Articles By Ed Miseta
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Should Russia Be Your Choice For Clinical Trials?
8/27/2013
Years ago, being a CRO in Russia was not an easy endeavor. Politics, as well as the state of medicine and healthcare in the country, made it a difficult place to perform trials. With improvements that have been made in both medicine and technology, and the changing political landscape, the country is now a very different place. This has significantly improved the job of the CRO, and has made the country a growing and successful area to conduct clinical trials.
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Your CRO Just Acquired Another CRO – Now What?
7/27/2013
A year ago, Wendel Barr, CEO of CRO Synteract, was frustrated. His company was profitable, he had talented personnel, Synteract was managing a wide variety of projects, and his clients were satisfied with their level of service. Despite this success, his potential to grow the business was constrained. Synteract was a U.S.-based firm with limited presence overseas. As a result, his company often found itself forced to leave money on the table, especially as its customers moved to larger, Phase 3 trials. “It became clear to us that in order to provide the range of services our customers required, we had to have more offices in Europe, beyond our office in Prague,” he says. “If you want to be a full service provider from Phase 1 to Phase 4, you have to be global.”
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Eliminate Clinical Trial Fatigue With More Effective Recruitment & Retention
6/18/2013
The average cost to develop a new drug, for most companies, is in the billions. A key contributing factor to that figure is the cost of enrolling patients. One study has shown that between 2008 and 2011, the cost for a patient in a Phase 1 trial went from $15,000 to over $20,000. For Phase 2 that cost rose from $20,000 to $35,000, and for Phase 3 it rose from $25,000 to $47,000. The smallest increase occurred in Phase 4, where costs rose from $13,000 to $17,000 (see The High Cost of Clinical Research – Who’s To Blame And What Can Be Done?). When a patient drops out of a study, the costs go even higher.
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Five Technology Trends That Will Impact Clinical Research
6/11/2013
Zikria Syed, CEO of enterprise software company NextDocs, has seen many technology advancements in life sciences, including open standards, mobile access, tablets, and cloud computing. However, despite the cost and compliance advantages offered by many of these advancements, clinical research firms are still slow in adopting them. Research conducted by his firm shows this dynamic is about to change.
“Our sales and marketing personnel talk to clinical researchers and their CIOs every day,” he says. “I believe there is a message we are delivering to them that they are finally starting to understand: There is a technology shift going on that your peers are starting to take advantage of. If you do not embrace these changes as well, you will soon be operating at a costly productivity disadvantage.” -
WIB Profile - bluebird bio Scientist On 10 Years Of Performing Tech Transfers
Kelly Kral has worked in the pharmaceutical industry for more than 10 years. She started her career at Genzyme, working as a process engineer developing a fed batch process for the production of adenovirus in HEK293 suspension cells. Her responsibilities included media screening, cell growth characterization, and virus production in shake flasks, spinners, and bioreactors. She assisted in process transfer to a CMO and authored process documentation, skills she used extensively in her work as group leader for upstream process development at Percivia and in her current role of scientist I at bluebird bio.
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UPS Worldport: A Transportation And Logistics Modern Marvel
One of the joys of working in media is the amount of travel I get to do as part of the job. While boarding planes and sitting in airports can become exhausting and tedious at times, I do get to visit some pretty amazing places that I otherwise would not have the opportunity to access. Visits to major cities like Boston, Chicago, and NYC are always enjoyable, as are visits to landmark places such as the New York Stock Exchange. Since I have been involved in the life sciences space, I have also gotten to visit some pretty memorable manufacturing facilities such as CMC Biologics, Therapure Biopharma, and Gallus Biopharmaceuticals.
Recently I had the privilege of attending a tour of the enormous UPS Worldport facility in Louisville, KY. To say this hub is incredible would be an understatement. The place is more amazing than Disney World, and should probably be considered as a contender for the eighth wonder of the modern world.
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Pain In The Chain Survey: Time To Capitalize On Untapped Opportunities
UPS has released its 7th annual UPS Pain in the (Supply) Chain Survey of executives in the pharma, biopharma, and med device industries. While this latest version of the survey shows executives still have concerns over the economy, rising costs, and regulatory challenges, there are opportunities companies can capitalize on to help move the industry forward.
On the positive side, the growth of the global population and the middle class, along with a rise in the median age has created a growing demand for healthcare services. The report notes in order to capitalize on these new opportunities, companies will need to move quickly to make strategic changes to their supply chains. Unfortunately, supply chain change seems to come slowly, and in the current risk-inherent environment, may be impeding growth in the industry.
While some companies are reacting to emerging opportunities by transforming their supply chains, the report states the winners in tomorrow's healthcare marketplace will be those companies that make their supply chains more flexible and efficient, and begin making those changes as soon as possible. Those that don’t may be taking on the greatest risk of all.
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Albumin Addresses Need For Better And Longer-Lasting Drugs
A recent article in the Wall Street Journal addressed the most recent research and technologies in pharma that are making drugs more efficient. One protein that is leading the advancements in this area is albumin.
The albumin developed by Novozymes makes it possible to produce better and longer lasting drugs. The development started more than 20 years ago in Nottingham, UK, when the Bass Brewery was seeking novel ways to generate value from its waste yeast. To do so, it established a company to assess the feasibility of making albumin from brewer’s yeast. The brewery eventually sold off the company, and Novozymes has since acquired the technology. Novozymes now produces albumin for a number of pharmaceutical companies, although the process currently uses a more efficient yeast developed by Novozymes rather than brewer’s yeast.
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Flexibility In Biologics Manufacturing: How To Determine If Stainless, Flexible Stainless, Or Single-Use Is Right For You
Meet customer needs by providing manufacturing options to suit every preference.
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Supply Chain Security Goes High Tech To Cut Losses
If anyone can be called an expert on pharmaceutical shipments, Chuck Forsaith certainly fits the bill. Forsaith is director of supply chain security at Purdue Pharma Technologies and chairman of the Pharmaceutical Cargo Security Coalition (PCSC). He previously served as a municipal and state police officer, as well as directing security operations at a U.S. military installation. When it comes to the safety of pharmaceutical shipments, he believes security is getting better, resulting in a dramatic decrease in security breaches. However, there is still a lot more that can be done to make everyone more vigilant and hopefully put an end to the huge financial losses and health risks posed by the theft of pharmaceutical products. The ramifications of poor security cannot be overemphasized. As Forsaith notes in every presentation he gives, no one has ever suffered an adverse medical event from watching a stolen television set.