The logic of biologics

By Catherine

Written by Catherine Bolgar, in association with WSJ custom studios

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Biologics have long been the great hope in the fight against non-communicable diseases.  Cancer, cardiovascular and chronic respiratory diseases, diabetes and mental health account for 63% of all deaths world-wide. According to a 2011 World Economic Forum report, these diseases will cost some $47 trillion in lost global output over the next two decades. Unsurprisingly, biologics are grabbing an increasing share of the blockbuster drugs market; in 2014 they represented six of the world’s 10 best-selling pharmaceuticals.

Unlike conventional chemical-based drugs, biologics are organic and consist of larger molecules, with thousands of times more atoms. Their greater complexity, however, means that “the regulatory pathway is more cumbersome,” notes Ranjith Gopinathan, program manager, life sciences in the European health-care practice of Frost & Sullivan, a global market research and consulting firm. Of the 41 new drugs approved by the U.S. Food and Drug Administration in 2014, only 11 were biologics.

Never the less, biologic drugs that have been approved have made a huge and rapid impact. Take Sofosbuvir (sold by Gilead as Solvaldi), an anti-viral medication that helps cure hepatitis C. With some 150 million sufferers world-wide, the drug became a global best seller within its first year on the market.

One of the hottest areas in biologics is the development of monoclonal antibodies. These mimic the body’s natural antibodies and have proven to be particularly effective in cancer treatment. They can make cancer cells more visible to the immune system, block growth signals, prevent new blood vessel formation in tumors, and deliver radiation or chemotherapy to cancer cells.

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Trastuzumab (sold by Roche as Herceptin), for example, is a monoclonal antibody that targets the HER2+ receptor in breast cancer, a genetic variation found in 15% of  breast cancer patients. When used with other chemotherapy drugs, Herceptin increases survival rates 37%. Roche has come up with other biologics—pertuzumab (sold as Perjeta) and trastuzumab emtasine (sold as Kadcyla)—that can further improve Herceptin’s results, says Barbara Gilmore, a senior industry analyst at Frost & Sullivan.

Another monoclonal antibody, launched on the U.S. market in March 2015, is dinutuximab, (marketed by United Therapeutics as  Unituxin). Containing mouse and human components, it helps the immune system find and destroy cancer cells by targeting a substance found on the surface of neuroblastoma tumor cells. Neuroblastoma cancer starts in the nervous system and typically afflicts children under five.

Monoclonal antibodies are key to the success of targeted therapeutics, a process that attacks diseases without affecting healthy cells and tissues. Meanwhile, advances in companion diagnostics and genetic profiling would bolster personalized medicine.

“The growth will be in personalized medicine and targeted therapeutics,” says Mr. Gopinathan. “More efficient drug-development processes based on the disease pathophysiology and genetic risk factors would be game-changers in the industry.” He predicts: “Biologics will continue to outpace overall pharma growth.”

Another promising growth area lies in non-brand versions of biologics, known as “biosimilars.” These are analogous to the $261 billion generic drugs market that replicates conventional drugs whose patents have expired.

One such biosimilar, developed by Novartis, is Zarxio , a version of Amgen’s filgrastim (sold as Neupogen), which helps prevent infection during chemotherapy. Amgen is also developing six of its own biosimilar drugs.  “Here’s a biotech company that makes biotech drugs, and even though they have a robust pipeline, they’re also making biosimilars,” says Ms. Gilmore. “It’s very smart. There’s money to be made there.”

Frost & Sullivan forecases a 60% compound annual growth in the biosimilar market between 2012 and 2019. A RAND Corp. study estimates  that biosimilars could reduce spending on biologic drugs in the U.S. by $44 billion over the next decade, while Spain’s University of the Basque Country forecasts €20 billion savings in Europe through 2020.

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However, getting biosimilars into the market remains a major challenge. Biologics’ complexity makes them hard to replicate because they use biological processes or living organisms to create the drugs’ molecules.

The European Union has approved only 19 biosimilar drugs since 2006, and the U.S. approved its first biosimilar, Zarxio, in March 2015. Herceptin lost its patent protection last year in Europe and will lose its U.S. patent in 2019, but no biosimilars have yet been approved in those jurisdictions, an indication of how difficult the process is.

