Ed Miseta
For more than a decade, Ed Miseta served as the Chief Editor of Clinical Leader. His tenure sadly ended in July 2023 when he passed away after a two-year battle with multiple myeloma. During his time as Chief Editor, Ed interviewed hundreds of executives from sponsor companies, patients, and technology and service providers. He regularly reported on best practices and advancements in clinical trials, detailing how both small and large sponsor companies navigate the changing landscape. In addition to his writing, Ed hosted numerous Clinical Leader Live! digital events that allowed his audience to listen to and interact with experts throughout clinical trials on a host of important issues. Beyond his duties for Clinical Leader, Ed frequently moderated and spoke at many conferences and events related to clinical trials.
Ed studied Business Economics at Penn State University and earned a Master’s degree in Business Administration. He spent 10 years in banking and investments and taught economics at Penn State for 8 years before joining Clinical Leader.
ARTICLES BY ED MISETA
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Thermo Fisher To Acquire PPD4/15/2021
In an effort to create greater customer and shareholder value, Thermo Fisher Scientific has announced plans to acquire clinical research organization PPD for a cash purchase price of $17.4 billion. The purchase will also include the assumption of approximately $3.5 billion of net debt.
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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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Opdivo And Praluent Expected To Lead The Class Of 20153/25/2015
Which pharma offerings should you keep an eye on in 2015? Thomson Reuters has released its 2015 Drugs To Watch report, with insights into those medications expected to enter the market this year and make a big splash for their developers.
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ISPE Releases Drug Shortages Prevention Plan At Annual Meeting10/15/2014
ISPE has released its Drug Shortages Prevention Plan at a media conference held during its annual meeting at Caesars Palace in Las Vegas. Present at the conference were new president and CEO John Bournas, strategic advisor John Berridge, and Drug Shortage Prevention Plan leaders Joe Famulare, Paul D'Eramo, Donna Gulbinski, and Sam Venugopal.
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ISPE Set To Address Drug Shortages At Annual Meeting10/6/2014
Drug shortages continue to plague the pharmaceutical industry. According to a GAO report on shortages, dated February 2014, the number of shortages continues to increase in the U.S., as well as around the world. In 2007 there were 154 shortages, 114 new shortages and 40 ongoing from a prior year. In 2012, there were 456 shortages, 195 news ones and 261 ongoing. As of June 30, 2013, there were already 73 new shortages and 288 ongoing.
The public health importance of these shortages cannot be overemphasized. Shortage situations have included zinc for parenteral nutrition in neonates and premature infants, doxorubicin for ovarian and other cancers, and Propofol for anesthesia.
Clearly something needs to be done. “ISPE believes efforts to address this complex and multi-faceted problem of drug shortages requires close collaboration and clear communication between the pharma industry and global health authorities,” says Francois Sallans, VP and chief quality officer for Johnson & Johnson, and presenter at the 2014 ISPE-FDA CGMP Conference. “We believe The Drug Shortages Prevention Plan being assembled by ISPE will provide guidance to pharma and global health authorities to manage drug shortages more effectively. But more importantly we are looking into ways for the two groups to manage these shortages more proactively as well. That is an important component that we need to have in place in order to make these shortages rare, but short-lived.”
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Patient Demand, Vaccines, And Drug Delivery: Q&A With Steve Wick Of 3M Drug Delivery Systems4/24/2014
New technologies are changing the drug delivery approaches used for both small and large molecule manufacturers. Additionally, the more empowered patient is causing many pharma companies to re-evaluate their drug delivery strategies. We spoke with Steve Wick, Senior Technical Director for 3M Drug Delivery Systems, about these topics as well as how the drug delivery landscape might change over the next 5 to 10 years.
What technologies are currently changing drug delivery approaches for small molecules? For large molecules? How will these advances impact the pharmaceutical industry?
For small molecules specifically, I believe that we will see two different trends in drug delivery. The first will be toward the targeting of drug delivery through the use of technology such as nanoparticles or even aptamers.
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Acquisition Expands Phase I Capabilities12/3/2013
Clinical research firm PRA has announced it will be acquiring privately-held specialty research firm CRI Lifetree. CRI’s focus has been on early stage patient population studies with a focus in Human Abuse Liability (HAL), addiction, pain, psychiatry, neurology, pediatric and infectious disease services.
With three Clinical Pharmacology Centers and over 200 beds, combined with over 20 years of clinical experience, CRI is one of the largest providers of patient population Phase I and confined Phase II-III services in the United States.
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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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Five Technology Trends That Will Impact Clinical Research6/11/2013
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.”