Science Pool

Gene therapy has evolved as an attractive modality to tackle and/or even cure a broad range of diseases. EVOgenes is built on a team with long-standing pharma expertise in various gene therapy-related technologies and indications.

Take a look at our factsheet to discover the broad spectrum of state-of-the-art services enabling gene therapy product development we offer.

Date: 18th - 20th October 2023

Location: Espace Centenaire, Paris 

Attending: Tim Potter

Learn more about The 35th GMP Symposium

• The genotoxic potential is one of the major risks associated to potential pitfalls in drug development.
• True positive results in the genotoxicity screening observed during the Lead Optimization phase not always represent a showstopper, but need to be carefully characterized.
• In this scenario, the toxicologist could provide a strategy supporting the next IND enabling phase by adopting the most effective risk management to allow the highest success rate possible.
• The process proposed can be adapted to any scenario, and provides data supporting the risk assessment ensuring the lowest attrition and the ethical use of animals.

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Read our latest poster on Differentiated transcriptomic signatures detectable in primary human hepatocytes transduced by AAV-based vectors: A potential enabler for in vitro safety profiling.

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Date: 24 - 27 October 2023

Location: Brussels, Belgium

Join our Gene Therapy experts at ESGCT 2023! We will be presenting a scientific poster at the event 'Differentiated transcriptomic signatures detectable in primary human hepatocytes transduced by AAV-based vectors: A potential enabler for in vitro safety profiling'. Attendees: Patrice Douillard, James Hallinan, Friedrich Scheiflinger, Michela Gabaldo, Joana Ribeiro. Meet the team at Booth #8 to discuss your requirements.

Learn more about ESGCT

Date: 10th - 11th October 2023

Location: Milan, Italy - At Bayer

Attending: Andrea Nizzardo

The next IBIG Forum is coming! #IBIGFORUM2023

After last year's great success, the IBIG Forum looks forward to meeting you again this year to share experiences, address similar statistical issues from different angles, and have fun together!

Our Research Expert Biostatistician • Pharmacometrics, Andrea Nizzardo, will chair a session on "The estimands journey: from theory to practice" 

Summary:

The estimands framework has been introduced in 2019 by the Addendum to the ICH E9 guideline on statistical principles for clinical trials to improve alignment between clinical questions, objectives, design, and analysis of clinical trials. Since its release, the addendum has rapidly impacted the drug development world, triggering interest and discussions. Many efforts have been made to clarify the theory behind the framework to strengthen the interaction between relevant stakeholders and between sponsors and regulators. Now that the framework has started to be broadly adopted, several challenges have arisen during its implementation. The session will focus on experiences and case studies on practical issues encountered when adopting the framework in clinical trials.

When?  
Pre-Forum courses:  9 October

IBIG Forum 2023: 10 and 11 October.

Where?
Milan, at Bayer (https://lnkd.in/dqUZCMYp)

What?
Five Forum sessions with quality interventions and speakers on current topics and innovative approaches:
·        Artificial Intelligence and Machine Learning
·        Historical data supporting drug approval
·        Decision Making
·        Estimands Application
·        Real World Evidence
Plus two very interesting and applicative pre-forum courses:
·         A pragmatic approach to multiple endpoints resolution
·         R in Clinical Trial Reporting

Registrations are still open at this link: https://lnkd.in/dMsPqq4M

Learn more about the IBIG FORUM 2023