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Last week, the Trump administration announced it was evaluating proposals to allow consumers to buy drugs legally from Canada. HHS Secretary Alex Azar said that the Trump administration will consider new rules that would allow states, pharmacies and other parties to bring drugs from Canada as part of pilot projects. In addition, the U.S. Food and Drug Administration (FDA) might allow manufacturers to import the U.S. version of their drugs that they sell internationally.

Canada, however, is opposed to this policy. An April briefing for Canadian officials stated, “Canada does not support actions that could adversely affect the supply of prescription drugs in Canada and potentially raise costs of prescription drugs for Canadians.” The briefing was prepared by the Canadian foreign ministry to be used by Canadian officials speaking with U.S. officials.

In a follow-up with Canadian ministry officials at Health Canada, the ministry told Reuters they had “made Canada’s position clear” to federal and state officials in the U.S. and was prepared to “take action to ensure Canadians have uninterrupted access to the prescription drugs they need.”

Today, Canada’s primary pharmaceutical lobby group, Innovative Medicines Canada (IMC), urged the Canadian government to respond to the U.S. plans before it caused drug shortages in Canada. An earlier version of its briefing called for a government ban of all drug exports “unless otherwise permitted by regulation.”

A May Canadian talking points document stated, “Wholesalers should not be permitted to export drugs in bulk from Canada, and there should be strict and significant penalties for exporting drugs where their export is prohibited by law.”

IMC’s members include major biopharma companies based in the U.S. and internationally. It works closely with PhRMA, the Pharmaceutical Research and Manufacturers of America, the industry’s lobbying group in the U.S.

“Our government’s priority is ensuring that all Canadians can get and afford the medications they need,” stated Alexander Cohen, a spokesman for Canada’s health minister. “All statements and decisions surrounding Canada’s drug supply are made based in the best interest of Canadians, and we are examining all options to ensure it remains secure.”

At this time there appears to be no timeline for the United States’ rules changes and not all drugs would qualify. For example, insulin for diabetes, which has drawn recent criticism over its high price, would not be eligible for importation under at least one of the outlined proposals. And even if the rules did change to allow it, it might not be available for years because of a lengthy rulemaking process.

The GOP typically is opposed to the importation of drugs from other countries. President Trump has placed decreasing drug prices a priority for his administration, although at two-and-a-half years into his term, no significant changes have been made, but with the 2020 election heating up, he’s making another effort.

In fact, Azar has traditionally been opposed to importation, once calling it a “gimmick.” Now, Azar said, “What we’re saying today is we’re open,” referring to a proposed rule, which needs to be finalized. “There is a pathway. We can be convinced.”

A minimum of 10 U.S. states, including Florida, have passed or proposed legislation that would allow these types of imports, but actual shipments are illegal without federal approval.

Reuters reviewed IMC position papers and found that the organization says it might not be possible for biopharma companies to enforce contract terms with Canadian buyers that forbid the re-export of medicines.
“Although purchasing agreements with suppliers may contain clauses that would prevent bulk export to the U.S., many Canadian pharmaceutical companies are subsidiaries of U.S. corporations and may become obliged to do so through U.S. legislation,” the IMC warned in July.

The IMC suggested a first step would be for the Canadian government to publicly address the issue and state it would protect drugs intended for the Canadian market. And it did.

“We recognized the new situation brought on by American announcements, and Health Canada will continue to ensure that our priority is always ensuring that Canadians have access to the medication they need at affordable prices,” Canadian Prime Minister Justin Trudeau stated last week.

The U.S. Food and Drug Administration (FDA) approved Daiichi Sankyo’s Turalio (pexidartinib) for adults with symptomatic tenosynovial giant cell tumor (TGCT).

TGCT is a rare, non-malignant tumor that can be aggressive locally. It affects the synovium-lined joints, bursae and tendon sheaths, which causes decreased mobility in the affected joint. It is typically benign, but because it affects the joints, can be debilitating.

