Victoria Sung — Direct/Cross
1,025 linesDIRECT EXAMINATION BY MR. LEACH:
MR. LEACH: DR. SUNG, I UNDERSTAND YOU HAVE A CLEAR MASK THAT YOU WOULD BE MORE COMFORTABLE WEARING IN COURT; IS THAT CORRECT?
VICTORIA SUNG: YES.
MR. LEACH: AND WITH THE COURT'S PERMISSION, CAN SHE WEAR THAT MASK?
JUDGE DAVILA: YES, OF COURSE. ANY OBJECTION, COUNSEL? CAN YOU STATE YOUR NAME SO WE CAN ENSURE OUR COURT REPORTER CAN HEAR YOU APPROPRIATELY.
VICTORIA SUNG: IT'S VICTORIA SUNG.
JUDGE DAVILA: MAYBE A LITTLE CLOSER TO THE MICROPHONE WOULD BE HELPFUL.
VICTORIA SUNG: VICTORIA SUNG.
JUDGE DAVILA: THANK YOU. COUNSEL.
BY MR. LEACH:
MR. LEACH: GOOD AFTERNOON, DR. SUNG. WOULD YOU PLEASE DESCRIBE FOR US YOUR EDUCATIONAL AND PROFESSIONAL BACKGROUND?
VICTORIA SUNG: YEAH. SO I HAVE AN UNDERGRADUATE DEGREE FROM U.C. BERKELEY AND PH.D. FROM GEORGETOWN UNIVERSITY.
MR. LEACH: AND WHEN DID YOU OBTAIN YOUR PH.D. FROM GEORGETOWN UNIVERSITY?
VICTORIA SUNG: IN 1998.
MR. LEACH: AND WHAT HAVE YOU DONE PROFESSIONALLY SINCE OBTAINING YOUR PH.D. FROM GEORGETOWN?
VICTORIA SUNG: SO I HAVE WORKED -- I DID A SHORT POSTDOCTORAL FELLOWSHIP IN STANFORD. AND THEN I MOVED ON TO INDUSTRY, AND I'VE WORKED AT A NUMBER OF DIFFERENT COMPANIES SINCE THEN. ABOUT FIVE YEARS AT SUGEN, WHICH WAS ACQUIRED BY PHARMACIA AND PFIZER, AND FOUR YEARS AT CHIRON, WHICH WAS ACQUIRED BY NOVARTIS.
JUDGE DAVILA: DR. SUNG, I'M SORRY TO ASK YOU. CAN YOU MOVE A LITTLE CLOSER. THE ACOUSTICS HERE ARE CHALLENGING. THANK YOU.
BY MR. LEACH:
MR. LEACH: IF YOU COULD PULL THE MICROPHONE A LITTLE BIT CLOSER SO WE CAN ALL HEAR YOU THROUGH THE MASK.
VICTORIA SUNG: YES.
MR. LEACH: AND FOR THE COURT REPORTER, WHO IS TRANSCRIBING EVERYTHING, SO WHEN WE USE NEW COMPANIES, I'LL COMMIT TO GO AS SLOWLY AS I CAN, AND IF YOU CAN DO THE SAME, THAT WOULD BE GREAT. SO YOU WORK FOR A COMPANY CALLED SUGEN?
VICTORIA SUNG: YES.
MR. LEACH: AND WHAT WAS SUGEN?
VICTORIA SUNG: SO SUGEN WAS A SMALL BIOTECH COMPANY IN SOUTH SAN FRANCISCO, AND I WAS THERE UNTIL ABOUT 19 -- NO, ABOUT 2003.
MR. LEACH: AND I HEARD YOU MENTION CHIRON. WHAT IS CHIRON?
VICTORIA SUNG: CHIRON IS ANOTHER BIOTECH COMPANY IN EMERYVILLE. IT WAS ACQUIRED BY NOVARTIS, AND I WAS THERE UNTIL ABOUT 2007.
MR. LEACH: AND WHAT DID YOU DO AFTER CHIRON?
VICTORIA SUNG: THEN I MOVED TO CELGENE WHERE I WAS IN THE SOUTH SAN FRANCISCO -- OR SORRY, THE SAN FRANCISCO MISSION BAY OFFICE, AND I WAS THERE FOR ABOUT TEN YEARS, JUST OVER TEN YEARS.
MR. LEACH: AND SO YOU JOINED CELGENE AT SOME POINT IN 2007, 2008?
VICTORIA SUNG: YEAH. IT WAS ACTUALLY PHARMION, WHICH WAS ACQUIRED BY CELGENE.
MR. LEACH: AND THEN YOU REMAINED WITH CELGENE UNTIL SOMETIME IN 2017, 2018?
VICTORIA SUNG: CORRECT.
MR. LEACH: AND SO WHAT DID YOU DO AFTER THAT?
VICTORIA SUNG: SO THEN I JOINED ARCH ONCOLOGY, A STARTUP BIOTECH FIRM WHICH IS IN BRISBANE, CALIFORNIA, AND I WAS THERE FOR JUST OVER THREE YEARS.
MR. LEACH: OKAY. AND WHAT ARE YOU DOING TODAY?
VICTORIA SUNG: AND SO I JUST STARTED THREE MONTHS AGO AT A NEW COMPANY CALLED ADITUM BIO IN OAKLAND, CALIFORNIA.
MR. LEACH: GREAT. I WOULD LIKE TO FOCUS ON THE TIME PERIOD, IF WE COULD, WHILE YOU WERE AT CELGENE. DO YOU HAVE THAT TIME PERIOD IN MIND?
VICTORIA SUNG: UH-HUH.
MR. LEACH: AND WHAT IS CELGENE?
VICTORIA SUNG: CELGENE AT THE TIME IS A -- WAS A BIO PHARMA COMPANY. IT'S NOW BEEN ACQUIRED BY BRISTOL MYERS SQUIBB.
MR. LEACH: AND WHEN YOU SAY A BIO PHARMA COMPANY, WHAT DO YOU MEAN?
VICTORIA SUNG: A COMPANY THAT DEVELOPS DRUGS FOR VARIOUS INDICATIONS.
MR. LEACH: AND DID YOU WORK WITHIN A PARTICULAR GROUP WITHIN CELGENE?
VICTORIA SUNG: I DID.
MR. LEACH: AND WHAT GROUP WAS THAT?
VICTORIA SUNG: IT WAS CALLED TRANSLATIONAL DEVELOPMENT.
MR. LEACH: AND WHAT IS TRANSLATIONAL DEVELOPMENT?
VICTORIA SUNG: SO TRANSLATIONAL DEVELOPMENT IS -- IT'S AN ITERATIVE PROCESS WHICH INVOLVES DEVELOPING RESEARCH TO THE POINT OF BRINGING IT TO CLINICAL TRIALS, UNDERSTANDING THE MECHANISM OF DRUGS, AND THEN TAKING DATA FROM THE CLINICAL TRIALS, FROM THE PATIENTS, AND MAKING SURE THAT YOUR DRUG WORKS LIKE IT'S SUPPOSED TO. AND IF IT DOESN'T, TRYING TO UNDERSTAND WHY AND WHY CERTAIN PATIENTS MIGHT RESPOND AND WHY OTHERS DON'T.
MR. LEACH: WHAT WERE YOUR RESPONSIBILITIES WITHIN TRANSLATIONAL DEVELOPMENT WITHIN CELGENE?
VICTORIA SUNG: SO I HAD A DUAL RESPONSIBILITY. ONE WAS TO HEAD A LAB GROUP DOING RESEARCH IN THE PROGRAMS THAT I PARTICIPATED IN; AND THEN THE OTHER WAS TO ACTUALLY SIT ON DEVELOPMENT TEAMS, CLINICAL DEVELOPMENT TEAMS AND WORK ON DRUGS THAT WERE IN LATER STAGE DEVELOPMENT AND BEING EVALUATED IN PATIENTS.
MR. LEACH: AND USING A PARTICULAR EXAMPLE IN MIND, CAN YOU GIVE US A SENSE OF HOW YOU WOULD WORK WITH CLINICAL DEVELOPMENT TEAMS AND WHAT YOU WOULD DO WITHIN THAT CONTEXT?
VICTORIA SUNG: YES. SO I WAS THE SORT OF RESIDENT SCIENTIST I GUESS. SO I HAD A VIEW IN ON HOW THE DRUG WAS DEVELOPED FROM THE START, FROM THE SELECTION OF THE DRUG AND THE TESTING OF THE DRUG BEFORE PATIENT TRIALS. AND THEN I WOULD SIT ON THE TEAMS AND HELP TO ANSWER CERTAIN QUESTIONS ABOUT HOW THE DRUG MIGHT WORK IN THE PATIENTS. AND SO WE WOULD OPERATIONALLY, YOU KNOW, GATHER SAMPLES FROM PATIENTS WHILE THEY WERE TAKING THE DRUG AND THEN TRY TO UNDERSTAND LEVELS OF CIRCULATING PROTEINS IN THEIR BLOOD TO MAKE SURE THAT THEY WERE, YOU KNOW, GOING IN THE RIGHT DIRECTION, FOR EXAMPLE, WHILE THEY WERE ON THE DRUG.
MR. LEACH: SO, FOR EXAMPLE, YOU WOULD LOOK AT PARTICULAR PROTEINS AFTER A DRUG WAS GIVEN TO A PATIENT TO SEE HOW THE BODY AND THE BLOOD IS REACTING?
VICTORIA SUNG: YES.
MR. LEACH: I WANT TO DRAW YOUR ATTENTION TO THE TIME PERIOD 2009. AT OR AROUND THAT TIME, WAS CELGENE DEVELOPING A DRUG KNOWN AS ACE-011?
VICTORIA SUNG: YES.
MR. LEACH: WHAT IS ACE-011?
VICTORIA SUNG: ACE-011 IS A LARGE MOLECULAR BIOLOGIC DRUG. IT IS AN ACTIVIN RECEPTOR, A-C-T-I-V-I-N, TO AN INHIBITOR BASICALLY, YEAH.
MR. LEACH: AND DOES ACE-011 GO BY SOME OTHER NAME?
VICTORIA SUNG: YES. IT HAD A NAME SOTATERCEPT, S-O-T-A-T-E-R-C-E-P-T.
MR. LEACH: AND WHAT WAS CELGENE IN THIS 2009 TIME PERIOD HOPING THAT ACE-011, OR SOTATERCEPT, WOULD DO?
VICTORIA SUNG: IT WAS BEING DEVELOPED FOR A NUMBER OF DIFFERENT INDICATIONS. WE HAD IN LICENSED IT FROM A COMPANY IN CAMBRIDGE, MASSACHUSETTS, AND IT WAS BEING LOOKED AT FOR TREATMENT OF ANEMIA IN ASSOCIATION WITH KIDNEY DISEASE AND OTHER DISEASES WHERE ANEMIA IS FOUND.
MR. LEACH: SO IT WAS A DRUG THAT YOU HOPED WOULD TREAT ANEMIA?
VICTORIA SUNG: YES.
MR. LEACH: AND BONE LOSS?
VICTORIA SUNG: YEAH, ORIGINALLY, YES, BONE LOSS.
MR. LEACH: AND IN THIS 2009 TIME PERIOD, WHERE IN THE STAGES OF DEVELOPMENT WAS CELGENE WITH ACE-011, OR SOTATERCEPT?
VICTORIA SUNG: IT WAS JUST POST PHASE I.
MR. LEACH: AND DOES PHASE I HAVE A PARTICULAR SIGNIFICANCE TO FOLKS IN THE BIOTECH WORLD?
VICTORIA SUNG: SO IT'S THE FIRST IN MAN, THE FIRST TIME A DRUG IS EVALUATED IN A PATIENT FOR SAFETY PRIMARILY.
MR. LEACH: IN OR AROUND 2009, WAS CELGENE PREPARING TO PERFORM CLINICAL TRIALS TO EVALUATE ACE-011 WITH PATIENTS?
VICTORIA SUNG: YES.
MR. LEACH: OKAY. AND WHAT ESSENTIALLY WAS THE HOPE OF THAT STUDY OR THAT TRIAL?
VICTORIA SUNG: THERE WERE MULTIPLE TRIALS, BUT THERE WAS ONE TRIAL BEING -- WHERE THE DRUG WAS BEING EVALUATED WITH PATIENTS WITH CHRONIC KIDNEY DISEASE, AND THE HOPE WAS THAT IT WOULD PREVENT ANEMIA IN THESE PATIENTS. AND THERE WERE OTHER TRIALS ONGOING AS WELL, AND CHEMOTHERAPY INDUCED ANEMIA.
MR. LEACH: AND WITHIN THE TRANSLATIONAL MEDICINE GROUP OF CELGENE, WHAT WAS YOUR ROLE VIS-A-VIS THIS CLINICAL TRIAL?
VICTORIA SUNG: SO MY ROLE WAS TO SUGGEST CERTAIN END POINTS OR PROTEINS IN THE BLOOD TO MEASURE THAT MIGHT HAVE SOME BEARING ON WHETHER OR NOT THE DRUG WAS WORKING AS IT SHOULD BE.
MR. LEACH: WHEN YOU SAY "END POINTS," WHAT DO YOU MEAN?
VICTORIA SUNG: PROTEINS IN THE BLOOD IN CIRCULATION.
MR. LEACH: AND CAN YOU GIVE US SOME EXAMPLES?
VICTORIA SUNG: SO SOMETHING LIKE A HORMONE, YOU COULD MEASURE SOMETHING LIKE ESTROGEN OR ANDROGENS. IT COULD BE A NUMBER OF OTHER ANALYTES, THINGS LIKE SODIUM LEVELS, SUGAR, ANYTHING LIKE THAT YOU WOULD GET IN A BLOOD TESTS WHEN YOU GO TO THE DOCTOR.
MR. LEACH: AT OR AROUND THIS TIME, DID CELGENE ENTER INTO AN AGREEMENT WITH A COMPANY CALLED THERANOS TO PROVIDE SERVICES TO CELGENE RELATING TO THIS TRIAL?
VICTORIA SUNG: YES.
MR. LEACH: AT A HIGH LEVEL, WHAT WAS YOUR UNDERSTANDING OF WHAT THERANOS WAS DOING?
VICTORIA SUNG: SO MY UNDERSTANDING WAS THAT THERANOS WAS DEVELOPING A PLATFORM TO ANALYZE THESE END POINTS THAT WE JUST MENTIONED, AND THAT THEY COULD DO IT WITH A VERY SMALL VOLUME OF BLOOD IN A VERY EFFICIENT WAY, AND THIS WOULD BE A HUGE ADVANTAGE FOR PATIENTS AND FOR HEALTH CARE PROVIDERS, RESEARCHERS, FOR EVERYONE.
MR. LEACH: AND HOW DID THAT CORRELATE TO THE CLINICAL TRIAL THAT CELGENE WAS PERFORMING?
VICTORIA SUNG: SO THE END POINTS THAT I MENTIONED THAT WE WERE LOOKING AT IN THE CLINICAL TRIAL INVOLVED DRAWING BLOOD FROM PATIENTS. SO USUALLY THESE ASSAYS REQUIRE A CERTAIN VOLUME OF BLOOD AND SO, YOU KNOW, IT MIGHT BE LARGER THAN SOMETHING THAT THERANOS'S ASSAY REQUIRED. SO, AGAIN, IT WAS -- THE PURPOSE OF THESE, THE ASSAYS, WAS TO MEASURE AN END POINT IN THE BLOOD.
MR. LEACH: OKAY. AND WAS THERANOS ALONE IN DOING THIS OR DID YOU HAVE OTHER BLOOD TESTING COMPANIES INVOLVED?
VICTORIA SUNG: YEAH, THERE ARE MANY OTHER BLOOD TESTING COMPANIES, AND THERE ARE VARIOUS ASSAYS OR TESTS FOR THE SAME END POINTS THAT ARE OFFERED AROUND THE WORLD.
MR. LEACH: OKAY. AND DID YOU WORK CLOSELY WITH FOLKS FROM THERANOS IN CONNECTION WITH THIS PROJECT?
VICTORIA SUNG: I DID.
MR. LEACH: AND LET ME DRAW YOUR ATTENTION -- YOU SHOULD HAVE A WHITE BINDER UP IN FRONT OF YOU. IF I COULD ASK YOU TO TURN, PLEASE, TO TAB 5039, WHICH I OFFER INTO EVIDENCE. I UNDERSTAND THERE'S NO OBJECTION.
MR. CLINE: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 5039 WAS RECEIVED IN EVIDENCE.)
BY MR. LEACH:
MR. LEACH: DR. SUNG, IF WE CAN DRAW YOUR ATTENTION TO -- FIRST OF ALL, HAVE YOU HAD A CHANCE TO REVIEW THIS DOCUMENT BEFORE?
VICTORIA SUNG: RIGHT NOW?
MR. LEACH: PRIOR TO YOUR TESTIMONY, DO YOU THINK YOU'VE SEEN THIS DOCUMENT?
VICTORIA SUNG: YES.
MR. LEACH: LET ME DRAW YOUR ATTENTION TO PAGE 5, THE FIRST EMAIL IN THE STRING. IF WE CAN HIGHLIGHT THE SUBSTANCE OF THE EMAIL AT THE BOTTOM. PERFECT. DO YOU SEE THE EMAIL FROM GARY -- FROM YOU TO GARY FRENZEL AND SUREKHA GANGADKHEDKAR -- LET ME START AGAIN. DO YOU SEE THE EMAIL FROM YOU TO GARY FRENZEL AND SUREKHA GANGADKHEDKAR ON OR ABOUT NOVEMBER 9TH, 2009?
VICTORIA SUNG: YES.
MR. LEACH: OKAY. AND THE SUBJECT IS CELGENE CLINICAL TRIAL. DO YOU SEE THAT?
VICTORIA SUNG: YES.
MR. LEACH: AND IS THAT A REFERENCE TO THE CLINICAL TRIAL FOR ACE-011?
VICTORIA SUNG: YES.
MR. LEACH: OKAY. YOU WROTE, "HI GARY AND SUREKHA, IT WAS VERY NICE TO MEET YOU LAST FRIDAY AND I'M SORRY I HAD TO CUT SHORT MY VISIT. AS WE DISCUSSED, I WILL TRY TO COME UP WITH A TIME SLOT IN THE NEXT COUPLE OF WEEKS WHEN THE THREE OF US, ALONG WITH LEA AUKERMAN AND SHARIANNE LOUIE CAN MEET AND DISCUSS BIOMARKER ASSAYS FOR THE ACE-011 CKD TRIAL." DO YOU SEE THAT LANGUAGE?
VICTORIA SUNG: UM-HUM.
MR. LEACH: FIRST OF ALL, THIS SUGGESTS YOU WENT OUT TO VISIT THERANOS AROUND THIS TIME PERIOD. DID YOU DO THAT?
VICTORIA SUNG: YES.
MR. LEACH: TELL ME ABOUT YOUR TRIP TO THERANOS.
VICTORIA SUNG: IT WAS JUST A BRIEF INTRODUCTORY TRIP, I THINK, TO MEET SOME OF THE STAFF, AND ALSO TO UNDERSTAND A LITTLE BIT MORE ABOUT THE PROGRAM, I MEAN, THE PROGRAM THAT THEY WERE GOING TO HELP US WORK ON AND THEIR ASSAY SYSTEM.
