By Deborah Borfitz 

February 27, 2024 | Out of a field of over 100 nominations, CliniSpan Health—a relationship management platform for social media influencers—was named as the winner of the inaugural Startup Pitch Contest held earlier this month at the Clinical Trial Tech Venture, Innovation, and Partnering event co-located with the Summit for Clinical Ops Professionals (SCOPE) in Orlando. CliniSpan outcompeted four other finalists before a live panel of judges to gain the title. 

On the listening end of the pitch contest with their scoring rubrics were Jessica Federer, board member with Angelini Ventures out of Rome, Italy; Andrew Hedin, who leads the healthcare practice for Cambridge, Massachusetts-based Bessemer Venture Partners; Dan Hydes, CEO and cofounder of U.K.-based IgniteData; and Ward Lemaire, head of data management and central monitoring at J&J Innovative Medicine. 

Company founder and CEO Dezbee McDaniel made the case for CliniSpan. The whole goal is to maximize the power of social media to increase clinical trial participation among people of color residing in underserved communities, he explained. 

While about 40% of the U.S. population are people of color, their rate of inclusion in clinical trials ranges from 2% to no more than 16%, McDaniel began. It is therefore no surprise that when they take marketed drugs as prescribed, they may experience adverse side effects lowering rather their improving their health status—and, consequently, trust in their healthcare providers.   

McDaniel’s own aunt with breast cancer was one of those people, he shared. She experienced rare side effects every time she was given chemotherapy, “even when doctors assured her that she would not... [and they] couldn’t answer the question of why this was happening.” 

After learning about the underrepresentation of black women in trials for these drugs, McDaniel said, he was motivated to build the influencer relationship management platform powered by artificial intelligence (AI) for cultural education and engagement in underserved communities. An influencer-matching algorithm can be applied to the patient recruitment campaign for any trial and home in on the influencers most like the desired trial participants in terms of their gender, age range, and racial/ethnic background. 

Sponsors and CROs pay for the matching service with a monthly subscription fee set according to the number of submitted studies and view count, he said. Over the past three years, CliniSpan has worked with over 7,400 social media influencers across the U.S. and Canada on more than 20 trials, bringing in more than $1 million in revenue and on average improving diversity and inclusion rates more than seven-fold. 

Exceeding Expectations

The company has performed particularly well in the therapeutic areas of COVID, asthma, and eczema, said McDaniel, and the customer base includes some top-20 pharma companies. The next investment round is intended to help CliniSpan reach the break-even point over the next 18 months when revenues are expected to double while costs will grow by only about 30%. 

For one recent study, the technology delivered the desired participants in two weeks rather than three months—six times faster than expected—and at a 46% lower per-person cost. It could gain utility industry-wide and a paper will publish to further the case, he noted. 

One of the biggest obstacles overcome by CliniSpan was to convince influencers in underserved communities to help promote health equity, McDaniel continued, since they are typically familiar with the Tuskegee Syphilis Study and similar research abuses of the past. It was all a matter of educating and empowering them to use their influence for the greater good.  

Social media is used in a culturally competent way to help reach more people in underserved communities faster than anybody else has managed to do and for less money, he said of the value proposition. The company has to date raised a modest $150,000 and yet over the past three years grown revenues by more than 200%. 

Advisors to CliniSpan include executives from X (formerly Twitter) and MTV, and some of its advisors are customers helping position the platform to be even more value-generating. The plan is to build out the 

AI infrastructure further for the next iteration of the technology and double the number of social media influencers on the platform to 15,000. Sponsors have up until now used the technology on a study-by-study basis, but a licensing structure is being created to enable greater scaling.      

Dezbee expects to spin the company out in another three to five years due to diversity mandates set forth by the Food and Drug Administration (FDA). CliniSpan differentiates itself from competitors like Sprinklr based partly on the training it provides to influencers about HIPPA (Health Insurance Portability and Accountability Act) and clinical research history. 

The greatest problem on the horizon, he says, is ensuring that the predictive analytics continue working properly as more influencers join the platform. It’s an issue that the company looks to solve in the initial beta phases. 

Other Delay-Tackling Tactics 

Here are a few particulars about the other finalists in the contest, in alphabetical order: 

Bloqcube, a clinical trials management and financial systems software company 

Speeding up trials beleaguered by multiple systems and data integrity challenges that can delay payments to investigators and sites is the mission of Bloqcube, says founder and CEO Rama K. Rao. The iPad-based, blockchain-empowered platform enables “smart contracting” and a track-and-trace process ensuring supplies reach their destination on time. 

Bloqcube differentiates itself from similar platforms by providing real-time data in a unified platform that includes the financial module—and domain expertise for each of those technology solutions. It was nominated for a best startup award by the Galien Foundation for two consecutive years, Rao says. Last fall, Bloqcube took home first prize in the ConV2X 2023 Ignition Pitch Competition. 

Although the business was challenged by the pandemic, the sales pipeline is gaining traction with three signed letters of intent, reports Rao. Bloqcube was mentioned in four Gartner Hype Cycle Reports focused on the life sciences in 2022 and its AI algorithm has been independently validated. 

