Clinical Trials at Home? Science 37's Answer to Pharma's Problem
Francesca Billington is a dot.LA editorial intern. She's previously reported for KCRW, the Santa Monica Daily Press and local publications in New Jersey. Before joining dot.LA, she was a communications fellow at an environmental science research center in Sri Lanka. She graduated from Princeton in 2019 with a degree in anthropology.
Convincing people to take part in life-saving clinical drug trials was difficult even before the pandemic. But the coronavirus halted efforts by many drugmakers, as hospitals and research facilities closed or channeled their resources to COVID.
Science 37, which just raised $40 million to expand their virtual medical trials at people's homes, could keep their studies going while others closed. And it's holding itself up as the future of clinical trials, though it has limitations.
"As many in the industry have realized over the past few months, a virtual or decentralized research model can help keep patients and study teams safe, support the global effort to contain the virus, and provide business continuity during the pandemic," said Chris Ceppi, the company's chief product officer.
The Los Angeles-based startup is backed by some of the biggest names in pharma including Novartis, Amgen and Sanofi. It's raised a total of $140 million to build out what they call a decentralized clinical trial system.
Science 37 designs and connects virtual clinical trials through its platform. The system allows drugmakers and academic institutions to reach more people, many of whom might not otherwise participate, including patients living far from clinic sites.
The FDA has indicated the shift to home participation is promising, as it speeds up the traditionally protracted business of data gathering. But adapting the clinical trial process for home environments poses risks.
Questions around regulation and testing precision will be critical as Science 37's software rolls out said Dr. SriniVas Sadda, a UCLA ophthalmology professor and president of the Stein Eye Institute.
"You can have personnel who are trained to do everything correctly, but when you go to a patient's home there'll be variations," Sadda told dot.LA in an interview Thursday. "That's where you lose the standardization."
At traditional clinical trial centers, patients are examined and evaluated using the same equipment under the same conditions, right down to the temperature in the room. This ensures data is collected the same away, even across centers.
That's tough to replicate at homes. But for some drug trials, such rigid controls aren't necessary, Sadda said.
"That's where you have to choose which trials are amenable to this type of remote approach," he said. "You have to pick and choose wisely to make sure you don't introduce an unwanted bias into the study."
Concerns about protocol are addressed through the regulatory process, company spokesman Lawrence Lloyd said. He pointed out that studies wouldn't be approved if data wasn't consistent.
Science 37 has ongoing trials that range in size from dozens to thousands of patients, Ceppi said.
"We know that virtualization can be applied to studies in every major therapeutic area and phase of research," he said. Choosing trials usually depends on "how many in-person, 'hands-on' interactions are required between participants and the trial team."
The startup said it will use the capital to expand its tech platform and accelerate global expansion. Ceppi said the platform will be deployed in more than 30 countries and is now available in more than 40 languages.
The funding round was led by Lux Capital, Redmile Group, and PPD, Inc. and joined by ongoing investors including Novartis, Amgen, Sanofi Ventures, Alphabet's GV and Glynn Capital. New investors include LifeSci Ventures and Mubadala Ventures.
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When the founders who lead the ten young startups selected for the 2020 Techstars LA class begin their three month accelerator program Monday, they won't be gathering in the Mid-Wilshire office and shaking hands as every other class has done. Like the rest of us, they will be working at home because of the coronavirus. Dinners, meetings, socializing, and mentoring sessions will all be online.
"A big part of the magic of the program is the relationships that are from proximity and from everyone working together in the same space and so what we're doing is we're endeavoring to create as much as that connection in the virtual world as possible," said Anna Barber, managing director of Techstars LA.
