Surekha Gangakhedkar — Cross/Redirect (Continued)
1,869 linesSUREKHA GANGAKHEDKAR: SUREKHA GANGADKHEDKAR.
(GOVERNMENT'S WITNESS, SUREKHA GANGAKHEDKAR, WAS PREVIOUSLY SWORN.)
JUDGE DAVILA: THANK YOU VERY MUCH. MR. WADE.
CROSS-EXAMINATION (RESUMED) BY MR. WADE:
SUREKHA GANGAKHEDKAR: GOOD MORNING.
MR. WADE: I HAVE SOME ADDITIONAL QUESTIONS FOR YOU TODAY. DO YOU STILL HAVE THE TWO BINDERS UP IN FRONT OF YOU ON THE WITNESS STAND?
SUREKHA GANGAKHEDKAR: YES, I DO.
MR. WADE: I WANT TO STEP BACK A BIT TO WHEN YOU JOINED THE COMPANY. I BELIEVE YOU TESTIFIED THAT YOU WERE RECRUITED BY DR. IAN GIBBONS TO JOIN THE COMPANY; IS THAT CORRECT?
SUREKHA GANGAKHEDKAR: SO DR. GIBBONS I BELIEVE WAS FUNCTIONING AS A DIRECTOR FOR TECHNOLOGY AND ASSAY DEVELOPMENT.
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: AND HE HAD HELD NUMEROUS POSITIONS IN A LONG CAREER IN WORKING IN SILICON VALLEY; IS THAT RIGHT?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: YOU FOCUSSED ON DEVELOPING ASSAYS FOR WORK WITH PHARMACEUTICAL COMPANIES INITIALLY; CORRECT?
MR. WADE: AND THESE WERE TESTS THAT WERE DEVELOPED THAT REQUIRED SIGNIFICANTLY SMALLER SAMPLES OF BLOOD THAN WAS TYPICAL AT THAT TIME; IS THAT RIGHT?
SUREKHA GANGAKHEDKAR: I BELIEVE SO.
SUREKHA GANGAKHEDKAR: I THINK SO.
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: AND WE SAW SOME OF THE ACCOMPLISHMENTS LAST WEEK. BUT YOU WERE ALSO RECOGNIZED BY SOME OF THE LEADERS OF THE COMPANY; RIGHT?
MR. WADE: LET ME SHOW YOU WHAT SHOULD BE IN YOUR BINDER AS EXHIBIT 10492. DO YOU HAVE THAT EMAIL IN FRONT OF YOU?
SUREKHA GANGAKHEDKAR: I DO.
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED AND MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 10492 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
SUREKHA GANGAKHEDKAR: CORRECT.
SUREKHA GANGAKHEDKAR: I DON'T EXACTLY REMEMBER THE PROJECT, BUT IT COULD RELATE TO SOME OF THE ASSAYS THAT WERE DEVELOPED IN HOUSE.
SUREKHA GANGAKHEDKAR: I THINK SO.
SUREKHA GANGAKHEDKAR: CORRECT.
SUREKHA GANGAKHEDKAR: YES, I DID.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 10493 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
SUREKHA GANGAKHEDKAR: SO I DEVELOPED AN ASSAY FOR C-REACTIVE PROTEIN. THE ASSAY CONDITIONS ARE SPECIFIED IN THE EMAIL. SO WHAT WE ARE SAYING -- WHAT I AM SAYING IN THIS EMAIL IS I CONFIRMED THAT THE ASSAY THAT WAS DEVELOPED WAS THE -- THE RESPONSE WAS CONFIRMED BY TESTING A SET OF CLINICAL SERUM ON THE TEST THAT WAS DEVELOPED AGAINST A REFERENCE TEST.
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: OKAY. DO YOU RECALL LAST WEEK, I THINK JUST BEFORE WE HAD THE BREAK, WE STARTED TO TALK ABOUT HOW YOU HAD DONE SOME WORK WITH CELGENE. DO YOU RECALL THAT?
MR. WADE: AND YOU WERE INVOLVED IN DEVELOPING AN ASSAY FOR THERANOS FOR THERANOS'S WORK FOR DEVELOPING AN ASSAY FOR CELGENE; CORRECT?
MR. WADE: AND IT WAS ONE THAT WOULD MEASURE A PARTICULAR COMPOUND THAT CELGENE WAS LOOKING TO DEVELOP?
MR. WADE: AND SO THIS WAS SO ULTIMATELY THAT THEY COULD DEVELOP OR USE THAT ASSAY IN A CLINICAL TRIAL?
SUREKHA GANGAKHEDKAR: I DO.
SUREKHA GANGAKHEDKAR: SO BASICALLY THIS IS A REPORT OF THE STUDY THAT WAS CONDUCTED.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 9002 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: I'D LIKE TO DRAW YOUR ATTENTION TO PAGE 8150 AT THE BOTTOM, NUMBER ENDING 8150, AND DRAW YOUR ATTENTION TO THE TOP THERE. THIS WAS THE ELISA -- THIS IS A DESCRIPTION OF THE ELISA ASSAY THAT YOU HAD DEVELOPED FOR CELGENE?
MR. WADE: AND IF I COULD BRING YOU TO 8203. THIS IS THE PORTION OF THE DOCUMENT THAT SET FORTH THE PROTOCOL THAT WAS USED; IS THAT RIGHT?
SUREKHA GANGAKHEDKAR: I THINK IT'S DON VU.
SUREKHA GANGAKHEDKAR: HE'S DR. PETER BRYAN.
SUREKHA GANGAKHEDKAR: SO HE WAS THE STUDY SPONSOR.
MR. WADE: OKAY. AND IF WE CAN GO TO -- I'M GOING TO GO BACK TO PAGE 8145. THIS IS THE GLP COMPLIANCE STATEMENT; IS THAT RIGHT?
MR. WADE: AND THIS WAS THE CERTIFICATION THAT THERANOS'S WORK WAS DONE IN COMPLIANCE WITH THE RULES AND GUIDANCE FROM THE FDA?
MR. WADE: AND IF I CAN BRING YOU TO THE NEXT PAGE WHERE IT SAYS QUALITY ASSURANCE STATEMENT. DO YOU SEE THAT?
MR. WADE: AND THERE ARE TWO INDIVIDUALS IDENTIFIED THERE AS CERTIFYING TO THAT. DO YOU KNOW WHO THOSE INDIVIDUALS ARE?
SUREKHA GANGAKHEDKAR: SO THEY WERE IN EITHER THE QUALITY DEPARTMENT OR THE MANUFACTURING DEPARTMENT.
MR. WADE: IF I CAN DRAW YOUR ATTENTION TO THE PAGE MARKED 8156 AT THE BOTTOM. AND WITHIN -- DO YOU SEE THE SECTION 14.2, THE METHOD ACCEPTANCE?
MR. WADE: AND I'D LIKE TO DRAW YOUR ATTENTION TO THE SECOND PARAGRAPH IN THAT SECTION, THE INTRA-DAY ACCURACY AND PRECISION. DO YOU SEE THAT?
MR. WADE: AND THE LAST SENTENCE HERE DESCRIBES HOW NO MORE THAN ONE QC OUTLIER MAY BE EXCLUDED FROM THE STATISTICAL CALCULATIONS FOR A GIVEN VALIDATION RUN, AND A MAXIMUM OF 2 QC OUTLIERS MAY BE EXCLUDED FROM THE COMBINATION -- FROM THE COMBINED THREE CORE RUNS. DO YOU SEE THAT?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: AND THERE ARE SOME OTHER OUTLIER PRINCIPLES THAT ARE USED WITHIN LABORATORY SCIENCE AS WELL; CORRECT?
MR. WADE: AND IF I COULD DRAW YOUR ATTENTION TO THE NEXT PAGE, PAGE 19. THERE'S ANOTHER SECTION THIS TIME ON INTER-DAY ACCURACY AND PRECISION. DO YOU SEE THAT?
MR. WADE: AND JUST ONE LAST REFERENCE ON PAGE 8194. THIS IS WHERE YOU AND MR. FRENZEL SIGNED OFF ON THIS VALIDATION REPORT; CORRECT?
SUREKHA GANGAKHEDKAR: I THINK SO.
SUREKHA GANGAKHEDKAR: CAN YOU REPEAT THE NUMBER, PLEASE?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 10500 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
SUREKHA GANGAKHEDKAR: HE WAS THE PROJECT MANAGER FOR THIS PROJECT.
SUREKHA GANGAKHEDKAR: CORRECT.
MR. WADE: AND IF WE JUST GO TO 2470, WHICH IS NEAR THE END. THIS REPORT WAS SIGNED OFF ON BY YOU AS THE STUDY DIRECTOR; RIGHT?
SUREKHA GANGAKHEDKAR: YEAH.
MR. WADE: AND IF I COULD DRAW YOUR ATTENTION TO 13763. ACTUALLY, YOU RECALL THAT THE COMPANY ACKNOWLEDGED RECEIPT OF THIS REPORT; IS THAT RIGHT?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: YEAH. WE CAN SKIP THAT EXHIBIT THEN. I WANT TO ASK YOU ABOUT SOME WORK FOR ANOTHER PHARMACEUTICAL COMPANY. DO YOU RECALL THAT YOU WORKED ON A PROJECT FOR CENTOCOR?
SUREKHA GANGAKHEDKAR: SO WE HAD TO DEVELOP ASSAYS FOR A CENTOCOR PRODUCT, AS WELL AS OTHER BIOMARKERS, THAT WOULD BE AS PER THEIR RECOMMENDATIONS.
SUREKHA GANGAKHEDKAR: SO THIS IS MY SUMMARY OF THE ASSAY DEVELOPMENT THAT WAS CONDUCTED FOR THE PRODUCT FROM CENTOCOR.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 9110 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
SUREKHA GANGAKHEDKAR: CORRECT.
SUREKHA GANGAKHEDKAR: CORRECT.
SUREKHA GANGAKHEDKAR: ESSENTIALLY LOOKING AT THE IMPACT ON THE ASSAY OF DIFFERENT MATRIXES LIKE HEMOLYZED BLOOD, LIPEMIC PLASMA, AND SERUM.
SUREKHA GANGAKHEDKAR: YES, THEY CAN.
MR. WADE: AND SO YOU HAVE TO ASSESS THAT IN ORDER TO MAKE SURE THAT THE ASSAY FUNCTIONS PROPERLY?
MR. WADE: AND IN THE COURSE OF DEVELOPING THIS ASSAY, YOU TESTED VARIOUS DILUTION LEVELS IN ORDER TO OPTIMIZE THE ASSAYS; CORRECT?
SUREKHA GANGAKHEDKAR: SO ESSENTIALLY BECAUSE THE RANGE OF THE TARGET WAS REALLY WIDE, WHAT WE HAD REALIZED IS THE ASSAY DID REQUIRE TWO SEPARATE DILUTIONS TO FUNCTION, TO COVER BOTH ENDS OF THE ASSAY RANGE.
MR. WADE: AND SO TO ASCERTAIN THAT, YOU ACTUALLY TESTED MULTIPLE DIFFERENT DILUTION LEVELS; CORRECT?
SUREKHA GANGAKHEDKAR: IT IS.
SUREKHA GANGAKHEDKAR: SO I'M SUMMARIZING HERE THAT THE FINALIZED INSTRUMENT PROTOCOL USES A 2 DILUTION SCHEME, 20 AND 8000X.
MR. WADE: AND IF WE CAN GO TO PAGE ENDING 9257. UP AT THE TOP, DO YOU SEE WHERE IT SAYS ASSAY VALIDATION?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: I DON'T HAVE ANY MORE QUESTIONS ABOUT THAT DOCUMENT. I WANT TO FOCUS BEYOND THE WORK ON PHARMACEUTICAL ASSAY DEVELOPMENT AND SOME OF THE OTHER IMMUNOASSAY R&D WORK THAT YOUR TEAM COMPLETED.
SUREKHA GANGAKHEDKAR: OKAY.
MR. WADE: THE TEAM COMPLETED WORK ON A LARGE NUMBER OF IMMUNOASSAYS THAT IT DEVELOPED FROM SCRATCH; CORRECT?
MR. WADE: AND PART OF WHAT YOU WERE WORKING ON WITH THOSE ASSAYS WAS THE ABILITY TO USE A MUCH SMALLER SAMPLE?
SUREKHA GANGAKHEDKAR: YEAH.
MR. WADE: AND PART OF YOUR WORK WAS ALSO DESIGNED TO DEVELOP ASSAYS THAT COULD RUN MORE QUICKLY; RIGHT?
SUREKHA GANGAKHEDKAR: WE DID.
SUREKHA GANGAKHEDKAR: IT IS.
SUREKHA GANGAKHEDKAR: SOME CAN BE DEVELOPED IN THREE MONTHS. SOME CAN TAKE A YEAR OR MORE.
MR. WADE: AFTER THE INITIAL WORK OF DEVELOPING THE ASSAYS WITH THE PHARMACEUTICAL COMPANIES, THERE WAS A SHIFT IN FOCUS; RIGHT?
MR. WADE: AND THE FOCUS BEGAN TO BE DEVELOPING ASSAYS THAT WERE THE MOST COMMONLY ORDERED TESTS; CORRECT?
SUREKHA GANGAKHEDKAR: I WOULD -- I THINK SO.
MR. WADE: AND THAT WAS PART OF AN EFFORT TO DEVELOP ASSAYS FOR THERANOS'S RETAIL PARTNERSHIPS; RIGHT?
MR. WADE: AND JUST SO WE CAN HAVE A SENSE OF IMMUNOASSAYS, THERE ARE HUNDREDS OF IMMUNOASSAYS; RIGHT?
SUREKHA GANGAKHEDKAR: SEVERAL HUNDRED, YES.
SUREKHA GANGAKHEDKAR: SO WE HAD A PRIORITY LIST, SO WE WERE DEVELOPING ALONG THE LIST THAT WAS PROVIDED TO US.
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: BUT THERE'S A SMALLER SUBSET OF ASSAYS THAT ARE THE MOST COMMONLY ORDERED AND USED IN TRADITIONAL MEDICAL SETTINGS?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: AND THE GOAL WAS TO COVER TESTS THAT WOULD COVER APPROXIMATELY 95 TO 98 PERCENT OF THE RETAIL ORDERS. DO YOU RECALL THAT?
