By Arthur O. Tzianabos, PhD, CEO of Lifordi Immunotherapeutics, as part of the From the Trenches feature of LifeSciVC As the biotech industry continues to pick up steam, I have been getting a number of phone calls from folks in

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Novartis recently announced the acquisition of Mariana Oncology, an emerging biotech focused on advancing a radioligand therapeutics platform, for up to $1.75 billion in upfronts and future milestones. The capstone of its three short years of operations, this acquisition represents

The post Mariana Oncology’s Radiopharm Platform Acquired By Novartis appeared first on LifeSciVC.

Having just turned 50, I’ve been reflecting on my first half-century of late… many fun and impactful moments, a few regrets, and a life I’ve tried to live to the fullest. One thread that has run throughout it has been

The post A Molecular Biologist’s Advice For Life appeared first on LifeSciVC.

By Arthur Tzianabos, CEO of Lifordi Immunotherapeutics, as part of the From The Trenches feature of LifeSciVC Greetings from Lake Winnipesaukee in NH where I am at this time every year. It’s midsummer and vacation time for me and the

The post A Biotech Midsummer’s Madness appeared first on LifeSciVC.

When university and hospital trusts were called to the UK parliament last year to answer questions on why they were not following the rules on reporting results, we saw how effective the questioning from politicians was. Those of you who watched the parliamentary session saw the pressure the university representatives were put under. Because the politicians asked […]

The Wall Street Journal has an interesting article on the use of “Big Data” to identify and solicit potential clinical trial participants. The premise is that large consumer data aggregators like Experian can target patients with certain diseases through correlations with non-health behavior. Examples given include “a preference for jazz” being associated with arthritis and “shopping online for clothes” being an indicator of obesity.

We've seen this story before.

In this way, allegedly, clinical trial patient recruitment companies can more narrowly target their solicitations* for patients to enroll in clinical trials.

In the spirit of full disclosure, I should mention that I was interviewed by the reporter of this article, although I am not quoted. My comments generally ran along three lines, none of which really fit in with the main storyline of the article:

1. I am highly skeptical that these analyses are actually effective at locating patients
   
2. These methods aren't really new – they’re the same tactics that direct marketers have been using for years
   
3. Most importantly, the clinical trials community can – and should – be moving towards open and collaborative patient engagement. Relying on tactics like consumer data snooping and telemarketing is an enormous step backwards.

The first point is this: certainly some diseases have correlates in the real world, but these correlates tend to be pretty weak, and are therefore unreliable predictors of disease. Maybe it’s true that those struggling with obesity tend to buy more clothes online (I don’t know if it’s true or not – honestly it sounds a bit more like an association built on easy stereotypes than on hard data). But many obese people will not shop online (they will want to be sure the clothes actually fit), and vast numbers of people with low or average BMIs will shop for clothes online.  So the consumer data will tend to have very low predictive value. The claims that liking jazz and owning cats are predictive of having arthritis are even more tenuous. These correlates are going to be several times weaker than basic demographic information like age and gender. And for more complex conditions, these associations fall apart.

Marketers claim to solve this by factoring a complex web of associations through a magical black box – th WSJ article mentions that they “applied a computed algorithm” to flag patients. Having seen behind the curtain on a few of these magic algorithms, I can confidently say that they are underwhelming in their sophistication. Hand-wavy references to Big Data and Algorithms are just the tools used to impress pharma clients. (The down side to that, of course, is that you can’t help but come across as big brotherish – see this coverage from Forbes for a taste of what happens when people accept these claims uncritically.)

But the effectiveness of these data slice-n-dicing activities is perhaps beside the point. They are really just a thin cover for old-fashioned boiler room tactics: direct mail and telemarketing. When I got my first introduction to direct marketing in the 90’s, it was the exact same program – get lead lists from big companies like Experian, then aggressively mail and call until you get a response.

The limited effectiveness and old-school aggressiveness of these programs comes is nicely illustrated in the article by one person’s experience:

Larna Godsey, of Wichita, Kan., says she received a dozen phone calls about a diabetes drug study over the past year from a company that didn't identify itself. Ms. Godsey, 63, doesn't suffer from the disease, but she has researched it on the Internet and donated to diabetes-related causes. "I don't know if it's just a coincidence or if they're somehow getting my information," says Ms. Godsey, who filed a complaint with the FTC this year.

