COVID-19 Scientific Breakthroughs Invigorate Vaccine Market
Vaccines stimulate the immune system to produce a protective humoral and cellular response to a disease, without causing that disease. By harnessing the natural activity of the immune system, vaccines are a powerful and pivotal tool for achieving public health.
The COVID-19 pandemic has catalyzed a remarkable mobilization in vaccine development. The SARS-CoV-2 virus genome was sequenced almost instantly after the first cases were identified, and new vaccines entered clinical trials within a couple of months, followed by regulatory approval and rollout of national vaccination programs within a year. This compares to a more typical development cycle of 5-10 years. Several of these vaccines use platform technologies, in some cases approved for the first time, which will enable even more rapid updates following the discovery of new variants.
Certara’s Vaccine Platform for COVID-19
For the past four years, Certara has been developing a robust, regulatory-ready QSP platform for assessing and managing immunogenicity (IG). As the pandemic gripped the world, the Certara team realized that its IG platform could be reworked and extended for vaccines. Instead of trying to minimize the immune response, the team switched its focus to maximizing the immune response for the COVID-19 vaccine.
The model was calibrated using the structure of actual COVID-19 vaccines, replicating all the published data and demonstrating that they could predict with a virtual trial the outcomes of an actual clinical trial using those vaccines. The model also enabled the prediction of immunological responses that may not be measurable in actual patients, such as the level of memory B cells, which is used to compare and optimize various dosing schedules in the virtual trials. Results from the COVID-19 vaccine platform have already been submitted to a global regulatory agency to support clinical trial designs.
Predicting Vaccine Dosing for Sub-populations
Most clinical studies of investigational vaccines are initially conducted in healthy adults. After getting regulatory approval for a vaccine for adults, vaccine developers need to determine which vaccine dose will generate the maximum antibody response for different subpopulations such as children, the elderly, and pregnant women. For example, vaccination timing for infants six months and older is scheduled around routine checkups. Until 6 months of age, infants rely on transferred maternal antibodies. Thus, for pregnant women, it’s also important to determine which vaccination timing will provide maximal immunity for the newborn. Modeling and simulation can be used in lieu of clinical studies to assess the timing and efficacy of maternal vaccinations.
Assessing Your Vaccine’s Competitive Landscape
In brief, MBMA incorporates parametric models based on literature data and in-house data. It quantifies the effect of treatment, time, and patient population characteristics on the outcomes.
It can include trial-level covariate relationships on the dose-response models to account for between trial differences in patient populations. It also allows for simultaneous modeling of multiple endpoints and can therefore link biomarkers (e.g. immunogenicity) to clinical endpoints (e.g. incident rate or hospitalization). Like network meta-analysis, it can provide indirect comparisons and simulations of head-to-head trials, but it uses longitudinal dose- response models for individual vaccine or vaccine classes. It can also be used for simulations of trials and trial success predictions.
Piet van der Graaf 现任 Certara 高级副总裁兼 QSP 负责人，同时也是莱顿大学系统药理学教授。Piet 是 2013 - 2016 年莱顿药物研究学术中心的研究主任。1999 - 2013 年，Piet 在辉瑞公司的研发生物学、药代动力学和药物代谢、以及临床药理学等部门担任过多种领导职务。Piet 于2012 - 2018 年担任 CPT: Pharmacometrics & Systems Pharmacology 的创始主编，随后成为 Clinical Pharmacology & Therapeutics 的主编。Piet 曾在伦敦国王学院师从诺贝尔奖获得者 Sir James Black，接受了临床医学的博士培训。他曾获得 2024 年美国临床药理学与治疗学会（ASCPT）颁发的 Gary Neil 药物开发创新奖，同时也是国际定量药理学会（ISoP）2021 年领袖奖的获得者。Piet 是英国药理学会的当选委员，在定量药理学和药物开发领域发表了超过 200 篇同行评议的论文。
Specializing in pharmacometrics application to complex biotechnology products since 2005, Mike’s research focuses on the application of mathematical models of biology, (patho)-physiology, pharmacology and disease that quantify beneficial and undesirable interactions between drugs and patients to predict outcomes. He has held roles at ZymoGenetics and Amgen.
Dr. Cheung has over a decade of experience working in the pharmaceutical industry at AstraZeneca, with her role as Senior Pharmacometrician and Project manager of AZ Paediatric working group. She obtained her Ph.D. from the University of Manchester, on the topic of Structural Identifiability Analysis in Pharmacokinetic and Pharmacodynamic Models.
Piet van der Graaf 现任 Certara 高级副总裁兼 QSP 负责人，同时也是莱顿大学系统药理学教授。Piet 是 2013 - 2016 年莱顿药物研究学术中心的研究主任。1999 - 2013 年，Piet 在辉瑞公司的研发生物学、药代动力学和药物代谢、以及临床药理学等部门担任过多种领导职务。Piet 于2012 - 2018 年担任 CPT: Pharmacometrics & Systems Pharmacology 的创始主编，随后成为 Clinical Pharmacology & Therapeutics 的主编。Piet 曾在伦敦国王学院师从诺贝尔奖获得者 Sir James Black，接受了临床医学的博士培训。他曾获得 2024 年美国临床药理学与治疗学会（ASCPT）颁发的 Gary Neil 药物开发创新奖，同时也是国际定量药理学会（ISoP）2021 年领袖奖的获得者。Piet 是英国药理学会的当选委员，在定量药理学和药物开发领域发表了超过 200 篇同行评议的论文。
Specializing in pharmacometrics application to complex biotechnology products since 2005, Mike’s research focuses on the application of mathematical models of biology, (patho)-physiology, pharmacology and disease that quantify beneficial and undesirable interactions between drugs and patients to predict outcomes. He has held roles at ZymoGenetics and Amgen.
Dr. Cheung has over a decade of experience working in the pharmaceutical industry at AstraZeneca, with her role as Senior Pharmacometrician and Project manager of AZ Paediatric working group. She obtained her Ph.D. from the University of Manchester, on the topic of Structural Identifiability Analysis in Pharmacokinetic and Pharmacodynamic Models.
