March 2015

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FDA Commissioner Hamburg Addresses Budget and Medical Innovation

FDA Commissioner Dr. Margaret Hamburg did double duty in March, testifying before committees in both the House of Representatives and the U.S. Senate. On March 4 she spoke before the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration on FDA’s FY 2016 Annual Budget.  The agency has requested $4.9 billion to support essential functions and priority needs. To see her testimony, please go here.  On March 10 she addressed the Senate’s Committee on Health, Education, Labor, and Pensions about “Continuing America’s Leadership in Medical Innovation for Patients.” Throughout the hearing, Commissioner Hamburg referenced challenges in clinical trials for Alzheimer’s disease. To see her address, please go here

FDA to Hold Workshops on Endpoints and Regulatory Science

The FDA is holding two events of interest over the next few weeks.

The first is a workshop titled “Clinical Outcomes Assessment Development and Implementation: Opportunities and Challenges.” It will provide updates on “accomplishments, challenges, and ongoing efforts in the use of clinical outcome assessments (COAs), and plan for the future of COA development and utilization in drug development programs, including how to incorporate the patient voice in drug development using well-defined and reliable patient-centered outcome measures.” This workshop will be held on April 1 in Silver Spring, Md.  Go here for more information.The next workshop, “The 2015 Office of Regulatory Science and Innovation (ORSI) Science Symposium,” is intended to “increase scientific collaborations with government institutions, academia, industry and other stakeholders, working to improve science, training, and networking in accordance with the FDA mission of the advancement of regulatory science.”  It will be held in on April 27 in Silver Spring, Md.  More details can be found here.

U.K. Government Announces Creation of Dementia Discovery Fund

The British government has announced the formation of the Dementia Discovery Fund to support innovative research to help find new ways to prevent and treat dementia and Alzheimer’s disease. The fund has initial commitments of close to $100 million, including support from GlaxoSmithKline, Johnson & Johnson, Biogen Idec, Eli Lilly, and Pfizer. To find out more about the fund, go here.

Simple Blood Test Could Detect Beta Amyloid Proteins, Say Experts

Experts at UCLA have announced in an article in the journal Neurology that they have the first evidence that development of a simple blood test could provide confirmation of beta amyloid proteins in the brain. According to the researchers, blood-based biomarkers offer an advantage because they are “safe, affordable, and easy to administer in large groups.”  Currently no reliable blood-based test exists. Go here for more information.

16-Year-Old’s Alzheimer’s Device Featured at White House Science Fair

The annual White House Science Fair held on March 23 featured some amazing inventions from young scientists and engineers throughout the country. One inventor of note was 16-year-old Kenneth Shinozuka.  His grandfather has Alzheimer’s and is prone to leaving his bed and wandering at night. Kenneth developed a sensor device that detects when his grandfather leaves his bed; the device then sends an alert to a caregiver’s smartphone. We congratulate Kenneth on both his invention and his invitation to the fair. You can learn more here.

New Novel Approach to Treating Inherited Alzheimer’s Explored by Experts

New research offers promise of a novel approach for developing drugs to treat inherited Alzheimer’s. Experts replaced normal presenilin-1 genes in mice with Alzheimer’s-causing versions of the human gene to investigate how genetic changes may lead to the disorder.  They had some surprising findings. “This study is the first example of a mouse model in which a familial Alzheimer’s mutation is sufficient to cause neurodegeneration. The new model provides an opportunity that we hope will help with the development of therapies focusing on the devastating neurodegenerative changes that occur in the disease,” said Dr. Raymond Kelleher, a co-leader of the study.  See the study in the journal Neuron.

Website Offers Comprehensive Info for Alzheimer’s Prevention Research

A website hosted by the Global Aging Research Network offers valuable information for those focused on Alzheimer’s prevention research.  It contains regular updates on scientific literature, funding opportunities, and important research outcomes. We invite you to check out the website here.