ARTICLES BY ED MISETA
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COVID-19 & The Virtual Trial Rush: Front-Line Insights5/19/2020
The COVID-19 pandemic caught many sponsor companies and sites unprepared. Clinical trial participants were told to stay home for their own safety and to relieve the burden on site personnel. For companies that had millions invested in trials that required data from those patients, panic set in and the rush was on for new technology solutions.
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New Biologics Create Need For Patient-Friendly Injectors3/8/2016
Analysts forecast that by the end of 2016, 50 percent of the top 100 drugs on the market will be biologics. Currently more than 900 biologic drugs are in development to treat a broad range of conditions, including cancers, immunologic disorders, and rare and chronic diseases. That the majority of new injectable treatments are biologics will present a new challenge in delivery of the medicines.
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Using The Cost Of Adverse Events To Determine Drug Safety2/4/2016
There are limitations to the drug approval system we currently have in place that is based on clinical trials. Data disclosures are often deemed inadequate, regulatory review and approval can be a lengthy process, and many would argue there is a bias in the industry and academia against publishing negative results.
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UPS Pain In The Chain Survey: Pharma Makes Gains In Compliance, Partnerships2/1/2016
UPS' Pain in the Chain survey is one of the best ways to understand where life science companies stand on the issues making logistics a headache and keeping executives up at night. Since 2008, the survey of healthcare and life science supply chain professionals has attempted to determine the needs of these companies.
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Is The Pharma Industry Really An Enemy?10/15/2015
I consider myself to be a fan of the pharmaceutical industry. This is not simply because I write for a media group that covers the pharma industry. I feel like I was a fan even before taking on my current job. It may have started a few years ago when an ailment of old age (I’m 52) began to inconvenience me and disrupt my sleep. One little white pill taken once per day has now relieved me of that issue. So, while there are many industries that bring happiness and efficiencies into my life, only one of those industries has the potential to save the lives of patients with life threatening illnesses, and ease the suffering of others. That is the pharmaceutical industry.
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WIB Profile: Mergers, Funding, & Financing Continue To Surge In Biotech7/2/2015
Faith Charles is a Corporate Securities and Transactions Partner and Chair of Life Sciences for the law firm Thompson Hine LLP. To gain some insight into the legal challenges that exist for small life science companies, I asked attorney Charles to be the next participant in my Women in Bio profile series.
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Should You Outsource Your Pharma Supply Chain?6/11/2015
Have you thought about taking the bold step of outsourcing some or all of your pharma supply chain? If so, you won’t be the first company to consider it. But is outsourcing the best option?
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Lilly Banks On Equity Investing To Grow Pipeline5/22/2015
Lilly continues to partner with academic institutions and biotech companies, and more recently has been entering into a greater number of collaborations with other Big Pharma companies. But one area where the company has devoted significant resources, and which is certainly a big part of Lilly’s partnering strategy, is equity investing.
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WIB Profile: Sponsors And CMOs Require Production Flexibility5/19/2015
Drug manufacturers today are increasingly demanding flexibility in their manufacturing processes. So who better to provide those solutions than someone who has spent her career dealing with change.
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Is The Orphan Drug Act Hurting The Patient Population?5/18/2015
The intent of the Orphan Drug Act was a good one. The problem is the success of the act may now be discouraging pharma companies from pursuing medicines that would be more beneficial to the patient population as a whole, in order to pursue a more profitable treatment for an orphan disease with a much smaller number of patients.