TGCT is estimated to occur in 11 to 50 cases per million person-years based on data from three countries. It appears in two types, localized, which occurs in 80 to 90% of cases, and diffuse, which accounts for 10 to 20%. Surgical resection is the standard of care, but in patients with a recurrent, difficult-to-treat, or diffuse type of TGCT, the tumor can wrap around bone, tendons, ligaments and other parts of the joint, making it difficult to remove and surgery may not be an option. TGCT is also called pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS).

“The FDA approval of Turalio represents a paradigm shift in the treatment of carefully selected TGCT patients who face significant disease morbidity and for whom surgery is not an option,” stated William D. Tap, chief of the Sarcoma Medical Oncology Service at Memorial Sloan Kettering Cancer Center and lead investigator for the Phase III ENLIVEN trial. “We now have a new oral treatment option that can have a meaningful clinical benefit in select patients, including a reduction in tumor size.”

The approval is for only “select” patients where surgery isn’t an option. It also comes with a Boxed Warning for liver toxicity, which has been a problem in several clinical trials with the drug. As a result, the FDA is requiring Daiichi Sankyo to offer the drug through a Risk Evaluation and Mitigation Strategy (REMS) Program, where only certified physicians can prescribe the drug. Biologics by McKesson, a specialized independent pharmacy for cancer and other complex therapies is the exclusive specialty pharmacy for Turalio.

In a Phase III trial, 13% of patients receiving the drug dropped out of the study because of serious adverse events, compared to only 1.7% of the control cohort. There were two irreversible cases of cholestatic liver injury among 768 patients receiving the drug, one dying and the other receiving a liver transplant.

Regulators, however, felt the benefits outweighed the risk.

“TGCT can cause debilitating symptoms for patients such as pain, stiffness and limitation of movement,” stated Richard Pazdur, director of the FDA’s Oncology Center of Excellence. “The tumor can significantly affect a patient’s quality of life and cause severe disability.”

In the first part of the ENLIVEN trial, 120 patients were randomized 1:1 to receive either Turalio at 1000 mg/day for two weeks followed by 800 mg/day for 22 weeks or matching placebo. The key efficacy outcome measure was overall response rate (ORR) at 25 weeks, which was the proportion of patients having a complete or partial response after 24 weeks as assessed by blinded independent central review (BICR).

The second part of the trial was a long-term, open-label trial after the completion of part 1 where patients could continue to receive Turalio or begin receiving the drug.

Sosei Group Corporation inked a strategic multi-target partnership with Takeda Pharmaceutical to find, develop and commercialize small molecules and biologics that modulate G protein-coupled receptor (GPCR) targets. The initial focus will be on gastrointestinal targets.

Under the terms of the deal, Sosei will use its proprietary GPCR-focused structure-based drug design abilities with Takeda’s discovery, development and therapeutic expertise to work on multiple GPCR targets selected by Takeda. Although they will involve a variety of diseases, the initial focus is on high-priority gastrointestinal targets.

Takeda will pay $26 million upfront and in near-term payments to Sosei, as well as pay for research over the length of the deal. Potential milestone payments could exceed $1.2 billion. Sosei is also eligible for tiered royalties on net sales of any products that come out of the deal. Takeda holds global rights to develop and commercialize drugs for each novel target through specified pharmacological approaches.

“Takeda and Sosei Heptares have enjoyed a strong relationship over the years, with its venture arm having been an early investor in Heptares,” stated Malcolm Weir, executive vice president and chief R&D officer at Sosei. “Today’s newly announced partnership is the culmination of recent discussions to identify new and exciting programs where our combined expertise can be directed towards challenging diseases and targets to deliver new medicines for patients.”

About two weeks ago, Sosei entered a similar deal with Roche’s Genentech, to also focus on GPCR targets of interest to Genentech. That was also for $26 million upfront with milestones that could exceed $1 billion.

Of interest to these companies is Sosei Heptares’ expertise in GPCRs. There are hundreds of these compounds coded for in the human genome, and they are the target of about a third of all marketed drugs. Many believe the so-called “orphan” GPCRs will made good targets for new drugs.

