Thread by @MilesGCohen

#ElizabethHolmes trial day 32:

Holmes will be back on the stand.

(pics taken before 5 a.m.)

T-2 hours until #ElizabethHolmes returns to the stand.

Catch up on her suprise Friday testimony:

abcnews.go.com/US/theranos-fo…

Courtroom is packed and awaiting Holmes' testimony.

Prosecutor Jeff Schenk and defense attorney Kevin Downey just returned from the judge's chambers.

While we wait here is a recap of Holmes Friday testimony:

"We worked for years with teams of scientists and engineers to miniaturize all of the technologies in a laboratory," she told the jury on Friday.

abcnews.go.com/US/theranos-fo…

While we wait, take a peek at the "Theranos 1.0" as admitted into evidence on Friday.

The jury also saw Holmes' first patent application, filed the summer after her freshman year at Stanford.

And her tabletop prototype. She pointed out its "little white pumps" and "valves" to the jury on Friday.

Katie Trefz, one of Holmes' three attorneys who sits at the defense table, was also called back to the judge's chambers by the courtroom deputy Adriana Kratzmann.

Jeff Schenk and Kevin Downey are also still back there.

No indication on the hold up.

#ElizabethHolmes is not in the courtroom either.

Here come the lead attorneys out of the judge's chambers, followed by the court reporters.

Downey for the defense huddled up with his co-counsel Lance Wade and Andrew Lemons

Holmes took her seat at the defense table. Still no judge.

Nor jury.

The jury has filed in. All 14 of them. Still waiting on Judge Edward. J Davila.

Davila took his bench -- he apologized for the delay but did not say what happened.

#ElizabethHolmes took her seat at the stand.

Holmes testified she brought the "Theranos 1" to demo to Novartis in Switzerland, and there they encountered a "significant challenge."

It had to do with the cartridge's adhesive. The layers had loosened, she said.

So w/ her scientists and engineers, "We went back to the table," she testified.

They worked on the next iteration of the device.

It had nothing to do with problems with Theranos' assays or development of software, Holmes said.

We are looking at a picture of a Theranos' device and Holmes is explaining it to the jury.

She is looking down at the screen in front of her on the stand as she explains, and looking back up at Downey.

By the end of 2007 #Theranos developed their 3.0 series device, about a year after the Novartis demo, Holmes said.

Dr. Ian Gibbons and Gary Frenzel led the development of assays during the period theranos was working to develop the 3.0, she said.

“What effect did you think [the 3.0] had on the use of automation, on conducting blood testing?" Downey asked

"We thought this was a really big idea, b/c the robots that were used in the traditional lab had not been miniaturized to put in a device at the point of care," she said

The human processing, Holmes said, "would not be required in the same way with this device."

We saw a research abstract Holmes was sent titled "Pre-analytical variability: the dark side of the moon in laboratory testing" (appears to be the one linked)

pubmed.ncbi.nlm.nih.gov/16599826/

"I understood that this was saying the majority of the error that happens in the lab testing process happens in what they’re calling pre-analytical processing samples," Holmes said.

Which meant, "if we had the ability to automate much of that process, we could reduce the error associated with traditional lab testing," she testified.

Holmes has kept her eye contact on Kevin Downey and the screen in front of her which displays exhibits, while testifying this morning.

A contrast from Friday.

Not many smiles.

Dr. Gibbons conclusions from a presentation on the 3.0 device:

-Performance design goals have been demonstrated
-The system is now in clinical evaluation at several sites
-Results have been excellent
-Scale up, GMP documentation and 510k submissions are in hand

Holmes takeaway after seeing the presentation:

“That we were hitting the design goals for this system, and the system was performing in away that was excellent in clinical sites,” she testified.

We are looking at another presentation from Dr. Gibbons June 2008.

“Another update from Dr. Gibbons about the performance of our tech in clinical studies,” Holmes said.

In the presentation — "Stanford AML study"

A study conducted with stanford on AML patients, "these are cancer patients," Holmes said.

"These patients were very sick and their immune systems weren’t working very well anymore…very high risk that they could get infected," Holmes explained.

"We were measuring their blood trying to predict when that could happen so they could get medication or antibiotics in the future when tests like this were made available in the future," she continued.

AML/Sepsis study conclusions (slide)

-Very clear patterns of disease progression, remission and effects of therapies are apparent.
-Good correlations with outcomes are apparent

....

