China Trials

“China Trials” is the true story of the only American biotechnology company to be invited into China to develop and market its biologic drug product. The final clinical trials of Vital Therapies’ novel liver support product were run at two hospitals in Beijing in hepatitis B patients, which is the fourth largest cause of all deaths in China. The Chinese FDA and liver physicians delivered on all their promises of help except the final and most important one: a fast decision on approval to market the life-saving product in China; we are still waiting!

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"Terry Winters hails from London, has degrees in chemistry and spent most of his career as an early-stage venture capitalist investing in medical start-ups sourced from universities. He finished his career running one of those start-ups that his fund supported and whose story is told in these pages."

– JOE WILSON

“The story starts at Baylor College of Medicine in Houston, Texas but quickly pivots to China when the chaotic course of the first start-up company runs into regulatory issues at the US FDA which threaten its viability. The story spans a period of almost 30 years and is a case study for anyone considering doing business in China."

– Terry Winters, PhD

“China Trials” is the true story of the only American biotechnology company to be invited into China to develop and market its biologic drug product. The final clinical trials of Vital Therapies’ novel liver support product were run at two hospitals in Beijing in hepatitis B patients, which is the fourth largest cause of all deaths in China. The Chinese FDA and liver physicians delivered on all their promises of help except the final and most important one: a fast decision on approval to market the life-saving product in China; we are still waiting!

The story starts at Baylor College of Medicine in Houston, Texas but quickly pivots to China when the chaotic course of the first start-up company runs into regulatory issues at the US FDA which threaten its viability. The story spans a period of almost 30 years and is a case study for anyone considering doing business in China. We experienced at first hand all of the problems that may be familiar to the reader, plus a few more. Even though we came away empty-handed, we saw China as few are blessed with seeing it and left with a love of the Chinese people but no respect for its ruling class. The story is also a primer in liver disease and the quest for a cure for liver failure told in a way that can be understood by a non-scientist.

The author tells the story in the first person since, as CEO of the company, he experienced most things that are described in this book. Terry Winters hails from London, has degrees in chemistry and spent most of his career as an early-stage venture capitalist investing in medical start-ups sourced from universities. He finished his career running one of those start-ups that his fund supported and whose story is told in these pages.

ABOUT THE AUTHOR:
Terence Winters, PHD

Terry Winters was born in the midst of a German air raid in Exeter, England in 1942 where his father was sent to help prepare for D-Day, after surviving Dunkirk. After his christening in Exeter’s 11 th century Norman/Gothic cathedral, he was well prepared for an eventful life. Raised in London, he attended Addey & Stanhope Grammar School, originally founded in about 1670 by John Addey and Samuel Pepys and fell in love with science and with chemistry in particular. He studied chemistry at the University of Wales in Swansea, graduating with a BSc and a PhD in 1967.

A post-doctoral fellowship at UCLA confirmed that he was not suited to academia and he went into the business side of chemistry after becoming a polymer chemist at Goodyear in Akron, Ohio and a US citizen in 1972. He sold Goodyear’s technology around the world and then, after the oil shock in 1977, joined Diamond Shamrock in Cleveland. licensing technology both out and in to be the basis of new businesses and starting his 45-year career at the commercial edge of science.

In 1981, he was fortunate to become one of a team of two running Diamond Shamrock’s venture capital fund at the start of the Reagan revolution and the nascent biotechnology business. He soon crossed into the private VC world and was a partner in 5 VC funds based in Denver and then in Phoenix. He has founded and invested in over 25 university-sourced company start-ups and sat on over 20 boards of directors.

Approaching retirement in 2003, he took on the leadership of one of the companies he helped to found, San Diego-based Vital Therapies (VTL), thereby crossing the chasm to run a company rather than just being an investor. VTL was developing a radically new cellular therapy for liver failure and this book is the story of the wild ride that resulted in running the key clinical trials in China and a 5-year quest to gain approval for the product in China where he encountered many challenges you don’t find in the US. He was a hands-on CEO and experienced these situation up close and personal.

He retired in 2018 and resides in Scottsdale, Arizona where he lives with Eileen, his wife of 42 years. He is busy playing golf, writing books and founding exciting new companies because “Old VC’s never die, they only fade away…….”