The Bio Report

One of the issues researchers face is getting access to needed biospecimens with detailed clinical data that can expand the understanding of a specific disease or treatment. The difficulty in obtaining biospecimens can hamper R&D productivity, extend the time of project, and increase costs. Novaseek has developed a platform that provides access to real world data and supports the ability to define patient cohorts based on detailed clinical criteria, such as demographics, diagnoses, medications, and lab test results, and supports the collection of biospecimens at various time points. The platform also offers healthcare organizations an opportunity to develop a new source of revenue. We spoke to Kate Torchilin, CEO of Novaseek, about the challenges researchers face in getting biospecimens, how Novaseek seeks to address that, and how the company’s platform can help to accelerate biomedical research.

Evaluate Pharma, in its latest World Preview report, is projecting solid growth for prescription drug sales through 2022. Driving that growth is both the new products expected to come to market during that time and the industry’s embrace of orphan drugs, the source of half of that growth. We spoke to Antonio Iervolino, head of forecasting for Evaluate, about the new report, the growing number of drug approvals, and the challenges drugmakers face that could alter the outlook for the industry.

The growing promise to harness biology to address environmental, agricultural, health, and energy needs is fueling a new bioeconomy. The state of engineering biology will be on display at the SynBioBeta SF 2016 conference in South San Francisco October 4 through October 6. We spoke to John Cumbers, founder of SynBioBeta, about the state of the industry, the challenges it faces, and the long-term potential it holds for transforming our manufacturing sector.

About 380,000 infants in the United States—about one in 10— are born prematurely each year. Preterm births, defined as any birth before 37 weeks of pregnancy, is the leading cause of death for infants and puts these babies at greater risk for cerebral palsy, respiratory and cardiovascular complications, and delays in development. Sera Prognostics has developed a predictive diagnostic that can identify pregnant woman at risk of delivering prematurely, allowing for interventions. We spoke to Greg Critchfield, CEO of Sera Prognostics, about the test, how it works, and what it take to get doctors to adopt the test and payers to reimburse for it.

The Johns Hopkins University School of Medicine and the Salk Institute for Biological Studies are leading a $15.4 million effort to develop new systems for quickly screening libraries of drugs for potential effectiveness against schizophrenia and bipolar disorder. The National Institute of Mental Health is funding the work. We spoke to Hongjun Song, professor of neurology and neurosciences at the Johns Hopkins University School of Medicine, about the effort, the challenges of understanding the underlying biological mechanism of these disorders, and how the consortium expects to change the development of drugs to treat mental illnesses.

The recent controversy over Mylan Pharmaceuticals sharp increase to the price of its EpiPen, an emergency injection of epinephrine to treat someone suffering a severe and potentially fatal allergic reaction, has once again ignited public debates over drug pricing. While drugmakers have been in the sights of the public, other players in the supply chain have escaped scrutiny. David Balto, a Washington, D.C.-based antitrust attorney, in a recent piece in The Hill, calls attention to the role pharmacy benefits managers play in the price equation. We spoke to Balto about PBMs, their growing power, and the perverse incentives they have to work against the best interest of consumers.

Werner’s and Hutchinson-Gilford Progeria Syndromes are rare, genetic diseases that causes children to appear to suffer from advanced aging at young ages. The syndromes are of particular interest to researchers because of the potential they may have to help understand the biology of normal again and lead to ways to counter aging-related diseases. We spoke to Brian Kennedy, president and CEO of the Buck Institute for Research on Aging, about his progeria research, the potential to repurpose existing drugs to combat these syndromes, and what insights into normal aging are being gained from the study of progeria.

Concern about the spread of the Zika virus has sparked efforts to develop therapies and vaccines to counter it. But the outbreak reflects a growing threat from zoonetic diseases, once thought of as being contained to tropical regions, that are making incursions into the developed world. We spoke to Jim Pannucci, director for infectious disease research at Southern Research, about Zika, the work his organization is doing around the virus, and whether we need to rethink investment in prevention and treatment of such diseases.

Lee Hood was a visionary who helped enable the genomics age. Journalist Luke Timmerman, in his newly published biography of Hood, chronicles the scientist career and achievements, as well as the controversies that surrounded him. We spoke to Timmerman about Hood, the conflicts that shaped his career, and the significance of his contributions to the field of biology.

Despite continued scientific and medical progress, the American Society of Clinical Oncology offered a mixed picture in its annual report on The State of Cancer Care in America earlier this year. While advances have been made in combating some cancers, mortality rates for others remain unchanged or have increased. There’s disparity in care, concerns about the rising cost of therapy, and uncertainty about how new payment models will affect care. We spoke to Julie Vose, immediate past president of ASCO, about the report, where additional work is needed, and how to balance the need to make cancer care affordable while encouraging innovation.

