Sygnature Discovery’s Early CMC Development Expansion: Unveiling New Opportunities
Sygnature has announced the set-up of a state-of-the-art Early Candidate Developability Screening Group. Located at our headquarters in Nottingham, UK, the new service line will expand our offerings to customers by bridging into formal preclinical drug development and paving the way for clinical trials.
With over £1m of capital investment already committed, the new world-class facility and business unit will be operational in September 2021 and is being set up to work along-side our complementary chemistry, in vitro and in vivo pharmacology and DMPK capabilities.
Sygnature will create robust development strategies tailored to the characteristics of each individual API and through access to our well-equipped pre-formulation and formulation development laboratories rapidly and unbiasedly identify the most phase-appropriate development approach to overcome even the most complex of bioavailability challenges.
Dr Richard Weaver SVP of Pre-Clinical Development commented on the new service offering: “There is an increasing need for engaging the formulation scientist at an earlier stage and most importantly having constant and iterative dialogue with the DMPK, Pharmacology and Chemistry teams. Inadequate bioavailability in many late-stage research and development compounds is a real modern-day challenge. There is often a way forward if the reasons for the poor bioavailability are not due to DMPK reasons. A key part of this process is making the human efficacious dose prediction range as early as possible and feeding this information to the formulating scientists, along with the theoretical gains that can be made”.
Dr Mark Saunders, previously founder and CEO of Kuecept is working with Sygnature Discovery to help build this value-added capability. Dr Saunders said: “I am delighted to be working with the team at Sygnature Discovery to help build this new capability. Already we have been able to attract leading scientific talent to drive this initiative and I am confident of the advice and experimental capability that we will be able to give to clients to help get much needed new medicines on the market with minimal hurdles and the maximal chance of the achieving right drug exposure to fit the need”
Dr Paul Overton, Chief Operating Officer, continued “Our expansion of the value chain into early CMC development will be of significant benefit to our customers as we partner with them from early drug discovery. The expansion into the formulation space fits with our strategic goal of being able to have the line of sight of the clinic and feeding this into our earliest discussions with the customer to maximise their chance of clinical success”.
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