ARTICLES BY ED MISETA
Pharma’s Investment In RWE Is Beginning To Pay Off
For years the life sciences industry has heard about the benefits of investing in real-world evidence (RWE) and real-world data (RWD). According to a recent report from Deloitte, that investment may finally be paying off for companies that climbed onboard and have been building those capabilities.
The First Controlled Clinical Trial For A CRISPR Enhanced Bacteriophage Therapy
Several companies are working on bacteriophage therapies, using natural bacteriophage isolated from the environment. Those treatments use the cell’s machinery to create new virus particles that burst out of the cell, killing it in the process and infecting other cells. Locus Biosciences has demonstrated that the CRISPR-Cas3 mechanism makes crPhage significantly more effective at killing target bacteria than their natural counterparts.
Janssen Study Shows How To Create Patient Diversity In Trials
Patient diversity is a problem that exists in clinical trials. Participants across all therapeutic areas have tended to be Caucasian and male. With the FDA now pressuring pharma companies to run trials with patients who better resemble the overall population, a scramble is on to make trials more diverse.
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.
Virtual DIA 2020: Regulators, Patients, Technology, And Networking
COVID-19 has disrupted lives around the world. The trade show industry, which has been critical to knowledge sharing, networking, and relationship-building has also been significantly impacted by travel restrictions and responsible social distancing practices. Even the DIA Global Annual Meeting, the largest industry gathering in the clinical and regulatory space, has announced it will be a virtual event.
Regeneron’s COVID-19 Trial Reaches Patients In 5 Days
AdventHealth’s most serious COVID-19 patients were in the ICU and needed immediate help. When it learned about a clinical trial being conducted by Regeneron Pharmaceuticals, it acted quickly. “We were able to get this trial up and running in a record period of time,” states Dr. Steven Smith. “We signed the documents with Regeneron and were administering the drug to our patients in less than five days.”
The (Almost) Insurmountable Recruitment Challenges Of Antibiotic Clinical Trials
Clinical trials are difficult. Every clinical executive I interview can rattle off a list of challenges they face and how they are attempting to overcome them. Still, anyone who thinks they have it tough conducting trials should pause and have a moment of reflection for those companies fighting to stay afloat in the challenging area of antibiotics.
A Biopharma That Had To Pivot Twice To Forge Ahead
Not many thriving companies experience disappointing clinical trial results, jump into an entirely new therapeutic area, and emerge with investor support and renewed hope for an entirely different class of patients. Millendo has done it twice.
COVID-19 Presents Unique Challenges For Oncology Trials
With the COVID-19 pandemic hitting countries around the world, many sponsor companies and sites are scrambling to implement remote monitoring solutions to protect their patients while not disrupting the data collection process. Unfortunately, for oncology patients, some of these technologies are not an option.
Post COVID-19: Clinical Trials Will Never Be The Same
FDA guidance on protecting the safety of patients suddenly has sponsors scrambling for technologies that will allow them to gather patient data without having them travel to hospitals and clinics. Many companies are also contacting IRBs for guidance on modifying protocols to better accommodate patients. I took this opportunity to speak with Donald Deieso, Ph.D., chairman and CEO of WCG, to discuss the current state of clinical trials, and where we can expect the industry to go from here.