Genedata Profiler

Join our guest, Christoph Bredack, Business AccountManager at Genedata Selector, as he shares his extensive experience in the European biopharma industry. Christoph offers valuable insights into the implementation of NGS-based assays within a validated environment. Discover the essential steps needed to ensure compliance and innovation in NGS-based assays. 

Join our guest,Christoph Bredack, Business Account Manager at Genedata Selector. Christoph shares his experience as a reviewer of the ICH Q5A and provides insights on the regulatory requirements for NGS assay validation.

Join our guest, Dr. Siamaque Kazem, Senior Scientist and Team Leader at Johnson & Johnson Innovative Medicine, and our host, Dr. Valentina Armiento, for an insightful discussion on the quality and safety of vaccines in GMP settings. They will delve into the latest updates in the regulatory landscape with an emphasis on the increasing importance of NGS-based assays.

In this episode, our host Dr. Raed Hmadi engages in an insightful dialogue with our guest, Aurora Signorazzi, Scientist & Project Leader at Johnson & Johnson. Aurora sheds light on her experiences regarding the validation of in-house NGS-based assays and explores the impact of the ICH Q5A(R2) guideline and the new draft of the 2.6.41 chapter of the European Pharmacopoeia for the detection of viral extraneous agents.

Join our host, Dr. Valentina Armiento, for an insightful conversation with our guest, Ludwig Macko, Head of Development at Genedata Selector. Ludwig shares his expertise and experiences in the validation of NGS-based workflows in GxP environments, with a special focus on the implications of the recent ICH Q5A(R2) guideline update. www.genedata.com/selector

Discover the best practices for implementing NGS-based assays for biosafety testing with Genedata Selector in our latest podcast. Join our host, Valentina Armiento, PhD, as she talks with our guest, Devon Ryan, PhD, Head of Scientific Consulting at Genedata Selector. Devon shares valuable insights on establishing and maintaining GxP-compliant NGS-based biosafety workflows for biopharmaceutical organizations in the context of the recent ICH Q5A(R2) guideline update. www.genedata.com/selector

Our latest podcast highlights the importance of data-driven insights in advancing disruptive cell therapy modalities for cancer and autoimmune disease patients. Have a listen and discover how two data science experts, implementing digital strategies in their respective innovative biotechnology companies maximize the value of complex data to empower smarter decision-making while overcoming data challenges. Host: Justyna Lisowska (Genedata Profiler) Guests: Daniel Nunez (Cabaletta Bio), Ohad Manor (Century Therapeutics)

Cell therapies generate a wealth of complex data throughout the product lifecycle. If well-integrated and analyzed they can give rise to actionable insights accelerating discovery and clinical development. Our latest podcast highlights the value of a data-driven approach for improved cell therapy efficacy, quality, and patient safety. Hosts: Marie-Ange Kouassi and Justyna Lisowska Guests: Cristal Thompson