Podcasts

Season Two: Episode 1

Human Factors and the 737 Max with Dr. Mica Endsley

In this episode we explore the tragic failure in human factors engineering on the Boeing 737 MAX and why early incorporation of the user’s needs and limitations is key to developing better, safer products. Dr. Mica Endsley, former Chief Scientist of the Air Force and founder of SA Technologies, joins us to discuss Human Factors Engineering and what we can learn from the 737 MAX tragedies.

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Season Two: Episode 2

Elixir Sulfanilamide and the FD&C Act

How did a formulation change, turn a life saving drug into a poison? How did tragedy push US lawmakers into passing a new act to regulate Food, Drugs, and Cosmetics? Historian Vanessa Burrows with the FDA joins us to share the story of Elixir Sulfanilamide and the FD&C Act of 1938. This is a story of what can go wrong when morality, science, and businesses are done wrong.

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Intermission: Intern Hailey Nold

Hailey Nold joined Inside Out Quality for season two to help with planning, research, and locating guests. Learn more about Hailey and how she made our work so much fun on this intermission!

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Season Two: Episode 3

Primodos: Zebrafish, GLP, and Unanswered Questions

Primodos, a hormone-based pregnancy test, was given to women between 1959 and 1978. Its development occurred before GLP and before standardized testing for teratogenesis (causing birth defects). There are data and suspicions that it caused birth defects, but more questions remain.

This episode of Inside Out Quality explores the story of this in vivo diagnostic with Dr. Neil Vargesson, from the University of Aberdeen, Scotland, UK. Learn another reason for the importance of Good Laboratory Practices and why pre-clinical studies are key to keeping people safe.

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Intermission: Intern Jeni

In this intermission, we interview Jenifer Fjelstad. Jeni is an undergraduate at Augustana University in Sioux Falls and supports the podcast through her internship. Learn more about her on this intermission!

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Season Two: Episode 4

When Milk Goes Bad: With Kate Haiar

In 1909, buying food came with risk. Sadly, in a Rhode Island orphanage, 22 infants died from contaminated condensed milk. Today that's unheard of. Why? GMP manufacturing, FSMA, and other quality and regulatory controls. 

Kate Haiar, Quality Director for Regulatory and Audits and Sunbutter Divisions at Red River Commodities joins me to discuss all things food quality. Join us on this episode as we break away from our usual discussions on drugs and devices to explore other areas the FDA regulates.

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Intermission: Megan McCray

On this intermission, I interview Megan McCray, who moved to South Dakota to study Human Factors Engineering. Learn about human factors, a dog with excessive toe fur, and more about Megan and her studies in the USD graduate school.

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Season Two: Episode 5

Cargo Cult Quality: Better Science Through Rituals

Quality Assurance is all about controlling variation in the midst of science and human behavior. We have outcomes we want, but sometimes take quirky paths to get there.

We explore this with help from Dr. Lamont Lindstrom's and "Cargo Cults," a name attributed to social movements from Melanesian Islanders, and scientists who embraced rituals to improve their research.

We are also joined by Defense Analyst, Dr. Tina Elie, and Neuroscientists Drs. Michael Long and Robert Froemke on this journey to understand and perhaps embrace rituals!

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Intermissions: Joni Ekstrum

South Dakota has a thriving biotech network, thanks largely to Joni Ekstrum, Executive Director for South Dakota Biotech. Joni also helped make this podcast happen.

In this episode we get to know Joni better and learn what Joni likes best about the biotech world and her work with SD Bio. Enjoy!

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Season Two: Episode 6

The Lubeck Disaster: Expecting the Unexpected

In episode 6 of Inside Out Quality podcast, we explore a vaccine contamination disaster in the early 1930's Germany.

Dr. Gregory Fox, Professor and Pulmonary Physician at the University of Sydney, joins Aaron to discuss what went wrong, and how expecting the unexpected can alert us that something could be awry.

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Intermission: Sue Lancaster

After graduating from the University of South Dakota, Sue Lancaster jumped into the local biotech community to help bring a variety of products to market, which has included technologies from two faculty at South Dakota State University. Learn more about her career journey and other fun details on this intermission!

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Season Two: Episode 7

BSE: One Protein, Three Perspectives.

"Mad Cow Disease" emerged in the United Kingdom in 1986. Named from the symptoms seen in cattle, it was eventually renamed more appropriately to Bovine Spongiform Encephalitis (BSE). When humans are infected, the disease seen is variant creutzfeldt-jakob disease (vCJD).  

