Biotechnology Innovation Organization

ACRO testifies about clinical trials in New Jersey

Tuesday, October 24, 2017

ACRO Executive Director Doug Peddicord, Ph.D., testified at a public hearing of the New Jersey Division of Consumer Affairs about a regulation that, if adopted, would have a devastating impact on the availability of clinical trials for patients in New Jersey and cripple the ability of New Jersey physicians to conduct industry-sponsored clinical trial research on investigational therapies.

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Industry reacts to proposed regulatory fee increase

Monday, March 27, 2017

President Trump’s proposed budget would require drug and device makers to pay more than double the current fees for regulatory approval, a concern that has many in the industry asking for more detail. The proposed budget posits the fee increases would improve the speed of regulatory approval, but specifics for how that outcome would be achieved have yet to be provided. The suggested budget also cuts nearly $6 billion from the NIH, which would greatly impact medical research funding.

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Study: Biomarkers improve drug LOA exponentially

Tuesday, May 31, 2016

The Biotechnology Innovation Organization (BIO) released a study of clinical development success rates. The study, conducted in partnership with Amplion and Biomedtracker, recorded and analyzed 9,985 clinical and regulatory phase transitions, across 1,103 companies. Using clinical trial data from the past decade, “Clinical Development Success Rates 2006-2015” compares groups of diseases, drug modalities and other attributes to generate the most comprehensive analysis, to date, of biopharmaceutical R&D success.

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