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Friday, December 28, 2018

Help patients beat holiday blues


The holiday season is classically known as a happy time of year, but this is not always the case for some patients.
During these months, the holiday season can trigger stress related to increased expectations, finances, and family interaction, but it typically resolves once the holidays are over. However, there are other conditions that can persist past the holiday season and may require more intervention to resolve.
Moreover, patients living in cold weather climates often face symptoms consistent with Seasonal Affective Disorder (SAD). Reduced sunlight from lake-effect and daylight-savings strategies can cause a drop in serotonin levels that may trigger depression. SAD, which is a characterized by a decline in mood and associated symptoms, typically occurs in the fall and winter months, when there is less sunlight, cold weather, less outdoor activities, noted reductions in social interaction, and increased isolation.
Providers don’t have to practice in mental health to have an impact on patients with these concerns and disorders. We have the power to identify, treat, or refer patients to a higher level of care, and in some cases, save a life.
Here are a few ways we can help patients who deal with stress and depression during the holidays and winter months:
  • Encourage patients to avoid overindulging and to moderate intake of all food and alcohol to help regulate emotions during these stressful months. Urge patients that are prone to depression or the holiday blues to include more fresh foods, raw vegetables, and fruit in their diets—these foods are known to boost serotonin and dopamine in the brain, improving an individual’s mood.
  • Ask patients to continue with their regular medication routine. If they are on an antidepressant or mood stabilizer, encourage them to maintain compliance and keep up with refills to ensure they don’t run out of supply.
  • Recommend that patients maintain or increase their physical activity. Increased activity releases endorphins (mood helpers) at greater levels.
  • Suggest patients talk about how they are feeling to friends, family, or trusted counsel. If their feelings are ever accompanied by suicidal thoughts with a plan, encourage them to call 911, immediately go to the emergency room, and/or contact National Suicide Prevention Lifeline at 1-800-273-TALK.
  • Explain to patients the benefits of getting outside of themselves, in a healthy way, and practicing self-care whenever they can. That may be by volunteering for those less fortunate, practicing guided meditation and mindfulness (the Calm® app is great), immersing themselves in nature, and increasing sun exposure. Numerous studies show that spending time in nature improves concentration, decreases inflammatory markers, and improves energy.
  • Develop a mental health toolkit for your practice with ‘ready to use’ resources for providers and patients, including mental health screening tools for different diagnoses. Connect with local National Alliance on Mental Health (NAMI) chapters or research local mental health affiliates to form a community calendar of holiday events that are open to the public, make a list of Alcohol and Narcotics Anonymous meetings in your area for those with addiction, and collect healthy, easy-to-make holiday recipes. NAMI and Mental Health America have good examples of patient handouts that can be accessed online and easily printed. Also, don’t forget about the providers and office staff, because this season can be overwhelming for them too. Offer a workplace wellness activity like yoga or meditation to ease any provider burnout.
  • Assess all patients’ susceptibility to substance abuse, which can increase during the winter months. In particular, maintain an open dialog with teenagers in your practice as this population is more likely to resort to drugs and alcohol to cope with emotional distress.
While the festive spirit of the holidays sweeps the country, it’s important that we remain cognizant of the “holiday blues” that can take hold of patients who may be particularly vulnerable to these messages.
Working in mental health has taught me a lot about resilience, and I am grateful to play a part in patients regaining control of their lives. There isn’t a cure for a lot of the conditions I treat, but I am a firm believer in collaborative care and utilizing resources outside of your practice to help patients. Psychiatry is a team sport, and I have had the privilege of working with some of the brightest minds in the field.