Although these two deals definitely mark the industry’s interest in Sosei Heptares, it’s not all coming up roses. In March 2018, Teva Pharmaceutical returned rights to HTL0022562 to Sosei, which was being developed for migraine and other severe headaches. That was part of a cost-cutting effort by Teva’s new chief executive officer Kare Schultz. Teva already had a migraine drug, fremanezumab, which has since been approved by the U.S. Food and Drug Administration (FDA) for migraine under the brand name Ajovy.

And in September 2018, Sosei and Allergan voluntarily suspended clinical trials of HTL0018318 in Alzheimer’s and other forms of dementia because of safety problems. The drug is a selective small molecule muscarinic M1 receptor agonist. It was in Phase I trials in the U.S. and Phase II trials in Japan.

Still, the two deals are big deals for Sosei.

“The therapeutic approach presented through this collaboration provides an exciting avenue for discovery in gut inflammation and motility disorders,” stated Gareth Hicks, head, Gastroenterology Drug Discovery Unit at Takeda. “We’re eager to advance the identified targets through our research pipeline, in partnership with Sosei Heptares, to accelerate the development of new therapies for patients.”

Amicus Therapeutics, based in Cranbury, New Jersey, announced positive interim results from its CLN6 Batten disease gene therapy program. The Abigail Wexner Research Institute (AWRI) at Nationwide Children’s Hospital is running the ongoing Phase I/II clinical trial of a one-time intrathecal administration of AAV-CLN6 gene therapy for CLN6 Batten disease.

Batten disease is a fatal neurologic illness that results in children losing the ability to walk, speak, think and see. Batten disease is part of a family of rare, fatal, inherited diseases of the nervous system also known as neuronal ceroid lipofuscinoses, or NCLs.

A specific gene mutation causes a cascade of issues that interfere with a cell’s ability to recycle specific molecules. Each of the genes is called CLN and has a different number as its subtype. There are 13 known types of Batten disease generally referred to as CLN1-8; 10-14. Although they all have similar features and symptoms, they vary in severity and age of onset. Most begin during childhood.

It is estimated that the CLN6 disease affects about 1,000 children worldwide.

Interim efficacy data for the first eight children showed a positive impact on motor and language function compared to a natural history dataset, as well as comparisons within sibling pairs. Treatment was generally well tolerated.

“This program and these initial results represent the heart and soul of who we are and why we do what we do at Amicus,” stated John F. Crowley, chairman and chief executive officer of Amicus. “These interim clinical data suggest that our gene therapy in CLN6 Batten disease has the potential to halt the progression of this devastating fatal disease that untreated destroys brain function and kills children. It is remarkable that most children in this study appear to show stabilization, particularly the younger children who were able to maintain high baseline motor and language scores for up to two years.”

Crowley added, “We know that brain damage here is irreversible, and early intervention will be critical to preserve the ability to speak and walk. We look forward to presenting additional data throughout this year and continuing to advance our CLN6 and other Batten disease gene therapy programs that all apply the same AAV technology platform developed by Dr. Brian Kaspar and his former colleagues at Nationwide Children’s. Early intervention is crucial, so we move forward with a great sense of urgency here for these children and their families.”

The AAV-CLN6 gene therapy uses an adeno-associated virus (AAV) capsid to deliver a normal gene segment.

The interim data showed meaningful impact on motor and language function, evidence of disease stabilization in seven out of the eight children after treatment, and a favorable safety profile. Data from the patients was compared to a natural history cohort as well as sibling comparisons, both within the trial group and via natural history analysis.

Of the eight, the one child who didn’t respond was the oldest in the cohort, who received treatment at six-and-a-half years of age. This reinforced the idea that early intervention is important. The disease is typically diagnosed around the age of four or five and is typically fatal by the age of 10.

There is a single approved treatment for a different subtype, CLN2 Batten disease, which was approved in the U.S. in April 2017. It is BioMarin Pharmaceutical’s enzyme replacement therapy Brineura (cerliponase alfa).

