Revolutionizing Clinical Trials with AI and Pharmacists. Digital Health Interview with Gerald Finken

In a recent episode of Digital Health Interviews, our host Alex Koshykov sat down with Gerald Finken, a veteran in the pharmaceutical industry and a pioneer in clinical trial management. Finken’s journey from a young pharmacist to a successful entrepreneur and innovator in clinical supplies management is a testament to his passion for improving healthcare and clinical research.

Early Career: From Pharmacy School to Big Pharma

Gerald Finken’s journey in the healthcare industry began with a clear vision. He recalls, “I knew very early on I wanted to be in the healthcare profession.” This drive led him to pharmacy school and, upon graduation, straight into the heart of the pharmaceutical industry at Bristol-Myers Squibb.

It was at Bristol-Myers Squibb that Finken found his niche in clinical supplies, which would become the foundation of his expertise in clinical research and trials. “Right out of college, I’m working as a pharmacist in the pharmaceutical industry, and started my career right off the bat by having an opportunity to work in clinical supplies,” Finken reminisces.

The Entrepreneurial Leap: Founding Clinical Supplies Management

After 12 years in the corporate world, Finken felt the entrepreneurial itch. A move to Fargo, North Dakota, prompted by his wife’s teaching job, catalyzed his next big venture.

“When I got out to Fargo, North Dakota, I realized how much I missed what I was doing. And so I started consulting and one thing led to another,” Finken explains. This led to the birth of Clinical Supplies Management (CSM), a company he started with nothing more than “a Visa card and an $8,000 a month contract.”

Finken’s entrepreneurial spirit and determination shone through as he bootstrapped CSM for 20 years, growing it to two locations and 150 employees. He proudly states, “I worked on that, bootstrapped it for 20 years, and grew it to two locations, 150 employees.”

Scaling Up: From Local to Global

Recognizing the need to compete on a global scale, Finken made a strategic decision to bring in private equity. This move allowed CSM to expand rapidly into Europe through acquisitions.

“I brought in private equity and immediately before the ink was dry on my deal and my private equity deal, we already had our two tuck-one acquisitions in Europe,” Finken recounts. “So overnight we became a cornerstone success in the packaging and labeling business.”

The Entrepreneurial Spirit: Always Looking for the Next Challenge

Despite the success and eventual sale of CSM to Clinton Jim, Finken wasn’t ready to retire. When asked why he wasn’t done yet, Finken chuckles, “Yeah, my wife asked the same question. Why aren’t you? Wasn’t done yet.”

This restlessness stems from Finken’s recognition of persistent problems in the pharmaceutical industry. He points out, “Nine out of 10 drugs fail. That’s terrible. Alex, that’s terrible. Yet this is what we live with because everybody’s making money, right?”

Looking to the Future: Embracing Digital Health and AI

As the interview progresses, Finken touches on the potential of digital health and AI in addressing longstanding issues in clinical trials. He emphasizes the need for a fresh perspective: “I think it’s time we have to step back and start taking a look at the digital age and what is digital health.”

Finken’s journey continues as he looks to solve ongoing challenges in clinical trials, from recruitment to dispensing clinical supplies. His approach? “I’m a big believer that you tech-enable a service, right? And that you move it down that path and then get more efficient with technology.”

The Pandemic’s Impact on Clinical Trials

The COVID-19 pandemic brought unprecedented challenges to the healthcare industry, but it also accelerated innovation in clinical trials. Gerald Finken reflects on this period with a mix of sorrow and hope:

“As awful as it was, it did push to the forefront the Science 37s, the Metables, and their technology. Now, granted, it happened so fast, that they weren’t ready. And everybody talks about their platforms that weren’t quite ready and stuff.”

Despite the initial hurdles, Finken believes that the shift towards decentralized clinical trials (DCTs) is here to stay. He emphasizes, “Based on what I’m seeing with RxE2 and where we’re going, it’s here and it’s here to stay.”

The Future of Clinical Trials: A Hybrid Approach

Finken strongly advocates for a decentralized hybrid model in clinical trials. He argues that this approach is crucial for addressing long-standing issues in the industry:

“If we do not go to a decentralized hybrid model, if we don’t use it, and to me an entirely different model, to close out the studies, companies will still make money. Farmers will still be around. We’ll still find ways to do this. But the benefits won’t be realized for decades to come when it could be recognized in a decade.”

