Gerald Finken: “Believe it or not, this has never been done before”

I want to make clinical trials available to everyone, everywhere by bringing the practice of pharmacy into clinical research. Believe it or not, this has never been done before. It will improve healthcare by giving people worldwide clear access to more lifesaving medicines and access to the medication experts — the pharmacist. As a part of my series […]

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I want to make clinical trials available to everyone, everywhere by bringing the practice of pharmacy into clinical research. Believe it or not, this has never been done before.

It will improve healthcare by giving people worldwide clear access to more lifesaving medicines and access to the medication experts — the pharmacist.

As a part of my series about “Big Ideas That Might Change The World In The Next Few Years” I had the pleasure of interviewing Gerald E. Finken, R.Ph., M.S., founder and CEO of RxE2.

Gerald is a licensed pharmacist with almost 40 years of experience in the biotechnology and pharmaceutical industries. In 1997, he founded Clinical Supplies Management, Inc. (CSM), a clinical supplies packaging and labeling company, where he invented On-Demand packaging and labeling as well as Clinical Trial Research Pharmacist (CTRP®) services. He also pioneered Direct-to-Patient services. In 2013, he founded Center Point Clinical Services and subsequently created the innovative Siteless CRO model. In 2020, Gerald launched RxE2 where he now serves as CEO. Gerald focuses on innovation, disruptive business strategies, and growth opportunities.

Thank you so much for joining us! Can you tell us a story about what brought you to this specific career path?

My big sister, Shirley, who is two years older, was my inspiration. She was so competitive and determined to achieve. From a very early age she told me that we were going to college and medical school to become doctors. Sounded good to me.

My sister excelled at high school with her eye smack on the medical school ball. She went off to study pre-med and then was accepted to medical school.

I, however, had detoured. In high school, my love for competitive sports overshadowed my academic ambitions. Spending all of my time on the field took a toll on my grades and I started to question my chances of being accepted into medical school, let alone my ability to get through the course work.

The summer vacation of my junior year of high school, my sister, who was home from college, suggested that instead of being a doctor I should consider being a pharmacist. I asked, “What is a pharmacist?” She replied, “You know, the person behind the counter at the pharmacy. They are professionals and they help people.”

I thought: great idea. I wanted to pursue a career in healthcare and to help people. So, I applied to pharmacy school the following year under early admission and never looked back.

Can you share the most interesting story that happened to you since you began your career?

I started my career working at a large pharmaceutical company. A few months into the job, I teamed up with colleagues to start the first clinical supplies packaging and labeling company.

By day we worked at the pharmaceutical company and by night, my partners and I spent our time writing a business plan, a competitor analysis, and detailed financials.

After two years, and many meetings with my partners and various VCs later, we closed a 1M dollars seed investment in our start-up.

The whole experience was exhausting, but it was also exhilarating. We had achieved what so few companies had achieved. We were funded.

I was on top of the world as we met with the lawyers to finalize the legal paperwork for incorporating. I remember taking the 4-inches of legal paperwork home and showing my wife. I was so proud.

It was also the last time I heard from my two partners. Secretly, they had decided to go into business without me and legally solidified this with our lawyers. Though I had written 75% of the business plan, they felt that I was too young to be a partner in this venture.

I was devastated. It took me six months to start feeling like myself again.

I learned a valuable lesson and ten years later I started my own packaging and labeling company called Clinical Supplies Management, Inc. (CSM), without VC backing and without partners. It was a great success and in 2018 the company was sold for an initial consideration of 150 Million dollars.

Which principles or philosophies have guided your life? Your career?

Work hard and if things are not working out, work harder. Be honest. Use the principles of Problem Analysis to work everything out.

Ok. Let us now move to the main focus of our interview. Can you tell us about your “Big Idea That Might Change the World”?

I want to make clinical trials available to everyone, everywhere by bringing the practice of pharmacy into clinical research. Believe it or not, this has never been done before.

How do you think this will change the world?

It will improve healthcare by giving people worldwide clear access to more lifesaving medicines and access to the medication experts — the pharmacist.

Keeping “Black Mirror” and the “Law of Unintended Consequences” in mind, can you see any potential drawbacks about this idea that people should think more deeply about?

Yes, money can get in the way. What do I mean by this?

Clinical trials often start out with lots of goodwill to help people. Then, as there is progress, the corporations get involved and the data collection and analysis process often times becomes convoluted and the data itself is often misunderstood or even misused for financial gain.

For example: a patient may report they are feeling well, but in their voice or facial expressions you can see that this answer is not quite right. If the person collecting this information is only listening to the answer to “check-the-box” to collect data, then the true value may be missed. If this happens too many times, the drug may be approved, but when it is introduced into the market, problems may arise.

Was there a “tipping point” that led you to this idea?Can you tell us that story?

