ADME-Tox & Outsourcing
Recommended Articles

The following articles and papers are useful for further understanding of the usefulness of early ADME-Tox and of using contract research organizations to increase speed and reduce costs.

Articles by Apredica Authors

The Emerging Role of ADME in Venture Capital, Katya Tsaioun, Touch Briefings Drug Discovery, 20-21, 2007
VC firms are increasingly expecting in vitro and in vivo ADME Tox data not only from the firms they have funded, but also from the ones they are considering funding.

De-Risking Drug Discovery with ADDME — Avoiding Drug Development Mistakes Early, Katya Tsaioun and Mary Jacewicz, ATLA 37, 47–55, 2009
The advent of early ADMET screening has increased the elimination rate of weak drug candidates early in the drug-discovery process, and decreased the proportion of compounds failing in clinical trials for ADMET reasons.

Cardionomics: a new integrative approach for screening cardiotoxicity of drug candidates, Katya Tsaioun, Expert Opinion on Drug Metabolism & Toxicology, June 2009, Vol. 5, No. 6, 647-660
The consequences of a failure to detect potential cardiovascular safety issues before clinical launch can have an enormous cost for the pharmaceutical industry, when major drugs are withdrawn due to lawsuits as well as loss of time and resources. An integrated cardionomics approach may reduce the risk of drug withdrawals as a result of unexpected clinical cardiac safety issues.

ADDME – Avoiding Drug Development Mistakes Early: central nervous system drug discovery perspective, Katya Tsaioun, Michel Bottlaender, Aloise Mabondzo for the Alzheimer's Drug Discovery Foundation, BMC Neurology 2009, 9(Suppl 1):S1 12 June 2009
The advent of early absorption, distribution, metabolism, excretion, and toxicity (ADMET) screening has increased the attrition rate of weak drug candidates early in the drug-discovery process, and decreased the proportion of compounds failing in clinical trials for ADMET reasons. This paper reviews the history of ADMET screening and its place in pharmaceutical development, and central nervous system drug discovery in particular. Assays that have been developed in response to specific needs and improvements in technology that result in higher throughput and greater accuracy of prediction of human mechanisms of absorption and toxicity are discussed. The paper concludes with the authors' forecast of new models that will better predict human efficacy and toxicity.

Preclinical ADME-Tox

Building Better Pipelines with ADME-Tox
...the industry is pursuing strategies to uncover potential problems related to bioavailability, pharmacokinetics, or toxicity earlier in the development process—even before drug candidates enter human testing.

Introducing In Vitro ADMET Studies Earlier
Also new on the market is the ability to assess inhalation routes of drug delivery, an expedient and relatively noninvasive route of delivery for respiratory therapeutics, CNS drugs, and pain analgesics.

ADMET Increasingly Integral to Discovery
ADMET is no longer a nice-to-do tool. It has become an integral part of drug discovery and development....

Drug R&D benefits from ADME/Tox technology
The advancement of ADME/Tox technologies will give rise to considerable time and cost savings as early screening and increasingly innovative solutions continue to underline the importance of this technology in drug development.

New In Vitro, Modeling Tools May Cut Tox Attrition
It used to be that the number of drugs failing preclinically due to poor pharmacokinetics hovered at about 40%, but in recent years, that has dropped to about 10%. The reason? Improved in vitro and animal models played a key role, as did more extensive use of tools like mass spectrometry and liquid chromatography/mass spectrometry (LC/MS).

Drug-Discovery Outsourcing

No More Swinging for the Fences in Biotech
...instead of having to sink billions into people and bricks and mortar, early stage work on a discovery can begin with a small staff and 1,000 square feet in an office park. ...if the drug fails, there is not an expensive facility to shutter and a large staff to lay off.

Hitching a Ride with the Speed Demons of Drug Development
...the fastest development companies delivered as much as a 17-month development speed advantage over average performers and as much as a three-month regulatory speed advantage. Fastest companies, for example, terminate 56% of their discontinued projects in Phase I, whereas slowest companies terminate only one-third of discontinued projects in that time frame. And drug companies that have higher relative CRO usage report completing their projects closer to projected time frames and submitting their projects more than one month closer to projected submission dates.

The Fastest Drug Developers Also Reap the Greatest Rewards
Speed demon companies – the fastest drug developers – are consistently implementing efficient R&D practices across their portfolios. A one day speed advantage ... typically saves $37,000 in out-of-pocket development costs and nets an additional $1.1 million in daily prescription revenue for an average performing drug. Tufts reports that is because the fastest companies terminate 56% of discontinued projects in Phase I clinical development versus 36% for the slowest companies.

Drug Development Partnerships, Outsourcing, Inevitable in Future
Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development: "Increasingly, R & D productivity gains will depend on developers focusing on what they contribute best to the drug development value chain and partnering with organizations that provide capabilities that are too expensive to develop or maintain internally, or are outside of the company's core competencies."

CRO’s Drug R&D Contribution Has Never Been More Significant
Contract Research Organisations' (CROs) contribution to drug development has never been more crucial with faster development, earlier decisions on project failures, and higher approval success rates becoming the norm amongst outsourcing partnerships.

BMS Claims Outsourcing No Longer an Option
Outsourcing has become so paramount in a pharmaceutical’s infrastructure and drug discovery strategy that it can no longer be considered an option, according to a Bristol Myers Squibb (BMS) senior scientist.