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JoyHub<p><a href="https://www.joyhub.io/" target="_blank">JoyHub</a> 's enterprise software integrates multifamily operator systems into a single, centralized data platform. </p><p><a href="https://brdg.app/s/io9a3s" target="_blank">Contact the founder >></a> </p>
Ayana Therapy<p><a href="https://www.ayanatherapy.com/" target="_blank">Ayana Therapy</a> provides online therapy for minorities with an emphasis on intersectionality. </p><p><a href="https://brdg.app/s/gdwa78" target="_blank">Contact the founder >></a></p>
CLLCTVE<p><a href="http://cllctve.com/" target="_blank">CLLCTVE</a> is a platform connecting college creatives with brands targeting Gen-Z consumers. </p><p><a href="https://brdg.app/s/bgc9pp" target="_blank">Contact the founder >></a></p>
Lactation Lab<p><a href="https://www.lactationlab.com/" target="_blank">Lactation Lab</a> provides breast milk analysis and personalized recommendations for mothers to optimize their child's health and nutrition. </p><p><a href="https://brdg.app/s/t0173z" target="_blank">Contact the founder >></a></p>
Preveta<p><a href="https://www.preveta.com/" target="_blank">Preveta</a> is transforming cancer care by arming clinicians with data and insights to improve outcomes, and blazing a trail for providers to deliver value-based care.</p><p><a href="https://brdg.app/s/odhs9o" target="_blank">Contact the founder >></a></p>
Shop Latinx<p><a href="https://shoplatinx.com/" target="_blank">Shop LatinX</a> is the leading fashion and beauty lifestyle brand with products designed by and for the Latinx community. </p><p><a href="https://brdg.app/s/0luryb" target="_blank">Contact the founder >></a></p>
Sike Insights<p><a href="https://sikeinsights.com/" target="_blank">Sike Insights</a> powers remote teams to work better together. Our first product, Kona, is an AI-powered Slackbot that helps you communicate. </p><p><a href="https://brdg.app/s/d5ejl2" target="_blank">Contact the founder >></a></p>
StatsHelix<p><a href="http://statshelix.com" target="_blank">StatsHelix</a> is a B2B gametech company focused on esports and streaming. </p><p><a href="https://brdg.app/s/j4yp3j" target="_blank">Contact the founder >></a></p>
Thrive Education<p><a href="https://thrive-education.co/" target="_blank">Thrive Education</a> provides remote tele-assessments for learning differences (LDs) such as dyslexia, ADHD, and autism. </p><p><a href="https://brdg.app/s/1dn2dc" target="_blank">Contact the founder >></a></p>
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Eliminating battery waste, developing new hair growth therapy, fixing carbon dioxide. These are among some of the ambitious problems that companies are trying to solve at the First Look SoCal Innovation Showcase beginning Tuesday.
Hosted by nonprofit Alliance for SoCal Innovation, the online event connects early-stage tech and life science companies with investors and serial entrepreneurs.
BioZen Batteries Aims to Solve Our Energy Storage Issues<img lazy-loadable="true" src="https://dot.la/media-library/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yNDI0Nzg5MS9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYyNTg3OTYyNn0.y9dSMjovB1GtsQ1SZhKiPTIJY3VW0XOE2YXd-JN1xYU/image.jpg?width=980" id="95064" class="rm-shortcode" data-rm-shortcode-id="c3ad9197ad70005802e6d34d6da3c29d" data-rm-shortcode-name="rebelmouse-image" />
Left to right: BioZen Batteries' co-founders Zach Rengert, Nate Kirchhofer and Eric Brigham.<p>Nate Kirchhofer, co-founder and CEO of <a href="https://biozenbatteries.com/" target="_blank">BioZen Batteries</a>, wants to make batteries that will outlive him.</p><p>Santa Barbara-based BioZen creates organic electrolytes, the active material inside a specific type of battery called a "redox flow battery." It's a different type of technology that differs from the lithium batteries often used in mobile applications like cars and phones. Only 5% of those get recycled.</p><p>BioZen's batteries are well suited for green, large-scale energy storage, Kirchhofer said. For example, batteries that help solar panels connect to the grid or provide backup during disasters when the power goes out.</p><p>Kirchhofer, an electrochemist, founded the company in June of 2019 with Zach Rengert, a materials chemist, and Eric Brigham, the company's CFO. Kirchhofer and Rengert met while getting their doctorate at UC Santa Barbara.