At Evotec, we've reimagined the traditional research and development process to create an integrated continuum. This approach seamlessly bridges the traditionally established gap between discovery and development, expediting the journey of assets from target identification to clinical development and onward to commercialization. 

Our integrated R&D mindset enables us to break free from the constraints of sequential phases, significantly shortening timelines while ensuring superior quality. We consider and prioritize the requirements of the next phase at every step.

Within our integrated R&D programs, we kickstart the combined discovery and development effort in the lead optimization phase. Here, we refine the target product profile, assess early developability/liability across multiple series, and strategize the nomination of the preclinical development candidate (PDC). We engage senior development experts early on to explore efficient pathways to PDC Nomination and subsequent IND/CTA submission. 

As the lead optimization phase advances and promising candidates emerge, our joint discovery and development team crafts a tailored plan for candidate nomination. This team includes the development expert panel (DEP), featuring experts in key development areas such as API (chemistry), early formulation & developability, ADME, toxicology, and clinical development. The development project leader, an expert in scientific development strategy and integrated management, takes the reins for the IND-enabling phase following PDC nomination. 

Our final PDC Nomination plan encompasses all activities necessary to mitigate risks of candidate failure later in development and to address liabilities identified in earlier discovery stages. Pharmaceutical developability and non-regulated safety activities specifically aim to confirm the candidate’s “readiness” to enter into development. 

Activities range from synthetic route/scalability assessment to analytical methods setup, characterization of physical form of solids (salts, polymorphism), physical & light stability, photosafety evaluation, development of preclinical formulation with PK profiling in rat and non-rodent species, 7-day investigative in vivo toxicity in rat study, etc. These activities are seamlessly integrated into the broader plan, allowing other discovery activities to proceed in parallel.

Recognizing that each program has unique needs, our joint discovery-development team designs a customized strategy for PDC nomination, considering advanced lead properties, clinical requirements, and partner-specific needs.

The decision to commence IND-enabling activities is also part of this continuum, with flexibility to adapt timing based on program specifics. Our collaborative team of experts evaluates program benefits and risks, providing tailored scenarios to expedite the transition into IND-enabling and clinical development.

Experience the future of R&D with our integrated, end-to-end approach, where efficiency, quality, and adaptability converge for accelerated success.