MR. LEACH: OKAY. DID YOU MEET MS. HOLMES ON THIS OCCASION?
VICTORIA SUNG: I THINK SO, YES.
MR. LEACH: AND DID YOU SEE A THERANOS DEVICE?
VICTORIA SUNG: WE DID.
MR. LEACH: AND WHAT DID YOU OBSERVE?
VICTORIA SUNG: IT WAS A SMALL, VERY EFFICIENT LOOKING BOX WITH, YOU KNOW, A CARTRIDGE THAT COULD GO IN THE FRONT A LITTLE BIT LIKE AN OVEN OR A SMALL LIKE TOASTER OVEN.
MR. LEACH: AND WAS THIS INTERESTING TO YOU?
VICTORIA SUNG: YES, IT WAS.
MR. LEACH: HOW SO?
VICTORIA SUNG: I THOUGHT THE IDEA THAT YOU COULD USE SOMETHING SO EFFICIENT AND SMALL ON SITE AT A LAB OR IN A CLINIC TO TEST FOR THESE BLOOD END POINTS WAS A GREAT IDEA AND VERY EFFICIENT AND FAST AND EASY, REQUIRING VERY LITTLE BLOOD FROM THE PATIENT. SO, YES, I WAS INTERESTED.
MR. LEACH: WAS THE SIZE OF THE DEVICE, THE PORTABILITY OF THE DEVICE SOMETHING THAT WAS ATTRACTIVE TO YOU FOR USE IN CLINICAL TRIALS?
VICTORIA SUNG: YES.
MR. LEACH: AND YOU WRITE ABOUT A MEETING TO DISCUSS BIOMARKER ASSAYS FOR THE ACE-011 CKD TRIAL. DO YOU SEE THAT LANGUAGE?
VICTORIA SUNG: YES.
MR. LEACH: AND WHAT IS A BIOMARKER ASSAY?
VICTORIA SUNG: I GUESS A BIOMARKER ASSAY IS BASICALLY A TEST THAT MEASURES ACTIVITY IN A PERSON IN RESPONSE TO, IN THIS CASE, THE ACE-011 DRUG.
MR. LEACH: AND CAN YOU GIVE US AN EXAMPLE OF WHAT ONE OF THOSE MIGHT BE?
VICTORIA SUNG: SO, FOR EXAMPLE, IF YOU USE THIS DRUG, IT BLOCKS ACTIVIN RECEPTOR SIGNALLING, AND THIS SIGNALLING IS INVOLVED IN RELEASE OF FOLLICLE STIMULATING HORMONES FROM THE PITUITARY GLAND IN THE BRAIN. AND SO THIS DRUG, IF IT'S GIVEN TO A PATIENT, WOULD INHIBIT RELEASE, AND SO THEREFORE, YOU SHOULD SEE SOME SORT OF DROP OR DECREASE IN FOLLICLE STIMULATING HORMONE IN THESE PATIENTS.
MR. LEACH: OKAY. YOU THEN WROTE, "IN THE MEANTIME, I WILL TRY TO GET SOME CLARITY AND PRIORITIZATION REGARDING THE LIST OF BIOMARKERS. HOPEFULLY, WE CAN THEN COME TOGETHER AND IMPLEMENT REALISTIC TIMELINES WHICH ALLOW YOU TO FULLY VALIDATE THE ASSAYS." WHAT WERE YOU GETTING AT THERE?
VICTORIA SUNG: SO I THINK THE FIRST CONVERSATION WE HAD WAS SIMPLY INTRODUCTORY, AND THE SECOND ONE THAT WE WERE PLANNING TO HAVE WAS MORE SPECIFIC TO THE PROGRAM, AND WE WANTED TO COME UP WITH A LIST OF ASSAYS THAT THERANOS COULD WORK ON TO USE IN THEIR PLATFORM AND THAT WE COULD INCLUDE IN OUR TRIAL.
MR. LEACH: YOU THEN WROTE IN THAT LAST SENTENCE IN THAT FIRST PARAGRAPH, "I THINK I MENTIONED THAT FP/FV WILL LIKELY BE JUNE 2010." WHAT IS FP/FV?
VICTORIA SUNG: FIRST PATIENT, FIRST VISIT.
MR. LEACH: SO THAT WOULD BE THE FIRST PATIENT TO VISIT?
VICTORIA SUNG: IN THAT TRIAL.
MR. LEACH: IN CELGENE'S CLINICAL TRIAL?
VICTORIA SUNG: UH-HUH.
MR. LEACH: LET'S MOVE FORWARD IN THE CHAIN, AND I DRAW YOUR ATTENTION TO PAGE 3. DO YOU SEE THERE'S ANOTHER EMAIL DOWN AT THE BOTTOM FROM YOU TO MS. GANGADKHEDKAR AND MR. FRENZEL?
VICTORIA SUNG: YES.
MR. LEACH: AND DO YOU APPEAR TO HAVE PASTED PORTIONS AN EMAIL FROM ELIZABETH HOLMES TO RANDALL STEPHENS AND VICTOR SLOAN?
VICTORIA SUNG: YES.
MR. LEACH: AND LET'S FOCUS ON THE FIRST PART OF YOUR EMAIL HERE. YOU WROTE, "HI SUREKHA AND GARY, JUST WANTED TO TOUCH BASE WITH YOU AGAIN REGARDING THE ONGOING ASSAY DEVELOPMENT THAT THERANOS IS WORKING ON FOR THE ACE-011 PROJECT." DO YOU SEE THAT LANGUAGE?
VICTORIA SUNG: UH-HUH.
MR. LEACH: AND IF WE CAN ZOOM OUT, MS. HOLLIMAN, AND LOOK AT THE BOTTOM PORTION. AND TO FACILITATE THIS LIST OF BIOMARKERS -- AS PART OF THIS DISCUSSION OF THE LIST OF ASSAYS, DR. SUNG, DID YOU PASTE PORTIONS OF AN EMAIL FROM MS. HOLMES TO OTHERS -- TO FOLKS AT CELGENE ON NOVEMBER 12TH, 2009?
VICTORIA SUNG: YES.
MR. LEACH: OKAY. THERE ARE TWO NAMES HERE, RANDALL STEPHENS AND VICTOR SLOAN? WHO ARE THEY?
VICTORIA SUNG: RANDALL STEVENS WAS THE HEAD OF THE IMMUNOLOGY AND INFLAMMATION GROUP AT CELGENE, AND VICTOR SLOAN AT THE TIME WAS THE PRIMARY PHYSICIAN WORKING ON THIS ACE-011 TRIAL, ALSO IN THAT SAME GROUP. HE'S A NEPHROLOGIST.
MR. LEACH: DOWN AT THE BOTTOM, MS. HOLMES APPEARS TO BE WRITING, "RANDALL, PER OUR CONVERSATION, I HAVE INCLUDED THE LIST OF ANALYTES EXCERPTED FROM THE PROTOCOLS DISCUSSED IN OUR MEETINGS." IF WE CAN CONTINUE TO THE NEXT PAGE, MS. HOLLIMAN. YOU SEE THERE'S A LONG LIST OF ANTIBODY ASSAYS. WHAT ARE THESE, DR. SUNG?
VICTORIA SUNG: SO THESE ARE ALL EXAMPLES OF END POINTS THAT WE WOULD BE INTERESTED IN MEASURING IN OUR PATIENTS.
MR. LEACH: AND THE FIRST ONE IS HGB. DO YOU SEE THAT?
VICTORIA SUNG: YES.
MR. LEACH: AND IS THAT HEMOGLOBIN?
VICTORIA SUNG: YES.
MR. LEACH: FURTHER DOWN THERE'S VIT D, IS THAT VITAMIN D?
VICTORIA SUNG: YES.
MR. LEACH: AND THEN DOWN TOWARDS THE BOTTOM THERE'S ESTRADIOL, FSH, AND LH. DO YOU SEE THAT?
VICTORIA SUNG: UM-HUM.
MR. LEACH: WHAT ARE THOSE?
VICTORIA SUNG: SO FSH IS FOLLICLE STIMULATING HORMONE; LH IS LUTEINIZING HORMONE; AND ESTRADIOL IS A FORM OF ESTROGEN BASICALLY. THEY'RE ALL HORMONES.
MR. LEACH: AND THOSE ARE HORMONES THAT YOU WANTED TO MEASURE TO SEE HOW THEY WERE REACTING TO THE DRUG ACE-011?
VICTORIA SUNG: CORRECT.
MR. LEACH: OKAY. LET'S GO TO PAGE 2, PLEASE, IF WE COULD. IF WE CAN FOCUS ON THE EMAIL AT THE BOTTOM WITH THE SUBSTANCE. PERFECT, MS. HOLLIMAN. IT LOOKS LIKE YOU HAVE A NUMBER OF QUESTIONS FOR THE FOLKS AT THERANOS, DR. SUNG. "1, WHAT BONE BIOMARKERS, IF ANY, DO YOU ALREADY HAVE AVAILABLE?" DO YOU SEE THAT?
VICTORIA SUNG: UH-HUH.
MR. LEACH: WHY WERE YOU ASKING THAT?
VICTORIA SUNG: I WAS JUST INTERESTED TO SEE IF WE HAD TO DEVELOP, YOU KNOW, ALL OF THESE FROM SCRATCH OR SOME OF THEM FROM SCRATCH OR IF THERE ONES ALREADY DEVELOPED THAT WE COULD USE IN OUR TRIAL.
MR. LEACH: OKAY. AND IN QUESTION 3 YOU WRITE, "HOW MANY ASSAYS PER CARTRIDGE AND DOES THE THERANOS SYSTEM REQUIRE A CONTROL CHANNEL FOR EACH ASSAY?" DO YOU SEE THAT LANGUAGE?
VICTORIA SUNG: UH-HUH.
MR. LEACH: AND WHAT WERE YOU GETTING AT?
JUDGE DAVILA: IS THAT YES?
VICTORIA SUNG: YES.
MR. LEACH: THANK YOU, YOUR HONOR.
MR. LEACH: AND WHAT DID YOU MEAN, "ASSAYS PER CARTRIDGE"?
VICTORIA SUNG: HOW MANY END POINTS OR ANALYTES COULD BE TESTED PER CARTRIDGE.
MR. LEACH: LET ME NEXT DRAW YOUR ATTENTION TO PAGE 1 IF WE COULD. IF WE COULD FOCUS ON THE DECEMBER 2009 EMAIL DOWN AT THE BOTTOM. DR. SUNG, DO YOU SEE WHERE YOU WROTE, "I INCLUDE A LIST OF BIOMARKERS ARRANGED ACCORDING TO PRIORITY." DO YOU SEE THAT?
VICTORIA SUNG: YES.
MR. LEACH: AND DID YOU ENDEAVOR TO TAKE THE LIST THAT MS. HOLMES AND OTHERS FROM THERANOS HAD PROVIDED YOU AND PUT THEM INTO PRIORITIES FOR CELGENE'S EVALUATION?
VICTORIA SUNG: SO THE LIST WAS ACTUALLY ORIGINATED FROM US, FROM CELGENE, AND SO, YES, I DID PUT THOSE IN SOME SORT OF ORDER TO PRIORITIZE THEM.
MR. LEACH: AND THEN IF WE CAN ZOOM OUT, PLEASE, AND GO TO THE TOP. YOU APPEAR TO WRITE HERE, DR. SUNG, "IS IT POSSIBLE FOR THERANOS TO FIND OUT MORE ABOUT THE ASSAYS USED AT ICON?" AND THEN YOU INCLUDE A WEB ADDRESS. "THEY HAVE VALIDATED PRETTY MUCH ALL OF THE ASSAYS ON OUR LIST AND ARE CURRENTLY ONE OF OUR PREFERRED VENDORS." WHAT DID YOU MEAN BY THAT? WHAT WERE YOU GETTING AT?
VICTORIA SUNG: SO ICON IS A COMPANY THAT RUNS SOME OF THESE SAME TESTS IN A TRADITIONAL MANNER, AND SO THE IDEA WAS TO HOPEFULLY RUN THE TESTS AT THERANOS AND THEN RUN THEM ALSO AT ICON, AND THESE ARE VALIDATED ASSAYS, AND THEN WE WOULD COMPARE THE RESULTS TO SEE IF THEY'RE IN ALIGNMENT.
MR. LEACH: AND WHY DID YOU WANT TO COMPARE THE THERANOS ASSAYS AGAINST A GOLD STANDARD?
VICTORIA SUNG: SO IT'S A VERY ROUTINE THING THAT WE DO WHEN WE'RE TESTING NEW ASSAYS BECAUSE WE JUST WANT TO MAKE SURE THAT IT PERFORMS UP TO STANDARDS BEFORE USING IT.
MR. LEACH: OKAY. AND IN THAT LAST SENTENCE YOU WROTE, "IN MY MIND, THIS IS ONE WAY TO CONVINCE OUR COMPANY AND PROJECT TEAMS THAT THE THERANOS PLATFORM IS THE WAY TO GO." WHAT DID YOU MEAN BY THAT?
VICTORIA SUNG: SO WHEN WE ORIGINALLY STARTED WORKING WITH THERANOS, MY UNDERSTANDING WAS THAT THERE WAS AN AGREEMENT THAT WE WOULD TEST THE PLATFORM AND POTENTIALLY -- YOU KNOW, AT LEAST IN THIS ONE TRIAL, AND IF IT WAS SUCCESSFUL, THAT WE WOULD IMPLEMENT IT FOR OTHER TRIALS AS WELL. SO THAT'S WHAT THIS SENTENCE REFERRED TO.
MR. LEACH: OKAY. THANK YOU. I'D LIKE TO NOW DRAW YOUR ATTENTION TO WHAT WE HAVE MARKED AS EXHIBIT 5414. AND I MOVE THIS INTO EVIDENCE, YOUR HONOR. I UNDERSTAND THERE'S A STIPULATION.
MR. CLINE: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED, AND MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 5414 WAS RECEIVED IN EVIDENCE.)
BY MR. LEACH:
MR. LEACH: DR. SUNG, DO YOU SEE AT THE TOP YOUR NAME IN THE TO LINE FROM SOMEONE NAMED CAROLYN BALKENHOL?
VICTORIA SUNG: YES.
MR. LEACH: AND IF WE COULD START ON PAGE 3, MS. HOLLIMAN. AND IF WE CAN ZOOM IN ON THE SUBSTANCE OF THE EMAIL AT THE TOP. IS THIS ANOTHER EMAIL BETWEEN YOU AND THE FOLKS AT THERANOS ABOUT DEVELOPING ASSAYS FOR POTENTIAL EVALUATION IN THIS CLINICAL TRIAL?
VICTORIA SUNG: YES.
MR. LEACH: YOU WRITE IN THE SUBJECT LINE HERE, "CELGENE CLINICAL TRIAL - PD MARKER DEVELOPMENT. DO YOU SEE THAT?
VICTORIA SUNG: YES.
MR. LEACH: AND WHAT DID YOU MEAN BY PD MARKER DEVELOPMENT?
VICTORIA SUNG: PD STANDS FOR PHARMACODYNAMIC. IT'S JUST -- IT'S ANOTHER WAY TO SAY A BIOMARKER BASICALLY, A TEST TO MEASURE HOW THE DRUG IS WORKING.
MR. LEACH: AND DO YOU DISTINGUISH A PD MARKER FROM A PK MARKER?
VICTORIA SUNG: YES. SO THE PK --
MR. LEACH: LET'S GO SLOWLY WITH PK.
VICTORIA SUNG: PK STANDS FOR PHARMACOKINETIC, AND THAT'S WHEN YOU TALK ABOUT A PHARMACOKINETIC OR A BIO ANALYTICAL ASSAY, THIS IS USED TO MEASURE DRUG LEVELS IN A PATIENT AFTER YOU DOSE A PATIENT WITH THE DRUG.
MR. LEACH: AND WAS THERANOS ALSO DEVELOPING AN ASSAY TO MEASURE PK BIOMARKER IN THIS CLINICAL TRIAL?
VICTORIA SUNG: YES.
MR. LEACH: SO ESSENTIALLY THE DRUG CONCENTRATION?
VICTORIA SUNG: THE DRUG -- YEAH, EXACTLY.
MR. LEACH: IN THE EMAIL YOU WROTE, "HI GARY, SUREKHA, AND ELIZABETH, HOPE YOU ARE DOING WELL. WE HAVE FINALLY AWARDED A CONTRACT TO ACM, WHO WILL BE OUR CENTRAL LAB FOR THE RENAL STUDY." DO YOU SEE THAT LANGUAGE?
VICTORIA SUNG: YES.
MR. LEACH: AND WHO IS ACM?
VICTORIA SUNG: IT'S ANOTHER COMPANY LIKE ICON. IT'S A CENTRAL LAB AND THEY RUN THE ASSAYS THAT MEASURE THE END POINTS IN THE PATIENTS.
MR. LEACH: AND THEY'RE THE GOLD STANDARD?
VICTORIA SUNG: THEY WERE OUR GOLD STANDARD AT THE TIME, YEAH, ONE OF THEM.
MR. LEACH: AND A COMPANY YOU HAD USED IN THE PAST?
VICTORIA SUNG: YES.
MR. LEACH: AND WERE COMFORTABLE AND SATISFIED WITH THEIR ASSAYS?
VICTORIA SUNG: YES.
MR. LEACH: OKAY. AND THERE'S REFERENCE TO A RENAL STUDY. IS THAT THE ACE-011 TRIAL?
VICTORIA SUNG: YES.
MR. LEACH: THAT'S ANOTHER NAME FOR THE CLINICAL TRIAL THAT WE'VE BEEN TALKING ABOUT. AND YOU THEN WROTE, "I THINK ANOTHER FACE-TO-FACE MEETING WILL BE THE BEST WAY TO KICK OFF THIS PROCESS SO WOULD YOU PLEASE SEND ME A FEW DATES THAT WILL WORK FOR THE THREE OF YOU AND ANYONE ELSE WHO MIGHT BE RELEVANT TO THIS PROCESS?" DO YOU SEE THAT LANGUAGE?
VICTORIA SUNG: YES.
MR. LEACH: AND IS THE REMAINDER OF THIS EMAIL YOU SCHEDULING A TRIP OUT TO THERANOS IN APRIL OF 2010?
VICTORIA SUNG: YES.
MR. LEACH: OKAY. AND DESCRIBE FOR US WHAT HAPPENED ON THIS TRIP OUT TO THERANOS IN APRIL OF 2010.
VICTORIA SUNG: SO IT WAS A LONG TIME AGO, SO I DON'T REMEMBER DETAILS. BUT I DO REMEMBER WE VISITED THE COMPANY AND THERE WERE A FEW OF US FROM CELGENE AND A FEW ON THE THERANOS SIDE, AND WE JUST SAT DOWN AND TALKED A LITTLE BIT AGAIN ABOUT THE PLATFORM. THERE WERE SOME NEW FOLKS FROM CELGENE THAT JOINED US THAT DID NOT JOIN US ON THE FIRST TRIP. IT WAS, AGAIN, PRETTY HIGH LEVEL INTRODUCTORY, YEAH.
MR. LEACH: AND WAS MS. HOLMES THERE FOR THIS?
VICTORIA SUNG: I BELIEVE SO, YES.
MR. LEACH: LET ME DRAW YOUR ATTENTION NOW TO EXHIBIT 3849 IN YOUR BINDER. I OFFER 3849 INTO EVIDENCE PURSUANT TO STIPULATION.
