Regulations Rx

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/history

Frances Kelsey’s oral history 

Elixir sulfanilamide sample bottle

Oral Histories 

Video blogs

A 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 [email protected]  

 

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.