James Heywood (born October 4, 1966, in London, England) is an American MIT mechanical engineer who founded with his family the ALS Therapy Development Institute (ALS TDI) when his younger brother Stephen Heywood was diagnosed with amyotrophic lateral sclerosis (ALS) in December 1998. He is currently a director at AOBiome.
Conceived while James Heywood was moving cross country in March 1999 to be with his family, ALS TDI became the world's first non-profit biotechnology company and pioneered a new model for accelerating translational research by directly hiring scientists to develop treatments outside of the academic and for-profit corporate architecture. The institute’s initial approach focused on gene therapy and stem cells and ALS TDI was the first to publish on the safety of the use of stem cells in ALS patients. ALS TDI then pioneered a novel high-throughput in-vivo validation program that tested more treatments in preclinical studies than all other labs combined and led to two drugs being tested in clinical trials. The culmination of this work is a paper published in the journal "Amyotrophic Lateral Sclerosis" that identified crucial errors present in many existing preclinical studies that could lead to false positive results. The results suggest that false positive results may rest with the methods used by researchers and not the models themselves. The paper has clear clinical implications, as ALS TDI was unable to replicate a number of prior animals studies from the field that led to clinical trials that ultimately failed in humans.
Stephen Heywood died in the fall of 2006 when his ventilator accidentally disconnected shortly before ALS TDI began a comprehensive program to use industrial discovery approaches to understand the disease. In August 2007, after serving as ALS TDI’s CEO for nine years and having raised $50m in funding, Heywood stepped down and joined the Institute’s board of directors. He retains the title "Alex and Brit d’Arbeloff Founding Director" in honor of their support and involvement in the creation of ALS TDI.