
The Bio Report
629 episodes — Page 10 of 13

How Surveillance and Data Are Bringing Precision to the Treatment of Prostate Cancer
The development of a biomarker to identify people with prostate cancer increased the diagnosis of the disease, but did little to suggest the appropriate course of treatment for individual patients. Kenneth Pienta, professor of urology and co-director of the Johns Hopkins University InHealth Signature Initiative, is trying to change that by using surveillance and extensive data gathering to continuously stratify patients and refine treatment approaches. Pienta, who will be speaking at the Precision Medicine World Conference in Mountain View, California January 22 to 24, discussed InHealth, how its transforming the treatment of prostate cancer patients, and why it may be a model for applying precision medicine approaches to a broad range of diseases.

Why Life Sciences M&A Should Heat up This Year
A surge in merger and acquisition activity in the life sciences is expected this year, according to a new report from EY. The company annual M&A Firepower Report says increased competition, new sources of capital, and the change in U.S. corporate tax laws will drive greater dealmaking in the sector. We spoke to Jeff Greene, EY global life sciences transaction advisory services leader, about the report, the drivers of the activity, and why nontraditional players in the sector may be in a better position to make a splash in 2018.

The Outlook for Biotech in 2018
We conclude our biotech review-preview series with our final installment this week as we take a look at the year ahead as the industry readies for the JPMorgan Healthcare Conference. We spoke to Jon Gardner, U.S. News Editor for EP Vantage, about the EP Vantage 2018 Preview(http://bit.ly/2CT2RDP), the outlook for big-value drug launches, and whether dealmaking or clinical success will drive stock prices in 2018. As a note, this podcast was recorded prior to Spark Therapeutics announcement of its pricing for its gene therapy Luxturna.

The Year in Biotech and What to Watch in 2018
In the second installment of our three-part review-preview series of podcasts, we continue an annual tradition by sitting down with Adam Feuerstein, senior biotech writer for STAT, to discuss the year that was in biotech and what to look for in 2018. We talked to Feuerstein about the themes that emerged in 2017, his annual best and worst biotech CEOs, and what he’ll be watching at JPMorgan and beyond.

The Year in Immuno-Oncology and What to Watch in 2018
It’s that time of year when we begin to look back and think ahead. Starting with this week’s interview, we begin a three-part review-preview series to discuss the year in biotech and what to look for in 2018. In 2017, there were exciting developments in the area of immune-oncology with the approval of the first Car-T therapies and Gilead’s acquisition of Kite Pharma. As the year approached the finish line, investors got to view data from a range of studies at the American Society of Hematology meeting in Atlanta, setting the stage for 2018 when data from studies looking at combinations of immunotherapies will be closely watched. We spoke to Brad Loncar, CEO of Loncar investments, about the state of immunotherapies, what caught his attention at the ASH meeting, and what he’ll be watching in 2018.

What the Approval of the First Digital Pill Means for the Future of Healthcare
Last month Otsuka Pharmaceutical and Proteus Digital Health won U.S. Food and Drug Administration approval for what’s being hailed as the first digital pill. Abilify Mycite, a drug-device combination that marries Otsuka’s Abilify, used to treat schizophrenia, with Proteus’ ingestible sensor, wearable sensor, and smartphone app intended to monitor and improve compliance. We spoke to George Savage, chief medical officer of Proteus, about the technology, other potential uses, and how it may help address the quality and cost of healthcare.

Why Public Health Systems Need to Be Better Prepared for Extreme Weather Events
Climate change and the increasing frequency and intensity of extreme weather events carry a toll on human health. Not only do floods, hurricanes, and other similar phenomenon cause death and injury, they also create long-term health effects. Jesse Bell, a research scientist at the North Carolina Institute for Climate Studies at North Carolina State University recently examined the issues in an article in the Journal of the Air & Waste Management Association. We spoke to Bell about the health consequences of these weather events, the challenges they create for public health systems to plan and prepare, and why new research is needed to better understand the relationship between these events and human health.

Former CDC Director Takes on World’s Leading Cause of Death
Tom Frieden, after eights years of running the U.S. Centers for Disease Control and Prevention, is turning his sights to global health. Frieden has set a goal of saving 100 million lives from cardiovascular disease in low- and middle-income countries by applying proven strategies used in developed countries. His program Resolve to Save Lives, an initiative of Vital Strategies, will also work to prevent infectious disease epidemics and pandemics by strengthening public health systems in these nations. We spoke to Frieden about the initiative, whether strategies that worked in the developed world can be translated to low- and middle-income countries, and what it will take to be successful.

