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American James Allison and Japanese Tasuku Honjo won the 2018 Nobel Prize for Physiology or Medicine on Monday for game-changing discoveries about how to harness and manipulate the immune system to fight cancer...The seminal discoveries by the two Laureates constitute a landmark in our fight against cancer...Allison...worked on a protein known as CTLA-4 and realized that if this could be blocked, a brake would be released, unleashing immune cells to attack tumors...Honjo...separately discovered a second protein called PD-1 and found that it too acted as an immune system brake, but with a different mechanism...The discoveries led to the creation of a multibillion-dollar market for new cancer medicines. In particular, drugs targeting PD-1 blockade have proved a big commercial hit, offering new options for patients with melanoma, lung and bladder cancers...

Widespread in other industries, continuous manufacturing features what's essentially an end-to-end assembly line, through which raw materials are steadily fed and constructed into final products...It's seen as faster and more flexible than the tried-and-true system of batching that forms the foundation of pharma manufacturing. The Food and Drug Administration is eagerly encouraging its use ...on a whole, the industry remains wedded to batch production. The reasons for why are many, but foremost is a reluctance to overhaul finely tuned manufacturing networks or to introduce new risks into drug development...Doing something different like continuous was going outside the box...Using an uninterrupted production process eliminates, or significantly reduces, the "hold times" in between steps that are typical in batch manufacturing. For J&J, production of Prezista used to take about two weeks from start to finish using batch methods...through continuous manufacturing, production takes only three days...since the raw ingredients don't need to transition in and out of production for quality testing, continuous manufacturing systems can run over a longer period of time, potentially upping output...For all of the advantages of continuous manufacturing over batch production, drugmakers must weigh switching over against retooling carefully crafted production networks.

Medical errors of all kinds, including medication errors, are now the third highest cause of death in the United States and may be responsible for 10% of all deaths in the country, according to a 2016 study by Johns Hopkins Medicine. According to the National Academy of Medicine, preventable medication errors harm 1.5 million Americans annually and cost hospitals an additional $3.5 billion each year...“I think the problem is becoming worse because this is a complex medical system that we have,”...Strategies to prevent medication errors in recent years include a move to electronic prescribing and adding barcodes to drug products. But experts say these efforts have not eliminated the need for vigilance among pharmacists, technicians, and other healthcare professionals in the community and hospital setting. Here’s more on the actions pharmacists need to take to avoid some of the most common medication errors.

• Processing Errors
• Dosage Errors
• Care Transition Errors
• Alert Fatigue Errors
• Other Errors
• Technology on the Horizon

Virtual trials could address some of the problems that come with developing new drugs, but a host of challenges remain before they can become routine...Last October, AOBiome Therapeutics...announced the results of a 12-week clinical trial of an experimental acne drug. In the randomized double-blind and placebo-controlled trial, a topical spray containing a beneficial bacteria was shown to be safe and effective in reducing the severity and number of acne lesions, the company said...The drug must successfully go through another round of testing–what’s called a Phase III trial–before AOBiome can apply to the Food and Drug Administration for marketing approval...Volunteers for the completed trial were recruited through social media and internet advertisements, and more than 8,000 people were screened online to see if they were eligible. The resulting 372 participants received the drug or a placebo in the mail and used company-issued iPhones to take selfies of their acne, a phone app to send the photos to physician-investigators for evaluation, and video conferencing to communicate with study staff...That’s markedly different from a typical drug trial...AOBiome’s acne drug trial, there were no in-person screening interviews, and no doctor visits. The trial was entirely what people in the trade call “virtual.”...Whether virtual clinical trials are the way forward is a matter of some debate, and industry analysts say a host of challenges remain before virtual trials–which currently represent a tiny fraction of the more than 100,000 registered clinical research studies in the United States–become the norm. These include overcoming a conservative corporate culture, ensuring that the technology is easy for patients to use, managing and analyzing the enormous amount of data that round-the-clock sensors generate, and proving the data’s reliability and validity to regulators...

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.