By Ivana Magovčević-Liebisch, CEO of Vigil Neuroscience, as part of the From The Trenches feature of LifeSciVC In the last decade, our industry has made great strides in combating cancer by harnessing the body’s own immune system. As it was

The post Neuro-Immunology: The Promise Of A Differentiated Approach To Neurodegenerative Disease appeared first on LifeSciVC.

By Robert Clarke, CEO of Kinaset Therapeutics, as part of the From The Trenches feature of LifeSciVC Strategic considerations of when and how to consider raising additional capital to support clinical development in an improving but still volatile market. As

The post To B or Not to (Series) B appeared first on LifeSciVC.

Results reporting requirements are pretty clear. Maybe critics should re-check their methods?

Ben Goldacre has rather famously described the clinical trial reporting requirements in the Food and Drug Administration Amendments Act of 2007 as a “fake fix” that was being thoroughly “ignored” by the pharmaceutical industry.

Pharma: breaking the law in broad daylight?

He makes this sweeping, unconditional proclamation about the industry and its regulators on the basis of  a single study in the BMJ, blithely ignoring the fact that a) the authors of the study admitted that they could not adequately determine the number of studies that were meeting FDAAA requirements and b) a subsequent FDA review that identified only 15 trials potentially out of compliance, out of a pool of thousands.


Despite the fact that the FDA, which has access to more data, says that only a tiny fraction of studies are potentially noncompliant, Goldacre's frequently repeated claims that the law is being ignored seems to have caught on in the general run of journalistic and academic discussions about FDAAA.

And now there appears to be additional support for the idea that a large percentage of studies are noncompliant with FDAAA results reporting requirements, in the form of a new study in the Journal of Clinical Oncology: "Public Availability of Results of Trials Assessing Cancer Drugs in the United States" by Thi-Anh-Hoa Nguyen, et al.. In it, the authors report even lower levels of FDAAA compliance – a mere 20% of randomized clinical trials met requirements of posting results on clinicaltrials.gov within one year.

Unsurprisingly, the JCO results were immediately picked up and circulated uncritically by the usual suspects.

I have to admit not knowing much about pure academic and cooperative group trial operations, but I do know a lot about industry-run trials – simply put, I find the data as presented in the JCO study impossible to believe. Everyone I work with in pharma trials is painfully aware of the regulatory environment they work in. FDAAA compliance is a given, a no-brainer: large internal legal and compliance teams are everywhere, ensuring that the letter of the law is followed in clinical trial conduct. If anything, pharma sponsors are twitchily over-compliant with these kinds of regulations (for example, most still adhere to 100% verification of source documentation – sending monitors to physically examine every single record of every single enrolled patient - even after the FDA explicitly told them they didn't have to).

I realize that’s anecdotal evidence, but when such behavior is so pervasive, it’s difficult to buy into data that says it’s not happening at all. The idea that all pharmaceutical companies are ignoring a highly visible law that’s been on the books for 6 years is extraordinary. Are they really so brazenly breaking the rules? And is FDA abetting them by disseminating incorrect information?

Those are extraordinary claims, and would seem to require extraordinary evidence. The BMJ study had clear limitations that make its implications entirely unclear. Is the JCO article any better?

Some Issues

In fact, there appear to be at least two major issues that may have seriously compromised the JCO findings:

1. Studies that were certified as being eligible for delayed reporting requirements, but do not have their certification date listed.

The study authors make what I believe to be a completely unwarranted assumption:

In trials for approval of new drugs or approval for a new indication, a certification [permitting delayed results reporting] should be posted within 1 year and should be publicly available.

It’s unclear to me why the authors think the certifications “should be” publicly available. In re-reading FDAAA section 801, I don’t see any reference to that being a requirement. I suppose I could have missed it, but the authors provide a citation to a page that clearly does not list any such requirement.

But their methodology assumes that all trials that have a certification will have it posted:

If no results were posted at ClinicalTrials.gov, we determined whether the responsible party submitted a certification. In this case, we recorded the date of submission of the certification to ClinicalTrials.gov.

If a sponsor gets approval from FDA to delay reporting (as is routine for all drugs that are either not approved for any indication, or being studied for a new indication – i.e., the overwhelming majority of pharma drug trials), but doesn't post that approval on the registry, the JCO authors deem that trial “noncompliant”. This is not warranted: the company may have simply chosen not to post the certification despite being entirely FDAAA compliant.

