Author: David Altman

Getting academic diagnostic discoveries to market: 6 tips from industry

diagnosticsdiagnostics (008) Loading of QIAsymphony platform“Wouldn’t it be great if we could come up with a noninvasive diagnostic assay to detect pancreatic cancer at an earlier, more treatable stage?” asked Lori Aro of Myriad Genetics. Her company has been trying to do so for years. So why hasn’t it happened?

Aro, senior director for new product planning at Myriad, outlined the business obstacles at a recent panel hosted by Boston Children’s Hospital’s Technology and Innovation Office (TIDO).

First, who are the target patients for a pancreatic cancer test? Skinny diabetics, patients with chronic pancreatitis, patients with hereditary cancer risk — or all three? “Those three patient types all sit in different doctor’s offices,” said Aro. Simultaneously reaching endocrinologists, gastroenterologists and high-risk patients would be an insurmountable challenge, Myriad concluded.

Second, the assay would likely need to be validated in all three patient populations, with confirmatory imaging. Could the test populations be large enough to make the results statistically significant?

Third, a new test wouldn’t change care, as there is no treatment for pancreatic cancer. In fact, no current data show that earlier diagnosis improves survival. So who would pay for it?

Aro’s story exemplifies just some of the challenges in developing a new diagnostic test.

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Microbiome therapeutics: 6 takeaways from a MassBio panel

microbiome therapeuticsSeeing the surprising success of “poop pills” in gastrointestinal C. difficile infection, pharma companies and startups are embracing the microbiome as a new therapeutic target for an astonishing range of maladies. To learn what pioneering companies in the space are thinking about the hope and the hype, Vector recently attended a panel on microbiome therapeutics at the MassBio Annual Meeting.

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Cloud-based complex care platform empowers clinicians and families alike

care coordination planningFor children with complex medical needs, care coordination across medical specialties is a major pain point, as is communication across multiple provider systems. And patients aren’t the only ones feeling the burden. Consider these startling statistics:

  • $25-$45 billion is wasted annually in the U.S. due to poor communication in health care.
  • $45 billion has been invested in tools that record and bill for care, but don’t manage care.
  • 40 percent of medical malpractice claims stem from poor communication.

Isaac Kohane, MD, PhD, and Kenneth Mandl, MD, of the Boston Children’s Hospital Computational Health Informatics (CHIP) program, felt care coordination was an area ripe for a technological solution.

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Risk mitigation made easy: Apps make hospital safety proactive

A environmental health & safety hospital hot zone
A hospital ‘hot zone’

Hospitals are among the most hazardous workplaces in the U.S. In 2011, according to the Occupational Safety and Health Administration, 253,700 accidents were reported, an average of 6.8 work-related injuries for every 100 full-time employees. Rates of injuries reported to OSHA are decreasing in all industries except for hospitals, whose rates are double the average.

Could a set of digital apps help identify and reduce occupational and environmental risks in a quick and efficient manner? That is what Nick Kielbania, MS, CSP, CHMM, director of Environmental Health & Safety (EH&S) and Adrian Hudson, PhD, MCompSc, principal software architect at Boston Children’s Hospital, set out to create.

Their web-based solution, enabled for Apple and Android devices, is called the BCH Environmental Health and Safety Application Suite. Designed to aid hospital emergency response, safety and support services, the applications encompass fire, clinical, research, construction and environmental safety, with additional apps for on-call and administrative personnel.

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Can the collaborative economy work in health care?

Airbnb Uber model health care
Airbnb and Uber have disrupted the hotel and taxi industries by finding and tapping unused assets. What's in store for medicine?

David Altman is manager of marketing and communications in Boston Children’s Hospital’s Technology and Innovation Development Office.

Robin Chase, co-founder of Zipcar and current CEO of Buzzcar, envisions collaboration as the future of the world’s economy. Her concept, PeersIncorporated, brings excess capacity of consumer goods or assets—such as unused time or untapped data—to online platforms and apps where consumers (“peers”) provide insights that drive business growth.

Speaking recently at Boston Children’s Hospital, Chase elaborated on the concept of excess capacity, which is the basis of Buzzcar. Typically, families pay an average of $9,000 a year—$25 a day—for cars they use only 5 percent of the time. That unused time represents value and economic potential. Buzzcar’s platform harnesses that unused capacity, allowing multiple peers to supply and book cars on an easy-to-use website at a low cost.

