The Bio Report

A team of biohackers is developing the first open source protocol to produce insulin simply and economically. The hope is that their work will serve as the basis for generic production of insulin and provide a foundation for continued research into improved versions of the life saving biologic. We spoke to Anthony Di Franco, co-founder of the Open Insulin project and a board member of Counter Culture Labs, about the work, the challenges they are encountering, and whether the DIY movement can teach the corporate world anything about cost-effective innovation.

A large number of clinical trials underlying the approval of drugs never come into public view. This not only has legal and ethical ramifications, but implications for the healthcare system as a whole. We spoke to Jennifer Miller, founding president of Bioethics International and assistant professor at the NYU School of Medicine about her recent study in BMJ Open, part of an effort to improve transparency through the creation of a Good Pharma Scorecard. Miller discussed the study, the scorecard, and the state of transparency in the pharmaceutical industry.

The power of genetic engineering will soon be available for the home thanks to the Amino One, a piece of hardware about the size of a laptop computer that would allow users to manipulate the DNA of microorganisms for productive purposes or just plain fun. We spoke to Julie Legault, founder and CEO of Amino One’s creator Amino Labs, about the device, its target market, and the implications of putting the tools of synthetic biology into the hands of kids.

New gene editing technologies are expanding the ease and power with which scientists can manipulate biological systems with the promising of addressing not only human health issues, but problems the plant faces with regards to food, fuel, and the environment. But while much of the concerns raised about the potential consequences of this technology have focused on its use in humans, Elizabeth Alter, assistant professor of biology at City University of New York’s York College, argues its potential environmental implications will likely be far more significant. We spoke to Alter about her recent op-ed in The New York Times, the need for public discussion about the technology, what should be done today as we work through broader questions of policy.

The U.S. Securities and Exchange Commission last week finalized rules on crowdfunding that opens the door for the participation of non-accredited investors. The rules complete a long process for the commission set into motion by the passage of the JOBS Act. We spoke to Richard Swart, director of research for the Program for Innovation in Entrepreneurial and Social Finance at the University of California at Berkeley and chief strategy officer for the crowdfunding investment site NextGen Crowdfunding, about the new rules, how this will change the investment landscape, and what it all means for the biotech industry.

Growing challenges in the areas of health, food, energy, and the environment have increased efforts to harness biology to create sustainable solutions to global problems. With advances in the ability to engineer microbes to perform desired tasks, the rapidly evolving area of synthetic biology is expected to fundamentally reshape industrial processes and give rise to a new bioeconomy. Leading scientists, entrepreneurs, and investors will gather in San Francisco November 4 through 6 for SynBioBeta SF 2015 to explore the state of synthetic biology. We spoke to Richard Kitney, professor of biomedical systems engineering at Imperial College London and one of the leading scientists behind the United Kingdom’s efforts in synthetic biology, about the upcoming conference, where the state of the science is today, and why scaling up to industrial sized processes remains a big challenge.

A new class of immunotherapies is promising to radically alter the treatment of cancers and has generated excitement among investors for their groundbreaking potential. Now the Loncar Cancer Immunotherapy ETF provides a way for investors to bet on the sector through an exchange traded fund that consists of both Big Pharma and emerging growth biotechs leading the sector. We spoke to Brad Loncar, CEO of Loncar Investments and creator of the ETF, about the fund, why the focus on this narrow slice of the biotech world, and why he thinks immunotherapies will dramatically reshape cancer care in the years ahead.

Wall Street doesn’t like uncertainty and there are a number of policy issues now brewing that threaten to create some uncertainty for the biotechnology industry. As the BIO Investor Forum kicks off in San Francisco October 20 and 21, bringing together investors and CEOs for two days of panels and presentations, the conference will turn its attention to policy issues and the effects they have on valuations within this industry. We spoke to Sara Radcliffe, president and CEO of the California Life Sciences Association and a policy panelist and the BIO Investor Forum, about policy issues the industry faces, the growing controversy over pricing, and what policy matters investors should be watching.

The medtech industry has enjoyed robust M&A activity, strong financings, and a rise in R&D investments, but other numbers point to troubling developments that threaten the future health and growth of the industry, according to a new report from EY. We spoke to Ellen Licking, EY Life Sciences lead analyst, about the report, concerns about the venture capital industry’s move away from the sector, and questions about who will fund early-stage innovation that will be necessary for the future growth of the industry.

Vtesse, a rare disease drug development company, this week announced that it was initiating a late-stage pivotal trial for its lead experimental therapeutic to treat Niemann-Pick Type C1 disease. The start of the trial for the nine month old company represents a major milestone and suggest its history with the National Institutes of Health and the rare disease drug accelerator Cydan Development may point to new ways of cutting the time and cost of advancing a drug to market. We spoke to Ben Machielse, CEO of Vtesse, about the rapid pace at which the company has been able to move, the role NIH has played, and whether this points to new ways to accelerate the drug development process.

