The Bio Report

Caelum Biosciences, a Fortress Biotech company, is a clinical-stage biotech developing treatments for rare and life-threatening diseases. It’s lead therapeutic in development is a novel antibody to treat patients with amyloid light chain amyloidosis, a rare disorder of the bone marrow that causes misfolded proteins to accumulate in tissue and organs throughout the body and cause damage. We spoke to Michael Spector, president and CEO of Caelum, about the company’s business model, its lead therapeutic, and how the competitive landscape for a rare disease therapy may shape development strategies.

Incubators create success stories, but usually aren’t thought of as success stories themselves. The newly renamed MBC Biolabs, which started with humble beginnings in a utility closet as the first technology incubator in the University of California system, has been a big success by meeting the needs of entrepreneurial scientists. We spoke to Doug Crawford, managing director of Mission Bay Capital and General Manager MBC Biolabs, about its recent rebranding, how it operates, and its plans for expansion.

Across the continuum of drug discovery, development, and delivery there’s a growing effort to incorporate the patient perspective into the process. Last year FasterCures, the nonprofit focused on accelerating and improving medical research, held a multi-stakeholder workshop to discuss the challenges and opportunities of patient reported outcomes and how to make them a more powerful tool for incorporating patients’ perspectives into R&D and care decision-making. A new report from the organization captures the results of that workshop. We spoke to Cynthia Grossman, director of science of patient input at FasterCures, about the report, why patient reported outcome measures and patient-centric outcomes are not one and the same, and what can be done to better reflect what matters to patients.

CellMax Life believes it can transform cancer diagnostics with its affordable non-invasive tests for early cancer detection. The company says with its platform it has been able to overcome the challenge of detecting rare circulating tumor cells in pre-cancer and early-stage cancer patients when the disease can be successfully treated. We spoke to Atul Sharan, co-founder and CEO of CellMax, about the challenges of liquid biopsies, how the company’s technology works, and why he thinks it has the potential to change the way cancer is diagnosed today.

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.

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.

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.

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.

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.

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.