Samsung BioLogics, Controversy over Drug Data Manipulation

Reporter Paul Lee / approved : 2023-06-02 07:54:46
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[Alpha Biz=(Chicago) Reporter Paul Lee] Controversy over drug-related data manipulation has erupted at Samsung BioLogics.

According to SBS Biz on the 2nd, Samsung BioLogics (CEO John Lim, hereinafter Samsung Bio) launched a full investigation into several years' worth of pharmaceutical data earlier this year and detected arbitrary changes in some pharmaceutical data.

The survey was led by Sam McHour, vice president of Samsung Bio's Quality Operation Center, the broadcaster reported.

The investigation found that the random change in data in question was committed by executives and employees of Samsung Bio's research and development organization MSAT·Manufacturing Science And Technology.

MSET also neglected to separate accounts related to software login to prevent data manipulation.

After the investigation, Samsung Bio dismissed the team leader and group leader of the MSET organization. Lee Sang-yoon, a general executive, was also confirmed to have resigned a year after moving from Celltrion to Samsung Bio.

"It is true that the issue occurred," Samsung Bio said. "The issue is a violation of Samsung Bio's internal GMP standards, which are stricter than regulators, which does not mean that there is a problem with the final product quality."

 

Alphabiz Reporter Paul Lee(hoondork1977@alphabiz.co.kr)

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