Star Trek Diagnostics
The communicators envisioned by Star Trek have come to life, thanks to today’s smartphones, so why not also the medical tricorders used by Drs. ‘Bones’ McCoy and Beverly Crusher? In October, a research team led by Tony Jun Huang, Ph.D., of Pennsylvania State University published proof-of-concept results in the journal Lab on a Chip showing success for the technology behind the tricorders.
The team’s miniature device uses two sound waves as acoustic tweezers to help sort a continuous flow of cells into five outlets on a dime-sized microfluidic chip. Researchers tested their device on human white blood cells affected by leukemia by first focusing them into the main channel, then separating them into five channels.
Dr. Huang’s team is among several researchers developing tricorders. Peter Jansen, Ph.D., now at the University of Arizona, developed an open-source version while a grad student in the Cognitive Science Laboratory at McMasters University. Qualcomm hopes to advance the technology with its Tricorder X-Prize Contest, which promises a $10 million top prize for the winning tricorder. Launched in January 2012, the contest is set to run about 42 months, leaving the winner to be decided by mid-2015.
The Texas Biomedical Research Institute has applied for a U.S. patent for a once-in-a-lifetime HIV vaccine designed to stop transmission of the virus during sex. It’s not an AIDS cure but the next best thing, since 90% of HIV infection cases occur during intercourse, when the virus passes through the body’s epithelial cells.
In January, according to the San Antonio Express-News, researchers will begin inoculating rhesus monkeys at the institute with various dosages of the vaccine at the vagina, rectum, mouth or skin—monitoring their immune response and then infecting them with different HIV strains to test their ability to protect against infection.
“By about 2015 we should know if the works, or if it was just a great dream,” said Claire Gauduin, a researcher in Texas Biomed’s department of virology and immunology who invented the vaccine along with Philippe Blancou of France’s University of Nice-Sophia Antipolis.
Health Data Commons
Decades of segregated collections, paper and electronic, of human health information vital to drug discovery may give way in the coming decade or so to a single “health commons” or pool of publicly available health data, depending on the success of an initiative taking shape. Consent to Research (CTR) is looking to collect data on 100,000 people during the commons’ first year, and on 1 million people during the effort’s first five years, CTR head John Wilbanks told attendees at this year’s TED Global conference in Edinburgh, Scotland last June.
The more data collected, the easier it will be to apply modeling techniques leading to new hypotheses about connections between human health, DNA, and the choices people make in life. One early bellwether will be how many of the 100,000 people whose data will be returned to them by the Athena Breast Health Network opt to contribute that information to the commons.
More drugs are being approved with annual costs that exceed $100,000 a year, and more will be in coming years. Among recent example is Ariad Pharmaceuticals’ drug Iclusig (ponatinib), approved by FDA December 14 for adults with chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia.
Iclusig is being priced at $115,000 per year’s supply; it is Ariad’s first approved branded drug product. Another recently approved drug, Cometriq (cabozantinib), is an inhibitor of multiple receptor tyrosine kinases approved November 29 for treating progressive, metastatic medullary thyroid cancer (MTC).
Drug developer Exelixis plans to price Cometriq at $9,900 for a 28-day supply, or more than $119,880 annually. All the same, biopharma drug developers will want to make up from somewhere the money they will lose as generic competition grows, and as Washington reduces reimbursements as part of the Affordable Care Act. For what it’s worth, Forbes’ Matt Herper made the same prediction last year. Things surely have not changed since then.
Costlier Generics, Too
Generic drug makers will be subject this year to new fees enacted as part of the Generic Drug User Fee Amendments of 2012 (GDUFA), part of the Food and Drug Administration Safety and Innovation Act enacted in July by President Obama. Companies will have to pay for applications, as well as Drug Master Files (DMFs) that will cost them as much as $20,000 to $30,000 each.
While FDA says the fees will amount to less than ten cents for the average generic prescription, PCI Synthesis says in its predictions for 2013 that the extra costs “could have an adverse effect on the generic drug industry,” especially smaller companies. “Could”? More like “will,” and you can bet generic drug makers “will” try to recoup that cost with higher prices. So much for generics as the low-cost alternative to brand-name drugs.