People with multiple chronic conditions represent about 5 percent of the patient population in the United States, but account for half of the nation’s healthcare spending. In order to improve care and reduce costs overal there’s an urgent need to do a better job of treating these patients, according to a recent perspective in the New England Journal of Medicine from the heads of five leading healthcare foundations. We spoke to David Blumenthal, president of the Commonwealth Fund and one of the authors of the piece, about why improving care for this population is critical, why there’s not a single solution to treating what is actually a diverse population of patients, and what these foundations are doing to address the problem.

Neglected diseases and drugs to counter addiction represent unmet medical needs, but they have been areas that pharmaceutical companies have been reluctant to pursue. Savant HWP is in clinical development on an experimental drug that targets both of these indications. We spoke to Stephen Hurst, CEO of Savant HWP about the company’s strategy, the unique compound that can address two seemingly unrealated indications, and the role priority review vouchers can play in providing drug developers with incentives to pursue indications that might otherwise be ignored.

The use of biomarkers has long held the promise accelerating drug development and producing safer and more targeted drugs to meet the needs of patients. The explosion of genetic, proteomic, and metabolomic data, as well as the emergence of the human microbiome, is rapidly growing the world of biomarkers, but with that comes challenges for researchers and drug developers about knowing what’s available and how well validated these biomarkers may be. We spoke to John Audette, president and co-founder of Amplion, about the company’s database, which seeks to make biomarker information accessible to researchers, the role biomarkers can play in improving the drug development process, and how their increased use can bring about a long anticipated era of precision medicine.

Incubators and accelerators have been proliferating in California, but little has been done to track their activities and analyze their performance. The California Business Incubation Alliance recently released a study of the performance of incubators and accelerators in California, the contribution they make to the state’s economy, and whether they deliver value to the entrepreneurs that use them. We spoke to Matt Gardner, CEO of the California Technology Council and lead author of the report, about its findings, why gathering data about incubators and accelerators is so challenging, and why the findings include a word of caution to entrepreneurs. As a matter of full disclosure, Matt is a friend, client, and partner and I served as an editor on this report.

The growing problem of antibiotic-resistant bacteria and the evolution of next-generation sequencing technology is giving rise to new approaches to combat what’s become a serious global health threat. Epibiome, which describes itself as a precision microbiome engineering company, is working to develop cocktails of bacteriophages to use in animal and human health. We spoke to Nick Conley, CEO of Epibiome, about the urgent need for new therapeutics, the renewed interest in phages, and Epibiome’s unique approach to address the problem.

The ability to find and tumor cells and DNA fragments shed by tumors circulating in the blood has given rise to liquid biopsies. This emerging area of diagnostics promises to improve cancer care, better monitor patient response to a therapy, personalize care, and provide earlier evidence of recurrence. We spoke to Andre de Fusco, CEO of Cynvenio, about the company’s liquid biopsy rare cell isolation platform, and its implications for changing how cancer patients

KaloBios, a biotech best known for a series of disastrous events including failed clinical trials, a bankruptcy filing, lawsuits, and the arrest of its CEO, is being reborn. In the process, it may provide a valuable contribution to the ongoing discussion over drug pricing. In April, the development-stage company unveiled a pricing plan based on transparency, affordability, and reasonable profit. We spoke to Cameron Durrant, CEO of KaloBios, about his efforts to clean up the mess he inherited, turnaround the fortunes of the company, and introduce an innovate pricing model that could reshape the way industry thinks about pricing its products.

Despite a rapid advance of technology there’s been little change in the preclinical drug development process. Vium is hoping to change that by using sensors, automation, and bioinformatics to change the way data is gathered in the preclinical process to fuel better and faster decisions about the potential value of an experimental drug. We spoke to Tim Robertson, co-founder and CEO of Vium and Joe Betts-Lacroix, co-founder and CTO of Vium, about the company, how its hoping to change the preclinical drug development process, and why that’s essential.

The biotechnology industry continued to post record numbers, attract significant investment, and won approval for a solid number of new drugs in 2015. Nevertheless, EY in its new Beyond Borders report warns that there’s a deceleration within the industry that points to threats that could undermine the robust growth it has enjoyed. We spoke to Glen Giovannetti, EY Global Biotechnology Leader, about the new report, the need for the industry to innovate pricing models for new drugs, and why as companies seeks to demonstrate the value of a product they will need to consider the unique perspective of each payer.

Wall Street’s attention will turn to Chicago as the annual meeting of the American Society of Clinical Oncology gets underway June 3 to June 7. Though this is a scientific conference, it is one closely watched by investors, who have been pouring through the abstracts that have been available and keeping an eye open for late-breakers that could move stocks. We spoke to Jon Gardner, deputy news editor for EP Vantage, about the ASCO meeting, what the early abstracts say, and who will likely be making headlines at this year’s meeting.