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Nov 10, 2010

Quotient and Bend Partner to Provide Formulation Expertise for Clinical Trial Design

  • Drug formulations company Bend Research and early clinical development services specialist Quotient Clinical are combining their expertise to help clients accelerate the formulation of drug compounds entering clinical trials. The nonexclusive collaboration will combine Bend’s formulation capabilities with Quotient’s RapidFACT™ clinical trials design service, which will allow clients to access Bend’s formulations at Quotient’s clinical research site. The firms claim their collaboration means customers will be able to screen and optimize formulations rapidly during human testing.

    “The versatility of designing and implementing clinical trials using RapidFACT provides our clients with a game-changing advantage in advancing their compounds,” claims Bend president and CEO Rod Ray. Quotient points out that poorly soluble compounds are becoming more prevalent in the industry’s pipeline, which makes formulation expertise a key feature in progressing promising candidates.

    “Access to Bend Research’s leading formulation expertise through this collaboration will provide our customers with reliable, rapid, and efficient drug formulation platforms,” adds Mark Egerton, managing director of Quotient Clinical.

    Quotient Clinical is a business unit of Quotient Bioresearch. Its RapidFACT package integrates the firm’s formulation development, drug product manufacture, and clinical testing platforms. The firm says RapidFACT allows candidate formulations to be rapidly screened, selected, and validated on the basis of their performance in man.

    Bend Research specializes in the development of drug delivery technologies. The firm’s spray-dried dispersion (SDD) technology is designed to overcome the otherwise poor oral bioavailability of many drug candidates due to their low aqueous solubility. The firm has also developed two controlled-release tablet technologies designed to provide drug release in a predictable, reliable manner.It says both dosage forms are driven by osmotic/hydrostatic pressure and provide steady-state, zero-order release that is generally independent of gastrointestinal pH and agitation. Bend has in addition developed two oral multiparticulate platform technologies that it says have been successfully applied to solve a range of drug-delivery requirements.

    In October Bend teamed up with PPD for a collaboration in the areas of formulation development, analytical testing, and clinical supplies manufacturing. The aim is to provide pharmaceutical and biotechnology companies with a full range of chemistry, manufacturing, and controls (CMC) development services.

    As part of the collaboration the two companies will refer potential business opportunities to one another in the areas of compound characterization, particle engineering, formulation development, clinical trial material (CTM) manufacturing, analytical development, stability programs, and GMP release and quality control testing.

    In September Bend signed a three-year agreement with Bristol-Myers Squibb (BMS), under which Bend will provide its formulation development and manufacturing services to its partner for preclinical and clinical development. As part of the collaboration Bend is making its SSD technology available to BMS. Bend will also manufacture drug product intermediates and drug products at its cGMP facility for BMS clinical trials.


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