Amicus is also working to develop gene therapies for CLN3, CLN8 and CLN1 variations of Batten disease. The CLN3 program began clinical trials at the beginning of this year.

This morning, Pfizer announced that its off-patent medicines company, Upjohn, will merge with generic drugmaker Mylan to form a new pharmaceutical company with projected 2020 revenues of up to $20 billion.

The potential merger of the companies has been teased for the past several days but is now a reality. The new company will have numerous well-known brands in its portfolio, including the Epi-Pen, Viagra, Lipitor, Celebrex and others. The structure of the deal is known as an all-stock, Reverse Morris Trust transaction. Upjohn will be spun off to Pfizer shareholders and then combined with Mylan. Each share of Mylan’s stock will be converted into one share of the new company. Pfizer shareholders would own 57% of the combined new company and Mylan shareholders will own 43%, the companies said this morning. As could be expected, shares of Mylan are soaring in pre-market trading. The stock was up more than 20% before the opening bell. That’s a needed boost for the company, which has seen a significant dip in its share prices over the past several years due to pricing controversies over its Epi-Pen.

Pfizer and Mylan have not yet announced a name for the new company. They said it will be “renamed and rebranded” when the deal is officially closed. However, a leadership structure is already in place. Mylan’s current Chairman of the Board Robert J. Coury will serve as executive chairman of the new company and Upjohn’s current president, Michael Goettler, will serve as chief executive officer. Rajiv Malik, the current president of Mylan, will serve as president of the new company. Two noted Mylan executives will not be part of the new company. Current Mylan CEO Heather Bresch will retire upon the close of the transaction, and Ken Parks, chief financial officer of Mylan, will depart the company. The company will be based in the United States with facilities located in Pittsburgh, Shanghai and Hyderabad, India. The combined Upjohn and Mylan are expected to drive a “sustainable, diverse and differentiated portfolio of prescription medicines, complex generics, over-the-counter products and biosimilars” It will be supported by an established infrastructure and supply chain, as well as a strong management team.

Pfizer CEO Albert Bourla said the new company will be a “new champion for global health” with therapies for a wide range of therapeutic areas. The new company, Bourla said, will allow Pfizer to maintain the “financial flexibility” to continue to advance its pipeline and provide strong returns to shareholders.

“By bringing Mylan’s growth assets to Upjohn’s growth markets, we will create a financially strong company with true global reach. I’m also excited about the management team, which combines strong executive talent from both companies, whose commitment to improving global health for patients and to delivering returns to shareholders are great assets for the new company,” Bourla said in a statement.

For Pfizer, the decision to form the new company with Mylan comes as the pharma giant is undergoing its own restructuring. Last year, the company announced its intentions to reorganize itself into three different business units, including an innovative medicines business and established medicines business. Following that announcement, Pfizer and GlaxoSmithKline teamed up to create a global consumer healthcare company. Pfizer and GSK combined their consumer healthcare businesses.

For the past 18 months, Mylan’s Coury said he has been listening to shareholders who have expressed concern about the company. Today’s announcement with Pfizer, is a response to those concerns, he said and “represents a transformative move for Mylan.” Not only will the company have many trusted brand-name drugs, but it will also have an immediate global presence.

Goettler said he is excited to be leading the new company and delivering on the shared commitment of delivering transformative medicines, as well as shareholder return.

Out of the gate, the new company is expected to have pro forma 2020 revenues of $19 to $20 billion. But, the company will be saddled with some debt as well. Pfizer and Mylan said the new company will have approximately $24.5 billion of total debt outstanding at closing.

Trying to make a real-world data study as easy as possible for practitioners and participants requires a great deal of work behind the scenes, experts say, but careful planning pays off.

Representatives of GlaxoSmith Kline’s Salford Lung Study (SLS) say there are unique challenges in conducting a trial that brings together both clinical research and real-world data.

The benefit of such hybrid studies is their ability to answer questions about a therapy’s safety and efficacy while simultaneously collecting information about the best way to implement that therapy in a real-world setting.

