Equity in Clinical Trials

The United States is made up of 40% People of Color (POC), but POC only represent only 2% up to 16% of clinical trial participants! That means that certain groups would:

1. Take improper dosage amounts

2. See inadvertent side effects from taking medicines that were not tested on people that are similar to them

This problem is huge as it affects many different under-served groups who suffer from this: women, African Americans, LatinX just to name a few. Companies are spending $8B per year on clinical trial recruitment in order to reach more diverse patients. They are solving this today by sending doctors into communities to share education and information on trials, but those Doctors are not of and from these communities. They are not able to build trust in these communities. There are a couple of reasons companies are motivated to solve this.

1. The FDA is pressuring companies to have more diverse participants and putting out requirements.

2. Markets are projected to be more diverse by 2050. So, if companies want to serve markets into the future, then they need to be able to make drugs work for all of the different groups.

CliniSpan Health has created the Digital Health Influencer model. It leverages influencer marketing in the clinical research industry to build trust and drive health equity. The influencers look like, walk like, and talk like the people they are trying to reach and actually know their community- which makes it easier to trust them.  Our process can easily push someone from being a follower on social media to being an enrolled patient in a clinical study. 

Step 1: Influencer posts educational and action-oriented content to their social media page to reach followers (Instragram, Facebook TikTok)

Step 2: Their followers are able to sign up on the CliniSpan platform

Step 3: Users are sent personalized study suggestions. Users input 3 data points: zip code, therapy areas of interest and current medications. Using that data, we personalize study suggestions to each user

Step 4: User refers and enrolls into relevant study opportunity to become a patient

Target User: 

• African American or Hispanic
• 18-35
• College educated (or currently in college)
• Lives in urban or suburban area

This is our primary target user. This is a group that is highly underserved. African American and Hispanic populations together are only around 5% of all clinical trial enrollees, which also means medicines are not as tailored to those communities either. For this group, having content that is in laymens terms and creates an easy path to access of studies is what they need that CliniSpan gives them. The general way of getting into a study has been to go to ClinicalTrials.gov. The language there is hard to understand for the average citizen and also does not create an easy path to access- some studies require a phone call and some require you to email someone, but none make an easy one-button process for starting in a clinical trial like CliniSpan does. 

Our founding team has seen ALL sides of this problem. Dezbee and Rashaad come from low-income communities and both have family members (Black women) that were taking medicines and seeing the rarest side effects even though Doctors assured they would not (patient side). This fuels them to work on this because they come from the underserved communities we solve for and have experienced this exact problem. Knowing that their work will make their communities better on a micro and macro scale is really important to them.

For Dr. David Lipsitz, he was a physician for 20+ years and provided medicines to minority and underserved communities. He saw how they took improper dosage amounts and were affected differently (physician side). He knew that this could improve his patients lives if we created a system for easier understanding and access.

So, from the physician and patient side, we have seen how this affects people. We know every nook and cranny of this problem and how to go about solving it in a way that people are comfortable with and actually WANT! 

We have currently educated over 2 million people in underserved groups on clinical research. 

We are currently have 3200+ people on our CliniSpan User platform that are referring and enrolling into studies. 

We have referred 2000+ people and enrolled 180+ people from an underserved group into a fitting clinical trial. 

Our database in international serving the US and Canada. Our top 5 US states are TX, CA, NY, FL, and NC. 

1. B2B Content

2. Creating Patient Content (B2C Content) - videos, social, etc.

CliniSpan Health is currently having challenges with more content produced and pushed strategically. We would really look to Solve and the Solver community to help us think through how to grow our content strategy from where it is on both sides: B2B and B2C. 

This is one of the barriers to scale that we are facing. When we are able to develop and distribute more effective content, we can scale relationships on both sides of the market much more rapidly. 

Our solution is THE FIRST platform to leverage influencer marketing in clinical research. Influencer marketing has become popular in recent years and helped to grow numerous industries. The clinical trial industry is quite antiquated as it relates to social media as a marketing tool and its general processes for operating trials. This process connects social media marketing as we know it today to make it easy for someone to go from follower to patient in a clinical trial. 

