Tag: Clinical Trials

High-Profile Start-Ups Inato And Prenosis Show AI ‘Best Practice’

May 28, 2025

By MICHAEL MILLENSON

Treating artificial intelligence as just one ingredient in a business success recipe was a prominent theme at the MedCity INVEST 2025 conference, with this AI “best practice” advice epitomized by high-profile start-ups Inato and Prenosis.

“You need to build a business model that makes sense, then use AI,” cautioned Raffi Boyajian, principal at CIGNA Ventures and a panelist at the MedCity INVEST 2025 conference in Chicago.

That sentiment was echoed and emphasized by fellow investors Aman Shah, vice president of new ventures at VNS Health, and Dipa Mehta, managing partner of Valeo Ventures. Both emphasized the necessity in a tough economic environment to find a “burning platform” that could immediately boost a customer’s bottom line.

In a separate panel, high-profile start-ups Inato and Prenosis accentuated that AI approach.

Innovation Customers Need

Inato was named by Fast Company magazine as one of the Most Innovative Companies of 2024, and that same year chosen by Fierce Healthcare as one of its Fierce 15. The Paris-based company connects drugmakers with otherwise hard-to-enroll patients for clinical trials by means of an AI-based platform that has attracted more than 3,000 community research sites in over 70 countries. By making clinical trials “more accessible, inclusive, and efficient,” in the company’s words, breaking a shocking pattern where 96% of trials do not include a representative population, Inato has established partnerships with more than a third of the top 30 pharmaceutical firms.

In describing its technology, Inato says it “assembled an AI agent to de-identify patient records, quickly determine which trials are relevant to each patient and evaluate patients against inclusion and exclusion criteria to assess eligibility” accurately and at scale. However, that phrase, “assembled an AI agent,” obscures a subtler process.

Liz Beatty, Inato’s co-founder and chief strategy officer, described using “off-the-shelf” large language models like ChatGPT and Claude and then optimizing them for a particular process with algorithms attuned to each model. As new models appear, the company adjusts accordingly. Although Beatty did not offer an analogy, there seemed an obvious parallel to a chef choosing among the right ingredients in the right proportions to ensure a recipe’s success.

Said Beatty, “I hear, ‘Let’s apply AI to everything.’ That’s not the right answer.” Investors are convinced enough that Inato does have the right answer that they’ve poured in $38.2 million, according to Pitchbook.

AI has also been central to the success of Prenosis. The company’s Sepsis ImmunoScore was the first Food and Drug Administration-approved tool using AI to predict the imminent onset of an often-deadly condition known as sepsis. Integrated into the clinical workflow, it was hailed by Time magazine as one of “the best inventions of 2024,” while Bobby Reddy Jr., Prenosis co-founder and chief executive officer, was subsequently named to the Time100 Health List recognizing influential individuals in global health.

Chicago-based Prenosis describes itself as an artificial intelligence company tailoring therapy to individual patient biology as part of “a new era of precision medicine.” As with Inato, though, the AI headline hides a more complex reality.

Sepsis is a heterogenous syndrome with close to 200 different symptoms possibly at play. “AI brings it together so we can understand the process of deterioration,” Reddy said. The company used machine learning to develop and validate a sophisticated algorithm, according to a New England Journal of Medicine study.

But the right AI was only one product ingredient. Prenosis also assembled a database of thousands of patients and set up a “wet lab” to find sepsis biomarkers – and to use for other conditions as the company expands its offerings – based on what is now 120,000 blood samples. Adding biomarkers to EHR data enabled the company to position itself as a more accurate, real-time complement to the sepsis tool Epic provides free to hospitals using its EHR.

“That’s our competitive advantage,” Reddy said.

Focused AI

Just as Inato focused on AI for its specific purposes, Prenosis also focused on a crucial goal. The AI was used “first and foremost to fit the FDA model for approval,” said Reddy.

Sepsis is caused by an overactive immune response to infection. It costs the U.S. health care system billions of dollars annually while claiming the lives of at least 350,000 people – more than all cancers combined, according to the Prenosis website. The World Health Organization has labeled sepsis a threat to global health, and the economic impact of just this one condition amounts to an average 2.7% of a nation’s health care costs, according to a 2022 study.

Unmentioned by Reddy at the INVEST conference was that a U.S. hospital’s performance in preventing and effectively treating sepsis is a factor in value-based payment by Medicare and in the hospital patient safety score published by the Leapfrog Group. A “burning platform,” indeed.

For Prenosis and Inato alike, AI best practice is based on practicality. As Reddy put it, AI is “just a tool” in product development.