MR. CLINE: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 3849 WAS RECEIVED IN EVIDENCE.)
MR. LEACH: I THINK THAT'S 3489 AND I'M LOOKING FOR 3849, MS. HOLLIMAN. WONDERFUL. THANK YOU. IF WE CAN ZOOM IN ON THE TOP HALF OF THE EMAIL. KEEP GOING DOWN TO THE BOTTOM. OR THE WHOLE EMAIL. THANK YOU. PERFECT.
MR. LEACH: DO YOU SEE YOUR NAME IN THE FROM LINE, DR. SUNG?
VICTORIA SUNG: YES.
MR. LEACH: AND IS THIS TO ELIZABETH HOLMES?
VICTORIA SUNG: YES.
MR. LEACH: AND THE SUBJECT IS ACE-011 PROGRAM. DO YOU SEE THAT?
VICTORIA SUNG: YES.
MR. LEACH: AND THAT'S A REFERENCE TO THE CLINICAL TRIAL WE'VE BEEN TALKING ABOUT?
VICTORIA SUNG: CORRECT.
MR. LEACH: I WANT TO DRAW YOUR ATTENTION TO THE SECOND PARAGRAPH WHERE YOU WROTE, "AS LEA AND I MENTIONED DURING OUR LAST VISIT TO PALO ALTO, WE UNFORTUNATELY DO NOT HAVE ANYONE IN OUR GROUP WITH BIO ASSAY DEVELOPMENT/VALIDATION EXPERIENCE, SO HAD PLANNED TO HIRE A CONSULTANT TO HELP US UNDERSTAND THE FINER POINTS OF WHAT YOUR TEAM IS WORKING HARD TO ACHIEVE." DO YOU SEE THAT LANGUAGE?
VICTORIA SUNG: YES.
MR. LEACH: AND THEN YOU WROTE, "ORIGINALLY OUR PLAN WAS TO WORK WITH RON BOWSHER ON THE PD ASSAYS SINCE HE IS ALREADY ASSISTING PETER BRYAN WITH THE ACE-011 PK ASSAY DEVELOPMENT PROCESS." LET ME ASK SOME QUESTIONS ABOUT THAT SENTENCE. WHO IS PETER BRYAN?
VICTORIA SUNG: PETER BRYAN WAS A SCIENTIST IN THE PK OR BIO ANALYTICAL GROUP AT CELGENE.
MR. LEACH: SO YOU'RE FOCUSSED ON PD BIOMARKERS AND HE'S ON THE PK SIDE; IS THAT FAIR?
VICTORIA SUNG: CORRECT.
MR. LEACH: AND WHO IS RON BOWSHER?
VICTORIA SUNG: SO RON BOWSHER IS A CONSULTANT THAT CELGENE HAD HIRED TO HELP OUT WITH ASSAY DEVELOPMENT AND WAS WORKING WITH PETER ON THE PK ASSAY FOR ACE-011.
MR. LEACH: AND WHAT WERE YOU ASKING OF MS. HOLMES IN THIS EMAIL?
VICTORIA SUNG: SO I AM NOT AN ASSAY DEVELOPMENT EXPERT, AND WE DIDN'T HAVE ANYONE IN THAT CAPACITY TO WORK WITH ME, AND SO AS WE OFTEN DO IN COMPANIES, WE TRY TO FIND SOMEONE THAT CAN PROVIDE THAT EXPERTISE. AND SO THE HOPE WAS THAT RON, AS AN ASSAY DEVELOPMENT EXPERT, COULD HELP US AND CONSULT WITH US ON THE DEVELOPMENT OF THESE ASSAYS AT THERANOS.
MR. LEACH: AND DID YOU END UP GETTING AUTHORITY TO WORK WITH DR. BOWSHER ON THIS?
VICTORIA SUNG: I DON'T REMEMBER.
MR. LEACH: OKAY. LET ME FOCUS ON THE BOTTOM PORTION OF THIS EMAIL. YOU WROTE, "WE WOULD LIKE THE CONSULTANTS TO HAVE ACCESS TO DATA GENERATED FROM OUR PATIENT SAMPLES SO THAT WE CAN COMPLETE THE VALIDATION PROCESS." DO YOU SEE THAT?
VICTORIA SUNG: UH-HUH.
MR. LEACH: AND THEN "THIS IS ONE OF THE GOALS OF THE RENAL CLINICAL TRIAL AND ALSO THE REASON WE WILL BE COORDINATING THE THERANOS SAMPLING SCHEDULE TO COINCIDE WITH THE ACM SAMPLING SCHEDULE." WHAT DID YOU MEAN BY THAT?
VICTORIA SUNG: SO THIS GOES BACK TO THE COMPARING SORT OF THE TEST ASSAY TO WHAT WE WERE CONSIDERING THE STANDARD, AND SO WE WANTED TO MAKE SURE THAT THE SAMPLES THAT WERE COLLECTED FROM OUR PATIENTS WOULD BE THE SAME SAMPLES THAT WOULD BE ASSAYED ON THE ONE HAND BY ACM AND ON THE OTHER USING THE THERANOS PLATFORM.
MR. LEACH: OKAY. YOU CONTINUE IN THAT PARAGRAPH, "THE WORK THAT WE PUT INTO VALIDATING YOUR TECHNOLOGY IN THIS EXPLORATORY STUDY WILL DIRECTLY INFLUENCE WHETHER WE CONTINUE TO IMPLEMENT THE THERANOS TECHNOLOGY IN FUTURE TRIALS. THE TEAM WILL BE LOOKING TO TRANSLATIONAL DEVELOPMENT TO ENDORSE THE TECHNOLOGY AND IT IS MY HOPE THAT WE WILL BE ABLE TO DO SO WHOLEHEARTEDLY." DO YOU SEE THAT LANGUAGE?
VICTORIA SUNG: YES.
MR. LEACH: AND TRANSLATIONAL DEVELOPMENT, THAT'S YOUR GROUP; CORRECT?
VICTORIA SUNG: YES.
MR. LEACH: AND DID YOU EVER VALIDATE THERANOS'S TECHNOLOGY?
MR. LEACH: OKAY. AND DID TRANSLATIONAL DEVELOPMENT EVER ENDORSE THE TECHNOLOGY AS IT WAS YOUR HOPE TO DO?
MR. LEACH: WHY NOT?
VICTORIA SUNG: ULTIMATELY WE TRIED TO DEVELOP A NUMBER OF ASSAYS WITH THERANOS AND WE, AS HAD PLANNED, DID THE STANDARD, THE COMPARISON TO THE STANDARD TESTS, AND THERE WAS SOME OVERLAP, BUT WE FELT THAT THE RESULTS DIDN'T MATCH UP OR COORDINATE OR ALIGN AS CLOSELY AS WE WOULD LIKE. AND SO, AT LEAST FOR THIS TRIAL, WE MADE THE DECISION NOT TO MOVE FORWARD.
MR. LEACH: WHEN YOU SAY, "THE RESULTS DID NOT MATCH UP OR CORRELATE AS MUCH AS YOU WOULD LIKE," WHAT DO YOU MEAN BY THAT?
VICTORIA SUNG: SO IN SOME CASES THE ASSAYS DID NOT MEASURE A WIDE ENOUGH RANGE OF THE ANALYTE IN THE BLOOD, AND IN SOME CASES THE NUMBERS WERE JUST DIFFERENT FROM THE STANDARD ASSAY. IN SOME CASES THEY WERE CLOSE AND THEY WERE THE SAME, BUT IT WAS A MIX. AND SO WHAT WE WERE LOOKING FOR IS REALLY FAIRLY CLOSE, IF NOT COMPLETELY THE SAME AS THE STANDARD ASSAYS SO THAT WE CAN MOVE FORWARD WITH THIS NEW TECHNOLOGY.
MR. LEACH: AND AT THE END OF THE DAY YOU DIDN'T SEE THAT WITH THERANOS?
MR. LEACH: LET ME DRAW YOUR ATTENTION, PLEASE, TO WHAT WE HAVE MARKED AT EXHIBIT 541. I OFFER EXHIBIT 541 INTO EVIDENCE PURSUANT TO STIPULATION, YOUR HONOR.
MR. CLINE: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 541 WAS RECEIVED IN EVIDENCE.)
MR. LEACH: DR. SUNG, WHILE WE'RE WAITING FOR EXHIBIT 541 TO COME UP, I WOULD ALSO DRAW YOUR ATTENTION TO EXHIBIT 5416, WHICH I ALSO OFFER INTO EVIDENCE PURSUANT TO STIPULATION.
MR. CLINE: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED, AND THAT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 5416 WAS RECEIVED IN EVIDENCE.)
MR. LEACH: MS. HOLLIMAN, I CAN USE THE ELMO IF WE'RE NOT ABLE TO PULL THIS UP.
(PAUSE IN PROCEEDINGS.)
MR. LEACH: IT'S NOT COMING UP ON MY SCREEN. THERE WE GO. THANK YOU, MS. KRATZMANN.
(PAUSE IN PROCEEDINGS.)
BY MR. LEACH:
MR. LEACH: DO YOU SEE THAT ON THE SCREEN, DR. SUNG?
VICTORIA SUNG: YES.
MR. LEACH: AND IS THIS AN EMAIL FROM YOU TO ELIZABETH HOLMES, DANIEL EDLIN, DANIEL YOUNG, AND RONB@2BS-STATS.COM?
VICTORIA SUNG: YES.
MR. LEACH: AND IS THAT RON B., IS THAT RON BOWSHER?
VICTORIA SUNG: YES.
MR. LEACH: AND DANIEL EDLIN, WHO DID YOU UNDERSTAND HIM TO BE?
VICTORIA SUNG: I DON'T REMEMBER HIS EXACT TITLE, BUT HE WAS SOMETHING LIKE A PROGRAM OR PROJECT MANAGER I BELIEVE THAT I WAS WORKING WITH AT THERANOS.
MR. LEACH: OKAY. AND IN THE CC LINE THERE'S NIANHANG CHEN. WHO IS DR. CHEN?
VICTORIA SUNG: SO DR. CHEN WAS A PHARMACOKINETICIST, AND SO SHE WORKED WITH PETER BRYAN IN THAT SAME GROUP TO MODEL HOW THE DRUG WOULD BEHAVE IN THE HUMAN, IN THE PATIENTS.
MR. LEACH: THAT'S ON THE PK SIDE, MEASURING THE CONCENTRATION OF THE DRUG?
VICTORIA SUNG: EXACTLY.
MR. LEACH: IN THE TRIAL? AND I -- THE SUBJECT OF THIS IS FOR OUR DISCUSSION THIS MORNING. DO YOU SEE THAT?
VICTORIA SUNG: YES.
MR. LEACH: AND DO YOU SEE TWO ATTACHMENTS, EVALUATION OF THERANOS PK ASSAY METHOD AND SUMMARY OF PD RESULTS?
VICTORIA SUNG: YES.
MR. LEACH: AND BEFORE I GET TO THOSE ATTACHMENTS, WE ALSO MARKED EXHIBIT 5416. IS THAT AN EMAIL FROM MS. HOLMES ACKNOWLEDGING RECEIPT OF THIS?
VICTORIA SUNG: YES.
MR. LEACH: MS. KRATZMANN, I UNDERSTAND WE'RE BACK RUNNING ON THE ELECTRONIC COPY. IF WE CAN SWITCH BACK TO THAT.
(PAUSE IN PROCEEDINGS.)
BY MR. LEACH:
MR. LEACH: ARE YOU ABLE TO SEE THAT ON THE SCREEN NOW, DR. SUNG?
VICTORIA SUNG: YES.
MR. LEACH: AND DID YOU DRAFT THE POWERPOINT SUMMARY OF PD RESULTS IN THIS EMAIL?
VICTORIA SUNG: I DID.
MR. LEACH: AND DID DR. CHEN AND HER TEAM DRAFT THE POWERPOINT EVALUATION OF THERANOS PK ASSAY METHOD?
VICTORIA SUNG: YES.
MR. LEACH: AND IN OR AROUND THIS MARCH 2012 TIME PERIOD, DID YOU HAVE A DISCUSSION WITH FOLKS AT THERANOS ABOUT THE SUBSTANCE OF THE POWERPOINTS?
VICTORIA SUNG: YES.
MR. LEACH: AND DO THE POWERPOINTS REFLECT CELGENE'S CONCLUSIONS ABOUT THE PERFORMANCE OF THERANOS'S PK ASSAYS AND THE PD ASSAYS?
VICTORIA SUNG: YES.
MR. LEACH: OKAY. AND LET ME DRAW YOUR ATTENTION TO PAGE 4. DO YOU SEE WHERE IT SAYS EVALUATION OF THERANOS PK ASSAY METHOD FROM THE CLINICAL PK PERSPECTIVE?
VICTORIA SUNG: YES.
MR. LEACH: AND IS THIS THE POWERPOINT THAT DR. CHEN PREPARED?
VICTORIA SUNG: YES.
MR. LEACH: AND YOU WERE THERE WHEN THE MESSAGES IN THIS POWERPOINT WERE DELIVERED TO THERANOS?
VICTORIA SUNG: YES.
MR. LEACH: OKAY. AND A PK ASSAY, AGAIN, WHAT DOES THE PK ASSAY METHOD REFER TO?
VICTORIA SUNG: IT'S THE PHARMACOKINETIC ASSAY OR BIO ANALYTICAL ASSAY THAT MEASURES THE AMOUNT OF DRUG CIRCULATING.
MR. LEACH: LET ME DRAW YOUR ATTENTION TO THE NEXT PAGE, PAGE 5. DO YOU SEE AT THE TOP WHERE IT SAYS, RUN A PK SAMPLE WITH THERANOS SYSTEM?
VICTORIA SUNG: YES.
MR. LEACH: AND WHAT IS DEPICTED HERE?
VICTORIA SUNG: SO I THINK THIS WAS MEANT TO DEPICT THE STEPS THAT ONE WOULD TAKE TO USE THE THERANOS PLATFORM FROM COLLECTING, PREPARING THE INSTRUMENT TO COLLECTING THE BLOOD AND HOW YOU WOULD TEST THE BLOOD IN THE INSTRUMENT.
MR. LEACH: AND SO THIS IS A DESCRIPTION OF HOW THE THERANOS DEVICE WAS USED IN THE CELGENE TRIAL?
VICTORIA SUNG: MORE OR LESS, YES.
MR. LEACH: OKAY. PLEASE LOOK AT PAGE 3. I'M SORRY, PAGE 6 OF THE EXHIBIT, PAGE 3 OF THE POWERPOINT. NEXT PAGE BASICALLY. THIS SLIDE SAYS RUN A PK SAMPLE WITH QPS SYSTEM. DO YOU SEE THAT?
VICTORIA SUNG: YES.
MR. LEACH: AND WHAT IS THE QPS SYSTEM?
VICTORIA SUNG: SO THE QPS IS ANOTHER COMPANY THAT WAS RUNNING OUR SORT OF STANDARD PK ASSAYS FOR THE TRIAL.
MR. LEACH: AND WHAT DOES THIS FLOW CHART CONVEY?
VICTORIA SUNG: THE SAME STEPS AS THE PRIOR, SO THE STEPS ONE WOULD TAKE TO MEASURE THE END POINTS IN BLOOD USING THIS SYSTEM, THE QPS ASSAY.
MR. LEACH: OKAY. IF WE LOOK AT THE BOX ON THE LEFT, IT SAYS, DRAW 2 ML BLOOD; ALLOW TO CLOT AT RT. IS THAT ROOM TEMPERATURE?
VICTORIA SUNG: YES.
MR. LEACH: FOR ONE TO TWO HOURS?
VICTORIA SUNG: UH-HUH.
MR. LEACH: AND THEN WE CONTINUE WITH THE PROCESS. WITHIN TWO HOURS OF COLLECTION, CENTRIFUGE BLOOD?
VICTORIA SUNG: YES.
MR. LEACH: AND IS THAT A PROCESS THAT YOU HAD TO EMPLOY WITH THE QPS SYSTEM?
VICTORIA SUNG: YES.
MR. LEACH: AND LET'S LOOK AT THE NEXT PAGE, PAGE 7 OF THE EXHIBIT. THIS SAYS COMPARISON OF PK ASSAYS: THERANOS VERSUS QPS. DO YOU SEE THAT LANGUAGE?
VICTORIA SUNG: UH-HUH.
MR. LEACH: AND WHAT IS CONVEYED HERE?
VICTORIA SUNG: SO I THINK NIANHANG CHEN MEANT TO SHOW THE GROUP A COMPARISON OF THE RESULTS, OR, I'M SORRY, THE SORT OF NECESSARY PROCEDURE FOR THE THERANOS ASSAY VERSUS THE QPS ASSAY. SO ALL OF THESE THINGS IN THE FIRST COLUMN ARE THE DIFFERENT PARTS OF RUNNING THE ASSAY, AND SO THEY'RE ALL INVOLVED IN GETTING A RESULT FROM THE ASSAY, AND THERE ARE ADVANTAGES AND DISADVANTAGES OF BOTH, BUT YOU CAN SEE THEM COMPARED SORT OF HEAD TO HEAD HERE IN THIS TABLE.
MR. LEACH: THE FIRST ROW SAYS MATRIX, AND THEN THERE'S A COLUMN FOR THERANOS AND QPS, AND ONE SAYS WHOLE BLOOD AND SERUM. WHAT DOES THAT MEAN?
VICTORIA SUNG: SO THE MATRIX IS THE SAMPLE THAT IS COLLECTED, SO WHETHER IT'S BLOOD OR URINE, FOR EXAMPLE, AND IN THIS CASE IT'S BLOOD. SO FOR THE THERANOS SYSTEM, IT WAS VERY NICE BECAUSE THEY COULD ASSAY WHOLE BLOOD WITHOUT PREPPING THE SAMPLE. BUT FOR THE QPS SYSTEM, YOU HAD TO SPIN OUT THE SERUM FROM THE WHOLE BLOOD BEFORE YOU COULD RUN THE TEST.
MR. LEACH: AND THE NEXT ROW SAYS COLLECTED BLOOD VOLUME. WHAT IS CONVEYED THERE?
VICTORIA SUNG: SO THAT'S THE AMOUNT OF BLOOD THAT IS NECESSARY FOR THE ASSAY, AND YOU CAN SEE THERE THAT THERANOS REQUIRED A VERY, VERY SMALL AMOUNT COMPARED TO THE QPS WHICH REQUIRED 2 ML.
MR. LEACH: THE NEXT LINE SAYS, "CALIBRATIONS RANGE," AND IN THE THERANOS BOX IT SAYS, "40 TO 4000 NG/MILLILITER (INSUFFICIENT!)." WHAT DOES THAT MEAN?
VICTORIA SUNG: THAT WASN'T MY SLIDE, SO I CAN'T REALLY SPEAK TO THAT.
MR. LEACH: WHAT IS THE CALIBRATION RANGE GENERALLY?
VICTORIA SUNG: SO THAT'S GENERALLY THE RANGE OF THE ASSAY, SO THE AMOUNT OF ANALYTE OR WHAT YOU'RE TRYING TO DETECT IN THE ASSAY.
MR. LEACH: AND THEN THERE'S A LINE, DILUTION OF SAMPLES AND ABILITY TO REASSAY. CAN YOU HELP US UNDERSTAND WHAT IS IN THOSE TWO ROWS?