2. Studies that were previously certified for delayed reporting and subsequently reported results

It is hard to tell how the authors treated this rather-substantial category of trials. If a trial was certified for delayed results reporting, but then subsequently published results, the certification date becomes difficult to find. Indeed, it appears in the case where there were results, the authors simply looked at the time from study completion to results posting. In effect, this would re-classify almost every single one of these trials from compliant to non-compliant. Consider this example trial:

• Phase 3 trial completes January 2010
• Certification of delayed results obtained December 2010 (compliant)
• FDA approval June 2013
• Results posted July 2013 (compliant)

In looking at the JCO paper's methods section, it really appears that this trial would be classified as reporting results 3.5 years after completion, and therefore be considered noncompliant with FDAAA. In fact, this trial is entirely kosher, and would be extremely typical for many phase 2 and 3 trials in industry.

Time for Some Data Transparency

The above two concerns may, in fact, be non-issues. They certainly appear to be implied in the JCO paper, but the wording isn't terribly detailed and could easily be giving me the wrong impression.

However, if either or both of these issues are real, they may affect the vast majority of "noncompliant" trials in this study. Given the fact that most clinical trials are either looking at new drugs, or looking at new indications for new drugs, these two issues may entirely explain the gap between the JCO study and the unequivocal FDA statements that contradict it.

I hope that, given the importance of transparency in research, the authors will be willing to post their data set publicly so that others can review their assumptions and independently verify their conclusions. It would be more than a bit ironic otherwise.
Thi-Anh-Hoa Nguyen, Agnes Dechartres, Soraya Belgherbi, and Philippe Ravaud (2013). Public Availability of Results of Trials Assessing Cancer Drugs in the United States JOURNAL OF CLINICAL ONCOLOGY DOI: 10.1200/JCO.2012.46.9577

In 2010, Melanie Reid fell off a horse and was paralyzed below the shoulders.

“You think, ‘I am where I am; nothing’s going to change,’ ” she said, but many years after her accident, she participated in a medical trial of a new, noninvasive rehabilitative device that can deliver more electrical stimulation than similar devices without harming the user. For Reid, use of the device has led to small improvements in her ability to use her hands, and meaningful changes to her daily life.

“Everyone thinks with spinal injury all you want to do is be able to walk again, but if you’re a tetraplegic or quadriplegic, what matters most is working hands,” said Reid, a columnist for The Times, as part of a press briefing. “There’s no miracles in spinal injury, but tiny gains can be life-changing.”

For the study, Reid used a new noninvasive therapeutic device produced by Onward Medical. The device, ARC-EX (“EX” indicating “external”), uses electrodes placed along the spine near the site of injury—in the case of quadriplegia, the neck—to promote nerve activity and growth during physical-therapy exercises. The goal is to not only increase motor function while the device is attached and operating, but the long-term effectiveness of rehabilitation drills. A study focused on arm and hand abilities in patients with quadriplegia was published 20 May in Nature Medicine.

Researchers have been investigating electrical stimulation as a treatment for spinal cord injury for roughly 40 years, but “one of the innovations in this system is using a very high-frequency waveform,” said coauthor Chet Moritz, a neurotechnologist at the University of Washington. The ARC-EX uses a 10-kilohertz carrier frequency overlay, which researchers think may numb the skin beneath the electrode, allowing patients to tolerate five times as much amperage as from similar exploratory devices. For Reid, this manifested as a noticeable “buzz,” which felt strange, but not painful.

The study included 60 participants across 14 sites around the world. Each participant undertook two months of standard physical therapy, followed by two months of therapy combined with the ARC-EX. Although aspects of treatment such as electrode placement were fairly standardized, the current amplitude was personalized to each patient, and sometimes individual exercises, said Moritz.

The ARC-EX uses a 10-kilohertz current to provider stronger stimulation for people with spinal cord injuries.

Over 70 percent of patients showed an increase in at least one measurement of both strength and function between standard therapy and ARC-EX therapy. These changes also meant that 87 percent of study participants noted some improvement in quality of life in a followup questionnaire. No major safety concerns tied to the device or rehabilitation process were reported.

Onward will seek approval from the U.S. Food and Drug Administration for the device by the end of 2024, said study coauthor Grégoire Courtine, a neuroscientist and cofounder of Onward Medical. Onward is also working on an implantable spinal stimulator called ARC-IM; other prosthetic approaches, such as robotic exoskeletons, are being investigated elsewhere. ARC-EX was presented as a potentially important cost-accessible, noninvasive treatment option, especially in the critical window for recovery a year or so after a spinal cord injury. However, the price to insurers or patients of a commercial version is still subject to negotiation.

The World Health Organization says there are over 15 million people with spinal cord injuries. Moritz estimates that around 90 percent of patients, even many with no movement in their hands, could benefit from the new therapy.