SUREKHA GANGAKHEDKAR: I'M SORRY, WHAT DO YOU MEAN BY "TRACKED"?
MR. WADE: AND WE'LL GO THROUGH SOME OF THEM. IF I COULD CALL YOUR ATTENTION TO EXHIBIT 10496. THIS IS AN EMAIL CHAIN BETWEEN YOU AND MS. HOLMES?
MR. WADE: AND I BELIEVE YOU TESTIFIED BEFORE, BUT THE RESEARCH AND DEVELOPMENT WORK WAS SOMETHING THAT MS. HOLMES CARED A LOT ABOUT; RIGHT?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: AND THIS IS AN EMAIL EXCHANGE BETWEEN THE TWO OF YOU DISCUSSING A PLAN FOR THE DEVELOPMENT OF ASSAYS; IS THAT RIGHT?
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 10496 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: AND IF WE START WITH THAT BOTTOM EMAIL. DO YOU SEE IT SAYS, "DANIEL WILL BE SENDING THE LIST OF ELISA ASSAYS FOR OUR INITIAL ROUTINE TESTING CARTRIDGE?" DO YOU SEE THAT?
SUREKHA GANGAKHEDKAR: HE DID.
MR. WADE: AND IT SAYS IN THE THIRD FULL PARAGRAPH, "WE NEED TO DEVELOP A PROJECT PLAN FOR THE DEVELOPMENT TIMELINES OF THESE ASSAYS." DO YOU SEE THAT?
SUREKHA GANGAKHEDKAR: YEAH.
MR. WADE: AND THEN ON THE BOTTOM IT SAYS, LAST PARAGRAPH, IT SAYS, "WHEN WE MEET, I ALSO WANT TO CONNECT ON THE RECRUITING PLAN AND TIMELINES FOR GETTING MORE ELISA TEAM MEMBERS IN HOUSE." DO YOU SEE THAT?
MR. WADE: AND, IN FACT, IF YOU LOOK UP AT THE TOP EMAIL, IN THIS EMAIL MS. HOLMES ACTUALLY RESPONDS TO HERSELF TO MAKE ANOTHER POINT. DO YOU SEE THAT?
MR. WADE: AND SHE SAYS THAT YOU SHOULD ASSUME THAT YOU HAVE AT LEAST ANOTHER 8 TO 15 PEOPLE ON THE TEAM WORKING ON THAT?
SUREKHA GANGAKHEDKAR: I DID.
SUREKHA GANGAKHEDKAR: YES, I DO.
MR. WADE: AND AS PART OF THE PRIORITY THAT WAS PUT ON ASSAY DEVELOPMENT, YOU SERVED TO HOLD REGULAR TEAM MEETINGS TO DISCUSS ASSAY DEVELOPMENT. DO YOU RECALL THAT?
SUREKHA GANGAKHEDKAR: YES. SO BASICALLY THIS IS SHARING THE UPDATE OR THE PROGRESS ON THE ASSAYS THAT WERE BEING DEVELOPED WITH THE LARGER TEAM, INCLUDING OTHER MEMBERS OF THE ORGANIZATION.
MR. LEACH: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 07215 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: AND THIS IS THE MEETING WHERE YOU DISCUSSED YOU WOULD SHARE THE RESULTS OF YOUR WORK WITH OTHER MEMBERS OF THE TEAM?
SUREKHA GANGAKHEDKAR: CORRECT.
SUREKHA GANGAKHEDKAR: CORRECT.
MR. WADE: AND ULTIMATELY YOU KNEW THAT THESE ASSAYS WERE GOING TO BE IMPLEMENTED IN THE CLIA LABORATORY?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: AND SO DID YOU THINK IT WAS PRUDENT TO HAVE DR. GELB INVOLVED IN SOME OF THESE DISCUSSIONS?
SUREKHA GANGAKHEDKAR: SO HE WAS LEADING THE DEVELOPMENT FOR THE GENDER CHEMISTRY ASSAYS.
MR. WADE: AND PART OF THIS WORK THAT YOU WERE DOING, YOU GAVE MS. HOLMES REGULAR UPDATES ON THE PROGRESS OF THE TEAM?
SUREKHA GANGAKHEDKAR: YES, I DID.
MR. WADE: AND LET'S LOOK AT 10497. AND THESE ARE A SERIES OF EMAILS BETWEEN YOU AND MS. HOLMES ON THE ASSAY DEVELOPMENT WORK?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. LEACH: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 10497 WAS RECEIVED IN EVIDENCE.)
MR. WADE: DO YOU SEE THERE'S AN EMAIL JANUARY 11TH, 2011, WHERE YOU HAD PROVIDED MS. HOLMES WITH AN UPDATE?
MR. WADE: AND THEN IT LOOKS LIKE A COUPLE OF MONTHS LATER SHE ASKED FOR AN UPDATE ON THE TOP 95 PERCENT. DO YOU SEE THAT?
MR. WADE: AND THIS WAS THE 95 PERCENT -- THIS WAS THE PROJECT THAT WE TALKED ABOUT A COUPLE MINUTES AGO WHERE YOU WERE TRYING TO DEVELOP THE ASSAYS THAT WOULD COVER 95 PERCENT OF THE TESTS?
MR. WADE: AND IT LOOKS LIKE YOU WERE WORKING REMOTELY AND SO YOU WEREN'T ABLE TO GET YOUR -- ACCESS ONE OF YOUR DOCUMENTS ON THE VPN; RIGHT?
SUREKHA GANGAKHEDKAR: RIGHT.
SUREKHA GANGAKHEDKAR: I WAS REFERRING TO THE EXCEL FILE AND TO THE PREVIOUS EXCEL FILE AND THEN GIVING THE UPDATE.
MR. WADE: OKAY. SO YOU COULDN'T ATTACH IT, BUT YOU REFERRED TO IT AND GAVE A TEXTURAL UPDATE TO MS. HOLMES?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: OKAY. AND WE'LL SEE IN THE FUTURE A LOT OF TIMES YOUR SPREADSHEETS ARE SENT AROUND, AREN'T THEY?
SUREKHA GANGAKHEDKAR: YEAH.
SUREKHA GANGAKHEDKAR: YES, I DID.
MR. WADE: DO YOU SEE THAT? AND THEN IT LOOKS LIKE MAYBE WHEN YOU GOT BACK INTO THE OFFICE, UP ON THE TOP, THAT YOU HAD SENT THE SPREADSHEET THAT YOU HAD REFERRED TO. DO YOU SEE THAT?
MR. WADE: AND LET'S TAKE A LOOK AT THAT ATTACHMENT. WE'LL PULL IT UP ON THE SCREEN FOR YOU. MR. BENNETT, IF WE CAN BLOW THAT UP JUST A LITTLE BIT. THANK YOU. AND THIS IS A LIST OF THE 30 PRIORITY ASSAYS THAT YOUR TEAM WAS WORKING ON AT THE TIME?
SUREKHA GANGAKHEDKAR: I THINK SO.
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: AND THEN IT LOOKS LIKE THERE WERE ANOTHER NINE ASSAYS THAT WERE UNDER DEVELOPMENT; RIGHT?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. LEACH: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 7202 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: AND DO YOU SEE IN THE EMAIL AT THE TOP THIS PROVIDES AN UPDATE OF ALL ASSAYS IN THE 95 PERCENT LIST?
MR. WADE: AND YOU'RE INCREDIBLY ORGANIZED SO YOU ACTUALLY CODE THINGS BY COLOR ACCORDING TO PROGRESS; IS THAT RIGHT?
SUREKHA GANGAKHEDKAR: YEAH.
SUREKHA GANGAKHEDKAR: I DO.
SUREKHA GANGAKHEDKAR: YEAH.
MR. WADE: AND THERE'S A SPREADSHEET ATTACHMENT AGAIN. CAN WE -- I'M SORRY. COULD I -- COULD WE ADMIT, YOUR HONOR, EXHIBIT 10941?
MR. LEACH: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 10491 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: AND LET'S TAKE A LOOK AT THE SPREADSHEET. AND DO YOU SEE THERE'S A TAB THAT SAYS COMPLETED 6-8-12?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: AND IF WE CAN GO TO THE FIRST TAB THAT SAYS TIMELINES. DO YOU SEE UP AT THE TOP IT IDENTIFIES ADDITIONAL ASSAYS ACROSS THE COLUMNS THAT IDENTIFIES ADDITIONAL ASSAYS THAT ARE IN DEVELOPMENT?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: IF I COULD CALL YOUR ATTENTION TO EXHIBIT 7297. AND THIS IS ANOTHER UPDATE FROM THE ELISA TEAM ON ITS PROGRESS?
SUREKHA GANGAKHEDKAR: I DID.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 7297 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: AND IT'S A PRETTY SIMPLE TRANSMITTAL EMAIL. AT THIS POINT SHE PROBABLY GETS A SENSE OF YOUR WORK AND YOU'RE TRACKING PROGRESS; RIGHT?
SUREKHA GANGAKHEDKAR: SHE DID.
MR. WADE: AND LET'S LOOK AT THE ATTACHMENT. THIS IS ANOTHER SPREADSHEET. DO YOU SEE THAT? AND DO YOU RECALL THAT THE PREVIOUS TABS HAD TRACKED ASSAYS BASED ON 95 PERCENT OF COVERAGE?
MR. WADE: AND ONCE THERE WAS SUFFICIENT PROGRESS MADE, ADDITIONAL ASSAYS WERE PROVIDED TO THE PLAN; RIGHT?
SUREKHA GANGAKHEDKAR: IT IS.
SUREKHA GANGAKHEDKAR: UH-HUH, YES.
MR. WADE: AND MAYBE I SAW ONE OF YOUR SPREADSHEETS THAT TRACKED POTENTIALLY 400 IMMUNOASSAYS. DOES THAT SEEM LIKE THE RIGHT NUMBER?
MR. WADE: AND THAT'S -- TO DO THAT, 74 ASSAYS WERE NEEDED; IS THAT RIGHT? I CAN SCROLL DOWN FOR YOU.
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: THE COMPANY'S ANALYSIS THAT HAD IDENTIFIED 74 ASSAYS THAT WOULD COVER 98 PERCENT OF THE ORDERS; IS THAT RIGHT?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: AND YOUR WORK, YOUR WORK IN YOUR TEAM WAS DEVELOPED TOWARDS THOSE ASSAYS IN THE FIRST INSTANCE?
MR. WADE: BUT THIS PARTICULAR PROJECT AND THE FOCUS AT THIS TIME WAS COVERING 98 PERCENT FOR RETAIL?
MR. WADE: IF WE CAN GO -- IF YOU LOOK AT THE GREEN ROWS, I COUNT 63 COMPLETED ASSAYS AND 8 THAT ARE UNDER DEVELOPMENT. DOES THAT SEEM ABOUT RIGHT?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: AND IF WE GO TO THE ATTACHMENT -- OR, I'M SORRY, THE TAB THAT SAYS COMPLETED, THE SECOND TO LAST. DO YOU SEE THAT? AND THIS WAS A SHEET THAT COVERED ALL OF THE ASSAYS THAT YOU HAD DEVELOPED?
MR. WADE: AND LET'S GO TO THE BOTTOM THERE AND TAKE A LOOK. AT THIS POINT THERE HAD BEEN 93 THAT HAD BEEN COMPLETED; RIGHT?
MR. WADE: AND IF WE CAN GO TO THE ATTACHMENT THAT SAYS -- OR I'M SORRY, THE TAB THAT SAYS PROGRESS. DO YOU SEE THAT?
MR. WADE: AND AGAIN, ACROSS THE TOP THIS TRACKS THE PRODUCT -- THE PROGRESS OF ASSAYS THAT WERE IN DEVELOPMENT BUT NOT YET COMPLETED; IS THAT RIGHT?
MR. WADE: AND IF WE CAN FOCUS FOR A SECOND ON THIS LEFT-HAND ROW WHERE IT SAYS EXPERIMENT UP AT THE TOP. DO YOU SEE THAT?
SUREKHA GANGAKHEDKAR: UH-HUH.
MR. WADE: ARE THOSE THE 26 DIFFERENT STEPS THAT EVERY ASSAY WOULD GO THROUGH IF IT WAS APPLICABLE TO THAT ASSAY?
SUREKHA GANGAKHEDKAR: YES, THEY WOULD.
MR. WADE: AND IN THE END THE GOAL WAS TO DESIGN AN ASSAY THAT CORRELATED TO AN EXISTING COMMERCIALLY AVAILABLE ASSAY?
MR. WADE: AND JUST SO WE'RE ALL CLEAR, THE CLIA VALIDATION, THAT MEANS VALIDATED SO YOU CAN USE ON PATIENTS?
SUREKHA GANGAKHEDKAR: IT DIDN'T BECAUSE THIS WAS -- ESSENTIALLY WE ARE MAKING SURE THAT OF THE ASSAY THAT IS DEVELOPED APPROPRIATELY AND IS SPECIFIC OR SENSITIVE ENOUGH THAT WHEN IT GOES INTO THE NEXT STAGE OF VALIDATION WE DON'T HAVE ANY SURPRISES.
MR. WADE: RIGHT. AND THEN IT GOES OVER THE CLIA LAB, AND THE CLIA LAB PEOPLE PICK IT UP AND THEY DO THE VALIDATION FOR CLIA PURPOSES?
MR. WADE: AND ONCE THE WORK FOR AN ASSAY WAS COMPLETE, THAT WOULD BE DOCUMENTED IN A WRITTEN REPORT?
MR. WADE: SO, FOR EXAMPLE, FOR THE 93 ASSAYS THAT WE HAD IDENTIFIED THERE WOULD BE A REPORT FOR EACH INDIVIDUAL ONE?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: AND THEY WOULD VARY A BIT FROM ASSAY TO ASSAY, BUT THE GENERAL IDEA WAS TO CONFIRM EACH OF THE STEPS THAT HAD BEEN TAKEN IN THE DEVELOPMENT OF THE ASSAY?
MR. WADE: LET ME JUST GO BACK BRIEFLY TO THAT SPREADSHEET THAT WE JUST LOOKED AT IN THE COMPLETED TAB. IF WE GO TO THE TOP, WHAT IS THE FIRST ASSAY THERE?