Michael L. Millenson is president of Health Quality Advisors & a regular THCB Contributor. This first appeared in his column at Forbes

Lynda Brown-Ganzert, RxPx

Feb 24, 2025

Lynda Brown-Ganzert is CEO of RxPx. The company is the 2022 merger of the company she founded, Curatio, which was a support system for rare disease patients, with RxMx, a complementary service that helped clinicians manage patients on treatment or clinical trials. Lynda says that somehow I inspired the merger! (Although I don’t remember it, nor did she send me my 10%!). Now the company is supporting rare disease patients, funded primarily by pharma, across the globe. Lynda gives a full demo of both the clinician and patient experience–coordinating meds, labs, imaging, appointments, content, symptoms, patient reported outcomes, peer and coach support, and more. And she discusses how a great PE takeover works. (Not all of them are!)–Matthew Holt

Interview with Dr Pamela Tenaerts, Medable

Jun 8, 2023

Pam Tenaerts is the Chief Scientific Officer of Medable, which went from being a small company creating software helping clinical researchers to design their own experiments to being the big dog in remote clinical trials during the pandemic. Medable has raised over $500m in the past 3 years. Pam has a stellar research background and this interview covers the gamut about how clinical trials work, which companies are involved, how remote (or hybrid) trials actually work, and what the likely outcome for clinical research will be. If you have any interest in understanding the state of play in pharma R&D, this is compulsory viewing–Matthew Holt

The Future of Clinical Trials at Pfizer

Sep 22, 2022

BY JESSICA DaMASSA

From de-centralized clinical trials to real world data (RWD), real world evidence (RWE), and even social media, the future for clinical research at Pfizer sounds increasingly tech-enabled and focused on meeting and engaging patients where they are.

Pfizer’s Head of Clinical Trial Experience, Judy Sewards, and Head of Clinical Operations & Development, Rob Goodwin, drop in to chat about what Pfizer’s approach to clinical research looks like now, after the rapid evolution it underwent to “lightspeed” the development of the Covid-19 vaccine.

The big change? Rob says they are “obsessed” with de-centralized trials, with nearly 50% of clinical trial visits still happening virtually. And, beyond the convenience factor, both point to de-centralization as a critical factor in being able to recruit more patients into trials as well as improve the diversity of their participant groups. In the end, the decentralized approach, says Judy, is “not just a matter of equity, but good science as well.”

And what about improvements to the cost of drug development? Is it too soon to tell if de-centralization will make an impact on the bottom line? Innovation may be expensive to implement at first, but, explains Rob, “If you can recruit your trial faster, overall, the cost of development goes down and speed to the patient goes up.”

We chat through the full suite of benefits that de-centralized clinical trials are bringing Pfizer and its patient populations, and get into the utility of real-world data, which also saw new notoriety when the Covid-19 vaccine was being developed. How is RWD impacting clinical research even when it’s not being used as evidence in a regulatory approval process? Watch and find out more about how data innovation is shaping the future of pharma!

Cancer Centers Rebounding From COVID-19 Can Grow By Making the Most of New Technologies for Clinical Trials

Jul 8, 2021

For community cancer centers that rely on patient reimbursement to stay afloat, a smart data-driven approach to clinical trials provides a foundation for future growth.

Dr. Tandy Tipps

By TANDY TIPPS and BRENDA NOGGY

Covid-19’s tragic, devastating impact on cancer treatment is now well documented. Cancer screenings dropped by almost 90 percent at the peak of the pandemic. Billing for some leading cancer medications dropped 30 percent last summer. Studies found a 60 percent decrease in new clinical trials for cancer drugs and biological therapies.

Cancer centers, like every part of the US health system, have a lot of ground to make up. Those community cancer centers without grants and other institutional advancement funds, experience financial and human resources as major constraints to charting a path to growth. For them, successful programs which generate revenues for expansion or break even help them maintain fiscal health. Often, unfortunately, too often their research programs lose money.

Clinical trials have not been a viable revenue source because of the difficulty in accurately predicting patient enrollment and the challenges of managing trial portfolios, a task that requires streamlined feasibility processes that include querying baseline populations for new trials and potentially eligible patients.

The hard work of patient screening and trial matching requires clinical coordinators, physician investigators and research support staff to spend between three to eight manually scouring databases of electronic medical records and unstructured files to find patients eligible for trials based on increasingly complex inclusion and exclusion criteria. This costly process does not take into consideration the pre-screening efforts in patient matching that may not be reimbursable.

Resources are also needed to implement feasibility processes to accurately predict how many patients might enroll in a trial if they are eligible. Most community-based sites do not have an accurate ability to query their current patient populations by disease cohort or mutation in real time. They often rely on physicians’ memories to estimate patient numbers for trial feasibility questionnaires, which must returned to sponsors quickly, usually before cancer centers have definitive recruitment numbers.