VICTORIA SUNG: SO THE DILUTION OF SAMPLES, SOMETIMES THE ASSAY IS DEVELOPED SUCH THAT THE SAMPLES REQUIRE DILUTION IN ORDER TO RUN THEM, SOMETIMES NOT, AND THE ABILITY TO REASSAY IS JUST IF YOU HAVE SAMPLE LEFT OVER, FOR EXAMPLE, IF SOMETHING GOES WRONG IN THAT FIRST RUN, YOU CAN TAKE THE LEFT OVER SAMPLE AND JUST RUN THE ASSAY AGAIN.
MR. LEACH: OKAY. LET ME DRAW YOUR ATTENTION TO THE NEXT PAGE, PAGE 8. UP AT THE TOP IT SAYS COMPARISON OF PK DATA: THERANOS VERSUS QPS. DO YOU SEE THAT LANGUAGE?
VICTORIA SUNG: YES.
MR. LEACH: AND IN PARENTHESIS IT SAYS (REN-001 PART 1). WHAT DOES THAT MEAN?
VICTORIA SUNG: SO REN-001 WAS THE NAME OF THE RENAL OR KIDNEY TRIAL THAT WE WERE RUNNING, AND IT WAS RUN IN TWO PARTS AND THIS WAS PART 1.
MR. LEACH: AND IN THE FIRST ROW THERE'S A COMPARISON OF THERANOS AND QPS WITH THE HEADING SAMPLES WITHOUT RESULTS. DO YOU SEE THAT?
VICTORIA SUNG: YES.
MR. LEACH: AND WHAT DOES THAT MEAN?
VICTORIA SUNG: I THINK IT MEANS THAT THERE A WERE CERTAIN SUBSET OF SAMPLES THAT DIDN'T GIVE USEABLE RESULTS FROM BOTH THERANOS AND QPS.
MR. LEACH: AND DOES THIS INDICATE THAT 14.1 PERCENT OF THE THERANOS SAMPLES CAME BACK WITHOUT RESULTS?
VICTORIA SUNG: YES, OR RESULTS THAT WERE UNDETECTABLE OR NOT.
MR. LEACH: AND THAT'S COMPARED TO LESS THAN 2 PERCENT FOR QPS?
VICTORIA SUNG: CORRECT.
MR. LEACH: AND HOW ABOUT WITH SERUM CONCENTRATION? WHAT IS CONVEYED IN THAT ROW?
VICTORIA SUNG: SERUM -- YEAH, I CAN'T SPEAK TO THAT DIRECTLY. I THINK IT WAS SOMETHING THAT DR. CHEN AGAIN WAS LOOKING AT IN TERMS OF THE STARTING POINT OF THE MATRIX USING SERUM TO MEASURE THE END POINTS. SO THERE NEEDED TO BE SOME SORT OF CONVERSION WHILE USING THE THERANOS SYSTEM, WHEREAS FOR THE QPS IT LOOKS LIKE THERE WAS NO MANIPULATION OF DATA NEEDED, IT WAS JUST A DIRECT MEASUREMENT OF THE SERUM CONCENTRATION OF THE DRUG.
MR. LEACH: AND THE NEXT ROW WAS CONCENTRATION VARIABILITY. WHAT IS CONCENTRATION VARIABILITY?
VICTORIA SUNG: SO THAT'S THE DRUG CONCENTRATION I THINK IN THE SLIDE IS WHAT SHE'S REFERRING TO, AND IT'S SORT OF THE VARIATION, THE VARIABILITY OF THE DRUG DETECTED IN THE BLOOD IN THE SAMPLES WHILE MEASURING THE THERANOS PLATFORM VERSUS QPS.
MR. LEACH: AND IS HIGH VARIABILITY GOOD OR BAD OR INDIFFERENT?
VICTORIA SUNG: BAD.
MR. LEACH: AND SO YOU WANT TO HAVE LOWER --
VICTORIA SUNG: SO, YEAH, YOU WANT A LOWER.
MR. LEACH: AND LET'S LOOK AT PAGE 9, PLEASE. DO YOU SEE WHERE IT SAYS INDIVIDUAL CONCENTRATION PROFILES, THERANOS WHOLE BLOOD VERSUS QPS SERUM?
VICTORIA SUNG: YES.
MR. LEACH: AND AT A HIGH LEVEL, WHAT IS DEPICTED ON THIS SLIDE?
VICTORIA SUNG: SO THESE GRAPHS ARE INDIVIDUAL PATIENT GRAPHS, AND EACH OF THEM DEPICTS THE RELATIONSHIP BETWEEN THE DAY AFTER THE PATIENT RECEIVES THE DRUG AND THE AMOUNT OF DRUG THAT IS CIRCULATING IN THE BLOOD.
MR. LEACH: AND THE BLUE LINE IS FOR QPS AND THE RED LINE IS FOR THERANOS IN THESE VARIOUS GRAPHS?
VICTORIA SUNG: YES.
MR. LEACH: AND DOWN AT THE BOTTOM THERE ARE TWO BULLETS. THE SECOND ONE SAYS, "THERANOS WHOLE BLOOD DATA SHOWED MORE FLUCTUATIONS." IN THIS CONTEXT, ARE FLUCTUATIONS DESIRABLE OR UNDESIRABLE?
VICTORIA SUNG: THEY'RE UNDESIRABLE.
MR. LEACH: PLEASE LOOK AT THE NEXT PAGE. DO YOU SEE AT THE TOP WHERE IT SAYS CONVERSION OF THERANOS WHOLE BLOOD CONCENTRATIONS TO SERUM CONCENTRATIONS?
VICTORIA SUNG: UH-HUH.
MR. LEACH: AND AT A HIGH LEVEL, WHAT IS CONVEYED HERE?
VICTORIA SUNG: SO THIS BASICALLY REFERS TO THE PRIOR SLIDE, THE CONVERSION FACTOR I THINK THAT WAS NECESSARY TO COMPARE THE TWO. AND SO THE RED SOLID LINE IN THE MIDDLE IS SORT OF WHERE YOU FOCUSSED YOUR ATTENTION, AND ALL OF THE BLUE DOTS ARE DEVIATIONS FROM THAT QPS SORT OF STANDARD. SO THE FURTHER AWAY FROM THAT SOLID RED LINE AND THE ZERO THERE WOULD HAVE BEEN MORE DEVIATION OR VARIATION THERE IS.
MR. LEACH: SO YOU WANT TO HAVE BLUE DOTS WITHIN THE RED LINES HERE. IS THAT WHAT I'M HEARING?
VICTORIA SUNG: IDEALLY WITHIN THE TWO DOTTED, YES, THE 25 PERCENT RANGE.
MR. LEACH: AND THE BULLET DOWN AT THE BOTTOM SAYS "67 PERCENT SAMPLES HAD GREATER THAN 25 PERCENT DIFFERENCE IN SERUM CONCENTRATION BETWEEN THERANOS AND QPS METHOD." DO YOU SEE THAT?
VICTORIA SUNG: YES.
MR. LEACH: AND WAS THAT GOOD NEWS OR BAD NEWS OR SOMETHING ELSE FOR THERANOS?
VICTORIA SUNG: WELL, IT'S NOT GOOD NEWS. IT BASICALLY JUST SHOWS THAT THE ASSAY DID NOT PERFORM AS WELL AS WE HAD HOPED.
MR. LEACH: LET'S LOOK AT THE NEXT PAGE, PLEASE, PAGE 11. I'M SORRY, PAGE 12, MS. HOLLIMAN. PERFECT. THIS SLIDE -- AT THE TOP IT SAYS MEAN (PLUS, MINUS SD) CONCENTRATION PROFILES THERANOS VERSUS QPS. DO YOU SEE THAT, DR. SUNG?
VICTORIA SUNG: YES.
MR. LEACH: AND WHAT IS PLUS MINUS SD IN THIS CONTEXT?
VICTORIA SUNG: STANDARD DEVIATION, SO THE VARIATION OR DEVIATION FROM AN AVERAGE, FOR EXAMPLE, A MEAN CONCENTRATION.
MR. LEACH: OKAY. AND IN THE GRAPH, WHAT IS BEING DEPICTED HERE IN THE GRAPH WITH THE RED LINES AND THE GREEN LINES AND THE BLUE LINES?
VICTORIA SUNG: SO THIS IS AN AVERAGE OF THE SAME SORT OF DATA WE'VE LOOKED AT. SO THE DAYS FOLLOWING DOSING COMPARED TO THE AMOUNT OF DRUG THAT IS CIRCULATING IN THE PATIENT, AND THIS IS MEASURED BY EITHER THE QPS SYSTEM USING SERUM OR THERANOS USING EITHER BLOOD OR SERUM AS THE STARTING POINT.
MR. LEACH: AND THEN IN THE BULLET DOWN AT THE BOTTOM IT SAYS, "MEAN CONCENTRATION PROFILES WERE NOT CONSISTENT BETWEEN THERANOS AND QPS. "CONCENTRATION VARIABILITY WAS HIGHER WITH THERANOS THAN THE QPS METHOD." IS CONCENTRATION VARIABILITY DESIRE OR UNDESIRABLE IN THIS CONTEXT?
VICTORIA SUNG: UNDESIRABLE.
MR. LEACH: AND THE MEAN CONCENTRATION PROFILES NOT BEING CONSISTENT BETWEEN THERANOS AND QPS, WHAT DID THAT MEAN?
VICTORIA SUNG: SO WE WERE COMPARING, AGAIN, SORT OF A TEST ASSAY TO THE STANDARD AND HOPING TO FIND ALIGNMENT, AND SO EVEN THOUGH THE PATTERN IS SIMILAR, THEY DID NOT OVERLAP WITH EACH OTHER, WHICH MEANS THAT THE THERANOS PLATFORM WAS NOT YIELDING THE SAME RESULTS AS THE STANDARD ASSAY.
MR. LEACH: AND WAS THAT WHAT CELGENE WAS HOPING TO SEE?
MR. LEACH: LET ME DRAW YOUR ATTENTION TO THE NEXT PAGE, PAGE 13. DO YOU SEE WHERE IT SAYS INDIVIDUAL SERUM PK PARAMETERS THERANOS VERSUS QPS?
VICTORIA SUNG: YES.
MR. LEACH: AND WHAT IS DEPICTED HERE?
VICTORIA SUNG: SO, AGAIN, I THINK THESE ARE -- EACH LITTLE NUMBER ON THE X AXIS IS A SEPARATE PATIENT, AND SO THESE GRAPHS ARE SHOWING DIFFERENT PK PARAMETERS. SO THE FIRST, FOR EXAMPLE, IS THE MAXIMUM CONCENTRATION OF DRUG REACHED AT THIS TIME IN THE PATIENTS. SO THESE ARE ALL MEASURES THAT ALLOW YOU TO CHARACTERIZE THE DRUG DISPOSITION IN THE PATIENT.
MR. LEACH: IN THE BULLET IT SAYS, "GREATER THAN 40 PERCENT DIFFERENCE IN THE VALUE BETWEEN TWO METHODS OCCURRED IN AT LEAST 2 SUBJECTS (33 PERCENT OF SUBJECTS ARE HIGHER) FOR EACH PARAMETER." WAS THAT GOOD NEWS OR BAD NEWS OR INDIFFERENT FOR THERANOS?
VICTORIA SUNG: IT'S NOT -- AGAIN, IT'S NOT GOOD NEWS BECAUSE WE'RE HOPING FOR MUCH SMALLER PERCENTAGE VARIATION.
MR. LEACH: LET ME DRAW YOUR ATTENTION TO THE LAST SLIDE, PLEASE, OF THIS POWERPOINT, PAGE 14. DO YOU SEE WHERE IT SAYS VARIABILITY IN SERUM PK PARAMETERS THERANOS VERSUS QPS?
VICTORIA SUNG: YES.
MR. LEACH: AND WHAT IS DEPICTED HERE?
VICTORIA SUNG: SO THIS IS LOOKING AT THESE PARAMETERS THAT I JUST SAW IN THE PRIOR SLIDES. SO THE PK PARAMETERS, THEY'RE LISTED ON THE BOTTOM, AND YOU'RE LOOKING AT THE COEFFICIENT OF VARIATION. SO IT'S KIND OF THE FREQUENCY OR THE SPREAD OF VARIABILITY AND, AGAIN, COMPARING THE PLATFORM AT THERANOS USING BLOOD AND SERUM AS THE STARTING POINT, AND THEN ALSO USING SERUM IN THE QPS SYSTEM.
MR. LEACH: AND THERE'S A BULLET "HIGHER PK PARAMETER VARIABILITY WITH THERANOS THAN THE QPS METHOD." HERE VARIABILITY IS NOT DESIRABLE?
VICTORIA SUNG: NOT DESIRABLE.
MR. LEACH: LET ME DRAW YOUR ATTENTION, PLEASE, TO THE POWERPOINT THAT YOU PREPARED -- WELL, BEFORE I GET TO THE NEXT POWERPOINT. THE OVERALL MESSAGE THAT DR. CHEN CONVEYED IN THIS MEETING, WAS IT NEGATIVE? WAS IT POSITIVE? WHAT WAS -- WHAT DID SHE COMMUNICATE?
VICTORIA SUNG: FROM THE BEST I CAN RECOLLECT, SHE COMMUNICATED THAT THE THERANOS PLATFORM WAS NOT UP TO STANDARD FOR MEASURING THE PK OR THE DRUG AMOUNTS IN THE BLOOD OF THESE PATIENTS.
MR. LEACH: LET'S LOOK AT YOUR POWERPOINT, THE ONE YOU PREPARED, AND IF WE CAN GO TO THE NEXT PAGE, PAGE 15, DR. SUNG. DO YOU SEE THE TITLE ACE-011 REN-001, PART 1?
VICTORIA SUNG: YES.
MR. LEACH: AND PD END POINTS: FSH, LH, AND ESTRADIOL?
VICTORIA SUNG: YES.
MR. LEACH: AND WHAT DID YOU MEAN BY THAT?
VICTORIA SUNG: SO WE CHOSE THREE OF THOSE END POINTS TO LOOK AT HERE IN THIS SLIDE DECK AND THOSE ARE LISTED HERE, FSH, LH, AND ESTRADIOL. SO THE PURPOSE OF THIS DECK WAS TO COMPARE, SIMILAR WITH WHAT WE JUST TALKED ABOUT, THE THERANOS PLATFORM VERSUS THE STANDARD ASSAY PLATFORM.
MR. LEACH: OKAY. IS END POINT ANOTHER WORD FOR ASSAY?
VICTORIA SUNG: ASSAYS MEASURE END POINTS.
MR. LEACH: OKAY. THANK YOU.
VICTORIA SUNG: UH-HUH.
MR. LEACH: AND LET'S LOOK AT PAGE 16 OF THE EXHIBIT, THE NEXT PAGE. YOU HAVE A SLIDE ENTITLED REFERENCE VALUES. PLEASE EXPLAIN WHAT YOU'RE COMMUNICATING HERE TO THE FOLKS AT THERANOS.
VICTORIA SUNG: SO THIS WAS JUST THE NORMAL, HEALTHY INDIVIDUAL RANGE OF THESE END POINTS THAT YOU WOULD FIND IN MEN AND IN WOMEN, ESTRADIOL, FSH, AND LH. SO IT'S TO GIVE YOU KIND OF AN IDEA OF WHAT A NORMAL, HEALTHY PERSON MIGHT COME IN AS.
MR. LEACH: AND THEN BENEATH THAT YOU WROTE, ACM ASSAY RANGE. WE NEED TO SPEAK ONE AT A TIME, SO I'LL FINISH MY QUESTION. ACM WAS THE GOLD STANDARD THAT CELGENE HAD HIRED?
VICTORIA SUNG: YES.
MR. LEACH: AND WHAT IS CONVEYED ON THIS BOTTOM PART, ACM ASSAY RANGE, THERANOS ASSAY RANGE?
VICTORIA SUNG: SO THE ASSAY RANGE DESCRIBES THE CONCENTRATION, THE LOW AND THE HIGH END OF CONCENTRATION OF THESE VARIOUS END POINTS THAT CAN BE MEASURED USING THE RESPECTIVE ASSAYS.
MR. LEACH: OKAY. LET'S LOOK AT THE NEXT PAGE, PAGE 17. DO YOU SEE AT THE TOP WHERE IT SAYS PATIENT 21003?
VICTORIA SUNG: YES.
MR. LEACH: AND WHAT DOES THAT REFER TO?
VICTORIA SUNG: THAT WAS ONE OF THE PATIENTS IN OUR RENAL-001 TRIAL.
MR. LEACH: AND THIS PATIENT WAS A 60-YEAR OLD FEMALE?
VICTORIA SUNG: YES.
MR. LEACH: AND DO YOU -- IN THE LEFT COLUMN THERE'S ESTRADIOL, FSH, LH WITH SOME ROWS FOR D 1, D 15, D 29. WHAT DOES THAT REPRESENT?
VICTORIA SUNG: THOSE REPRESENT THE DAY THAT THE MEASUREMENT WAS TAKEN.
MR. LEACH: AND SO D 29 WOULD BE 29 DAYS OUT FROM THE --
VICTORIA SUNG: FROM THE START OF THE TRIAL, YEAH.
MR. LEACH: AND ARE THE ACM RESULTS FOR THESE THREE ASSAYS CONVEYED IN THE MIDDLE ROW?
VICTORIA SUNG: YES.
MR. LEACH: AND SO FOR ESTRADIOL FOR PATIENT 21003 ON DAY 1, THE ACM MEASUREMENT WAS 10?
VICTORIA SUNG: YES.
MR. LEACH: AND WHAT WAS THE THERANOS MEASUREMENT FOR THAT DATE?
VICTORIA SUNG: IT WAS OUT OF RANGE, SO THERE WAS NO VALUE THAT WAS GIVEN.
MR. LEACH: AND WHAT DOES THAT MEAN?
VICTORIA SUNG: THAT THE ASSAY WASN'T ABLE TO MEASURE THE CONCENTRATION IN THAT SAMPLE.
MR. LEACH: AND FOR DAY 15, THIS PATIENT MEASURED 10 FOR ACM. AM I READING THAT CORRECTLY?
VICTORIA SUNG: YES.
MR. LEACH: AND THE THERANOS RESULT, AGAIN, WAS OUT OF RANGE?
VICTORIA SUNG: YES.
MR. LEACH: AND ON DAY 113, THE ACM RESULT AGAIN WAS 10, AND WHAT WAS THE THERANOS RESULT?
VICTORIA SUNG: 46.7.
MR. LEACH: AND WHAT WERE YOU INTENDING TO CONVEY TO THERANOS BY CORRELATING THE ACM AND THE THERANOS RESULTS ON THIS SLIDE?
VICTORIA SUNG: SO THE IDEA WAS BASICALLY JUST TO SHOW THE SIMILARITIES AND DIFFERENCES BETWEEN THE TWO ASSAYS IN TERMS OF THE RESULTS.
MR. LEACH: AND WHAT -- WERE YOU SEEING MORE SIMILARITIES OR MORE DIFFERENCES?
VICTORIA SUNG: SO IN THIS CASE THERE WERE MORE DIFFERENCES THAN SIMILARITIES.
