Ed Miseta - Chief Editor, Clinical Leader & Outsourced Pharma
Research Report Shows Phase II/III Spending Will Increase
Research firm Industry Standard Research recently published its Phase II/III Study Trends and Market Outlook report. The goal of this report is to provide readers with a high-level view of the Phase II/III clinical development space to illustrate current market dynamics and inform strategic planning. Continue Reading..
AI And Machine Learning Prepare Pharma For The Data Onslaught
When I reached out to several clinical executives in my network for their thoughts on trends that will impact trials in the coming year, the two mentioned most frequently were AI and decentralized trials. Continue Reading..
Pets, Perseverance, And Manufacturing Facility Bring Biotech Success
Patricia Lawman, cofounder and CEO of the biotech firm Morphogenesis, explains the company’s unlikely genesis and different approach to animal testing. Continue Reading..
How Flexion Pivoted To Become A Commercial Biotech
Unfortunately, Flexion’s incorporation coincided with the financial crisis of 2007-2008, and the assumption that large pharma’s would pay premiums for successful proof of concept assets came under pressure. Continue Reading..
The Benefits & Challenges Of Head-To-Head Trials
In Lilly’s immunology portfolio, eight different H2H clinical trials have been conducted thus far. Four of those trials were conducted in parallel with a Phase 3 trial and four were conducted after it. Although the benefits are attractive to a sponsor company, H2H trials can present some unique risks. Continue Reading..
A Quick Transition From Research Firm To Clinical-Phase Biotech
Since Oct. 2018, Anne Whitaker had to figure out how to transition Aerami Therapeutics from a research firm to a clinical-phase company. It’s been a complicated and challenging journey. Continue Reading..
DIA And CRO Leadership Awards Go Virtual
The team behind DIA’s Annual Meeting was able to put together an event that was as informative and engaging as past years, despite the short and very hectic time frame. More than 200 sessions took place virtually, with 120 of those being on demand. Continue Reading..
Why Is Antibiotic Development In The U.S. Disappearing?
Today, 95 percent of antibiotics in development are being studied by smaller biotechs, including Paratek Pharmaceuticals. Today, the company is on a strong trajectory, but its ups and downs show why antibiotic companies fail and few new antibiotics reach patients. Continue Reading..
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. Continue Reading..