SUREKHA GANGAKHEDKAR: THYROID STIMULATING HORMONE.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 9397 WAS RECEIVED IN EVIDENCE.)
JUDGE DAVILA: 9397?
JUDGE DAVILA: I THINK THAT WAS ADMITTED.
COURT CLERK: IT WAS IDENTIFICATION BY ANOTHER WITNESS, YOUR HONOR.
BY MR. WADE:
SUREKHA GANGAKHEDKAR: CORRECT.
SUREKHA GANGAKHEDKAR: YEAH.
MR. WADE: AND THIS -- ACTUALLY, IF I CAN GET THE WHOLE PART AT THE TOP. THIS SET FORTH THE ASSAY INFORMATION?
MR. WADE: AND THIS LOOKS KIND OF COMPLICATED. WE WON'T GO THROUGH ALL OF THE DETAIL HERE, BUT DO YOU THINK THIS ACCURATELY DESCRIBES THE WORK THAT WAS DONE?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: AND THAT WAS GENERALLY THE IDEA THAT YOU ASKED -- THAT WAS GENERALLY THE GOAL OF THE PREPARATION OF THE REPORT?
MR. WADE: AND ONE PARTICULAR THING I NOTE HERE IN 1.1.2 IS THE TOTAL TIME TO RUN THIS ASSAY WAS 30 MINUTES?
SUREKHA GANGAKHEDKAR: THE DIFFERENT STEPS FOR THOSE STAGES WERE 30 MINUTES, BUT ON THE READER THE TIME WOULD BE LONGER.
SUREKHA GANGAKHEDKAR: YEAH.
MR. WADE: AND IF YOU LOOK AT 947 AND IF WE CAN BLOW UP THE ANTIBODY SCREENING THERE. DO YOU SEE THAT?
MR. WADE: AND THIS INDICATES THAT YOUR TEAM TESTED 22 DIFFERENT POTENTIAL ANTIBODIES IN THE COURSE OF DETERMINING WHICH ONE WOULD WORK BEST FOR THIS ASSAY; RIGHT?
SUREKHA GANGAKHEDKAR: CORRECT.
SUREKHA GANGAKHEDKAR: IT IS.
MR. WADE: AND THE GOAL OF DOING THAT IS TO FIGURE OUT WHICH ANTIBODY WOULD, WOULD ATTACH MOST SUCCESSFULLY. AM I USING THE RIGHT WORD THERE?
SUREKHA GANGAKHEDKAR: SO BASICALLY FINDING THE BEST REAGENT THAT COULD BE USED IN THE THERANOS SYSTEM.
SUREKHA GANGAKHEDKAR: SO BASICALLY THE COMBINATION OF THE REAGENT, THAT WOULD GIVE US THE DESIRED SPECIFICITY AND SENSITIVITY.
MR. WADE: OKAY. AND IF WE GO TO 955, SECTION 1.4. THIS ASSAY DEVELOPMENT PROCESS INVOLVED TESTING THE ASSAY ON A THERANOS DEVICE?
MR. WADE: IF WE CAN GO BACK AGAIN TO 7297 IN THAT COMPLETED TAB. SO FOR ALL OF THESE IMMUNOASSAYS YOU WOULD EXPECT TO SEE COMPLETED REPORTS?
MR. WADE: AND I THINK BY STIPULATION WE'RE GOING TO MOVE FOR THE ADMISSION OF THE IMMUNOASSAY REPORTS.
MR. LEACH: YES.
JUDGE DAVILA: YES.
MR. WADE: (HANDING.) AND I THINK BY STIPULATION, YOUR HONOR, WITH AGREEMENT FROM THE GOVERNMENT AND FOR THE BENEFIT OF OUR BELOVED COURT REPORTER, WE WILL ENTER THE PARTICULAR EXHIBIT NUMBERS FOR THESE VIA WRITTEN STIPULATION THAT WE'LL SUBMIT TO THE COURT.
MR. LEACH: THAT'S FINE, YOUR HONOR, YES.
JUDGE DAVILA: ALL RIGHT. THANK YOU.
BY MR. WADE:
MR. WADE: AND IF YOU CAN JUST LOOK GENERALLY AT THE FIRST VOLUME OF THE BINDERS, THESE ARE THE TYPES OF REPORTS THAT YOUR TEAM PREPARED FOR EACH AND EVERY ONE OF THE ASSAYS?
SUREKHA GANGAKHEDKAR: YEAH.
SUREKHA GANGAKHEDKAR: IT IS.
MR. WADE: DID YOU FEEL PROUD OF YOUR TEAM AND ALL OF THE WORK THAT IT HAD DONE TO ACCOMPLISH THIS?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: DO YOU RECALL THAT SOMETIMES MANY OF THESE REPORTS ARE LABELLED ASSAY DEVELOPMENT REPORT? DO YOU SEE THAT?
SUREKHA GANGAKHEDKAR: SO I'M MORE ALIGNED WITH CALLING THEM DEVELOPMENT REPORTS.
SUREKHA GANGAKHEDKAR: YES. YES.
MR. WADE: AND IF I WOULD JUST DRAW YOUR ATTENTION TO ONE EXHIBIT 9143, WHICH IS IN EVIDENCE AS PART OF THIS COMPILATION. IT MAY BE IN THE SECOND VOLUME WHICH IS ON THE --
SUREKHA GANGAKHEDKAR: I DO.
SUREKHA GANGAKHEDKAR: THAT WAS BECAUSE THE PROJECT MANAGERS WOULD SEEK THESE, THESE ASSAY DEVELOPMENT REPORTS AND THEN THEY WOULD PROPOSE USING THOSE AS CALLING THEM LIKE VALIDATION REPORTS. AND EACH TIME WE WERE CONSISTENT THAT THESE ARE ASSAY DEVELOPMENT REPORTS.
MR. WADE: OKAY. AND BECAUSE I WANT TO BE CLEAR OF THE DIFFERENCE THAT WE'RE TALKING ABOUT HERE. THESE REPORTS WERE NOT CLIA VALIDATION REPORTS?
SUREKHA GANGAKHEDKAR: CORRECT.
MR. WADE: OKAY. AND I BELIEVE YOU LEFT THE COMPANY BEFORE MANY OF THE CLIA VALIDATION REPORTS WERE FINALIZED, BUT IT IS YOUR UNDERSTANDING THAT THEY WERE WORKING ON CLIA VALIDATION REPORTS IN THE CLIA LAB AS WELL; RIGHT?
MR. WADE: I'M HAPPY TO TELL YOU WE WON'T SPEND ANY MORE TIME GOING THROUGH THE DETAILS OF ALL OF THAT WORK. SO IF YOU WANT TO MOVE THE BINDERS ASIDE, WE CAN DO THAT.
SUREKHA GANGAKHEDKAR: OKAY.
MR. WADE: AND YOU MENTIONED THE PROJECT MANAGERS. THERE WERE TIMES WHERE YOU UNDERSTOOD THAT MS. HOLMES WOULD BE OUT TALKING TO DIFFERENT OUTSIDE AUDIENCES; RIGHT?
MR. WADE: AND AHEAD OF THOSE MEETINGS SOMETIMES MS. HOLMES OR ONE OF THE PROJECT MANAGERS WOULD COME TO YOU TO GET AN UPDATE ON WHAT WAS GOING ON?
SUREKHA GANGAKHEDKAR: YEAH.
SUREKHA GANGAKHEDKAR: I WOULD THINK SO.
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: LET'S LOOK AT 7216. DO YOU SEE THAT THIS IS AN EMAIL CHAIN WHERE MS. HOLMES IS WORKING TO GET AN UPDATE IN ADVANCE OF A MEETING?
MR. WADE: OKAY. I WOULD MOVE THE ADMISSION OF -- AND YOU'RE ON THAT EMAIL, RIGHT, MA'AM? YOU'RE ON THIS EMAIL?
SUREKHA GANGAKHEDKAR: YES, I AM.
MR. LEACH: OBJECTION. FOUNDATION. 802.
JUDGE DAVILA: YOU NEED TO LAY A LITTLE BIT MORE FOUNDATION, MR. WADE, IF YOU WOULD.
MR. WADE: YOU HAD TALKED ABOUT HOW IN ADVANCE OF THESE MEETINGS THE WAY THAT THE COMPANY WOULD GET UPDATED INFORMATION TO PROVIDE TO EXTERNAL AUDIENCES WAS TO COMMUNICATE TO YOU VIA EMAIL AND TO REQUEST UPDATES?
MR. WADE: AND YOU KNEW THAT THEY WERE GOING TO BE TALKING TO PEOPLE OUTSIDE OF THE COMPANY ABOUT THE INFORMATION?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: SO DID YOU ALWAYS WORK TO MAKE SURE THAT YOU WERE PROVIDING ACCURATE UP-TO-DATE INFORMATION?
MR. WADE: AND THAT THIS WOULD GIVE MS. HOLMES THE INFORMATION THAT SHE NEEDED TO GO OUT AND COMMUNICATE TO THOSE EXTERNAL AUDIENCES?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 7216 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: AND HERE THIS IS AN EMAIL BETWEEN YOU AND MS. HOLMES ON NOVEMBER 16TH AND 17TH OF 2011?
MR. WADE: AND SHE ASKED THE ASSAY TEAM LEADS TO IDENTIFY UPDATES FOR AN UPCOMING MEETING WITH REPRESENTATIVES FROM THE DEPARTMENT OF DEFENSE?
SUREKHA GANGAKHEDKAR: I THINK SO.
SUREKHA GANGAKHEDKAR: PSA AND VITAMIN D.
SUREKHA GANGAKHEDKAR: SO I'M RESPONDING HERE SAYING THAT VITAMIN D IS NOT COMPLETE SO THERE IS NO ADDITIONAL DATA. AND FOR PSA I COULD RESEND THE EARLIER DATA.
SUREKHA GANGAKHEDKAR: SO SHE'S ASKING TO SEND THE PSA DATA.
SUREKHA GANGAKHEDKAR: THE VITAMIN D DATA.
SUREKHA GANGAKHEDKAR: CORRECT.
MR. WADE: OKAY. AND YOU TALKED ABOUT THIS HAPPENING GENERALLY, BUT IS THIS THE EXAMPLE OF THE KIND OF REQUEST THAT YOU WOULD RECEIVE IN YOUR POSITION?
MR. WADE: IF WE CAN GO TO THE GOVERNMENT BINDER, EXHIBIT 1109, WHICH IS IN EVIDENCE, AND I'D LIKE YOU TO LOOK AT PAGE 5. I'M SORRY, I KNOW YOU HAVE A LOT OF BINDERS UP THERE. I'LL GIVE YOU A SECOND. SO EXHIBIT 1109?
SUREKHA GANGAKHEDKAR: I DO.
MR. WADE: OKAY. THIS IS A DOCUMENT WHERE YOU SET FORTH SOME OF YOUR ORGANIZATIONAL PRINCIPLES IN CONNECTION WITH HOW YOU TRACKED YOUR PROJECTS?
MR. WADE: AND WE TALKED ABOUT THE ASSAY DEVELOPMENT REPORTS, BUT YOU ALSO MAINTAINED OTHER ADDITIONAL DATA FILES AND THE LIKE?
MR. WADE: WE NOW HAVE IT UP ON THE SCREEN. AND SOME OF THOSE FILES WERE MAINTAINED ON THE J DRIVE UNDER THE EXPERIMENTAL LOG?
MR. WADE: SO BEYOND THOSE REPORTS THAT WE TALKED ABOUT, THERE WERE OFTENTIMES MANY, MANY SPREADSHEETS AND TABLES OF DATA THAT SORT OF FED INTO A SUMMARY -- THE SUMMARY OF THAT REPORT; RIGHT?
SUREKHA GANGAKHEDKAR: RIGHT.
SUREKHA GANGAKHEDKAR: UH-HUH.
SUREKHA GANGAKHEDKAR: RIGHT.
SUREKHA GANGAKHEDKAR: RIGHT.
MR. WADE: NOW, YOU RECALL ON YOUR DIRECT EXAMINATION YOU WERE ASKED SOME QUESTIONS ABOUT EMAILS REGARDING THE R&D PROCESS ON THE 4 SERIES DEVICE? DO YOU RECALL THAT?
SUREKHA GANGAKHEDKAR: SURE.
MR. WADE: AND THE R&D PROCESS IS ACTUALLY DESIGNED TO IDENTIFY PROBLEMS AND POTENTIAL ISSUES AS YOU'RE DEVELOPING PRODUCT; RIGHT?
SUREKHA GANGAKHEDKAR: SO THE R&D PROCESS SPECIFICALLY FOR DEVELOPING ASSAYS WE DID HAVE A PLAN WITH HOW WE WOULD PROCEED WITH DEVELOPING THE ASSAYS.
SUREKHA GANGAKHEDKAR: UH-HUH.
MR. WADE: AND OCCASIONALLY AS YOU'RE WORKING ON THE DEVELOPMENT, THERE WOULD BE A SETBACK WITHIN THE PLAN?
SUREKHA GANGAKHEDKAR: IT IS.
SUREKHA GANGAKHEDKAR: UH-HUH.
SUREKHA GANGAKHEDKAR: RIGHT.
SUREKHA GANGAKHEDKAR: YEAH.
MR. WADE: AND IF THERE WAS A SETBACK OR A MISTAKE, YOU WOULD GO THROUGH THAT SAME PROCESS AGAIN; RIGHT?
SUREKHA GANGAKHEDKAR: IT IS.
MR. WADE: AND IN RESEARCH AND DEVELOPMENT SOMETIMES YOU HAVE TO FAIL BEFORE YOU COULD SUCCEED; RIGHT?
MR. WADE: NOW, WE TALKED ABOUT HOW ALL OF THIS HARD WORK THAT YOU WERE DOING IN RESEARCH AND DEVELOPMENT WAS ULTIMATELY GEARED TOWARDS USE OUT IN THE FIELD IF YOU WILL; RIGHT?
MR. WADE: AND THERE ARE TWO WAYS THAT THERANOS WAS LOOKING AT DEPLOYING THE SMALL SAMPLE ASSAYS; RIGHT?
MR. WADE: AND THE -- ONE WAY WAS TO USE THE ASSAY ON A THERANOS DEVICE THAT WAS DEPLOYED OUT IN THE FIELD; RIGHT?
