Inside Out Quality

“I will tell you something about stories. They aren't just entertainment. They are all we have to fight off illness and death. You don't have anything if you don't have stories.” ― Leslie Marmon SilkoThe story of Scott Jerome Parks captivated me and the filled headlines in 2010. His story led me to connect with people around the US and world and, ultimately, to Dr. Joel Carter, a palliative care physician. While treating patients, Joel discovered that stories alone provided relief from pain and improved the well being of patients suffering in the end stages of cancer.In this episode, Joel tells us the story which led him to this discovery. Deb Murphy and Pam McKenney also share their stories on overcoming cancer and how radiation treatment was a component in that fight. This podcast is all about sharing stories to encourage and educate those working to improve lives --let's continue our work of helping others make many more stories. To learn more about Dr. Joel Carter, visit his website here: https://joelcartermd.com/

Gordon Isaacs sat on a table at Stanford Medical School in 1955. A large linear accelerator shadowed behind him while he waited for treatment of the tumor growing in his retina. He made history as the first patient treated in the US with this radiation therapy approach. Linear Accelerators (LINACs) have come a long way since that time and have treated millions. How has there been so much success? The answer is a harmonization between quality and engineering. Dr. Todd Pawlicki, Professor and Vice Chair of the Department of Radiation Medicine and Applied Sciences at UC San Diego's School of Medicine joins Leslie and I to talk LINACs, Quality, and the role of Physicists in healthcare.  Dr. Pawlicki is an expert and leader in the field of radiation oncology (and quality nerd!). Click here to learn more about Dr. Pawlicki's work. ASTRO is the group of professionals working to continue improving radiation therapy. They helped connect me to Dr. Pawlicki and are a great resource for professionals and patients!   Information for patients can be found here  

Scott Jerome Parks died in 2007 from a radiation overdose. His slow, agonizing death captured headlines. Headlines were followed by a congressional hearing, where his dad shared of Scott's suffering and the need for reform in medical device and radiation safety.  As I learned of his story, it brought me to many more stories. The first being the Therac 25. Natalia Silvis-Cividjian also found the story of the Therac 25. She too became captured and harnessed its lessons to teach students the importance of effective software testing. Natalia is a lecturer at the Vrije University in Amsterdam and joins me to talk about software, radiation, and the tragedy of the Therac 25.To learn about Natalia's project to teach and preserve software bugs for teaching click here.    

In this episode, Dr. David Evans, Virologist at the University of Alberta joins Leslie and I, where we explore a question he once asked. Could he and his team synthetically recreate horsepox virus? Science is all about asking questions and creating experiments to answer them. These questions can make us uncomfortable. Quality Assurance also thrives on questions. Listen in while we discuss his experiment and ask him questions.Link to Dr. Evans' publication on horsepox virus:https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0188453 

In 1920, the US began recording deaths from Opioids; between 1920 and 1921, 105 people died from accidental overdose.In 2021, 80,816 people died from overdose on opioids (CDC). We are losing a battle. The opioid crisis is a healthcare system problem; one component of this system is the sales rep. In this episode, we interview Alec Burlakoff. Alec was the VP for sales at Insys and a master of sales and building teams. His skills, contributed to explosive sales of Fentanyl and current crisis. Alec joins Leslie and I, so we begin to understand how we each parts of healthcare contributed to the crisis. We discuss sales and Alec shares about his life and work. To learn more about Alec's current work, see his sites:Limitless! Sales Coaching  https://course.aburlakoff.com/homeSCHEDULE FREE 20 minute Consult https://bit.ly/3WEunxw

Michelle Hutchison is an actress, voiceover coach, writer, and producer. She also teaches professionals in the medical product industries on how to present more effectively-- we knew we couldn't talk about motivational speaking with talking about the speaking part!In this episode, Michelle talks about performance in presentations with Leslie and I to discuss getting past slide decks and communicating with skilled expression and your emotional palette. To learn more about Michelle's classes visit: https://www.skilledexpressions.com/

Earlier this year, I began searching for a Quality Assurance motivational speaker. This search introduced me to many amazing people; Bart Bosch is one of them.  Bart is the founder of Vlitix and specializes in utilizing quality systems as a value driver for organizations. If you want to turn Quality Assurance into a value driver for your company, this is your episode! Listen in as Bart and I discuss how quality can make your company more valuable and contribute to the bottom line. To reach out to Bart, his email is bart@vlitix.comhttps://www.vlitix.com/

In the world of GMPs and quality, it's easy to overlook the importance of pest management until its too late. In this episode,  Frank Meek, Manager of Technical Services at Rollins/Orkin joins us to tell us how Orkin approaches all things pest control, from prevention, investigations, and control of pest along with other services they provide the industry. Frank Meek is a Technical Services Manager for Rollins. As a board-certified entomologist and 30-year industry veteran, he is an acknowledged leader in the field of pest management.  He loves insects, spiders, and crawl spaces. Listen in as Frank shares his passion for pest control and teaches Leslie and I how to be better insect detectives.To reach out to Orkin's industry team, visit here: https://www.orkincommercial.com/ You can also visit: https://www.orkin.com