The article notes that one recruitment company, Acurian, has been the subject of over 500 FTC complaints regarding its tactics. It’s clear that Big Data is just the latest buzzword lipstick on the telemarketing pig. And that’s the real shame of it.

We have arrived at an unprecedented opportunity for patients, researchers, and private industry to come together and discuss, as equals, research priorities and goals. Online patient communities like Inspire and PatientsLikeMe have created new mechanisms to share clinical trial opportunities and even create new studies. Dedicated disease advocates have jumped right into the world of clinical research, with groups like the Cystic Fibrosis Foundation and Michael J. Fox Foundation no longer content with raising research funds, but actively leading the design and operations of new studies.

Some – not yet enough – pharmaceutical companies have embraced the opportunity to work more openly and honestly with patient groups. The scandal of stories like this is not the Wizard of Oz histrionics of secret computer algorithms, but that we as an industry continue to take the low road and resort to questionable boiler room tactics.

It’s past time for the entire patient recruitment industry to drop the sleaze and move into the 21st century. I would hope that patient groups and researchers will come together as well to vigorously oppose these kinds of tactics when they encounter them.

A person has tested positive in British Columbia, Canadian health officials said, though the results must be sent to another lab for confirmation.

Cochlear implants—the neural prosthetic cousins of standard hearing aids—can be a tremendous boon for people with profound hearing loss. But many would-be users are turned off by the device’s cumbersome external hardware, which must be worn to process signals passing through the implant. So researchers have been working to make a cochlear implant that sits entirely inside the ear, to restore speech and sound perception without the lifestyle restrictions imposed by current devices.

A new biocompatible microphone offers a bridge to such fully internal cochlear implants. About the size of a grain of rice, the microphone is made from a flexible piezoelectric material that directly measures the sound-induced motion of the eardrum. The tiny microphone’s sensitivity matches that of today’s best external hearing aids.

Cochlear implants create a novel pathway for sounds to reach the brain. An external microphone and processor, worn behind the ear or on the scalp, collect and translate incoming sounds into electrical signals, which get transmitted to an electrode that’s surgically implanted in the cochlea, deep within the inner ear. There, the electrical signals directly stimulate the auditory nerve, sending information to the brain to interpret as sound.

But, says Hideko Heidi Nakajima, an associate professor of otolaryngology at Harvard Medical School and Massachusetts Eye and Ear, “people don’t like the external hardware.” They can’t wear it while sleeping, or while swimming or doing many other forms of exercise, and so many potential candidates forgo the device altogether. What’s more, incoming sound goes directly into the microphone and bypasses the outer ear, which would otherwise perform the key functions of amplifying sound and filtering noise. “Now the big idea is instead to get everything—processor, battery, microphone—inside the ear,” says Nakajima. But even in clinical trials of fully internal designs, the microphone’s sensitivity—or lack thereof—has remained a roadblock.

Nakajima, along with colleagues from MIT, Harvard, and Columbia University, fabricated a cantilever microphone that senses the motion of a bone attached behind the eardrum called the umbo. Sound entering the ear canal causes the umbo to vibrate unidirectionally, with a displacement 10 times as great as other nearby bones. The tip of the “UmboMic” touches the umbo, and the umbo’s movements flex the material and produce an electrical charge through the piezoelectric effect. These electrical signals can then be processed and transmitted to the auditory nerve. “We’re using what nature gave us, which is the outer ear,” says Nakajima.

Why a cochlear implant needs low-noise, low-power electronics

Making a biocompatible microphone that can detect the eardrum’s minuscule movements isn’t easy, however. Jeff Lang, a professor of electrical engineering at MIT who jointly led the work, points out that only certain materials are tolerated by the human body. Another challenge is shielding the device from internal electronics to reduce noise. And then there’s long-term reliability. “We’d like an implant to last for decades,” says Lang.

In tests of the implantable microphone prototype, a laser beam measures the umbo’s motion, which gets transferred to the sensor tip. JEFF LANG & HEIDI NAKAJIMA

The researchers settled on a triangular design for the 3-by-3-millimeter sensor made from two layers of polyvinylidene fluoride (PVDF), a biocompatible piezoelectric polymer, sandwiched between layers of flexible, electrode-patterned polymer. When the cantilever tip bends, one PVDF layer produces a positive charge and the other produces a negative charge—taking the difference between the two cancels much of the noise. The triangular shape provides the most uniform stress distribution within the bending cantilever, maximizing the displacement it can undergo before it breaks. “The sensor can detect sounds below a quiet whisper,” says Lang.

