Evotec INDiGO®

Evotec INDiGO® is the fastest and most efficient approach to bring a program from candidate selection into clinical development. Our unique R&D site in Verona, Italy (formerly a Glaxo-Smith Kline Center of Excellence) co-locates manufacturing and non-clinical development, providing a unique opportunity to fully integrate all aspects of drug development.

For decades, the biotechnology industry has struggled to align complex functions towards a singular goal of getting to the clinic quickly and efficiently. The process has proven to be long, expensive, resource straining, and bursting with risk.

We believe the road to the clinic is difficult enough without the inefficiencies of the traditional multi-vendor approach to drug development, so we are offering a better solution. With our acquisition of Aptuit in 2017, Evotec is now the only organization with the capability to successfully deliver fully-integrated drug discovery and development programs. Our INDiGO product offers full integration of all scientific disciplines required by ICH guidelines, while functioning as a seamless transition from discovery phase. Our scientific development experts bring decades of experience in strategic planning, risk mitigation, and scientific execution, combining the best of two worlds: the capabilities and knowledge of a large pharma with the efficiency of a CRO. Being able to deliver R&D programs as a single organization creates a unique mind set to view programs as a continuum across discovery and development, where appropriate scientific goals are met for each phase while already considering goals of next phase.

Our INDiGO-Select product applies internal and external data on the most common causes of delay and product attrition, and provides a unique, flexible, and efficient approach to de-risking your identified clinical candidate. Applied towards a single molecule or a short list of candidates, this integrated package will address any remaining liabilities in terms of developability and safety that the discovery program may not have included so far. We will fully de-risk your molecule candidate to ensure its “readiness” for development before investing millions of dollars and months of cash burn in clinical-enabling studies. 

Applying INDiGO-Select as part of two-tiered approach or embedding it into the start of INDiGO program is a data-driven decision taking into account the data available so far, the level of acceptable risk and the acceleration required by your corporate milestones. After a careful analysis of any existing data, we will provide a gap analysis and specifically design the de-risking approach to the specific needs of your program. Your compound (or compounds) will be assessed for manufacturing scalability, solid state and formulation needs, in vitro and in vivo safety, and DMPK. With this data package in place, you will be provided with the information you need to nominate your clinical candidate with confidence. 

INDiGO is a fully integrated development program wherein clinical-enabling drug substance, safety assessment, clinical drug product, and regulatory activities are conducted at a single site and within a single contract, providing an fully integrated and optimally-efficient plan for IND/CTA submission. All these activities are governed by a project team with decades of pharmaceutical experience, and harmonized with our fully-equipped regulatory support team providing a robust, streamlined development engine with multi-disciplinary coordination to accelerate drug candidates into the clinic.

Having completed more than 82 INDiGO programs successfully, we have proven to be the fastest, most efficient, and most reliable path to the clinic. With a focus on quality, we successfully managed programs within different therapeutics areas (e.g. CNS, oncology, metabolic diseases) with complexity of organic chemistry (between 3-15 steps), supporting animal studies across non-rodent and rodent species, and formulating a range of clinical formulations (from fit for purpose to advanced) oral clinical formulations as well as managing poorly water soluble compounds with bio-enhanced strategies. Our INDiGO projects can be delivered in less than 52 weeks with custom timelines designed to address our partners’ needs, candidate properties and clinical development plans, while maintaining flexibility to reduce delays that can result from unanticipated technical issues.

Find out how Evotec can progress this efficient approach throughout clinical development by contacting us today.

• Accelerated drug development 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
• A dedicated and experienced project team of drug experts (with consultant-level expertise) led by an advanced governance mechanism featuring a Scientific Project Leader and Project Manager assigned to drive the strategy and delivery
• Custom-designed, flexible development plans that allow for real-time adjustments and adaptability in the event of unforeseeable scientific outcomes
• A fully-equipped regulatory team with the experience and capability to author, compile, and submit (via our own electronic gateway) regulatory filings worldwide and guide regulatory strategy
• Excellence in project governance, performance review and issue escalation management

• Integrated science “under one roof”
• Reduced tech transfer time and cost
• Flexibility and efficiency
• Aggressive timelines with track record of delivery
  • Drug development experts with pharma background
  • True extension of Partner’s organization
  • Leads to higher quality scientific solutions

• Professional alliance and project managers
• Top GxP standards for quality

Evotec INDiGO: Partnering with the experts – reliably designed drug development project plans with accelerated timelines.

Find out how Evotec INDiGO integrated approach can reduce risk, accelerate development schedules and optimize the efficiency of your drug development program.

Want to keep up to date with any INDiGO updates? Follow our INDiGO LinkedIn showcase page.