FMCSA Says Trucks Can Use Cameras Instead of Rear-View Mirrors


The Federal Motor Carrier Safety Administration (FMCSA) has reached a decision on Stoneridge, Inc.‘s SRI 4.85% application for an exemption to rules governing “Parts and Accessories Necessary for Safe Operation.” The regulatory body granted Stoneridge a five year exemption to install its camera monitoring system on trucks in lieu of two rear-view mirrors, finding that “use of the MirrorEye system in lieu of mirrors would likely achieve a level of safety equivalent to or greater than the level of safety provided by the regulation.”
The FMCSA decision effectively legalizes MirrorEye as an after-market product and opens the door for the National Highway Transportation Safety Administration (NHTSA) to gather data and conduct its own study once MirrorEye hits the road. NHTSA governs what can be installed on the factory floor by commercial vehicle OEMS; if and when that agency approves MirrorEye, the camera system can be built into trucks from the very beginning.
Stoneridge describes itself as “an independent designer and manufacturer of highly engineered electrical and electronic components, modules and systems principally for the automotive, commercial vehicle, motorcycle, agricultural and off-highway vehicle markets.” The company’s products include various actuators and sensors used in the automotive industry, the leading telematics platform for commercial vehicles in Brazil, and vision systems including the MirrorEye Camera Monitor System.
MirrorEye replaces a truck’s mirrors with integrated external digital cameras and digital monitors inside the cab. Stoneridge says that its system’s expanded field of view, ability to display full-color night vision, and automated camera panning to continuously track the end of the trailer makes its system safer than conventional rear view mirrors.
MirrorEye isn’t just supposed to be safer, though: the improved aerodynamics achieved in European trucks by removing external mirrors created a fuel cost savings of 2-3%, according to Stoneridge.

The era of “if you can’t see my mirrors, I can’t see you” may be coming to a close.
The FMCSA verified that MirrorEye’s “wide angle, narrow angle and look-down cameras expand[ed] the [field of view] by an estimated 25 percent,” and noted the system’s fail-safe design: “The CMS has independent video processing of multiple camera images so that in the unlikely event of an individual camera failure, the other camera images continue to be displayed. This ensures that real-time images are continuously displayed without interruption.”
FreightWaves spoke to Glynn Spangenberg, partner at Spangenberg Partners, which is Stoneridge’s commercial marketing and sales representatives to the trucking industry, by phone.
Spangenberg said that MirrorEye originated as a proposal to the ATA’s Future Truck Committee in 2013, and that the product debuted at the ATA’s conference in Las Vegas in 2016. Stoneridge’s application to the FMCSA for its exemption was completed in December of 2017, and was just now finally approved.
“The FMCSA has been tremendously diligent to ensure that untested technology does not reach the public market prematurely,” Spangenberg said. He went to recount how delivering a truck equipped with MirrorEye technology to Washington D.C. and letting regulators climb inside and see its performance firsthand was a turning point for the product.
Spangenberg said that some of the government’s top policymakers, including Larry Minor, Associate Administrator for Policy at the FMCSA, Ryan Posten, Associate Administrator of Rulemaking at the FMCSA, and Jack Van Steenburg, the Chief Safety Officer and Assistant Administrator at the FMCSA, were all “blown away” by the demonstration.
“This is a foundational platform for the future,” Spangenberg said, noting opportunities in data storage and collection and the realtime insights into road conditions that could be gleaned from fully exploiting the technology.

12 Tech Trends To Watch Over The Next 12 Months

The evolution of technology spawns new generations of products and creates new markets for innovators.
Here’s a compilation of top tech predictions for 2019 based on separate reports from CB Insights and Loup Ventures.

1. Data Protection Becomes Geopolitical Issue

With increasing incidences of data breach and misuse, the accent is now on data protection. Most countries, including India and China, have demanded that multinationals localize data generated in their respective countries.
In the U.S., the data issue has elicited bipartisan support among lawmakers, said Loup Venture’s Doug Clinton.
“We see 2019 as a year of action in policy creation and expect to see a broad consumer data protection policy passed, although it may not be implemented until 2020 or later,” he said.

2. The Hyperpersonalization Trend

The year 2019 will witness cross-industry collaborations intended to better understand users in order to offer fine-tuned products, according to CB Insights.
“Personalization is inspiring more than just new product features. It’s also helping set preferences for services that are otherwise one-size-fits-all,” the firm said.
A case in point: Spotify Technology SA SPOT 1.46% tying with Ancestry.com to create unique playlists for individuals based on their DNA.

3. Smart Homes For Senior Citizens

Smart home-based technology will gain entry into senior citizen market, CB Insights said, citing recent patent filings.
Alphabet Inc GOOGL 0.51% GOOG 0.6% filed a patent for the use of “always on optical sensors” in houses that would capture data on cardiovascular function, the firm said.

4. Retail Channel Innovations

Even as physical stores have thinned out due to e-commerce dominance, a new trend is emerging: tapping into customers’ idle moments to push products. Riders can take advantage of the idle moments they spend in cabs for shopping as companies stock inventories into the cars of ride-hailing companies like Uber.