Emma Wawrzynek, a graduate student at MIT, says that working with PVDF is tricky because it loses its piezoelectric properties at high temperatures, and most fabrication techniques involve heating the sample. “That’s a challenge especially for encapsulation,” which involves encasing the device in a protective layer so it can remain safely in the body, she says. The group had success by gradually depositing titanium and gold onto the PVDF while using a heat sink to cool it. That approach created a shielding layer that protects the charge-sensing electrodes from electromagnetic interference.

The other tool for improving a microphone’s performance is, of course, amplifying the signal. “On the electronics side, a low-noise amp is not necessarily a huge challenge to build if you’re willing to spend extra power,” says Lang. But, according to MIT graduate student John Zhang, cochlear implant manufacturers try to limit power for the entire device to 5 milliwatts, and just 1 mW for the microphone. “The trade-off between noise and power is hard to hit,” Zhang says. He and fellow student Aaron Yeiser developed a custom low-noise, low-power charge amplifier that outperformed commercially available options.

“Our goal was to perform better than or at least equal the performance of high-end capacitative external microphones,” says Nakajima. For leading external hearing-aid microphones, that means sensitivity down to a sound pressure level of 30 decibels—the equivalent of a whisper. In tests of the UmboMic on human cadavers, the researchers implanted the microphone and amplifier near the umbo, input sound through the ear canal, and measured what got sensed. Their device reached 30 decibels over the frequency range from 100 hertz to 6 kilohertz, which is the standard for cochlear implants and hearing aids and covers the frequencies of human speech. “But adding the outer ear’s filtering effects means we’re doing better [than traditional hearing aids], down to 10 dB, especially in speech frequencies,” says Nakajima.

Plenty of testing lies ahead, at the bench and on sheep before an eventual human trial. But if their UmboMic passes muster, the team hopes that it will help more than 1 million people worldwide go about their lives with a new sense of sound.

The work was published on 27 June in the Journal of Micromechanics and Microengineering.

Acadia Pharmaceuticals did not disclose the buyer of the priority review voucher. The biotech received the voucher last year alongside the regulatory decision that made its drug Daybue the first FDA-approved treatment for the rare disease Rett syndrome.

The post Acadia Pharma Sells Voucher for Speedier FDA Drug Review for $150M appeared first on MedCity News.

Navigating the regulatory and ethical requirements of different medical data providers across many different countries, as well as safeguarding patient privacy, is a mammoth task that requires extra resources and expertise.  

The post AI is Revolutionizing Healthcare, But Are We Ready for the Ethical Challenges?  appeared first on MedCity News.

By fostering collaboration and seamless data integration into healthcare systems, the industry is laying the groundwork for a future in which “personalized medicine” is so commonplace within clinical practice that we will just start calling it “medicine.”

The post Driving Genetic Testing Adoption and Improved Patient Care through Health Data Intelligence appeared first on MedCity News.

As radiopharmaceuticals enter a new phase, industry leaders must rethink external services and internal capabilities to master the complexities of delivering advanced therapies.

The post Unlocking the Future of Radioligand Therapy: From Discovery to Delivering at Scale appeared first on MedCity News.

Neurogene’s Rett syndrome gene therapy has preliminary data supporting safety and efficacy of the one-time treatment. But a late-breaking report of a serious complication in a patient who received the high dose sent shares of the biotech downward.

The post Neurogene Gene Therapy Shows Signs of Efficacy in Small Study, But an Adverse Event Spooks Investors appeared first on MedCity News.

Now is the time for health plans to step up and embrace the tools and strategies that will not only meet regulatory demands, but also drive innovation in care delivery. 

The post Where Medicare Advantage Goes From Here appeared first on MedCity News.

The Pew Charitable Trusts joined dozens of research, health care, and nonprofit stakeholders in urging President-elect Joe Biden to prioritize and strengthen the national response to antibiotic resistance.

Research has consistently demonstrated strong links between people’s health and societal sectors such as employment, community development, education, housing, and transportation.