Slide cont:
-The samples will provide an excellent database for prognostic algorithm development and clinical assay validation
-Assay results have been precise
Study is about two thirds complete

Holmes on one of the points on Gibbon's conclusion slide.

"It meant our system was working well," she said.

We saw the published study briefly.

"The study showed some preliminary trends, indicating if you could take samples frequently you might actually be able to predict sepsis…but there was a very small sample of people in the study and more (studies?) were needed," Holmes said.

"I remember Dr Gibbons talking about the fact that the results were precise, but i'm not sure what was on the paper," she said in response to one of Downey's questions about the study.

We are looking at a #theranos presentation from 2009.

One slide: Completed Successes

There are 11 green bullet points, one reads Stanford study, the other 10 are Pharma companies.

"A success was that we had successfully achieved the objectives of the program," she said.

We are now going through the success bullets one by one.

The first is Novartis, which was a study,"testing markers of inflammation and looking at those markers in clinical patients who had some type of bone disorder," Holmes testified.

Downey pulled up an email chain Holmes exchanged with an individual from Novartis, Holmes said.

Subject: RE: apologies!!!

Attached: Theranos Novartis_Bone Study_Inflammation_Report_pdf

“I have attached the completed validation study report showing Theranos’ ability to run a multiplexed cartridge,” Holmes wrote to the Novartis employee.

Downey asked her to explain "reference assays" to the jury. she turned her head to the right where the 14 sit.

"[It's] just referring to traditional assays that are run in a clinical lab the way they were normally run," she explained.

Now AstroZeneca -- also listed on successes:

"AstroZeneca is validating the Theranos system by utilizing cartridges designed to run multiplexed assays….The theranos system will be incorporated into a clinical trial utilzing oncology subjects in the UK," an agreement read.

“We worked with the royal XX hospital in the UK and testing was done on patients compared to the traditional clinical lab," Holmes testified.

I think, Holmes said, some of the testing was done in homes, other in a clinic.

She understood part of the study would validate the Theranos system, Downey elicited.

and that she would be able to participate in AstroZeneca run clinical trials if it performed well

Another pharma co #Theranos worked w/: Merck

"Merck was interested in a test named GLP-1 which is used for diabetes. It's a really hard test and specifically measuring that test at low levels is hard so they wanted to see how well theranos test performed at low levels" she said

-completed study

-theranos tech evaluated

-outcome: "Merck sent data back to theranos' showing how well we performed against... traditional lab assays and said they would start working with us to find a clinical study using our tech," Holmes said.

But it never happened.

Bristol Meyers also agreed to do a study, Holmes said.

Theranos tech was shipped to New Jersey she said, to test against traditional assays in their lab.

Centocor next:

"[The] trial was a study in Belgium in which people were doing our blood tests at their homes and also going into a clinic. And tests at the theranos system were compared to tests at a traditional lab," Holmes said.

“It performed well,” she said of her tech

Downey elicited that Theranos was paid for the study.

We looked at an email from Stanley Belkowski of Centocor who Holmes said was, "going to a big biomarker meeting [with pharma companies], and he’s asking if he could present data from tests centocor did on our system," on Oct 14, 2011.

And were taking a 20-25 minute break...hearing we end at 1-130 so in the closing stretch already.

Holmes stood for the jury at the stand, as they filed out for break.

She appeared to look down at them as they passed.

One out of the 14 jurors returned Holmes look (from the stand) as they filed back into their seats.

Downey begins with Glaxosmithkline

A document which read: GSK evaluation of theranos systems:

GSK Metabolic Biomarker Lab comments, as Downey highlighted.

-Data show good correlation.

-Machine worked well"

"I remember them saying that they thought our system eliminated the need for the lab,” Holmes said.

(A conclusion on the document also indicated such)

Schering-Plough is the next pharma company brought up, which eventually became Merck.

Prosecutors called a Schering-Plough witness who testified she hadn't nor knew of anyone who had approved of their logo on a report #Theranos sent to Walgreens.

The witness was Dr. Connie Cullen.

"Please call me before your Merck call just had a great call with connie Cullen," a Theranos employee wrote to Holmes on 3/3/2010

Holmes understood the content to mean that Cullen was offering to be a reference as Theranos worked on other contracts with Merck (who had by then, I believe) merged with Schering-Plough

"She said someone in her group reviewed the draft validation from a long time ago and thinks it would be helpful to have the scientists talk one on one," the employee began in her email.

"hen she started talking about running the combined groups and said that they’ve done a high level analysis w/ the new organization and that the Merck folks are intrigued by it," she continued.