Adesis - Organic Synthesis for Life Science and Biomaterials

Adesis is a multi-dimensional contract research organization (CRO) specialising in organic synthesis in milligrams to kilogram quantities, for the life sciences and biomaterials industry. It is also a major purveyor of orthogonally-functionalised heterocycles (Advance Heterocyclic Intermediates initiative), which leverages proprietary chemistry expertise in pyridines, azaindoles, and other azaheterocycles.

These building blocks, when incorporated in biologically-active molecules may:

• Facilitate reduction in protein-binding
• Increase solubility at physiological media
• Modify metabolism and tissue deposition of drug candidates

The validation of biological hypothesies requires timely chemistry commitments, which Adesis is known for. Examples of the diverse chemistry projects that we undertake include:

• Early stage proof-of-concept (POP) projects to validate biological hypotheses
• Validation of screening hits for exploratory medicinal chemistry (hit-to-lead)
• In-depth structure-activity relationship (SAR) studies
• Building blocks for combinatorial and parallel synthesis chemistry
• Intermediates for expediting medicinal chemistry SAR campaigns
• Enabling timely pre-clinical and INDA-compliant in vivo studies

Key chemistry support functions for pre-clinical and drug development studies include:

• Reference agents for bio-profiling studies
• Reference metabolites, including putative metabolites
• Ex vivo syntheses for metabolites
• Stable isotope labelling of bioactive and biomaterial agents

• Key intermediates for pharmaceuticals
• Key intermediates for biomaterial and biosensor applications
• Initial single batch materials for in-life studies
• Process improvement preparatory to cGMP production (including transfer to client’s designated cGMP contractor)

Outsourcing should be a strategic component of any sponsor’s research and development portfolio, instead of an ad hoc decision. It is a decision which factors in:

• Cost-risk benefits (internal versus external)
• Timing
• Potential CROs skill set capabilities and business practices

In medicinal chemistry, a good operational strategy allows in-house chemists to focus on the design and assembly of new lead molecules versus routine syntheses which can be outsourced. Virtual biopharmaceutical companies have embraced outsourcing in order to direct maximum start-up funds to reaching proof-of-concept (instead of immediate creation of infrastructure).

Value creation and principles for organic synthesis projects

The Adesis business model provides flexibility for creating value for customers that encounter the question should custom projects be done on a best efforts, time and materials basis (FTE) in which the sponsor assumes most of the risk vs. a fixed price in which the CRO takes all of the risk.

Pricing is quite different depending on who is the prime risk taker. Furthermore, is the expense of a custom synthesis for a particular compound prudent? Irrespective of the client’s decision, Adesis does not sacrifice on quality and timeliness on assigned projects.

One-off organic synthesis projects and full time equivalents (FTEs)

Single compound (one-offs) projects are bid at a guaranteed fixed price for labour; raw materials may either be included in the fixed price or back-charged at cost. The decision to back-charge raw materials depends on the anticipated reliability of the synthesis procedure provided, as well as scalability. One-off projects are typically more traditional Kilo Lab projects involving large quantities of material.

Full time equivalents (FTEs) are committed full time to the sponsor. FTE-based projects are quoted on time and materials, with back-charge of raw materials. These are research oriented projects and / or difficult projects, where the substantial technical risks preclude quoting a fixed price.