2020 was a difficult year for dental providers as the COVID-19 pandemic swept across the country. When stay-at-home orders went into effect in the spring, dental offices closed their doors to all but emergency patients.

The United States is grappling with two severe health crises: the COVID-19 pandemic and an opioid epidemic that appears to be worsening as more people deal with stress and isolation as they face increased barriers to medical care. Preliminary numbers for 2020 show that overdose deaths were outpacing the record-setting number of more than 71,000 fatalities in 2019.

Jardiance is a popular drug used to treat type 2 diabetes and help reduce cardiovascular risk. DTC campaigns […]

The post Jardiance DTC Ads: Consumer Reactions on Social Media appeared first on World of DTC Marketing.

Given his views on vaccines, pharma companies, and medical science, if Robert F. Kennedy Jr. assumed control of […]

The post The Danger of An RFK Jr Leading The FDA appeared first on World of DTC Marketing.

We’ve all seen Medicare Advantage (MA) plans become a significant player in the healthcare industry. Yet, with the […]

The post The Dark Side of Medicare Advantage Incentives appeared first on World of DTC Marketing.

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.

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. 

OTTAWA - Canada has detected its first presumptive case of H5 bird flu in a person, a teenager in the western province of British Columbia, health officials said on Saturday (Nov 9). The teenager likely caught the virus from a bird or animal and was receiving care at a children's hospital, the province said in a statement. The province said it was investigating the source of exposure and identifying the teenager's contacts. The risk to the public remains low, Canada's Health Minister Mark Holland said in posting on X. "This is a rare event," British Columbia Health Officer Bonnie Henry said in a statement. "We are conducting a thorough investigation to fully understand the source of exposure here in B.C." H5 bird flu is widespread in wild birds worldwide and is causing outbreaks in poultry and US dairy cows, with several recent human cases in US dairy and poultry workers. There has been no evidence of person-to-person spread so far. But if that were to happen, a pandemic could unfold, scientists have said.

Michelle Yeoh had never heard of Wicked before she was asked to join the cast of the movie-musical. The Oscar-winning actress plays Madame Morrible in the new film version of the hit stage show, which is based around characters first seen on screen in 1939 movie The Wizard of Oz. She's confessed she knew nothing about the popular musical before she was approached by director Jon M. Chu about joining the cast. According to The Hollywood Reporter, she said: "At that point, I had no clue what he was talking about because I had not seen Wicked the musical before. I knew Wizard of Oz, who doesn't, but not Wicked because I hadn't been going to the theatres and was not doing what I love which is watching musicals for quite a while, I hate to say." The new movie stars Cynthia Erivo as Elphaba and Ariana Grande as Glinda during their time at Shiz University in the Land of Oz with Michelle's character Madame Morrible serving as the school's headmistress. Michelle went on to say: "So I read it [the script] and called Jon back and said, 'This is a musical and she sings'. And he said, 'Oh easy, you'll have fun, you're up for the challenge.'

TORONTO — A teenager is in critical condition in a British Columbia children's hospital, sick with Canada's first presumptive human case of avian influenza. "This was a healthy teenager prior to this, so no underlying conditions," said provincial health officer Bonnie Henry in a news conference on Tuesday (Nov 12). "It just reminds us that in young people this is a virus that can progress and cause quite severe illness and the deterioration that I mentioned was quite rapid." British Columbia health officials said on Saturday the province had detected Canada's first human case of H5 bird flu in a teenager.

WASHINGTON — US President-elect Donald Trump said on Nov 12 that Elon Musk and former Republican presidential hopeful Vivek Ramaswamy will lead the newly created Department of Government Efficiency. Musk and Ramaswamy "will pave the way for my Administration to dismantle Government Bureaucracy, slash excess regulations, cut wasteful expenditures, and restructure Federal Agencies", Trump said in a statement. Trump said their work would conclude by July 4, 2026, adding that a smaller and more efficient government would be a "gift" to the country on the 250th anniversary of the signing of the Declaration of Independence. Businessman and former Republican presidential candidate Vivek Ramaswamy attends Donald Trump's campaign event sponsored by conservative group Turning Point Action, in Las Vegas, Nevada, US, Oct 24, 2024. PHOTO: Reuters file The appointments reward two Trump supporters from the private sector.