This episode explores the story of how a prion shaped the beef and biotech industries and revealed a failure in questions and ethics. We are joined by Dr. Fiona Houston (senior researcher and veterinarian), Anne McVey (ethics advocate and mother of a victim), and Kelly Creighton (biologics manufacturing regulatory expert).

Join us to learn how scientists tackle emerging infections, why we need to ask the hard questions, and how this prion has shaped the industry. 

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Intermission: Chris Schilken, GOED

Chris Schilken is the Deputy Commissioner and the Director of Business Development in the South Dakota Governor’s Office of Economic Development. South Dakota has a growing Biotech community and Chris is key to helping businesses connect to state resources to help both startups and larger companies.

He joins us on this intermission as we learn more about him and how he can help.

Learn more or contact the Governor's Office of Economic Development here:
https://sdgoed.com
goedinfo@state.sd.us

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Season Two: Episode 8

The Beauty of Regulations

The FDA stands for The Food and Drug Administration, but they are also key in regulating the cosmetic industry.  In 1938, The Federal Food, Drug, and Cosmetic Act gave the FDA the responsibility for regulating cosmetics and protecting customers. 

To explore how cosmetics are regulated, Charmain Rodriques, Regulatory Affairs Manager at LVMH joins us to explore how the FDA, FTC, and even customers shape the cosmetic industry. Hope you enjoy!

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Intermission: Shannon Van Buskirk

Meet Shannon Van Buskirk, South Dakota Biotech's member relations specialist

On this intermission, we meet Shannon Van Buskirk. She recently joined SD Bio to provide extra support for members and is jumping into our community. She brings a background in pharmaceutical sales, talent on the piano, and a passion for meeting new people. If you haven't met her yet, you definitely should!

 NOTE: This Intermission was recorded the week before Thanksgiving, and Aaron showed up wearing a turkey hat for the interview. :-)

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Season Two: Intermission Joni & Aaron

In this intermission Aaron Harmon, podcaster and General Manager for Inanovate Inc. joins us, as Joni Ekstrum interviews Aaron and takes her turn at hosting an episode.   

Aaron started this podcast with the hopes of sharing stories and exploring the world of quality assurance through interviews with amazing people. On this episode you'll get to know him more as he sits on the other side of the questions. 

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Season Two: Episode 9

After The Warning Letter with FDA Attorney Amanda Johnston 

Warning Letters are more than a slap on the wrist. They are the first step in what can be a costly remediation and legal battle.

How do we prevent them? What is within the power of the FDA and government when they spot quality issues? To help us with these questions and more, we are joined by Amanda Johnston of Gardner Law. Amanda has over a decade of experience in FDA Regulatory Law and experience with all sizes of companies.
 
Visit the Gardener Law website

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Season Two: Episode 10

Emotions in Quality: De-escalation and a Tribute

Quality Assurance professionals are tasked with bringing continuous improvement to organizations. This means change. Change can evoke emotions.  Do we prepare our quality professionals to navigate emotional conflict?   

This episode discusses tactics to minimize and de-escalate conflict in the workplace with help from Joel Reinesch, Assistant Professor of Criminal Justice at Dakota Wesleyan University, former Police Officer, and Marine. 

Special Agent Wade Krieger inspired the idea for this podcast and had planned to record this with me. He passed away in 2021. The episode is a tribute to him.

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Season One: Episode 1

Starting Out In Quality – Management Matters

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! 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. We also will be joined by Stephanie Armstead, Director of Quality at Prairie Aquatech.

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Season One: Episode 2

NASA and the SAPA Investigation – Supplier Management

In this episode, Diane and I interview Special Agent Wade Krieger from NASA's Office of Inspector General. He shares insight and lessons learned from the investigation into supplier fraud from SAPA Materials.

We also discuss best practices in investigations and supplier management with Lindsey Marshall from OmegaQuant, a Sioux Falls company ranked in the Inc. 5,000 list.

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Season One: Episode 3

“Conversation with Adam Litwin M.D. – Personnel Qualification”

This episode explores the story of two individuals charged with impersonating a physician. One, Gerald Barnes, had motivations of money and caused the death of John Mckenzie. The other, Adam Litwin, had a passion for medicine, caused no harm, and later completed medical school and is now a physician. The difference was engagement and passion for medicine. 

Quality systems require that employees are qualified. Diane and I discuss this with Adam Litwin M.D. and Bill McGuckin of Oxenham Group.