MR. LEACH: OKAY. FURTHER DOWN FOR THE ASSAY FSH, THERE'S A COUPLE OF N/A'S IN THE THERANOS COLUMN FOR D 29 AND D 113. DO YOU SEE THAT?
VICTORIA SUNG: YES.
MR. LEACH: AND WHAT DOES THE N/A REPRESENT?
VICTORIA SUNG: SO I DON'T REMEMBER EXACTLY, BUT USUALLY IF I USE THAT, IT PROBABLY MEANT THAT THERE WAS NOT A SAMPLE AVAILABLE, THAT SOMETHING HAPPENED WITH THE SAMPLE, EITHER IT WASN'T COLLECTED PROPERLY OR IT WASN'T VIABLE, SOMETHING LIKE THAT.
MR. LEACH: OKAY. LET'S GO TO THE NEXT PAGE, PLEASE. PAGE 18 OF THE EXHIBIT. DO YOU SEE WHERE IT SAYS PATIENT 21005 AT THE TOP?
VICTORIA SUNG: YES.
MR. LEACH: AND DID YOU INCLUDE THE RESULTS FOR ALL OF THE PATIENTS IN THIS POWERPOINT?
VICTORIA SUNG: I DON'T RECALL. PROBABLY WHATEVER WE HAD AVAILABLE AT THE TIME.
MR. LEACH: OKAY.
VICTORIA SUNG: YEAH.
MR. LEACH: AND HOW DID YOU SELECT WHO WENT INTO THE POWERPOINT? I GUESS WHY WERE YOU SELECTING THE PARTICULAR PATIENTS?
VICTORIA SUNG: I THINK IT WAS UP TO THAT TIME POINT, WHATEVER IT WAS, THAT WE DECIDED WE WOULD ASSESS AND COMPARE THE ASSAYS, IT WAS WHO WAS ENROLLED IN THE TRIAL AT THE TIME AND WE HAD SAMPLES COLLECTED FROM THEM AND RESULTS. IT WAS KIND OF A ROLLING ENROLLMENT, AND AS TIME GOES, MORE PATIENTS ARE ENROLLED, SOME DROP OUT. SO AT THIS PARTICULAR TIME, THESE WERE THE PATIENTS FOR WHOM WE HAD SAMPLES AVAILABLE.
MR. LEACH: OKAY. AND ON THIS SLIDE I WANT TO DRAW YOUR ATTENTION AGAIN TO THE -- DRAW YOUR ATTENTION THIS TIME TO THE LH ASSAY. FOR D 1, DAY 1, WHAT WAS THE RESULT FOR ACM?
VICTORIA SUNG: 2.9.
MR. LEACH: AND WHAT WAS THE RESULT FOR THERANOS?
VICTORIA SUNG: OUT OF RANGE.
MR. LEACH: AND WAS THE THERANOS RESULT ALSO OUT OF RANGE FOR D 15 AND D 29?
VICTORIA SUNG: YES.
MR. LEACH: OKAY. AND WHAT WERE YOU TRYING TO CONVEY TO THERANOS WITH THIS SLIDE FOR PATIENT 21005?
VICTORIA SUNG: THE SAME THING. JUST THAT THERE WASN'T GOOD ALIGNMENT BETWEEN THE LH IN THIS CASE RESULTS FROM THEIR PLATFORM COMPARED TO THE ACM ASSAY.
MR. LEACH: OKAY. LET'S LOOK AT THE NEXT SLIDE, PLEASE, PAGE 19. IS THIS A SLIDE FOR PATIENT 31008?
VICTORIA SUNG: YES.
MR. LEACH: AND IS THIS ALSO INTENDED TO DEMONSTRATE THE LACK OF ALIGNMENT BETWEEN THE ACM AND THE THERANOS ASSAYS?
VICTORIA SUNG: YES.
MR. LEACH: OKAY. AND DOES THE REMAINDER -- DO PAGES 20 THROUGH 23 CONCLUDE -- INCLUDE ADDITIONAL DATA WITH RESPECT TO ADDITIONAL PATIENTS DESIGNED TO SHOW THE LACK OF ALIGNMENT BETWEEN THE ASSAYS?
VICTORIA SUNG: YES.
MR. LEACH: LET ME -- WE CAN PUT THAT DOCUMENT ASIDE, DR. SUNG. I WANT TO DRAW YOUR ATTENTION, PLEASE, TO WHAT WE HAVE MARKED AS EXHIBIT 3893. I MOVE THE ADMISSION OF 3893.
MR. CLINE: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 3893 WAS RECEIVED IN EVIDENCE.)
BY MR. LEACH:
MR. LEACH: DR. SUNG, I'D LIKE TO DRAW YOUR ATTENTION TO THE MIDDLE PORTION OF THE PAGE, THE EMAIL AT 12:16 P.M. THERE WE GO. DO YOU SEE THE EMAIL FROM YOU TO DANIEL EDLIN?
VICTORIA SUNG: YES.
MR. LEACH: AND DO YOU SEE YOU'VE COPIED MS. HOLMES AND DANIEL YOUNG?
VICTORIA SUNG: YES.
MR. LEACH: AND AS A GENERAL MATTER, WHY DID YOU COPY MS. HOLMES ON EMAILS?
VICTORIA SUNG: I THINK FROM THE START OF THE PROJECT WE JUST THOUGHT IT WOULD BE GREAT TO KEEP HER IN THE LOOP AND AWARE OF ONGOING ACTIVITIES, RESULTS, THINGS LIKE THAT.
MR. LEACH: OKAY. YOU WROTE IN THIS EMAIL, "THANK YOU FOR YOUR EMAIL AND IDEAS. AT LAST WEEK'S PROJECT TEAM MEETING, WE HAD DECIDED TO SIMPLY WAIT UNTIL YOUR NEXT-GEN MACHINES ARE READY AND THEN DEPLOY THEM TO THE THREE CLINICAL SITES WHICH HAVE PRIOR EXPERIENCE." DO YOU SEE THAT?
VICTORIA SUNG: YES.
MR. LEACH: AND WHAT WERE YOU CONVEYING TO THERANOS HERE?
VICTORIA SUNG: THAT AT THIS POINT WE AS A TEAM INTERNALLY HAD DECIDED TO HALT FURTHER DEPLOYMENT OF THEIR MACHINES TO THE CLINICAL SITES AND FURTHER TESTING USING THEIR PLATFORM.
MR. LEACH: WHY HAD CELGENE DECIDED TO HALT DOING THAT?
VICTORIA SUNG: SO INTERNALLY WE DISCUSSED THE ADVANTAGES AND DISADVANTAGES OF THE THERANOS PLATFORM VERSUS THE STANDARD TRADITIONAL TESTS, AND I THINK WE HAD DECIDED THAT WE WOULD RATHER STICK WITH, YOU KNOW, THE LESS VARIABILITY IN THE RESULTS AND STICK WITH THE SORT OF STANDARD ASSAYS AND TESTS RATHER THAN TO GO WITH SOMETHING NEW AT THERANOS.
MR. LEACH: AND STICK WITH THE GOLD STANDARD?
VICTORIA SUNG: STICK WITH THE STANDARD, YEP.
MR. LEACH: OKAY. AFTER THE DATE OF THIS EMAIL, APRIL 3RD, 2012, DID YOU DO ANY FURTHER WORK WITH THERANOS?
VICTORIA SUNG: NO, I DIDN'T.
MR. LEACH: WAS THERE EVER ANY FOLLOWUP ABOUT YOUR NEXT GENERATION OR THERANOS'S NEXT GENERATION MACHINE?
VICTORIA SUNG: NOT WITH ME, NO.
MR. LEACH: DID ANYONE FROM THERANOS COME BACK TO YOU AND PRESENT ADDITIONAL INFORMATION THAT CHANGED YOUR CONCLUSION NOT TO GO FORWARD WITH THEM?
VICTORIA SUNG: SO THE CONCLUSION WAS NOT CHANGED. I DON'T RECALL EXACTLY IF THERE WERE FOLLOW-UP CORRESPONDENCES.
MR. LEACH: OKAY. DID YOU EVER TELL ANYONE AT THERANOS THAT CELGENE HAD COMPREHENSIVELY VALIDATED THERANOS'S TECHNOLOGY?
MR. LEACH: WOULD YOU AGREE WITH THE STATEMENT THAT CELGENE HAD COMPREHENSIVELY VALIDATED THERANOS'S TECHNOLOGY?
MR. LEACH: WHY NOT?
VICTORIA SUNG: SO THE FULL VALIDATION WOULD REQUIRE A LOT MORE WORK THAN WE DID, BUT I THINK IT WOULD START WITH BETTER ALIGNMENT OF THE RESULTS FROM THE THERANOS PLATFORM VERSUS THE STANDARD ASSAYS, AND THEN WE WOULD GO FROM THERE TO DO FURTHER WORK IN ORDER TO DEMONSTRATE THAT THE TWO PLATFORMS ARE COMPARABLE, AND THEN THE ADVANTAGES FROM THE THERANOS PLATFORM WOULD THEN COME INTO PLAY WITH LESS BLOOD DRAWN AND SO FORTH. BUT WE NEVER GOT THERE.
MR. LEACH: I'D LIKE TO DRAW YOUR ATTENTION, PLEASE, TO WHAT IS IN EVIDENCE AS EXHIBIT 7753. DR. SUNG, DO YOU SEE AN EXCEL SPREADSHEET ON THE SCREEN?
VICTORIA SUNG: YEAH, I DO.
MR. LEACH: AND DO YOU SEE THERE'S A NUMBER OF PHARMACEUTICAL COMPANIES LISTED IN THE LEFT COLUMN, COLUMN A?
VICTORIA SUNG: YES.
MR. LEACH: OKAY. DO YOU SEE THE NAME CELGENE IN ROW 7?
VICTORIA SUNG: YES.
MR. LEACH: AND DO YOU SEE, AS YOU GO ACROSS IN THE ROWS, THERE ARE PARTICULAR YEARS AND MONTHS, 2007, 2008, CONTINUING FORWARD IN TIME?
VICTORIA SUNG: YES.
MR. LEACH: OKAY. AND IF WE CAN GO TO THE RIGHT ALL OF THE WAY TO THE GRAND TOTAL COLUMN IN W, MS. HOLLIMAN. DO YOU SEE THE $5 MILLION NUMBER ASSOCIATED WITH CELGENE?
VICTORIA SUNG: YES.
MR. LEACH: OKAY. AT THE TIME YOU WERE DOING YOUR WORK, DID YOU HAVE ANY IDEA THAT CELGENE WAS THERANOS'S BIGGEST PHARMACEUTICAL PARTNER?
MR. LEACH: OKAY. AND ARE YOU AWARE OF ANY WORK BETWEEN CELGENE AND THERANOS AFTER APRIL OF 2012 AND THE EMAIL THAT WE SAW ABOUT THE NEXT GENERATION MACHINES?
VICTORIA SUNG: NO, I WAS NOT.
MR. LEACH: MAY I HAVE A MOMENT, YOUR HONOR?
JUDGE DAVILA: YES.
(DISCUSSION AMONGST GOVERNMENT COUNSEL OFF THE RECORD.)
MR. LEACH: NO FURTHER QUESTIONS, YOUR HONOR. THANK YOU, DR. SUNG.
JUDGE DAVILA: CROSS-EXAMINATION?
MR. CLINE: YES. THANK YOU, YOUR HONOR.
CROSS-EXAMINATION BY MR. CLINE:
MR. CLINE: DR. SUNG, GOOD AFTERNOON. I REPRESENT ELIZABETH HOLMES. MAY I APPROACH, YOUR HONOR?
JUDGE DAVILA: YES.
BY MR. CLINE:
MR. CLINE: I'M GOING TO HAND YOU A BINDER THAT LOOKS BIG, BUT WE'RE GOING TO GO THROUGH IT QUICKLY. OKAY?
VICTORIA SUNG: YES.
COURT CLERK: COUNSEL, COULD YOU JUST STATE YOUR NAME FOR THE RECORD, PLEASE.
MR. CLINE: YES. MY NAME IS JOHN CLINE.
MR. CLINE: THE PROJECT THAT YOU WORKED ON WITH THERANOS WHILE YOU WERE AT CELGENE WAS THE ACE-011 PROJECT; CORRECT?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND YOU BEGAN INTERACTING WITH THERANOS ON THAT PROJECT IN NOVEMBER OF 2009; RIGHT?
VICTORIA SUNG: AROUND THAT TIME, YES.
MR. CLINE: ALL RIGHT. AND WERE YOU AWARE AT THAT POINT THAT CELGENE AND THERANOS HAD HAD A CONTRACTUAL RELATIONSHIP FOR OVER A YEAR AT THAT POINT?
MR. CLINE: DID YOU BECOME AWARE OF THAT AT SOME POINT?
VICTORIA SUNG: SOMEONE DID TELL ME, YES.
MR. CLINE: OKAY. SO YOU CAME TO UNDERSTAND THAT THERE WAS A --
VICTORIA SUNG: THERE WAS SOME RELATIONSHIP, YES.
MR. CLINE: ALL RIGHT. AND IT PREEXISTED THE ACE-011 PROJECT; RIGHT?
VICTORIA SUNG: I'M NOT SURE EXACTLY WHEN. I MEAN, I WAS ONLY WORKING ON THAT PROJECT, SO I WAS TOLD ABOUT THE RELATIONSHIP WHEN WE STARTED WORKING WITH THERANOS, NOT BEFORE.
MR. CLINE: ALL RIGHT. AND I THINK IN -- WE DON'T NEED TO PULL UP THE EXHIBIT, BUT YOU BEGAN YOUR EFFORTS WITH THERANOS WITH A VISIT TO THERANOS; CORRECT?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND YOU'RE BASED IN SAN FRANCISCO OR NEARBY, SO IT WASN'T TOO FAR OF A TRIP FOR YOU?
MR. CLINE: AND YOU MET AT THERANOS WITH GARY FRENZEL. DO YOU REMEMBER THAT NAME?
VICTORIA SUNG: I REMEMBER THE NAME, YES. IT'S HARD TO REMEMBER THE ROLES AND THE FACES, BUT YEP.
MR. CLINE: I UNDERSTAND. IT WAS A LONG TIME AGO. AND YOU MET DR. SUREKHA GANGADKHEDKAR?
VICTORIA SUNG: YES, I BELIEVE SO.
MR. CLINE: AND YOU INTERACTED WITH HER FOR QUITE SOME TIME?
VICTORIA SUNG: REGULARLY, YEAH, DURING THE TIME WE WERE WORKING WITH THERANOS. SHE WAS, I BELIEVE, A SCIENTIST, SO MAYBE LIKE MY COUNTERPART ON THE THERANOS TEAM.
MR. CLINE: LET ME -- I JUST WANT TO MOVE QUICKLY THROUGH THE CHRONOLOGY HERE. TAKE A LOOK IN YOUR BINDER, THE ONE THAT I JUST HANDED YOU, AT EXHIBIT 13985. DO YOU HAVE 13895 UP THERE?
VICTORIA SUNG: I DO.
MR. CLINE: AND YOU HAVE AN EMAIL TO GARY FRENZEL AND SUREKHA GANGADKHEDKAR?
VICTORIA SUNG: YES.
MR. CLINE: AND I OFFER EXHIBIT 13895.
JUDGE DAVILA: IT'S ADMITTED AND IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 13895 WAS RECEIVED IN EVIDENCE.)
BY MR. CLINE:
MR. CLINE: IF WE CAN JUST PULL UP THAT TOP EMAIL. ESSENTIALLY WHAT YOU ARE DOING IS UPDATING MR. FRENZEL AND DR. GANGADKHEDKAR ON WHAT WAS GOING ON; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND IN THE FIRST LINE YOU SAY, "HI GARY, JUST WANTED TO LET YOU KNOW THAT WE ARE STILL HAVING INTERNAL DISCUSSIONS AS TO HOW WE'D LIKE TO PROCEED WITH ASSAY VALIDATION FOR THE ACE-011 TRIAL." RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND YOU WERE HAVING DISCUSSIONS, AS ANY BIG COMPANY DOES, ABOUT HOW YOU WERE GOING TO HANDLE THINGS PROCEDURALLY; CORRECT?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND AT THE BOTTOM OF THAT PARAGRAPH YOU SAY, "OUR TRANSLATIONAL DEVELOPMENT GROUP (INCLUDING ME) DOESN'T REALLY HAVE A BACKGROUND IN ASSAY VALIDATION/DEVELOPMENT, SO WE MIGHT ALSO BE WORKING WITH AN EXTERNAL CONSULTANT TO GUIDE US." RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND, IN FACT, YOU DID BRING ON AN EXTERNAL CONSULTANT; RIGHT?
VICTORIA SUNG: YES, WE DID.
MR. CLINE: NOW WE'RE GOING TO MOVE FORWARD. IF YOU WOULD PULL UP EXHIBIT 13896. DON'T PULL IT UP YET. TURN TO 13896. THIS IS AN EMAIL FROM A MS. BALKENHOL AT THERANOS TO YOU DATED MAY 3RD, 2010; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: I OFFER 13896.
MR. LEACH: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 13896 WAS RECEIVED IN EVIDENCE.)
BY MR. CLINE:
MR. CLINE: AND THE SUBJECT LINE IS AGENDA FOR MAY 7 FACE TO FACE. DO YOU SEE THAT?
VICTORIA SUNG: YES.
MR. CLINE: AND IF YOU TURN THE PAGE, YOU ACTUALLY HAVE THE AGENDA; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND YOU TESTIFIED ON DIRECT ABOUT A MEETING THAT HAPPENED FACE TO FACE IN THIS PART OF 2010. DO YOU RECALL THAT?
VICTORIA SUNG: YES.
MR. CLINE: THIS WAS THAT MEETING; RIGHT?
VICTORIA SUNG: SO I DON'T KNOW IF IT WAS THAT MEETING. I'M JUST LOOKING AT THE ATTENDEES. SO, YES, I THINK THAT WAS THE MEETING. SORRY. I WAS LOOKING AT THE CELGENE SIDE. I DON'T BELIEVE THAT EVERYONE THERE ON THE CELGENE SIDE -- SO YES, IT SAYS BY PHONE. RIGHT.
MR. CLINE: SO THIS WAS A MEETING IN MAY OF 2010 TO TRY TO MOVE THE ACE-011 ASSAY VALIDATION PROJECT FORWARD; CORRECT?
VICTORIA SUNG: YES.
MR. CLINE: VARIOUS PEOPLE WERE THERE FROM THERANOS, AND VARIOUS PEOPLE FROM CELGENE, AND SOME PEOPLE WERE ON THE PHONE; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND IT LOOKS LIKE YOU WERE PRESENT IN PERSON; RIGHT?
VICTORIA SUNG: I WAS.
MR. CLINE: AND ON THE THERANOS SIDE, MR. BALWANI, MR. FRENZEL, DR. GANGADKHEDKAR, MS. HOLMES, DR. YOUNG; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND DANIEL YOUNG WAS A PH.D. WHO YOU DEALT WITH ON THIS PROJECT; CORRECT?
VICTORIA SUNG: CORRECT.
MR. CLINE: ONE OF THE ITEMS -- IF WE GO TO THE NEXT PAGE OF THIS DOCUMENT, ONE OF THE ITEMS THAT YOU DISCUSSED DURING THIS MEETING, AND I'M ABOUT TWO-THIRDS OF THE WAY DOWN THIS PAGE, WAS ASSAY VALIDATION PLAN/DEVELOPMENT TIMELINE?