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AudioHub app: Bringing hearing tests into the 21st century

sound wave AudioHub audiologyThere are 36 million Americans with hearing loss. Nearly 15 percent of children ages 6 to 19 have some level of hearing problems, according to the CDC, and the elderly population’s need for audiologic services is growing. Yet the number of audiologists is predicted to decrease in the coming years, increasing the need to make audiology practices more efficient.

For the past seven years, audiologists at Boston Children’s Hospital’s Department of Otolaryngology and Communication Enhancement have recorded hearing test results using an audiogram software application called Mi-Forms. The software was developed in 2007 to help with documentation. At the time, most audiology clinics used (and most still use) pen and paper, so Mi-Forms was a big advance. It’s been used by more than 90,000 Boston Children’s patients, reducing the clinic’s administrative burden by an estimated 11 percent.

However, over time, limitations became apparent.

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New therapeutic development models build researchers’ commercialization savvy

Academic and industry partners are explicitly working to fill pharma pipelines.
Academic and industry are explictly partnering to fill pharma pipelines.

Academic researchers and physician innovators are great at making research discoveries and developing inventions at an early stage. But if you were to fund them to turn their research findings into a product, would they have the expertise and experience needed to be successful? Most would not.

The investment community talks about the innovation funding gap, a.k.a. the “valley of death.” But there is also a knowledge gap on the part of academic researchers when it comes to transforming their technologies into therapeutics. Most want their findings to lead to new treatments for patients, but they lack the experience and expertise that companies have to advance early-stage research to a clinical stage. That includes expertise in designing pre-clinical experiments and navigating regulatory pathways for commercial development.

Academics often enter agreements with pharmaceutical companies, many of which are early-stage research grants. Often, these industry-sponsored research projects end with a scientific publication and are unsuccessful in generating new therapeutics—a subpar outcome for the company investor.

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Stopping blindness: The drug-eluting contact lens

drug-eluting contact lens
(John Earle Photography)

Growing up, my grandmother’s eyes were always a problem. For years, she was losing her central vision to glaucoma, and numerous surgeries and treatments did not seem to help. Later in life, she could not see my face but could always tell who I was when I was close.

Glaucoma is the leading cause of irreversible blindness worldwide. While FDA-approved medications such as latanoprost can prevent vision loss by reducing pressure in the eye, their beneficial effects are limited by poor patient compliance: At six months of treatment, compliance is estimated to be little more than 50 percent.

Why? First, the medications are typically delivered as eye drops, and the drops themselves can cause stinging and burning. The drops also contain preservatives that can cause ocular surface disease.

Perhaps most importantly, latanoprost and other glaucoma drugs halt the disease’s progression but do not reverse it. Taking the drugs does not provide positive feedback that will motivate patients, such as relieving pain.

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The Accelerating Medicines Partnership: Transforming biomedical consortia and R&D

Group handshake representing a consortiumDavid Altman is manager of marketing and communications in Boston Children’s Hospital’s Technology and Innovation Development Office.

Successful therapeutic development requires multiple stakeholders along the path from discovery to translation to clinical trials to FDA approval to market availability. At various points along this path, academia, industry, government, hospitals, nonprofits and philanthropists may work together. Would bringing these stakeholders together from start to finish lead to greater success?

A growing number of private-public consortia are launching in defined “pre-competitive” spaces where potential rivals collaborate to generate tools and data to accelerate biomedical research. In 1995, consortia were rare in health care: Only one was created. In 2012, 51 new consortia were launched, according to the organization Faster Cures.

Why? you may ask. Banding together in consortia can reduce costs, minimize failures and shorten the timeline to approval for new drugs.

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The ever-changing, interwoven regulatory and drug-pricing landscape

Tangled roots
Drug approval is increasingly intertwined with pricing questions.

At last month’s BioPharm America conference, what I originally thought would be a run-of-the-mill panel wound up being a frank discussion about regulatory and pricing challenges that pharma and biotech companies are facing today. I hadn’t realized these two challenges are intertwined so closely.

The regulatory and pricing paths for new drugs in the United States have become increasingly difficult to navigate. Due to outside policy pressures, the FDA is scrutinizing drugs more than in the past, requiring much more data. Even when a drug is approved, there is no guarantee that payers will cover its full cost, as they are starting to consider the drug’s overall value—improving quality of life and decreasing costs—along with its effectiveness.

Meanwhile, in many European single-payer countries, pharmaceutical companies are being told how to price their drugs before they are considered for approval by the regulatory agencies. The likely effect is less return on investment on new drugs, which could in turn decrease the pace of innovation.

Vaughn Kailian, managing director of MPM Capital, a health care venture capital investment firm, led an eye-opening conversation around these topics.

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