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Elizabeth Holmes- Case Archive
personpersonConstance CullenConstance CullenFormer Schering-Plough scientist who oversaw an evaluation involving Theranos.← All People
WitnessSchering-Plough

Constance Cullen

Former Schering-Plough scientist who oversaw an evaluation involving Theranos.

AppearedFederal Criminal Trial
280 lines·7 proceedings·5 mentions

About

Constance Cullen testified for the United States about Schering-Plough's 2009 evaluation of Theranos. Drawing on her molecular-immunology and bioanalytical-laboratory experience, she distinguished a limited beta test, in which one sample was tested once, from a separate $279,000 project to validate three inflammatory markers.

Cullen said a May due-diligence meeting did not provide sufficient technical detail. Holmes answered almost all questions and, at times, interrupted Theranos personnel to whom Cullen had directed them. The expected report was not presented in May and arrived in December. Cullen said Theranos generated the report's data and conclusions, and she denied that she or, to her knowledge, anyone at Schering-Plough approved their accuracy. She also rejected a later description of the work as Schering-Plough's independent technical validation, along with a report version bearing Schering-Plough branding and a broader accuracy conclusion.

On cross-examination, Cullen agreed that the narrow beta test appeared favorable, that the device worked well as far as her team could tell, and that its sensitivity impressed her. She confirmed, however, that her technical concerns remained within Schering-Plough and that she gave Holmes and Theranos no positive or negative assessment of the final report. Merger-related demands interrupted her follow-up, and she ultimately did not respond.

Defense counsel also tested Cullen's recollection of the timing and sequence of communications. She relied on emails for dates she did not independently recall and could not say with certainty which exchange was her last with Holmes. Cullen nevertheless maintained a distinction between the written protocol, which she agreed met requirements, and the project's execution, which she said would not have met regulatory validation requirements.

Trial Record (7)

FederalFederal Criminal TrialAug 31, 2021 – Jan 3, 2022Called by prosecution

Cullen described Schering-Plough's limited beta test and separate Theranos validation project, rejecting claims that Schering-Plough independently performed or endorsed the validation. On cross-examination, she acknowledged favorable impressions from the narrow beta test and confirmed that she did not communicate her later concerns or final assessment to Holmes or Theranos.

Day 24

Day 26

DirectConstance Cullen — DirectConstance CullenJeff Schenk10highlights154lines spoken

Summary

Cullen said Theranos performed the paid validation itself, provided insufficient technical detail, and later characterized an unendorsed Theranos report as Schering-Plough's independent validation.

Highlights (10)

testimony highlightCullen distinguished Theranos's validation from Schering-Plough's separate beta testing, explaining that the validation work occurred at Theranos and that Schering-Plough's role was limited to reviewing documents.Open in transcript →
evidence eventThe court admitted the services agreement and invoice, and Cullen testified that Schering-Plough was to pay Theranos $279,000 for validation of three analytes on Theranos machines.Open in transcript →
testimony highlightCullen described the May 2009 due-diligence meeting as technically unsatisfactory, saying Holmes answered almost all questions, interrupted responses from other Theranos personnel, and provided responses Cullen regarded as indirect or evasive.Open in transcript →
Quote“YES, I ASKED A LOT OF QUESTIONS. MY RECOLLECTION IS THAT THE ANSWERS TO THE QUESTIONS WERE NOT NECESSARILY FORTHCOMING. SO I WAS DISSATISFIED, QUITE HONESTLY, WITH THE RESPONSE TO THE QUESTIONS IN THAT THERE WAS INSUFFICIENT TECHNICAL DETAIL FOR US TO BE ABLE TO EVALUATE THE TECHNOLOGY.”— Constance CullenCullen directly described why the May 2009 meeting did not satisfy Schering-Plough's technical due-diligence needs.Open in transcript →
Show all 10 highlights
Quote“I MEAN THAT THERE WERE NO DIRECT ANSWERS TO QUESTIONS, AND THE QUESTIONS ARE FAIRLY TECHNICAL, SO THE ANSWERS SHOULD BE FAIRLY TECHNICAL AND DIRECT. AND SO, YOU KNOW, THERE WERE WHAT I DESCRIBE AS CAGEY RESPONSES OR ATTEMPTS TO REDIRECT TO OTHER TOPICS OF DISCUSSION.”— Constance CullenThe testimony characterized the responses to technical questions as indirect and redirected rather than technically specific.Open in transcript →
admissionCullen said Schering-Plough sought an update because it had paid for work expected at the May meeting, but the Theranos validation report was not provided until December; she denied that she or, to her knowledge, anyone at Schering-Plough endorsed its conclusions.Open in transcript →
Quote“BECAUSE SCHERING-PLOUGH HAD PAID $279,000 FOR THIS WORK. WE HAD EXPECTED TO RECEIVE IT AT THAT MAY DUE DILIGENCE MEETING, AND WE DID NOT.”— Constance CullenCullen connected Schering-Plough's follow-up request to the payment and the absence of the expected work at the May meeting.Open in transcript →
confrontationAfter a Walgreens email characterized the attached report as Schering-Plough's own independent technical validation, Cullen rejected that characterization and explained that the separate beta test involved one sample tested once without a predefined protocol or acceptance criteria.Open in transcript →
Quote“YES. BETA TESTING WAS WE HAD TWO INSTRUMENTS IN THE LABORATORY AND WE HAD A VOLUNTEER FROM THE LAB PROVIDE A BLOOD SAMPLE AND WE MEASURED C REACTIVE PROTEIN. TO MY RECOLLECTION IT WAS A SINGLE DETERMINATION.”— Constance CullenCullen defined the narrow scope of Schering-Plough's hands-on beta test, distinguishing it from a comprehensive technical validation.Open in transcript →
evidence eventThe government compared the report Cullen received with the version attached to the Walgreens email. Cullen identified a Schering-Plough logo on the latter and rejected both the original conclusion and the expanded claim that Theranos results surpassed current gold-standard reference methods.Open in transcript →
CrossConstance Cullen — CrossConstance CullenJohn D. Cline7highlights126lines spoken

