The Bio Report

Non-steroidal anti-inflammatory drugs are the most widely used medications in the world. They are used to treat pain resulting from diseases such as arthritis, but these drugs can raise blood pressure and cause serious problems including heart attacks, strokes, and death. We spoke to Paul Waymack, founder, chairman, and chief medical officer of Kitov Pharmaceuticals about its efforts to bring to market a combination therapy that addresses these safety concerns. Waymack discussed the issues surrounding pain medications, his company’s approach, and how the company’s smart FDA strategy is significantly cutting its cost and time to market.

The American Association for Cancer Research, with seven leading cancer research centers, has launched Project GENIE to determine how to better tailor treatments to patients’ individual cancers. The effort will take tumor genomic profiling data from the various institutions and aggregate it into a single database for researchers to harness. We spoke to Barrett Rollins, chief scientific officer at the Dana-Farber Cancer Institute, about the project, how far down the path of precision medicine we have travelled, and how he expects it to reshape cancer care in the years to come.

As medical device makers are building network connectivity and intelligence into their products, they are adding new vulnerabilities and risks as well. The U.S. Food and Drug Administration has just issued draft guidance for postmarket management of cybersecurity of medical devices. It follows previous guidance on premarket submissions for management of cybersecurity in medical devices. We spoke to Russell Jones, partner with Deloitte & Touche, cyber risk leader for the firm’s State of California Practice and co-leader of the firm’s medical device safety and security practice, about the FDA actions, how these connected devices can be exploited by hackers, and what medical device makers can learn from industries that have already faced these issues.

The pharmaceutical industry appears to have lost ground in 2015 on the ongoing debate around drug pricing, a problem that Christopher Bowe sees in part as a failure of leadership within the industry. In a recent guest column in Forbes, Bowe, who advises industry CEOs on communicating their strategies and ideas, argued that the industry needs CEOs capable of reframing the discussion with fresh ideas, forging new alliances, and disrupting existing business models. We spoke to Bowe about this leadership vacuum, why it is critical for the industry to move beyond its tired arguments, and what it needs to do to rebuild trust and credibility with the public.

As 2015 came to a close, Congress passed a package of tax extenders that among other things expanded the Research and Development Tax Credit and made it permanent. The move represents a big win for innovation-based industries, but the life sciences in particular, which will benefit from a new provision that allows companies to capitalize on the credit ahead of producing revenue. We spoke to Dan Mennel, California Market Leader of Strategic Federal Tax Services for Grant Thorton and Matt Gardner, CEO of the California Technology Council, about the R&D tax credit, what it does, and what it means for the life sciences.

The year 2015 was another big one for biotech with record dealmaking, big drug approvals, and solid performance, but it somehow didn’t feel as good as it looks on paper. Pricing concerns that garnered big attention are expected to grow in intensity in the new year with the presidential election and negotiations for the renewal of the Prescription Drug User Fee Act. We spoke to Adam Feuerstein, senior columnist for TheStreet.com, about the year in biotech, the highs and lows, and what’s ahead in the new year.

Growing costs pressures, the integration of technology, and the transformation of the patient into a healthcare consumer is giving rise to a new health economy. In its report on the top health industry issue for 2016, PwC highlights the forces expected to have the most impact on the industry in the coming year. We spoke to Karla Anderson, principal of U.S. pharmaceuticals and life sciences for PwC, about the report, how an increasing emphasis on value is reshaping the sector, and what’s in store for 2016.

Despite a record number of new drug approvals this year, the return on R&D investment for the largest pharmaceutical companies continues to fall, according to a new report from the Deloitte Centre for Health Solutions and Deloitte’s R&D services group. In fact, the report finds R&D returns for this group of companies have fallen to their lowest point since Deloitte began tracking them in 2010. We spoke to Neil Lesser, principal with Deloitte Consulting in the Life Sciences strategy practice and a leader in the Research & Development strategy practice, about the report, the pressures on the industry that are hurting returns, and what R&D strategies companies can pursue that might reverse the trend.

Retail prices for more than 100 widely used specialty drugs rose nearly 11 percent in 2013, according to a new report from AARP Public Policy Institute. The report found that the average annual cost of a specialty drugs used to treat chronic diseases rose to more than $53,000 — greater than the U.S. median income and more than twice the $23,500 median income of people on Medicare. We spoke to Leigh Purvis, director of health services research in AARP’s Public Policy Institute about the report, trends that are fueling demand for these drugs, and whether there are public policy solutions to rein in rising drug prices that can be implemented without harm to innovation.

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.