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Biocom California Newsletter Article

Evotec’s offering of integrated preclinical development approaches help fast track and meet R&D needs.

The Fastest Route to the Clinic

  • 2020-09-03T19:00:00.000+0000
  • California
  • Author: Evotec

Drawing on more than 30 years of drug development experience, Evotec can identify and solve challenges early in your project. It is significant that the experience of much of the scientific staff at Evotec has been attained within the pharmaceutical industry, rather than simply for the pharmaceutical industry. Working as a highly integrated team and consistently sharing their insights and experience, Evotec scientists take solution-driven approaches, enabled by the broad perspective of their knowledge and their experience in bringing successful drugs to market.

Evotec pre-clinical experts perform the full spectrum of pre­clinical safety studies, with the assurance of accurate and balanced assessments even when meeting the tightest deadlines, with a flexible range of in vitro, in vivo and in silico studies that can provide confidence in translation to man:

  • ADME, PK and DDI studies
  • Safety Assessment
  • Bioanalysis
  • Pathology
  • Early Formulation
  • SEND

and with the expertise to support development of all therapeutic modalities (e.g. small molecules, biologics, gene and cell therapy).

The fully AAALAC-accredited facilities in Verona, Italy, have extensive experience supporting GLP and non-GLP studies in a wide variety of species, including primates.

Evotec can also design bespoke solutions in support of toxicological investigations based on study design needs and compound physico-chemical properties. Our dedicated team of pre-clinical formulators has in-depth understanding of complex bioavailability issues and provide integrated formulation support into the early tox phase and GLP IND-enabling studies. All the knowledge gathered during early formulation stages is a starting point for later clinical formulation development.

Unusually, Evotec is also expert in abuse liability assessment, required by regulatory authorities at the time as NDA submission for all CNS active drugs. Such expertise includes:

  • Consulting on abuse liability strategy, including 8-factor analysis
  • Evaluation of chemical similarity to drugs of abuse
  • Broad range of behavioural studies including: drug discrimination; self-administration; withdrawal; locomotor activity conducted under GLP compliance
  • Integration of behavioural assessment with DMPK assessment to establish PK/PD relationship

Increasingly, abuse liability assessment is incorporated early in development to allow for proper risk mitigation. Thus, planning for potential abuse liability should begin at the candidate selection stage to avoid unexpected surprises during early clinical trials.

If you wish to learn more about our abuse liability assessment capabilities and what our team can do for your projects, you can request a one-hour free consultancy meeting with our experts.

Recently published are two educational webcasts which provide insights on practical and methodological approaches to preclinical drug abuse liability assessment of novel CNS-active candidates in light of International Regulatory Agencies' recommendations.

You may also be interested in joining our webinar series focused on drug transporters hosted by Cyprotex, an Evotec Company.

These pre-clinical capabilities, along with high-end integrated CMC capabilities, can also serve as part of an INDiGO program, Evotec’s custom and proprietary solution designed to de-risk and accelerate IND-enabling programs.

INDiGO has proven to dramatically reduce time and costs during the IND-enabling phase of development. Through this program a drug candidate can be advanced from candidate selection to IND-submission in less than 52 weeks. Learn how Evotec’s INDiGO solution allowed a small US biotech to rapidly and efficiently achieve regulatory submission of their key asset in just 37 weeks.

Get in touch with an expert at [email protected] to meet and fast track your drug development needs.

With our team of scientific experts, working under a strict continuity plan, Evotec is maintaining full operational capacity throughout the COVID-19 pandemic.