ARTICLES BY ED MISETA

• COVID-19 & The Virtual Trial Rush: Front-Line Insights

  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.

• Using The Cost Of Adverse Events To Determine Drug Safety

  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.

• Is The Pharma Industry Really An Enemy?

  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.

• Is The Orphan Drug Act Hurting The Patient Population?

  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. 

• TransCelerate Moves Forward With Electronic Label Initiative

  TransCelerate BioPharma has announced an innovative electronic labels (e-labels) information channel to support its member companies. The initiative will work to enhance label usefulness for patients, while providing more consistent labeling approaches for sites. The initiative offers the potential to reduce clinical labeling timelines in the investigational supply chain and create cost efficiencies for pharma companies.  

• To Hear The Voice of the Patient, Create An Advocacy Department

  Lori Abrams, head of advocacy, diversity and patient engagement for Global Development Operations at BMS, had to build a department and recruit personnel to form a group that would ensure the voice of the patient is included in the design and execution of trials.

• Opdivo And Praluent Expected To Lead The Class Of 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.

• When Measuring Clinical Quality, Beware Of The Metrics Trap

  When discussing the topic of measuring quality in clinical trials, Mike Howley advises sponsors and CROs not to place too much focus on metrics. 

• 21st Century Cures Gets Closer To Revolutionizing The Pharma Industry

  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 21^st Century cures initiative last year, I felt it was something the industry needed.

• Will The State Of New York Stifle Pharma Innovation?

  An anti-trust lawsuit is pending in the U.S. Court of Appeals for the Second Circuit that could have an impact on the ability of a pharmaceutical company to innovate and invest in medicines they think will best serve patient needs.