Biodefense and Special Pathogen Vaccines in Development

Biodefense and Special Pathogen Vaccines in Development

Vaccine Development Gerald R. Kovacs, Ph.D. Scientific Director Advanced BioScience Laboratories Maryland, USA 1 Vaccine design and development Vaccines work by mimicking disease agents and stimulating the immune system to build up defenses against them 2 History of Vaccines 1798 - Edward Jenner noted: Smallpox and Cowpox: Milkmaids frequently contracted cowpox which caused lesions similar to that smallpox

Milkmaids who had cowpox almost never got smallpox Jenners experiment: Collected pus from cowpox sores Injected cowpox pus into boy named James Phipps Then injected Phipps with pus from smallpox sores Phipps did not contract smallpox First to introduce large scale, systematic immunization against smallpox 3 How do vaccines work? Live attenuated virus Carrier vaccines

Antigen presentation DNA vaccines T-helper cell Antigen presentation Killer T cell Non-infectious vaccines B cell: antibodies (neutralize & bridge) By inducing adaptive immunity & memory! 4 Vaccine Development IND

Agent Antigen ID Vaccine Candidate Vaccine Characteri zation Preclinical GMP Manufact ure EUA Phase 1 Phase 2

Animal Efficacy Model Development Proof of Concept Feasibility Formulation Identity Purity Stability Risk Assessments 3-7 years Potency Toxicology Dosage Schedule Mech. of Action Markers Adjuvant 1-2 years

BLA Phase 3 Safety Phase 4 Pivotal Animal Efficacy GMP Production GLP Toxicology GCP Evaluation Quality Control Quality Assurance Regulatory Affairs 5-10 years 5 Probability of Success in Transition

Probability of transition between each phase of development 57% PreClinical 72% Phase 1 57% 41% 79% Phase 2 32% 71% Phase 3 23% 80% BLA

Market 18.4% Cumulative probability of success through each phase 6 Vaccine Development Timeline From idea to approval can take decades and $100s of millions. 1995. Licensed to Aviron. 2003. Approved for use. 1967. FluMist concept published in Nature 1991. Developed with NIAID support and licensed to Wyeth Effective vaccines for many diseases (HIV, Malaria) elusive after substantial

investment of resources 7 EBOLA VIRUS VACCINES 8 Ebola Vaccines in Development Discovery Preclinical Phase 1 Phase 2 USAMRIID replicons and VLPs Bavarian Nordic MVA

GSK ChAd3 GSK ChAd3 Protein Sciences subunit Profectus VSV Merck G-VSV Novartis RNA Inovio DNA J&J/Bavarian Nordic P/B Vaxart Oral NovaVax VLP

Phase 3 GSK ChAd3, Merck VSV, Placebo TJU Attenuated rabies vector Mapp BioP ZMapp 9 Emerging and Re-emerging Infectious Diseases 10 Future of Vaccines

Public-Private Partnerships Continued research on host-pathogen responses Innovation and rational design of vaccines Use of systems biology Rapid and flexible production platforms Effective regulatory pathways Long term federal and private industry support 11 THANK YOU 12

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