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Elizabeth Holmes- Case Archive
personpersonFabrizio BonanniFabrizio BonanniFormer Amgen executive and Theranos board member who joined the company during its 2016 restructuring.← All People
WitnessTheranos

Fabrizio Bonanni

Former Amgen executive and Theranos board member who joined the company during its 2016 restructuring.

AppearedFederal Criminal Trial
269 lines·6 proceedings·3 mentions

About

Fabrizio Bonanni testified for the defense about his service on Theranos's board beginning in 2016, after the company was already confronting regulatory, compliance, and press-related difficulties.

On direct examination, Bonanni drew on his quality, compliance, manufacturing, and regulatory background to explain his understanding of the 4 Series Minilab. He described the device's components and testing functions. He also recounted board discussions about responding to criticism, his preference for formal regulatory validation, and efforts to strengthen quality-management and corporate-compliance systems.

Bonanni said Holmes sought and implemented advice, committed resources to improvement efforts, and allowed him access to company personnel and information. He described her as technically knowledgeable, energetic, and receptive, while identifying a lack of focus and difficulty moving individual projects through regulatory approval as weaknesses.

Cross-examination established the boundaries of Bonanni's account. He joined the board in 2016, was unfamiliar with the Edison device, and did not know what Holmes had told earlier investors. He acknowledged that the Minilab 4.2 was neither commercially used for patient testing nor cleared by the FDA, that later Zika work raised quality and data-generation concerns, and that a claim of about 200 available assays would have been inaccurate in 2016.

Bonanni did not dispute Dr. Kingshuk Das's decision to void patient test results, but he resisted treating that decision as proof that every earlier system was inaccurate. On redirect, he clarified that the voiding decision had been made before he arrived at Theranos.

Trial Record (6)

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

Fabrizio Bonanni testified for the defense about the Minilab and the quality, compliance, and regulatory work undertaken after he joined Theranos's board in 2016. Cross-examination established that his knowledge postdated earlier investor representations and that the Minilab he discussed was neither commercially used for patient testing nor cleared by the FDA.

Day 36

ProceduralMotion to Exclude Fabrizio Bonanni Testimony and Late Disclosures1highlightMentioned

Summary

The government sought to exclude Fabrizio Bonanni's proposed testimony based on relevance and late disclosures. The defense argued that his knowledge of Minilab capabilities and Holmes's later conduct bore on intent. The court raised foundation, hearsay, discovery, and scheduling concerns but issued no exclusion ruling.

Mentioned in this proceeding.

Highlights (1)

otherThe defense argued that Bonanni's observations of Holmes's conduct in 2016 supported its state-of-mind theory; the court questioned the testimony's temporal limits, personal-knowledge foundation, and potential hearsay issues.Open in transcript →
DirectFabrizio Bonanni — DirectFabrizio BonanniKatherine Trefz9highlights189lines spoken

Summary

Bonanni explained the Minilab through demonstratives and described Theranos's 2016 board debates, regulatory strategy, and quality and compliance reforms. He praised Holmes's receptiveness to advice but identified operational focus and regulatory execution as weaknesses; several proposed opinions were excluded.

Highlights (9)

objectionAfter Bonanni said he was impressed by the device's capabilities, the court allowed that answer to remain but sustained a relevance objection to a question about his impression of Holmes.Open in transcript →
evidence eventThe court authorized four short videos as demonstratives only, and Bonanni used them to explain cartridge loading, internal components, hematology operations, and clinical-chemistry processing.Open in transcript →
testimony highlightBonanni described a board debate between responding publicly with institutional data and prioritizing regulatory clearance; he favored FDA and European validation and said Theranos followed that approach.Open in transcript →
Quote“MY VIEW WAS THAT THE VALIDATION THAT MATTERED IN THIS WHOLE DISCUSSION WAS THAT OBTAINED BY FDA AND OTHER REGULATORY AGENCIES, AND THAT THE COMPANY SHOULD PURSUE -- WITH A VERY HIGH FOCUS ON THE PURSUIT OF CLEARANCE BY FDA AND BY THE EUROPEANS IN PARTICULAR.”— Fabrizio BonanniBonanni distinguished his preferred regulatory-validation strategy from other directors' proposed public response to criticism.Open in transcript →
Show all 9 highlights
testimony highlightBonanni testified that Theranos undertook major quality and compliance efforts in 2016, including new leadership, a board committee, a corporate compliance program, and a more complete quality-management system.Open in transcript →
Quote“THERE WERE ELEMENTS OF THAT SYSTEM IN PLACE AT THERANOS AS I FIRST VISITED. THEY NEEDED TO BE STRENGTHENED AND MADE MORE COMPLETE.”— Fabrizio BonanniBonanni acknowledged that Theranos's quality-management system was incomplete when he arrived.Open in transcript →
testimony highlightBonanni praised Holmes's vision, technical knowledge, energy, and willingness to accept advice, while identifying lack of focus and difficulty advancing one project through regulatory approval as weaknesses.Open in transcript →
Quote“AND I NEVER HAD A "BUT" FROM ELIZABETH HOLMES. SHE WAS DILIGENT IN LISTENING AND INTERNALIZING WHAT SHE RECEIVED AS ADVICE FROM A NUMBER OF PEOPLE, INCLUDING ME.”— Fabrizio BonanniBonanni gave a memorable assessment of Holmes's response to criticism and advice during his board service.Open in transcript →
Quote“PERHAPS THE AREA OF FOCUSSING; PERHAPS THE AREA OF BEING INCREDIBLY PERSEVERING IN ACHIEVING -- IN BRINGING ONE ELEMENT OF THE HUNDREDS OF ONES THAT WERE IN DEVELOPMENT, BRINGING ONE THROUGH THE GOAL AND THE TARGET OF REGULATORY APPROVAL, AND THE FACT THAT THERE WERE SO MANY DIFFERENT COMPLEX THINGS BEING WORKED ON THAT I THOUGHT COULD HAVE BEEN IMPROVED.”— Fabrizio BonanniBonanni identified diffuse focus and difficulty carrying a single development effort through regulatory approval as Holmes's operational weaknesses.Open in transcript →
CrossFabrizio Bonanni — CrossFabrizio BonanniJeff Schenk6highlights67lines spoken

