Tag Archive: preclinical

Aug 07

FDASIA, Part 3: Generating Antibiotic Incentives Now (GAIN) and Drug Approval and Patient Access Changes

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part weekly series, we are covering the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical …

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May 27

Bridging the Valley of Death: Bringing New Drugs from the Bench to the Clinic

Bridge

To bring a new medicine to the stage of clinical trial testing requires on the order of $500,000 to one million dollars and then seven to ten years of clinical trials and around $800 million dollars before getting to market.  However, it is doable, and one can point to successful biotechs such as Genentech, Amgen, …

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May 09

Conference Recap – 2011 Society of Toxicology Annual Meeting

The Society of Toxicology’s (SOT) 50th Anniversary Annual Meeting was held on 05-10 March 2011 in Washington, DC.  Several members of Cato Research’s Nonclinical Sciences Development group were amongst the more than 7,000 toxicologists from 50 countries in attendance this year.  The five-day event provided scientists with countless opportunities to discuss the latest scientific achievements …

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Feb 17

New Book – Principles of Anticancer Drug Development

Recently, Humana Press/Springer published a new book, Principles of Anticancer Drug Development. Neil Clendeninn M.D., Ph.D., a Senior Clinical Research Physician for Cato Research, served as an editor for the book, which has been described as a practical guide to the design, conduction, analysis and reporting of clinical trials with anticancer drugs.

May 25

Optimizing Drug Development and Preclinical Considerations for Oncology Indications

The Montgomery County (Maryland) Department of Economic Development will be hosting its next lunch meeting on Thursday, 27 May 2010 at the Shady Grove Innovation Center.  The topic of the meeting will be, “Optimizing Drug Development and Preclinical Considerations for Oncology Indications,” and the featured speakers will be Tariq Allana, Ph.D., and Jack Snyder, M.D., …

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