Dimitry Sayenko, who studies spinal cord injury recovery at Houston Methodist and was not involved in the study, praised the relatively large sample size and clear concern for patient safety. But he stresses that the mechanisms underlying spinal stimulation are not well understood. “So far it’s literally plug and play,” said Sayenko. “We don’t understand what’s happening under the electrodes for sure—we can only indirectly assume or speculate.”

The new study supports the idea that noninvasive spinal cord stimulation can provide some benefit to some people but was not designed to help predict who will benefit, precisely how people will benefit, or how to optimize care. The study authors acknowledged the limited scope and need for further research, which might help turn currently “tiny gains” into what Sayenko calls “larger, more dramatic, robust effects.”

Elemind, a 5-year-old startup based in Cambridge, Mass., today unveiled a US $349 wearable for neuromodulation, the company’s first product. According to cofounder and CEO Meredith Perry, the technology tracks the oscillation of brain waves using electroencephalography (EEG) sensors that detect the electrical activity of the brain and then influence those oscillations using bursts of sound delivered via bone conduction.

Elemind’s first application for this wearable aims to suppress alpha waves to help induce sleep. There are other wearables on the market that monitor brain waves and, through biofeedback, encourage users to actively modify their alpha patterns. Elemind’s headband appears to be the first device to use sound to directly influence the brain waves of a passive user.

In a clinical trial, says Perry [no relation to author], 76 percent of subjects fell asleep more quickly. Those who did see a difference averaged 48 percent less time to progress from awake to asleep. The results were similar to those of comparable trials of pharmaceutical sleep aids, Perry indicated.

“For me,” Perry said, “it cuts through my rumination, quiets my thinking. It’s like noise cancellation for the brain.”

I briefly tested Elemind’s headband in May. I found it comfortable, with a thick cushioned band that sits across the forehead connected to a stretchy elastic loop to keep it in place. In the band are multiple EEG electrodes, a processor, a three-axis accelerometer, a rechargeable lithium-polymer battery, and custom electronics that gather the brain’s electrical signals, estimate their phase, and generate pink noise through a bone-conduction speaker. The whole thing weighs about 60 grams—about as much as a small kiwi fruit.

My test conditions were far from optimal for sleep: early afternoon, a fairly bright conference room, a beanbag chair as bed, and a vent blowing. And my test lasted just 4 minutes. I can say that I didn’t find the little bursts of pink noise (white noise without the higher frequencies) unpleasant. And since I often wear an eye mask, feeling fabric on my face wasn’t disturbing. It wasn’t the time or place to try for sound sleep, but I—and the others in the room—noted that after 2 minutes I was yawning like crazy.

How Elemind tweaks brain waves

What was going on in my brain? Briefly, different brain states are associated with different frequencies of waves. Someone who is relaxed with eyes closed but not asleep produces alpha waves at around 10 hertz. As they drift off to sleep, the alpha waves are supplanted by theta waves, at around 5 Hz. Eventually, the delta waves of deep sleep show up at around 1 Hz.

Ryan Neely, Elemind’s vice president of science and research, explains: “As soon as you put the headband on,” he says, “the EEG system starts running. It uses straightforward signal processing with bandpass filtering to isolate the activity in the 8- to 12-Hz frequency range—the alpha band.”

“Then,” Neely continues, “our algorithm looks at the filtered signal to identify the phase of each oscillation and determines when to generate bursts of pink noise.”

To help a user fall asleep more quickly [top], bursts of pink noise are timed to generate a brain response that is out of phase with alpha waves and so suppresses them. To enhance deep sleep [bottom], the pink noise is timed to generate a brain response that is in phase with delta waves.Source: Elemind

These auditory stimuli, he explains, create ripples in the waves coming from the brain. Elemind’s system tries to align these ripples with a particular phase in the wave. Because there is a gap between the stimulus and the evoked response, Elemind tested its system on 21 people and calculated the average delay, taking that into account when determining when to trigger a sound.

To induce sleep, Elemind’s headband targets the trough in the alpha wave, the point at which the brain is most excitable, Neely says.

“You can think of the alpha rhythm as a gate for communication between different areas of the brain,” he says. “By interfering with that communication, that coordination between different brain areas, you can disrupt patterns, like the ruminations that keep you awake.”

With these alpha waves suppressed, Neely says, the slower oscillations, like the theta waves of light sleep, take over.

Elemind doesn’t plan to stop there. The company plans to add an algorithm that addresses delta waves, the low-frequency 0.5- to 2-Hz waves characteristic of deep sleep. Here, Elemind’s technology will attempt to amplify this pattern with the intent of improving sleep quality.

Is this safe? Yes, Neely says, because auditory stimulation is self-limiting. “Your brain waves have a natural space they can occupy,” he explains, “and this stimulation just moved it within that natural space, unlike deep-brain stimulation, which can move the brain activity outside natural parameters.”