5. Automation Of Last Mile Delivery

Efforts are on to automate last-mile delivery, which is an expensive service with a human driver, costing anywhere between 1.50 and 4 euros, equating roughly to $1.75 to $4.50, CB Insights said, quoting McKinsey estimates.

6. Wearable Sleep Aid Technology

CB Insights sees wearable tech infiltrating the sleep market in 2019, with Fitbit Inc FIT 1.62%launching SleepScore — a sleep tracking program — that gives insight into the oxygen levels in the bloods and detects events that disrupt breathing during sleep.
The firm expects more sleep technology will enter the market in 2019.

7. Smart Buildings

With the accent on comfort and productivity at workplaces, smart buildings could be a tech trend in 2019. Occupancy sensors that draw data on the number of people in a room and adjust HVAC systems accordingly could see wide adoption.
Buildings will also begin to emphasize personalization, CB Insights said.

8. Green Logistics

Although owning an electric car remains relatively expensive and inconvenient for an individual, environmental consciousness could drive increasing electrification of buses used for school and public transit.
“Coupled with the urgency of decreasing emissions and the long-term lowered costs that come with electrification, expect to see other large fleets of vehicles go green in 2019,” according to CB Insights.

9. China On Forefront Of Social Media Innovation

China-based social networking activity is likely to influence Western tech, amid Chinese firms’ international foray and market share expansion with non-Chinese users.

10. Reduced Screen Time

The most interesting trend of could be a trend of reduced technology usage in light of rising mental health issues such as depression and anxiety tied to device usage, as well as the constant distraction associated with tech addictions, according to Loup Ventures.
The firm sees at least some segments of the population making conscious attempts to reduce tech use. Reducing tech time could be a top-10 New Year resolution, Loup said.

11. The Big Apple

Apple Inc. AAPL 0.05% is on track for a fruitful year in 2019, according to Loup Ventures.
The firm sees Apple outperforming the rest of the FAANG stocks in 2019 amid the rollout of its new reporting methodology that increases revenue and earnings visibility and a planned 5G rollout in 2020 or 2021.
Apple is also set to benefit from the regulatory headwinds besetting Facebook, Inc. FB 0.98%, Alphabet and Amazon.com, Inc. AMZN 1.17%.
Apple is likely to launch a new branded video streaming service similar to Netflix, Inc. NFLX 0.27%‘s in late 2019.

12. Automotive

Tesla Inc TSLA 5.65% is expected to maintain over 50-percent market share in the U.S. electric vehicle market despite legacy automakers such as General Motors Company GM 0.26% andVOLKSWAGEN AG/ADR VLKAY plunging into the sector.
Facebook’s Oculus is set to launch Oculus Quest, the first all-in-one 6DoF VR headset, in spring 2019. Munster believes Quest will be the first mainstream VR headset.
2019 could the year of tech unicorn IPOs, according to Loup Ventures. The firm expects four or more brand-name American tech companies valued at over $10 billion going public next year.

AHA survey: Hospital mergers decrease costs


However, critics note the survey of hospital executives does not necessarily show that savings generated by mergers are passed on to healthcare consumers.


