Dec. 2, 2020

This paid piece is sponsored by South Dakota Biotech.

Whether you work directly in quality assurance, in the broader health care and bioscience industries or are just looking to learn more about this growing field, you’ll want to listen in on a new locally produced podcast.

“Inside Out Quality” is produced and co-hosted by Aaron Harmon. An SDSU graduate with a doctorate in biological sciences, he’s the director of quality and general manager of Inanovate, a medical device startup.

He previously was a senior scientist with Novartis Animal Health, where he spent 10 years developing animal vaccines, and worked in USD’s biomedical engineering department, supporting the GMP facility, teaching and working with small biotech companies to help develop their products.

His podcast co-host, Diane Cox, is a quality management systems consultant based in Sioux Falls with several years of experience in the medical device industry.

“We hope this appeals to those interested in biotech/medtech or quality assurance in general,” Harmon said. “The stories are all pretty amazing too, so I hope anyone in the general public will enjoy them.”

The podcast is backed by South Dakota Biotech, the state affiliate of the international BIO organization.

“We’re excited to offer this new way for those within our industry and those interested in it to learn more about the field of quality assurance as well as the groundbreaking businesses finding success in South Dakota,” said Joni Johnson, executive director of South Dakota Biotech.

“This is an area that is underserved with content, and we know Aaron and Diane are going to bring something incredibly valuable to their listeners.”

Harmon shared more with us on what listeners can expect from the new podcast.

First, why start a podcast?

There were so many reasons! First, I noticed that many researchers and entrepreneurs view quality and regulations as barriers. The FDA is often viewed as a hindrance and not an agency that keeps people safe. I disagree with this idea and believe that quality systems are a tool to enable the right products to move through development quickly and really help people, and I really believe in the FDA’s mission. As a recent example, the FDA relaxed regulations to enable many companies to bring antibody tests and hand sanitizer to the market to help combat the pandemic. There are now 215 companies that had to have their sanitizer pulled from shelves due to contamination, and 176 companies had their antibody test kits removed from the market for poor accuracy. This podcast is all about helping people see the value in regulations and quality systems.

Also, while at Novartis, a friend and I started a podcast called “Worms and Germs.” We only made it available within the company, but we had a blast doing it and learned so much in the process. Another big reason is the people and stories. In our early work on “Inside Out Quality,” I have been able to talk with so many fascinating people. It’s a rewarding experience that I can share with listeners now.

What would you say is the overall theme of the podcast? What kind of content can people expect?

The theme revolves around how quality assurance and regulations are there to protect companies and their customers. Each episode explores a specific area by examining an incident when quality systems failed or were nonexistent and how it could have been avoided.

The FDA was formed following a medical disaster. Every major law/act in the U.S. was put in place because patients were killed or harmed by the products meant to heal/help them — e.g., contaminated diphtheria antitoxin, sulfanilamide, Lash Lure, thalidomide and Relax-A-Cizor. We now are seeing this again in the U.S. with the opioid crisis and companies like Theranos.

Our focus primarily is avoidable and teachable disasters. The first episode is not primarily this flavor, but it will become very apparent in future episodes. I try to get people who are close to what happened. In the case of the NASA and Sapa incident, the lead investigator from NASA is on the show. In the case of a person falsely claiming to be a physician and practicing medicine, we were able to get Adam Litwin on the show, who himself was arrested for pretending to be a physician. I try to find guests who bring a lot more knowledge on the particular incident or topic.

What can people expect from the first episodes?

We wanted our first podcast to be a jump into how to start up a quality system and why management support is so critical. Leadership is critical in quality – along with being a legal requirement! So we’ll hear from Doug Mofle, a scientist who worked with me at Novartis Animal Health for many years, and his wife, Robin, who is a consultant in quality systems. To be honest, as friends, they were forgiving as we worked through the kinks of a first episode. But they’re also great people to explain why these topics are so important as they both spent their careers in companies transitioning in quality systems. At one point, they both moved to New Zealand to help establish a GMP facility for vaccine production.

We also will be joined by Stephanie Armstead, director of quality at Prairie AquaTech. When we came up with the idea for the podcast, we knew we also wanted to highlight local companies and engage them on the discussion on how quality systems can help make better products.

Future episodes will feature the lead investigator in NASA’s fraud investigation into subcontractor Sapa Profiles, a man who was arrested for impersonating a doctor who later became a doctor, and many other amazing guests and representatives from exciting local biotech businesses.

We plan to release a new podcast approximately every other week, and I expect the podcasts to evolve as Diane and I continue to learn and adjust.

Podcasts are like a team sport to me. Diane is my co-host. She brings great questions, perspective and way more knowledge on quality systems. Nate Poeppel is our audio mixer and has enabled us to have really high-quality recordings. Barbara Dorrel-Christen has provided the graphics design and web support and has been vital to us looking good online.

Joni Johnson and South Dakota Biotech can’t be thanked enough for supporting this with both ideas and financially. Finally, our guests are amazing! They have given us so much time and been flexible to help tell their stories and share their knowledge. We are seeing so much passion when they talk with us; it’s such an honor to have them on our episodes.

Ready to listen? “Inside Out Quality” can be found on the South Dakota Biotech website sdbio.org/podcasts, and it’s  available through Apple Music, Google Podcasts and Spotify.