Gaps and Opportunities in Moving Candidate Vaccine from ... · witthawat.wir@mahidol.edu. Overview: •Preclinical study for vaccine development •FVSMU experience for biological

Gaps and Opportunities in Moving Candidate Vaccine from Pre-Clinical

Studies toPhase I Clinical Trials:

in vivo Pre-Clinical study

Assist.Prof.Witthawat Wiriyarat,

Faculty of Veterinary Science, Mahidol University

witthawat.wir@mahidol.edu

Overview:

•Preclinical study for vaccine development

• FVSMU experience for biological product testing

•Gaps and opportunities in in vivo preclinical study

Pre-clinical study

• Preclinical testing is a prerequisite to moving a candidate vaccine from the laboratory to the clinic and includes all aspects of testing conducted prior to clinical testing of the product in humans.• product characterization • proof of concept/immunogenicity studies • safety testing in animals

WHO, 2005

Pre-clinical study

• Nonclinical studies in animals are valuable tools for identifying possible risks to the vaccinees and helping to plan protocols for subsequent clinical studies in human subjects.

• However, in all cases, when safety testing in animals is performed, there should be a clear rationale for doing so and the study should be performed in compliance with the national and international laws for the protection of laboratory animals, biosafety requirements and with good laboratory practice (GLP).

WHO, 2005

• Pharmacokinetic studies

• Absorption

• Distribution

• Metabolism

• Excretion

• Toxicology studies• Single-dose toxicity• Repeat-dose toxicity• Local tolerance• Genotoxicity• Carcinogenicity• Reproductive and

developmental toxicity

Pre-clinical study

• Pharmacodynamics studies

• Immunogenicity• Potency

WHO, 2005

List Sponsor

Safety of reverse genetic influenza vaccine in

chicken

Thai-NIH

Safety of reverse genetic influenza vaccine in

BALB/c mice

Thai-NIH

Safety of recombinant BCG/HIV in guinea pig Thai-NIH

Safety of influenza H1N1 2009 vaccine in mice Thai GPO

Safety of influenza H5N2 vaccine in mice Thai GPO

Efficacy of inactivated avian influenza vaccine

in chicken

FVM, KU

FVSMU experience for biological product testing

List Sponsor

Efficacy of reverse genetic avian influenza vaccine

in chicken

FVM, KU

Efficacy of inactivated avian influenza vaccine in

quail

FVS, CU

Immunogenicity of recombinant

Vaccinia/Influenza virus in BALB/c mice

F.Med,

Siriraj

Hospital

New Mycobacterium tuberculosis antigen testing

in guinea pig for TB diagnosis development

NSTDA

Snake anti-venom activation in rabbit CRI

FVSMU experience for biological product testing

Gaps and opportunities to develop

Human power and expertise

• Lab animal vet

• Lab animal vet pathologist

• Study designer and statistician

• Microbiologist

• Immunologist

• Engineer/technician

• QA personnel

Dr.Tanit KasantikulPathobiology resident at Department of Pathobiology and Diagnostic Investigation, Michigan State University, USA

Dr. Yada AkkhawattanangkvlLab animal medicine resident at University of Tennessee Health Science Center, USA

FVSMU staff in residency training program

Study facilities

•Animal facilities; ABSL 2 and 3

• Laboratories; •Pathology lab, •Microbiology lab • Immunology lab

Progress of construction

Progress of construction

Conceptual design for ABSL3 facility at FVSMU, Kanchanaburi

campus

Model for ABSL3 facility at FVSMU, Kanchanaburi campus

Establishment of Mahidol-NVI center for non-clinical testing of vaccine

Quality assurance

• Study facilities and working procedure have to comply with the quality regulations;

• GLP• AAALAC• ISO• Biosafety certification

Animal model

• Type

• Quality

• Cost

Summary of signs of disease and

pathology present in the different animal models for influenza virus

Margine I and Krammer F, Pathogens, 2014

Support

•Budget

•Policy

• Education

•Component of quality system; • Certify/accreditation body

ASEAN Economic Community(AEC)

(ABAC-DNT, 2011)

Thank you