Case study

Metris

Development of a novel vaginal drug delivery system

In early 2001 PA was approached by Metris Therapeutics, a specialist pharmaceutical company focusing on women’s healthcare, to assist it with establishing a manufacturing process for products to be used in the treatment of benign gynaecological conditions such as menorrhagia/dysmenorrhea, using a novel vaginal drug delivery system. A patent covering the concept of the vaginal delivery system (VDS) was previously filed.

PA’s initial brief was to turn the concept into a prototype for use in preclinical testing in order to determine whether the physical characteristics of the product in vitro lent themselves to a safe and effective delivery system. PA was also invited to advise on clinical and regulatory aspects of the clinical development programme. From significant experience of running product development programmes involving multiple suppliers, PA recognized the need to establish a formal project team structure comprising function specific workstreams, whose activities would be monitored by a project office and governed by a project steering committee.

This structure and PA’s rapid prototyping ability were major contributory factors to ensuring that the project team met the objectives of taking the concept to phase-one clinical trials within 16 months (including the successful submission of an IND application), and to phase-two trials within 24 months.