SUREKHA GANGAKHEDKAR: NOT VERY -- NOT IN TOO MUCH DETAIL.
MR. WADE: NOT SPECIFICALLY, BUT GENERALLY THAT THE GOAL WAS TO DEPLOY THESE AFTER FDA APPROVAL. THAT WAS ONE PATH THAT SOME IN THE COMPANY WERE WORKING ON; RIGHT?
SUREKHA GANGAKHEDKAR: CORRECT.
SUREKHA GANGAKHEDKAR: CORRECT.
MR. WADE: AND THERANOS WAS WORKING ON A PROCESS TO TAKE THE ASSAYS THAT YOUR TEAM HAD DEVELOPED AND USE THEM AS LDT'S WITHIN THE CLIA LAB?
SUREKHA GANGAKHEDKAR: YEAH, I HAVE THAT.
MR. LEACH: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 487 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: AND LET'S LOOK IN THE FIRST EMAIL IN THE CHAIN AT THE BOTTOM, WHICH IS ON PAGE 2. SORRY. DO YOU SEE THAT THERE?
SUREKHA GANGAKHEDKAR: YEAH.
MR. WADE: AND WITHIN THIS EMAIL HE'S OUTLINING A GENERAL APPROACH TO VALIDATING AN ASSAY AS A LABORATORY DEVELOPED TEST UNDER THE CLIA REGULATIONS; RIGHT?
SUREKHA GANGAKHEDKAR: IT LOOKS LIKE AN OVERALL MASTER VALIDATION PLAN FOR ELISA ASSAYS ON THERANOS DEVICES.
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. LEACH: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 9921 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: AND THIS WAS JUST OVER A WEEK AFTER DR. GELB HAD SENT YOU THE BASIC OUTLINE OF THE -- HOW TO VALIDATE AN ASSAY. DO YOU RECALL THAT?
SUREKHA GANGAKHEDKAR: I THINK SO.
SUREKHA GANGAKHEDKAR: RIGHT.
SUREKHA GANGAKHEDKAR: YEAH, I'M THE REVIEWER, YES.
MR. WADE: OKAY. IF WE CAN GO TO THE THIRD PAGE OF THE DOCUMENT AND LOOK AT THE TOP TWO NUMBERS THERE. NOW, THE FIRST -- SECTION 1 SETS FORTH THE SECTION THAT IS CONSISTENT WITH I BELIEVE YOUR PRIOR TESTIMONY WHICH IS TO DEFINE THE MASTER VALIDATION PLAN FOR THE CLIA VALIDATION OF ELISA ASSAYS; RIGHT?
MR. WADE: AND THEN IN THE SCOPE SECTION IT SETS FORTH THE STANDARDS THAT ARE TO BE APPLIED FOR THAT VALIDATION; RIGHT?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: AND IT SETS FORTH THE OPERATIONAL TIMELINE FOR THE VALIDATION OF THE LAB DEVELOPED TESTS?
MR. WADE: AND JUST SO WE'RE CLEAR ON TERMINOLOGY, THE COMPANY'S GOAL AT THIS TIME WAS FOR ALL OF THE ASSAYS THAT YOU WERE DEVELOPING IN R&D TO BECOME LAB DEVELOPED TESTS WITHIN THE CLIA LAB?
MR. WADE: IF I CAN DIRECT YOU TO PAGE 6. DO YOU SEE WHERE IT SAYS TESTING SYSTEMS UP AT THE TOP THERE?
SUREKHA GANGAKHEDKAR: I THINK THEY HAD STARTED SOME DEVELOPMENT ON THE 4.0'S.
MR. WADE: OKAY. DO YOU THINK THAT MAYBE THE DEVELOPMENT HAD STARTED BUT THE ONLY SYSTEM THAT HAD ACTUALLY PERFORMED ASSAYS EXTERNALLY WAS THE 3.0; IS THAT RIGHT?
SUREKHA GANGAKHEDKAR: YES. YES.
MR. WADE: IF I CAN DRAW YOUR ATTENTION TO EXHIBIT 5388, WHICH IS IN THE GOVERNMENT'S BINDER, I BELIEVE, AND IN EVIDENCE. IF WE CAN PULL THAT UP. AND IF WE JUST BLOW UP THE TOP THIRD OF THE DOCUMENT. THIS IS A DOCUMENT I THINK YOU HAVE BEEN ASKED SOME QUESTIONS ABOUT LAST WEEK. DO YOU RECALL?
MR. WADE: AND THIS IS AN EMAIL FROM DR. SIVARAMAN TO YOU AND DR. YOUNG AT THE END OF JULY OF 2013?
MR. WADE: AND ONE OF THEM IS A WORD DOCUMENT OF THAT 2011 VALIDATION PLAN THAT WE HAD JUST GONE THROUGH; IS THAT RIGHT?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: OKAY. AND IF YOU LOOK AT THE TOP EMAIL, DR. SIVARAMAN NOTES THAT SHE'S ATTACHING A VALIDATION PLAN FOR THE SIX ASSAYS IN A CARTRIDGE SUMMARY FORMAT. DO YOU SEE THAT?
MR. WADE: AND SHE SAYS AND ALSO ATTACHED IS THE LDT VALIDATION PLAN WORD DOCUMENT THAT ARNE HELPED DEVELOP IN 2011. DO YOU SEE THAT?
MR. WADE: AND THAT IT NOTES THAT THAT PLAN WAS BEING USED AS THE TEMPLATE FOR THE CLIA VALIDATION WORK THAT THE COMPANY WAS DOING IN 2013?
SUREKHA GANGAKHEDKAR: WHAT WAS THE NUMBER AGAIN?
MR. WADE: 1031. IT SHOULD BE IN THE BLACK BINDER I THINK. I CAN HAND YOU A COPY IF THAT'S EASIER. MAY I APPROACH, YOUR HONOR?
SUREKHA GANGAKHEDKAR: YEAH, I DON'T FIND IT HERE.
JUDGE DAVILA: GO RIGHT AHEAD. PLEASE.
SUREKHA GANGAKHEDKAR: I HAVE IT.
MR. WADE: AND THIS IS AN EMAIL FROM YOU TO DR. YOUNG, DR. ROSENDORFF, MS. HOLMES IN AUGUST OF 2013?
MR. WADE: AND YOU WERE WORKING WITH DR. YOUNG AND DR. ROSENDORFF ON THE CLIA VALIDATION PLAN AT THIS TIME?
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1031 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: AND WE TALKED ABOUT THIS PERIOD IN AUGUST. THIS WAS A SHORT TIME AFTER YOU RETURNED FROM INDIA. DO YOU RECALL THAT?
MR. WADE: AND THIS IS WORKING TO GET EVERYONE ON THE SAME PAGE WITH RESPECT TO THE VALIDATION EFFORTS?
MR. WADE: AND THIS IS AN UPDATED DOCUMENT THAT CONTINUED TO SERVE AS A TEAM'S GUIDE FOR THE ASSAY DEVELOPMENT WORK?
SUREKHA GANGAKHEDKAR: I THINK SO.
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: AND THE EFFECTIVE DATE OF THIS WAS 8/23/13. WAS THE IDEA THAT YOU WERE GOING TO UPDATE THIS?
MR. WADE: LET'S TAKE A LOOK AT PAGE 227 AT THE BOTTOM. THIS, AGAIN, DISCUSSES THE PURPOSE OF THE DOCUMENT IS TO SET FORTH THE PLAN FOR THE VALIDATION OF THE IMMUNOASSAYS?
MR. WADE: AND THIS WAS TO BE APPLIED TO ALL OF THE ELISA ASSAYS THAT WERE GOING TO BE PUT UNDER THE THERANOS DEVICES?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: AND IT DEFINED THE PERFORMANCE SPECIFICATIONS THAT WOULD BE NEEDED IN ORDER TO VALIDATE THE ASSAYS?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: AND DO YOU RECALL THE CLIA REGULATIONS WERE A VERY LENGTHY THICK SET OF MATERIALS THAT SET FORTH ALL SORTS OF DIFFERENT REQUIREMENTS?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: BUT THE MASTER VALIDATION PLAN HERE SETS FORTH ONE SPECIFIC SECTION WITH RESPECT TO THE PERFORMANCE CRITERIA; CORRECT?
MR. WADE: YOUR HONOR, I WOULD MOVE THE ADMISSION OF 7603A, WHICH IS JUST THAT ONE PROVISION OF THE CFR THAT IS INCORPORATED INTO THE COMPANY DOCUMENT.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S RECEIVED, ADMITTED, AND IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 7603A WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: AND IT SPECIFICALLY SETS FORTH THE SPECIFICATIONS THAT ARE REQUIRED UNDER THE FEDERAL CLIA REGULATIONS?
MR. WADE: AND THOSE SPECIFIC PROVISIONS WERE INCORPORATED INTO THE MASTER VALIDATION PLAN TO BE APPLIED TO EACH ELISA ASSAY; CORRECT?
MR. WADE: I CAN TAKE DOWN THAT REGULATION. I'D LIKE TO MOVE BACK TO THE MASTER VALIDATION PLAN AND LOOK AT 3.1. DO YOU SEE THAT?
SUREKHA GANGAKHEDKAR: SO HOW CLOSE THE TEST RESULT IS TO AN ACCEPTED REFERENCE VALUE.
MR. WADE: AND THERE ARE A LOT OF MATERIALS THAT HELP DEFINE WHAT "ACCURATE" MEANS WITHIN LABORATORIES; RIGHT?
SUREKHA GANGAKHEDKAR: I THINK IT'S CLINICAL LAB STANDARDS INSTITUTE.
MR. WADE: AND AGAIN, THEY'RE VERY DENSE MATERIALS THAT SET FORTH A LOT OF SPECIFICITY TO THE PERFORMANCE CHARACTERISTICS THAT A LAB IS SUPPOSED TO MEET; RIGHT?
MR. WADE: AND THOSE, THOSE STANDARDS ARE BEING INCORPORATED INTO THIS POLICY WITHIN THE CLIA LAB AT THERANOS?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: AND WE WON'T PUT IT UP, BUT IF YOU WOULD JUST LOOK QUICKLY AT THE BOTTOM OF 23 -- WELL, WHY DON'T WE PUT IT UP. WHY DON'T YOU PUT UP 239 AT THE BOTTOM. NO, I'M SORRY. NOT -- PAGE 239. DO YOU SEE THERE IT STARTS ON PAGE 239 BUT CONTINUES ON THE SECOND HALF OF 240, AND THERE ARE A NUMBER OF REFERENCES AND STANDARDS THAT ARE INCORPORATED WITHIN TO THIS PLAN; RIGHT?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: IF WE CAN GO BRIEFLY TO PAGE ENDING IN 228, SECTION 3.5. THIS DEFINES CALIBRATION. AND WHAT IS CALIBRATION?
SUREKHA GANGAKHEDKAR: SO THEY ALREADY HAVE DEFINED CALIBRATION HERE. ESSENTIALLY ESTABLISHING THE RELATIONSHIP BETWEEN THE VALUES OF QUANTITIES INDICATED BY THE MEASURING INSTRUMENT OR VALUES THAT ARE PRESENTED BY A REFERENCE MATERIAL OR STANDARDS.
MR. WADE: AND THIS SETS FORTH THE STANDARD THAT THERANOS USED FOR CALIBRATION, WHICH -- DO YOU SEE THAT?
SUREKHA GANGAKHEDKAR: SO THIS IS THE DEFINITION SECTION ON WHAT CALIBRATION MEANS.
MR. WADE: AND YOU MAY HAVE NO REASON TO KNOW, BUT DO YOU KNOW THAT SECTION 1255 INCORPORATES A WHOLE ANOTHER SET OF STANDARDS?
MR. WADE: LET'S GO BACK TO PAGE -- SECTION 4 WHICH IS ON PAGE 229. AND DO YOU SEE THE RESPONSIBILITY SECTION THERE?
MR. WADE: AND IT SAYS THAT UNDER THIS POLICY WHO IS RESPONSIBLE FOR DIFFERENT FUNCTIONS. DO YOU SEE THAT?
MR. WADE: AND UNDER THE POLICY, WHO IS RESPONSIBLE FOR ENSURING THAT THE IMMUNOASSAYS ARE QUALIFIED AND VALIDATED BEFORE THEY'RE USED WITH PATIENTS?
SUREKHA GANGAKHEDKAR: SO 4.1 SAYS THAT IT'S THE RESPONSIBILITY OF THE LABORATORY DIRECTOR.
MR. WADE: AND, IN FACT, THE CLIA REGULATION SPECIFICALLY PUT THAT RESPONSIBILITY ON THE LAB DIRECTOR, DID THEY NOT?
MR. WADE: AND IT ALSO SERVES TO MAKE MS. HOLMES AWARE OF ALL OF THESE IMPORTANT STANDARDS WITHIN THE LAB, DOES IT NOT?
SUREKHA GANGAKHEDKAR: IT DOES.
MR. WADE: DO YOU RECALL LAST WEEK YOU WERE ASKED SOME QUESTIONS BY THE GOVERNMENT ABOUT THE SHARING OF INFORMATION WITHIN THE COMPANY?
SUREKHA GANGAKHEDKAR: I'M SORRY, COULD YOU REPEAT.
MR. WADE: IN THE COURSE OF THESE EVENTS YOU'VE MET WITH THE GOVERNMENT A COUPLE OF TIMES; RIGHT?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: AND DO YOU RECALL THAT IN THAT MEETING YOU TOLD THE GOVERNMENT THAT RESTRICTIONS ON SHARING INFORMATION DID NOT HAVE MUCH IMPACT ON YOUR WORK? DO YOU RECALL THAT?
SUREKHA GANGAKHEDKAR: BECAUSE I WAS FOCUSSING ON THE ELISA WORK, THE INFORMATION RELATED TO THE OTHER GROUPS I WAS NOT AWARE OF.
MR. WADE: OKAY. BUT THE GOVERNMENT -- DO YOU RECALL THAT THE GOVERNMENT ASKED YOU IF THE RESTRICTIONS ON SHARING INFORMATION WITH OTHER GROUPS MADE YOUR WORK HARDER AND YOU SAID IT DID NOT HAVE MUCH IMPACT ON YOUR WORK?
