Science Pool

Our popular, easy-to-follow guide: 'Everything you need to know about ADME' is now on its 5th edition.

Read about:

• an in-depth overview of physicochemical properties, drug metabolism, permeability and drug transporters, drug-drug interactions and plasma protein binding
• an assessment for current methods available for determining ADME properties 
• how ADME data are interpreted and used
• relevance to the regulatory guidance

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Watch the webinar to learn more about recent updates in CYP induction!

 

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About the Webinar

Cytochrome (CYP) P450 induction is a well-established mechanism for increased prevalence of DDIs. Whilst its study in vitro has been described in regulatory guidance for over 20 years, data interpretation methods and details for study design have evolved and the best approaches for study of small molecules and other therapeutics are still being discussed within CROs, pharma and biotechs.

In this webinar our expert, Katie Plant, describes the most recent updates in CYP induction. By reviewing and consolidating literature and recent perspectives from Innovation and Quality Induction Working Group (IQ IWG) alongside the regulatory guidance, this provides a comprehensive overview and outlines the recommended approach to assess CYP induction in vitro. When supported by well-designed in vitro assays and batch qualification using a known set of CYP3A4 inducers, relative induction score (RIS) correlation analysis serves as a useful tool enabling the magnitude of clinical CYP3A4 induction to be predicted and used to support decision-making for investigating potential DDI risk.

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About the Speaker

 

Katie Plant Principal Scientist | Cyprotex Discovery Ltd Katie Plant is a Principal Scientist in the Drug Metabolism group at Cyprotex, UK, responsible for operational delivery of high-throughput screening assays covering metabolic stability, enzyme inhibition and induction, alongside supporting clients in designing and interpreting DDI studies to support regulatory submission, supporting R&D and bespoke studies and driving continuous improvement projects.

Watch the webinar to learn more!

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Toxicokinetic evaluation is a regulatory and scientific requirement in the drug development process. To obtain plasma, blood is generally withdrawn by a conventional venous collection method. Microsampling is a less invasive sampling technique, which allows to reduce the stress correlated to the conventional blood sampling and to decrease the number of rodents for a preclinical study. The implementation of microsampling in particular, in non-human primate can reduce the stress and promote a positive interaction with technical staff which improves the overall well-being of the animal (refinement).

In this poster we summarise the work done to evaluate the possible influence of the blood sampling method on drug plasma concentrations, using LC-MS/MS methods in non-human primate for four drugs selected based on acid-base and volume of distribution properties.

The poster was presented by our expert Rossella Cardin at the 24th International Reid Bioanalytical Forum held in Cambridge, UK, on June 13-16, 2022.

 

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INDiGO is the fastest and most efficient platform to bring a program from candidate selection through IND and beyond.

Once your clinical candidate is selected, this fully-integrated clinical-enabling package provides inter-disciplinary coordination of all aspects of drug development, conducted and managed by a dedicated Evotec team, and usually at a single Evotec site.

Key features:

•  Accelerating your drug discovery and research programs through interdisciplinary integration and expert coordination of all activities “under one roof”
• Industry-leading timelines, taking your program from the selection of an optimal clinical candidate to regulatory submission typically in less than 52 weeks
• Expert management by experienced, dedicated project managers and drug development professionals
• Seamless knowledge transfer across disciplines, maximizing the quality and efficiency of the overall development package
• Custom-designed, flexible development plans that allow for real-time adjustments and adaptability to unforeseeable scientific outcomes
• Excellence in project governance, performance review and issue escalation management

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Download this fact sheet to learn more about cytochrome P450 (CYP) induction including:

• Background information
• Assay details and protocol summary
• Data generated in the CYP induction assay

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Download this fact sheet to learn more about cytochrome P450 (CYP) relative induction score (RIS) including:

• Background information for the CYP induction RIS method
• Assay details and protocol summary for the CYP induction RIS method
• Data generated in the CYP induction RIS assay

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Download this fact sheet to learn more about hepatocyte stability including:

• Background information
• Assay details and protocol summary
• Data generated in the hepatocyte stability assay

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About the Webinar

This exciting collaboration between Evotec and Professor Dirk Grimm from the University of Heidelberg will review the current challenges facing the field of gene therapy.

The webinar includes:

• A short introduction to AAV gene therapy
• Recent clinical findings
• Lessons we have already learned regarding improving AAV-based gene therapies
• Strategies for next generation canidates
• Efficacy and safety evaluation in preclinical models and their translatability into humans

 

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About the Speakers

 

	Werner Höllriegl VP, Head of In Vivo Gene Therapy | Evotec Werner Höllriegl is heading In Vivo Gene Therapy at Evotec GT in Orth an der Donau, Austria. He received his degree in Veterinary Medicine from the University of Veterinary Medicine Vienna, Austria. After spending a couple of years as Assistant Professor at the Department of Anesthesiology, he moved into industrial research spending more than 15 years in different Pharma Companies (Baxter, AstraZeneca, Novartis Institutes for BioMedical Research, Baxalta, Shire, Takeda) in Research and Nonclinical Development, focussing on biologics and in vivo gene therapy.
	Hanspeter Rottensteiner VP, Head of In Vitro Gene Therapy | Evotec Hanspeter Rottensteiner is heading In Vitro Gene Therapy at Evotec GT in Austria. Biochemist by training, Hanspeter has more than 10 years in academia, and 15 years of experience in Pharma (Baxter, Takeda) in senior positions. He brings significant expertise in drug development of biologics and gene therapies, with a strong focus on rare diseases. He received his degree in Biochemistry from the University of Vienna, Austria.
	Rüdiger Fritsch Principle Scientist, Metabolic Disease | Evotec Rüdiger Fritsch is heading a transcriptomics team at Evotec. He has recieved his PhD from the Max Planck Institute for Biophysical Chemistry. With over 15 years of experience as a biologist, Rüdiger has a strong expertise in omics.
	Dirk Grimm Professor of Viral Vector Technologies Medical Faculty and the Department of Infectious Diseases/Virology | Heidelberg University Dirk Grimm is heading the "Virus-host interactions" research group within the Department of Infectious Diseases/Virology. He has over 25 years of experience in AAV capsid and genome engineering as well as  in human gene therapy. Dirk has trained under AAV experts Jürgen Kleinschmidt (German Cancer Research Center Heidelberg) and Mark Kay (Stanford University School of Medicine).

Watch the webinar to learn more!

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Download this fact sheet to learn more about our regulatory ADMET services including:

• Full support of development projects to fulfill and anticipate regulatory requirements
• Accelerated development process with a full vision through all drug development phases up to filing
• Dynamic team of expert scientists capable of handling projects of any complexity in regulated environment
• Full integration with in-house bioanalytical and safety assessment groups
• Tailored studies and programs based on specific client needs

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Learn more about our safety assessment services including:

• Toxicology core capabilities
• Safety pharmacology (GLP) studies
• Genetic toxicology (GLP) studies
• Additional capabilities such as bioanalytical method development and GLP validation, DMPK, immunoassays, immunogenicity testing, immunotoxicology assays

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