Moreover, unlike generics, biosimilars are not much cheaper than their originals to produce. Mr. Gopinathan calculates that “the price reduction is, at most, 30%.” Health care’s great hope will still come at a price.

 

For more from Catherine, contributors from the Economist Intelligence Unit along with industry experts, join the Future Realities discussion.

How Medicine Makes Sense of Big Data

By Catherine

Written by Catherine Bolgar*

Big data for Medical

Big data is a game-changer for medical research. The ability to analyze vast sets of information, thanks to bigger and faster computers, is helping researchers to understand diseases, tease out genetic factors and spot patterns.

More researchers are looking at big data and understanding how we can utilize [it] in a better manner,” says Ervin Sejdic, assistant professor of electrical and computer engineering at the University of Pittsburgh, U.S., and founder of its Innovative Medical Engineering Developments lab.

In the past, clinicians would get data from patients and hold it up to metrics to try to see something by looking among different patient groups. “What they’re doing is flushing out the details. But the devil lies in the details,” Dr. Sejdic says. “The details are where we start understanding things. What’s really shifting in medicine is the fact that, yes, there is data, but let’s look at whole data sets.”

At the same time, better and smaller electronics, from smartphones to sensors you can wear, can compile more information at a detailed level and over bigger populations. “Researchers are looking at the interactions between different physiological systems. Sometimes these interactions break down in people with various diseases. Sometimes you have to look at the level of a minute, or an hour, or a day,” Dr. Sejdic says. “What big data is going to enable us to do is finally look at a human system as a system, rather than as individual components put together.”

Big data also is helping doctors and researchers to view diseases in shades of gray, rather than with a purely black-and-white outlook.

In the past, diseases were viewed in a simplistic way: a person is healthy or a person has disease. We would get specific information about the two states and compare the difference,” says Sergei Krivov, research fellow at the University of Leeds, U.K., who recently published research on the monitoring of kidney-transplant patients using big data techniques.

With transplants, he says, “There are two outcomes: perfect or problems. We are trying to find a single parameter to describe where you are between these two stages and what is the prognosis.” Based on the indicator, doctors can decide at an earlier stage whether to intervene into the process.

What I would like to see in the future is the following picture,” Dr. Krivov says. “A sizable part of the population frequently gives blood for analysis, for example during regular visits to their doctors. This would go to a data center. Based on this data for five or 10 years, we could determine indicators describing the degree of progression or the likelihood to occur for different diseases. We will give back this information as numbers, which is easy to interpret. This, in turn, will encourage patients to participate.”

One indicator patients might get with this approach is their biological age. “So you’re 30 years old, but your biological age is 20—or 40,” Dr. Krivov says. “Changes in your diet, exercise or lifestyle affect biological age. You might get younger, biologically. That would be reinforcement to the patient that he or she is doing well.”

DNA moleculeSome recent uses of big data include predicting the future of metabolic syndrome, advancing neuroscience, identifying dangerous pathogens, and conducting cancer research, among many others. DNA sequencing is getting cheaper thanks to big data, and genetic sequencing with big data is becoming a key part of epidemiology, because it helps trace chains of infection. Big data is helping researchers not only to understand the different genetic mutations in cancer, but also to personalize medicine: different mutations respond differently to treatments, and getting the right treatment straight away spares patients from side effects of treatments that aren’t effective for their particular kind of cancer.

However, challenges remain for big data to reach its full potential of analyzing many kinds of information from many patients. With computers, it’s “garbage in, garbage out,” so data needs to be structured to ensure consistency. Information often isn’t shared because organizations lack procedures or systems for communication. Advances in technology are helping to overcome some of those challenges, according to “The ‘Big Data’ Revolution in Healthcare,” a study by McKinsey & Co.

Big data is still a work in progress in medicine. “If a certain number of people have a disease, the task of searching for them will take minutes instead of days,” Dr. Sejdic says. “But for other things, it will still take days because you need to develop software first for analyzing the data.”