</p><p>There hasn't yet been a push for sustainable batteries because it isn't economically incentivized, Kirchhofer told dot.LA. He said that his batteries are cheaper than competitors.</p><p>Kirchhofer's product fits into a growing renewable energy market and a social movement in which individuals want to do their part. He's worked for four startups but says this one is poised to make the biggest impact.</p><p>"If it's not our generation that solves climate change, there's not another chance. There's not another Earth." he said. "If we can make these batteries happen, we can truly integrate renewable energy and stop the petroleum-dominated energy paradigm we're part of."</p>
Amplifica's founder Dr. Maksim Plikus
Amplifica Treats Baldness with Mole Molecules<p>Back in 2013, Amplifica's founder Dr. Maksim Plikus began studying hairy moles. Though some find the growths unsightly, his work showed promise for baldness treatment.</p><p>He, along with colleagues at UC Irvine, discovered that molecules from moles that grow excessive hair can induce follicle growth when administered anywhere on the skin.</p><p>"As long as you can tease it out and replicate it in the form of purified molecules, you can achieve essentially what we think would be a novel, revolutionary solution to baldness," Plikus told dot.LA.</p><p>Plikus said his company is the first to solve hair loss by replicating cells from hairy moles to stimulate hair growth. At the moment, hair follicle research has emerged as a leading experimental model for studying stem cells.</p><p>By 2025, hair-loss products are projected to surpass $12 billion, Plikus said. But only two drugs are FDA approved and require daily treatment in the form of pills, which he said come with long-term side effects.</p><p>Amplifica says it's poised to put a more effective and convenient solution on the market. Pinkus' proposed product is a topical solution requiring less frequent application, like getting Botox injections a few times per year.</p>
FixingCO2 Aims to Recycle Fuel from the Air<img lazy-loadable="true" src="https://dot.la/media-library/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yNDI0ODM4My9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYzMzA1ODA4MH0.9RqwD9zUN1et1kor8zNPj8WH2kOX6SrysdpRDFT5QMc/image.jpg?width=980" id="daa89" class="rm-shortcode" data-rm-shortcode-id="9851b177139c4b5e06bd9c96fb395083" data-rm-shortcode-name="rebelmouse-image" />
FixingCO2's team. CEO Eldar Akhmetgaliyev is at right.<p><a href="https://fixingco2.com/" target="_blank">FixingCO2</a> got its start on Mars. Like the name says, the company aims to fix the global carbon problem that's fueling climate change.</p><p>In 2018, co-founder Alma Zhanaidarova's professor and research group at UC San Diego received a grant from NASA to build out a reactor that makes renewable fuels and chemicals from carbon dioxide, often a byproduct of industrial waste. The technology was being developed in anticipation of a one-day human mission to Mars, where 95% of the atmosphere is carbon dioxide.</p><p>Now, the San Diego-based startup is commercializing their product for earthlings.</p><p>"It's a different application but the same core technology," co-founder Eldar Akhmetgaliyev told dot.LA. "Instead of making fuels from oil or any other fossil sources, we can make them essentially from air."</p><p>The team is developing the hardware to capture industrial emissions blamed for much of the Earth's warming. The product has significant application for the aviation industry, where planes are built to burn jet fuel that produces carbon emissions.</p><p>"These kinds of technologies provide them a pathway to decarbonization," he said. "They can use fuels made from CO2 so they're not contributing to climate change."</p><p>As fires burn through California and the Pacific Northwest, Akhmetgaliyev said there's urgency for innovators in the carbon tech market. "We're pretty much turning our planet into Mars," he said.</p><p>He said that by 2050, about 14% of overall carbon reduction will come from carbon capture and utilization (CCUS) technology like his.</p><p>"The market hasn't met its opportunity and with the effects of climate change being seen everyday, there's going to be more drive towards these low carbon technologies."</p>
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