VICTORIA SUNG: UH-HUH.
MR. CLINE: I'M SORRY, I NEED YOU TO SAY YES OR NO.
VICTORIA SUNG: OH, YES.
MR. CLINE: AND THAT WAS REALLY THE MAIN TOPIC OF THE MEETING WAS HOW TO GET THE ASSAY VALIDATION PLAN MOVING; RIGHT?
VICTORIA SUNG: OH, YES.
MR. CLINE: AND IF YOU WOULD GO TO EXHIBIT 13897 IN YOUR BINDER, PLEASE. THIS IS AN EXCHANGE OF EMAILS BETWEEN YOU AND DR. GANGADKHEDKAR. DO YOU SEE THAT?
VICTORIA SUNG: UH-HUH, YES, I DO.
MR. CLINE: I MOVE 13897 IN.
MR. LEACH: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 13897 WAS RECEIVED IN EVIDENCE.)
BY MR. CLINE:
MR. CLINE: IF YOU LOOK AT THE BOTTOM OF THE FIRST PAGE OF THIS EXHIBIT, THIS IS A MAY 7TH, 2010 EMAIL FROM YOU TO GARY FRENZEL, DR. GANGADKHEDKAR, AND DR. YOUNG; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND COPY ELIZABETH HOLMES?
VICTORIA SUNG: YES.
MR. CLINE: AND IT LOOKS LIKE YOU WENT HOME FROM THIS MEETING AND WROTE THIS TO KIND OF MEMORIALIZE WHAT HAPPENED; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND YOU SAY, "THANK YOU FOR ALL OF YOUR TIME THIS MORNING; WE FELT THAT OUR MEETING WAS VERY PRODUCTIVE AND INFORMATIVE." RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND THAT'S HOW YOU FELT; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND DR. GANGADKHEDKAR RESPONDS TO YOU, COPYING MR. FRENZEL, NOT COPYING MS. HOLMES, AND SAYS ESSENTIALLY THAT SHE, TOO, THOUGHT THE MEETING WAS PRODUCTIVE; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND SHE ATTACHED A PRESENTATION THAT WAS MADE AT THE MEETING; RIGHT?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND THIS IS DATED -- IF YOU'LL TURN TO THE FIRST PAGE OF THE EXHIBIT -- OR THE SECOND PAGE OF THE EXHIBIT. WE HAVE A LENGTHY, IT LOOKS LIKE A POWERPOINT, CELGENE POWERPOINT ASSAY DEVELOPMENT UPDATE; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: DATED MAY 7TH, 2010, WHICH WAS THE DATE OF THE MEETING; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND IF YOU TURN A COUPLE OF PAGES FURTHER, THERE'S A PAGE -- THAT'S THE ONE -- THAT SAYS ASSAY DEVELOPMENT PROCESS. DO YOU SEE THAT?
VICTORIA SUNG: YES.
MR. CLINE: AND THEN THERE'S A LONG LIST OF THINGS THAT NEED TO HAPPEN TO DEVELOP AN ASSAY; RIGHT?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND IT WAS A COMPLICATED PROCESS; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND GOING BACK TO AN EARLIER EMAIL THAT WE TALKED ABOUT, YOU ARE A SCIENTIST AND PH.D. BUT YOU'RE NOT AN SPECIALIST IN ASSAY DEVELOPMENT? IS THAT FAIR?
VICTORIA SUNG: THAT'S CORRECT.
MR. CLINE: AND YOU HAD THE CONSULTANT THAT YOU BROUGHT IN; RIGHT?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND ON THE PK SIDE, YOU HAD DR. BRYAN, PETER BRYAN?
VICTORIA SUNG: YES.
MR. CLINE: AND ALSO DR. --
VICTORIA SUNG: CHEN.
MR. CLINE: -- CHEN, WHO WAS THE ONE WHO DID THE POWERPOINT WE TALKED ABOUT?
VICTORIA SUNG: YES.
MR. CLINE: AND DID YOU WORK CLOSELY WITH DR. BRYAN AND DR. CHEN AS YOU MOVED THIS PROJECT FORWARD?
VICTORIA SUNG: SO WE DID MOVE THE PROJECT FORWARD TOGETHER. IT WAS TWO PIECES OF A PUZZLE, AND SO THEY WERE GEOGRAPHICALLY SEPARATE FROM WHERE I WORKED, AND SO WE HAD WEEKLY MEETINGS WITH THE TEAM TO UPDATE EACH OTHER. BUT IT WASN'T A CLOSE RELATIONSHIP. BUT, YOU KNOW, WE MOVED FORWARD TOGETHER ON THIS PIECE.
MR. CLINE: OKAY. LET'S GO TO 13898. WE HAVE FURTHER EMAILS INVOLVING YOU, DR. GANGADKHEDKAR, AND OTHERS; CORRECT?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND I OFFER 13898.
MR. LEACH: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 13898 WAS RECEIVED IN EVIDENCE.)
BY MR. CLINE:
MR. CLINE: AND THE TOP EMAIL ON PAGE 1 IS FROM DR. GANGADKHEDKAR TO YOU AND OTHERS AND SHE SAYS, "HI VICKI, ATTACHED IS THE PROGESTERONE REPORT." RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND THIS WAS THE FIRST OF A SERIES OF ASSAY VALIDATION REPORTS THAT YOU RECEIVED FROM THERANOS; CORRECT?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND THEN IF YOU FLIP OVER A COUPLE OF PAGES, SEVERAL PAGES, YOU FIND THE ATTACHMENT AND IT SAYS ASSAY DEVELOPMENT REPORT; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND THIS WAS SENT IN RESPONSE TO, GOING BACK TO PAGE 1 OF THE EXHIBIT, AN EMAIL FROM YOU TO DR. GANGADKHEDKAR AND OTHERS WHERE YOU SAY, "ONE MORE REQUEST; FOR THE PD ASSAYS THAT WE ARE INCLUDING IN PART 1, WE HAVE NOT SEEN ANY ASSAY DEVELOPMENT DOCUMENTATION/VALIDATION REPORTS." RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND SO DR. GANGADKHEDKAR IS RESPONDING TO THAT AND SENDING YOU THE FIRST OF SEVERAL; RIGHT?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND LET'S GO TO 13900. 13899.
VICTORIA SUNG: 13899?
MR. CLINE: 13899.
VICTORIA SUNG: I HAVE 898 AND 999.
MR. CLINE: 13899? NOT THERE?
VICTORIA SUNG: UNLESS THESE ARE OUT OF ORDER.
MR. CLINE: MAY I APPROACH?
JUDGE DAVILA: YES.
BY MR. CLINE:
MR. CLINE: PLEASE FORGIVE THE HIGHLIGHTING. I'M JUST GOING TO HAND YOU THE DOCUMENT TO SAVE A LITTLE TIME (HANDING).
VICTORIA SUNG: OKAY. THANK YOU.
MR. CLINE: WHAT IS THAT DOCUMENT, SINCE I DON'T HAVE IT IN FRONT OF ME?
VICTORIA SUNG: IT'S AN EMAIL FROM KAPIL GADKAR TO ME.
MR. CLINE: AND DR. GADKAR WAS ANOTHER DOCTOR AT THERANOS THAT YOU DEALT WITH; CORRECT?
VICTORIA SUNG: CORRECT.
MR. CLINE: I OFFER 13899.
MR. LEACH: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 13899 WAS RECEIVED IN EVIDENCE.)
BY MR. CLINE:
MR. CLINE: DR. GADKAR IS TELLING YOU THAT VALIDATION REPORTS ARE FORTHCOMING; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: MAY I TAKE THAT BACK FROM YOU? MAY I APPROACH?
JUDGE DAVILA: YES.
BY MR. CLINE:
MR. CLINE: LET ME TAKE THAT BACK FROM YOU. LET'S GO TO 13900. DO YOU HAVE THAT?
VICTORIA SUNG: YES.
MR. CLINE: AND THIS IS ANOTHER EMAIL FROM DR. GADKAR TO YOU AND MANY OTHERS; CORRECT?
VICTORIA SUNG: UH-HUH, YES.
MR. CLINE: I OFFER 13900.
MR. LEACH: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 13900 WAS RECEIVED IN EVIDENCE.)
BY MR. CLINE:
MR. CLINE: NOW, THIS IS A JULY 26TH, 2010 EMAIL; CORRECT?
VICTORIA SUNG: YES.
MR. CLINE: AND THE SUBJECT IS VALIDATION REPORTS FOR 3 PD MARKERS. DO YOU SEE THAT?
VICTORIA SUNG: YES.
MR. CLINE: AND THE THREE MARKERS ARE LH, FSH, AND ESTRADIOL; RIGHT?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND TELL US AGAIN WHAT LH IS.
VICTORIA SUNG: LUTEINIZING HORMONE.
MR. CLINE: AND FSH?
VICTORIA SUNG: FOLLICLE STIMULATING HORMONE.
MR. CLINE: AND THE BODY OF THE EMAIL SAYS, "HELLO ALL, ATTACHED PLZ FIND THE ASSAY VALIDATION REPORTS FOR THE 3 PD MARKERS OF LH, FSH, AND ESTRADIOL." RIGHT?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND, IN FACT, WE DON'T HAVE TO GO THROUGH THEM, BUT IF YOU LOOK AT THE ATTACHMENTS TO THIS, THE VALIDATION REPORTS ARE ATTACHED; CORRECT?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND WHEN THESE VALIDATION REPORTS WERE RECEIVED AT CELGENE, WHAT DID YOU DO WITH THEM? DID YOU REVIEW THEM YOURSELF? DID YOU PASS THEM ON TO DR. BRYAN? WHAT HAPPENED WITH THEM?
VICTORIA SUNG: YEP. SO I MAY HAVE LOOKED AT THEM MYSELF. BUT, AGAIN, NOT BEING AN EXPERT IN THIS AREA, I'M PRETTY SURE THAT THEY WERE PASSED ALONG TO SOMEONE WHO REVIEWS THESE SORTS OF DOCUMENTS FOR THEIR INPUT.
MR. CLINE: ALL RIGHT. SO YOU WOULD PASS THEM ALONG TO SOMEONE WHOSE JOB IT WAS TO REVIEW DOCUMENTS LIKE THIS FOR --
VICTORIA SUNG: WHO HAS EXPERTISE IN ASSAY DEVELOPMENT, YES.
MR. CLINE: AND THE PURPOSE OF PASSING THEM ALONG WAS TO HAVE THEM REVIEWED; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: ALL RIGHT. YOU PROBABLY WILL NOT BE ABLE TO ANSWER THIS QUESTION MANY YEARS LATER, BUT DO YOU RECALL WHO AT CELGENE WAS RESPONSIBLE FOR THE SCIENTIFIC REVIEW OF THESE ASSAY VALIDATION REPORTS THAT YOU WERE RECEIVING?
VICTORIA SUNG: YEAH. I MEAN, THE -- RON BOWSHER WAS THE CONSULTANT WHO WE TRIED TO ENGAGE TO HELP US OUT, SO IT'S POSSIBLE HE REVIEWED THEM. BUT OTHER THAN HIM, I CAN'T RECALL.
MR. CLINE: NO PROBLEM. LET'S GO TO 13901. THE SECOND EMAIL DOWN IS ONE FROM YOU TO DR. GANGADKHEDKAR; CORRECT?
VICTORIA SUNG: YES.
MR. CLINE: I OFFER 13901.
MR. LEACH: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED AND IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 13901 WAS RECEIVED IN EVIDENCE.)
BY MR. CLINE:
MR. CLINE: AND ESSENTIALLY YOU'RE THANKING DR. GADKAR FOR SHARING THE VALIDATION REPORTS WITH YOU; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: THE ONES WE JUST LOOKED AT?
VICTORIA SUNG: YES.
MR. CLINE: OR WE WERE TALKING ABOUT; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND HE'S THANKING YOU FOR YOUR PATIENCE WHILE THERANOS FINALIZED THOSE REPORTS; RIGHT?
VICTORIA SUNG: RIGHT.
MR. CLINE: AND LET'S GO TO 421. ACTUALLY, EXHIBIT 421 IS NOT THE ONE I WANT YOU TO LOOK AT. LET ME ASK YOU THIS: DO YOU RECALL IN MARCH 2011 THERE WAS A MEETING TO SORT OF REVIEW THE PROGRESS OF THE VALIDATION PROCESS?
VICTORIA SUNG: YES. ON OUR END, YES, THERE WAS.
MR. CLINE: AND A MEETING WITH THERANOS?
VICTORIA SUNG: YES, AND THEN A MEETING WITH THERANOS, UH-HUH.
MR. CLINE: ALL RIGHT. AND ONE OF THE THINGS THAT HAPPENED -- DO YOU REMEMBER WHERE THAT MEETING WAS HELD?
VICTORIA SUNG: I THINK IT WAS BY PHONE. I DON'T THINK IT WAS IN PERSON, AT LEAST I DON'T REMEMBER BEING -- MAKING ANOTHER TRIP.
MR. CLINE: ALL RIGHT. SO THERANOS PEOPLE ON THE PHONE AND CELGENE PEOPLE ON THE PHONE?
VICTORIA SUNG: CELGENE PEOPLE ON THE PHONE.
MR. CLINE: WAS YOUR CONSULTANT ON THE PHONE? DO YOU RECALL?
VICTORIA SUNG: I DON'T RECALL. I DON'T THINK SO. WE DIDN'T NORMALLY DO THAT.
MR. CLINE: AND ONE OF THE THINGS THAT WAS AGREED AT THAT MEETING WAS THAT THERANOS WOULD PROVIDE A REPORT ON PART 1 OF THE ACE-011 PROJECT; CORRECT?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND CELGENE WAS GOING TO PROVIDE A FORMAT FOR THAT REPORT; CORRECT?
VICTORIA SUNG: SORRY, A --
MR. CLINE: I'M SORRY, YOU WERE ADJUSTING YOUR MASK THERE. DO YOU RECALL THAT CELGENE WAS GOING TO PROVIDE THERANOS WITH THE FORMAT FOR THE REPORT?
VICTORIA SUNG: I DON'T REMEMBER THAT. I DON'T REMEMBER ANYTHING ABOUT THE FORMAT. BUT I THINK WE WERE EXPECTING SOME SORT OF SUMMARY.
MR. CLINE: YOU WERE EXPECTING A REPORT FROM --
VICTORIA SUNG: YES, SOME SORT OF REPORT, YEAH, SUMMARIZING WHAT HAS BEEN DONE.
MR. CLINE: ALL RIGHT. ALL RIGHT. LET'S GO TO EXHIBIT 5049. YOU'RE NOT ON THIS EMAIL; CORRECT?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND THIS IS AN EMAIL FROM DR. GADKAR TO DR. BRYAN?
VICTORIA SUNG: YES.
MR. CLINE: AND EVEN THOUGH YOU'RE NOT ON IT, I'M GOING TO OFFER IT INTO EVIDENCE.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 5049 WAS RECEIVED IN EVIDENCE.)
BY MR. CLINE:
MR. CLINE: SO IT'S AN EMAIL FROM DR. GADKAR TO DR. BRYAN, AND THE SUBJECT IS FINAL REPORT FOR ACE-011 PK. DO YOU SEE THAT?
VICTORIA SUNG: YES.
MR. CLINE: AND DR. GADKAR SAYS TO DR. BRYAN, "ATTACHED IS THE FINAL REPORT AFTER THE FINAL INTERNAL QA AND AUDIT. I HAVE ATTACHED THE VALIDATION PROTOCOL AND THE SIGNED AMENDMENTS IN THE APPENDIX. LET ME KNOW WHAT THE NEXT STEPS ARE." RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND WE'RE GOING TO LOOK AT OR HAVE AN EXHIBIT WITH THE REPORT HERE IN A SECOND, AND THE REPORT IS NOT ATTACHED TO THE EXHIBIT. BUT DO YOU RECALL RECEIVING THE FINAL PK REPORT AROUND THIS TIME?
VICTORIA SUNG: NO, BUT I WOULD NOT HAVE BEEN THE ONE TO RECEIVE IT. IT WAS THE OTHER TEAM IN THE PETER BRYAN AND NIANHANG CHEN TEAM THAT WOULD HAVE RECEIVED THAT.
MR. CLINE: WOULD YOU HAVE SEEN IT AT ALL?
VICTORIA SUNG: I DON'T KNOW THAT I WOULD -- NO, NOT IN THAT CASE.
MR. CLINE: ALL RIGHT. SO LET'S GO TO EXHIBIT 9002, WHICH IS IN EVIDENCE. THIS IS THE REPORT THAT WAS ATTACHED TO THAT EMAIL FROM DR. GADKAR TO DR. BRYAN. LOOKING AT IT NOW, DOES THIS RING A BELL FOR YOU? HAVE YOU SEEN THIS BEFORE?
VICTORIA SUNG: YOU KNOW, IT'S TOO LONG AGO. I'VE SEEN SO MANY VALIDATION REPORTS, I CAN'T SAY I'VE SEEN THIS SPECIFIC ONE. IT MAY HAVE BEEN CIRCULATED. BUT AGAIN, THIS WAS NOT MY -- THIS WAS SOMETHING THAT PETER BRYAN AND DR. CHEN WERE DEALING WITH THAT SIDE OF IT, I PROBABLY WOULD NOT HAVE BEEN ASKED NECESSARILY FOR ANY FEEDBACK.
MR. CLINE: ALL RIGHT. SORRY. I INTERRUPTED YOU. JUST TO BE CLEAR, WHEN YOU SAY THAT SIDE OF IT, THEY WERE DEALING WITH THE PK SIDE AND YOU WERE DEALING WITH THE PD?
VICTORIA SUNG: CORRECT.
MR. CLINE: OKAY. SO LET'S GO TO EXHIBIT 13907. NOW, THIS AGAIN, TO BE CLEAR, IS AN EMAIL THAT YOU'RE NOT ON. IT INVOLVES DR. GADKAR AND THEN SOME PEOPLE WITHIN CELGENE. DO YOU SEE THAT?
VICTORIA SUNG: YES.
MR. CLINE: ALL RIGHT. EVEN THOUGH YOU'RE NOT ON IT, I'M GOING TO OFFER IT 13907.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 13907 WAS RECEIVED IN EVIDENCE.)
BY MR. CLINE:
MR. CLINE: ALL RIGHT. SO LET'S, LET'S START AT THE BOTTOM OF PAGE 1 AND CARRY OVER TO THE TOP OF PAGE 2. IT'S AN EMAIL FROM PETER BRYAN TO, IT LOOKS LIKE A GROUP CALLED NONCLINICAL REPORTS. DO YOU SEE THAT?
VICTORIA SUNG: HOLD ON. OH, YES, I SEE IT NOW.
MR. CLINE: YOU SEE THAT?
VICTORIA SUNG: YES.
MR. CLINE: AND ESSENTIALLY, THIS IS THE CONTINUATION OF THE CHAIN FROM THE EMAIL THAT WE JUST LOOKED AT WHERE DR. GADKAR WAS CONVEYING THE REPORT TO DR. BRYAN; RIGHT?
VICTORIA SUNG: RIGHT.