The U.S. Department of Health and Human Services has been working to move Medicare from fee-for-service to value-based payments. It’s seeking to get 90 percent of payments to being value-based by 2018. The problem, according to a recent Viewpoint in JAMA, is that when addressing life-ending chronic conditions faced by older patients, traditional professional standards that drive today’s metrics don’t effectively address patient desires. We spoke to Joanne Lynn, director of the Altarum Institute’s Center for Elder Care and Advanced Illness and lead author of the JAMA Viewpoint, about what value-based care means for patients near the end of their lives, the need to recognize the great variance in patient desires, and how healthcare systems will need to change to account for this.

The California legislature earlier this month passed a bill that would allow physicians to aid terminally ill patients who wanted to end their lives. California would become the fifth state to enact such legislation. We spoke to David Grube, national medical director of Compassion & Choices, a nonprofit working to expand end of life options, about the legislation, how attitudes among the public and physicians have changed, and what we’ve learned since Oregon passed the first such law 17 years ago.

The U.S. Food and Drug Administration recently released long-awaited draft guidance regarding the naming of biologics, biosimilars, and interchangeable biologics. At the same time the agency released a proposed rule to apply the naming scheme to six current biological products with, or expected to soon have, biosimilar competitors. We spoke to Gillian Woollett, senior vice president with the healthcare business strategy and public policy advisory firm Avalere Health, about the FDA’s actions, their implications, and some potential unintended consequences.

The National Comprehensive Cancer Network in October will release a new tool designed to help doctors understand the value of different cancer therapies by taking into account the costs of treatments. The effort from the influential group follows similar initiatives by Sloan Kettering Cancer Center and the American Society of Clinical Oncology. We spoke to Bob Carlson, CEO of the National Comprehensive Cancer Network, about the rising costs of cancer care, the new tool, and what impact it will likely have on drug pricing in the future.

President Jimmy Carter, at a recent press conference discussing his cancer diagnosis and treatment, expressed his wish to outlive the last Guinea worm. The Carter Center, since 1986, has led a global effort to eradicate Guinea worm disease with great success and its goal is within reach. We spoke to Ernesto Ruiz-Tiben, director of The Carter Center’s Guinea Worm Eradication Program, about its efforts, the history behind it, and what lessons can be drawn in combating other public health threats throughout the world.

Sprout Pharmaceuticals earlier this week won a controversial U.S. Food and Drug Administration approval of Addyi, the first drug approved in the United States to treat female sexual dysfunction. Following the news, Valeant Pharmaceuticals said it would acquire Sprout for $1 billion. We spoke filmmaker Liz Canner, director of the documentary Orgasm, Inc., about Addyi, the drug industry’s long standing pursuit of a female Viagra, and why its approval is troubling to many people.

Earlier this month in a preemptive challenge from Amarin Pharma against the U.S. Food and Drug Administration a federal judge ruled that the FDA cannot prohibit a drugmaker from promoting the off-label use of a drug if it does so through the dissemination of truthful and non-misleading information. The decision about the First Amendment Rights of a pharmaceutical company is seen as a significant ruling in a long-standing battle between the agency and the industry that has played out over the past 20 years. We spoke to John Kamp, executive director of the Coalition for Healthcare Communication, about the case, the issues behind it, and its implications for how the industry and agency will act going forward.

Drugmakers about 10 percent of the time fail to report serious adverse events to the U.S. Food and Drug Administration within the time required, according to a recent study in the Journal of the American Medical Association. We spoke to Pinar Karaca-Mandic, study co-author and associate professor of Health Policy and Management at the School of Public Health at the University of Minnesota, about the study, the concerns it raises, and whether regulators need to rethink the way adverse events are reported.

A growing problem with drug resistant infections acquired in hospitals is catching the eye of Consumer Reports, which has added the incidence of two common and deadly infections to their hospital ratings. The ratings come in the second part of a three-part investigation in the antibiotic crisis. We spoke to Doris Peter, director of Consumer Reports’ Health Ratings Center, about the study, what the highest rated hospitals are doing that the lower rated ones are not, and things patients can do to safeguard themselves when they face a hospital stay.

The controversy over the high price of new drugs and the question of the value they provide will come under increased scrutiny thanks to a grant to a Boston-based nonprofit that works to get at these questions. The Laura and John Arnold Foundation this week announced it is providing $5.2 million to the Institute for Clinical and Economic Review aimed at transforming the way new drugs are evaluated and priced. We spoke to Sarah Emond, COO of the institute, about the work it does, what this new grant will do to expand that work, and how to get a the question of the value of new drugs.