Going beyond sleep to sedation, memory, and mental health

Applications may eventually go beyond inducing and enhancing sleep. Researchers at the University of Washington and McGill University have completed a clinical study to determine if Elemind’s technology can be used to increase the pain threshold of subjects undergoing sedation. The results are being prepared for peer review.

Elemind is also working with a team involving researchers at McGill and the Leuven Brain Institute to determine if the technology can enhance memory consolidation in deep sleep and perhaps have some usefulness for people with mild cognitive impairment and other memory disorders.

Neely would love to see more applications investigated in the future.

“Inverse alpha stimulation [enhancing instead of suppressing the signal] could increase arousal,” he says. “That’s something I’d love to look into. And looking into mental-health treatment would be interesting, because phase coupling between the different brain regions appears to be an important factor in depression and anxiety disorders.”

Perry, who previously founded the wireless power startup UBeam, cofounded Elemind with four university professors with expertise in neuroscience, optogenetics, biomedical engineering, and artificial intelligence. The company has $12 million in funding to date and currently has 13 employees.

Preorders at $349 start today for beta units, and Elemind expects to start general sales later this year. The company will offer customers an optional membership at $7 to $13 monthly that will allow cloud storage of sleep data and access to new apps as they are released.

If you’ve ever tried to get a bandage to stick to your elbow, you understand the difficulty in creating wearable devices that attach securely to the human body. Add digital electronic circuitry, and the problem becomes more complicated. Now include the need for the device to fix breaks and damage automatically—and let’s make it biodegradable while we’re at it—and many researchers would throw up their hands in surrender.

Fortunately, an international team led by researchers at Korea University Graduate School of Converging Science and Technology (KU-KIST) persevered, and has developed conductor materials that it claims are stretchable, self-healing, and biocompatible. Their project was described this month in the journal Science Advances.

The biodegradable conductor offers a new approach to patient monitoring and delivering treatments directly to the tissues and organs where they are needed. For example, a smart patch made of these materials could measure motion, temperature, and other biological data. The material could also be used to create sensor patches that can be implanted inside the body, and even mounted on the surface of internal organs. The biocompatible materials can be designed to degrade after a period of time, eliminating the need for an invasive procedure to remove the sensor later.

“This new technology is a glimpse at the future of remote healthcare,” says Robert Rose, CEO of Rose Strategic Partners, LLC. “Remote patient monitoring is an industry still in its early stages, but already we are seeing the promise of what is not only possible, but close on the horizon. Imagine a device implanted at a surgical site to monitor and report your internal healing progress. If it is damaged, the device can heal itself, and when the job is done, it simply dissolves. It sounds like science fiction, but it’s now science fact.”

Self-healing elastics

After being cut a ribbonlike film was able to heal itself in about 1 minute.Suk-Won Hwang

The system relies on two different layers of flexible material, both self-healing: one is for conduction and the other is an elastomer layer that serves as a substrate to support the sensors and circuitry needed to collect data. The conductor layer is based on a substance known by the acronym PEDOT:PSS, which is short for Poly(3,4-ethylenedioxythiophene) polystyrene sulfonate. It’s a conductive polymer widely used in making flexible displays and touch panels, as well as wearable devices. To increase the polymer’s conductivity and self-healing properties, the research team used additives including polyethylene glycol and glycol, which helped increase conductivity as well as the material’s ability to automatically repair damage such as cuts or tears.

In order to conform to curved tissues and survive typical body motion, the substrate layer must be extremely flexible. The researchers based it on elastomers that can match the shape of curved tissues, such as skin or individual organs.

These two layers stick to each other, thanks to chemical bonds that can connect the polymer chains of the plastic films in each layer. Combined, these materials create a system that is flexible and stretchable. In testing, the researchers showed that the materials could survive stretching up to 500 percent.

The self-healing function arises from the material’s ability to reconnect to itself when cut or otherwise damaged. This self-healing feature is based on a chemical process called disulfide metathesis. In short, polymer molecules containing pairs of linked sulfur atoms, called disulfides, have the ability to reform themselves after being severed. The phenomenon arises from a chemical process called disulfide-disulfide shuffling reactions, in which disulfide bonds in the molecule break and then reform, not necessarily between the original partners. According to the KU-KIST researchers, after being cut, their material was able to recover conductivity in its circuits within about two minutes without any intervention. The material was also tested for bending, twisting, and its ability to function both in air and under water.

This approach offers many advantages over other flexible electronics designs. For example, silver nanowires and carbon nanotubes have been used as the basis for stretchable devices, but they can be brittle and lack the self-healing properties of the KU-KIST materials. Other materials such as liquid metals can self-heal, but they are typically difficult to handle and integrate into wearable circuitry.

