June 20, 2011 08:08 ET

Antisense & Other Emerging Technologies to Drive Drug Development Cost Down

ROCKVILLE, MD--(Marketwire - Jun 20, 2011) - has announced the addition of the new report "Lead Generation Strategies and Technologies in Drug Development - Emerging Techniques Such as Antisense Technology Will Allow Innovators to Minimize Costs," to their collection of Pharmaceuticals market reports. For more information, visit

The FDA has been continuously criticized for its overly strict standards surrounding drug approvals. Following the cases of Vioxx, Exubera (insulin human [rDNA origin]) as well as product recalls of "Made in China" drugs, the agency has been more cautious in analyzing the risks and benefits of drugs before approving them.

In 1996 the number of NMEs approved was 53. This declined to just 17 in 2002. In 2008, the number of NMEs approved was 21, reflecting a better picture than in 2007 when only 16 drugs, the lowest number of the last 13 years, were approved.

This reduction in NME approvals reflects the need to accelerate the lead generation process by which potential lead molecules reach trials. The faster the molecule enters trials, the faster the results of its efficacy can be seen and applied.

The in silico method of drug discovery is preferred over traditional laboratory methods due to its ability to process large amounts of data in comparatively less time. This preference is also based on its low cost and the growing computational resources of in silico methods.

With modern day drug discovery encompassing large quantities of compounds and reducing the time period needed to examine them, the assistance of computer technology is inevitable. Thus, the need for the storage, management and analysis of large quantities of compounds has given rise to CADD as a tool to accelerate the modern day drug discovery process. CADD utilizes computational chemistry to discover and enhance optimization of the study drugs and related biologically active molecules. The objective is to predict the binding strength of given molecules in relation to their target.

Currently, CADD represents various computational methods and resources used to assist the drug design and discovery process. Some of the major developments in CADD features include digital repositories, design libraries, fold recognition and virtual screening.

Digital repositories contain detailed information on drugs and other useful compounds which are useful for studying the capabilities of chemical reactions. Similarly, design libraries also have the potential to generate molecular variants. It also allows for the selection and sampling of chemical compounds with diverse characteristics. Fold recognition is used for studying sequence structure homology between protein sequences and structures and are helpful for inferring binding sites and molecular functions. Finally, virtual screening, a computerized version of HTS, allows the systematic evaluation of large chemical libraries to identify potential lead candidates that can be synthesized and tested.

Major stages of drug discovery that can utilize CADD include hit identification using virtual screening, hit-to-lead optimization of affinity and selectivity and lead optimization of other pharmaceutical properties while maintaining affinity.

Lead generation studies make use of systems or models such as in vitro, in vivo and in silico models in order to conduct preclinical research and development studies. Absorption, distribution, metabolism, excretion and toxicology (ADMET) studies are conducted initially to investigate and correlate the test compound's chemical properties in preclinical systems with those of humans.

There are a considerable number of contract research organizations (CROs) providing a wide range of preclinical design and testing services. Some of the top CROs such as Covance and Cyprotex offer both customized and standardized lead generation services and models to their clients (pharmaceutical and biotechnology companies) and continue to grow with strategic acquisitions and partnerships. Furthermore, CROs from Asian countries, notably India and China, such as Jubilant Biosys, Advinus and Shanghai ChemPartner are also emerging with customized offerings on early phase drug discovery.

For biopharmaceutical companies, the early stages in the drug development process play a crucial role in discovering and bringing safe and effective new compounds to the market. Outsourcing at this stage helps biopharmaceutical companies to access global patient populations and conduct rigorous early phase clinical research with decreased costs and in less time.

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