KEY TAKEAWAYS

An updated survey for AHA found that mergers of hospitals within 30 miles of each other generated savings of more than $6.6 million in annual operating expenses at acquired hospitals.
That may be true, critics contend, but it’s difficult to determine if healthcare consumers are seeing lower prices because of it.
As state and federal regulators take a harder look at hospital mergers, an American Hospital Association-sponsored study suggests that in-market consolidations decrease costs and expand patient services.
The survey, In Hospital Mergers: Foundation for a Modern, Efficient and High-Performing Health Care System of the Future, is an update from a 2017 survey that interviewed health system executives on the benefits of mergers and acquisitions, and examined data on the impact on costs and quality.
The report comes as the AHA levelled criticism against the Federal Trade Commission for a hospital merger review process that AHA said was “overbroad” and “does not properly credit the many pro-consumer benefits of hospital transactions, and ignores key realities of the marketplace.”
The newly extended survey—conducted by Charles River Associates—found that mergers of hospitals within 30 miles of each other generated savings of more than $6.6 million in annual operating expenses at acquired hospitals.
“These findings are important because antitrust authorities and some researchers have suggested that mergers involving hospitals in closer proximity can raise particular competitive issues,” the survey found.
“Data demonstrating that there are somewhat greater cost savings from such mergers, no increase in revenues and some evidence of quality improvements underscore the procompetitive potential of such mergers and their likely benefits for patients,” the survey said.
Matt Schmitt, an assistant professor of strategy at UCLA, whose research was cited in the Charles River report, says the findings are true, to an extent.
“My own research and that of CRA suggests that the average hospital merger reduces costs. That said, there is likely substantial heterogeneity across mergers,” Schmitt said in an email to HealthLeaders.
“Some mergers likely reduce costs by quite a bit, whereas others have no effect (or even increase costs). I believe that it is unwise to apply the results of these aggregate studies to individual mergers: in my view, case-by-case analysis is necessary,” he said.
Schmitt says it’s “much less apparent” if merger savings trickle down to consumers in the form of lower healthcare prices.
“There are two steps here. First, whether those savings trickle down to insurers in the form of lower negotiated rates,” he said. “Second, whether those lower negotiated rates trickle down to consumers in the form of lower premiums and/or more generous benefits.”
Schmitt said the CRA report’s attempt to examine revenue per admission “is very rough.”
“For example, it includes Medicare and Medicaid, when negotiated rates between hospitals and commercial insurers is what we really want to see,” he said. “Unfortunately, given the proprietary nature of hospital/insurer negotiations, it is not easy to get access to good data on those rates.”
Schmitt said one study published in May found higher post-merger prices when the merging hospitals are geographically close.
“Overall, the jury remains out with respect to whether hospital mergers benefit consumers, both financially and perhaps more importantly with respect to the quality of care,” Schmitt said.

Massachusetts Biotechs Raise $2.4 Billion in 2018 IPOs


Biotechs across the globe have raised a significant amount of capital through initial public offerings this past year. The total amount of IPOs raised this year is around $8.2 billion, eclipsing 2014’s record of $6.5 billion. In the state of Massachusetts, 17 companies combined to raise $2.4 billion in IPOs over the course of 2018.
Most of the IPOs that occurred in the Bay State have been well-documented by BioSpace. But, with a new calendar year upon us, it’s a good idea to look back at a banner year of capitalization that may not repeat when January rolls around. With the turn of the year only days away, BioSpace takes a look at some of the key Massachusetts-based IPOs.

It should be no surprise that Moderna Therapeutics hit the top spot for IPOs. The company set an industry record with a $604 million IPO this month. Moderna, which focuses on messenger RNA (mRNA) therapeutics, has a development pipeline of 21 programs. The company has 10 products in the clinic, nine in Phase I and one in Phase II.
Cambridge, Mass.-based Rubius Therapeutics secured $277 million in its IPO. As the company looks to file an Investigative New Drug Application for RTX-134 in the first part of 2019, Rubius wanted to secure enough funding to support the development of the treatment for phenylketonuria (PKU). Rubius specializes in engineering red blood cells to have medicinal purposes. The company’s therapeutic program turns stem cells into red blood cells and then introduces genetic material into the cells to express specific proteins, which will make them uniquely suited for treating a variety of diseases, including cancer and metabolic disorders
Homology Medicines closed out its IPO at $163 million, a little higher than the $144 million after the first round of trading. Homology is developing a gene-editing technology that it believes is safer than other existing technologies, such as the popular CRISPR-Cas9. Homology has developed its AMEnDR (AAV-Mediated Editing by Direct Homologous Recombination) platform for rare genetic diseases. The company’s lead therapy HMI-102 is being developed for the treatment of adult phenylketonuria (PKU), a metabolic disease caused by a mutation in the PAH gene.
With a focus on developing a gene therapy treatment for Duchene muscular dystrophy, Solid Biosciences raised $133 million in its IPO. The company is developing SGT-001, a novel adeno-associated viral (AAV) vector-mediated gene transfer treatment that is under investigation for its ability to address the underlying genetic cause of DMD. The company’s belief is that SGT-001 could be a one-time treatment for the devastating disease regardless of genetic mutation or stage of the disease.
Lexington, Mass.-based Translate Bio raised $115 million in its IPO to support development of its cystic fibrosis treatment, MRT5005. MRT5005 is an mRNA product candidate designed to treat the underlying cause of cystic fibrosis. The company planned to initiate a Phase I/II trial for MRT5005 in the middle of 2018.
About the same time Translate Bio filed, another Massachusetts-based company, Neon Therapeutics also filed for its IPO. The company raised $100 million to support the development of NEO-PV-01, a personal cancer vaccine designed uniquely for each patient based on DNA mutations from the patient’s tumor.
In addition to Neon Therapeutics, Massachusetts saw a number of $100 million IPOs from biotechs this year. Also hitting that century mark was Replimune and Magenta Therapeutics.
Other Bay State biotechs that went public this year are, according to a list compiled by Bostonomix, are Avrobio, which raised $114 million; Surface Oncology, which raised $108 million; Restorbio, which raised $97 million; Scholar Rock, which raised $86 million; Evolo Biosciences, which raised $84 million; Entasis Therapeutics, which raised $75 million; Cue Biopharma and Unum Therapeutics, which both raised $69 million; and Constellation Pharmaceuticals, which raised $60 million.

