Monthly Archives: November 2008

Fast Solubilisation for Proof of Concept and Safety Animal Work

Poor solubility is an increasingley common problem in Drug Development and Discovery, it impacts on a technology in two main ways. A soluble formulation is required early on for early animal proof of concept studies which adds to the project risk if large amounts of money are going to be spent before you know if you have a good product opportunity. Secondly it will add to your cost of materials once your product is finally developed.

The first of these risks however can be manged, one of Damien’s clients, Agenda1, has developed a service that can help. SOLENT (SOLubility ENhancement Technology), the foundation is a proprietary pre-formulation matrix, comprising a wide variety of combinations of liquid-based GRAS (generally regarded as safe) formulation excipients approved for preclinical and clinical use (including pH adjustment, co-solvents, mico-emulations, SEDDS, oils, lipids and cyclodextrins).

The technology enables products to be “screened” in various potential formulations to quickly ascertain potential formulations, its quick and cheep enough to get your product into animals and man for Proof of concept and early safety studies. Then with a positive result you can confidently invest in a full formulation programme.

Link to Agenda1 website

For more information on this vital new service contact: Ian Siragher at Agenda1 on 01274 326073

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology), we work with our clients to define a development target, define a development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch using the contact form or email Damien at damien.bove@idaconsultants.com

Course – The Regulations of Phase I/II Clinical Trials

Damien has teamed up with Dr Tony Lockett to deliver a course on the regulations of Phase I/II clinical trials.

The course will be delivered in Leeds on the 25th February 2009.

It is an introductory course on the regulatory aspects of planning a Phase I/II clinical trial, and how these trials should progress the development of your technology. The course is presented by a seasoned professional, who has planed and implemented clinical trials for large pharmaceuticals companies, and small spin out biotechnology companies and national defence organisations, presents a tried and tested course, that will arm anybody planning, running, reporting and purchasing a Phase I/II clinical trial with all they need to know.

For more information on this course or to download the brochure follow this link -  Course Details

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology), we work with our clients to define a development target, define a development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch using the contact form or email Damien at damien.bove@idaconsultants.com