Equity in Rare Disease 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.

This problem is even further exacerbated when we look at rare disease prevalence in underserved communities. These communities are getting these diseases at higher rates and getting served lesser than their counterparts to solve for it. Patients dealing with rare diseases and are in underserved communities are not getting the proper attention and access to new care and CliniSpan Health changes that fact of life for them. Sickle Cell, Melanoma, and Colorectal Cancer are some problem areas we are or have focused on for rare diseases in underserved communities.

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 rare disease study. We are able to partner with influencers that have rare disease themselves. They are likely to have similar people following them.  This helps make our model work better because they know and understand the cultural competencies of a rare disease patient and would know how, why, and when a clinical trial is right for someone in the same shoes. 

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

Platform Demo Link

Target User: 

• African American or Hispanic
• 18-35
• College educated (or currently in college)
• Lives in urban or suburban area
• Suffering with Rare Disease Criteria

This is our primary target user for rare disease studies. 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 (myself) and Rashaad come from low-income communities and both have family members (Black women) that suffered from rare diseases where they were taking medicines and seeing the rarest side effects even though Doctors assured they would not (patient side). My aunt particularly suffered from a rare type of Breast Cancer and saw the rarest side effects despite Doctor promises that she would not and she began to lose trust in her relationship with him as a health professional.We know what it is like for underserved patients to live with rare diseases because they saw it first hand. This fuels us to work on this because we 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 rare disease 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! 

Main Challenge: Creating B2B Content for Rare Disease Pharma Customers

CliniSpan Health is currently having challenges with getting more rare disease content produced and pushed strategically on the B2B side. We want to bring on many more rare disease trials than we currently operate.  We would really look to the Prize community to help us think through how to grow our content strategy from where it is on the B2B side. Prize judges and advisors will have great insights into what they would want to see from us to make a purchase decision and that is the insight we are looking for.

Our Team Lead is of and from an underserved, rural community. Dezbee knows the way of life of these communities and how to culturally integrate clinical research into their lives. 

Dezbee also has had his own experience helping with a rare disease patient in his Aunt Sherri and knows what a rare disease patient might experience. He knows some subjects are touchy, how to communicate with them, how their eating habits change. Rare disease patients really feel a deeer connection to healthcare providers when they feel understood. Dezbee understands because he had to grasp it in order to help create a better patient experience for his Aunt Sherri. He is now doing that for communities at large and is a great fit for this based on life experiences. 

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 rare disease clinical trial. 

This solution can have HUGE impact in these communities. We will see measurably higher levels of education AND involvement in rare disease 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 in rare diseases. 

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 on rare diseases. 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 100+ and enroll 50+ to a rare disease trial over the next year. We will do this by pushing our influencers' followers to our platform and getting them referred/enrolled into the right rare disease study. We have 2 active rare disease studies in our portfolio currently (with more coming in Q3 and Q4). 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 2 million people in underserved communities on rare diseases and have referred 1000+ and enrolled 500+ into rare disease 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 rare disease 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 are currently helping Exelixis to recruit People of Color for a Metastatic Colorectal Cancer(MCC) study. They shared their data that showed they are already at an inclusion rate of 36% for POC, when the average is around 5%. Our model is helping to create a 7x more inclusive MCC study. With this help, the plan is to be able to adhere to new FDA Clinical Trial Diversity Regulations and gain FDA approval. (after becoming significantly more difficult to obtain because of diversity metrics)

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. 

7 FT, 1 PT

2 years on the market

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 raised $265k in non-dilutive and VC capital. 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. We are at a place where we can sustain at this level of growth for some time, but we want to grow faster and more efficiently.

So, we are now currently fundraising as of Q4 2022. We are looking to complete our $750k-$1M SEED round by end of Q2 2023. We have closed $150k of that. We are currently in due diligence with Morgan Stanley and Echo Capital to close the rest of our SEED round. 

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

We have raised $265k 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. We are in 30-45 day due diligence period with two other investors: Morgan Stanley and Echo Capital with potential to close the round between both check sizes.