The SLS, the first major drug trial conducted under “real world” conditions, evaluated GSK’s Relvar among 4,233 patients with asthma and 2,802 patients with chronic obstructive pulmonary disease (COPD). The studies were designed as open-label, Phase 3, randomized trials.

The goal of the trial was to show the benefit of a once-daily administered drug, says Elaine Irving, senior director and head of real-world study delivery at GSK, which can’t be done in a blinded scenario. GSK focused the trial on practical endpoints that physicians use in day-to-day practice, Irving says, and tried to keep the patients as close to routine care as possible. Active randomization helped maintain scientific rigor.

The first lesson learned, Irving points out, was how many moving parts such a seemingly simple study can have. “The simpler we make the concept,” she says, “the more complicated it is behind the scenes and the longer it takes to get one of these studies actually started.”

“I think this study took four years of discussion and planning before we hit the first subject to be recruited.” The sheer numbers of stakeholders in the asthma study alone — 74 physician practices, 132 community pharmacies, 165 trainers and facilitators and 4,233 patients — meant determining everyone’s needs was heavy lifting.

But buy-in is essential, Irving says. “These types of studies can’t be done unless you have a partnership with all the different parties.” For the SLS, this meant reaching into all corners of the community in Salford and South Manchester, England, to gather local hospitals, primary care doctors, academic experts and health informatics specialists. In addition, SLS coordinators kept national regulators up to date.

And keeping eligibility standards broad resulted in a more representative study population. Instead of employing traditionally rigid clinical trial inclusion criteria, the SLS tried to reach out to everyone in the community with asthma and COPD, even smokers and people with other comorbid conditions.

In the COPD study, 11,720 patients registered to participate at their local doctor’s office, 5,658 were found to be eligible, and 2,802 — 50 percent — were enrolled, a far cry from the 841 patients who would have qualified under more traditional clinical trial standards.

Support for the physicians involved also was a key factor. Trial designers wanted to place as little burden on them as possible. “If we had the design right,” Irving says, “we were asking [them] to do their jobs. We weren’t asking much else.” The SLS provided nurse support teams to take on extra tasks related to the trial, such as identifying patients, conducting study visits and data entry.

Training also was a necessary component. These were research-naïve medical professionals, Irving points out, who needed education in good clinical practices and trial procedures. Local pharmacies also needed training in handling investigational drugs and good manufacturing practices.

It was also important to make the study team as diverse as possible, Irving says, combining clinical statisticians used to working only with eCRF data with epidemiologists who specialize in real-world practice. “That involves bringing two completely different worlds together,” she says.

Using real-world data also requires a change in mindset, Irving stresses. Data was collected from patients only when it didn’t interfere with their regular care, and then only when the data added value to the study.

Outcomes and safety data were collected from the electronic record systems at general practices and pharmacies. That presented a challenge all its own, according to Martin Gibson, University of Manchester professor and head of the team that created the technology behind the study.

When it comes to electronic data records, “standards are like toothbrushes — everyone’s got one, but nobody wants to share,” Gibson says. And varied data sources in an RWD study make standardizing difficult. They may have different coding systems, data may be duplicated, sources may be difficult to query.

In a real-world study, it’s necessary to either build or buy “a system that brings all those different data standards together,” he says.

The outcome of GSK’s efforts ultimately was positive. The SLS demonstrated not only that Relvar was safe and effective, but also that it improved patient outcomes in a real-world setting, a factor that may strengthen the drug’s position among payers.

-By Sony Salzman

On completion of three years of operations, Global Regulatory & Consumer Insights (GRCIS) has opened it’s first overseas office in Ontario, Canada. The team is excited to face a new challenges and a new landscape.