As a demonstration, the team created a multifunction sensor that included humidity, temperature, and pressure sensors that was approximately 4.5 square centimeters. In spite of being cut in four separate locations, it was able to heal itself and continue to provide sensor readings.

Implant tested in a rat

To take the demonstration a step further, the researchers created a 1.8-cm² device that was attached to a rat’s bladder. The device was designed to wrap around the bladder and then adhere to itself, so no adhesives or sutures were required to attach the sensor onto the bladder. The team chose the bladder for their experiments because, under normal conditions, its size can change by 300 percent.

The device incorporated both electrodes and pressure sensors, which were able to detect changes in the bladder pressure. The electrodes could detect bladder voiding, through electromyography signals, as well as stimulate the bladder to induce urination. As with the initial demonstration, intentional damage to the device’s circuitry healed on its own, without intervention.

The biocompatible and biodegradable nature of the materials is important because it means that devices fabricated with them can be worn on the skin, as well as implanted within the body. The fact that the materials are biodegradable means that implants would not need a second surgical procedure to remove them. They could be left in place after serving their purpose, and they would be absorbed by the body.

According to Suk-Won Hwang, assistant professor at KU-KIST, a few hurdles remain on the path to commercialization. “We need to test the biocompatibility of some of the materials used in the conductor and substrate layers. While scalable production appears to be feasible, the high cost of disulfide derivatives might make the technology too expensive, aside from some special applications,” he says. “Biocompatibility testing and material synthesis optimization will take one to two years, at least.”

Over the past 20 years, technological advances have enabled inventors to go from strength to strength. And yet, according to the legendary inventor Dean Kamen, innovation has stalled. Kamen made a name for himself with inventions including the first portable insulin pump for diabetics, an advanced wheelchair that can climb steps, and the Segway mobility device. Here, he talks about his plan for enabling innovators.

How has inventing changed since you started in the 1990s?

Dean Kamen: Kids all over the world can now be inventing in the world of synthetic biology the way we played with Tinkertoys and Erector Sets and Lego. I used to put pins and smelly formaldehyde in frogs in high school. Today in high school, kids will do experiments that would have won you the Nobel Prize in Medicine 40 years ago. But none of those kids are likely in any short time to be on the market with a pharmaceutical that will have global impact. Today, while invention is getting easier and easier, I think there are some aspects of innovation that have gotten much more difficult.

Can you explain the difference?

Kamen: Most people think those two words mean the same thing. Invention is coming up with an idea or a thing or a process that has never been done that way before. [Thanks to] more access to technology and 3D printers and simulation programs and virtual ways to make things, the threshold to be able to create something new and different has dramatically lowered.

Historically, inventions were only the starting point to get to innovation. And I’ll define an innovation as something that reached a scale where it impacted a piece of the world, or transformed it: the wheel, steam, electricity, Internet. Getting an invention to the scale it needs to be to become an innovation has gotten easier—if it’s software. But if it’s sophisticated technology that requires mechanical or physical structure in a very competitive world? It’s getting harder and harder to do due to competition, due to global regulatory environments.

[For example,] in proteomics [the study of proteins] and genomics and biomedical engineering, the invention part is, believe it or not, getting a little easier because we know so much, because there are development platforms now to do it. But getting a biotech product cleared by the Food and Drug Administration is getting more expensive and time consuming, and the risks involved are making the investment community much more likely to invest in the next version of Angry Birds than curing cancer.

A lot of ink has been spilled about how AI is changing inventing. Why hasn’t that helped?

Kamen: AI is an incredibly valuable tool. As long as the value you’re looking for is to be able to collect massive amounts of data and being able to process that data effectively. That’s very different than what a lot of people believe, which is that AI is inventing and creating from whole cloth new and different ideas.

How are you using AI to help with innovation?

Kamen: Every medical school has incredibly brilliant professors and grad students with petri dishes. “Look, I can make nephrons. We can grow people a new kidney. They won’t need dialysis.” But they only have petri dishes full of the stuff. And the scale they need is hundreds and hundreds of liters.

I started a not-for-profit called ARMI—the Advanced Regenerative Manufacturing Institute—to help make it practical to manufacture human cells, tissues, and organs. We are using artificial intelligence to speed up our development processes and eliminate going down frustratingly long and expensive [dead-end] paths. We figure out how to bring tissue manufacturing to scale. We build the bioreactors, sensor technologies, robotics, and controls. We’re going to put them together and create an industry that can manufacture hundreds of thousands of replacement kidneys, livers, pancreases, lungs, blood, bone, you name it.

So ARMI’s purpose is to help would-be innovators?

