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22 of the top 25 pharma companies use HumanFirst to deploy connected products for clinical trials
One of the biggest themes in healthcare over the last year has been the quick move toward digital care; that is thanks, in large part, to an increase in FDA clearances for digital health products, along with heavy investment in technology. What that means is that care is no longer confined to just the 15 minute appointment with a doctor, but can now be done 24/7, and from anywhere.
While that has led to accelerated adoption of connected tools in both clinical trials and routine care, it has not been without controversy, said Andy Coravos, founder and CEO of decentralized clinical trial startup HumanFirst, which announced a new name on Tuesday, along with a $12 million Series A round of funding.
"During my time as an Entrepreneur in Residence in the FDA's Digital Health Unit, it became clear to me, that, similar to pharmacies which evaluate, prepare, and dispense drug components, our healthcare system needs infrastructure to evaluate, prepare, and dispense connected technologies components," she said.
"Questions around the security, accuracy, and bias in the data from wearables have made researchers and developers confront the complexity of bringing these technologies to market."
Founded in 2017, the company's Atlas platform helps its customers, which includes 22 of the 25 largest pharmaceutical companies in the world, deploy connected products for clinical trials and remote patient monitoring, utilizing the company's dataset of over 1000 connected sensor technologies. It has over 3000 digital clinical measures classified in over 150 categories, and over 300 medical conditions, spanning over 25 therapeutic areas.
For example, in the past year, the company's primary customer has been pharma sponsors who have had to shift their trials to the home. Most often, HumanFirst works with study teams who believe a decentralized trial approaches could speed up the study, reduce participant burden, and provide more valuable and patient-centric information. For example, a team might believe that a connected sensor is the best way to measure what matters to patients and they want to better understand how their drug impacts quality of life metrics such as sleep and activity.
"The team has questions such as: What’s the best way to measure sleep? Which wearables can accurately measure sleep? Which sensors have been successfully used in a clinical trial already? The interactive measures and technology reports provided through the Atlas platform enable these questions to be answered," said Coravos.
Another use case might involve a customer conducting a landscape analysis/portfolio strategy for a specific therapeutic area to understand what digital measures have been well studied in a particular area, such as Immunology or Neurology. In these instances, customers will run hypotheses and develop queries using the Atlas dataset to identify therapeutic areas and also technologies that are most amenable to digital measures.
HumanFirst can also be used for cataloging digital measures and technologies previously deployed within the organization.
"The adoption of digital endpoints has increased 5x during the pandemic, and many teams are struggling to understand what measures and technologies have been deployed across their organizations. We have an API-driven platform that makes it easy to track sensor deployments, and integrate it into bigger systems when needed," said Coravos.
That growth in digital adoption is why it’s vital to help organizations safely, effectively, and equitably deploy connected products for clinical trials and remote patient monitoring, she told me and its one of the reasons the company spearheaded the creation of The Digital Measures Playbook of open-access best practices for capturing patient signals and decreasing risk when deploying, managing, and monitoring connected products in home-based settings."
HumanFirst's tools draw from The Playbook, following a three step process: measures, technologies and operations. In terms of measures, the Atlas platform helps researchers and providers to build an evidence base for the concepts they want to measure. After building that evidence base, the second step, technology, makes it easy to look at a product’s evidence, including peer reviewed papers and clinical trials, utility/usability, security features, data governance, and economic considerations.
The company has already taken those first two steps and now plans to use the new funding to get to step three, operations, by supporting more at-home distribution of sensors.
The few funding round was led by Maverick Ventures, along with Lux Capital, Arkitekt Ventures, Boost VC, SV Angel, and Village Global. Threshold Ventures and over 30 angel investors, including Alice Zhang, Alyssa Atkins, Ariel Dora Stern, Ashley Yesayan, Beth Turner, Chris Hsu, Chris Mansi, Christina Cacioppo, Deon Nicholas, Dina Burkitbayeva, Ellen Chisa, Ellen Da Silva, Elliot Cohen, Evan Coravos, Felicia Cucuru, Ginny Fahs, Howie Liu, Jamie Gates, Jessica Cole, Josh Hannah, Julia Austin, Khaled Kteily, Laura Behrens Wu, Linda Xie, Lisa Marrone, Nat Turner, Noah Zimmerman, Katie and Reade Fahs, Samuel Whitaker, Ted Leonsis, Tom Janssen, Yuval Gonczarowski, and Zach Weinberg. This brings the company's total funding to $15 million.
Part of the plan going forward is to also expand into new product offerings, including historical tech catalog, while also growing the team by hiring across product, engineering, operations and commercialization.
Ultimately, the company's goal is to give people more agency over their health and wellness by ensuring that healthcare at home is as reliable and trustworthy as it is within the hospital or the research site. That will reduce healthcare costs, keep people healthier, and keep them out of the hospital.
That notion is where the company's new name originates, Coravos told me.
"HumanFirst has been a company value from the earliest days. As a team, we strive to reduce human suffering by taking time to understand those who use, make, and are supported by our products," she said.
"Our name change from Elektra Labs to HumanFirst is meant to reflect the company’s focus on enabling healthcare operations at home. Through this process, we are giving individuals more agency over their health and wellness. We’re all humans, and if we do our jobs well and shift to more preventative and value-based care, perhaps we can decrease the number of times we become a patient."
(Image source: gohumanfirst.com)
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