Canada is widely regarded as the fourth most important destination for Clinical Research in world and as one of the most important country for clinical studies to support new drug registrations. “The increasing demand for regulatory services work in Canada drove the need for increased capacity,” said Mr. Tarun Pandotra

Tarun, GRCIS’s Founder & Director added. “We are now in better positioned to meet the continued needs of our customers in this region. Opening a Canada office for GRCIS is an exciting and significant milestone in the company’s evolution and is evidence that GRCIS acknowledges and embraces the full potential that the Canada can bring to the global business going forward”

About GRCIS

GRCIS is transforming regulatory services through our people, innovation and transparency. GRCIS provides personalized service customized to the unique requirements of each study. We support with our innovative approach through flexible and reliable service, delivered by skilled employees dedicated to ensuring that sponsors achieve their long-term goals.

We serve our clients across all phases of pharmaceutical and biotech drug development by combining therapeutic and operational expertise with local knowledge.  At GRCIS, we are looking to the future, not the past. Our increasingly forward-thinking approach to transforming the Regulatory landscape will continue to make a difference to healthcare patients around the world.

Google officially entered the clinical space with the launch of their Verily Study Watch last month.

One of their driving goals with this device is to help researchers passively capture human health data. Among other things, Verily will use the watch to facilitate the Project Baseline study, an ongoing investigation of myriad human health concerns. Of course, a watch capable of collecting wearers’ data already exists.

Now the question that we can’t stop asking is “How the Verily Study Watch will stack up against the Apple Watch and ResearchKit?”

The Apple Watch and ResearchKit

Revealed in September of 2014, the Apple Watch is a powerful, multi-functional device for tracking movement, sleep, and other personal health data.

The Apple ResearchKit was inspired by a 2013 conversation between Dr. Stephen Friend, founder of Sage Bionetworks and Mike O’Reilly, Apple’s VP of medical technologies, after a presentation Dr. Friend gave at Stanford’s MedX conference.

“Imagine ten trials, several thousand patients. Here you have genetic information, and you have what drugs they took, how they did. Put that up in the cloud, and you have a place where people can go and query it, [where] they can make discoveries,” said Friend.

His ideas of open science and data sharing were not only the foundation of his nonprofit Sage Bionetworks, but also spoke to O’Reilly, who sought Dr. Friend out after the presentation.

Apple’s ResearchKit debuted in March of 2015, following somewhat closely on heels of the Apple Watch. On its website, ResearchKit is described as “an open source framework introduced by Apple that allows researchers and developers to create powerful apps for medical research. Easily create visual consent flows, real-time dynamic active tasks, and surveys using a variety of customizable modules that you can build upon and share with the community.”

The Apple Watch and Apple ResearchKit were naturally a dynamic duo from the start. Since data can be gathered via the Apple Watch and subsequently analyzed and applied through ResearchKit, the combination of the two technologies has shown a lot of potential for passively capturing critical human health data.

Ethical Concerns about Apple’s Approach

There are a variety of benefits to using Apple’s dream team for collecting data for clinical trials. The Apple Watch is a hot commodity, and already worn across the globe for fitness and fashion purposes. Moreover, in the clinical research sphere, numerous types of Electronic Device Report Outcomes (eDROs) technology are becoming more widely utilized by the day.

While wearable tech is convenient on both the potential volunteers’ and researchers’ end of things, there are a number of ethical concerns that have sprung up around use of the Apple Watch and ResearchKit.

This clinical research realm is a bit like the Wild West, an unexplored frontier yet to be fully regulated. A major concern is self-reported criteria such as age.

One reporter for The Verge wrote, “When you open up “Asthma” — one of the five ResearchKit apps released yesterday — you’re asked a number of questions, including about your age. If you say you’re not over 18, you’re ineligible. But answering “yes” to the age question, and going through a few other questions (Are you pregnant? No. Do you live in the US? Yes.) lets you know that you’re eligible for the study.”

Granted, the article was written shortly after ResearchKit’s release, and Apple has undoubtedly spent the last two years working hard as usual. Still, there is a degree of uncertainty when it comes to this type of data. If we start requiring some type of ID scan, how do we match that identification to the device’s owner? How do we prove they aren’t forgetting it at home when they exercise or even lending it to a friend before the friend exercises?

