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AUTM Joins Senator Birch Bayh in Opposition to Free Agent Concept

Posted on April 19, 2012 by Jeffrey Waldin |

A position paper released this week states opposition of AUTM on behalf of it members to the free agent concept, which would allow researchers to shop their technologies to other offices for commercialization, while the institution still retains its rights…

Major Research Sponsor Pushes for Open Source Publication

Posted on April 18, 2012 by Jeffrey Waldin |

There has been increasing tension between the philosophy of making research results freely available to encourage further investigation, and the philosophy that subscription journals, especially those with established credentials, provide an indication of the quality of those results, the cost…

Citizen Science Meets Clinical Research

Posted on April 16, 2012 by Matthew Tanner |

Amateur clinical researcher Melanie Swan recently published a paper in the journal Personalized Medicine, proposing a model for “extending crowdsourced studies beyond small-group experimentation to large-scale intervention-based research studies that are professionally run and scientifically rigorous, in effect creating a…

How FDA Makes Benefit-Risk Determinations for Medical Devices

Posted on April 12, 2012 by Matthew Tanner |

In March 2012, FDA issued a finalized version of its guidance titled, “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications”. Although the explicit scope of this guidance is limited, the benefit and risk considerations are broadly…

USDA AWIC: Meeting the Information Requirements of the Animal Welfare Act Workshops

Posted on April 11, 2012 by Matthew Tanner |

Workshops to be held at The National Agricultural Library in Beltsville, Maryland on May 9-10, 2012 and October 3-4, 2012. Click here for more information. The objectives of the workshop are to provide: An overview of the AWA and its information requirements; A review…

Why Don’t Patients Enroll?

Posted on April 9, 2012 by Matthew Tanner |

According to RDP Clinical Outsourcing, pharmaceutical companies and trial sites need to think more strategically about recruitment. Almost 80% of clinical trials are delayed, with 20% being delayed for 6 months or more. There are a number of reasons why…

Handling Clinical Trial Protocol Amendments in InfoEd

Posted on April 9, 2012 by Matthew Tanner |

According to a study by the Tufts Center for the Study of Drug Development, almost 60 percent of clinical trial protocols for new drugs are amended at least once. The first step with any amendment is to understand what changes…

Reminder: New requirements for Semi-Annual Inspections based on the 8th Guide

Posted on April 7, 2012 by Matthew Tanner |

OLAW requires Assured Institutions to complete a Semi-Annual Inspection based on criteria set forth in the 8th Edition of the Guide for the Care and Use of Laboratory Animals by December 31st, 2012. All programmatic changes need not be completed (as…

Dual Use Research of Concern

Posted on April 6, 2012 by Roger Wood |

Dual use research of concern is “that research with the highest potential for yielding knowledge, products, or technology that could be misapplied to threaten public health or other aspects of national security.” A Public Consultation Meeting is being held on…

USDA and APHIS, Happy Anniversary!

Posted on April 6, 2012 by Matthew Tanner |

This year marks the 150th anniversary of the USDA and the 40th of APHIS (Animal and Plant Health Inspection Service). A successor of the Bureau of Plant Industry in 1972, APHIS plays a key role in the surveillance and eradication…