Kamen: We are not going to make a product. We’re not even going to make a whole company. We’re going to create baseline core technologies that will enable all sorts of products and companies to emerge to create an entire new industry. It will be an innovation in health care that will lower costs because cures are much cheaper than chronic treatments. We have to break down the barriers so that these fantastic inventions can become global innovations.

This article appears in the November 2024 print issue as “The Inventor’s Inventor.”

During a panel discussion at the Behavioral Health Tech conference, experts shared the promise psychedelic medicines hold for mental health and why employers may want to consider offering them as a workplace benefit.

The post 4 Things Employers Should Know About Psychedelic Medicines appeared first on MedCity News.

While startups in highly regulated industries like healthcare and finance are almost certain to face heightened scrutiny, there are controllable factors that can offset these challenges.

The post The Startup Economy is Turbulent. Here’s How Founders Can Recognize and Avoid Common Pitfalls appeared first on MedCity News.

Building trust while simultaneously building products, selling, recruiting, and fundraising can feel impossible. But it’s required whether you have the time or not, and it doesn’t stop no matter how big you grow.

The post The Trust-Building Playbook: 5 Tips Every Digital Health Marketer Needs to Know appeared first on MedCity News.

Faulty diagnostic tests can compromise both patient care and the nation’s response to infectious diseases—as made all too clear earlier this month when the Food and Drug Administration issued a safety alert about a COVID-19 test that carries a high risk of false negative results.

Technology has revolutionized the way people live their lives. Individuals can use smartphones to access their bank account, shop from almost any store, and connect with friends and family around the globe. In fact, these personal devices have tethered communities together during the coronavirus pandemic, allowing many people to maintain much of their lives remotely.

The Food and Drug Administration published a concept paper in early January that describes a preliminary proposal for how the agency will ensure that companies developing antibiotics for administration to animals establish defined, evidence-based durations of use for all medically important antibiotics.

Yesterday’s conference sessions surfaced interesting questions and approaches regarding the post-acute sector, bundled payment, emergency medicine and anesthesia. Post-Acute Focus: With more and more focus on the need to rationalize and re-organize the post-acute sector, we have seen multiple industry leaders start to evolve their strategies.  I blogged yesterday about AccentCare’s interesting strategy in the...… Continue Reading

In response to President Obama’s National Cancer Moonshot initiative to eliminate cancer, the USPTO has launched the “Cancer Immunotherapy Pilot Program.” The Pilot Program provides an accelerated review for applications related to cancer immunotherapy and is set to launch in July 2016. According to the USPTO, this initiative: aims to cut the time it takes to...… Continue Reading

A large amount of wind, much discussion about the U.S healthcare, and the public getting soaked again – if you were thinking about Washington, DC and the new Congress, you’re 3,000 miles away from the action. This is the week of the annual JP Morgan Healthcare conference in San Francisco, with many thousands of healthcare...… Continue Reading

Addressing the Social Determinants of Health:  Is the healthcare industry pushing a rock up a hill?  We collectively are trying to provide healthcare with improved quality and reduced cost, but the structure of the nation’s healthcare system remains heavily siloed with the social determinants of health often falling wholly or partly outside the mandate and...… Continue Reading

Day 3 of the JPMorgan healthcare conference was one of striking contrasts between the old and the new. (And, by the way, the rain finally stopped for a day, but it will be back tomorrow to finish off the last day of the conference). The Old:  Sitting in the Community Health Systems (CHS) presentation and...… Continue Reading

Some interesting presentations on the last day of the JPMorgan Healthcare Conference that concentrated on common themes – the increasing importance of ancillary business line to bolster core business revenue and of filling in holes to achieve scale and full-service offerings. Genesis Healthcare – The largest U.S. skilled nursing facility (SNF) provider, which also is...… Continue Reading

Act now for the best deal on SAS Global Forum 2016 registration. You already know that SAS Global Forum will pay for itself in learning opportunities.

Currently, more than 20 SAS products, solutions, and technology packages interact with Hadoop. Read this book to understand how to maximize your big data assets.

This paper highlights the many enhancements to SAS/ETS software and demonstrates how these features can help your organization increase revenue and enhance productivity.

To mark Breast Cancer Awareness Month, we speak to inspiring Singaporeans about their journey in battling and overcoming cancer.  Warda Ismail gets anxious about things easily, especially when it comes to her health.  So much so that her doctor once told her that she is a "borderline hypochondriac", she shared with AsiaOne in an interview.  For the uninitiated, hypochondria is a condition where a person is excessively and unduly worried about having a serious illness. To keep her mind at ease, the 44-year-old preschool educator has the habit of going for regular medical checkups.  Though she was vigilant, her worst nightmare came true — she was diagnosed with breast cancer on May 8 this year.  And in the midst of her recovery journey, she got more terrible news — her mother, who had been caring for her, was diagnosed with stage-three gall bladder cancer.  Despite the string of unfortunate events, Warda persevered and tried to have a more positive outlook on life and her health. 

