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James M. Wilson

American geneticist; director of the University of Pennsylvania's Institute for Human Gene Therapy at the time of the 1999 gene therapy trial in which Jesse Gelsinger died. Founder of Genovo.

5 links, 2 backed by primary records

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Legal records

Federal False Claims Act settlement over the University of Pennsylvania gene therapy study

  1. 9 Feb 2005 Settled with U.S. Department of Justice: does not admit the government's allegations 1Terms: no sponsoring of FDA-regulated trials for five years, and three years of supervised clinical work.

Connections 5

founded

  • Genovo 1992 Scholarship & press 23

    He denied in 1999 that money drove his research and said the financial relationship was fully explained on the consent form.

worked at

settled with

  • U.S. Department of Justice 9 Feb 2005 does not admit the government's allegations Primary record 1

    Terms: no sponsoring of FDA-regulated trials for five years, and three years of supervised clinical work.

owns a stake in

  • Genovo Scholarship & press 34

    A Harvard course case study, citing Robert Steinbrook (2008) and the Wall Street Journal of 10 August 2000, says Wilson and his family held 30 percent, non-voting. We could not open either source. A 2017 scholarly article says only that he was allowed to control up to 30 percent of the stock. No relative is named in any source we read.

involved in

  • The Gelsinger gene therapy trial led the trial Scholarship & press 4678

    The FDA wrote to him on 30 November 2000 and rejected his written explanation in 2002, as the Daily Pennsylvanian reported. He denied that money drove his research.

Timeline 2 dates
  1. 1992 James M. Wilson founded Genovo
  2. 9 Feb 2005 James M. Wilson settled with U.S. Department of Justice
Proof 8 sources
  1. U.S. Settles Case of Gene Therapy Study That Ended With Teen's Death (U.S. Attorney's release of 9 February 2005, reprinted in Almanac), University of Pennsylvania Almanac, 15 Feb 2005. Primary record
    As set forth in the Agreements, Penn, CNMC, and Drs. Wilson, Batshaw and Raper do not admit to the government’s allegations and contend that their conduct was at all times lawful and appropriate.
    Dr. Wilson will not serve as a sponsor of an FDA-regulated clinical trial for a five-year period starting today.
  2. Gene study at Penn under fire, The Daily Pennsylvanian, Nov 1999. Scholarship & press
    Wilson founded a private gene-therapy company called Genovo in 1992
  3. Ethical Considerations in Phase I studies: Gelsinger Case, HarvardX (Harvard T.H. Chan School of Public Health), course case study. Scholarship & press
    Prior to his move to UPenn, Dr. Wilson had founded Genovo Inc., which had the rights to market his discoveries related to gene transfer
    Dr. Wilson and his family had a 30% nonvoting equity stake in Genovo
  4. Death but one unintended consequence of gene-therapy trial, CMAJ, 2001. Scholarship & press
    Wilson, director of the Penn institute where Gelsinger was treated
    Wilson, director of the Penn institute where Gelsinger was treated, owned stock in a company, Genovo, that provided financing for the institute.
    He was considered an ideal candidate for the trial, led by Dr. James Wilson, director of the Institute for Human Gene Therapy at the University of Pennsylvania.
  5. Statement from Penn, 9 February 2005 (Almanac, vol. 51, no. 21), University of Pennsylvania Almanac, 15 Feb 2005. Primary record
    Penn faculty members Dr. James M. Wilson and Dr. Steven Raper may continue to make ongoing contributions to medical research.
  6. Wilson may lose research ability, The Daily Pennsylvanian, 14 Dec 2000. Scholarship & press
    In its letter to Wilson, the FDA concluded that Wilson “failed to adequately protect the safety and welfare of subjects” and that he “submitted misleading and inaccurate statements” to Penn’s review board.
  7. Gene therapy: An Interview with an Unfortunate Pioneer, Scientific American, 1 Sep 2009. Scholarship & press
    Wilson now believes that the teen died from a rare phenomenon called antibody-dependent enhancement.
    Wilson admits, however, that there is no way to prove it, because none of Gelsinger’s pretreatment blood samples remain.
  8. Wilson explanation rejected by FDA, The Daily Pennsylvanian, 11 Feb 2002. Scholarship & press
    The Food and Drug Administration has rejected Institue for Human Gene Therapy Director James M. Wilson's letter of explanation
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