Ed Miseta - Chief Editor, Clinical Leader & Outsourced Pharma
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..
Lilly Slams The Brakes On New Clinical Trial Activity
Conducting clinical trials during the COVID-19 pandemic is no easy task. Recognizing this unfortunate change in events caused by COVID-19, Eli Lilly and Company has made the difficult decision to delay most new clinical study starts and pause enrollment in most ongoing studies. Continue Reading..
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. Continue Reading..
A Small Biopharma That Doesn’t Use CROs
When it comes to conducting clinical trials, most emerging companies choose to access external resources through partnering with CROs. That is what makes Martin Lehr, CEO of Context Therapeutics different. He prefers to bypass CROs and take part in Investigator-Sponsored Trials (ISTs). Continue Reading..
Patient Diversity Starts With Community Connections
When it comes to clinical trials, the pharmaceutical industry still has a patient diversity problem. The face of patients in clinical trials is not representative of the face of America or the individuals projected to be most in need of the medications being developed. Continue Reading..
Technology Advancements Spur Adoption Of Virtual Trials
Virtual trials have been around for years, so why are they still met with skepticism? Clinical trial executives from Janssen and Astellas weigh in on this hot topic for 2020. Continue Reading..
What Exactly Is A Virtual Clinical Trial?
Oracle Health Sciences and the CNS Summit have released a research report on the use of virtual components (patient-facing technologies) in clinical trials. The findings are the result of focus group interviews and supplementary research with key stakeholders involved with clinical trials. Continue Reading..