HONG KONG — China's National Health Commission (NHC) published its first set of guidelines to standardise the diagnosis and treatment of obesity, with more than half of China's adults already overweight and obese, and the rate expected to keep rising.  The guidelines, made public on October 17, come as China experiences an upward morbidity trend of its overweight and obese population. The rate of overweight or obese people could reach 65.3 per cent by 2030, the NHC said.   "Obesity has become a major public health issue in China, ranking as the sixth leading risk factor for death and disability in the country," the guidelines said. China is facing a twin challenge that feeds its weight problem: In a modernising economy underpinned by technological innovation, more jobs have become static or desk-bound, while a prolonged slowdown in growth is forcing people to adopt cheaper, unhealthy diets.

BEIRUT/JERUSALEM — The Israeli military pounded Beirut's southern suburbs with airstrikes on Tuesday (Nov 12), mounting one of its heaviest daytime attacks yet on the Hezbollah-controlled area, and struck the middle of the country where more than 20 people were killed. Smoke billowed over Beirut as around a dozen strikes hit the southern suburbs starting in midmorning. After posting warnings to civilians on social media, the Israeli military said it struck Hezbollah targets in Beirut's Dahiyeh area and later said it dismantled most of the group's weapons and missile facilities. Israel said it had taken steps to reduce harm to civilians and repeated its standing accusation that Hezbollah deliberately embeds itself into civilian areas to use residents as human shields, a charge Hezbollah rejects. In northern Israel, two people were killed in the city of Nahariya when a residential building was struck, Israeli police said. Hezbollah later claimed responsibility for a drone attack that it said was aimed at a military base east of Nahariya.

As a group of friends circled a hearse, chants were heard. Then, they stopped and bowed to the portrait displayed at the front of the vehicle. This was not a typical Buddhist funeral, but rather the unconventional birthday celebration of a funeral director, reported Shin Min Daily News. According to the Chinese evening daily, a video circulating online showed the friends chanting a birthday song. The hearse's interior had been decorated with balloons and a birthday banner, with the man even laying inside for photos. The clip garnered criticism from netizens, with some deeming it overboard and disrespectful to the funeral industry. In an interview with Shin Min, director of Xin An Funeral Services Chen Weisong (transliteration) explained that he had celebrated his birthday at the company's premises with his friends and family last week. Halfway through the performances by singers, his employees and business partners had surprised him with the birthday-themed hearse bearing his portrait. Chen told 8world he was not angry and did not think it was taboo. "I was too embarrassed to turn down their gesture," he said. 

SINGAPORE - When an online retailer began selling his products on e-commerce platform Qoo10 in August 2023, he did not bat an eyelid when it took 30 to 45 days for the platform to disburse his first payout, compared with about three to seven days for other e-commerce sites he was using. But nearly a year later in July, payments owed to his business by Qoo10 had ballooned to about $1.6 million, as the platform’s payment delays exceeded two months and disbursements began trickling in, in smaller amounts. The Singaporean, who wanted to be known only as Mr T and did not wish to divulge what he sold, pulled the plug on his Qoo10 shop this year in the middle of July, and filed a civil claim with the courts. He obtained a default judgment in October for Qoo10 to pay him what he is owed, after the e-commerce site failed to serve a notice of intention to contest or not contest the claim. Mr T, who added that he had borrowed nearly $1 million from banks, friends and relatives to pay his suppliers, said: “I am not holding out hope that I will get much, or any, of my money back from Qoo10... By this point, I just want closure because it’s been so stressful.”

A grand prize of $10 million is up for grabs at the upcoming Toto draw on Thursday (Nov 14) at 9.30pm. The Group 1 prize money has snowballed over the past three draws after no Group 1 winners were picked. According to Singapore Pools' website, the prize started at $1.2 million on Nov 4 before snowballing to $2.9 million on Nov 7 and $6 million on Nov 11. The last draw on Monday yielded three Group 2 winners who won $215,010 each. Tomorrow's draw will be a cascade draw, meaning that the prize money will be split between the Group 2 winners in the event that no Group 1 winner is chosen. If there are no Group 2 winners, the prize will be split among the Group 3 winners, and so on. The last time a Group 1 prize snowballed above $10 million was during the October 21 draw where two lucky winners bagged over $6.6 million each.