How a Public-Private Consortium Is Revolutionizing Cancer Drug Discovery
A public-private consortium is seeking to cut the time it takes to discover and advance new cancer therapies to the clinic to one year from the six years it takes on average today. Accelerating Therapeutics for Opportunities in Medicine, or ATOM, brings together scientists from government, academia, and industry with the ambitious goal of harnessing supercomputers to transform cancer drug discovery into a rapid process that can determine molecules that will be safe and effective before advancing them to human clinical trials. We spoke to Michelle Arkin, a member of ATOM and associate professor of pharmaceutical chemistry at the University of California, San Francisco’s school of Pharmacy, about the consortium, the approach its taking, and why it may alter the way therapies for a much broader range of diseases than cancer are developed.

How Faulty Thinking Can Derail Life Sciences M&A Deals
Merger and acquisitions may be a path to creating value for life science companies, but talks can breakdown because of flaws in management thinking that skew their sense of the value of their company. Oded Ben-Joseph, managing director of Outcome Capital, applied behavioral economics to the M&A front to discuss how cognitive biases can derail M&A transactions in an article in the September issue of In Vivo. We spoke to Ben-Joseph about cognitive biases, why the life sciences sector is particularly prone to the problem, and what executives can do to minimize their effects.

Targeting Drug-Resistant Bacteria with an Ancient Enemy
The growing problem of bacterial resistance to antibiotics represents a significant public health threat. That’s been made worse by the dearth of new therapies that have come to market. AmpliPhi Biosciences is developing bacteriophages, viruses that infect and kill bacteria, to provide a way to target drug-resistant bugs. We spoke to Paul Grint, CEO of AmpliPhi about the health need, AmpliPhi’s approach, and why harnessing these natural killers of bacteria may provide a promising source of new therapeutics.

A Bioelectronic Approach to Treating Autoimmune Diseases
Bioelectronic therapies are being developed to treat a number of conditions that currently can only be addressed using pharmaceutical interventions. Thync, a bioelectronics company, believes its technology that targets the cervical and thoracic spinal nerves to modulate the autonomic nervous system, can be used to treat variety of ailments including mental health, inflammatory disorders, and skin conditions. It points to a growing body of scientific literature that demonstrates the important role the nervous system plays in regulating the body’s immune response. We spoke to Thync CEO Isy Goldwasser about the technology, how it works, and why the company’s first clinical trial of it will be as a potential treatment for psoriasis.

Harnessing Patient Data to Improve Drug Development Efficiency
Despite the growing volume of electronic health records, they have so far left the recruitment of clinical trial patients, clinical trial designs, and site selection largely unchanged. The result is that drug companies are often designing clinical trials with gaps in information about the patient population they are serving, the medical issues these patients face, and where they can find them. This adds to the high cost and long timelines required to move an experimental therapy through clinical development. TriNetX is trying to address this problem through its health research platform that allows drug developers to analyze large amounts of patient data from healthcare organizations within its network. We spoke to Gadi Lachman, CEO of TriNetX, about its platform, how it works, and why he believes this could lead to more efficient drug development.

How Colorifix Is Trying to Turn the Textile Industry Green
Synthetic biology is promising to harness living organisms to replace industrial processes that rely on toxic chemicals, consume large amounts of energy and water, and leave environmental degradation in their wake. One such example of a company seeking to transform an industry in this way is Colorifix, which is developing a revolutionary dyeing process to help the textile industry dramatically reduce its environmental impact in a cost-effective way using a synthetic biology based approach. We spoke to Orr Yarkoni, founder and CEO of Colorifix, about the company, how it is using synthetic biology to change the process of dyeing materials, and why he expects it to change the environmental toll of the textile industry.

Targeting Patients as Sick as Dogs
Kindred Biosciences is looking to leverage the billions of dollars that others have invested in approved drugs by modifying, improving, and repurposing them for the animal market. The company believes it can formulate, develop, and win approval for these medicines for between $3 million and $5 million each in a matter of three to five years, and capture markets that range between $10 million and $100 million annually. We spoke to Richard Chin, founder and CEO of Kindred, about the business strategy, the company’s pipeline, and the opportunity created by our willingness to spend big money on our pets.

