a par with clean drinking water in
terms of number of lives saved due to disease prevention.
Two to three million deaths are prevented,
750,000 children are saved from disability,
low and middle-income countries will benefit from vaccines
by a $150 billion over the next 10 years,
and the estimated return on investment into vaccines is 44 times the initial investment.
1:18
The earliest description of what would become vaccination was in China in the 1000s.
That concept of vaccination (or what was referred to
as 'variolation') continued over the course of the centuries.
Early vaccines started with crude transfer of
diseased tissue from infected persons, and evolved into serums and toxoids,
and later (given advances and purification and manufacturing processes)
into the vaccines produced today.
The development of vaccines followed some of the biggest epidemics in history,
including smallpox, yellow fever, measles, rubella, polio, Ebola, and many others.
In many cases, vaccination has led to eradication of these diseases.
Another important innovation was the first aluminum adjuvant in the 1900s,
which served to boost the immune response to certain types of vaccines.
Interestingly, although the anti-vaccine movement seems like a relatively new phenomenon,
the Anti-Vaccination League of America held its first meeting in New York in 1882.
One argument they made was that smallpox was a result of 'filth', and not an actual contagion.