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Biotech Drug Discovery, FDA Approval, and Drug Development

FierceBiotech examines the FDA’s new drug development process critical to Biotech and Pharma companies. From biotech drug discovery and drug development technology to clinical testing and the FDA approval process, FierceBiotech’s newsletters bring you the information you need to stay on top of emerging and well as mature companies."

Biotech Drug Discovery

Biotech drug is a unique and special form of science that lies between basic science research and drug development,” says Franz Hefti, PhD, Merck Research Laboratory in the January issue of Drug Discovery and Development. “Drug discovery is not a random event. It starts with deciding what questions to ask to identify potential targets for a disease and later focuses on developing strategies to find effective candidates that selectively modulate those targets.”

FierceBiotech takes a look at this early stage of biotech drug development as well as the cheminformatics and medical informatics involved in the drug discovery process. Biotech drug discovery begins with scientists looking at cellular, genomic and proteomic activities which effect diseases. The R&D activity of biotech drug discovery companies is what will eventually produce the candidate for FDA approval 10 years and $300 million later.

FierceBiotech delivers news not only about the laboratory activities of Pharma companies but also the medical informatics companies enabling better organization and collaborataion and therefore speeding up the biotech drug discovery process. FierceBiotech looks at all parts of the biotech drug discovery and drug development process: Target Identification, Lead Validation, Lead Identification, and Lead Optimization.

FDA Approval

FierceBiotech also gives equal weight to the lengthy drug testing, clinical research, and FDA approval process. Starting with animal and human cell testing, FierceBiotech brings you the important news garnered through each phase of testing.
 
Each Tuesday, FierceBiotech outlines the drugs, companies, and outcomes in each phase of the new drug approval process with links to additional drug approval information and press releases. Finally FierceBiotech covers the new drug application process, the final step before FDA approval.
 
The FDA approval process looks at the same data FierceBiotech sends its readers to determine the risks and benefits of any new drug. This focus on biotech drug discovery, drug development, and FDA approval makes FierceBiotech essential for drug industry professionals.

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