SUREKHA GANGAKHEDKAR: BECAUSE WE WERE FOCUSSED ON CONTINUING TO DEVELOP THE ELISA ASSAYS, AND AS PART OF -- I THINK MANY TIMES WE WERE PART OF THIS OMNIPLEX PROTOCOL, AND SO WE TRIED TO FOCUS ON WHAT WE HAD TO DO FOR OUR OWN TECHNOLOGY.
MR. WADE: OKAY. DO YOU RECALL THAT YOU TOLD THE GOVERNMENT THAT THERE WERE A FEW ENGINEERS THAT WERE ASSIGNED TO WORK WITH YOUR GROUP THAT AIDED INTER-GROUP COORDINATION?
MR. WADE: AND WE SAW THAT MEETING INVITE FOR YOUR ELISA TEAM MEETING WHERE YOU INVITED PEOPLE FROM OTHER GROUPS IN TO OBSERVE THE PROGRESS THAT YOUR WORK HAD MADE; RIGHT?
MR. WADE: AND, IN FACT, MANY OF THE DOCUMENTS THAT YOU'VE BEEN ASKED ABOUT HAVE INCLUDED DR. PANGARKAR; RIGHT?
MR. WADE: AND MANY OF THE DOCUMENTS THAT YOU'VE BEEN SHOWN WERE -- SHOWED THE INVOLVEMENT OF DR. ANEKAL. DO YOU RECALL THAT?
SUREKHA GANGAKHEDKAR: YES. SO THE EMAILS, WE WOULD SHARE THE UPDATE WITH THE KEY LEADS OF WHO WERE INVOLVED FOR A COMBINED CARTRIDGE. BUT THE GENERAL GUIDANCE IN THE ORGANIZATION WAS ALWAYS NOT TO SHARE INFORMATION WITH OTHER GROUPS.
SUREKHA GANGAKHEDKAR: AND VICE VERSA.
MR. WADE: OKAY. I'M SORRY TO INTERRUPT YOU. OR MAYBE TO SHARE -- TO BE CAREFUL ABOUT HOW IT WAS SHARED WITH THE GROUP LEAD IF IT WAS TO BE SHARED?
SUREKHA GANGAKHEDKAR: SO IF YOU SEE THE EMAILS ONLY HAVE HIGH LEVEL INFORMATION. IT DIDN'T GO INTO ALL THE DETAILS OF EACH OTHER LIKE CHEMISTRY FUNCTIONS. SO TYPICALLY IT WAS MENTIONED SEVERAL TIMES IN MEETINGS NOT TO TALK ABOUT YOUR DETAILS OF YOUR ASSAYS OR YOUR PROJECTS OR ISSUES.
MR. WADE: WELL, LET'S LOOK AT 853, WHICH IS IN EVIDENCE. IF WE CAN PUT THAT UP. THIS IS ONE OF THE EMAILS THAT THE GOVERNMENT ASKED YOU ABOUT YESTERDAY --
SUREKHA GANGAKHEDKAR: UH-HUH.
MR. WADE: AND THIS PARTICULAR EMAIL WAS SHARED WITH SEVERAL PEOPLE OUTSIDE OF YOUR GROUP; RIGHT?
MR. WADE: AND THIS INCLUDES SOME PRETTY DETAILED INFORMATION ABOUT SOME OF THE WORK THAT HAD BEEN DONE?
SUREKHA GANGAKHEDKAR: IT DOES.
MR. WADE: AND IF WE CAN JUST LOOK AT 3968. THIS IS A DOCUMENT THAT ACTUALLY SETS FORTH SOME SETBACKS THE COMPANY HAD WITH RESPECT TO CERTAIN DEVICES SO IT COULD BE UPGRADED; RIGHT?
SUREKHA GANGAKHEDKAR: THIS IS SPECIFICALLY WHERE THE INDIVIDUALS IN THE TEAM THAT IS UPGRADING THE 3.0'S TO 3.5'S IS ASKING SPECIFICALLY. SO THE ELISA TEAM WAS USING THESE DEVICES SO THE INDIVIDUALS WHO ARE RESPONSIBLE FOR UPGRADING THE DEVICES WERE SEEKING THE INFORMATION. BUT IF YOU SEE SOME OF THE OTHER EMAILS, I THINK IT'S STILL A HIGH LEVEL. I WOULDN'T KNOW HOW EXACTLY THEY ARE DEVELOPING THE GENERAL CHEMISTRY ASSAYS, WHAT PROGRESS THEY ARE MAKING, WHAT KIND OF CHALLENGES THEY ARE FACING EVEN THOUGH I THINK AT SOME POINT THEY WERE USING THE EDISON, MODIFIED VERSION OF THE ELISA EDISONS FOR THEIR WORK AS WELL.
MR. WADE: SO SOMETIMES ON A NEED-TO-KNOW BASIS INFORMATION WAS SHARED AND YOU'RE SUGGESTING OTHER TIMES IT WAS NOT; IS THAT FAIR?
MR. WADE: AND I JUST HAVE TWO MORE QUESTIONS ON THIS DOCUMENT TO ASK YOU ABOUT. MAY I APPROACH, YOUR HONOR?
JUDGE DAVILA: YES.
MR. WADE: I'M PUTTING IN FRONT OF YOU WHAT HAS BEEN MARKED AS EXHIBIT 10521 AND 10522. DO YOU SEE THOSE?
MR. LEACH: NO OBJECTION.
JUDGE DAVILA: THEY'RE ADMITTED. THEY MAY BE PUBLISHED.
(DEFENDANT'S EXHIBITS 10521 AND 10522 WERE ADMITTED.)
BY MR. WADE:
MR. WADE: LET'S START WITH 10521. THIS IS A MEETING AND THE SUBJECT IS THE ELISA VALIDATION PLANS ON THE ADVIA. DO YOU SEE THAT?
MR. WADE: AND HE INVITED YOURSELF AND DR. ROSENDORFF. DR. ROSENDORFF IS IN A DIFFERENT GROUP; RIGHT? HE WAS THE CLIA LAB DIRECTOR?
SUREKHA GANGAKHEDKAR: I DON'T RECOLLECT EXACTLY WHICH DEPARTMENT HE WAS IN.
SUREKHA GANGAKHEDKAR: I BELIEVE HE WAS -- I DON'T RECOLLECT WHICH DEPARTMENT HE WAS IN. I DON'T RECOLLECT.
SUREKHA GANGAKHEDKAR: I BELIEVE IT WAS EREZ GALIL.
MR. WADE: AND WITH THESE PEOPLE FROM DIFFERENT GROUPS WHO WERE WORKING ON THIS SAME PROJECT; RIGHT?
SUREKHA GANGAKHEDKAR: SO ESSENTIALLY IT IS MEMBERS OF THE ELISA TEAM AND CLIA LAB DIRECTOR, ADAM.
SUREKHA GANGAKHEDKAR: NO, I DON'T RECOLLECT WHICH DEPARTMENT HE WAS REPRESENTING.
JUDGE DAVILA: ALL RIGHT. LET'S TAKE OUR BREAK NOW, LADIES AND GENTLEMEN. LET'S TAKE 45 MINUTES, PLEASE. SO WE'LL HOPEFULLY BE BACK IN SESSION JUST BEFORE NOON. SO PLEASE REMEMBER THE ADMONITION THAT IS IN PLACE. WE ARE GOING TO END TODAY AT 2:00 O'CLOCK, LADIES AND GENTLEMEN. I'M GOING TO ASK YOU, HOPEFULLY TOMORROW WE CAN END AT 3:00? AND PERHAPS FRIDAY IF YOU CAN CHECK WITH YOUR SCHEDULES AND SEE IF THAT COMPORTS. AT SOME POINT, FAIR WARNING, I'M GOING TO ASK IF WE CAN GO TO 4:00 ONE DAY, TOO, JUST TO CATCH UP. AND YOU CAN BE THINKING ABOUT THAT AND LET ME KNOW IF THAT PRESENTS AN ISSUE. ALL RIGHT. WE'LL BE IN RECESS. THANK YOU.
(LUNCH RECESS TAKEN AT 11:04 A.M.) AFTERNOON SESSION
(COURT CONVENED AT 11:57 A.M.)
(JURY IN AT 11:57 A.M.)
JUDGE DAVILA: ALL RIGHT. WE'RE BACK ON THE RECORD. ALL PARTIES PREVIOUSLY PRESENT ARE PRESENT AGAIN, ALL COUNSEL AND MS. HOLMES, AND OUR JURY AND ALTERNATES. AND THE WITNESS IS ON THE STAND. WOULD YOU LIKE TO CONTINUE, MR. WADE?
MR. WADE: GOOD AFTERNOON. BEFORE THE BREAK WE WERE TALKING A LITTLE BIT ABOUT INTERACTIONS WITH DR. ROSENDORFF. DO YOU RECALL THAT?
MR. WADE: AND I'D LIKE TO ASK YOU A COUPLE MORE QUESTIONS ABOUT YOUR INVOLVEMENT WITH HIM IN THE PERIOD LEADING UP TO THE CLIA VALIDATION PROCESS?
MR. WADE: AND IT'S A CHAIN THAT INVOLVES YOU, DR. SIVARAMAN, DR. YOUNG, AND MS. HOLMES. DO YOU SEE THAT?
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 3966 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: IF I CAN DRAW YOUR ATTENTION TO THE BOTTOM EMAIL BEFORE DR. YOUNG. IF WE CAN BLOW THAT UP. DO YOU SEE THIS IS PART OF THE EFFORT TO WORK TOWARDS A VALIDATION OF IMMUNOASSAYS ON THE ADVIA MACHINE?
MR. WADE: AND THERE WAS A QUESTION THAT WAS RAISED AS PART OF THAT PROCESS ABOUT THE PROTOCOL THAT WAS TO BE USED. DO YOU SEE THAT?
SUREKHA GANGAKHEDKAR: PERHAPS. I DON'T RECOLLECT AT THIS POINT.
SUREKHA GANGAKHEDKAR: CORRECT.
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: LET'S JUST LOOK AT THAT QUICKLY, THE EMAIL ABOVE. THIS IS YOUR ACKNOWLEDGEMENT AND RECEIPT OF THE GUIDANCE THAT HAD BEEN CONVEYED FROM DR. ROSENDORFF THROUGH DR. YOUNG; CORRECT?
SUREKHA GANGAKHEDKAR: YES. YES.
MR. WADE: AND DO YOU SEE THAT THAT IS A -- THE BOTTOM EMAIL IS AN EMAIL FROM DR. ROSENDORFF TO YOU AND OTHERS?
MR. WADE: THAT'S A MASTER VERIFICATION PLAN FOR THE THERANOS MODIFIED IMMUNOASSAYS ON THE ADVIA 1800?
MR. WADE: AND DR. ROSENDORFF WAS COMMUNICATING THIS DOCUMENT IN ORDER TO GET COMMENTS AND REVIEW?
MR. LEACH: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 10503 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: AND HERE DR. ROSENDORFF IS NOT ONLY COMMUNICATING TO YOU, BUT HE'S COMMUNICATING TO DR. YOUNG AND COPYING MR. BALWANI. DO YOU SEE THAT?
SUREKHA GANGAKHEDKAR: MS. GHARAATI.
SUREKHA GANGAKHEDKAR: SO SHE WAS ACTUALLY A MEMBER OF THE ELISA ASSAY DEVELOPMENT TEAM, BUT I THINK SHE WAS WORKING WITH THE CLIA LAB DIRECTOR.
MR. WADE: OKAY. AND THIS IMMUNOASSAY VERIFICATION PLAN IS BEING CIRCULATED FOR COMMENTS FROM EVERYONE?
SUREKHA GANGAKHEDKAR: I BELIEVE SO.
MR. WADE: AND LET'S GO BRIEFLY TO THAT ATTACHMENT. THIS IS THE MASTER VERIFICATION PLAN FOR THE THERANOS'S-MODIFIED IMMUNOASSAYS ON THE ADVIA 1800. DO YOU SEE THAT?
MR. WADE: AND THAT IS THE -- THESE ARE THE FINGERSTICK ASSAYS THAT WERE GOING TO BE RUN ON THE ADVIA 1800?
SUREKHA GANGAKHEDKAR: I DON'T REMEMBER EXACTLY. IF IT SAYS FINGERSTICK, YES.
MR. WADE: AND THIS WAS THE VERIFICATION FOR THE SMALL SAMPLES OF IMMUNOASSAYS TO BE RUN ON THE ADVIA 1800?
MR. WADE: AND DO YOU RECALL WHETHER YOU PROVIDED ANY COMMENTS TO DR. ROSENDORFF ON THIS DOCUMENT?
SUREKHA GANGAKHEDKAR: I DON'T REMEMBER IF I RESPONDED TO THIS OR NOT.
MR. WADE: OKAY. YOU DID HAVE SOME COMMUNICATIONS WITH DR. ROSENDORFF ABOUT THE COMPANY'S APPROACH ON USING THE 3.0 AND 3.5 DEVICES IN THE ADVIA 1800; CORRECT?
SUREKHA GANGAKHEDKAR: I MET WITH HIM, YES.
MR. WADE: YEAH. AND YOU CONVEYED SOME OF THE CONCERNS THAT YOU TALKED ABOUT LAST WEEK TO DR. ROSENDORFF?
SUREKHA GANGAKHEDKAR: YES. I HAD QUESTIONS ON THE LAUNCH AND THE DETAILS OF HOW IT'S GOING TO GO.
MR. WADE: AND ULTIMATELY YOU REMEMBER HIM NOT BEING CONCERNED ABOUT SOME OF THE CHANGES THAT THE COMPANY HAD MADE IN THIS REGARD; RIGHT?
MR. LEACH: OBJECTION. FOUNDATION. HEARSAY.
JUDGE DAVILA: DO YOU WANT TO LAY A FOUNDATION, COUNSEL.
BY MR. WADE:
MR. WADE: WELL, WE JUST TALKED ABOUT A CONVERSATION THAT YOU HAD ABOUT SOME OF THE CHANGES THAT THE COMPANY WAS IMPLEMENTING; RIGHT?
