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As new concepts for drug discovery in the post-genomic age continue to be introduced, synthetic organic chemistry continues to be pivotal to the success of these programs. Adesis, Inc. is a contract research organization (CRO) specializing in organic synthesis.
We specialize in the synthesis of milligrams to kilogram quantities including:
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 1) cost-risk benefits (internal vs. external), 2) timing, 3) potential CRO's skillset capabilities and business practices. In medicinal chemistry, this strategy allows in-house chemists to focus on the design and assembly of new lead molecules vs. 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 infra-structure.
- 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
- Intermediates for expediting med chemistry SAR campaigns
- Drug candidates for in vivo studies
- Reference agents for bioprofiling
- Reference metabolites
- Building blocks for combinatorial chemistry
- Key intermediates for pharmaceuticals
- Key intermediates for biomaterial and biosensor applications
Value Creation and Principles
Our business model provides flexibility for creating value for customers who face the question: a) should custom projects be done on a best efforts, time and materials basis (FTE) in which the sponsor assumes most of the risk? or b) by a fixed price in which the CRO takes all of the risk (one-off). 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?
Single Compound (One-offs) projects are bid at a guaranteed fixed price for labor; 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 (FTE's) 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. FTE projects generally involve smaller amounts of material (500 mg to 50 grams).
Additional benefits for contracting full time equivalents (FTE) versus contracting multiple one-off type projects include:
Relationships are absolutely essential to the success of all outsourcing initiatives. We typically undertake one-off projects initially where Adesis, Inc. assumes the risk during the crucial getting acquainted period. Shared risk can then be considered, if mutually agreeable, such as:
- Reliable Capacity: FTE contracts provide our clients consistent and reliable laboratory capacity. In a one-off situation, timely project start-up maybe hampered by inadequate available personnel.
- Flexibility and Responsiveness: The data-driven dynamics of the drug discovery environment often necessitates changes in goals. For example, late-breaking biological or physicochemical data on an investigational molecule will prompt its deprioritization in favor of another lead. Consequently, the scale-up synthesis of a target molecule may need to be modified mid-stream or suspended. The FTE approach allows for projects to change without the need to adjust a work order.
- Project Execution Facilitation: Projects may be initiated immediately when the chemistry is provided, there is no time lapse for proposal writing and contract approval process.
In addition to expeditious synthesis campaigns, we also maximize value for customers through our operations. For example, FTE projects have the support of a full service kilo lab on the same site to make unavailable raw materials as one-offs. This allows the sponsor considerable budget flexibility and ensures that projects will not be delayed because of raw material backorders.
- One-off projects and catalog sales initially (cf, vide infra)
- Evolve to FTEs for appropriate projects
- Blend of one-off, FTE and catalog sales offers best value to both parties.
Catalog of Advanced Intermediates: This initiative provides functionalized azoles (pyridines, pyrrolidines, and imidazoles) in order to facilitate drug discovery. These intermediates, when incorporated into bioactive molecules, may reduce protein-binding, enhance solubility in physiological media, and/or modified P450 metabolic processes. Our extensive synthetic expertise allows us to offer these intermediates at lower cost vs. custom synthesis.
Our business principles encompass the following:
- Plan for success, and be successful on every project
- Deliver high purity final product(s) and intermediates
- Meet negotiated time lines
- Add value for our customers, with attention to cost-effectiveness and operational efficiencies.