Virtual trials are growing in acceptance. The patient-centric aspect of these trials makes them easier to recruit and retain patients and accelerate timelines, while also providing patient data to researchers in real time. But will virtual trials also mean the end of CROs?
Abeona Therapeutics is developing investigational gene and cell therapies for people living with serious and rare diseases. Last year, Abeona held a ribbon-cutting ceremony to celebrate the groundbreaking of a manufacturing facility that is one year later producing gene therapy material for their clinical and pre-clinical programs. As is the norm with gene therapy, Abeona uses a virus as vehicles to deliver functional copies of defective genes.
Artificial Intelligence (AI) is finally making its way into the realm of clinical trials, but not without challenges that need to be overcome. In part two of this roundtable discussion on AI, our experts examine some of the challenges arising, operationalizing AI at the point of care, and the barriers that must continue to be overcome.
Artificial Intelligence (AI) is making its way into the realm of clinical trials. While most of the talk I hear seems to center on clinical trial recruitment and using AI to mine electronic medical records (EHRs), that application seems to only scratch the surface. Experts predict monitoring drug adherence, pre-emptive risk monitoring, decision-making, diagnostics, and process optimization are other areas where the technology is expected to make an impact.
DIA’s Inspire Awards have grown every year that Barbara Lopez Kunz, global chief executive for DIA, has been with the organization. Kunz, who has been with DIA since 2013, notes it has become the place to be for attendees travelling to the annual meeting.
If you work in clinical operations, you’re probably aware of how closely that function must work with manufacturing. There are numerous decisions that have to be made around clinical packaging, interactive response technology (IRT) software, labeling of the clinical supplies, and the actual logistics of getting the supplies to the right place at the right time.
Thirty years ago, patient recruitment was a challenge for pharma companies. Today the patient participation rate in trials still hovers around five percent and is not expected to improve anytime soon. Patient recruitment remains a challenge that pharma must work to overcome.
The Alzheimer’s disease space is not an easy one for pharma companies to navigate. In 2018 alone, Lundbeck, Takeda, Merck, Janssen, AstraZeneca, and Eli Lilly and Company all faced setbacks or poor trial results. Unfortunately, few spaces in the life sciences have fathered failure to the extent that experimental Alzheimer’s drugs have.
In March 2019, Genentech announced the submission of a New Drug Application (NDA) to the U.S. FDA for Venclexta in combination with Gazyva. The combination therapy is for people with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions.
Albireo Pharma is a clinical-stage biopharmaceutical company that was launched in 2008. One of the company’s more promising assets, A4250, is a novel bile acid modulator that has been in development for rare cholestatic liver diseases. The product, which acts locally in the gut, can effectively drain excess bile acids that get stuck in a patient’s liver. In conducting trials with pediatric patients in this space, Albireo faces four challenges common to developers of pediatric rare disease drugs.