PharmaLex participates in Inno4vac

PharmaLex
August 24, 2021
12:39 pm
Press Releases
inno4vac, innovation, public-private partnership

PharmaLex participates in Inno4vac, a newly established European public-private partnership to innovate vaccine development

The Innovative Medicines Initiative 2 (IMI2) Joint Undertaking mobilised more than € 33 million to support Inno4vac, an innovative public-private partnership to accelerate vaccine R&D timelines. It will focus on the design and application of new and highly advanced predictive models to allow a faster development and manufacturing of novel vaccines.

Frankfurt, Germany – 10 August, 2021, PharmaLex Group

Vaccination is one of the most impactful public health interventions in history, saving the lives of an estimated 2.5 million people¹ every year and protecting millions more from illness and disability. Classical vaccine research and development timelines remain nevertheless long and costly, as it takes on average more than 10 years and costs more than € 800 million ² to bring a new vaccine to the market. Leveraging advances in technology and data science will be instrumental in providing new paths to vaccine development as the accelerated development of COVID vaccines demonstrated.

Inno4vac is a new interdisciplinary partnership funded by the Innovative Medicines Initiative 2 (IMI2) that aims to foster health innovation by incorporating scientific and technological breakthrough from the academic and biotech sectors into industry. It is coordinated by the European Vaccine Initiative (based in Germany), with the support from the Sclavo Vaccines Association (based in Italy), for the scientific coordination, and involves 41 partners from 11 different European countries, including 37 academic institutions and SMEs, as well as GSK, Sanofi Pasteur, CureVac and Takeda as industry partners.

PharmaLex Statistics and Data Science team is proud to be part of this collaboration and to contribute to this innovative program. Under PharmaLex guidance mathematical and statistical models will be developed that will accelerate the development and improve the quality of new vaccines. It’s 40+ expert team will share its 10-year experience in bioprocesses with a wide consortium of experts for the success of this breakthrough initiative in vaccine.

Overall, four main areas will be addressed by Inno4vac in an integrated manner:

artificial intelligence will be used for in silico vaccine immune response and efficacy prediction;
a modular computational platform will be developed for in silico modelling of vaccine bio-manufacturing and stability testing;
new and improved controlled human infection models (CHIM) of influenza, Respiratory Syncytial Virus (RSV) and Clostridium difficile will be established to enable early vaccine efficacy evaluation, and
novel cell-based human in vitro 3D models will be developed to reliably predict immune protection.

The ultimate goal of the combined effort pursued by Inno4vac is to develop more predictive biological and mathematical models of vaccine performance, and thereby to accelerate the development of new vaccines. The design of a sustainability plan will also be carried out by the project partners to ensure the long-term access to the project results, including models, beyond the duration of the Inno4vac project.

The PharmaLex Statistics and Data Science team will contribute to develop and qualify mathematical and statistical models that will be made available on the computational platform. Furthermore, it will deliver in silico modelling of vaccine bio-manufacturing and stability testing. The expertise of the PharmaLex team in applied Bayesian statistics, Machine Learning and Artificial Intelligence will be used for three main purposes:

Multivariate Bayesian models to assist Design Space determination for the development of vaccine product guaranteeing product quality and stability by assessing the impact of CPPs on CQAs and stability.
Models to predict vaccine stability, including accelerated testing. It implies assessing stability within a reduced amount of time in the framework of development studies, evaluating the risk of temperature excursions, support shelf-life approval and comparability in case of change of bioprocess.
Models to evaluate and guarantee the robustness of the process and the product.

All those mathematical models will be implemented in the cloud-based bio-manufacturing platform.

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About PharmaLex <Confidence beyond compliance>:

PharmaLex is a leading provider of specialized services for the pharma, biotech and MedTech industries. We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology-enabled solutions to support you through the entire product lifecycle. We deliver exceptional results — going above and beyond the standard to deliver tailor-made solutions worldwide.

The PharmaLex Group now has over 1,500 employees, with 42 offices in 25 countries and more than 1000+ satisfied clients worldwide.

Quick facts about Inno4vac:

Start Date: 01/09/2021

End Date: 28/02/2027

Coordinator: European Vaccine Initiative (EVI)

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 101007799. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.

www.imi.europa.eu

This communication reflects the author´s view and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained herein.