MR. CLINE: AND WHAT DR. BRYAN IS DOING IS SENDING IT ON TO THE DOCUMENTATION PEOPLE AT CELGENE; RIGHT?
VICTORIA SUNG: I ASSUME SO, YES.
MR. CLINE: AND HE SAYS, "SHIRLEY AND NATALIE, I HAVE COMPLETED THE SCIENTIFIC REVIEW FOR ACE-011-DM PK-001. I HAVE BEEN DEALING DIRECTLY WITH KAPIL, ALTHOUGH SUREKHA," THAT'S DR. GANGADKHEDKAR, "IS THE PI. "PETER." DO YOU SEE THAT?
VICTORIA SUNG: UH-HUH, YES.
MR. CLINE: AND IS THIS CONSISTENT WITH YOUR MEMORY THAT IT WAS DR. BRYAN WHO WAS RESPONSIBLE FOR THE SCIENTIFIC REVIEW OF THIS FINAL ASSAY VALIDATION REPORT?
VICTORIA SUNG: SO I DON'T KNOW IF HE WAS THE FINAL REVIEWER, BUT HE WOULD HAVE BEEN A REVIEWER, YES, OF THIS REPORT.
MR. CLINE: SO WHEN YOU SEE HIM SAYING HERE "I HAVE COMPLETED THE SCIENTIFIC REVIEW," THAT'S NO SURPRISE TO YOU; RIGHT?
MR. CLINE: AND THEN IF YOU FLIP OVER TO PAGE 1, MS. GAGLIARDO FROM CELGENE IS SENDING AN EMAIL TO DR. GADKAR ASKING HIM TO SUBMIT A REPORT THAT IS CONSISTENT WITH THE FDA ELECTRONIC SUBMISSION GUIDELINES; RIGHT?
VICTORIA SUNG: RIGHT.
MR. CLINE: AND HE THINKS HE'S DONE SO, BUT HE'S NOT SURE; RIGHT?
VICTORIA SUNG: RIGHT.
MR. CLINE: OKAY. YOUR HONOR, I PROBABLY HAVE GOT ANOTHER TEN MINUTES.
JUDGE DAVILA: LET ME CHECK WITH THE GOVERNMENT TO SEE WHAT THEIR REDIRECT MIGHT BE.
MR. LEACH: VERY MINIMAL AT THIS POINT, YOUR HONOR.
JUDGE DAVILA: IF I WERE TO ASK THIS JURY TO STAY UNTIL 4:30, WOULD WE BE FINISHED WITH THIS WITNESS?
MR. LEACH: CERTAINLY, YOUR HONOR.
MR. CLINE: ABSOLUTELY.
JUDGE DAVILA: LADIES AND GENTLEMEN, IF WE STAYED ANOTHER 25 MINUTES, WOULD THAT OFFEND ANYONE? I SEE NO HANDS. THANK YOU. CONTINUE, MR. CLINE.
MR. CLINE: I WILL TALK QUICKLY.
MR. CLINE: ALL RIGHT. LET'S GO TO 13902. THIS IS AN EMAIL FROM DR. GADKAR TO YOU COPIED TO DR. YOUNG; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: I OFFER 13902.
MR. LEACH: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 13902 WAS RECEIVED IN EVIDENCE.)
BY MR. CLINE:
MR. CLINE: DR. GADKAR IS SENDING YOU AN ASSAY VALIDATION REPORT FOR IGF-1; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND IF YOU LOOK, THE REPORT IS ATTACHED?
VICTORIA SUNG: YES.
MR. CLINE: ALL RIGHT. THE REPORTS THAT YOU'RE RECEIVING FROM DR. GADKAR ARE THESE PD ASSAY VALIDATION REPORTS?
VICTORIA SUNG: YES.
MR. CLINE: AND WERE THERE OTHER ASSAY VALIDATION REPORTS GOING TO THE PK SIDE TO YOUR KNOWLEDGE OTHER THAN THE ONES THAT WE HAVE ALREADY SEEN?
VICTORIA SUNG: SO THERE WOULD HAVE BEEN ONE SINGLE VALIDATION REPORT FOR THAT. THERE'S JUST ONE PK ASSAY.
MR. CLINE: AND THAT'S THE ONE WE SAW?
VICTORIA SUNG: AND THAT'S THE ONE WE SAW.
MR. CLINE: ALL RIGHT. VERY GOOD. ALL RIGHT. WE SPENT SOME TIME ON YOUR DIRECT GOING THROUGH THE POWERPOINT THAT DR. CHEN PREPARED; IS THAT RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND THEN THERE'S ANOTHER POWERPOINT I GUESS THAT YOU PREPARED; IS THAT RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND DR. YOUNG WAS INVOLVED -- WAS THAT A PHONE CALL OR A FACE-TO-FACE MEETING? DO YOU REMEMBER?
VICTORIA SUNG: I DON'T THINK THERE WERE ANY MORE FACE TO FACE MEETINGS AFTER THE INITIAL COUPLE THAT WE HAD IN THE 2009ISH, 2010 RANGE, YEAH.
MR. CLINE: ALL RIGHT. AND SO THIS HAPPENED -- THE DISCUSSION OF THOSE POWER POINTS WAS MARCH 5TH, 2012; CORRECT?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND YOU THINK THAT HAPPENED BY PHONE?
VICTORIA SUNG: I THINK IT HAPPENED BY PHONE, YEP.
MR. CLINE: ALL RIGHT. DO YOU REMEMBER DR. YOUNG BEING ON THAT PHONE CALL?
VICTORIA SUNG: I DON'T REMEMBER EXACTLY WHO WAS ON THAT PHONE CALL, BUT I ASSUME HE WAS BECAUSE HE HAD BEEN INVOLVED THE ENTIRE TIME.
MR. CLINE: OKAY. SO LET'S GO TO EXHIBIT 3893, WHICH I THINK IS IN EVIDENCE. IT MAY NOT BE IN THAT BINDER. IT WILL BE UP ON THE SCREEN, THOUGH, BECAUSE IT'S IN EVIDENCE. DO YOU SEE IT UP THERE?
VICTORIA SUNG: YES.
MR. CLINE: AND DO YOU REMEMBER YOU WERE ASKED SOME QUESTIONS ABOUT THAT ON YOUR DIRECT EXAMINATION; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: I WANT TO GO TO THE THIRD PAGE OF THAT EXHIBIT AND ACTUALLY STARTING ON THE VERY BOTTOM OF THE SECOND PAGE AND GOING TO THE THIRD PAGE, DO YOU SEE THERE'S AN EMAIL FROM DR. YOUNG TO YOU AND DR. CHEN, AND HE COPIED MS. HOLMES AND MR. EDLIN. DO YOU RECOGNIZE THAT AS AN EMAIL FROM YOUR CONSULTANT ON ASSAYS?
VICTORIA SUNG: YES.
MR. CLINE: ALL RIGHT. AND I DON'T WANT TO GO THROUGH THIS WHOLE EMAIL, BUT IN ESSENCE WHAT DR. YOUNG IS DOING IS RESPONDING TO THE CONCERNS THAT YOU HAD EXPRESSED ON BOTH THE PK SIDE AND THE PD SIDE IN THAT MARCH 5TH CALL; IS THAT RIGHT?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND HE GOES THROUGH IN SOME DETAIL AND DISCUSSES YOUR CONCERNS; RIGHT?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND HE PUSHES BACK TO SOME EXTENT ON THOSE CONCERNS; RIGHT?
VICTORIA SUNG: UH-HUH, YES.
MR. CLINE: AND THEN IF YOU GO -- LET'S GO TO PAGE 2 AS WE GO SORT OF BACKWARDS IN THIS EMAIL CHAIN. IF YOU LOOK AT MARCH 23RD, 2012 EMAIL, THIS IS FROM YOU TO DR. YOUNG AND DR. CHEN, COPIED TO MS. HOLMES AND MR. EDLIN. DO YOU SEE THAT?
VICTORIA SUNG: YES.
MR. CLINE: AND YOU SAY, "DANIEL, THANK YOU VERY MUCH FOR YOUR EMAIL AND FOLLOW-UP TO OUR DISCUSSION OF THE PK AND PD RESULTS; WE APPRECIATE THE TIME THAT YOU HAVE TAKEN TO REVIEW THESE DATA AND WILL LET YOU KNOW IF WE HAVE ANY FURTHER QUESTIONS AFTER REVIEWING THAT DATA AGAIN." CORRECT?
VICTORIA SUNG: CORRECT.
MR. CLINE: YOU DID NOT -- NEITHER YOU NOR DR. CHEN, TO YOUR KNOWLEDGE, EVER GAVE A SUBSTANTIVE RESPONSE TO DR. YOUNG'S RESPONSE TO YOUR CONCERNS; CORRECT?
VICTORIA SUNG: CORRECT.
MR. CLINE: THERE'S NO EMAIL THAT GOES POINT BY POINT TO HIS RESPONSE AND SAYS YOU'RE RIGHT ABOUT THIS, YOU'RE WRONG ABOUT THAT; RIGHT?
VICTORIA SUNG: I DON'T RECALL EVER REPLYING TO THAT EMAIL, BUT, AGAIN, IT'S A LONG TIME AGO.
MR. CLINE: SURE. AND YOU DON'T RECALL ANOTHER PHONE CALL WHERE YOU JUST WENT THROUGH WITH DR. YOUNG AND POINT BY POINT DISCUSSED HIS RESPONSE TO YOUR CONCERNS; RIGHT?
MR. CLINE: YOU CAN PUT THAT BINDER ASIDE. IF WE CAN GO TO 7753. CLOSE IT UP AND PUT IT ASIDE.
VICTORIA SUNG: OKAY.
MR. CLINE: AND FIRST I'D LIKE TO GO TO THE PAGE -- THANK YOU VERY MUCH. I'D LIKE TO GO TO THE PAGE THAT HAS AT THE BOTTOM, IN THE BOTTOM RIGHT HAND CORNER, THER-0905724. YOUR HONOR, MAY I APPROACH THE WITNESS AND HAND HER A PAPER COPY?
JUDGE DAVILA: YES.
MR. CLINE: (HANDING.)
MR. CLINE: THIS MIGHT BE A LITTLE BIT EASIER FOR YOU IF YOU HAPPEN TO NEED IT. FEEL FREE TO EITHER USE THE SCREEN OR THE PAPER DOCUMENT.
VICTORIA SUNG: THANK YOU.
MR. CLINE: NOW, DO YOU HAVE THAT PAGE? FEEL FREE TO TAKE YOUR TIME AND FIND IT IN THE DOCUMENT.
VICTORIA SUNG: YES.
MR. CLINE: DO YOU HAVE IT?
VICTORIA SUNG: YES, THE MASTER SERVICE PROVIDER AGREEMENT, YES.
MR. CLINE: AND THIS IS A CONTRACT BETWEEN CELGENE AND THERANOS; CORRECT?
VICTORIA SUNG: CORRECT.
MR. CLINE: DATED JUNE 27TH, 2008?
VICTORIA SUNG: YES.
MR. CLINE: DID YOU EVER REVIEW THIS CONTRACT?
MR. CLINE: DO YOU THINK BEFORE TODAY YOU HAVE EVER EVEN SEEN THIS CONTRACT?
VICTORIA SUNG: I MAY HAVE SEEN IT, BUT NOT -- I WAS NOT PART OF THE REVIEW AND I WASN'T AWARE OF THIS UNTIL AFTER IT WAS EXECUTED.
MR. CLINE: OKAY. SO LET'S NOW MOVE FORWARD TO THE PAGE MARKED THER-0905771, AND IT'S TOWARDS THE END OF THE PAGES THAT I'VE GIVEN YOU.
VICTORIA SUNG: OKAY.
MR. CLINE: ARE YOU THERE?
VICTORIA SUNG: YES.
MR. CLINE: AND THIS IS A STATEMENT OF WORK?
VICTORIA SUNG: YES.
MR. CLINE: AND YOU'RE FAMILIAR WITH STATEMENTS OF WORK FROM YOUR TIME AT CELGENE; RIGHT?
VICTORIA SUNG: CORRECT.
MR. CLINE: ESSENTIALLY IT DESCRIBES A PARTICULAR SET OF TASKS THAT ARE GOING TO BE PERFORMED BY ONE COMPANY AND IN CONJUNCTION WITH ANOTHER COMPANY; CORRECT?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND THIS IS THE STATEMENT OF WORK FOR THE ACE-011 PROJECT THAT WE'VE BEEN TALKING ABOUT; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND YOU WERE FAMILIAR WITH THIS AT THE TIME; RIGHT?
VICTORIA SUNG: WITH THE PROJECT, YES.
MR. CLINE: I'M SORRY?
VICTORIA SUNG: WITH THE PROJECT, YES.
MR. CLINE: OKAY. BUT YOU WERE FAMILIAR WITH THE PROJECT. YOU ALSO SAW THIS STATEMENT OF WORK AT THE TIME THAT YOU WERE WORKING ON THE PROJECT WITH THERANOS; RIGHT?
VICTORIA SUNG: SO THIS STATEMENT OF WORK WAS PUT INTO PLACE, I BELIEVE, AFTER WE GOT INVOLVED AND WERE STARTING TO THINK ABOUT HOW WE WERE GOING TO COLLABORATE WITH THERANOS.
MR. CLINE: SURE. MY QUESTION, AND YOU MAY NOT HAVE A CLEAR RECOLLECTION OF THIS, BUT AT THE TIME THAT YOU WERE WORKING WITH THERANOS, SO STARTING IN 2009, WERE YOU FAMILIAR WITH THIS STATEMENT OF WORK?
VICTORIA SUNG: SO THIS IS NOT IN MY SORT OF REALM AND I DIDN'T REALLY TAKE CARE OF THESE THINGS FROM -- YOU KNOW, AS A SCIENTIST THEY CAME TO ME AND I WOULD BE CONSULTED SOMETIMES AND SAY, YOU KNOW, ARE THESE OBJECTIVES -- YOU KNOW, LOOK AT THIS LITTLE SECTION. DO THESE OBJECTIVES MATCH WITH WHAT YOU WOULD SAY, DO YOU AGREE WITH THEM? THAT'S PRETTY MUCH THE EXTENT OF MY INVOLVEMENT IN THESE -- IN THE PAPERWORK, YEAH.
MR. CLINE: ALL RIGHT. LET'S GO TO THE LAST PAGE OF THIS DOCUMENT. IT'S -- THE BATES NUMBER IS 905774. DO YOU SEE THAT?
VICTORIA SUNG: YES.
MR. CLINE: AND THIS IS THE SIGNATURE PAGE FOR THE STATEMENT OF WORK; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND YOU SEE MS. HOLMES'S SIGNATURE, 18 NOVEMBER 2009; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND THEN THERE'S A RICK MORRISSEY WHO IS SIGNING IT FOR CELGENE; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND WHO IS MR. MORRISSEY?
VICTORIA SUNG: I BELIEVE MR. MORRISSEY AT THE TIME HEADED UP THE LARGER GROUP THAT THE PK GROUP REPORTED IN THROUGH. SO DRS. PETER BRYAN AND NIANHANG CHEN WOULD HAVE REPORTED THROUGH RICK. AND THIS IS -- I THINK, THE SOW WAS FOR THE PK ASSAY POTENTIALLY, NOT FOR THE PD ASSAYS THAT I WAS INVOLVED IN, JUST TO MAKE THAT CONTRAST.
MR. CLINE: OKAY. AND IF YOU LOOK AT -- GOING BACK TO THE FIRST PAGE OF THE STATEMENT OF WORK, 905771, DOWN AT THE BOTTOM THERE'S A HEADING PROJECT PARAMETERS. DO YOU SEE THAT?
VICTORIA SUNG: YES.
MR. CLINE: AND ESSENTIALLY IT DESCRIBES WHAT THERANOS IS SUPPOSED TO DO UNDER THE STATEMENT OF WORK; RIGHT?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND DOES THAT ALIGN WITH THE, AT LEAST THE PK PART OF THE ACE-011 PROJECT THAT WE'VE BEEN TALKING ABOUT?
VICTORIA SUNG: IT DOES.
MR. CLINE: AND THEN IF YOU GO -- TURN OVER TO PAGE 2 NOW OF THIS STATEMENT OF WORK, 905772. AND ABOUT A LITTLE BELOW THE MIDLINE YOU SEE A HEADING PROGRAM COST AND PAYMENT SCHEDULE. DO YOU SEE THAT?
VICTORIA SUNG: YES.
MR. CLINE: AND IT LOOKS LIKE THERANOS IS GOING TO GET PAID $500,000 FOR REALTIME PK ASSAY. DO YOU SEE THAT?
VICTORIA SUNG: YES.
MR. CLINE: AND A LITTLE BIT BELOW THAT YOU SEE THERE'S SUCCESS MILESTONES. DO YOU SEE THAT?
VICTORIA SUNG: YES.
MR. CLINE: AND ESSENTIALLY THIS IS HOW THE 500,000 IS GOING TO GET PAID; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND THIS IS A CUSTOMER WAY OF PAYING THINGS; CORRECT?
VICTORIA SUNG: YES.
MR. CLINE: YOU ACHIEVE A -- SORRY ABOUT THAT. IF YOU ACHIEVE A SUCCESS MILESTONE, YOU GET PAID; AND IF YOU DON'T ACHIEVE IT, YOU DON'T GET PAID; RIGHT?
VICTORIA SUNG: THAT'S CORRECT.
MR. CLINE: ALL RIGHT. AND SO THE FIRST OF THESE SUCCESS MILESTONES IS STATEMENT OF WORK EXECUTION; RIGHT?
VICTORIA SUNG: YES.
MR. CLINE: AND THAT'S BASICALLY SIGNING THIS DOCUMENT WE'RE LOOKING AT RIGHT NOW; RIGHT?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND THAT'S A PAYMENT OF $250,000?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND THEN THE NEXT SUCCESS MILESTONE IS PK ASSAY VALIDATION COMPLETION; RIGHT?
VICTORIA SUNG: RIGHT.
MR. CLINE: AND THE PAYMENT FOR THAT SUCCESS MILESTONE, ACHIEVING THAT SUCCESS MILESTONE IS $200,000; RIGHT?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND THEN THE FINAL SUCCESS MILESTONE IS ACCEPTANCE OF FINAL STUDY REPORT FOR PK ASSAY DEVELOPMENT; RIGHT?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND THE PAYMENT FOR ACHIEVING THAT SUCCESS MILESTONE IS $50,000; RIGHT?
VICTORIA SUNG: RIGHT.
MR. CLINE: AND THAT FINAL STUDY REPORT FOR PK ASSAY DEVELOPMENT IS THE REPORT THAT WE LOOKED AT EARLIER, RIGHT, THAT DR. BRYAN WAS SCIENTIFICALLY --
VICTORIA SUNG: WAS REVIEWING, YES.
MR. CLINE: AND, IN FACT, ALL OF THESE SUCCESS MILESTONES WERE ACHIEVED AND ALL OF THESE PAYMENTS WERE MADE; CORRECT?
VICTORIA SUNG: OH, I DON'T KNOW IF THEY WERE MADE.
MR. CLINE: YOU DON'T KNOW IF THE PAYMENTS WERE MADE?
VICTORIA SUNG: YEAH, I DON'T KNOW. I ASSUME THEY WERE MADE IF THEY WERE ACCEPTED.
