U.S. Gears Up Against Potential Biomedical Research Theft

The NIH and FBI are continuing to root out scientists from China and other countries who are accused of stealing biomedical research from U.S. institutions.

Twenty-four of more than 180 cases have already been referred to the Health and Human Services Department’s Office of the Inspector General at 71 U.S. institutions, including many of the country’s largest medical schools, says NIH.

The White House Office of Science and Technology Policy (OSTP) sent a letter in September to 18,000 members of the U.S. research community saying that “over the past several years, some nations have exhibited increasingly sophisticated efforts to exploit, influence, and undermine our research.”

OSTP Director Kelvin Droegemeier added that his office will hold meetings at a number of U.S. academic institutions to discuss the issue over the next few months.

ACRO, Congress Begin Work on New Cures Act

The Association of Clinical Research Organizations (ACRO) is working with the Congressional Research and Development Caucus (CRDC) and others on new legislation that would address recent innovations in clinical research.

Billed as a second 21st Century Cures Act, the legislation would focus on developments in patient engagement, use of real-world data and digital technologies.

ACRO and CRDC, chaired by Rep. Bill Foster (D-IL) and Rep. Jim Baird (R-IN), met in late October to discuss plans for the new bill.

The draft legislation, to be sponsored by Rep. Diana DeGette (D-CO) and Rep. Fred Upton (R-MI), is expected early next year.

Senate HELP Committee Schedules Nov. 20 Confirmation Hearing for Stephen Hahn

The Senate’s committee on Health, Education, Labor and Pensions will hold a confirmation hearing for Stephen Hahn as FDA Commissioner on Wednesday, Nov. 20.

The committee’s chair, Sen. Lamar Alexander (R-Tenn.), following a meeting this week with Hahn, said he believes he is “well-qualified to lead the agency” and brings “a crucial perspective” as a chief executive. Hahn currently is chief medical executive of the MD Anderson Center in Houston.

President Trump announced his intention to nominate Hahn to the agency’s leadership role on Nov. 1, and the nomination was officially sent to the Senate on Tuesday (CenterWatch Weekly, Nov. 4, 2019).

NCI Designates University of Wisconsin as National Coordinating Center

The University of Wisconsin has been selected as the national coordinating center for NCI’s Cancer Prevention Clinical Trials Network.

The $11.8 million grant places UW at the forefront of a research network consisting of three leading medical research centers in the U.S., including Northwestern University, the University of Arizona and the University of Texas.

The New Data Management, Auditing and Coordinating Center will coordinate activities across the network, including centralized data management and reporting, clinical trials auditing, and administrative and logistical coordination.

Takeda Gets Rights to MD Anderson Cancer Therapies

Takeda will collaborate with the University of Texas MD Anderson Cancer Center to develop and test innovative oncology therapies.

Under the arrangement, Takeda will have rights to up to four of the center’s natural killer (NK) cell therapies, derived from umbilical cord blood cells. The partners will collaborate on the development of a CAR NK-cell therapy platform in a trial starting in 2021.

New ALS App Set for Trial Use This Month

A new app for tracking progression of Amyotrophic Lateral Sclerosis (ALS) will be tested in clinical trials beginning this month, thanks to a $300,000 grant from the ALS Foundation.

The ALS iNVOLVE/eNGAGE app captures 80 patient data points a day using patients’ phones to measure movement and vocal strength.

The first clinical trial to use the app will enroll 50 patients across five ALS medical research sites, including Harvard, Massachusetts General Hospital, Duke University, Barrow Neurological Institute, University of California-San Diego and the University of Colorado.

T3D Therapeutics Gets Funding from NIA for Alzheimer’s Hopeful

In a field that has stumped scientists for nearly two decades, another hopeful Alzheimer’s compound has received a $15 million grant from a private investor to take its study into phase 2.

T3D Therapeutics out of North Carolina will begin phase 2 of its trial on drug T3D-959 in patients with mild-to-moderate Alzheimer’s. The drug targets folded proteins in the brain and works to combat sugars and fats that cause the plagues, tangles and inflammations seen in AD patients.

The trial, which also has support from the National Institute on Aging, expects to begin enrolling patients in the first quarter of 2020.

Grants Awarded to Reanalyze Suspect Trial Data

An organization that advocates for reanalyzing data from questionable past trials is awarding grants to researchers to look for flawed data and conclusions.

The Restoring Invisible and Abandoned Trials (RIAT) project has awarded three grants of $150,000 each this year to mine unpublished clinical trial information, including de-identified patient data, for details that could call into question the results of the trials.

The first study funded by RIAT began in January 2019. Researchers from the University of Adelaide are examining data from an influential study of the effectiveness and safety of Prozac and counseling for depressed adolescents.

More recent grants went to a psychologist in private practice for a study of unreported protocol deviations and findings in an often-cited trial to test alternative treatments for depression, and an Indiana University School of Public Health’s re-examination of a trial of a neuropathic pain drug in which the manufacturer allegedly cherry-picked results to obscure unfavorable findings.

RIAT plans to award three more grants in 2020.