SINGAPORE — On more than 460 occasions, a man forged Grab receipts and sent them to his company, causing the firm to disburse over $16,400 to him. He also made false medical certificates and an electronic letter purportedly from the Singapore Armed Forces, causing the Ministry of Health (MOH), where he worked as a temporary staff, to excuse him from reporting for work. On Nov 12, Muhammad Fariz Shaik Sha Marican, 33, pleaded guilty to two forgery charges. Two other similar charges will be taken into consideration during sentencing. Deputy Public Prosecutor Kelly Ng said that Fariz was employed by recruitment firm Persolkelly (PSK), which worked with MOH to provide manpower. Fariz was deployed by PSK in November 2021 to work as a temporary staff for MOH to support the ministry's Covid-19 operations. In April 2023, MOH checked on Fariz's annual leave balance as the ministry wanted to convert him into a staff member.

Fugitive lawyer Charles Yeo, who is in custody in the UK, is currently awaiting an extradition hearing, reported CNA on Tuesday (Nov 12).  A court date for the extradition hearing has not been determined, but Yeo is set to attend a bail hearing on Friday, according to the report. In an Instagram post on Nov 1, the former chairman of the Reform Party said the Singapore government had made a formal request for his extradition. In his post, Yeo also said that he will be presenting himself, together with his legal team, at Westminster Magistrates Court on Nov 11. Yeo left Singapore in July 2022 after being charged earlier that year with multiple offences relating to harassment and wounding the religious feelings of Christians in several social media posts. In August 2022, a warrant of arrest was issued against him for breaching the conditions for overseas travel while on bail.  He was allowed to travel to Vietnam for work, but failed to return to Singapore and claimed he was seeking political asylum in the UK. 

Feb 10, 2024

Assaf Zoran argues that it is crucial to hold Iran accountable and convey the cost associated with arming, training, financing, and promoting violence through proxies.

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.

Dec 15, 2023

Calder Walton writes that if proved, Victor Manuel Rocha's espionage would place him among the longest-serving spies in modern times. Allowing him to operate as a spy in the senior echelons of the U.S. government for so long would represent a staggering U.S. security failure.

The Indian socialist tradition is now moribund, but there was a time when it had a profound and mostly salutary influence on politics and society. Yet few people now know of its past vigour and dynamism. The Congress, the Communists, the regional parties, the Ambedkarites, and (especially in recent years) the Jana Sangh and the [...]

Pakistan's National Security Adviser to the Prime Minister, Mahmud Ali Durrani, on the 2008 bombing of the Indian Embassy in Kabul

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

In Ambassador Mulford's January 7 farewell call on External Affairs Minister Pranab Mukherjee, the Minister said he understood the seriousness of the error in releasing sensitive intelligence from the Mumbai terrorism investigations and pledged that the Ministry would not further disseminate that information.

Benazir Bhutto claimed that the Sindh Government had informed her that if she goes to Larkhana (her ancestral home), she would be attacked.

Embassy strongly recommends against providing a U.S. Government evaluation, saying it will inevitably expose performance gaps that would not meet American standards of training and equipment.

Benazir Bhutto's public comments that she would grant the IAEA access to Khan were highly controversial in Pakistan. Zardari's options for delivering on Benazir's promise is limited.

Pakistan's National Defense University's curriculum is designed to foster national pride, but many of its students and instructors have an anti-American bias.

Chinese officials had approached the Indian government for more information but had since been reportedly told by the Indian government that the information presented was sufficient to justify the listing.

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.

The Data Point is a bi-weekly newsletter in which The Hindu’s Data team decodes the numbers behind today’s biggest stories.  

Elections in Karnataka have increasingly become bipolar, with 77% of the seats recording bipolar contests in 2018

Sep 21, 2023

Recent scholarship on Sino-Indian relations in the 1950s has emphasized cooperation, revising previous narratives of an inexorable march towards the 1962 border war. This article reassesses that cooperation by focusing on India's role as an intermediary between the unrecognized government in Beijing and the United Nations (UN). Chinese sources reveal that Sino-Indian cooperation over UN affairs was complicated by competing conceptions of how the decolonizing world should fit into the international system and who should be at the helm. Despite such disagreements, the Cold War UN provided a setting where divergent post-colonial visions could be sublimated into meaningful international cooperation.