As a result, before COVID, an average of only 5 percent of patients had a chance of participating in trials, 50 percent of clinical trials failed to meet enrollment goals and less than 14 percent were completed on time. Cancer centers still incur the administrative and clinical resources required to maintain the protocols in the first place, however.

What’s the Latest with Evidation Health?

May 20, 2021

An email interview with the Co-CEO’s of Evidation Health

Over the last few weeks I’ve been conducting a back & forth email interview with Christine Lemke (L) & Deb Kilpatrick (R), the co-CEOs of Evidation Health. They raised $153 million in a Series E back in March (almost a small round these days!) but I wanted to understand a bit more about what the “new” Evidation was doing—Matthew Holt

Matthew Holt: Congrats on the latest funding. Clearly Evidation has evolved since its founding, but focusing first on the clinical trial study aspect, can you explain how the Achievement panel is structured? How was it put together? What are the typical ways that your clients use it, and what is the member experience?

Deb Kilpatrick: Our Achievement platform is the largest virtual connected research cohort in the United States, with more than 4 million users across all 50 states and representing nine out of every 10 ZIP codes. Through the platform, accessible via our app or through a browser, individuals have the opportunity to contribute to ground-breaking medical research in a number of ways: they can connect smartphones, wearables, and connected devices—think Apple Watches, Fitbits, CGMs, etc—that generate heart rate, activity, sleep quality, and other health-related data; they can connect health apps like Strava and MapMyFitness; and they can participate in surveys and provide patient-reported outcomes (PROs) of many forms.

And they do so with strong privacy protections for both data collection and data use, including use-case specific consents that can be sequential over time. This goes for new Achievers and those who have used the platform for years. And Achievers always have the option to remove themselves from any research project, and/or the platform altogether, at any time.

What do we do with that data? Evidation partners with leading health care companies, including nine of the top 10 biopharma companies in the world, to understand health and disease outside the clinic walls while measuring real world product impact. We’ve conducted virtual trials for almost a decade now, totaling more than 100 real-world studies across therapeutic areas.

“Essential Oncology”: The COVID Challenge

Apr 3, 2020

By CHADI NABHAN MD, MBA, FACP

One harsh Chicago winter, I remember calling a patient to cancel his appointment because we had deemed it too risky for patients to come in for routine visits—a major snowstorm made us rethink all non-essential appointments. Mr. Z was scheduled for his 3-month follow-up for an aggressive brain lymphoma that was diagnosed the prior year, during which he endured several rounds of intense chemotherapy. His discontent in hearing that his appointment was canceled was palpable; he confessed that he was very much looking forward to the visit so that he could greet the nurses, front-desk staff, and ask me how I was doing. My carefully crafted script explaining that his visit was “non-essential” and “postponable” fell on deaf ears. I was unprepared to hear Mr. Z question: if this is his care, shouldn’t he be the one to decide what’s essential and what’s not?

This is a question we are all grappling with in the face of the COVID-19 pandemic. The healthcare industry is struggling to decide how to handle patient visits to doctor’s offices, hospitals, and imaging centers, among others. Elective surgeries are being canceled and advocates are arguing that non-essential outpatient and ER visits should be stopped. Ideas are flying left and right on how best to triage patients in need. Everyone has an opinion, including those who ironically consider themselves non-opinionated.

As an oncologist, these various views, sentiments, tweets, and posts give me pause. I understand the rationale to minimize patients’ exposure and thus prevent transmission. However, reconsidering what we should deem “essential” has made me reflect broadly on our method of providing care. Suddenly, physicians are becoming less concerned about (and constrained by) guidelines and requirements. Learning how to practice “essential oncology” may leave lasting changes in our field.

Can we move on?

Jun 27, 2019

By CHADI NABHAN MD, MBA, FACP

Every so often, my cynical self emerges from the dead. Maybe it’s a byproduct of social media, or from following Saurabh Jha, who pontificates about everything from Indian elections to the Brexit fiasco. Regardless, there are times when my attempts at refraining from being opinionated are successful, but there are rare occasions when they are not. Have I earned the right to opine freely about moving on from financial toxicity, anti-vaxers, who has ‘skin in the game’ when it comes to the health care system, the patient & their data, and if we should call patients “consumers”? You’ll have to decide.

I endorse academic publications; they can be stimulating and may delve into more research and are essential if you crave academic recognition. I also enjoy listening to live debates and podcasts, as well as reading, social media rants, but some of the debates and publications are annoying me. I have tried to address some of them in my own podcast series “Outspoken Oncology” as a remedy, but my remedy was no cure. Instead, I find myself typing away these words as a last therapeutic intervention.