A Strategic Investor’s View of the Biotech Investment Landscape
When the BIO Investor Forum convenes in San Francisco October 17 and 18, a key point of discussion will be the availability of funding for emerging life sciences companies. One of the panelist addressing that issue this year will be Asish Xavier, vice president of venture investments for Johnson & Johnson Innovation’s venture arm JJDC. We spoke to Xavier about JJDC’s approach to investing as a strategic investor, the changing landscape for venture capital, and how competitive the environment is for access to compelling technologies today.

Bringing Gender Diversity into Biotech Boardrooms
In April 2016, the consulting firm LifeSci Advisors adopted a comprehensive action plan to advance gender diversity in the life sciences industry. It has partnered with Women in Bio and Girls Inc. of New York City to provide mentorship and advancement programs for women and girls in the STEM fields, started its own board diversity initiative, and created the LifeSci Advisory Board on Gender Diversity. We spoke to Michael Rice, LifeSci Advisors founding partner, about the state of gender diversity in biotech boardrooms, what the firm has been doing, and why it decided to focus its efforts there.

Why the FDA May Need to Rethink Its Approach to Gene and Cell Therapy
Regenerative medicine is rapidly moving from the lab to the clinic, but as life-saving therapies advance to the marketplace, there are questions about whether the U.S. Food and Drug Administration needs to modernize its regulatory approach to gene and cell therapies. We spoke to Michael Werner, executive director of the Alliance for Regenerative Medicine, about the state of the industry, the regulatory environment today, and whether it will ultimately be payers who are more demanding of data to convince them of the worth of a therapy.

VBL Targets Brain and other Cancers with Novel Immunotherapy
Glioblastoma is a devastating and fatal brain cancer that progresses rapidly. Median time from diagnosis to death is 12 to 15 months. In recurrent cases, treatment consists of both symptomatic and palliative therapies, but the disease remains fatal. VBL Therapeutics is developing a targeted anti-cancer gene-based therapy that is in late-stage testing for recurrent glioblastoma. We spoke to Dror Harats, CEO of VBL, about the therapy, how it works, and why it might be useful in treating a variety of cancers.

What Will It Take to Transform Healthcare to a System Focused on Prediction and Prevention
The promise of precision health is to transform a healthcare system that is today based on treating sickness to harnessing a range of technologies to predict and prevent illness. Health 2.0’s Technology for Precision Health Summit in San Francisco October 24 will explore the state of precision health and what’s needed to make it a reality. We spoke to Linda Molnar, chair of the summit, about precision health, what gaps in the healthcare continuum need to be addressed to create a healthcare system geared toward prediction and prevention, and how companies will make a business out of this.

Can a Direct Pitch to Patients Drive a Home Run for Obesity Drug
Winning regulatory approval for a drug to treat obesity would seem like a great accomplishment, but for Orexigen Therapeutics, that’s when the hard work began. After its marketing partner Takeda ended their agreement because of disappointing sales, the company found itself in the position of having to market a drug to doctors who often don’t consider obesity an illness and believe willpower and discipline, not a pill, is what’s needed. Orexigen’s solution centered on a novel approach. The company decided to make a pitch directly to patients and connect them to telehealth-based doctors, who could ensure use of the drug is appropriate and help them avoid the embarrassment they may feel when speaking to their own doctors. We spoke to Thomas Cannell, Chief Operating Officer and President of Global Commercial Products for Orexigen, about its obesity drug Contrave, its marketing strategy, and whether it represents a marketing model that others may follow.

Why Companies Across Industries Need to Develop a Bio Strategy
Though breakthroughs in the ability to read, write, and edit DNA have broad implications for healthcare, they are also fueling a far-reaching transformation of industries and laying the foundation for a new bioeconomy. The SynBioBeta conference, which has developed into a critical annual event for innovators and investors within the synthetic biology sector, will be held in San Francisco October 3 through October 5. We spoke to John Cumbers, founder of SynBioBeta, about trends within synthetic biology, key drivers and challenges for the sector, and why companies in all industries today need to begin crafting their own bio strategies.

Economist Argues Maximizing Shareholder Value Hurts Drug Innovation
The pharmaceutical industry has long argued that high drug prices are necessary to incentivize investment in and fund high-risk research and development of innovative new therapies. In a working paper published by the Institute for New Economic Thinking, William Lazonick, professor of Economics at the University of Massachusetts Lowell, and his colleagues challenge the industry’s premise. They argue that top pharmaceutical companies, spend more of their profits on buying back their shares to boost their stock prices than they do on R&D, a move that enriches senior executives. We spoke to Lazonick about the paper, why he believes this so-called financialized business model is counterproductive to innovation, and what steps he thinks are necessary to change the landscape.

