Science Pool

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!

Cardiotoxic drugs can display acute alteration in the mechanical function of the myocardium (functional changes) or morphological damage to cardiomyocytes and/or loss of viability (structural changes).   

In this poster, we focus on:

• the detection of functional cardiomyocyte changes through monitoring of calcium transients using human iPSC-derived cardiomyocytes
• the analysis of structural morphology using high content imaging (calcium homeostasis and mitochondrial function) as well as cellular ATP in human iPSC-derived cardiomyocytes
• the presentation of a strategy for understanding cardiotoxicity risk for novel compounds enabling in vitro to in vivo translation at an early stage in preclinical screening.

Read our poster to learn more about our research!

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Reaching IND stage is a major milestone for biopharmaceutical companies. For decades, the biotechnology industry has struggled to align complex functions towards the goal of getting to the clinic. The process is long, expensive, resource straining, and risky due to high attrition rates.

Recent industry benchmark data shows that neither the costs nor timelines of drug discovery have improved significantly in recent years - regardless of digital solutions and AI. Including the cost of attrition, it takes benchmark companies approx. $75 m just to achieve a single regulatory tox study start and still around 5.5 years to go from a target to an FGLP or IND.

Reaching IND Faster - A Significant Competitive Advantage

Evotec’s data shows that its integrated processes have led to high success rates and enabled reaching the IND milestone at around half the cost and in about 30% less time when compared with the above-mentioned benchmark. The approach has been validated by its own R&D activities and is increasingly demanded by its partners, too.

The reason is simple: time saving is very important, as the potential to reach IND 18 months faster than the competition adds real value in a competitive marketplace. This is especially true in a highly connected world, where many players are pursuing the same or similar scientific concepts.

The Solution: INDiGO

In order to provide a standardised, yet versatile solution to advance compounds to IND as a service for its partners and clients, Evotec has established INDiGO as a unique integrated, accelerated IND-enabling platform to reduce tech transfer times and costs. The platform is well-suited for a broad range of indications.

INDiGO offers interdisciplinary integration and expert coordination of all drug development activities under one roof. This enables unmatched timelines from candidate nomination to regulatory submission. The programme is led by experienced, dedicated project managers and drug development professionals, who are responsible for seamless knowledge transfer across disciplines, while maximising the quality of the overall development package and ensuring the highest quality standards.

INDiGO Highlights at a Glance

• More than 40 different functions across multiple disciplines
• Managed on an operational level by more than 100 experienced drug development professionals
• Industry leading timelines and excellent track record of on-time delivery
• > 35 completed programmes in the last 5 years
• High rate of client retention after first successful INDiGO programme

Learn more about:

INDiGO
Fast Tracked Drug Development in Just 37 Weeks