Bridging the Gap: Clinical Trials and Healthcare

One of Finken’s key observations is the need to integrate clinical trials more closely with healthcare. He states, “We’ve got to stop this nonsense of clinical trials over here, health care over here. And we’ve got to get regulatory bodies rethinking about data collection and how we can collect data now.”

Finken also highlights a significant gap in the industry: the lack of pharmacist involvement at the leadership level. “There’s no chief pharmacy officer in any of the industries, right? You have a chief medical officer. So many things, when you think about recruitment, compliance, adherence, and retention, what profession, a licensed professional is responsible for those? Pharmacists.”

The Technological Tidal Wave

Finken sees a technological revolution on the horizon that the industry isn’t fully prepared for. He cites advancements in areas like CAR-T therapy and the modeling of side effects as examples of how quickly the field is evolving.

“Technology has moved, has advanced us so far down the path of like modeling side effects. I mean, a thing of the past. But the issue is like, we’re not going to have drugs for millions of patients. We’re going to have drugs for 10,000 here, change the therapy a little bit for 10,000 here because of the modeling.”

Pharma’s Readiness for Innovation

When asked about the pharmaceutical industry’s readiness to adopt new technologies, Finken offers a nuanced perspective. He acknowledges the industry’s openness to innovation but also points out the challenges:

“I think they’re open to innovation. I mean, I was at a conference today where they had about innovation. The innovation officers there are open to it. But this is where like as a small company we think as a startup you had this innovation why aren’t you accepting it? We’re not putting ourselves in their shoes.”

Finken emphasizes the need for startups and innovators to understand the pharmaceutical industry’s constraints and requirements:

“They have like KPI, they need milestones, they have a huge organization. You can’t just take technology and put it into this one protocol and think that pharma is going to adopt this because they have procedures and processes and the data, the way they collect, and the vendors that they’ve had a vet and do quality insurance on.”

The Path Forward: KPIs and Realistic Approaches

Finken stresses the importance of key performance indicators (KPIs) and realistic approaches for innovators in the clinical trial space:

“We as smaller companies, the innovators, have got to get realistic about putting ourselves in their shoes and where’s the KPIs. Perfect example, we were at a conference a month ago. Some of my people were at a conference a month ago. There were, I think, 40 companies doing recruiting. None of us have KPIs.”

He suggests that companies should focus on proving their value through concrete metrics and data, rather than relying solely on marketing:

“It’s going to be about we have to do a better job of fulfilling our pitch, getting the KPIs, proving what we’re doing. And as you know, maybe be a little bit more prudent with our VC dollars, right, to make sure that the VC dollars aren’t going all to marketing.”

RxE2: Revolutionizing Clinical Trials with Pharmacist Involvement

Gerald Finken’s latest venture, RxE2, is built on a simple yet revolutionary premise: getting pharmacists involved in clinical trials. Finken explains the genesis of this idea:

“It’s based on the premise of getting pharmacists involved in clinical trials. We started with recruitment services to start. It’s a slow walk. I want pharmacists to be PIs (Principal Investigators), but there’s no way I can go to pharma companies and say let my pharmacists be PIs. It’s just not gonna happen.”

Instead, RxE2 is taking a strategic approach, starting with patient recruitment. Finken points out the untapped potential:

“We have ten pharmacies around that clinic with patients with the same indication, but this clinic has nothing to do with them. They don’t know those patients. So we said, listen, we think that we can find the same criteria you use in your clinic. We can use the same data, relationships, et cetera, to get those same, you know, 10 times the amount of patients into that one clinic.”

The Unique Position of Pharmacists in Healthcare

Finken emphasizes the unique relationship pharmacists have with patients:

“Pharmacists have a different interaction with patients than a doctor. If you’re seeing a doctor 12 times a year, you’re seeing me 50 times a year as a pharmacist.”

This frequent interaction allows pharmacists to gather real-world data that can be crucial for clinical trials. Finken recalls his experience from 20 years ago:

“We knew what was going on in the real world with the clinical drug trial, with the drug, what was happening. They would tell the physician, the PI, one thing, and they’d tell us something different.”

