The Bio Report

Inhaled insulin has been one of those biotech ideas that have seemed better on paper than in practice. Huge investments have been made to carry these products through challenging development only to end in market flops. Aerami Therapeutics, a company founded by one of the pioneers in the field, is advancing its version of inhaled insulin and building a pipeline of other inhaled biologics behind it We spoke to Anne Whitaker, CEO of Aerami, about its pursuit of inhaled insulin, why she believes the company will be able to avoid the pitfalls others have faced, and the case for delivering insulin and other biologics through the lung with its technology.

In August, Nabriva Therapeutics won U.S. Food and Drug Administration approval for Xenleta for the treatment of community-acquired bacterial pneumonia in adults. It was the first new antibiotic with a novel mechanism of action approved by the FDA in nearly two decades for the condition. We spoke to Ted Schroeder, CEO of Nabriva about Xenleta’s unique mechanism of action, why it may be less prone to the development of resistance, and why policymakers still need to take additional steps to spur development of novel antibiotics.

Healthcare decisions are often flawed because of the limited information on which they are based. But with the growing ability to capture massive amounts of data digitally and apply artificial intelligence to its analysis, there is a growing potential to gain better insights into healthcare and improve patient outcomes. Komodo Health has an ambitious plan to do that with its AI-drive platform that captures 15 million patient encounters with the healthcare system daily to provide a real-time picture of patients and their various encounters. We spoke to Aswin Chandrakantan, chief medical officer and senior vice president of corporate development at Komodo Health, about the changing data landscape, how Big Data has the potential to reshape healthcare decision-making, and what it is enabling everyone from patient groups to payers to do differently.

In the United States, more than 100,000 people are on a transplant waiting list and many other simply do not qualify. In 2009, 25 people per day died while on the waiting list. Transplant procedures are costly and require lifelong use of immunotherapies. BioLife4D is seeking to disrupt organ transplantation with the development of bioprinted hearts produced using a patient’s own cells. The technology also has the potential to have an impact in other areas, such as drug discovery and development. We spoke to Steve Morris, founder and CEO of BioLife4D, about its effort to bioprint a transplantable human heart, a recent milestone it achieved to produce a mini-heart, and the range of challenges it must overcome to make its vision a commercial success.

Sermo describes itself as a “virtual doctors’ lounge” where physicians can express their opinions and interact with other doctors. One of the newer features on the physician-only social network is the ability to crowdsource solutions for difficult cases. We spoke to Erin Fitzgerald, senior vice president of marketing at Sermo, about the social networking platform, how it’s used to solve hard-to-crack cases, and the business model underlying the free service for physicians.

Essential tremors, uncontrollable shaking of the hands, arms, and other parts of the body, have been traditionally treated through drugs or surgery. Cala Health is providing a new option to patients with its wristwatch-like neuromodulation device that uses electrical pulses to stimulate peripheral nerves to treat the condition. We spoke to Renee Ryan, CEO of Cala Health, about the company’s Cala Trio device, the potential for bioelectric medicine to treat a broader range of neurologic, psychiatric, and cardiologic indications; and what it will take to get payers and providers to embrace the technology.

The ability to engineer biological systems to replace chemical processes is making the promise of the emerging bioeconomy a reality. Some of the leading industry players, though, see a growing need to have a voice in the policy arena and have formed the Bioeconomy Alliance to ensure the sector can flourish and realize its potential. We spoke to Jason Gammack, chief commercial officer of Inscripta and a founding member of the Bioeconomy Alliance, about how synthetic biology is reshaping the economy, why there is a need for this new organization, and the issues it will address.

Efforts to develop effective therapies to treat Alzheimer’s disease have been stymied by a long history of clinical failures. Those disappointments have included two, late-stage failures of AC Immune’ Crenezumab, which the company is developing with it partner Roche. The two companies are continuing to pursue the drug under the belief that treating patients earlier in the progress of the disease will be critical. We spoke to Andrea Pfeifer, CEO of AC Immune, about the company’s efforts to identify and treat Alzheimer’s at its earliest stages, its efforts to develop a vaccine against the condition, and why she believes the future of Alzheimer care will involve combination therapies similar to what has emerged in the area of cancer.

The study of microbes and their interactions is changing our understanding of biology, but only a small fraction of microbial species have been cultured. One of the challenges researchers have faced is the limits of existing tools used to study microbes. We spoke to Peter Christey, co-founder and CEO of GALT, about our emerging understanding of the microbiome, the need for a technological transformation of microbiome-based science, and how his company is hoping to fuel the emergence of new insights with its high-throughput technology to isolate and cultivate microbes.

Cofactor Genomics believes RNA provides a better means than DNA and other biomarkers to diagnose disease, monitor health, and enhance treatment decisions. The company’s Predictive Immune Modeling provides insight into a cancer patient’s immune response at the tumor to determine whether an individual is likely to response to an immunotherapy. We spoke to Jarret Glasscock, founder and CEO of Cofactor Genomics, about its RNA diagnostics, the case for the use of multidimensional biomarkers, and the challenges it faces with physician adoption and reimbursement.