Q&A: metaMe CEO, Tim Rudolphi on Increasing the Accessibility of Disease Treatment with Digital Therapeutics

Hemi Ventures
Nov 25, 2019 · 5 min read

“I believe that there will be a tremendous change in the medical and healthcare ecosystem with the availability of a new therapeutic modality that’s much more convenient and safer for patients to utilize. People will use the term prescription digital therapeutic and they’ll know that it is a software equivalent to a drug that can be used to treat disease.”

metaMe Health is a Chicago-based prescription digital therapeutics company. The company’s lead product in development is Regulora. Regulora is the first digital implementation of a behaviorally-focused treatment that is intended to address the cognitive, behavioral and affective drivers of IBS. This is noteworthy because more than 30 million Americans, or about 10 percent of the US population, suffer from IBS. metaMe is also developing digital therapeutics for gastroesophageal reflux disease (GERD) and inflammatory bowel disease (IBD).

Hemi recently invested in the company’s $3.8M seed round. metaMe’s CEO, Tim Rudolphi, spoke with Hemi Ventures about his experiences developing new digital therapeutic treatments.

metaMe’s CEO Tim Rudolphi

Regulora is the first digital implementation of a behaviorally-focused treatment that addresses the cognitive, behavioral, and affective drivers of IBS. What inspired the invention?

Our founder, Danny Bernstein, has suffered from inflammatory bowel disease and irritable bowel syndrome his whole life. After learning about behavioral therapy treatments used at Northwestern University, he realized the possibility of providing these treatments digitally which would greatly increase their accessibility.

In September, metaMe Health received IRB (Institutional Review Board) approval to move forward with a pivotal clinical trial. In November, metaMe announces first subject enrolled in pivotal study. How will this impact the company?

We’ve had a lot of successes in the past six months and this is another big step for us. It shows that we put everything together in the appropriate way, not only in consultation with the FDA, but in development of the protocol for this study. We’re excited about the program, our partnership with our clinical research organization and having IRB approval. Now that we have that, we are starting to enroll patients in the trial.

Prescription digital therapeutics to prevent or treat diseases are still nascent. How do you think the industry will evolve in the next 3–5 years?

I believe that there will be tremendous change in the medical and healthcare ecosystem with the availability of a new therapeutic modality that’s much more convenient and safer for patients to utilize. In three to five years, enough prescription digital therapeutics companies are going to have proven their therapies safe and effective through the FDA that PDTs will be widely known in the marketplace. People will use the term prescription digital therapeutic and they’ll know that it is a software equivalent to a drug that can be used to treat disease.

You have 30 years of pharmaceutical and healthcare experience, holding leadership positions at large pharmas like Takeda and Parke-Davis (a subsidiary of Pfizer). What was your experience transitioning from large companies to a startup?

Many people look at my experience and think I’m a big pharma guy, but don’t realize that I actually helped start Takeda in the U.S. It was that experience that led me to leave Takeda and get back into the startup environment. I love the atmosphere where everyone has the same vision and there’s total alignment to accomplish it.

The company was recently named as one of the 50 leaders in the Chicago tech scene and also won the prestigious Sandoz Healthcare Access Challenge award earlier this year. How did you lead the team to achieve this?

I think it comes down to execution. Very simply, if you’ve got to go from point A to point B, then you have to prioritize. You have to move all of the obstacles out of the way to get to the final destination. That’s what we’ve done here as a team.

Regulora can potentially help more than 30 million Americans suffering from IBS. Leading a company that’s at the forefront of bringing prescription digital therapeutics to reality, what’s the long-term impact you’re trying to create?

There is a patient population that is suffering and actively trying to find solutions. We believe that taking therapy out of the clinic and putting it into the digital forum can really have a positive impact on those people. A broader group of people can have access to the therapy. Prescription Digital Therapeutics can increase access for other disease states as well and that’s really the goal.

What is your personal mission that led you to join metaMe as the CEO?

When I started in pharma 30 years ago, I didn’t realize how much personal joy or benefit I’d receive from bringing products to the marketplace that help patients. I was able to launch over 15 brands while in pharma, but over time while working in larger pharma companies, it became more and more difficult to make big change. It’s completely different in a small startup environment with a brand-new therapeutic modality. We are changing the way healthcare is delivered in the U.S.

What makes you excited to go to work every day?

I love getting things done. We have so much to do and I wake up each morning with a to-do list that is a mile long. I can easily see the progress we make each and every day and that makes me feel great. I love moving the ball forward and that’s what we’ve been able to do so far with metaMe.

What would people be surprised to learn about you?

I’m an introvert and a kind of a redneck. I’m very comfortable in a small group setting with my friends, and I’ve had to work hard to become more comfortable meeting new people and being in large crowds. I also like country music, ATVs, hunting, and fishing.

What’s your favorite memory working with Hemi?

I’m surprised by how much I enjoy working with Hemi. I was nervous going in to my first dinner with Paul and Amy, but I knew I had to do it because they were committed to investing in our company. The dinner was much more comfortable than I expected and a ton of fun; Amy and Paul were just real people. I enjoyed the evening so much that I still remember exactly what the restaurant looked like and where everyone was seated.

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