This solution can have HUGE impact in these communities. We will see measurably higher levels of education AND involvement in trials as a result. Ultimately, this will help to achieve Precision Medicine for all communities, but especially these underserved communities that have a higher need for more tailored medicines. 

Our impact goals are related to 1) education and 2) study participation from the underserved. 

Our goal over the next year is to educate 500,000 people in underserved communities. We will do this by educating people via social media and our digital health influencers sharing educational content on clinical trials to their many followers. 

We also have a goal to refer 1500+ and enroll 350+ over the next year. We will do this by pushing our infleuncers followers to our platform and getting them referred/enrolled into the right study. We have 10+ active studies in our portfolio that we are focusing on in order to drive these metrics. This is an impact metric that also directly drives revenue and growth. 

For a five year journey, our goals are just bigger and wider reaching. 

We aim to have educated over 5 million people in underserved communities and have referred 10,000+ and enrolled 1500+ into studies. But, more than numbers themselves, our vision is to have made clinical trials a regularly discussed and understood topic in underserved communities all across the US and the world!

We regularly measure and analyze how many people we are educating and getting to participate in studies and generate internal reports. The way that social impact is directly baked into our business model makes it easy to measure impact. For us, without meeting social impact goals, our business cannot grow. If our business grows at all, social impact is/was created. That is the best symbiotic relationship one can want a company to have from our standpoint.

We have already seen the impact in the short term from a huge case study. We helped to recruit African Americans for the Novavax COVID Vaccine study at one of the most important times in human history. Novavax put their data out that they reached 12% inclusion for African Americans in their study when the average is around 3%. Our model helped create a 4x more inclusive COVID Vaccine study and helped to make it more effective for African Americans immediately. With this help, their COVID Vaccine met FDA diversity guidelines and got approval in early 2022.

Our theory of change is that this microcosmic example will have a macro effect. Systemically, Pharma companies will be able to better serve minority and underserved communities and not have their operations suffer because they have a conduit to communities they could never reach. Underserved communities across the world will have safer medicines of any and all kind because of this work we do. The world is overall a safer and healthier place.

Our AI software platform powers our business and makes the process for influencers to push their followers from social media to an online platform to a study. 

It makes it easy for influencers to create and post content. They have a dashboard to manage this. 

Users have a dashboard to input information like: therapy areas of interest, medicines they take, and zip code. They can get personalized study suggestions (AI component) and also search for studies on the platform. 

We are a diversity company trying to reach many different communities. So, this is simple for us. Our team needs to reflect the communities we want to reach. So, we will have people of many different demographics on our team and as influencers. We have seen the clinical research industry try to serve communities that it does not reflect and how BIG of an issue that really is. So, we would be completely unaligned with our ethos if we were to not have DEI baked wholly into CliniSpan Health's DNA from day one. 

Our revenue is generated from the following services:

• Study Recruitment Services

1) Influencers' followers sign up on the platform

2) They input data on platform to receive personalized suggestions

3) Refer and potentially enroll into fitting study

We have a three part revenue model: 

• Licensing Fees-> monthly fee for study being on platform

• Referral Fees-> fee per qualified referral (passed a prescreener questionnaire) 

• Enrollment Fees-> fee per enrollee (signed informed consent and officially entered study)

We have been bootstrapped heavily up to this point. But, we are now currently fundraising as of Q4 2022. We are looking to complete our $750k SEED round by end of Q2 2023. 

Our revenue grew 350% in 2022 and we expect similar growth for this year so infused capital and some great strategic partnerships will really help take us to the next level. 

Revenue grew 350% in 2022 to over $500k. 

We have raised $250k total, mostly non-dilutive grants. 

Grants from: 

NC IDEA

VilCap/Johnson & Johnson

CVC

SAFE investment from Venture for America.

We closed $150k of that from JumpStart Foundry in Q4 2022 to open our SEED round.