One late evening as the sun was setting, I was on a bike ride north of Fargo, ND. It was in the Fall and the wheat fields were golden brown. The wind made the fields look like water as waves and waves of wind moved across the miles of wheat. I was lost in free thought when I had an epiphany of how to disrupt clinical research. I had been in the business for more than 35 years then and in an instant, I realized how things could be done differently. Thus, I came out of “retirement” to follow the path before me.

What do you need to lead this idea to widespread adoption?

New ideas are sometimes hard to accept — — not because they are difficult or problematic, but because they are new and hard to wrap our minds around. This is especially true if the process is ingrained in everyone’s mind, as is the case with clinical research. Think about trying to explain the Internet to someone living in the early 1900s.

There are two major things required for the widespread adoption of this idea:

1) For local, independent pharmacies to get involved.

2) The realization of pharmacy customers with pre-existing conditions that they can go to their local pharmacist to discuss what clinical trial options are available to them, how to enroll and how to participate. Their pharmacist can then work with them to find a match.

I plan to do my best to educate people that pharmacists do more than just dispense medication. They are available to people and patients almost 24/7 to discuss their healthcare and medications, answer their questions, and address their concerns — — all for free and even during pandemics.

This is the exact reason why the future of clinical trials should be managed at the pharmacy level. This way, people everywhere can enroll in clinical studies, with the guidance and instruction of their local pharmacist and physician.

What are your “5 Things I Wish Someone Told Me Before I Started” and Why.

1) Be patient.

“Rome was not built in a day” and “good things come to those who wait” are great sayings as these imply that you need a good foundation and wisdom to build something lasting. When I first graduated from college I wanted success immediately so I got involved in a get rich quick investment. What I learned from this is that there is no such thing and that the more prudent road to take is one of patience and hard work and this eventually leads to success.

There are two types of success, both of which are important: 1) Financial, which of course, most people want, and 2) sense of personal achievement. This is often harder to achieve.

2) Ask, Listen and Learn.

This is one of my favorite expressions because what I’ve learned is that I usually ask, talk and tell, which means that you don’t invite other people’s experiences and ideas. This shuts down the team approach which I have learned is crucial to success. The idea is to gain knowledge which leads to wisdom. As one of my colleagues always says (wisdom passed on from her late grandfather): “You don’t learn anything, if you’re the one doing the talking.”

3) Build ahealthy work-life balance.

To have a successful company you also need a successful home life. I almost learned the hard-way to do this, but am thankful that I not only applied my “work-harder” mentality to my work life, but I also applied it to my family life. For this reason, I made and continue to make sure that everyone at my company takes their vacations and do my best to make sure our company culture values the family.

4) Remember: First things first.

It is important to have a clear vision of what you want to achieve, but you must take the first step to get there. This must be done every day.

My first mentor in my first job would always shake his finger at me when I was too eager and would gently scold me with a smile on his face while saying “first things first”. In other words, slow down and think. Forty years later, my current mentor also often reminds me to slow down and do the “one thing” today that I need to get done to achieve my vision. I guess I am still too eager.

5) You cannot afford to, but you cannot afford NOT to.

When you begin in business, you do not know, what you do not know. You may end up spending lots of money on something you may not think is totally worth it. But eventually, you understand that those expenses were necessary and produced great value.

I found this to be true of marketing. When I first started I thought that this was an unnecessary expense, but as I became more business savvy, I realized that this is an area you must spend money on for business success, especially if the idea is disruptive.

Can you share with our readers what you think are the most important “success habits” or “success mindsets”?

Believe with unwavering conviction and actually “see” the success. If you have no doubts, you will succeed. Of course, you must do your part. So, work hard and if things are not going so well, work harder. Read Jeff Olson’s book, The Slight Edge and make sure that everyday you move yourself forward.

Some very well-known VCs read this column. If you had 60 seconds to make a pitch to a VC, what would you say? He or she might just see this if we tag them 🙂

The next disruption in clinical research will not be XaaS, it will be Service as a Service, going old-school and focusing on person-to-person relationships while using technology as a tool rather than a solution.

Everyone is saying that technology is a disruption in healthcare and they are using data mining, AI, and the Internet as a service. In time, these will prove to be true. But in the meantime, we need to improve the data we are collecting and lay a better foundation today to get there. We need to go back to the relationships we once had in healthcare to build those future systems and models.

Right now, healthcare is a mess. So how can we build the AI and do the datamining? How do we build a system based on a healthcare foundation that is crumbling?

We intend to bring back person-to-person business and interactions, leveraging the patient/pharmacist relationship to improve the existing clinical trial process and advance the quality of healthcare.

We will build upon the very important human social needs of trust and dependability, both natural in the patient/pharmacist relationship.

If a next XaaS solution could be a billion-dollar business, then a SaaS business has the potential to be a trillion-dollar business. Our model finally solves the time, cost, and quality clinical research issues that technology has not solved in 40 years.

How can our readers follow you on social media?

Thank you so much for joining us. This was very inspirational.

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