SUREKHA GANGAKHEDKAR: WELL, MY CONVERSATION WAS BASED UPON THE DETAILS OF THE LAUNCH, HOW IT WAS GOING TO GO AHEAD, WHAT WAS SOME OF THE PROCESS WORKFLOW. SO IN MY CONVERSATIONS WITH HIM I TRIED TO GET SOME ADDITIONAL DETAILS ABOUT THE LAUNCH PLANS.
MR. WADE: OKAY. AND DO YOU RECALL AS A RESULT OF YOUR INTERACTIONS WITH DR. ROSENDORFF COMING TO THE VIEW THAT HE WASN'T CONCERNED ABOUT THE APPROACH THAT THE COMPANY WAS TAKING?
SUREKHA GANGAKHEDKAR: WHAT I DID FIND WAS HE WAS -- HE DIDN'T SHARE MUCH DETAILS WITH ME. HE DIDN'T GO INTO ALL OF THE DETAILS OF HOW THE LAUNCH WOULD GO THROUGH, LIKE WHAT WAS THE PLAN, WHAT WAS THE WORKFLOW. SO HE DIDN'T SHARE DETAILS WITH ME. SO BASICALLY GOING INTO THAT MEETING I DIDN'T COME OUT WITH MORE INFORMATION THAN THAT WAS PREVIOUSLY ALREADY OUT THERE.
MR. WADE: I UNDERSTAND THAT, MA'AM. THANK YOU. I'M ASKING A VERY SPECIFIC QUESTION, WHICH IS DO YOU RECALL COMING TO THE VIEW THAT HE WAS NOT CONCERNED ABOUT THE APPROACH?
SUREKHA GANGAKHEDKAR: THAT WAS MY UNDERSTANDING.
MR. WADE: YOU TESTIFIED A LITTLE BIT LAST WEEK ABOUT HOW YOU TOOK SOME TIME OFF IN JULY AND AUGUST FOR WHAT WAS REFERRED TO AS A VACATION BY THE GOVERNMENT. DO YOU RECALL THAT?
MR. WADE: AND THIS WAS NOT JUST A TYPICAL VACATION; RIGHT? THIS WAS A LONG PLANNED FAMILY TRIP; RIGHT?
MR. WADE: AND PEOPLE WERE RESPECTFUL OF THAT TRIP AND YOUR NEED TO -- AND YOUR DESIRE TO TAKE THAT TRIP; RIGHT?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: YEAH. AND THERE WERE SOME ARRANGEMENTS THAT YOU HAD MADE SO THAT DR. SIVARAMAN COULD TEND TO SOME OF YOUR RESPONSIBILITIES WHILE YOU WERE GONE?
SUREKHA GANGAKHEDKAR: I DON'T RECOLLECT AT THIS TIME.
MR. WADE: AND WE SAW IN ONE OF THE PRIOR EMAILS THAT YOU WERE DOING SOME EMAIL AND VPN WORK REMOTELY. DO YOU REMEMBER WHETHER YOU HAD A CHANCE TO CHECK IN OR CATCH UP AT ALL ON THOSE ISSUES WHILE YOU WERE THERE?
SUREKHA GANGAKHEDKAR: I DON'T RECOLLECT.
MR. WADE: OKAY. WE HAVE ALSO TALKED ABOUT THE WORK THAT HAD BEEN ONGOING FOR A NUMBER OF YEARS WORKING TO BRING SOME OF YOUR R&D WORK TOWARD THE CLIA LAB. DO YOU RECALL THAT?
MR. WADE: AND IN THE PERIOD BEFORE YOU LEFT FOR INDIA, THERE WAS SOME WORK THAT HAD STARTED TOWARDS LDT VALIDATION ON THE 3.0 AND 3.5 DEVICES. DO YOU RECALL THAT?
SUREKHA GANGAKHEDKAR: NOT EXACTLY.
JUDGE DAVILA: YES. IS THIS TO REFRESH THE WITNESS'S RECOLLECTION?
JUDGE DAVILA: MR. LEACH, DO YOU HAVE THIS?
JUDGE DAVILA: OKAY.
BY MR. WADE:
MR. WADE: AGAIN, THE WORK ON THE LDT PROCESS HAD BEEN SOMETHING THAT HAD BEEN IN PLACE FOR A NUMBER OF YEARS; RIGHT?
MR. WADE: AND THERE WERE DIFFERENT THINGS THAT WERE BEING DISCUSSED AS PART OF THAT. I THINK YOU TESTIFIED DIFFERENT DEVICES AND THE LIKE. DO YOU RECALL THAT?
MR. WADE: AND THIS IS AN EMAIL FROM JULY OF 2013 BETWEEN YOU AND MS. HOLMES WITH RESPECT TO DOING SOME WORK ON THE 3.0'S IN ANTICIPATION OF THE LDT VALIDATION; RIGHT?
SUREKHA GANGAKHEDKAR: YES, THAT'S WHAT THIS EMAIL SAYS.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 13767 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: THIS IS AN EMAIL SENT ON JULY 13TH OF 2013. DO YOU SEE THERE'S A QUESTION POSED BY MS. HOLMES ABOUT THE RESULTS OF THE TESTING THAT WAS PERFORMED ON THE ELISA'S, ON THE 3.0'S, IN ANTICIPATION OF THE LDT VALIDATION? DO YOU SEE THAT?
SUREKHA GANGAKHEDKAR: I DON'T RECALL AT THIS POINT.
MR. WADE: OKAY. AND DO YOU SEE THERE'S A REFERENCE IN THE NEXT PARAGRAPH THAT CYTOMETRY AND GENERAL CHEMISTRY LDT VALIDATION WAS GOING TO BEGIN ON MONDAY AS WELL?
SUREKHA GANGAKHEDKAR: I DON'T RECALL AT THIS POINT.
MR. WADE: OKAY. DO YOU RECALL IN THE SAME GENERAL TIME PERIOD THERE WAS SOME WORK DONE ON THE MALE HEALTH CARTRIDGE AND WORKING TO GET THAT VALIDATED?
SUREKHA GANGAKHEDKAR: SO WE DID HAVE A MALE HEALTH CARTRIDGE, YES.
JUDGE DAVILA: YES.
MR. WADE: I'M SHOWING YOU WHAT HAS BEEN MARKED AS EXHIBIT 13768. AND DO YOU RECOGNIZE THIS IS AN EMAIL ABOUT WORK -- VALIDATION WORK BEING DONE ON THE MALE HEALTH CARTRIDGE?
SUREKHA GANGAKHEDKAR: I THINK THIS IS A DEMO FOR THE DATA FOR THE MALE HEALTH CARTRIDGE FOR A GROUP OF MULTIPLEX ASSAYS.
MR. LEACH: NO OBJECTION.
JUDGE DAVILA: AND IT'S ADMITTED AND MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 13768 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: AND LET'S LOOK AT THE TOP EMAIL. I THINK THIS IS YOUR RESPONSE TO MS. HOLMES. AND THIS DISCUSSES SOME WORK THAT WAS BEING DONE IN CONNECTION WITH THIS CARTRIDGE ON THE 3.0 AND THE 3.5 READERS. DO YOU SEE THAT?
SUREKHA GANGAKHEDKAR: I'M NOT SURE IF THIS IS THE VALIDATION OR IF THIS WAS FOR A DEMO CARTRIDGE.
MR. WADE: WELL, LET'S BRING THAT PRIOR EMAIL UP ONE MORE TIME, THE INITIAL EMAIL. YOU WERE RESPONDING TO AN EMAIL WHERE SHE WAS ASKING YOU QUESTIONS ABOUT TESTING THAT WAS DONE IN CONNECTION WITH LDT VALIDATION; RIGHT?
SUREKHA GANGAKHEDKAR: YEAH, SHE IS ASKING THAT QUESTION.
SUREKHA GANGAKHEDKAR: SO I'M RESPONDING TO THE DATA FOR THE MALE -- YES, THE ONE THAT IS DONE FOR THIS PARTICULAR CARTRIDGE.
SUREKHA GANGAKHEDKAR: I DON'T EXACTLY REMEMBER TODAY --
SUREKHA GANGAKHEDKAR: -- WHAT THIS WORK WAS FOR.
MR. WADE: OKAY. DO YOU RECALL THAT IN THIS JULY TIME PERIOD, THERE WAS ALSO SOME WORK THAT WAS BEING DONE TO ASSESS WHETHER SOME OF THOSE R&D ASSAYS THAT YOU HAD DEVELOPED COULD BE RUN ON OPEN PLATFORMS THAT WERE COMMERCIALLY AVAILABLE?
SUREKHA GANGAKHEDKAR: I DON'T RECOLLECT. CAN YOU SHARE THE DETAILS.
JUDGE DAVILA: YES.
JUDGE DAVILA: IS THIS TO REFRESH THE RECOLLECTION?
JUDGE DAVILA: SURE.
BY MR. WADE:
MR. WADE: THIS IS AN EMAIL DATED JULY 8TH, 2013, FROM YOU TO YOUR TEAM TALKING ABOUT SOME ASSAY DEVELOPMENT WORK; IS THAT RIGHT?
MR. WADE: AND THIS WAS A MEANS OF COMMUNICATING THE ASSIGNMENTS OUT SO THE WORK OF THE COMPANY COULD BE CARRIED OUT SWIFTLY AND EFFICIENTLY?
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 13770 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: SO AGAIN, IN THIS EMAIL IT TALKS ABOUT "WE ARE GOING AHEAD WITH THE CLIA/LDT VALIDATION OF THE FOLLOWING ASSAYS ON THE 384 PLATES." DO YOU SEE THAT?
MR. WADE: AND YOU CONVEYED TO YOUR TEAM THAT YOU WERE GOING TO GO FORWARD WITH THE VALIDATION OF THESE ASSAYS AND YOU GAVE ASSIGNMENTS TO TRY AND -- TO ASSIGN THESE TASKS TO MEMBERS OF YOUR TEAM; RIGHT?
MR. WADE: AND THE EXPECTATION WAS THAT THEY WOULD CARRY OUT THIS WORK AND REPORT BACK TO YOU; RIGHT?
MR. WADE: AND NOW ULTIMATELY THE 384 PLATES WERE NOT USED AS A COMMERCIALLY AVAILABLE PLATFORM; RIGHT?
SUREKHA GANGAKHEDKAR: I THINK SO.
SUREKHA GANGAKHEDKAR: I BELIEVE THE PLAN LATER CHANGED TO USE THE EDISON 3.0'S AND 3.5'S.
MR. WADE: YOU MENTIONED THE 3.0 DEVICES. DO YOU RECALL WORK BEING DONE ON THE MALE HEALTH CARTRIDGE WITH RESPECT TO THOSE DEVICES IN THIS GENERAL TIME PERIOD?
JUDGE DAVILA: YES.
MR. WADE: AND I'M SHOWING YOU WHAT HAS BEEN MARKED AS 13769. THIS IS AN EMAIL BETWEEN YOU AND DR. YOUNG DATED JULY 17TH, 2013; IS THAT RIGHT?
MR. WADE: AND IT RELATES TO WORK THAT WAS DONE IN CONNECTION WITH THAT MALE HEALTH CARTRIDGE; CORRECT?
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 13769 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: AND IF WE LOOK AT THE BOTTOM EMAIL FIRST. THIS TALKS ABOUT SOME OF THE WORK THAT WAS BEING DONE TO UPDATE THE ELECTRONICS AND PROTOCOLS ON THE EDISON 3.0?
MR. WADE: AND HE ASKED YOU TO RECOMMEND AN ASSAY TO USE TO IMPLEMENT THAT WORK ON THE 3.0 DEVICES; RIGHT?
MR. WADE: AND I BELIEVE YOU JUST TESTIFIED A MINUTE AGO THAT THERE WAS A SHIFT TO DO WORK ON THE 3.0 AND THE 3.5 DEVICES; RIGHT?
MR. WADE: AND YOU RESPOND TO DR. YOUNG WITH A PLAN -- YOU SET FORTH HOW THE PLAN IS TO TEST THE MALE HEALTH CARTRIDGE ON BOTH SYSTEMS; RIGHT?
MR. WADE: AND THAT WAS BECAUSE IT ACTUALLY HAD FIVE OF THOSE SIX ASSAYS THAT WE HAD IDENTIFIED JUST A MINUTE AGO; RIGHT?
MR. WADE: NOW, DO YOU RECALL LAST FRIDAY I ASKED YOU SOME QUESTIONS ABOUT HOW THE FOCUS OF THE WORK IN AUGUST AND SEPTEMBER OF 2013 NARROWED DOWN TO A FEW ASSAYS THAT THEY WERE FOCUSSED ON VALIDATING ON THE EDISON DEVICES?
MR. WADE: DO YOU RECALL THAT? AND I DIDN'T HAVE MY NUMBERS IN ORDER AT THAT TIME, BUT DO YOU RECALL THAT THERE WAS AN EMAIL THAT YOU WERE SHOWN WHERE DR. YOUNG INITIALLY IDENTIFIED 63 ASSAYS THAT THEY WERE GOING TO TRY TO PUT ON THE EDISON DEVICE?
SUREKHA GANGAKHEDKAR: IT WAS.
MR. WADE: AND ULTIMATELY THERE WAS A DECISION TO SCALE DOWN THE NUMBER OF ASSAYS THAT THEY WERE GOING TO PUT ONTO THE EDISON DEVICE; RIGHT?
SUREKHA GANGAKHEDKAR: I THINK SO.
SUREKHA GANGAKHEDKAR: I DON'T RECALL THE ENTIRETY OF THE PLAN.
MR. WADE: LET ME PULL UP EXHIBIT 1019, WHICH I THINK IS IN THE GOVERNMENT'S BINDER. IT'S IN EVIDENCE. I'LL PUT IT ON THE SCREEN FOR YOU. IF WE CAN FOCUS ON THE FIRST PARAGRAPH OF THE SECOND EMAIL FROM YOU TO THE GROUP. AND THIS IS AN EMAIL FROM YOU TO YOUR TEAM ON AUGUST 21ST, EXCUSE ME, ON AUGUST 21ST, 2013?
MR. WADE: AND DO YOU SEE IN THE SECOND SENTENCE WHERE IT SAYS "VALIDATION WILL START IN PHASES"?
MR. WADE: AND WILL DEPEND UPON RESOURCES, INCLUDING THE READERS AND THE CARTRIDGES. DO YOU SEE THAT?