Too much data can be a problem, too. “When you know what you want to find out, it’s a much easier problem,” he says. “But if you’re looking for new patterns, it’s more of a fishing expedition. Whenever we do clinical trials, we are flushing out the details. There’s so much information that it’s hard to track it. Until we do that, we won’t have a good understanding. The major change will occur in the next 10 to 15 years.”

*For more from Catherine, contributors from the Economist Intelligence Unit along with industry experts, join The Future Realities discussion.

Designing for the Medical Device Industry: The Future – Connected Health

By Helene
Initially posted by CORE77

With the explosion of wearable technology and legislation like the Affordable Care Act, the medical product industry is rapidly evolving. Healthcare is seeing unprecedented changes, creating new opportunities for devices that connect consumers and doctors to information faster, easier, and more efficiently.

“It’s coming to a point where there are just amazing breakthroughs every day,” says Tor Alden, Principal and CEO at HS Design (HSD), where he has been directly involved in medical design for over 14 years. “[Technologists] are innovating and changing the landscape of how healthcare is going to be done to the point where we’re not going to recognize it in the next three or four years from where it is now.” It’s a changing landscape that has caught the eye of many innovative startups, who now make up half of HSD’s client list.

These new products have amazing technology, but it needs to be humanized and centered on user needs to be successful.”

HSD is positioning itself to be a bridge connecting the medical and healthcare startups with the investment banker communities. Alden predicts that if the growth continues at this rate, that number could be closer to 80% in the next few years.

The AliveCor heart monitor. Designed by Karten Design.

One of the factors opening the door for innovation in the medical device industry is the Affordable Care Act. As requirements roll out for health care providers, there is an increasing need for new tools and products that ensure patient compliance. Take a typical hip replacement, for example: Under the Affordable Care Act, if a doctor or hospital is not tracking the compliance and rehabilitation of that patient and they return within a year with no improvement, the hospital owes money to the government. There’s a financial incentive to make sure patients get better and, therefore, to track and evaluate their progress. This could spur invention around hip replacements—possibly leading to one with a chip (i.e., embedded UDI) to track rehabilitation or remind patients to get complete their physical therapy exercises.

“The Affordable Care Act is a great opportunity for the design community right now. Everybody is trying to figure out how to innovate increase patient compliance and allow caregivers tools to manage the healthcare services,” says Alden. “Between that and the iHealth generation of iPhones, smartphones, iPads, and everybody wanting to have more control over their healthcare knowledge, there’s a huge opportunity for new products.”

In the century of the wearable device, nearly everyone has some type of personal fitness tracker. For the medical device industry, this means a rise in connected health as consumers clamor to track everything from their steps to calories to sleep cycles. With that surge in technology comes an accelerated need for the design and development of interfaces between the technology and the consumer. “This is the most interesting space that a designer could work today. It’s fascinating,” shares Aidan Petrie, Co-Founder and Chief Innovation Officer of Ximedica, a medical product development company headquartered in Rhode Island. “We work between humans and the products they use and make sure that they are more usable, satisfactory and safer.”

Ideation & Concept Design

Despite the incentive for new and better products, the medical device industry remains a difficult niche to break into, due to FDA regulations, enormous amounts of capital required, the need for a high level of specialization, and timelines that span 2–6 years. All these factors contribute to a high failure rate, causing many of these projects to be cancelled before they even reach the prototype stage.

Dassault Systèmes is trying to lower that rate of failure by creating software applications that help these companies better understand and anticipate these challenges from the beginning of a project. The software company released an all-in-one program called Ideation & Concept Design for Medical Device industry solution experience, a cloud-based platform designed specifically to take a team through the entire product development process. From initial ideation and market research to verification and validation, the system tracks deliverables and traceable requirements demanded of the strict FDA and other regulations around this sector. With Ideation & Concept Design for Medical Device, Dassault Systèmes shortens the amount of time it takes to bring a product to market, which is critical in a quickly expanding market where there is no time to waste.

The medical device industry will explode for the next twenty years. It will be the place to be focused as a designer,” says Petrie. “It’s great doing things that change people’s lives, and a product can still look beautiful at the same time.”


Check out Beyond the design of the Medical Device to dig deeper into this topic and access the “Ideation & Concept Design for Medical Device” information kit here, over on Dassault Systèmes’ site:  Ideation & concept design for medical device.



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