Gene therapy development is a complex endeavor, with evolving regulations and complicated study logistics. In this article, Premier Research and Premier Consulting explore the regulatory and clinical trial landscape for gene therapy trials and offer strategies for successfully negotiating the challenges of executing these studies.

The Biden administration wants to expand a federal COVID-19 tracking system created during the pandemic to provide a more detailed view of how respiratory and other infectious diseases are affecting patients and hospital resources, according to a draft of proposed rules reviewed by Reuters.

Patient groups mounted a public pressure campaign aimed at persuading the U.S. government to loosen proposed restrictions on new Alzheimer’s treatments, spending millions of dollars on television and local advertisements that began running during the March 13 morning political shows.

BrandShield, together with the Pharmaceutical Security Institute, announced its findings following a disruption program carried out from December 2020 to November 2021 involving the monitoring, detecting and removal of online threats. 

Hybrid versions of the coronavirus that combine genes from the Delta and Omicron variants – dubbed “Deltacron” – have been identified in at least 17 patients in the United States and Europe, researchers said. Additionally, new research adds to evidence that trained dogs could help screen crowds to identify people infected with the coronavirus.

As the health industry rapidly shifts to more patient-centric approaches to care and clinical research, technology is just as quickly becoming the cornerstone to effectively engage clinical study participants. Electronic clinical outcome assessments (eCOAs) are essential to ensuring that each clinical trial is optimized for the patient’s experience by being faster, more on-demand, and more customizable. Kris Gustafson – Vice President and Global Head IQVIA eCOA, IQVIA – discusses three key reasons to implement an eCOA strategy for clinical trials.

Atlas Venture successfully raised $450 million at the close of the venture capital firm’s thirteenth fundraising activity to support efforts to create and invest in new biotech firms that address many unmet patient needs. 

Drew Desjardins, Avalere Health

Historically, therapies focusing on niche markets face tremendous obstacles, from drug development and clinical trials to drug access. Drew Desjardins – EVP, Chief Strategy Officer, Fishawack Health – analyzes several key challenges for brand marketers readying to launch products in these small markets, along with solutions for driving better stakeholder experiences.  

Rare Patient Voice LLC, a leading patient recruitment firm, and MediFind, an advanced digital health platform helping people facing complex health challenges find better care, faster, published a report examining the current state of the diagnostic odyssey for patients with complex diseases during these times of global health issues.

Poor medication adherence tends to be a matter of people not taking their medicine as prescribed, due to access barriers. So how can placing an additional burden on patients be the answer?