Partnership Drives Development of Antibiotic to Combat Resistant Gonorrhea
Gonorrhea is a common sexually-transmitted infection, but the growth of an antibiotic-resistant strain of the disease is creating what the U.S. Centers for Disease Control and Prevention has called an urgent public health threat that requires aggressive action. Entasis Therapeutics is launching a pivotal study of Zoliflodacin, a new class of oral antibiotic that has demonstrated potent activity against resistant gonorrhea. The company last month entered into a novel partnership with the non-profit Global Antibiotic Research & Development Partnership to fund the pivotal trial and assure access to the drug in low- and middle-income countries if successful. We spoke to Manos Perros, CEO of Entasis, about Zoliflodacin, the partnership with GARDP, and whether it serves as a model for the development of a broader arsenal of new antibiotics.

CIRM-Funded Pipeline of Regenerative Therapies Advances
A number of clinical successes and the U.S. Food and Drug Administration’s granting of designations that provide accelerated pathways to experimental therapies speaks to the progress of research funded by the California Institute for Regenerative Medicine. We spoke to Kevin McCormack, senior director of public communications and patient advocate outreach for CIRM, about the growing pipeline of therapies, the changing regulatory environment, and whether the institute will have a future beyond its existing funding.

Technology Allows Drugmakers to Tag and Authenticate Individual Pills
The problem of counterfeit and falsified medicines is not just an economic problem for the pharmaceutical industry, but also a threat to public health. TruTag Technologies is seeking to address the problem with its nano-scale technology that allows drugmakers to encode information on individual doses of medication to authenticate a drug and provide details on its origin and intended market. We spoke to Barry McDonough, senior vice president of business development for TruTag, about the technology, how it works, and how it can address a global health concern.

Harnessing Mosquitoes to Fight the Spread of Infectious Disease
Mosquitoes are more than just pesky. Certain types of insect serve as efficient vectors for infectious diseases that pose great harm to humans. Oxitec, a subsidiary of Intrexon, has developed a genetically altered male of the Aedes aegypti mosquito designed to mate with wild females to produce offspring that die before becoming adults. The effort is meant to provide a highly targeted alternative to insecticides that are broad acting, can cause harm to humans and other animals, and may be unable to effectively reach their intended targets in urban environments. We spoke to Hadyn Parry, CEO of Oxitec, about how the company breeds billions of mosquitos that can’t reproduce, how it delivers them to where they are needed, and how the company is addressing the regulatory barriers to demonstrate its technology is safe and effective.

Biotech Industry Moves Towards a Patent Cliff
Scrutiny of drug prices around the globe is expected to exert growing pressure on the biopharmaceutical sector. EvaluatePharma, in its recently issued World Preview 2017, Outlook to 2022 says that despite consensus forecasts for worldwide drug sales hitting more than $1 trillion in 2022, it does reflect a drop from the same period last year. We spoke to Antonio Iervolino, head of forecasting for evaluate pharma, about the new report, the outlook for the sector and the potential for a new patent cliff with the advent of biosimilars.

PvP Takes a Unique Approach to Treating an Autoimmune Disease
Celiac disease, an autoimmune disorder that has helped to drive the gluten-free food craze, can carry serious complications. There’s no treatment for the disease, which afflicts an estimated 2.4 million people in the United States. PvP Biologics is taking a unique approach to treating celiac disease with its Kumamax, a synthetic enzyme that degrades the parts of gluten that trigger an immune response. We spoke to Adam Simpson, president and CEO of PvP Therapeutics, about the interesting history behind Kumamax, how it works, and why it will be the only drug PvP ever develops.

Uncertainty Hangs over the Biotech Sector
The lack of clarity over healthcare reform, changes to tax policy, and concerns about new pricing pressures are creating uncertainty over the future health of the biotech industry. EY, in its just released annual report on the industry, looks at the effect the growing uncertainty has had on the performance of the biotech companies and strategies for contending with what’s ahead. We spoke to Glen Giovannetti, Global Biotechnology Leader for EY, about the new Beyond Borders report, what the numbers tell us, and ongoing efforts for the industry to adapt to a healthcare world moving from volume to value.