There is no doubt that on-site, monitored clinical trials have limitations, and that the Apple Watch and ResearchKit will prove beneficial in the future; however, we must proceed carefully as we settle the unknown frontier.

How the Verily Study Watch Differs

So is the Verily Study Watch simply a second Apple Watch, late to the party? Definitely not.

Google’s wearable tech rendition is far from a simple knockoff of what came before it. In fact, as of right now, it’s not even going to be offered to the general public.

The Study Watch, true to its name, was built with consideration for the needs of clinical and other observational studies. It was tailored with the user’s experience in mind, and developed with feedback from clinicians, researchers, and users.

Verily Study Watch boasts the following main features:

• High quality signals
• Numerous physiological and environmental sensors. These include:
  • ECG
  • Heart rate
  • Electrodermal activity
  • Inertial movements
• Seamless usage
• A battery life of up to a week
  • This encourages better user compliance
• Robust firmware that can enable subsequent extensions such as
  • Over-the-air updates
  • New algorithms
  • User interface upgrades
• A low-power display that always shows the time
  • Sometimes instructions are displayed
  • No other feedback is given to the user
• Processor powerful enough to support real-time algorithms on the watch itself
• Impressive internal data compression and storage
  • Device can store weeks’ worth of data
  • It does not to be synced frequently– another feature that encourages constant wear and compliance

All of the Verily Study Watch’s data is encrypted. It is uploaded and processed through use of Verily’s own back-end algorithms and machine learning tools. The powerful device can store and process large volume of data, which is one of the ways they’ve set themselves apart.

According to the company’s introduction of their new product, “While numerous wearables exist in the market, we have a specific need outside of these offerings: namely, the scalable collection of rich and complex datasets across clinical and observational studies.”

Clearly, Google is breaking into the industry with a powerful bang.

Project Baseline

One of Verily’s goals is the ambitious and ongoing Project Baseline study, an extensive exploration of human health and sickness. Of course, the ultimate goal is to help enhance the former and cure the latter.

Last month, Verily announced that the first project will be a collaboration with Stanford Medicine and Duke University. The study will last four years and hopes to recruit up to 10,000 volunteers in California and North Carolina. The goal is to better identify risk factors for disease and to understand how people transition from healthy to sick.

The participants’ data will be collected via a combination of:

• Polls and surveys
• Visits to clinical research sites
• The Study Watch

Volunteers will even have the option to obtain some of their health results, both for their own knowledge and to share with their physicians if they choose.

“[…] the Project Baseline study dataset will include clinical, molecular, imaging, self-reported, behavioral, environmental, sensor, and other health-related measurements,” wrote Jessica Mega, chief medical officer for Verily, in a recent blog post.

Duke and Stanford are just the beginning of the collaborations with clinical and educational powerhouses that Verily envisions for the future. The company plans to connect with a broad range of partners across everything from academia, science, and medicine, to design, engineering, and the ever more important field of patient advocacy.

It will be interesting to see who is involved next and what findings the studies produce.

Conclusion

So far, it looks like comparing the Apple Watch and the Verily Study Watch might be like comparing apples and oranges… or even two things as different as apples and the kitchen table. While they are of course two somewhat comparable devices, the two companies have different intentions overall.

While the Apple Watch is an impressive piece of technology, it is meant for fitness tracking and everyday wear. When combined with ResearchKit, it becomes a clinical research tool. The Study Watch, on the other hand, is a more niche product. The company has stated the watch is not for sale and is instead jumping headfirst into the research arena. Perhaps as the two evolve, they will become more direct competitors, and perhaps the inverse will occur. As of right now, only time will tell.

Elon Musk said startup Neuralink, which aims to build a scalable implant to connect human brains with computers, has already implanted chips in rats and plans to test its brain-machine interface in humans within two years, with a long-term goal of people “merging with AI.”

