Month: July 2017

Ways Technology Can Assist the Field of Oncology


Originally published in Mediware’s Home Care Blog. Re-posted with permission.

MoonShot 2020, the official name of which is the National Immunotherapy Coalition, is “one of the most comprehensive cancer collaborative initiatives launched to date, seeking to accelerate the potential of combination immunotherapy as the next generation standard of care in cancer patients. This initiative aims to explore a new paradigm in cancer care by initiating randomized Phase II trials in patients at all stages of disease in 20 tumor types in 20,000 patients within the next 36 months. These findings will inform Phase III trials and the aspirational moonshot to develop an effective vaccine-based immunotherapy to combat cancer by 2020.” [1] The goal is to get oncology to the point where it is manageable, like today’s chronic diseases. However; with so much data surrounding this effort, it can be as overwhelming as finding a needle in a haystack.

Three companies are showing us how information technology could be the key in helping us decode possible solutions. Recently, IBM launched Watson Health Cloud to provide a secure and open platform for physicians, researchers, insurers, and companies that are focused on improving health outcomes. Specifically regarding oncology, Watson has teamed up with Memorial Sloan Kettering to “take information about a specific patient and match it to a huge knowledge base incorporating published literature and the treatment history of similar patients. Watson’s ability to mine massive quantities of data means that it can also keep up—at record speeds—with the latest medical breakthroughs reported in scientific journals and medical meetings. Additionally, because it utilizes cognitive computing, Watson continually ‘learns,’ thereby improving its accuracy and confidence in the treatment options it suggests.”

Microsoft is also entering the cancer research arena with its recently announced artificial-intelligence-powered solutions aimed at the disease. Although the company has several teams of researchers tasked with “solving” cancer, Microsoft says its overall efforts will take two basic approaches.

The first is “rooted in the idea that cancer and other biological processes are information processing systems.” Therefore, based on that assessment, Microsoft suggests that “the tools that are used to model and reason about computational processes—such as programming languages, compilers, and model checkers—[can be] used to model and reason about biological processes.”

Microsoft says its second approach is data driven and revolves around the concept that “researchers can apply techniques such as machine learning to the plethora of biological data that has suddenly become available and [can] use those sophisticated analysis tools to better understand and treat cancer.”

Lastly, computer graphic chip manufacturer Nvidia has announced its partnership with the National Cancer Institute, the U.S. Department of Energy, and several national laboratories in order to build an artificial intelligence framework. The framework, called CANDLE—or the Cancer Distributed Learning Environment—seeks to advance oncology research.

Nvidia says CANDLE will be used to “help discover the underlying genetic signatures present in DNA and RNA of common cancers that are predictive of treatment response from the mass of molecular data collected by the NCI genomic data commons.” CANDLE will also “accelerate the molecular dynamic simulations of key protein interactions to understand the underlying biological mechanisms creating conditions for cancer.” In addition, through “semi-supervised learning, CANDLE will automate information extraction and analysis of millions of clinical patient records to build a comprehensive cancer surveillance database of disease metastasis and recurrence.”

It’s exciting to see so many diverse groups working together toward a solution for cancer. Finding one, or possibly even several different options, will not only save the healthcare system millions but will also provide priceless benefits. While it remains to be seen how much funding will be allocated to projects such as Cancer MoonShot 2020 as well as other private investment, the life-altering effects of cancer can be felt regardless of political affiliation. Hopefully, the time is soon that we all can celebrate major breakthroughs through communication, cooperation, and persistence.

This shows that the specialty market continues to evolve. Staying ahead of both your competition and information will be key to an organization’s future success. Contact us for our unique solutions that will help you get an edge.

Biosimilars: Sandoz v. Amgen


Biosimilars, which are “highly similar” to already approved biological products, are becoming more important in the market because they enable patients to access more treatment options, particularly more expensive options, at prices that are more affordable. Obviously, the makers of the brand-name biologics are not in favor of biosimilars of their top-selling products. Recently, however, the Supreme Court of the United States gave biosimilars a win against brand biologics in the case of Sandoz v. Amgen. What does this mean for the specialty pharmacy market?

There are two issues that were answered by the Court in this case, which revolved around Amgen’s approved biologic, Neupogen.

– Did Sandoz, makers of the biosimilar product in question, give proper notice to Amgen of its intent to market a biosimilar of Neupogen?
– Is Amgen entitled to an injunction, stopping Sandoz’s application to the FDA until Sandoz gives Amgen its research and FDA application?

The court’s ruling in this case has now opened the door for biosimilars to enter the market faster, which gives specialty pharmacy patients more options for treatment.

The market for biosimilars was created by the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which was part of the Affordable Care Act, a.k.a. Obamacare. This act allowed for the creation of biosimilars and created a mechanism within the FDA for their approval. The Court, in Sandoz v. Amgen, looked to the BPCIA in establishing a decision in this case.

Sandoz and its biosimilar clearly won out on the first question. The court stated that the biosimilar manufacturer could simultaneously enter its application to the FDA and give notice of its intent to market to Amgen. This part is the most important part as it allows the biosimilar to reach the market faster. Amgen wanted the court to rule that the FDA application had to be approved before the notice of intent would be allowed. In ruling for the biosimilar, the Court denied Amgen more time to exclusively market Neupogen without biosimilar competition.

On the second question of the injunction, the biosimilar won again because the Court ruled that the question did not need an answer. Amgen had received the application and research information from Sandoz in discovery. Here, the Court intended to be cautious as the BPCIA did not bar the makers of brand-name biologics from obtaining relief in state court, which could have opened the door for more litigation in the states regarding patents for biologics.

These recent decisions have major consequences for the makers of brand biologics, who are trying to protect their patents. With the required notice of intent to market being 180 days, it’s possible that, if the FDA takes 180 days to approve a biosimilar application, the biosimilar can immediately start to market its treatment. This means more options. It also means that, as more biosimilars go to market, the higher the chances that the FDA will approve interchangeability of the various brands’ treatments.

Currently, no biosimilars are considered interchangeable. Also, theoretically, as there are more biosimilars introduced, it is hoped that biological pricing will go down even more. All of this means that there will be greater access to different treatments for specialty pharmacy providers to help their patients. True North offers solutions for healthcare providers who want to stay ahead.

This post can be originally seen on Mediware’s Blog.