Here are my random thoughts on the topics that have been rehashed & restated all over social media outlets (think: Twitter feeds, LinkedIn posts, Pubmed articles, the list goes on), that you will simply find no way out. Disclaimer, these are NOT organized by level of importance but simply based on what struck me over the past week as grossly overstated issues in health care. Forgive my blunt honesty.

Last Month in Oncology with Dr. Bishal Gyawali: April 2019

May 10, 2019

By BISHAL GYAWALI, MD

Keynote speech on the JAVELIN not going far enough to improve survival

The treatment landscape for metastatic renal-cell carcinoma has changed dramatically with the introduction of immunotherapies. Unfortunately though, we are promoting combinations over single agents without having much idea of added benefit of each drug. This is an important issue because when we combine two drugs, the only thing we are certain of are the added toxicities. PD-1 inhibitor nivolumab had improved OS when given in second line, however nivolumab was tested in combination with ipilimumab (not as a nivolumab monotherapy) in the first line trial. Now, pembrolizumab and avelumab have followed suit, although their combination partner was axitinib – a VEGF inhibitor. The control arm was sunitinib for both of the trials of pembrolizumab plus axitinib (KEYNOTE 426) and avelumab plus axitinib (Javelin 101). This is a little surprising because we are testing A B versus C, where both A and B haven’t been approved for the given setting – axitinib was approved for RCC in second line. Both these combinations improved PFS versus sunitinib but only the pembrolizumab combination has shown improved OS. However, I have doubts about the contribution of axitinib to these results. What would the outcome be if pembrolizumab alone is followed by sunitinib in second line? It is important to note that only one third of patients who discontinued sunitinib received PD-1 inhibitor subsequently in the KEYNOTE 426 trial. The important question for patients and clinicians would be to consider a survival difference had most of these patients received a PD-1 inhibitor subsequently. As for avelumab, the JAVELIN trial hasn’t reached as far as pembrolizumab and nivolumab have reached: The OS benchmark – so let’s reserve this combination until we see that benefit.

Have we successfully landed on the COMET?

We should remember that this combo-mania with PD-1/PD-L1 inhibitors may also backfire. Previously, the RCTs of nivolumab and pembrolizumab combos were halted in multiple myeloma for higher deaths in the combo arms. Another RCT IMblaze 370 also reports that atezolizumab, alone or in combination with cobimetinib, failed to improve survival versus regorafenib in patients with metastatic colorectal cancer. This time again A B failed versus C although C in itself is a drug with very marginal benefits in this setting. Also, I don’t understand testing A plus B combo when both A and B are unapproved for the disease.

Last Couple of Months in Oncology with Dr. Bishal Gyawali: March 2019

Mar 26, 2019• 2

By BISHAL GYAWALI MD, PhD

Hey, I’m back!

Well, you might not have noticed that my blogs were missing for the last three months but anyways, its good to be back. I was having a little time off blogs and social media as I was transitioning in my career but now I am back. Sometimes, it is very difficult to manage time for things that you must do versus things you enjoy doing, especially when these two don’t intersect. For me, these last few months the things I had to do were all bureaucratic while I couldn’t find the time for things I enjoy doing like writing these blogs. But now that we are back, let’s recap what has happened in the oncology world in the year 2019 so far. I can’t cover all of them, but will try to summarise the major events in oncology.

Hundred Foxes’ Howl versus One LION’s Roar

In my country, there is a saying that goes somewhat like the roar of one lion will scare hundreds of howling foxes away. In medicine, I guess, it translates as one good RCT trumps the results from hundreds of observational studies. For patients with advanced ovarian cancer, primary surgery to achieve complete resection is the most important treatment and prognostic factor. However, what to do with the lymph nodes is a question that has troubled the oncology community for a long time. Logically, it makes sense to remove the lymph nodes too because they are the sanctuary sites for cancer cells. However, lymph node dissection carries high morbidity. Although multiple observational studies suggested a survival benefit with lymph node dissection, the LION trial, now published in the NEJM, shows that for women with macroscopic complete resection of primary tumour, lymph node dissection increases morbidity (postoperative complications) and post-operative mortality rates but doesn’t improve survival. I am glad that this trial was carried out and these results will now save many women with ovarian cancer worldwide from unnecessary harmful procedures, but I am also sad that we didn’t answer this question until now and thus, many patients suffered unnecessarily. I hope this LION’s roar scares us from jumping to conclusions based on logic or observational data alone and without RCT evidence in future. Another lesson here is the importance of public funds in supporting RCTs like these.