Summary

The prosecution confined Bonanni's knowledge to his post-2016 board service and Minilab 4.2 work. He acknowledged regulatory and development limits but resisted broader conclusions about Edison testing and lacked knowledge of earlier investor communications.

Highlights (6)

admissionThe prosecution established that Bonanni joined the board in 2016, lacked personal knowledge of earlier Theranos events, and testified only about Minilab version 4.2. He confirmed that the device was not commercially used for patient testing or FDA cleared and, to his knowledge, generated no results used for medical decisions.Open in transcript →
rulingThe court overruled a foundation objection to whether Bonanni disagreed with Dr. Kingshuk Das's decision to void patient test results. Bonanni said he did not disagree and did not consider the decision wrong, while describing it as Das's decision to make.Open in transcript →
Quote“NO. THIS IS A GENERAL STATEMENT THAT YOU'RE MAKING THAT I AM NOT COMFORTABLE AGREEING OR DISAGREEING WITH.”— Fabrizio BonanniBonanni resisted converting his acceptance of specific test voiding into a categorical opinion about the accuracy of the entire Theranos testing system.Open in transcript →
Quote“I JOINED THE COMPANY TO INFLUENCE THE FUTURE OF THE COMPANY. I DID NOT -- WHAT YOU CALL THE EDISON DEVICE, I REALLY HAVE NO KNOWLEDGE OF AN EDISON DEVICE. ALL I WAS -- ALL I SAW WAS THE MINILAB AND THE EFFORTS WERE TO COMMERCIALIZE THE MINILAB. AND I HAVE SEEN IN THE NEWSPAPERS, ET CETERA, THE TERM EDISON. THAT IS NOT SOMETHING THAT I'M FAMILIAR WITH, AND I AM NOT COMFORTABLE TESTIFYING ABOUT IT ONE WAY OR THE OTHER.”— Fabrizio BonanniBonanni expressly limited his knowledge and favorable account to the later Minilab effort rather than the Edison device used before his board service.Open in transcript →
Show all 6 highlights
admissionBonanni testified that he would not have told investors in 2016 that a Theranos device could run about 200 assays because that would have been inaccurate, and that he would not have claimed a device had been deployed to a battlefield in Afghanistan.Open in transcript →
admissionBonanni acknowledged that he did not know what Holmes said in earlier meetings that led several named investors and investment firms to invest in Theranos.Open in transcript →
RedirectFabrizio Bonanni — RedirectFabrizio BonanniKatherine Trefz2highlights13lines spoken

Summary

Bonanni said the medical director, not a board member, had authority over the earlier test-voiding decision and acknowledged conducting no independent review. After he was excused, the defense called and swore Elizabeth Holmes.

Highlights (2)

testimony highlightBonanni confirmed that the test-voiding decision preceded his arrival and explained that voiding assays was within the clinical laboratory medical director's authority, not a board member's role.Open in transcript →
Quote“IT'S THE RESPONSIBILITY OF THE MEDICAL DIRECTOR OF A CLINICAL LAB TO VOID ASSAYS. HE HAS THE AUTHORITY TO DO THAT. IT WOULD CERTAINLY BE INAPPROPRIATE FOR A BOARD MEMBER OF ALL THINGS TO HAVE SOMETHING TO SAY ABOUT THAT.”— Fabrizio BonanniBonanni explained why he deferred to Dr. Das and distinguished the medical director's laboratory authority from a board member's role.Open in transcript →

Day 46

Day 47