There is a large and growing unmet medical need in the U.S. for patients with Alzheimer’s disease and their care givers. A March 2018 article on Forbes notes there are now 5.7 million Americans living with Alzheimer’s due to the aging baby boomer population. The cost of caring for them has now hit $277 billion.
If you were ready to begin clinical testing on a new molecule but discovered you already had an improved version of the drug in development, would you move forward with the program or delay the Phase 1 trial by more than 12 months? That is a decision Samantha Cobb, CEO of AdAlta, had to make. Her decision centered on the well-being of patients.
Why is it so hard to develop drugs for children with cancer? And what can be done about it? Those questions are central to a new study published in JAMA Oncology that explores new business models for funding drug development to treat pediatric cancers.
Sudip Parikh, SVP & managing director, Americas at DIA Global, sees two trends that will continue to have a profound impact on potentially powerful new treatments and the clinical trials that make them possible. Both will be front and center at DIA’s 2018 Annual Meeting.
The concept of extrapolation has been in existence for years at the FDA. Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer of the Neurology Business Group at Eisai, is excited about the current use of extrapolation in monotherapies. The FDA approval of FYCOMPA as a monotherapy for epilepsy patients was based on data extrapolation.
Ron Squarer believes for a company to be successful, especially in a capital-intensive area such as biotechnology, it has to know what it is good at and target those skills. Squarer is the CEO of Array BioPharma, a company focused on the discovery, development, and commercialization of targeted, small-molecule drugs to treat patients with cancer.
Getting drugs to cross the blood-brain barrier can be a challenge for sponsor companies. Kazia Therapeutics is working on a treatment for glioblastoma, the most common and aggressive form of brain cancer. Kazia will use an adaptive approach in a Phase 2 trial using a product which was designed by Genentech to cross the blood-brain barrier.
One area of patient centricity that might be getting overlooked is patient reimbursement. When patients travel to clinical sites for treatment, how much of their own money are they required to shell out? Are they being promised reimbursement for those expenses? And, if so, how long is it generally taking for them to receive the funds?
Should all pharma companies be conducting patient surveys? What questions should they be asking? Should common questions be asked for the purpose of benchmarking? A meeting was held last fall to answer those questions and determine the right path forward.
Six leading CROs, along with cloud-computing vendor Veeva Systems, have banded together to form Align Clinical CRO, a new industry standards group that hopes to make it easier for CROs and sponsors to work together. But Align Clinical CRO is not the first attempt to bring standards to the information discrepancies that arise between sponsors and CROs during clinical trials.
