BioAnalytical Laboratories Featured Articles
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Clinical Leader Expands Editorial Advisory Board
12/17/2015
Clinical Leader relies on the feedback of pharma industry professionals and consultants to guide its focus and direction. The website’s editorial advisory board, composed of consultants and executives from the pharma and bio industries, help guide the direction and focus of the site’s editorial content. Clinical Leader has announced that in 2015 it added 17 distinguished individuals to that board, including representatives of Eli Lilly and Company, Pfizer, The Avoca Group, PatientsLikeMe, BMS, Novartis, Shire, and more.
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The Challenge Of Vendor Selection, Cost Overruns, And Change Orders
10/23/2015
If you are in charge of clinical operations for a small pharma or bio company, you are likely very familiar with the challenges and frustrations associated with vendor selection, vendor management, timeliness, cost overruns, and change orders. I recently had the opportunity to speak with the director of clinical operations for a small pharma company that currently has assets in Phase 1 trials. Although he has spent a good amount of his 20-year pharma career working in Big Pharma, he was able to give me a nice perspective of the challenges he faces in his current company, and how he is attempting to overcome them.
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Five P’s For A Productive CRO Relationship
9/18/2015
You have done the research and selected a CRO that looks like it can meet all your research needs. Now you are about to entrust your precious samples to a team of people you may barely know. How do you safeguard your research, meet your timelines, and develop a productive working relationship with your CRO? Few things are less stressful than managing these relationships. A good CRO can bring your project in on time, meet all regulatory requirements, and do so with the level of quality you expect. Unfortunately, choosing the wrong CRO can result in delays, poor quality, and the feeling that you have a CRO that will require constant monitoring and hand-holding.
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WIB Profile: CROs Must Have The Ability To Deliver
9/3/2015
Zhaoqing (Ching) Ding has been involved with the sciences for more than 15 years. She earned a B.S. in Microbiology and a M.S. in Immunology, both from the University of California, San Diego. She then earned a Ph.D. in Immunology from the Stanford University School of Medicine before rounding out her education by attending the program in Innovation and Entrepreneurship from the Stanford University Graduate School of Business. She started her career performing research in academia before joining The Janssen Pharmaceutical Companies of Johnson & Johnson as a scientist in 2013. In this WIB profile article she shares her experience in working in academia versus pharma, the challenges of working with CROs, and the future potential of biotherapeutics.
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Is The Sunshine Act Reducing Clinical Research Spending?
8/24/2015
The intentions behind the passing of the Physicians Payment Sunshine Act were good. The Act required manufacturers of covered drugs, devices, biological products, and medical supplies to annually report to the Centers for Medicare & Medicaid Services (CMS) information regarding payments, ownership, investment interests, and other transfers of value to physicians and teaching hospitals. The intent was to reveal any conflicts of interest that might exist, with the end goal of hopefully bringing down healthcare costs. But even the most well-intentioned acts can have unforeseeable negative results. And it now seems the well-intentioned Sunshine Act may be having the unintended consequence of cutting down on the amount of investment making its way into clinical trials.
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Responding To Market Volatility In The Clinical Space
11/15/2012
At the 2012 AAPS meeting in Chicago, Clinical Leader sat down with Chad Briscoe, Ph.D., senior director of PRA’s Bioanalytical Laboratory in Lenexa, KS. Briscoe took time out to share his insights on strategic partnering and how PRA’s expansion of services is being driven by market demand.
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Successful Bioanalysis Outsourcing In Support Of Drug Development Program: Key To Risk Mitigation Planning For Mid-Study Method Transfer
9/15/2011
We have developed processes to enable consistent method performance during method transfer. This has ensured timely method transfer validation and study sample analysis in support of new drug development and product commercialization.