The Frost & Sullivan Excellence in Technology Award is given to select companies that have pioneered the development and introduction of innovative technology in the market, normally a technology that has either impacted or has the potential to impact several market sectors. The award recognizes successful technology development that is expected to bring significant contributions to the industry in terms of adoption, change and competitive posture. It also recognizes the overall technical excellence of a company and its commitment towards technology innovation.
An unprecedented number of New Molecular Entities (NMEs) are currently exiting the discovery phase and entering full development. However, whilst these drug candidates have the potential for improved pharmacology, they frequently have less than ideal biopharmaceutical and pharmacokinetic (PK) properties. With so many compounds to choose from, the problem is how to select the right molecules for full-scale development.
Currently, this selection process is made without the aid of in vivo human PK or absorption, distribution, metabolism and excretion (ADME) data. More importantly, it is based upon at least one to two years of intensive and costly pre-clinical work, which includes scale-up of the synthesis of the drug active, GMP manufacture and animal toxicology/ADME. However, despite extensive pre-clinical screening, around 30 percent of NMEs still "fail" in Phase I clinical testing.
Pharmaceutical Profiles has been very active in adopting human microdosing studies to counter this challenge. A typical human microdosing study involves the administration of microgram quantities of drug candidates, lightly labeled with 14 Carbon (14C), to healthy volunteers. Following collection of blood, urine and faeces from each subject, samples are analysed for 14C content using accelerator mass spectrometry (AMS) to determine Cmax, AUC and the terminal half-life of each compound. Human microdosing offers numerous advantages over the "traditional" approach to early product development. Only gram scale quantities of active pharmaceutical ingredients (APIs) are required, not the usual kilogram quantities for "first-in-man" Phase I studies.
This reduces pre-clinical toxicology and ADME package and saves considerable time and money during early development. The typical pre-clinical/human microdosing programme takes up to six months versus 12-18 months for a "standard" bio-availability study programme. Pharmaceutical Profiles has partnered with Xceleron, the world's only GLP accredited commercial AMS bio-analytical company for microdosing studies to deliver this service.
Pharmaceutical Profiles is an expert in the conduct of Human Drug Absorption (HDA) studies using the Enterion capsule to reveal the complex oral biopharmaceutical properties of NMEs. HDA studies, as part of Pharmaceutical Profiles' PKPlus service, provide a "route map" to later phase clinical development by demonstrating whether a drug is suitable for oral delivery, whether it will require "enabling technologies" to keep it in development or if it is a poor drug candidate and further development should be stopped, thereby saving time and millions of dollars in unnecessary development costs.
In the area of drug delivery, Pharmaceutical Profiles has added a new frontier to visualization studies through its gs3 service that assesses the 3D performance of inhaled products. Pharmaceutical Profiles' sophisticated imaging studies play a vital role in developing inhaled products. The data generated in such studies can prove that the drug is delivered to the target site and importantly quantify how much drug is deposited there.
These in vivo deposition data form a crucial link between in vitro development and large-scale clinical trials. As a result, in vivo imaging studies enable companies to commence expensive clinical programmes with a greater certainty of success, or alternatively identify areas of research requiring further in vitro investigations. This has significant potential to address the requirements of pulmonary drug targeting, especially regional lung absorption studies.
"Pharmaceutical Profiles clearly demonstrates leadership in integrating hi-tech medical imaging with sophisticated drug development processes to cut down the costs and time involved in early phase drug development", explained Frost & Sullivan industry analyst, Rajaram Sankaran. "The impact of such integration enhances the decision-making process and helps advance the best possible drug candidates to the later stages of their drug pipeline. Its pioneering efforts and high level of technology development make Pharmaceutical Profiles a deserving recipient of Frost & Sullivan's Excellence in Technology Award in the field of drug discovery and development", he added.
The industry's response to Pharmaceutical Profiles' hi-tech early phase accelerating services has been very encouraging. During 2003, Pharmaceutical Profiles undertook 50 complex clinical studies for major pharmaceutical companies, drug delivery companies and biotechnology companies located in North America, Europe and Japan.