2019 biotech preview: Money is pouring into the Bay Area and so is Big Pharma

Person to watch
The 25-year Genentech veteran — most recently in charge of clinical operations — after a year on the job is leading early cancer diagnostics company Grail toward a potential $500 million IPO. Grail is also launching a 50,000-person study to see if its technology can detect multiple cancer types earlier, particularly lung cancer.
Technology to watch
AI / ML
From Daphne Koller’s Insitro to Alice Zhang’s Verge Genomics Inc., artificial intelligence and machine learning are moving beyond hype to real-time lab use. The coming year is critical to proving the technology can not only help discover drugs but move compounds effectively and efficiently through clinical trials.

Trends to watch
Big Pharma reshaping Peninsula landscape
Big Pharma is taking a growing footprint on the Peninsula. So, while developers continue to build new biotech labs and offices at a record pace, space is being eaten up quickly by large and maturing companies — and those companies are booking years in advance.
Diving deeper into cancer immunotherapy
Drugs that mark tumors for death and boost the immune system’s reaction work for only a small percentage of cancer patients. But a number of companies are pursuing next-generation drugs to boost response rates and expand into different types of cancer.
Grail’s IPO may jumpstart more offerings
Early cancer detection company Grail, based in Menlo Park, is readying a big initial public offering. The potential $500 million IPO could reset investor interest in biotech after a lackluster fourth quarter of Bay Area IPOs.
Competition for talent
Thanks to a steady flow of venture capital and IPOs, life sciences companies are fighting for workers. But it’s a sellers market, so recruiters say companies need to find new ways to attract and retain employees, especially millennials.

5 Key events from 2018
Gilead’s new CEO
The Foster City-based drug powerhouse, which brought to market life-changing HIV and hepatitis C drugs, named Roche veteran Daniel O’Day as its new CEO and chairman as it pushes deeper into cancer.
Big IPOs — and then unease
Bay Area life sciences companies raised $2 billion through 15 initial public offerings. The biggest IPOs came in October, just before the market turned south.
Kilroy plants flag on Oyster Point
Kilroy Realty Corp. paid $308 million in May for a 40-acre waterfront site at the terminus of Oyster Point Boulevard, targeting as much as 2.5 million square feet of biotech lab and office space. Kilroy bought the site from a company controlled by China’s Greenland USA.
New drugs, new manufacturing
Gene therapies and cell therapies are pushing Bay Area companies to build their own manufacturing sites in the East Bay and Peninsula. Emeryville’s Gritstone Oncology Inc. opened a manufacturing facility in Pleasanton, for example, and gene therapy company Orchard Therapeutics is looking to build out space in Fremont.
AbbVie’s big lease
Drug maker AbbVie Inc. said in November that it would build out a research center in 479,000 square feet in BioMed Realty’s under-construction Gateway of Pacific in South San Francisco. The company also will roll up recent acquisitions, such as Pharmacyclics and StemCentrx.

Mitochondrial dysfunction biotech Stealth files for a $86 million IPO


Stealth BioTherapeutics, a US-based mitochondrial dysfunction biotech in clinical trials, filed on Friday with the SEC to raise up to $86 million in an initial public offering.
The Newton, MA-based company was founded in 2006 and plans to list on the Nasdaq under the symbol MITO. Stealth BioTherapeutics filed confidentially on October 26, 2018. Jefferies, Evercore ISI and BMO Capital Markets are the joint bookrunners on the deal. No pricing terms were disclosed.