The Bio Report

How Biomarkers Can Alter the View of and Approach to Alzheimer’s Disease

By the time signs of Alzheimer’s disease manifests in the form of memory problems, behaviorial changes, or loss of executive function, years of irreversible damage to the brain has already occurred. In the latest annual report from the Alzheimer’s Association, the organization looks at the potential for biomarkers to diagnose the disease at its earliest appearance and allow for treatments to hold the disease in check. We spoke to Heather Snyder, senior director of medical and scientific operations for the Alzheimer’s Association about the report, where efforts to validate biomarkers of early-stage Alzhimer’s disease stand, and why this holds the potential to change the way Alzheimer’s disease is viewed and treated much in the way diagnostic tools have turned heart disease into a chronic condition.

The Fight for Personalized Medicine Wages on Many Fronts

The Personalized Medicine Coalition’s recently issued its 2017 report on the opportunities and challenges for the industry. Chris Wells, communications director for the organization, will be kicking off The 4th Annual Business of Personalized Medicine Summit in South San Francisco March 28, drawing from the new report to discuss trends and the pace of advances. We spoke to Wells about the state of personalized medicine, the obstacles to greater clinical adoption, and what the growing legislative battles in Washington will mean for the industry.

Big Pharma and the Growth and Outlook for Orphan Drugs

Orphan drugs, therapeutics that target small patient populations, have become an enticing area for Big Pharma as companies are attracted to the premium prices, lower development costs, and faster path to market. A new EvaluatePharma report on the Orphan Drug market forecasts a compounded annual sales growth rate of more than 11 percent through 2022 with orphan drug accounting more than 20 percent of total worldwide prescription sales by then. We spoke to Jon Gardner, U.S. editor for EP Vantage, about the growth of orphan drugs, what’s driving the sector, and whether the way the industry is taking advantage of the Orphan Drug Act will cause policymakers to push back.

What the Recent Patent Ruling Means for the Future of Gene-Editing Technology

The Broad Institute has emerged victorious in a battle with researchers at the University of California, Berkeley over patents covering breakthrough gene-editing technology that allows scientists to easily and inexpensively alter genetic material with precision. Last month, the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office ruled that patents held by the Broad Institute relating to certain aspects of CRISPR-Cas9 gene editing did not interfere with those being sought by UC Berkeley researchers. We spoke to Kevin Noonan, Partner and Chair of the Biotechnology & Pharmaceuticals Practice Group of McDonnell Boehnen Hulbert & Berghoff and founding author of the Patent Docs blog, about the decision, what it means, and to what extent it resolves patent issues regarding the gene-editing technology.

Weighing What Limits Should Be Put on Gene Editing

Earlier this month the National Academy of Sciences and the National Academy of Medicine issued a report that considered the scientific, ethical, and governance issues surrounding human genome editing. The report comes as new gene editing technologies have reduced the cost and increased the ease of manipulating the human genome. We spoke to Alta Charo, co-chair of the study committee that wrote the report and professor of Law and Bioethics at University of Wisconsin-Madison, about the study, the potential for this science, and where the committee thought limits should be imposed.

Enlisting the Immune System in the War on Cancer

The emergence of cancer immunotherapies, drugs that activate and enlist the immune system to fight cancer, has emerged as a promising approach to combat the disease in its many forms. Lawrence Fong, co-leader for the Cancer Immunotherapy Program at the University of California, San Francisco, stands at the intersection of several initiatives involving UCSF to better understand the immune system’s response to cancer and develop more effective drugs in the battle against it. We spoke to Fong about the potential of immunotherapies, the various efforts underway at UCSF, and what we known and don’t know about the immune system.

Why Scientists Must Also Be Advocates

The start of Trump administration, a new cabinet, and a new Congress are raising concerns within the scientific community about how the changes in Washington will affect the health of science and innovation in the United States. At issue is not only funding for research, but a range of policy decisions relating to everything from public health to climate change that some fear will not be informed by science. We spoke to Mary Woolley, president of Research!America, about the new administration, why it is critical for scientists to become advocates, and the planned March for Science in Washington, D.C. this April.

Sernova Eyes Range of Disease for Implantable Cell Technology

For a number of diseases that require chronic administration of a substance naturally produced by the body, patients may have to rely on regular injections or infusions. Sernova is working to free patients from these types of regimes with it combination device and cell therapy that implants a pouch that contains living cells that produce the missing hormone, factor or other substance. We spoke to Phil Toleikis, CEO of Sernvoa, about its technology, the challenges involved in such an approach, and the company’s initial focus on diabetes and hemophilia.