Regulations Rx

We all know the song "I'm Just a Bill," but there are many nuances and political maneuvers in the process of bills being created and making their ways to become law. To help me learn more, Worth Hester joined me. Worth joined the faculty of the Government Affairs Institute at Georgetown University in 1988 as a Presidential Management Fellow and became an Assistant Director in 1999....

In the early 1860's the US was torn apart by war and opposing ideas. In the midst of the conflict, President Lincoln created the USDA, one of the first healthcare laws, and laid the foundations for what would now be known as the FDA.  To help me dive into President Lincoln's impact and explore the history of his presidency, I'm joined by Erin Carlson Mast, President and CEO of the L...

How does something intended for good, cause harm? That's the topic explored in this episode. The concept is Externalities, which is a cost or a benefit that affects a third party who is not directly involved in an economic activity or transaction. These impacts can be either negative or positive. This mundane-sounding concept can play out in big impacts. We explore how research meant to end a...

On our first episode of this season, Tracey shares the story of her son Mac who lost his life to the opioids. Despite years of creating laws and regulations, we haven't been able to stop the destruction. Biology is partly to blame. I’m joined by Lee Baugh, Associate Professor at the University of South Dakota and neuroscientist and researcher Jamie Bushman (also from the University of South D...

Our name has changed and new episodes are coming! I'm excited to bring you a new season, starting soon!

“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 Silko The 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 p...

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?...

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 t...

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 exp...

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 sale...

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 comm...

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 disc...

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...

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...

“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...

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 - T...

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 Univer...

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 experi...

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...

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 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 s...

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 que...

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 cont...

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