Science Pool

Learn more about our clinical services platform including:

• Fully integrated drug development services supporting preclinical and clinical needs,
  up to regulatory approval and commercial phases
• Clinical supply suitable from First in Human to Phase III, fully GMP-compliant and
  with capacity to handle active ingredients classified up to OEB5 (OEL>0.5 µg/m³)
• Additional capabilities such as API, formulation development, sample management, PK and statistical analyses, and metabolism

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Learn more about our abuse liability services including:

• Compound characterization
• Pharmacological assessment
• Preclinical Behavioral studies
• Integration within a multidisciplinary full-scope clinical-enabling program with chemistry,
  pharmacology, DMPK, safety assessment, regulatory and clinical support, all driven by our drug
  development experts

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Learn more about INDiGO and Evotec's integrated preclinical development capabilities to de-risk and accelerate IND-enabling programs:

• Typically, drug candidates can be advanced from candidate selection to IND-submission in 48–52 weeks
• Our experienced team not only executes R&D projects, but also proactively contributes to your scientific strategy
• Clients can either opt for the full INDiGO platform or selected preclinical development and CMC components

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Learn more about our pathology services including:

• GLP certification with highest quality standards and an impeccable regulatory inspection history
• Unparalleled flexibility with all capabilities in-house and under one roof
• ACVP/DECVP, MRCPATH, DECLAM, DECVCP qualified pathologists/clinical pathologists

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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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Learn more about Evotec's regulated LC/MS bioanalysis capabilities and expertise including:

• High quality service across all phases of pre-clinical and clinical drug development in compliance with GLP and GCP regulations
• More than 25 years of experience to perform LC/MS activities in a regulated environment
• Extensive bioanalytical method development expertise to meet the most demanding and challenging client needs
• Multidisciplinary collaboration enabling integrated solutions to accelerate the drug development process

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Learn more about Evotec’s polymerase chain reaction (PCR) services including:

• Therapeutic modalities
• Sample management capabilities
• PCR applications 
• Quantitative real time PCR (qPCR) and reverse transcription qPCR (RT-qPCR) applications, including copy number estimation assays, gene expression profiling and genotyping assaysRegulated PCR services

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Learn more about our ligand binding assays and how they can support biological drug testing in a regulated environment, including:

• Regulated bioanalysis
• Immunogenicity
• Immunotoxicity
• Biomarkers (safety and efficacy)
• Clinical Pathology
• Sample Management
• Additional activities

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Don't miss our educational webinar. In-house expert, Ellenia Bordini, will cover various early stage "alternative approaches" for the evaluation of metabolites in human and preclinical species, and how these can be used to direct preclinical safety testing for regulatory submission. 

Earlier this year, Evotec hosted a complimentary webinar, ‘INDiGO-Select: profiling and selecting your optimal clinical development candidate’.

INDiGO-Select focuses on better understanding (or increasing the knowledge) of the lead molecule chemistry, its physical-chemistry properties and preclinical DMPK and safety profile, helping to minimise the risk of failure during transition into the subsequent development stages. Evotec’s Manager, Integrated Development Programmes, Sabrina Pagliarusco and Senior Scientific Project Leader, Federico Tosini, take the audience on a journey starting with the war on attrition and a deeper dive into the importance of having a well-designed approach to de-risking. A relatively small investment at the candidate selection stage allows early identification of potential developability liabilities and challenges which consequently allow for a quicker reaction, at a lower cost.

Evotec’s approach to integrated solutions in drug development – INDiGO-Select and INDiGO – are then highlighted. The INDiGO-Select package is never the same for the candidate as it depends on the data that is generated during the discovery phase. To identify any gaps and technical risks, the key areas of focus are the chemistry and pharmaceutical properties, DMPK, the PK/PD relationship and preliminary safety assessment. The next stage – INDiGO - then accelerates early drug candidates into the clinic by reducing time from nomination to regulatory submission. The advantage is that this program can be customised based on data generated during the select and be conducted at a unique site while integrated, so all actions can be performed under the same roof.

Two case studies that used the INDiGO-Select package are then highlighted. The first focuses on low bioavailability, where the client – a small Biotech – has a therapeutic target in neurodegenerative diseases. The activities performed and data presented highlight the impact that an INDiGO-Select model can have on the progress of IND-enabling activities. A second example looks at chemistry and preclinical PK variability. For this particular case study, the objective was to increase the knowledge on the candidate profile and its developability, reducing the risks of later failure in the full development phase. In this instance, the compound was characterised further and, thanks to the data generated, some potential issues were identified to be considered and monitored during the customised development phase.

Choosing the INDiGO-Select model has a number of benefits including enhanced quality of selected drug candidates, increased probability of success later in development and an overall reduction of development costs and project timelines.

Discover more about INDiGO-Select by streaming this insightful webinar from our experts now!