Tag Archive: Phase 1

Oct 10 2012

Clinical Trial Reporting

On 26 September 2012, a notice was published in the Federal Register that the Department of Health and Human Services was transferring responsibility to the FDA for ensuring that clinical trial data is appropriately submitted to Clinical Trial Registry and Results Data Bank (which is also known as ClinicalTrials.gov) and that the data is complete …

Continue reading »

Nov 29 2011

Fifth China Medicinal Biotech Forum – Conference Recap

I recently returned from the Fifth China Medicinal Biotech Forum held in Beijing, China from 07-09 November 2011.  The purpose of this conference was to update graduate students in China on the latest trends in biotechnology.  This forum also allowed scientists from Europe, Australia, Japan, US, and South America to collaborate with Chinese colleagues at …

Continue reading »

Nov 10 2011

Free Webinar – Optimal Clinical Study Designs and International Regulatory Strategies

Please join us at a joint webinar between the Netherlands Centre for Human Drug Development (CHDR) and Cato Research that addresses current challenges and provides clinical and regulatory strategies to the most expeditious and cost-effective path towards clinical proof of concept and approval. The webinar will be held on Tuesday, 15 November 2011 from 1:00 to 2:00 PM ET.

Jul 28 2011

Imaginary patients, Imaginary data, et Cetero, et Cetero…

The FDA recently issued a letter to a CRO based in Cary, NC, outlining serious violations at one of their facilities including “widespread falsification of dates and times in laboratory records… and the apparent manipulation of equilibration samples to meet predetermined acceptance criteria.”  This letter is a follow-up to two on-site audits, conducted as a …

Continue reading »

May 27 2011

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, …

Continue reading »

May 12 2011

Conference Recap – Biomarker World Congress 2011

  Everywhere in the news today, we hear that we are in the era of personalized medicine – where new medicines will be tailor-made for individual patients.  Specifically, personalized medicine is dedicated to the concept hat the right drug is administered to the right patient at the right dose at the right time.  To get …

Continue reading »

May 11 2011

Conference Recap – BayBio 2011

The BayBio Annual Conference 2011 was held on 20-21 April 2011 in Burlingame, CA.  The event was attended by more than 1,000 San Francisco Bay Area biotech and life sciences professionals from over 400 companies. This year’s conference focused on funding trends and emerging markets in the life sciences industry.  In keeping with BayBio’s spirit …

Continue reading »

Jun 18 2010

DIA 2010 – Week in Review

The DIA 2010 Annual Meeting was a great success and Washington, DC was a great location.  In addition to the thousands of industry attendees, the location made it possible for this year’s meeting to include FDA representatives from all areas of the Agency. As previously mentioned, Will Lee and I attended the meeting.  For those …

Continue reading »

Jun 02 2010

Guidance for the Therapeutic Discovery Tax Credit

Credit you give yourself is not worth having. – Irving Thalberg For all you virtual biotechs and small start-up biotechs that survived the “Great Recession,” here is something to look forward to.  I’ve mentioned the Therapeutic Discovery Tax Credit before, but only in passing.  Now, though, the FDA Law Blog has brought to my attention …

Continue reading »