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Season One: Episode 4

The 2013 Baxter Mold Incident — Lessons in HEPA Filtration

In 2011, Chris Wall, an HVAC technician at a Baxter Healthcare manufacturing site in North Carolina inspected the HEPA filters in a room where sterile Saline IV Bags were filled. He found them to be contaminated with mold. Management stopped him from changing them for 2 years, until he finally reached for help to the FDA. The result was a warning letter and 18 million dollar fine. 

In this episode, Diane and Aaron meet with Tony Lee of AT Analytical to discuss the 2013 incident of mold contamination, and how to prevent mold contamination and ensure customer safety.

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Season One: Episode 5

Rotateq and Rotarix — A story of vaccine contamination and prevention

In 2010, two companies learned their vaccines for a childhood infection (rotavirus) had another virus present: porcine circovirus. Both companies couldn't detect the virus lurking in a key material used for vaccine manufacture, and it went undetected until an academic lab discovered with new technology. 

Virologist and Vaccine Developer Dick Hesse from Kansas State University joins me and Diane to discuss vaccine contamination. We are also joined by Julia Schaar with Medgene Labs a local livestock vaccine developer to share best practices for preventing product contamination.

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Season One: Episode 6

Thalidomide —The Drug and Woman That Changed the FDA Forever

In the late 1950's a new drug was launched in Europe. Clinical trials weren't like they are today; as a result, thousands of children suffered from extreme birth defects or died before birth due to Thalidomide. Frances Kelsey, a new FDA reviewer, pushed for safety data before allowing it to be approved US,  and spared the US from tragedy. 
 
We are joined by Neil Vargesson, Chair in Developmental Biology and expert in Thalidomide, as we discuss the drug's history and how it caused birth defects. Justine Peterson, P.A., joins us also to give a clinical perspective on drugs, trials, and how they shape her world.

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Season One: Episode 7

The 1983 Air Canada Incident and Design Controls

This episode of Inside Out Quality explore an Air Canada incident where a flight ran out of fuel at 40,000 feet in the air. Retired United Airlines Captain Sam Biondo joins Diane and Aaron to talk about aviation safety and this incident. Joe Ostendorf, a medical device regulatory consultant also joins Episode 7 to discuss design controls and how they can prevent your product develop from running out of fuel.

If you are interested in reaching out to Joe, he can be reached at joseph@ostendorfconsultingllc.com

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Season One: Episode 8

A Case of Counterfeit Rabies Vaccines and Supply Chain Risk

We are all familiar with counterfeit money, but what happens when your vaccine supply is counterfeit? In this episode, Diane and Aaron interview Dr. Karl Henson from The Medical City hospital in Pasig City of the Philippines. He shares their story of both identifying the counterfeit rabies vaccines that were injected into patients and the steps they took to prevent it from happening again.

To read their report: Counterfeit Rabies Vaccines: The Philippine Experience

Aaron and Diane are also joined by Daniel Stanton, President and Co-Founder of SecureMarking and author of Supply Chain Management for Dummies, and Mark Manning, Founder and CEO of iTrace Technologies. They discuss the impact of counterfeit goods on company revenue, and in the case of counterfeit pharmaceuticals and medical devices, the potentially dire consequences to patient health. Daniel and Mark educate on how counterfeit products enter the supply chain and what technologies are available to help manufacturers, including biotech companies, prevent it.

To reach out to Mark or Daniel:
Itracetech.com
securemarking.com

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Season One: Episode 9

TGN1412 and PMOA – Story of a monoclonal antibody that did the unexpected.

In this episode, Diane and Aaron are joined by Husain Attarwala, Head of Pharmacometrics and Clinical Pharmacology at Moderna and author of a paper diving into the 2006 failed clinical trial of TGN1412. They discuss how things went wrong, and what to consider when planning clinical trials to help keep study participants safe.
 
Kelly Creighton, VP for Regulatory and Strategic Development at Clinipace also joins the Inside Out Quality podcast to discuss the importance of understanding the Primary Mechanism of Action (PMOA) of biologics and FDA expectations. 

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Season One: Episode 10

A Horse Named Jim: The Biologics Control Act of 1902

In our last episode for season 1, Diane and Aaron dive into the story behind the first US law passed for protecting people from a medical product failure: The Biologics Control Act of 1902. Joining them is René Najera editor of the History of Vaccines. He helps explain the development of diphtheria antitoxin and discusses early product development and public perception.    

Also joining us is Kelly Creighton of Clinipace to discuss how regulations shape product development and help protect patients.

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