Abbott To Acquire Facet Biotech
Posted on | March 10, 2010 | No Comments
Abbott has agreed to acquire Facet Biotech for $27 per share in cash for a net transaction value of approximately $450m to enhance its early- and mid-stage pharmaceutical pipeline.
NIH and FDA Announce Collaborative Initiative to Fast-track Innovations to the Public
Posted on | February 25, 2010 | No Comments
“The U.S. Food and Drug Administration and the National Institutes of Health today unveiled an initiative designed to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients.”
“The initiative involves two interrelated scientific disciplines: translational science, the shaping of basic scientific discoveries into treatments; and regulatory science, the development and use of new tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality. Both disciplines are needed to turn biomedical discoveries into products that benefit people.”
“As part of the effort, the agencies will establish a Joint NIH-FDA Leadership Council to spearhead collaborative work on important public health issues. The Joint Leadership Council will work together to help ensure that regulatory considerations form an integral component of biomedical research planning, and that the latest science is integrated into the regulatory review process…more“
Sterling Life Sciences R and D / Manufacturing Opportunities
Posted on | February 10, 2010 | No Comments
With today’s economy we can always use whatever help is available. Here are some listings of executive level positions through Sterling-Hoffman that are yet unfilled.
*Senior Director, Analytical Technical Support (Pennsylvania)
*Director, Laboratory Operations Support Services (Ontario)
*Process Engineer (California)
USP Provides Information on Recall and Reissuance of USP 33–NF 28
Posted on | January 23, 2010 | No Comments
http://www.usp.org/USPNF/recall.html
USP 32–NF 27 is official at this time and remains official until further notice. USP 33–NF 28, which was released on November 1, 2009 and recalled on January 8, 2010, was not scheduled to become official until May 1, 2010 and should not be used. The current official standards in USP 32–NF 27 can be used with confidence.
Reason for Recall
USP recalled USP 33–NF 28 because of errors that occurred when monographs were redesigned into a new format. The redesign was intended to improve ease of use, streamline presentation, and update and harmonize terminology, but was not intended to change any of the monograph requirements. The effort was comprehensive: all of the ~4000 monographs in the USP 33–NF 28 were redesigned, encompassing more than 4100 pages, over 4 million words, and many figures and tables. While many of the monographs were successfully redesigned, a significant number contained errors.
While USP has an Errata process for issuing corrections to USP–NF on an on–going basis, this process was inadequate to address the number of errors resulting from the redesign. Because maintaining the integrity and accuracy of its standards is of paramount importance, USP recalled USP 33–NF 28 in its entirety.
BioWorld Today: Trial Subscription
Posted on | January 8, 2010 | No Comments
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To receive your FREE REPORT and FREE 30-DAY TRIAL to BioWorld Today, simply click here. Registration takes just 30 seconds and is FREE no credit card is required, and you’re under no obligation to buy anything, ever. There’s nothing to cancel.
Nilsen Consulting Webcast
Posted on | November 30, 2009 | No Comments
Join Nilsen Consulting for a webinar entitled “Bullet-Proof Analytical Methods Validation & Performance Monitoring: An FDA/ICH Compliant Six Sigma Approach” On Friday, December 11.
Starting time: 9:30 am, and again at 1:30pm, Eastern Standard Time (New York, GMT-05:00)
Duration: 2 hours
Presenter: Clifford Nilsen
This new, front-line approach, will revolutionize traditional methods validation paradigms, using Six Sigma statistical techniques to ensure proper evaluation of data and setting of meaningful, statistically sound acceptance criteria every step of the way. This is the future of both scientific and regulatory method validation expectations.
Your instructor, Clifford Nilsen, CSSBB, has 40 years experience in the pharmaceutical industry and is a leading expert in analytical laboratory management. He is a Certified Six Sigma Black Belt and has authored two books on analytical laboratory management and operations plus, has written columns for leading industry magazines. He is also a faculty member of the Parental Drug Association and has lectured in the USA and abroad on method validation and related topics.
Register now—No expensive hotel-based per person seminar fees, no travel expense and no lost work time. One registration fee can be used by a single audience, from one person to however many that are interested. All you need is a computer (windows or Mac) that has a speaker. Audio is VOIP. Session is interactive with a 30 minute Q&A session at the end of the presentation. Includes a downloadable copy of the presentation handouts and as a bonus, a traditional method validation protocol and report template.
Session fee (USD$): 475.00
Agenda:
- Introduction
- Overview of Lab Operations and basic statistical methods
- Method Validation – A Six Sigma Approach
- Method Performance Monitoring
- Overview of Measurement System Evaluation
- Question & Answer Period
Session number: 730 876 966
Password: (This session does not require a password.)
Audio conference: Use VoIP only
Host’s name: Clifford Nilsen
Host’s email: cnilsen@nilsenconsulting.com