The RxE2 Platform: Simplifying Clinical Trials for Pharmacists

RxE2 is developing a platform that aims to simplify the process for pharmacists to participate in clinical trials. Finken describes his vision:

“We have one login for all our pharmacists. They log in to me, and I give them the world. We’re going to have the one login for all pharmacists and then all the nonsense, all the tech that when you start thinking about wearables and everything is going to come through us through one platform.”

This approach, Finken argues, will make it easier for pharmacists to participate in clinical trials and provide valuable data and services.

The Future of Clinical Trials in Pharmacies

While not all clinical trials can be conducted in pharmacies, Finken sees great potential for certain types of studies:

“Anything in obesity, hypertension, diabetes, all those types of vaccine studies, they could all be done at the pharmacy. Much more efficient.”

He envisions a future where pharmacies play a central role in certain types of clinical trials, leveraging their operational efficiency and close relationships with patients.

Lessons from Pilot Programs

RxE2’s journey hasn’t been without its challenges. Finken candidly discusses the outcomes of their pilot programs with major pharmaceutical companies:

“They thought we were going to get randomized patients, and in the end, we didn’t. And some of that has to do with, again, really tough inclusion-exclusion criteria. But no one said no more, right?”

Finken emphasizes the importance of transparency and partnership in overcoming these challenges:

“To me, the only way this is going to work is true partnerships, and that is being open. We’re failing. This isn’t working. And because it’s like, if we don’t tell pharma where we’re failing, we’re taking decisions away from them.”

Despite not meeting initial expectations, Finken remains optimistic about the future:

“Give us another year, and we’ll have this, like MDD and other things, we’ll get a much better result than, or the equivalent result of what the clinics are getting. Clinics get 60% of the patients we need to close the gap and it’s in that gap where we’re working.”

The Founder’s Perspective: Challenges and Superpowers

When asked about the most challenging aspects of being a startup founder, Finken reflects on his strengths and the obstacles he faces:

“My superpower is a vision right and I’ve had this vision I see it so clearly how it’s going to work… I’ve just been so fortunate to hire just good people, you know, really good people to deliver.”

He highlights the strength of his team, including his chief pharmacy officer and technology group, which contribute to RxE2’s cutting-edge platform and upcoming patient app.

However, Finken also points out a significant challenge in the industry:

“The hardest thing for me, like as you mentioned earlier about innovation, everybody talks a good game, but no one wants it. And back to Clayton Christensen sustaining innovation, what’s the roof over our head? What puts food on the table?”

The Fear of Change and the Role of AI

Finken identifies the fear of change as a major obstacle in the industry:

“The biggest challenge I think is the fear of change. And if we just didn’t have that fear, as we all have that innate we could all get into psychology and economy and all this stuff, you know, and behavioral aspects. If we could just get over that and just move forward, you know, and get something even with like the patient in mind, you know, but then, well, again, we can.”

He also touches on the role of AI in the future of healthcare and clinical trials:

“We’re going to use AI for everything to get in, but then use the pharmacist, use the doctor, use the nurse. What does it mean? Where do we go?”

Optimism for the Future

Despite the challenges, Finken remains optimistic about the future of clinical trials and drug development:

“We already are. I mean, pharmacists, we have 400 pharmacists on our platform today working away, right? So they’re all ready now. We have pharmacists involved in clinical trials. So it’s launched. And now that’s happened, they’re never going back.”

He sees great potential in the pharmaceutical industry’s ability to develop new treatments:

“The cure for cancer is already found. The cure for the disease has already been found. How do we bring them to market?”

Finken draws inspiration from past successes in medical research, such as the response to the AIDS epidemic:

“I was living in the AIDS epidemic… And I had friends who passed away. It was just awful. And they talk about a motivated group to find solutions. And I think that’s just humankind, that we will find solutions.”

Advice for Startup Founders in the Clinical Trial Space

Finken offers valuable advice for other startup founders in the clinical trial space:

“I love the great pitch. Back it up. You know, put your money where your mouth is first. Like, you put your money in, go do your pilots, and then come out and raise money.”

He emphasizes the importance of having data to support your pitch:

“In the startup company, that first VC that I did, we brought our salaries in for the first year. So I was fortunate enough to be in a place where I was fortunate with real estate and stuff and so I put my money where my mouth is. And to come in bootstrapping with the pilots so when you start to pitch, you can back it up with data and not just pipe.”