Bobby Reddy, COO and co-founder of Pi Health, on the VatorNews podcast

On the VatorNews innovation podcast, Steven Loeb speaks to Bobby Reddy, MD, COO and co-founder of Pi Health, an oncology-focused health technology and clinical research company. The company launched in March with $30 million.

Highlights from the podcast:

0:46 - Reddy’s background: He started as a dermatologist and melanoma researcher at Harvard Medical School and Mass General Hospital where he learned about how to care for patients with melanoma, which was very serious at the time, especially in the stage four metastatic state. While there were several FDA approved drugs and targeted therapies a few years later, another challenge that was not immediately addressed was access. That was the origin of Pi Health, which is focused on creating an infrastructure for clinical trials globally that provides access for patients and that allows life sciences companies to develop medicines better, more cost effectively, and be able to access more patients.

6:52 - Clinical trial access for oncology: 85% of cancer patients are treated in a community setting, that is where they prefer to be treated. However, most oncology trials are in tertiary care centers and large academic settings. So, patients have to drive or travel very far to access clinical trials. That goes right into economic challenges, as patients have a hard time affording the other elements that are non medical for their care, like travel and being able to take care of their families. 

14:28 - Decentralized trials: There are trials where remote monitoring of patient data makes a lot of sense, but it has to be tailored to disease conditions and specific population groups because it's not always possible. Pi Health has a strong focus on oncology and it's hard to decentralize some critical aspects of oncology studies: often patients are very ill, so they need to be in a health system that can monitor them. Also, oncology medicines have to be observed carefully, as they have to be monitored for infusion reactions, so patients have to be in a place where they can be actively monitored.

18:47 - Pi Health’s solution: The company’s goal is to get as many health systems to participate in clinical trials: 95% of clinical trials will patients don't get to participate, and that's because a large part of those patients are in community settings that don't often have access to clinical trials and even the ones that do often have a challenge of finding the right clinical trial patients at the right time. Pi Health’s technology helps health systems, even those that are clinically trial naive, be able to participate, because it makes it easier for them to collect data and do the process of clinical trials with the least administrative burden. 

27:15 - Data collection: Data is often one of the most important parts of clinical trials because that's how regulatory agencies are able to fundamentally decide on the safety and effectiveness of medicines. One of the challenges is health systems and their use of electronic healthcare records, it was never designed to capture the data that regulators and all life science companies are looking for when they conduct clinical trials. Pi Health allows the data that regulators are looking for to make decisions on clinical trials to be captured at the very beginning: it captures structured data of patients that are important, not just in clinical care, but for clinical research. Then it uses AI tools that are able to take that structured data and make clinical documentation so that it could support the administrative tasks for physicians and nurses.

30:44 - Working with life science companies: Pi Health can act as a CRO for companies who are interested in using Pi Health to develop it to support their assets. For example, if a company is looking to conduct a phase two oncology study globally, with Pi Health can take on that initiative and do the study for the company. Often companies want to generate data for specific needs that are informative for their RMD goals and so the company can create projects that are aligned with what they're looking for.

38:18 - Tailoring the product for different markets: Pi Health needs to be able to make sure that they’re compliant with the local regulations and patient data privacy rules. This is why it's important to have a very strong local presence, and really also an ability to be open and understand what works for one specific country and what doesn't for others. The thing that doesn't change is that e very country's cancer patients unfortunately have the same stripes in all these areas, and the investigators have the same desires and challenges.