When preparing for a large Phase 3 trial, many small companies may need a Big Pharma partner to help them through the process. But how do you connect with large companies? And what are the best practices for working with them? A panel at the 2018 Clinical Leader Forum in Philadelphia attempted to bring some clarity to those questions.
On March 1, 2018, the Partners in Innovation, Education, and Research Consortium™ (PIER) became an LLC in the State of Delaware. The six founding members of PIER (Jefferson Health, Atlantic Health System, Drexel University, Einstein Healthcare Network, Geisinger Health System, and Main Line Health) hope to bring efficiencies and cost reductions to clinical research.
Nicole Gularte is currently battling cancer for the 8th time. The last time she had to do so, it seemed a CAR-T cell therapy trial might be the solution. This article is about her long battle with cancer, the struggle to get into a CAR-T cell trial, and the ups and downs she has faced along the way. Her story is an inspiration to others.
For researchers hoping to conduct clinical trials on cannabis-based products, the U.S. is not the most hospitable place. While other countries are legalizing the drug and conducting research on its possible medicinal uses, state and federal regulations on marijuana in the U.S. continue to stymie its use.
Syneos Health has released the results of a study conducted to gather real-world patient insights into the effectiveness of digital advertising to assist with clinical trial recruitment.
Everyone would like to have a quicker study start-up process. In many companies the process and the paperwork have not changed for decades, and the process is always time-consuming. Here is one company’s journey to a study start-up solution.
When Bruce Gillis, CEO of EpicGenetics, decided to look into fibromyalgia, he drew blood from 17 patients and analyzed 35 different immune system factors. When compared to a control group, he was astounded by the results. There was a huge disparity between the immune system markers for the 17 patients and those of the control group. That launched his quest for a cure.
Oftentimes, patients with rare diseases suffer from a myriad of complex symptoms. Unfortunately, given this complexity, rare diseases are not well understood by most general physicians. “With rare diseases, we do not have hundreds or thousands of physicians who are experienced in treating these diseases,” says Dr. Pushkal Garg, Chief Medical Officer at Alnylam Pharmaceuticals. To bring forward meaningful advances for the care of these patients, we must personally speak and listen to them and aggressively integrate their insights.”
For patients with sickle cell anemia, just getting through the day can be a struggle. Symptoms of the disease include vision problems, swelling of the hands and feet, and periodic episodes of pain that can last from a few hours to a few weeks. In this article Nick Leschly, CEO at bluebird bio, discusses the progress being made with its investigational gene therapy for sickle cell disease.
Poll results show that 24 million sexually active American women (55 percent) currently use no birth control method, yet these women have an 85 percent risk of becoming pregnant within one year. Additionally, of those American women who use birth control, about 8 million1 (36 percent) would prefer non-hormonal birth control. If successful in two clinical trials, Evofem’s Amphora product could transform birth control.