MR. WADE: AND DOES THIS REFRESH YOUR RECOLLECTION THAT THERE WAS TO BE A PHASED APPROACH IN THIS PERIOD?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: OKAY. IF I CAN NEXT FOCUS YOU ON EXHIBIT 3967, WHICH IS ALSO IN EVIDENCE. IT SHOULD BE IN THE GOVERNMENT BINDER. WE'LL BRING IT UP ON THE SCREEN. THE FIRST EMAIL ON THE TOP IS WHAT I'M INTERESTED IN. I'M NOT GOING TO ASK ANY SPECIFIC QUESTIONS, BUT DO YOU SEE IN THE EMAIL BELOW THERE WAS A LONGER LIST OF ASSAYS?
MR. WADE: A PRETTY LENGTHY LIST. AND IN THIS EMAIL THERE'S DISCUSSION OF THE PRIORITIES OF THE ASSAY DEVELOPMENT; IS THAT RIGHT?
SUREKHA GANGAKHEDKAR: CORRECT.
MR. WADE: AND THE FIRST PRIORITY WAS TO FOCUS, IN PHASE I WAS TO FOCUS ON TSH, VITAMIN D, AND TPSA. DO YOU SEE THAT?
MR. WADE: AND THEN THE NEXT PHASE WAS GOING TO BE THOSE THREE DOWN THERE, FREE THYROXINE, HCG, AND VITAMIN B-12; CORRECT?
SUREKHA GANGAKHEDKAR: CORRECT.
SUREKHA GANGAKHEDKAR: I GUESS.
MR. WADE: DO YOU RECALL SOME TESTIMONY FROM LAST WEEK ABOUT AN EMAIL THAT YOU RECEIVED FROM MR. BALWANI ON SEPTEMBER 2ND --
MR. WADE: IF WE CAN BRING THAT UP. THAT'S 3964. AND IF WE CAN FOCUS ON THE EMAIL FROM MR. BALWANI. DO YOU SEE THAT?
MR. WADE: AND HE REFERENCED HOW PEOPLE ON THE SOFTWARE TEAM HAD BEEN WORKING ALL WEEKEND AND UNTIL LATE IN THE MORNING, UNTIL 3:00 A.M.; RIGHT?
SUREKHA GANGAKHEDKAR: I DID NOT.
MR. WADE: AND IN THE EMAIL, HE ESSENTIALLY BOASTS ABOUT THE OPPRESSIVE HOURS THAT HIS TEAM WAS WORKING; IS THAT RIGHT?
SUREKHA GANGAKHEDKAR: UH-HUH.
MR. WADE: ON SATURDAY AND SUNDAY. AND HE WAS ESSENTIALLY WONDERING WHY YOUR TEAM WASN'T, WAS HE?
SUREKHA GANGAKHEDKAR: I WOULDN'T TAKE THIS JUST AS WONDERING. I MEAN, IT'S A LITTLE MORE -- THE INTENT IS A LITTLE MORE THAN JUST WONDERING WHERE WE WERE.
MR. WADE: IT IS MORE. HE WAS TRYING TO MAKE YOU FEEL GUILTY ABOUT THE FACT THAT YOU WEREN'T WORKING, WASN'T HE?
MR. WADE: IT'S PROBABLY MORE THAN THAT. YOU WERE PROBABLY PRETTY DEEPLY OFFENDED BY THIS EMAIL, WERE YOU NOT?
SUREKHA GANGAKHEDKAR: WELL, THIS WAS A COMMON THEME. THE EXPECTATIONS THAT THE ELISA TEAM WAS DOING LESS THAN EVERYBODY ELSE IN THE ORGANIZATION HAD BEEN SAID TO US BEFORE, TOO.
MR. WADE: AND WERE YOU AWARE THAT MR. BALWANI CRITICIZED MS. HOLMES ABOUT THAT BECAUSE SHE WAS THE SUPERVISOR OF THAT GROUP?
MR. LEACH: OBJECTION. CALLS FOR SPECULATION.
SUREKHA GANGAKHEDKAR: I'M NOT AWARE.
JUDGE DAVILA: SUSTAINED. THE ANSWER WILL BE STRICKEN.
BY MR. WADE:
MR. WADE: YOUR TEAM -- YOU INTERACTED WITH YOUR TEAM -- SOME MEMBERS OF YOUR TEAM ABOUT THIS EMAIL; RIGHT?
SUREKHA GANGAKHEDKAR: I THINK THEY WERE DISAPPOINTED THAT WHATEVER WORK THEY WERE DOING WAS NOT BEING RECOGNIZED.
MR. WADE: RIGHT. BECAUSE THEY HAD BEEN -- DR. SIVARAMAN, WHILE YOU WERE GONE, PICKED UP A WHOLE ANOTHER SET OF RESPONSIBILITIES; RIGHT? CORRECT?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: AND SHE -- MS. NOYES BELIEVED THAT THIS TEAM HAD GONE ABOVE AND BEYOND THE CALL OF DUTY WITH SOME OF THESE EFFORTS THAT THEY HAD BEEN UNDERTAKING ON THIS PROJECT; RIGHT?
MR. WADE: AND SHE THOUGHT THAT THEY HAD BEEN WORKING REALLY, REALLY HARD TO TRY AND MEET ALL OF THE GOALS; RIGHT?
SUREKHA GANGAKHEDKAR: IT DID.
MR. WADE: AND YOU RECOGNIZED AGAIN THAT THIS WAS NOT THE FIRST TIME THAT MR. BALWANI HAD MADE COMMENTS OF THIS KIND ABOUT YOUR GROUP; RIGHT?
MR. WADE: AND YOU UNDERSTOOD THAT MEMBERS OF YOUR TEAM WERE REACHING THEIR LIMIT ON THESE KINDS OF THINGS; RIGHT?
MR. WADE: AND YOU STOOD UP FOR YOUR GROUP; RIGHT? YOU RESPONDED TO MR. BALWANI AND DEFENDED THE WORK OF YOUR GROUP; RIGHT?
SUREKHA GANGAKHEDKAR: I DON'T RECOLLECT SENDING AN EMAIL TO MR. BALWANI.
SUREKHA GANGAKHEDKAR: WHICH BINDER IS THE NUMBER?
MR. LEACH: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 3962 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: AND AN EMAIL LIKE THIS IS NOT AN EASY EMAIL TO SEND TO THE PRESIDENT AND CHIEF OPERATING OFFICER OF THE COMPANY, IS IT?
SUREKHA GANGAKHEDKAR: NO, IT IS NOT.
MR. WADE: AND YOU SAID, "THE ELISA TEAM HAS BEEN WORKING VERY HARD TOWARD THE VALIDATION EFFORTS;" RIGHT?
MR. WADE: AND YOU TALKED IN THIS EMAIL ABOUT THE EXTRAORDINARY EFFORTS THAT YOUR TEAM HAD BEEN PUTTING FORTH, HAD YOU NOT?
SUREKHA GANGAKHEDKAR: I DID.
MR. WADE: LET'S LOOK AT 3964, WHICH IS IN EVIDENCE, I BELIEVE. NOW, THIS IS SENT THE VERY NEXT DAY; RIGHT?
MR. WADE: AND YOU STARTED BY PRAISING ALL OF THE HARD WORK AND ALL OF THE TIMES THAT THEY HAD PUT IN OVER THE WEEKEND WORKING ON THESE PROJECTS; RIGHT?
SUREKHA GANGAKHEDKAR: CORRECT.
MR. WADE: BECAUSE -- BY THE WAY, YOU SAY LONG WEEKEND THERE. THAT EMAIL THAT MR. BALWANI SENT ON MONDAY, THAT WAS LABOR DAY; RIGHT? SEPTEMBER 2ND WAS LABOR DAY?
SUREKHA GANGAKHEDKAR: YEAH. SO IT LOOKS LIKE I THINK THEY WORKED OVER THE WEEKEND, TOO.
MR. WADE: AND YOU PRAISE THEIR EFFORTS AND THEN YOU TRIED TO ADOPT SOME MINOR MODIFICATIONS TO SHIFT WORK TO BE RESPONSIVE TO MR. BALWANI. BUT YOU -- DID YOU SEND THIS MESSAGE BECAUSE YOU WANTED TO MAKE CLEAR TO YOUR TEAM THAT YOU SUPPORTED THEM AND ALL OF THEIR HARD WORK?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: AND THAT SAME DAY, THREE DAYS AFTER SHE GOT THAT EMAIL FROM MR. BALWANI, MS. NOYES RESIGNED AS WELL; RIGHT?
MR. WADE: AND YOU -- AFTER RESIGNING YOURSELF AND GETTING NOTICE FROM MS. NOYES, YOU WENT AND TALKED TO MONA RAMAMURPHY; RIGHT?
SUREKHA GANGAKHEDKAR: I TRIED TO.
JUDGE DAVILA: REDIRECT?
MR. LEACH: YES, YOUR HONOR. BRIEFLY.
REDIRECT EXAMINATION BY MR. LEACH:
MR. LEACH: GOOD AFTERNOON, MS. GANGAKHEDKAR. I WANT TO START WHERE WE LEFT OFF THE MEETING WITH MS. HOLMES WHERE YOU RESIGNED FROM THERANOS. DO YOU HAVE THAT IN MIND?
MR. LEACH: OKAY. AT THAT TIME YOU HAD CONCERNS ABOUT THE RELIABILITY OF THE 3.0?
MR. LEACH: AND DID YOU HAVE CONCERNS ABOUT THE RELIABILITY OF THE 3.5?
SUREKHA GANGAKHEDKAR: BASED ON -- YES, YES, BASED ON THE RECENT EMAILS FOR 3.5 PERFORMANCE.
MR. LEACH: AND DID YOU CONVEY THOSE EMAILS TO MS. HOLMES IN THE MEETINGS THAT YOU HAD WITH HER?
MR. WADE: YOUR HONOR, I'M REMINDING HIM THAT WE'RE ON DIRECT, AND I WOULD OBJECT TO THE FORM OF THE QUESTION.
JUDGE DAVILA: I'LL ALLOW THIS QUESTION. YOU CAN ANSWER THE QUESTION. MR. LEACH, IF YOU'LL MODIFY YOUR QUESTIONS.
MR. LEACH: THANK YOU, YOUR HONOR.
JUDGE DAVILA: YOU CAN ANSWER THE QUESTION.
SUREKHA GANGAKHEDKAR: SO I THINK OVERALL GENERALLY THE DISCUSSION WAS 3 AND 3.5'S.
BY MR. LEACH:
MR. LEACH: DID YOU CONVEY THOSE CONCERNS TO MS. HOLMES IN YOUR MEETING WHERE YOU RESIGNED FROM THERANOS?
SUREKHA GANGAKHEDKAR: SO I DID MENTION SOMETHING ALONG THE LINES THAT I WASN'T SURE HOW WE WOULD GO AHEAD WITH THE LAUNCH OF THE 3.0'S AND THE 3.0'S SYSTEMS.
MR. LEACH: OKAY. MR. WADE WALKED YOU THROUGH A NUMBER OF ASSAY DEVELOPMENT REPORTS. DO YOU RECALL GOING THROUGH THOSE ASSAY DEVELOPMENT REPORTS?
MR. LEACH: AND I THINK YOU HAVE TWO VERY THICK BINDERS UP ON THE WITNESS STAND WITH SOME OF THOSE ASSAY DEVELOPMENT REPORTS?
MR. LEACH: AT THE TIME OF YOUR RESIGNATION, DID THOSE ASSAY DEVELOPMENT REPORTS GIVE YOU ANY COMFORT ABOUT THE RELIABILITY OF THE 3.0 OR THE 3.5?
SUREKHA GANGAKHEDKAR: BECAUSE ESSENTIALLY THE WORK WAS DEVELOPMENT AND, I MEAN, WE WERE USING THE 3.0'S FOR DEVELOPMENT PURPOSES. WE WERE, LIKE, AWARE THAT THERE WERE FAILURES THROUGH THAT DEVELOPMENT PROCESS. AND THE UPGRADE DATA THAT WE WERE SEEING IN THE 3.5, THE RECENT 3.5 RUNS IN THE TIME OF LATE AUGUST KIND OF ALSO WAS SHOWING SOME ERRORS. SO IT DID RAISE CONCERNS THAT EVEN THE 3.5'S WERE SHOWING SOME PROBLEMS.
MR. LEACH: WHEN YOU DO AN ASSAY REPORT IN RESEARCH AND DEVELOPMENT, IS THAT THE END OF YOUR WORK?
SUREKHA GANGAKHEDKAR: CAN YOU REPHRASE?
MR. LEACH: SURE. IS THERE A DIFFERENCE BETWEEN AN ASSAY DEVELOPMENT REPORT IN RESEARCH AND DEVELOPMENT AND VALIDATION IN THE CLIA LAB?
MR. LEACH: AND WHAT IS THE DIFFERENCE?
SUREKHA GANGAKHEDKAR: SO PRIMARILY IN THE ASSAY DEVELOPMENT, DURING THE DEVELOPMENT WE DO HAVE A FLEXIBILITY TO RERUN SAMPLES WHERE THE CARTRIDGES HAVE FAILED OR THERE HAS BEEN A PROBLEM WITH THE ISSUE, BECAUSE WE'RE TRYING TO UNDERSTAND IF OVERALL THE ASSAY IS BEING DEVELOPED. IN THE CASE OF A VALIDATION, I DON'T THINK WE HAVE THAT FLEXIBILITY TO RERUN SAMPLES AND REEVALUATE.
MR. LEACH: AND SO IF YOU HAVE A COMPLETED ASSAY DEVELOPMENT REPORT IN RESEARCH AND DEVELOPMENT, IS THAT ENOUGH TO TEST SAMPLES ON PATIENTS?
MR. LEACH: DID YOU REVIEW CLIA VALIDATION AS MORE RIGOROUS THAN THE WORK YOU WERE DOING IN RESEARCH AND DEVELOPMENT?
MR. LEACH: AT THE TIME YOU RESIGNED TO MS. HOLMES, DID SHE BRING ANYTHING UP ABOUT THE ASSAY DEVELOPMENT REPORTS THAT YOU AND YOUR TEAM HAD WORKED ON?