Gabriel Licina is a leader in the world of independent science and was at the forefront of the biohacking culture. His work showed that exciting technology can be created from the home using networking, education, and freedom. I expected someone known as a Biohacker to be resistant to regulations and quality concepts, but I quickly learned the opposite. On this episode, Gabriel joins Leslie and I to talk about Biohacking, how he became an Independent Researcher, his research, and how the regulations are still important in this space for safety and progress.You can learn more about Gabriel here: https://www.scihouse.space/

“Are you disturbed at night and broken of your rest by a sick child suffering…. It will relieve the poor sufferer…and is the prescription of one of the oldest and best female physicians and nurses in the United States.” --This is not an ad about our podcast :) This is an add from 1905 for Mrs. Winslow's Soothing Syrup (a morphine based product advertised to help sooth children)FDA Historian Vanessa Burrows joins Leslie and I, as we dive into a notorious opioid product sold from the 1830's-1930's resulting in countless deaths and misled consumers. This episode underscores the importance of product labeling, advertising, and muckrakers in the history of drug development and regulations.To learn more about the work of the FDA's History Office, check out their site: www.fda.gov/history 

Jason Vuic, author and historian, joins Leslie and I to discuss one of the best examples of quality reputation and public perception: the Yugo. Zastava manufactured the low cost car in the 1980's, but low cost could not overcome the quality issues that turned the name Yugo, into a punchline for jokes. Car and Driver named it "Worst Car in History." Jason wrote the book: The Yugo -The Rise and Fall of the Worst Car in History and joins us to discuss the impact of quality on reputation and how the Yugo fits into history.To learn more about Jason Vuic and his work, see his website:  https://www.jasonvuic.com/home

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.

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.To learn more about Gardener Law, check out their website: https://gardner.law/ 

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!p.s. we recorded this the week before Thanksgiving, and I showed up wearing a turkey hat for the interview.

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. 

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!

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!      

"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 Encephalopathy (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.  

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

In this episode, 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 us to discuss what went wrong, and how expecting the unexpected can alert us that something could be awry. Read Dr. Fox's Paper on the Lubeck Disaster  Here

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!

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!To learn more about Cargo Cults check out Dr. Lindstrom's book:Amazon Scholar Space Dr. Michael Long's LabDr. Robert Froemke's Lab

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.

In 1909 food buying food came with a 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.      

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! 

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.To learn more about Dr. Vargesson's research, visit his site here: Link    Dr. Vargesson's research  publication discussed on this show: Link   

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!

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. To learn more about the FDA's history check out these sites: www.fda.gov/historyFrances Kelsey's oral history Elixir sulfanilamide sample bottleOral Histories Video blogsA synopsis of the Elixir Sulfanilamide tragedy

In season 2 we are bringing you intermissions: short interviews with local professionals and those that help make this podcast happen. We hope you enjoy!In this intermission, I interview Diane Cox and Nate Poeppel about one of things they have in common: a vegan diet. Join us as we discuss how they chose this diet, why they stick with it, and strategies they employ living in the Midwest. 

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.  Human Factors & Ergonomics Society: www.hfes.org

In our last episode for season 1, Diane and I 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 us is René Najera editor of the History of Vaccines (https://www.historyofvaccines.org/). 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.Stay tuned for season 2! 

In this episode, Diane and I 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.  We 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 us to discuss the importance of understanding the Primary Mechanism of Action (PMOA) of biologics and FDA expectations.  

We are all familiar with counterfeit money, but what happens when your vaccine supply is counterfeit? In this episode, Diane and I 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 https://pubmed.ncbi.nlm.nih.gov/32855990/We 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. We 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 us 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:http://itracetech.com/http://www.securemarking.com/    

Diane and I 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 us to talk us through aviation safety and this incident. Diane and I are also joined by Joe Ostendorf, a medical device regulatory consultant 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   

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. 

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 (https://www.medgenelabs.com/) a local livestock vaccine developer to share best practices for preventing product contamination.  

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 I meet with Tony Lee of AT Analytical (http://www.atanalytical.com/) to discuss the 2013 incident of mold contamination, and how to prevent mold contamination and ensure customer safety.   

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 (https://oxenhamgroup.com/).  

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 (https://www.nasa.gov/press-release/nasa-investigation-uncovers-cause-of-two-science-mission-launch-failures).We also discuss best practices in investigations and supplier management with Lindsey Marshall from OmegaQuant (https://omegaquant.com/), a Sioux Falls company ranked in the Inc. 5,000 list.    

In this episode, Diane and I discuss challenges small companies face when developing a quality system, and when it can go wrong. We also interview Stephanie Armstead, Director of Quality at Prairie Aquatec, a growing new company in Brookings, South Dakota (https://www.prairieaquatech.com/).