The Bio Report

Ten years ago, a group of San Francisco State University alumni working at Genentech got together with the Michael Goldman, the university’s chairman of the biology department, to establish the school’s annual Personalized Medicine Conference. This year, the conference will revisit topics from its past ten years as well as exploring the future of personalized medicine ask speakers to reflect on how personalized medicine has changed their lives. We spoke to SF State’s Goldman and Dan Maher, one of the alumni who drove the creation of the conference, about the state of personalized medicine, the pace of advances, and what’s surprised them most about where we are today.

The promise of precision medicine to provide more effective and safer cancer therapies that target the genetics driving each patient’s disease has been hindered by the lack of understanding of the specific genetic alterations underlying many cancers. Elana Fertig thinks math can solve that problem. Fertig, with a nod to the algorithm Netflix uses to help recommend movies users might like, is working to identify the genes that drive an individual’s cancer. Fertig, assistant professor of Oncology Biostatistics and Bioinformatics at Johns Hopkins Kimmel Cancer Center, discussed the proliferation of genetic data relating to cancer, how researchers may be able to capitalize on that, and how such an approach may also bring a new understanding of why patients suffer relapses and develop resistance to cancer therapies.

For anyone who has ever sought to find the price of healthcare services before obtaining them it will come as little surprise that information is not readily available. A recent study from Public Agenda, with support from the Robert Wood Johnson Foundation and the New York State Health Foundation, set out to find how Americans seek and use healthcare price information. We spoke to David Schleifer Director of Research for Public Agenda about what extent healthcare consumers seek price information, the implications of having a system with little price transparency, and what can be done to fix the problem.

As the Trump Administration calls for significant increases in military spending, it is also seeking steep cuts to the National Institutes of Health, the Centers for Disease Control and Prevention and programs used to address issues of global health. Michael Osterholm director of the Center for Infectious Disease Research and Policy at the University of Minnesota, in a recent op-ed in The New York Times argues that issues such as vaccine development, the need to combat antibiotic resistance, and respond to new infectious disease outbreaks are fundamental issues of national security. We spoke to Osterholm about global trends fueling the threat of infectious disease, the dangers of proposed budget cuts, and why the administration needs to invest in new ways to respond to the threats we face.

Recent mumps outbreaks are raising questions about strategies to combat the spread of the virus. One issue of concern is that the current vaccine is designed to protect against a different strain of the virus than the one that is sparking the outbreaks. Though the vaccine can help prevent some people from getting the disease or minimize its effects, the outbreaks have raised questions about whether a new vaccine is needed. We spoke to Stanley Plotkin, an expert on vaccines and a member of the editorial board of the journal Clinical and Vaccine Immunology, about what’s driving the outbreak, whether boosters can adequately address the problem, and why developing a new vaccine is not an easy solution to the problem.

The landmark legislation known as the Genetic Information Nondiscrimination Act of 2008, or GINA, anticipated growing concerns about genetic privacy, although it left much work undone. Now, though, as genetic information proliferates, proposed legislation would weaken protections by allowing employers to compel employees to share their genetic information in workplace wellness programs. Though voluntary, those who choose not to share this information could face thousands of dollars more for health insurance, according to reports. We spoke to Jeremy Gruber, past president of the Council for Responsible Genetics and someone credited with helping enact GINA, about the proposed legislation, what more needs to be done to protect genetic information, and how to best balance privacy concerns with the opportunities to leverage genetic data to better understand health and wellness.

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 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.

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.

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.

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.

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.

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.

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.

Telehealth, which encompasses an array of technologies to deliver healthcare, is a rapidly growing area. Stratus Video, a language services company, is making a push into telehealth where it sees a big opportunity to leverage its expertise and apply it to healthcare. We spoke to Lee Horner, president of the Stratus Telemedicine division, about telehealth trends, how its altering the practice of medicine, and whether it can deliver on the promise of improving care while reducing costs.

Drug discovery and development is a slow and costly process, but the Regeneron Genetics Center represents a drugmakers’ bet that harnessing large amounts of genetic data can point the way to better targets, greater success rates, and ultimately better drugs. We spoke to Aris Baras, vice president and head of the Regeneron Genetics Center ahead of the Precision Medicine World Conference 2017 in Silicon Valley about how large genetic studies are brining fundamental change to the drug development process, the approach Regeneron is taking, and why its becoming a necessary element of drug development today.

Last year, KemPharm was on its way to winning an FDA approval for its opioid Apadaz designed to deter users from snorting, injecting, or otherwise abusing it. But the regulatory agency stymied the company’s efforts when it declined to label it as an abuse-deterrent opioid. Apadaz is a prodrug that is converted to its active form through an enzyme present in the intestinal tract that releases the hydrocodone in it. The decision sent shares in KemPharm tumbling. Now, as the company works to resolve regulatory issues around Apadaz, it’s moving forward with the rest of its prodrug pipeline. We spoke to KemPharm CEO Travis Mickle about abuse-deterrence, the ongoing discussion with the FDA, the company’s prodrug pipeline.

In the realm of mental health, a lack of biologic measures for diagnosing and treating patients has at times made this an area where doctor’s subjective decisions can play a disproportionate role. Ehave is seeking to improve diagnosis and treatment of patients with its data-rich management, assessment, and remediation tools that sit on its cloud-based software platform. The company’s initial product focuses on ADHD, although it plans to roll-out other applications in the future. We spoke to Prateek Dwivedi, CEO of Ehave, about its platform, the problems the company is trying to address, and how digital technologies are changing the way doctors diagnose, treat, and interact with patients.

With 2016 drawing to a close and the biotech industry gearing up for the annual JPMorgan Healthcare Conference in San Francisco, we continued our holiday tradition of checking in with Adam Feuerstein, senior columnist for TheStreet. We spoke to Feuerstein about the year in biotech that was, the winners and losers of 2016, and what to look for at the JPMorgan Healthcare Conference and beyond.

While there has been much buzz in the industry over the potential for harnessing the microbiome and using it as a way to treat disease, it remains early days for the therapeutic pipeline. Rebiotix, which is delivering human-derived microbes to treat recurrent Clostridium difficile infections, is ready to move its lead experimental therapeutic into late-stage clinical testing. The company says it is the most advanced human clinical program evaluating a microbiota-based drug conducted in coordination with a regulatory authority. We spoke to Lee Jones, founder and CEO of Rebiotix, about the microbiome, the opportunity for drugs targeting the colonies of bacteria in the gut, and the indications beyond c. diff Rebiotix is pursuing.