SUREKHA GANGAKHEDKAR: I DON'T RECOLLECT. I DON'T THINK SO.
MR. LEACH: DID SHE SAY ANYTHING TO THE EFFECT OF "BUT WE'VE PREPARED 92 ASSAY DEVELOPMENT REPORTS IN RESEARCH AND DEVELOPMENT, WHY DO YOU HAVE THESE CONCERNS?" ANYTHING LIKE THAT?
SUREKHA GANGAKHEDKAR: SHE DID NOT.
MR. LEACH: MR. WADE WALKED YOU THROUGH A NUMBER OF EMAILS FROM THE 2005 AND 2011 TIME PERIOD WHERE MS. HOLMES PRAISED YOUR WORK. DO YOU RECALL THAT TESTIMONY?
MR. LEACH: AND WHY DID YOU NOT LEAVE THE COMPANY IN 2011?
SUREKHA GANGAKHEDKAR: BECAUSE AT THAT POINT WE WERE TOLD THAT WE ARE NOW MOVING INTO A NEWER SYSTEM, THE 4.0'S. WE HAD JUST AROUND THAT TIME I THINK HAD STARTED DEVELOPMENT, SO ALL OF THE EFFORT, LIKE ALL OF OUR WORK THAT WAS DONE BEFORE WILL FINALLY HAVE I THINK AN OPPORTUNITY TO BE USED ON A MORE COMPLEX AND MORE IMPROVED SYSTEM.
MR. LEACH: MORE IMPROVED THAN THE 3.0'S AND THE 3.5'S?
MR. LEACH: AND DID YOU EVER GET TO THAT POINT WITH THE 4.0'S?
MR. LEACH: MR. WADE ASKED YOU A NUMBER OF QUESTIONS ABOUT SILOING AT THERANOS. DO YOU RECALL THAT TESTIMONY?
MR. LEACH: AND IS IT YOUR BELIEF THAT INFORMATION AT THERANOS WAS SILOED?
MR. LEACH: I THINK MR. WADE MENTIONED A MEETING THAT YOU HAD WITH THE GOVERNMENT ON MAY 27TH, 2021. DO YOU RECALL HIM ASKING SOME QUESTIONS ABOUT THAT?
MR. LEACH: AND WAS THIS THE FIRST TIME THAT YOU HAD TALKED WITH THE GOVERNMENT IN MAY OF 2021?
MR. LEACH: DO YOU RECALL MEETING WITH THE AGENTS FROM THE FEDERAL BUREAU OF INVESTIGATION AND THE POSTAL INSPECTION SERVICE IN MAY OF 2016?
MR. LEACH: OKAY. AND AT THAT TIME WERE YOU REPRESENTED BY COUNSEL?
MR. LEACH: OKAY. AND DID YOU MEET WITH THOSE AGENTS VOLUNTARILY?
MR. LEACH: AND DID YOU BRING SOME OF THE DOCUMENTS THAT YOU HAD TAKEN FROM THERANOS WITH YOU TO THAT MEETING?
MR. LEACH: AND DID YOU TELL THE FBI AND THE POSTAL INSPECTION SERVICE THAT MUCH OF THE DATA GENERATED AT THERANOS WAS CONFIDENTIAL AND THE INDIVIDUAL GROUPS WITHIN THERANOS HAD ACCESS TO ONLY A PARTICULAR SUBSET OF DATA?
JUDGE DAVILA: OVERRULED. YOU CAN ANSWER THE QUESTION.
BY MR. LEACH:
MR. LEACH: AND AT THAT TIME YOU HAD NO AGREEMENTS WITH THE GOVERNMENT; IS THAT CORRECT?
SUREKHA GANGAKHEDKAR: CORRECT.
MR. LEACH: OKAY. DID YOU ALSO TELL THE AGENTS IN MAY OF 2016 THAT THE ONLY PEOPLE WITHIN THERANOS WITH ACCESS TO ALL OF THE DATA WAS MS. HOLMES, MR. BALWANI, AND CHRISTIAN HOLMES?
JUDGE DAVILA: WHY DON'T YOU REPHRASE THAT QUESTION IF YOU CAN.
BY MR. LEACH:
MR. LEACH: DID YOU ALSO, DID YOU ALSO ASK -- OR TELL THE AGENTS ABOUT WHO HAD ACCESS TO ALL OF THE DATA AT THERANOS?
MR. LEACH: AND WHAT DID YOU TELL THEM?
SUREKHA GANGAKHEDKAR: SO BASICALLY IT WAS MS. HOLMES AND MR. BALWANI.
JUDGE DAVILA: OVERRULED.
BY MR. LEACH:
MR. LEACH: MR. WADE ASKED YOU A NUMBER OF QUESTIONS ABOUT REACTIONS OF OTHERS ON YOUR TEAM IN THE AUGUST, SEPTEMBER TIME PERIOD OVER THE LABOR DAY WEEKEND. DO YOU RECALL SOME OF THAT QUESTIONING?
MR. LEACH: AND HE HAD QUESTIONS ABOUT WHAT MS. NOYES FELT AND WHAT MS. SIVARAMAN FELT AND THE QUESTIONING THAT YOU AND YOUR TEAM WERE GETTING FROM MANAGEMENT. DO YOU RECALL THAT?
MR. LEACH: AND DRAWING YOUR ATTENTION TO -- HOPEFULLY YOU STILL HAVE THE WHITE BINDER OUT THERE -- TO WHAT WE HAVE MARKED AS 3961. DO YOU RECOGNIZE THIS DOCUMENT?
MR. LEACH: AND DOES THIS REFLECT SOME OF THE THOUGHTS AND FRUSTRATIONS YOU AND YOUR TEAM HAD AT THIS TIME PERIOD?
MR. LEACH: YOUR HONOR, I OFFER EXHIBIT 3961 INTO EVIDENCE.
JUDGE DAVILA: SURE. GO RIGHT AHEAD. CAN THIS BE PUT UP ON JUST OUR SCREENS?
COURT CLERK: NO. COUNSEL --
JUDGE DAVILA: OKAY.
MR. LEACH: I CAN SHARE MY COPY, YOUR HONOR.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: CAN I SEE THE DOCUMENT. I DON'T HAVE A COPY UP HERE. THIS IS MULTI PAGES? YOU'RE ASKING TO GET THE ENTIRETY OF THE DOCUMENT IN?
MR. LEACH: THE FIRST TWO PAGES IS WHAT I'M FOCUSSED ON, YOUR HONOR, AND I THINK THIS IS DIRECTLY RESPONSIVE TO QUESTIONS THAT MR. WADE WAS ASKING.
JUDGE DAVILA: OKAY.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: ARE YOU OBJECTING TO EACH OF THESE EMAILS? THERE'S DIFFERENT PEOPLE HERE. I DO SEE THAT SOME OF THIS IS RESPONSIVE TO SOME OF THE QUESTIONS THAT YOU ASKED EARLIER.
MR. WADE: IT'S STILL HEARSAY, YOUR HONOR. I DIDN'T -- MY APOLOGIES. I DIDN'T MARK A DOCUMENT. I JUST ASKED ABOUT A RECOLLECTION.
JUDGE DAVILA: AND ARE YOU OFFERING THIS FOR THE TRUTH OF THE MATTER ASSERTED OR FOR SOME OTHER PURPOSE?
MR. LEACH: FOR NOTICE AND THE TRUTH OF THE MATTER ASSERTED.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: I THINK I MIGHT HAVE TO SUSTAIN THE OBJECTION AS TO MICHAEL CRAIG AND THAT LINE IS SUGGESTING IN THERE. MS. NOYES'S EMAIL I WOULD ALLOW IN.
MR. LEACH: OKAY. I CAN FOCUS JUST ON THAT ONE, YOUR HONOR.
JUDGE DAVILA: (HANDING.) IF YOU'RE OFFERING MR. CRAIG'S EMAIL FOR THE TRUTH OF THE MATTER ASSERTED, I'LL SUSTAIN THE OBJECTION.
MR. LEACH: OKAY. I WILL OFFER JUST PAGE 1 AND THE TOP OF 361 WITH MR. BALWANI'S COMMENT IS ALREADY IN EVIDENCE ELSEWHERE.
JUDGE DAVILA: OKAY. SO THE OBJECTION IS OVERRULED AS TO THOSE TWO DOCUMENTS.
(GOVERNMENT'S EXHIBIT 3961, TWO PAGES, WAS RECEIVED IN EVIDENCE.)
MR. LEACH: MS. HOLLIMAN, IF WE CAN DISPLAY -- ACTUALLY, I'LL USE THE ELMO FOR THIS.
MR. LEACH: DO YOU HAVE THE DOCUMENT IN YOUR BINDER, MS. GANGAKHEDKAR?
MR. LEACH: I'M SHOWING YOU THE TOP OF PAGE 2. DO YOU SEE THAT NOTE FROM MR. BALWANI THAT YOU WERE ASKED QUESTIONS ABOUT THE SOFTWARE TEAM BEING THERE UNTIL 3:07 A.M.?
MR. LEACH: AND I'D LIKE NOW TO SHOW YOU PAGE 1. THERE'S AN EMAIL FROM MS. NOYES. AFTER YOU FORWARDED THIS, "WHAT ABOUT TIME MAKING REAGENTS, QUALIFYING REAGENTS, DATA PROCESSING, PROCESSING THE SAMPLES AND ALIQUOTING THINGS, TROUBLESHOOTING ISSUES THAT COME UP AND REOPTIMIZING THE NEW TECAN. THIS IS SO FRUSTRATING AND INSULTING WHEN WE ARE ALL WORKING SO HARD." IS THIS SOME OF THE FRUSTRATION YOU RECEIVED FROM YOUR TEAM?
MR. LEACH: OKAY. AND WHAT IS MEANT BY "MAKING REAGENTS AND QUALIFYING REAGENTS," ET CETERA? CAN YOU GIVE US A SENSE OF WHAT THAT MEANS?
SUREKHA GANGAKHEDKAR: YEAH. SO THESE ARE REAGENTS THAT ARE USED IN THE ASSAY. SO THESE ARE AGENTS THAT WOULD BE ADDED INTO THE CARTRIDGE FOR THE TEST, AND SO THEY COULDN'T JUST BE USED OFF THE SHELF. SO WE HAD TO BUY THE RAW MATERIALS, PROCESS THEM, QUALIFY THOSE REAGENTS, AND THEN USE THEM IN OUR TESTS.
MR. LEACH: AND THAT'S ALL WORK THAT IS NECESSARY TO VALIDATE AN ASSAY IN CLIA?
MR. LEACH: AND THAT'S ALL WORK THAT NEEDED TO BE DONE, NOTWITHSTANDING THE ASSAY DEVELOPMENT REPORTS THAT YOU AND YOUR TEAM PREPARED?
MR. LEACH: AND MS. SIVARAMAN RESPONDS, "THIS IS AS MUCH AS WE CAN TAKE ALSO NOT THE FIRST TIME. WE SHOULD MEET WITH THEM IN 'REAL' TIME AND EXPLAIN THAT THIS IS UNFAIR. ALSO BRING UP ALL THE ISSUES." AND YOU WROTE "AGREE!" WAS THAT AN ACCURATE REFLECTION OF YOUR SENTIMENT AT THE TIME?
MR. LEACH: AND ONE MORE QUESTION BRIEFLY ABOUT MS. NOYES. I'M SHOWING YOU WHAT IS IN EVIDENCE AS EXHIBIT 9397. DO YOU RECALL BEING ASKED QUESTIONS ABOUT THIS TSH ASSAY DEVELOPMENT REPORT DURING YOUR CROSS-EXAMINATION?
MR. LEACH: AND THIS WAS PREPARED BY TINA NOYES WHO WORKED FOR YOU?
MR. LEACH: AND AGAIN, IS AN ASSAY DEVELOPMENT REPORT THE SAME THING AS VALIDATION IN THE CLIA LAB?
MR. LEACH: AND DOES THE LATTER INVOLVE MORE WORK?
MR. LEACH: AND WAS MS. NOYES ONE OF THE INDIVIDUALS WHO RESIGNED ON THE SAME DAY THAT YOU DID?
MR. LEACH: OKAY. THANK YOU, MS. GANGAKHEDKAR. THANK YOU, YOUR HONOR. I HAVE NO FURTHER QUESTIONS?
JUDGE DAVILA: RECROSS?
JUDGE DAVILA: MAY THIS WITNESS BE EXCUSED?
MR. LEACH: YES, YOUR HONOR. THANK YOU.
JUDGE DAVILA: THANK YOU. YOU'RE EXCUSED. THANK YOU.
SUREKHA GANGAKHEDKAR: THANK YOU.
JUDGE DAVILA: YOU'RE WELCOME. YOU CAN JUST LEAVE ALL OF THAT THERE, PLEASE. FOLKS, PLEASE FEEL FREE TO STAND UP AND STRETCH FOR JUST A MOMENT.
(STRETCHING.)
JUDGE DAVILA: I'LL ASK THE GOVERNMENT IF THEY HAVE ANOTHER WITNESS.
MR. BOSTIC: YES, YOUR HONOR. THE GOVERNMENT CALLS DR. AUDRA ZACHMAN.
COURT CLERK: COUNSEL, THE BINDERS.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: GOOD AFTERNOON. IF YOU WOULD WORK YOUR WAY UP HERE AND FACE OUR COURTROOM DEPUTY WHILE YOU RAISE YOUR RIGHT HAND, SHE HAS A QUESTION FOR YOU.
(GOVERNMENT'S WITNESS, AUDRA ZACHMAN, WAS SWORN.)
COURT CLERK: THANK YOU.
JUDGE DAVILA: PLEASE HAVE A SEAT. MAKE YOURSELF COMFORTABLE. FEEL FREE TO ADJUST THE CHAIR AND MICROPHONE AS YOU NEED. I'LL ENCOURAGE YOU TO SPEAK DIRECTLY INTO THE MICROPHONE. WHEN YOU ARE COMFORTABLE, WOULD YOU PLEASE STATE YOUR NAME AND THEN SPELL IT, PLEASE.
SUREKHA GANGAKHEDKAR: SURE. AUDRA ZACHMAN. A-U-D-R-A. Z-A-C-H-M-A-N.
JUDGE DAVILA: THANK YOU. COUNSEL.