SINGAPORE — Pupils who sat the PSLE will receive their results from 11am on Nov 20. The Education Ministry and Singapore Examinations and Assessment Board, in a joint statement on Nov 13, said arrangements have been made for pupils to collect their results. Pupils will get details on collection arrangements from their schools, it added. Those who are unable to collect their results from school in person can appoint someone to do so on their behalf on Nov 22. Eligible pupils will receive the Secondary 1 (S1) Option Form to select secondary schools with their PSLE results. Pupils are required to use their unique S1 personal identification number found on the top-right hand corner of the form to log in to the S1 Internet System to submit their school choices from 11.30am on Nov 20 to 3pm on Nov 26. Parents who need help with the online submission can contact the primary school before 3pm on Nov 26. Posting results will be released between Dec 18 and Dec 20 through SMS, the statement said. This information can also be accessed through the S1 Internet System or at the pupil's primary school.

JAKARTA — Indonesia said on Monday (Nov 11) it does not recognise China's claims over the South China Sea despite signing a joint maritime development deal with Beijing, as some analysts warned the agreement risked compromising the country's sovereign rights. Beijing has long clashed with its Southeast Asian neighbours over territory in the South China Sea, which it claims sovereignty over in almost its entirety via a "nine-dash line" on its maps that cuts into the exclusive economic zones (EEZ) of several countries. Joint agreements with China in the strategic waterway have for years been sensitive, with some claimant states wary of entering into deals they fear could be interpreted as legitimising Beijing's vast claims. An arbitral tribunal in 2016 said the Chinese claim, based on its old maps, has no basis under international law, a decision China refuses to recognise. A joint statement issued at the weekend during Indonesian President Prabowo Subianto's visit to Beijing mentioned the two countries had "reached important common understanding on joint development in areas of overlapping claims".

May 11, 2022

When the U.S. military trains other states’ forces, it tries to impart liberal norms such as respect for human rights. But when liberal norms clash, these soldiers prioritize loyalty to their unit, the military, and shared goals.

Nov 2, 2022

U.S. power extends beyond the military and economic spheres to include policing. The United States has used its global policing power to capture terrorists, warlords, and drug kingpins. But extradition is not simply a bureaucratic tool. States’ geopolitical interests shape their willingness to cooperate with others in extraditing fugitives. 

Feb 9, 2023

In the first comprehensive post-mortem analysis of the Noel Kempff Mercado Climate Action Project (NKMCAP), Reine Rambert and Amanda Sardonis examine how NKMCAP failed to live up to its potential, by focusing on three different dimensions of partnership effectiveness: 1) the sustainability of the partnership, 2) the effectiveness of the collaboration process itself, and 3) the achievement of the planned objectives. Rambert and Sardonis extract several transferable lessons from the challenges faced by NKMCAP that are highly consequential to partnership effectiveness.

This cable contains information which we hope will be useful to you in engaging host governments, media, and the public after the President's address.

In a wide-ranging meeting with CODEL McCaskill February 17, National Security Advisor Shivshankar Menon touched on several regional security and trade-related issues.

Menon emphasized that India had been tough on Pakistan with regard to accountability, but restrained in its rhetoric and actions.

Though the Northwest Frontier Province (NWFP) and Federally Administered Tribal Areas (FATA) continue to grab headlines for terrorist violence, poor and underdeveloped regions in the rest of "settled" Pakistan are increasingly the recruiting and training ground for extremism and militancy.

Pakistan is one of a handful of countries (including India, Brazil, and South Africa) that routinely oppose the United States in multilateral debates despite strong bilateral ties to the U.S.

Tarin requested that an additional $500 million of U.S. assistance flow through the GOP - in addition to the $174 million already committed - to bolster GOP credibility and allow the GOP to more adequately support its priorities.

Deputy Director Shen acknowledged the message but offered no further comment.

The Indian civil nuclear bureaucracy understands it is "essential" to advance cooperation with the U.S., but claims progress is stymied by the inability of U.S. firms to share sensitive technical information pending the authorizations required under U.S. licensing regulations.

In FY21, national parties and regional parties received ₹427 crore and ₹264 crore worth of funds, respectively, from unknown sources

NOTA continues to be salient in Naxalite areas, but its share has fallen in recent elections

National parties’ unknown income rose from 66% to 71% in the three years before and after the scheme’s introduction

The Pakistani Taliban on Monday claimed responsibility for the January 30 mosque attack in Peshawar which left 100 people dead and over 220 injured

Jan 10, 2023

The aim of the report is to focus specifically on the critical role of private sector investment in Ukraine’s economic reconstruction, and how the private sector, both within Ukraine and internationally, can enable Ukraine to win the peace. It provides a short overview of the economic challenges facing Ukraine, including governance, the sectors that will be critical to Ukraine's reconstruction, the roles and responsibilities for the G7, EU, IFIs, and DFIs, and then recommendations for how Ukraine and its partners can best attract private sector investment.