Its targeted customers are small- and mid-sized life science companies, contract research organizations, and sites, he says. Part of Bloqcube’s appeal is in minimizing the possibility of ransomware attacks—currently a top concern of chief information officers. 

Therapeutically, the company is focusing on oncology and neurology. It is looking to sign one or two customers at upwards of $50,000 per contract over the next 12 months.  

Humine Labs, offering a platform giving participants functional ownership of their health data 

Health equity is the top mission of Humine’s decentralized clinical trial platform that combines behavioral economics and Aleo’s Zero Knowledge blockchain to curb non-adherence, automate “trustless” source data verification, and ensure the representation of diverse populations in trials, according to cofounders Nafeh Shoaib (CEO) and Rohan Shanbhag (COO). In the U.S. alone, pharma companies have wasted $60 billion re-enrolling participants in mission-critical studies because 40% of them drop out within five months of trial start, they report.  

The nonadherence problem reflects a lack of privacy and data protection for participants, and research that is more extractive than collaborative, they say. It is well established that incentives to participate need to be adequate and convenient. With all this in mind, Humine offers participants cash compensation instantly after each study task is completed.   

Unlike apps on the market, Humine is a one-stop study hub where users can find and learn about studies, eConsent to participate, selectively share data from a wide array of sources, and stay actively engaged throughout the entire process, they say. The use of blockchain technology ensures data privacy, integrity, and security and removes the possibility of participant re-identification, while generating an immutable audit trail of study-related records. Data gets transferred to electronic data capture systems (EDCs) in whatever schema is needed. 

Humine is now working with Aleo and EDC providers to extend the business model across the entire drug life cycle through what company leaders are calling Zclinical, which would return a tiny fraction of drug profits back to the original participant pool. Targeted therapeutic areas are infectious and metabolic diseases, which represent a $4.5 billion market, Shoaib and Shanbhag report. 

A principal investigator has been identified for a pilot study, and the company is seeking $1.5 million in pre-seed funding for the next 18 to 24 months.  

InSilicoTrials, specializing in modeling and simulations to accelerate drug development 

The cloud-based platform of InSilicoTrials generates virtual patients to maximize the probability of clinical trial success, thereby improving the translatability of drugs from research mode to clinical use, according to COO Mario Torchia. In a use case with Merck, InSilicoTrials generated more than 3,000 patients with multiple sclerosis to test treatment effect and safety biomarkers and achieve $20 million in savings over four years.  

When InSilicoTrials was used by a biotech company for several central nervous system indications, $30 million in savings was realized and a new use was discovered for the compound under study, he reports. Members of the InSilicoTrials team have co-authored several scientific papers about the in-silico modeling approach and a practice-defining, open-access book is scheduled to be published in March. 

InSilicoTrials has a business model that is “completely aligned” with the interests of customers, which include big pharma, genetic pharma, and biotech companies, says Torchia. It has raised $4.8 million in funding for 2024, which is being used to expand operations and sales in the U.S. and Europe. 

To avoid introducing bias with the simulations, Torchia says, InSilicoTrials uses a combination of algorithms contributed by more than 72 centers worldwide with expertise in specific disease areas. The simulations have been accepted by regulators—in fact, the FDA last year issued guidance on the design and conduct of trials incorporating a synthetic control arm—although discussions are required before completely replacing real patients with virtual ones from historical studies or real-world data.  

OmniTrial, developer of Clinical Research Analytics Visualization Engine (CRAVE) 

Breakthrough treatments are taking too long to come to market and costing people their lives, which is what inspired the founding of OmniTrial, according to cofounder Sagit Goldenberg. The underlying problem is that pharma companies are still using spreadsheets and a lot of manual data processes. 

CRAVE is the cornerstone of the company’s efforts to speed things up by creating a single source of truth. Unlike dashboards of competitor systems, its charts simultaneously display both operational and financial data—and in actionable ways, she stresses, by finding the important correlations and pointing to them with intuitive, color-coded alerts.  

The technology provides a comprehensive package of lagging and leading indicators, promising users “practical, evidence-based solutions” to the challenges they face, Goldenberg adds. Using a scenario-planning tool, they can readily see how various parameters impact subject enrollment, timeline, and costs.     

OmniTrial has plans to integrate with a large language model later this year to support its transition from predictive to prescriptive analytics so CRAVE can simulate outcomes as well as provide suggestions for mitigating them, she announces. With limited data inputs, the platform will in seconds provide the ideal steps to take, including which sites to onboard to reach enrollment goals, saving sponsors months of research and planning time. 

The technology launches in March and small- and mid-sized pharma sponsors are being targeted as partners, says Goldenberg. A small pilot group of companies are the current users and the algorithm, which will initially rely solely on their data, will improve as the user base grows. 

Customers will access the technology via a monthly subscription fee based on the number of trials they want analyzed. Prescriptive analytics, when available, will come with an extra fee, as will customized packages of key performance indicators.  

OmniTrial has venture funding through the end of 2024. Once prescriptive analytics are in place, CRAVE will be integrated with ChatGPT already being used internally by many pharma companies, Goldenberg says.