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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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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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.
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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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21st Century Cures Gets Closer To Revolutionizing The Pharma Industry2/5/2015
If you’re a regular reader of my articles, you know my background is in economics, and I tend to favor free markets over more central control. But when I first became aware of the 21st Century cures initiative last year, I felt it was something the industry needed.
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FDA Regs Help Secure The Global Supply Chain10/27/2014
A better strategy, coordination, and additional tools will help keep medicines and ingredients safe.
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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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Pfizer Issues A Challenge – Cook Pharmica Delivers9/24/2014
When Pfizer approached Cook Pharmica about producing a monoclonal antibody, Cook saw it as an opportunity to demonstrate its ability to deliver a product to the specifications the sponsor desired. Cook was fairly new at the time, and had been working with clients for just over four years. The company looked good on paper, and was one of a few facilities that could produce ingredients as well as final drug products in the same facility. Still, Cook executives knew they needed to prove they could measure up to the five driving principles (quality, cost, adaptability, timeliness, and risk) that were crucial to Pfizer.
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Are Regulators Providing The Right Quality Incentives?9/8/2014
If you want to get a horse to move, there are two schools of thought on how to get it done. One says stand behind the animal with a stick and hit it until it does what you want. This method is not the most humane, and would not do much to endear you to the horse. The other approach says hold a carrot in front of the horse, and get it to move of its own volition. The carrot would be a reward to the animal for doing the right thing.
Looking at this situation in a different context, we all want quality outcomes in pharmaceutical manufacturing facilities. Good manufacturing practices will provide safe products to patients, prevent injury to workers, and minimize or eliminate plant shutdowns, which can ultimately lead to drug shortages. Guy Villax, CEO of CMO Hovione, believes the FDA and other regulatory agencies have many tools at their disposal that can be used to hit manufacturers for poor quality practices. In the future, he would like to see the oversight agencies make more use of carrots to get manufacturers producing to the standards that would benefit the entire industry.
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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.