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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Fact Sheets,
Formulation & CMC,
ADME/DMPK,
IND Enabling Studies/Preclinical Development,
Toxicology & Safety
Learn more about the use of transcriptomics in safety prediction including:
- the challenges in translation from animals to humans, and how human cell-based models are now being routinely used in toxicology
- how transcriptomic analysis is showing promise in enhancing safety prediction and providing additional mechanistic information
- an overview of how Cyprotex, and parent company Evotec, are offering a fully customised end-to-end in vitro transcriptomics service using the latest next generation sequencing technology (RNA-seq) and a leading bioinformatics platform
- the use of sophisticated machine learning and artificial intelligence to interpret the large and complex datasets
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Fact Sheets,
Toxicology & Safety
Download this fact sheet to learn more about formulating your way to successful toxicology studies including:
- Early formulation
- Material science - solid development
- DMPK
- In vitro, in vivo, and in silico models
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Fact Sheets,
Formulation & CMC,
Toxicology & Safety
The 12th edition of our Drug Discovery Update (DDup) provides insights into exciting new developments in 3D cell models including microtissues, organoids and organ-on-a-chip technology.
In this edition, it covers:
- an introduction to 3D cellular models
- the need for better models to improve translation from in vitro to in vivo
- the relevance of 3D cellular models to kidney disease modelling and drug induced toxicity prediction
- an overview of Evotec's 3D in vitro platforms
- glomerulus-on-a-chip to study kidney disease
- kidney organoids to study polycystic kidney disease
- organ microtissues to predict drug-induced toxicity
- interviews with experts Dr Christodoulos Xinaris, Dr Reiner Class, Dr Magali Ferro and Dr Stephanie Ryder
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Kidney diseases,
Articles & Whitepapers,
Toxicology & Safety,
Metabolic Disease & Complications
E.SOLVE is Evotec's solution to accelerate your journey to the clinic supporting your formulation strategy as early as possible from discovery to market approval.
Download this fact sheet to learn more about how E.SOLVE's full range of approaches improve solubilization and bioavailability to ensure that your API can progress through the drug discovery development pipeline faster.
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IND Enabling,
Fact Sheets,
Formulation & CMC,
Toxicology & Safety
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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Fact Sheets,
ADME/DMPK,
IND Enabling Studies/Preclinical Development,
Toxicology & Safety
Learn more about how our INDiGO-Select services help in profiling and selecting your optimal clinical development candidate with:
- Enhanced quality profile, speed of delivery, and probability of success of clinical candidates
- Early identification of developability gaps and liabilities in selection process, enabling thorough
de-risking of your candidate with flexible advanced lead optimization approaches
- Managed by skilled discovery scientists and complemented by experienced drug development
experts in CMC and preclinical development all under one roof
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INDiGO,
Fact Sheets,
IND Enabling Studies/Preclinical Development,
Toxicology & Safety,
Clinical Development
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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INDiGO,
Fact Sheets,
ADME/DMPK,
IND Enabling Studies/Preclinical Development,
Toxicology & Safety
Watch our webinar and learn about exciting new developments in toxicology prediction and how transcriptomics is transforming DILI prediction.
Drug-induced toxicity remains a major source of attrition in preclinical and clinical. In particular, drug-induced liver injury (DILI) can be difficult to predict as it often has poor translation from animals to humans and so issues are only picked up during clinical development or post-market approval. In fact, 18% of drug withdrawals from the market are caused by DILI. These statistics have led to a push within the industry to bring testing earlier using more human relevant cell-based models. However, challenges still exist and more accurate techniques are required to improve the predictive capabilities.
About the Webinar
The webinar covers our ground-breaking work in the field of transcriptomics. Cyprotex and Evotec have jointly created a fully integrated in vitro prediction platform using 2D and 3D cell-based models combined with high throughput RNA-seq and sophisticated machine learning and artificial intelligence techniques. The company is building the largest transcriptomic database in the world. This will be used to predict the likelihood of DILI risk, mechanistic information and similarity profiles to existing compounds. Our initial data shows an impressive accuracy of DILI prediction of 82% compared with 70% for a seven read-out HCS-based DILI platform.
About the Speaker
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Paul Walker PhD
VP, Head of Tox and Innovation Efficiency | Cyprotex
Dr Paul Walker is the Head of Toxicology at Cyprotex where he is responsible for the development of strategy, innovation and management of client work performed within the Toxicology Group. Paul obtained his Ph.D. from King’s College London in Molecular Toxicology being awarded the Tadion-Rideal prize for molecular sciences (2004). Paul further developed his understanding of molecular biology and toxicology during his post-doctoral years at the University of Manchester with a keen interest in the application of high content imaging and 3D models within this field. Paul joined Cyprotex in 2010 with his research interests focused on the role of drug metabolism in drug toxicity and in vitro assays to predict toxicity in early drug discovery.
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Watch the webinar to learn more!
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Videos & Webinars,
Toxicology & Safety
Watch the webinar to learn more about exciting new developments in predictive toxicology!
About the Webinar
In this webinar, Dr Alicia Rosell-Hidalgo will present how high content screening (HCS) and high throughput RNA-seq techniques in conjunction with 3D liver models can be used to improve toxicology prediction and gain an in-depth mechanistic understanding of drug-induced toxicity. The presentation will focus predominantly on drug induced liver injury (DILI) with relevant case studies to demonstrate utility in safety profiling.
About the Speaker
|
Alicia Rosell-Hidalgo PhD
Associate Principal Scientist | Cyprotex
Dr Alicia Rosell-Hidalgo is an Associate Principal Scientist in Toxicology at Cyprotex Discovery Ltd, a subsidiary of Evotec SE. She leads the in vitro research and development carried out in the UK site for the “Panomics” project, aimed at improving predictive toxicology through 2D and 3D cell-based models combined with high throughput RNA-seq and machine learning/artificial intelligence techniques. Alicia has a bachelor’s of science in Biology and master’s degree in Biochemistry at the University Complutense of Madrid. During her undergraduate years, she gained laboratory experience through collaborations with the Spanish National Research Council (CSIC) and the University of Brighton. In 2020, she was awarded a Ph.D. by the University of Sussex, where she researched drug-induced mitochondrial dysfunction.
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Watch the webinar to learn more!
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Tags:
Videos & Webinars,
Toxicology & Safety