Summary

Cullen acknowledged favorable but limited beta-test results and no contemporaneous negative feedback to Theranos, while maintaining that the later validation execution would not meet regulatory requirements.

Highlights (7)

admissionCullen agreed that Schering-Plough received two Theranos machines, tested one assay on one sample, thought the device worked well as far as the team could tell, and was impressed with its sensitivity.Open in transcript →
testimony highlightWhen defense counsel cited Holmes's description of a detailed validation program, Cullen distinguished the written protocol from its execution, saying the protocol met stated requirements but the execution would not align with FDA or health-authority validation requirements.Open in transcript →
Quote“I DON'T KNOW HOW TRUE IT WAS. THEY PROVIDED A VALIDATION PROTOCOL WHICH WAS SHOWN EARLIER. IT'S NOT -- I MEAN, IT HIT THE REQUIREMENTS. BUT AT THE END OF THE DAY, THE EXECUTION WOULD NOT HAVE BEEN IN ALIGNMENT WITH FDA OR HEALTH AUTHORITY REQUIREMENTS FOR VALIDATION.”— Constance CullenCullen preserved a central distinction between an acceptable written protocol and execution that she believed would not satisfy regulatory validation requirements.Open in transcript →
admissionCullen agreed that the revised expected start date was four days before the May 2009 visit and testified that, despite speed being a selling feature, the validation could not have been completed in four days.Open in transcript →
Show all 7 highlights
Quote“ONE OF THE, ONE OF THE SELLING FEATURES OF THE TECHNOLOGY WAS SPEED. BUT IN MY ESTIMATION, NO, IT COULD NOT HAVE BEEN COMPLETED IN FOUR DAYS.”— Constance CullenThe answer addressed the defense's timing argument while maintaining that the validation could not realistically have been finished before the May visit.Open in transcript →
admissionCullen confirmed that she did not voice her technical concerns to Holmes or Theranos after the May meeting, although she discussed them with Schering-Plough colleagues, and knew of no further written request beyond a June status inquiry.Open in transcript →
testimony highlightThe defense traced the December 2009 report and later follow-up emails; Cullen said the Merck merger delayed review, she did not follow up, and she ultimately gave Theranos neither positive nor negative feedback about the report.Open in transcript →

Day 37

DirectElizabeth A. Holmes — DirectElizabeth A. HolmesKevin M. DowneyMentioned

Summary

Holmes described the 1 Series cartridge failure, development of the 3 Series, research studies, and pharmaceutical validation work. She acknowledged limits and unrealized projects while saying internal presentations led her to believe a proposed 4 Series could run any blood test; several partner communications were admitted only for state-of-mind purposes.

Mentioned in this proceeding.

Day 46