Brain-machine interfaces have been around for awhile. Some of the earliest success with the technology include Brown University’s BrainGate, which first enabled a paralyzed person to control a computer cursor in 2006. Since then a variety of research groups and companies, including the University of Pittsburgh Medical Center and DARPA-backed Synchron, have been working on similar devices. There are two basic approaches: You can do it invasively, creating an interface with an implant that directly touches the brain, or you can do it non-invasively, usually by electrodes placed near the skin. (The latter is the approach used by startup CTRL-Labs, for example.)

Neuralink, says Musk, is going to go the invasive route. It’s developed a chip containing an array of up to 96 small, polymer threads, each with up to 32 electrodes that can be implanted into the brain via robot and a 2 millimeter incision. The threads are small — less than 6 micrometers — because, as Musk noted in remarks delivered Tuesday night and webcast, “If you stick something in your brain, don’t want it to be giant, you want it to be tiny.”

Once implanted, according to Musk, the chip would connect wirelessly to devices. “It basically Bluetooths to your phone,” he said. “We’ll have to watch the App Store updates to that one,” he added (the audience laughed).

Musk cofounded Neuralink in 2017 and serves as the company’s CEO, though it’s unclear how much involvement he has given that he’s also serving as CEO for SpaceX and Tesla. Company cofounder and president, Max Hodak, has a biomedical engineering degree from Duke and has cofounded two other companies, MyFit and Transcriptic. Neuralink has raised $66.27 million in venture funding so far, according to Pitchbook, which estimates the startup’s valuation at $509.3 million.

Both Musk and Hodak spoke about the potential for its company’s neural implants to improve the lives of people with brain damage and other brain disabilities. Its first goal, based on its discussions with such patients, is the ability to control a mobile device.

The company’s long-term goal is a bit more fantastical, and relates to Musk’s oft-repeated concerns over the dangers of advanced artificial intelligence. That goal is to use the company’s chips to create a “tertiary level” of the brain that would be linked to artificial intelligence. “We can effectively have the option of merging with AI,” he said.

“After solving a bunch of brain related diseases there is the mitigation of the existential threat of AI,” he continued. “This is the point of it.”

In terms of progress, the company says that it has built a chip and a robot to implant it, which it has implanted into rats. According to the whitepaper the company has published (which has not yet undergone any peer review), it was able to record rat brain activity from its chips, and with many more channels than exist on current systems in use with humans.

That said — as many healthcare startups have learned — it’s a long road to travel from rats to human, and not everyone makes it. For Neuralink, the first human clinical trials are expected for next year, though Hodak mentioned that the company has not yet begun to the FDA processes needed to conduct those tests.

(Neuralink isn’t the only group trying to do a scalable implant with flexible electrodes, either. Research showing success with a comparable device was published this week in the Proceedings of the National Academy of Sciences).

Not that Musk expects that you’ll be connecting your brain anytime soon. Despite the improvements to machine interfaces that the company was touting last night, Musk warned the crowd that many of the advancements he’s talking about are years or decades away.

“It’s not going to be like suddenly Neuralink will have this incredible new interface and take over people’s brains,” he said. “It will take a long time, and you’ll see it coming. Getting FDA approval for implantable devices of any kind is quite difficult and this will be a slow process.”

Novotech, an Asia-Pacific CRO, has further strengthened its presence in the region through a Partnership with the Skin Research Institute of Singapore (SRIS). With this partnership, the two groups will be working together to promote combined capabilities in skin research clinical trials.

The Partnership formalizes a long-standing working relationship between the two.

SRIS was established as a collaboration between Agency for Science, Technology and Research (A*STAR), National Healthcare Group (NHG) and Nanyang Technological University (NTU) to conduct high impact, inter-disciplinary skin research that would translate into improved health outcomes and quality of life.

Novotech now has over 20 significant Partnerships with some of the leading medical institutions in the region. The Partnership Program is designed to bring access to investigators, KOLs, and up to 4 million patients for its international biotech clients.

Novotech CEO Dr John Moller said the Partnership with SRIS will support the increasing demand from biotech clients for skin disorder studies in the Asia-Pacific region.