What Others Can Learn from COI’s Approach to Cost-Efficient Drug Development
The high cost of drug development, the challenge of translational research, and continuing concerns with R&D efficiency has had entrepreneurs, investors, and drugmakers open to experimenting with new models of innovation. COI Pharmaceuticals, born out of a collaboration between the pharmaceutical giant GlaxoSmithKline and Avalon Ventures, is one such model that is showing traction. With management expertise, R&D infrastructure, and a collaborative environment, COI is providing promising startups with a way to accelerate their development in a capital efficient way. We spoke to Jay Lichter, president and CEO of COI Pharmaceuticals, about the COI model, the challenges of cost-effective innovation, and what can be learned from COI’s experience.

Dyadic Seek to Bring Disruptive Technology to Biomanufacturing
The production of biologics is costly and takes time. Dyadic International has developed a proprietary manufacturing process that replaces the use of Chinese hamster ovary cells, long used to produce protein therapeutics, with a fungus that has a long history in industrial biotechnology applications. The company believes its process can produce drugs faster, in greater volumes, and at significantly lower costs than biotech processes in use today. We spoke to Mark Emalfarb, CEO of Dyadic, about its manufacturing process, the benefits it could bring, and why it may have big implications for drugmakers.

Enlisting the Immune System in the Battle Against Alzheimer’s
Alzheimer’s disease is the sixth leading cause of death and it continues to rise. Today it is costing the U.S. healthcare system $200 billion a year and there are no therapies that prevent, halt, or reverse the disease’s progression. United Neuroscience is taking a new approach to the disease with its endobody vaccines, a class of synthetic biologics it is developing to treat Alzheimer’s and other CNS conditions. We spoke to Ajay Verma, chief medical officer of United Neurosciences, about Alzheimer’s, the company’s platform technology, and the promise of enlisting the immune system in the fight against CNS diseases.

Overcoming the Delivery Challenges of Gene Therapy
Gene therapy represents an expanding area of potential to correct and modulate the activities of genes driving diseases. One of the major challenges these groundbreaking technologies face, though, is delivering them to where they need to go within the body to be effective. Nanogenic Solutions believes its solved the problem with its LipTide technology that marries a payload carrying-lipid with synthetic peptides that target cell suface receptors and allow DNA or RNA into the cell. We spoke to Simon Newman, director of preclinical development for Nanogenic Solutions, about the challenges of gene therapy, the LipTide technology, and what it could mean for advancing a range of RNA and DNA therapies.

Brexit Sparks Battle to House the EMA
Brexit, the United Kingdom’s plan to withdraw from the European Union, carries a long list of unintended consequences, one of which is the relocation of the European Medicines Agency. As many as 20 cities are competing to become the new home of the drug regulator. We spoke to Rory Mullen, International Investment Executive for IDA Ireland, about Dublin’s efforts to woo the EMA, the process going forward, and why its viewed as an economic prize.

New Safety Concerns Identified After FDA Approval of One in Three Drugs
Nearly one in three drugs has a postmarket safety event, according to a study published earlier this month in JAMA. The study looked at 222 novel therapies approved between 2001 and 2010. We spoke to Nicholas Downing, clinical fellow in the Department of Medicine at Brigham and Women's Hospital and lead author of the study, about the findings, the limits of clinical trials, and whether the U.S. Food and Drug Administration needs to do more to improve surveillance of drugs once they are approved.

Why Climate Change Is a Public Health Concern
Climate change is not often viewed as a public health threat, but it can have unexpected consequences on the spread of infectious diseases. As changing temperatures make new areas more hospitable to mosquitos, its can raise the risk of mosquito-borne diseases, such as dengue, chikungunya, and zika in areas not usual thought as prone to outbreaks of tropical disease. We spoke to Erin Mordecai, assistant professor of Biology at Stanford University and lead author of a recent study in PLoS Neglected Tropical Diseases that looks at how climate change may affect the spread of mosquito-borne disease. We spoke to Mordecai about the study, what it means for potential infectious disease outbreaks, and how public health officials and drugmakers in the developed world may need to think differently about neglected tropical diseases.

Reflections on the Progress and Promise of Personalzied Medicines
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.

Curing Cancer with Math
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.

How Healthcare Consumer Find and Use Price Information
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.

Why Infectious Disease Represents a National Security Threat
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 Raise Question If New Vaccine Is Needed
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.

Proposed Legislation Would Weaken Genetic Privacy Protections
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.

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.