The Regulatory Whisperer
By Dr. Nick van Terheyden aka Dr. Nick
Twitter: @drnic1
Host of Dr. Nick: The Incrementalist – #TheIncrementalist
On this episode I talked to Michael Hufford the CEO and Co-Founder of Lygenesis a company that is breaking the mold of organ replacement and enabling organ regeneration. They recently received FDA 2A clearance and additional funding and will be starting their first human trials shortly.
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Michaels background has helped him master the regulatory and investment landscape providing him with keen insights that help navigate the steps necessary for funding and safely and successful developing therapeutics offerings. His important Incremental point as he describes his regulatory super power; seeing things through the eyes of the regulator or investor is critical, or put another way:
“Speak regulatory, money, or science”
Prometheus for Livers
The history of Lygenesis includes multiple publications demonstrating that we can grow organs in our own lymph nodes – our very own personal bio-reactor. The animal results in pigs showed reversal of liver disease liver cells transplanted into lymph nodes were capable of forming ectopic livers that cured all the animals of otherwise-fatal disease (also in mice kidney tissue).
The current waiting list suffers from a profound supply/demand imbalance with more than 100,000 people waiting for organ transplants, many of whom will die still waiting for an organ to become available. This number is not fully representative since many do not even qualify to get on the transplant list.
Listen in to hear Michael share the exciting progress to data that has taken the human bio-reactor of lymph nodes, something that is hijacked for use by cancer cells and instead use it for good to generate liver, and in the future, pancreas, thymus and kidney. Delivering multiple organ transplants to many people from a single donor organ through an outpatient minor procedure.
About the Show
For years Dr. Nick van Terheyden aka Dr. Nick, has served as a voice on the impact of new technologies on healthcare, earning a reputation as a leading authority on where the future of medicine is going. Combining powers of observation and real world experience, Dr. Nick has seen many predictions come true and makes the case that innovations in healthcare can be accomplished incrementally, not just by moonshot events. Tune in to hear Dr. Nick: The Incrementalist and his guests discuss what the future of healthcare looks like, how we will get there, and what it will take to improve healthcare for all.
This article was originally published on the Dr. Nick – The Incrementalist blog and is republished here with permission.