MR. CLINE: ALL RIGHT. WHO WITHIN CELGENE WAS RESPONSIBLE FOR DETERMINING IF THERANOS HAD ACHIEVED THE SUCCESS MILESTONES AND SO DESERVED TO BE PAID?
VICTORIA SUNG: SO IT WOULD START WITH THE SCIENTISTS. SO PETER BRYAN AND NIANHANG CHEN, AND RICK MORRISSEY OVERSEEING THEM WOULD MAKE THAT CALL.
MR. CLINE: AND IF THEY DETERMINED THAT THE SUCCESS MILESTONE HAD BEEN ACHIEVED, THEN THE FINANCE PEOPLE --
VICTORIA SUNG: THEN THE FINANCE PEOPLE WOULD PAY.
MR. CLINE: WOULD PAY THE MONEY?
VICTORIA SUNG: CORRECT.
MR. CLINE: AND SO IF THE MONEY WAS PAID, IT'S FAIR TO CONCLUDE THAT THE SCIENTISTS HAD DECIDED THAT THE SUCCESS MILESTONE HAD BEEN ACHIEVED; RIGHT?
VICTORIA SUNG: THAT'S CORRECT.
MR. CLINE: ALL RIGHT. THAT'S ALL OF MY QUESTIONS. THANK YOU.
MR. LEACH: NO REDIRECT, YOUR HONOR. THANK YOU.
JUDGE DAVILA: MAY THIS WITNESS BE EXCUSED?
MR. CLINE: YES.
MR. LEACH: YES, YOUR HONOR.
JUDGE DAVILA: YOU'RE EXCUSED. THANK YOU FOR COMING IN, DOCTOR. WE'LL TAKE OUR BREAK NOW. WE'LL BE BACK IN SESSION FRIDAY MORNING, FRIDAY MORNING, LADIES AND GENTLEMEN. AS I INDICATED, COUNSEL, I'D LIKE TO BREAK AT 1:00 P.M. ON FRIDAY IF THAT'S CONDUCIVE TO YOUR SCHEDULES. LADIES AND GENTLEMEN, WE'LL BREAK FRIDAY AT 1:00 P.M. BEFORE I RELEASE YOU, AGAIN LET ME REMIND YOU, IT'S IMPORTANT THAT YOU PLEASE AVOID AS BEST YOU CAN AND PLEASE DO NOT DO ANY INVESTIGATION, ANY RESEARCH, DO NOT LISTEN TO ANY REPORTS ABOUT ANYTHING TO DO ABOUT THIS CASE OR DO ANY RESEARCH ABOUT ANYTHING WITH THIS CASE OR ANYONE INVOLVED IN IT. I'LL ASK YOU TOMORROW -- OR EXCUSE ME -- FRIDAY MORNING WHETHER OR NOT THAT HAS OCCURRED INADVERTENTLY OR IN ANY OTHER MANNER. SO HAVE A GOOD EVENING. WE'LL SEE YOU FRIDAY MORNING. THANK YOU. WE'LL START AT 9:00 A.M. WE'LL START AT 9:00.
(JURY OUT AT 4:17 P.M.)
JUDGE DAVILA: ALL RIGHT. PLEASE BE SEATED. THANK YOU. THE RECORD SHOULD REFLECT THAT OUR JURY HAS LEFT FOR THE DAY. ALL COUNSEL AND MS. HOLMES ARE PRESENT. ANYTHING FURTHER BEFORE WE BREAK?
MR. BOSTIC: VERY BRIEFLY, YOUR HONOR. TWO ISSUES THAT THE GOVERNMENT WANTED TO FLAG FOR THE COURT BOTH STEMMING FROM THE ONGOING CROSS-EXAMINATION OF DR. ROSENDORFF. FIRST, YESTERDAY THE DEFENSE ASKED DR. ROSENDORFF SOME QUESTIONS ABOUT THE THERANOS LABORATORY INFORMATION SYSTEM. THOSE QUESTIONS INVOLVED NOT ONLY THE CONTENT OF THAT DATABASE BUT ALSO DELVED INTO WHAT DR. ROSENDORFF WAS SHOWN AND SPECIFICALLY THE GOVERNMENT'S DECISION OR THE DEFENSE MIGHT CHARACTERIZE IT AS FAILURE TO SHOW DR. ROSENDORFF ANY EVIDENCE FROM THAT LABORATORY INFORMATION SYSTEM. AS THE COURT KNOWS, THE LIS WAS THE SUBJECT OF PRETRIAL LITIGATION. IN THE COURT'S MOTION IN LIMINE ORDER, THE COURT BARRED THE GOVERNMENT FROM INTRODUCING EVIDENCE THAT, IN FACT, THERANOS WAS RESPONSIBLE FOR THE DESTRUCTION OF THE LABORATORY INFORMATION SYSTEM. THAT ORDER, THOUGH, CONTEMPLATED THE POSSIBILITY THAT THE DEFENSE MIGHT OPEN THE DOOR TO THAT EVIDENCE BASED ON THE EVIDENCE AND QUESTIONS AT TRIAL. IT'S THE GOVERNMENT'S POSITION THAT YESTERDAY THE DEFENSE OPENED THE DOOR AND THAT THE GOVERNMENT SHOULD HAVE THE OPPORTUNITY AT THIS POINT TO ANSWER THAT CHALLENGE AND EXPLAIN TO THE JURY EXACTLY WHAT HAPPENED THROUGH INTRODUCING THAT EVIDENCE. WE'RE NOT ASKING THE COURT FOR A RULING AT THIS TIME. BUT I WANTED TO PUT THE COURT AND THE DEFENSE ON NOTICE THAT WE MAY ASK FOR THE COURT'S GUIDANCE ON THAT IN THE FUTURE.
JUDGE DAVILA: ALL RIGHT. THANK YOU. AND THIS WOULD NOT BE INQUIRED FROM DR. ROSENDORFF. THIS WOULD BE FROM OTHER EVIDENCE OR WITNESSES THAT YOU WOULD INTEND TO CALL?
MR. BOSTIC: THAT'S CORRECT, YOUR HONOR.
JUDGE DAVILA: I SEE. ANY COMMENT, MR. WADE?
MR. WADE: I THINK I MADE A PERTINENT INQUIRY OF THE WITNESS BASED ON THE WITNESS'S TESTIMONY THAT LIS WAS INFORMATION THAT HE ACCESSED ROUTINELY IN CONNECTION WITH INVESTIGATING MATTERS THAT COME UP, AND I ASKED WHETHER HE WAS SHOWN ANY OF THAT INFORMATION IN CONNECTION WITH NUMEROUS INCIDENTS, SPECIFIC INCIDENTS THAT HE WAS ASKED ABOUT ON DIRECT EXAMINATION. HIS ANSWER WAS NO. I DON'T THINK THAT OPENS THE DOOR. I DON'T THINK THAT GIVES THE GOVERNMENT TO SAY WHY, TO EXPLAIN WHY IT DIDN'T GATHER THAT EVIDENCE IN A TIMELY WAY.
JUDGE DAVILA: I THINK WHAT WE'LL ALL DO IS LET'S LOOK AT THE TRANSCRIPT --
JUDGE DAVILA: -- AND READ WHAT THE TRANSCRIPT SAYS. I DO RECALL A LINE OF QUESTIONING WHERE YOU LAID A FOUNDATION TO THE LIS AND YOU -- I THINK THE WITNESS TESTIFIED IN RESPONSE TO YOUR QUESTIONS ABOUT WHAT INFORMATION WAS PUT THERE, WHY, AND HOW IT WAS RETRIEVED. I RECALL A COLLOQUY ABOUT THAT.
JUDGE DAVILA: BUT LET'S LOOK AT THE TRANSCRIPT. THANK YOU FOR THE HEADS UP AND WE'LL, WE'LL -- WE'RE NOT GOING TO DISCUSS IT THIS AFTERNOON, BUT I THINK WE'LL DO A LITTLE BIT OF INDEPENDENT RESEARCH AND WE'LL TOUCH ON THIS AGAIN. I DON'T KNOW WHEN YOU, MR. BOSTIC, HAD THOUGHTS ABOUT ENGAGING THAT.
MR. BOSTIC: I'M NOT SURE EITHER, YOUR HONOR. IT'S SOMETHING THAT WE NEED TO THINK SOME MORE ABOUT HOW IT WILL FIT INTO THE REST OF THE TRIAL PRESENTATION.
JUDGE DAVILA: SURE.
MR. BOSTIC: BUT I WANTED TO RAISE IT IN THE INTEREST OF HAVING THE COURT AND THE PARTIES THINK ABOUT IT.
JUDGE DAVILA: GREAT.
MR. WADE: WE APPRECIATE THE DISCLOSURE, YOUR HONOR, BECAUSE I THINK IT MIGHT INVOLVE ANOTHER SIX OR EIGHT WITNESSES. SO I THINK IT WOULD BE GOOD TO, YOU KNOW, TO CONSIDER IT WITH THE TRANSCRIPT AND TO GET SOME ASSESSMENT AS TO WHETHER THAT'S A LIVE ISSUE.
JUDGE DAVILA: OKAY. GREAT. ANYTHING ELSE THEN?
MR. BOSTIC: YES, YOUR HONOR. JUST ONE MORE ISSUE. THE DEFENSE HAS INFORMED US THAT THE CROSS-EXAMINATION OF DR. ROSENDORFF IS LIKELY TO OCCUPY THE ENTIRE DAY OF TOMORROW. WE HAVE NOTICED THAT BASED ON THE LENGTH OF THE EXAMINATION AND THE SUBSTANCE THAT IT'S FREQUENTLY GONE INTO AREAS THAT ARE BEYOND THE SCOPE OF THE DIRECT. WE HAVEN'T OBJECTED, BUT OUR VIEW IS THAT WE ARE NOW LOOKING AT EVIDENCE THAT IS PART OF THE DEFENSE'S CASE-IN-CHIEF. I'M NOT SURE OF THE DEFENSE'S POSITION ON THAT, BUT IF THE COURT AGREES, IT MIGHT HAVE IMPLICATIONS FOR JURY INSTRUCTIONS AND THE LIKE.
MR. WADE: THE GOVERNMENT OFFERED A BROAD INDICTMENT OF THE LABORATORY PRACTICES AT THERANOS AND ESSENTIALLY PUT THE RESPONSIBILITY FOR THAT AT THE FEET OF MY CLIENT AND OTHERS. I THINK IT'S VERY APPROPRIATE. AND IT HAS PUT AT ISSUE THE ACCURACY AND RELIABILITY OF THE TESTS WHICH THEY ASKED THIS WITNESS TO OPINE ON ON NUMEROUS OCCASIONS. I'VE BEEN EXPLORING THOSE ISSUES WHICH WERE RAISED ON DIRECT. I UNDERSTAND THAT IT'S A LENGTHY EXAMINATION AND WILL CONTINUE TO BE A LENGTHY EXAMINATION, AND THAT'S IN PART BECAUSE OF THE LIMITED AND SELECTIVE NATURE BY WHICH THE GOVERNMENT CONDUCTED ITS EXAMINATION. IT REQUIRES A FAIR AMOUNT OF UNPACKING SO THAT THE JURY HAS THE APPROPRIATE CONTEXT TO UNDERSTAND THE INFORMATION THAT IS IN FRONT OF IT. AND WITHOUT THAT --
JUDGE DAVILA: DOES UNPACKING MEAN BEYOND THE SCOPE OF DIRECT?
MR. WADE: NO. BECAUSE THE WITNESS WHO IS LEGALLY RESPONSIBLE FOR THE LAB CAN'T GET UP AND SAY, FOR EXAMPLE, THAT THE QUALITY CONTROL RESULTS ARE CONCERNING AND DEEPLY TROUBLING TO HIM WITHOUT UNDERSTANDING THE CONTACT. IT'S APPROPRIATE CROSS-EXAMINATION TO UNDERSTAND THE CONTEXT IN WHICH HE'S MAKING THOSE STATEMENTS SO THAT THE JURY IS NOT MISLED BY THE EXAMINATION OF THE GOVERNMENT. THAT'S WHAT I'M DOING ON CROSS-EXAMINATION.
JUDGE DAVILA: THERE ARE TIMES WHEN THE WITNESS HAS TRIED TO OFFER HIS ADDITIONAL THOUGHTS TO CLARIFY AN ANSWER, AND I KNOW YOU'VE ASKED THE COURT TO STRIKE CERTAIN THINGS AND I HAVE. BUT IT MAY BE THAT -- AND I DON'T KNOW WHAT THE GOVERNMENT'S POSITION IS. THEY MIGHT, IF THEY DECIDE TO REDIRECT, THEY MIGHT GO INTO THAT ISSUE. IT'S, IT'S -- SOMETIMES A JUDGE IS PUT IN A POSITION WHERE SHE HAS TO LOOK AND SAY, WELL, THE WITNESS WANTS TO EXPLAIN HER ANSWER AND THE ATTORNEY ASKS A QUESTION, AND IT SEEMS LIKE IT'S ONLY FAIR TO ALLOW A WITNESS TO EXPLAIN THE ANSWER, AS YOU SAY, TO ALLOW THE JURY TO GET THE FULL CONTEXT OF THINGS. THIS IS SOME THAT IT'S A CHALLENGE FOR THE JUDGES TO TRY TO DECIDE, WELL, IS THAT REALLY AN EXPLANATION OR IS THAT SOMETHING ELSE? SO -- AND I DON'T KNOW, I'M NOT BEING -- I'M NOT MAKING ANY OBSERVATION ABOUT YOUR EXAMINATION AT ALL, BUT SOMETIMES A WITNESS FEELS COMPELLED AND SAYS I SHOULD HAVE SAID THIS, I SHOULD HAVE SAID THIS OR THIS IS SOMETHING THAT I MEAN TO ANSWER SUCH THAT YOU CAN BETTER UNDERSTAND THE CONTEXT OF MY RESPONSE.
MR. WADE: I CERTAINLY UNDERSTAND THAT AND THAT UNDOUBTEDLY GOES OR RELATES DIRECTLY TO THE LENGTH OF THE CROSS-EXAMINATION TO THE EXTENT SOME OF THOSE ANSWERS ARE OFFERED. THERE ARE TIMES WHERE I HAVE CONSIDERED IT TO BE SOMEWHAT RELATED AND I'VE LET IT GO. THERE ARE TIMES WHERE I CONSIDER IT TO BE EFFECTIVELY THE WITNESS'S DEFENSIVE IS CONDUCT OR THE EXPLANATION OF THE ITEM THAT IS PUT IN FRONT OF HIM THAT IS NOT THE ITEM PUT IN FRONT OF HIM, WHICH REALLY ISN'T DIRECTLY RELATED. AND IF THE GOVERNMENT WANTS TO GO BACK INTO THAT AND HAVE THE WITNESS PROVIDE MORE CONTEXT, OF COURSE THEY'RE WELCOME TO DO THAT ON REDIRECT, AND I'LL REPRESENT THAT I WON'T MAKE A SCOPE OBJECTION WITH RESPECT TO THAT.
JUDGE DAVILA: SURE.
JUDGE DAVILA: I POINT THAT OUT. I THINK WE ALL UNDERSTAND THE CHALLENGES OF THAT. BUT I THINK THAT -- I RECALL THIS AFTERNOON THE WITNESS STARTED TO SAY SOMETHING AND THEN HE SAID, WELL, NEVER MIND, HE THREW HIS HANDS UP. I THINK HE'S HEARD THE COURT SAY STRIKE FOR NONRESPONSIVE AND PERHAPS HE'S UNDERSTANDING THAT CONCEPT.
JUDGE DAVILA: IT IS. IT IS.
MR. WADE: I WOULD NOTE THAT -- AND I'M NOT SURPRISED BY THIS. THERE'S NO IN ANY WAY NEGATIVE JUDGMENT. OF COURSE, MR. BOSTIC THOUGHT WE WERE GOING TO HAVE A TWO AND A HALF HOUR DIRECT EXAMINATION. I THINK WE WERE ALL OF ONE DAY AND ALMOST HALF OF THE NEXT DAY. I'M NOT -- I DON'T THINK I'M YET PAST THAT AND YET WE'VE HAD SOME -- WE'VE LIMITED THE EXAMINATION TODAY AND WE STOPPED AT 2:00 O'CLOCK AND SO --
JUDGE DAVILA: AND SO CAN I ASK YOU "THE MR. BOSTIC QUESTION" ARE YOU CLOSER TO THE BEGINNING OR CLOSER TO THE END?
MR. WADE: I WOULD SUGGEST I'M AT LEAST AT HALFTIME, YOUR HONOR. YOU KNOW, SOMETIMES THE SECOND HALF IS THE MORE EXCITING HALF.
(LAUGHTER.)
MR. WADE: SO WE'RE GOING TO KEEP GOING. I'LL HAVE A BETTER ESTIMATE. AS I TOLD MR. BOSTIC, WE HAVE DISCUSSED MEETING AND CONFERRING WITH RESPECT TO THIS TOMORROW AND WITH RESPECT TO SOME OF THE RELATED ISSUES.
JUDGE DAVILA: WELL, WE DON'T HAVE A GAME CLOCK ON, DO WE?
JUDGE DAVILA: WELL, I SAY THAT AND I'M SUGGESTING THAT THERE IS NO TIME LIMIT IN A CRIMINAL CASE. YOU KNOW THAT. AND THE COURT IS NOT IN ANY WAY GOING TO SUGGEST THAT YOU HAVE TIME LIMITS ON THE PREPARATION. I'M NOT GOING TO INVOLVE IT AT ALL, IMPEDE YOUR CLIENT'S SIXTH AMENDMENT RIGHT TO A FAIR TRIAL AND TO PUT ON THE DEFENSE THAT SHE FEELS IS APPROPRIATE. I'M NOT SUGGESTING THAT AT ALL.
JUDGE DAVILA: BUT I DO WANT TO -- I'M MINDFUL OF OUR TIME ESTIMATE AND TRYING TO MANAGE THAT AS BEST WE CAN. THIS JURY HAS BEEN VERY GOOD ABOUT ME EXTENDING, TO CONTINUE WITH THE SPORTS DISCUSSION, EXTENDING THE GOAL LINES ON OUR TIME. SO THEY'VE BEEN VERY GOOD ABOUT THAT. AND WE'LL PROBABLY HAVE TO CONTINUE TO DO THAT.
MR. BOSTIC: YOUR HONOR, JUST TWO BRIEF POINTS IN RESPONSE. FIRST OF ALL, SO I DID TELL DEFENSE COUNSEL THAT I ESTIMATED MY DIRECT WAS GOING TO BE 2.5 HOURS-PLUS. THE PLUS ENDED UP DOING A LOT OF WORK IN THAT.
(LAUGHTER.)
MR. BOSTIC: BUT JUST FOR THE RECORD, I'M ACTUALLY NOT QUITE THAT BAD AS ESTIMATING. MORE IMPORTANTLY, ON THE SCOPE OF THE CROSS, THERE'S NO DOUBT THAT THE ACCURACY OF THERANOS'S TESTS ARE AT ISSUE IN THIS CASE. I'M NOT TRYING TO PREVENT THE DEFENSE FROM ANSWERING THOSE POINTS. BUT THAT DOESN'T SWALLOW THE RULE ABOUT THE SCOPE OF DIRECT AND THE CORRELATION TO THE SCOPE OF CROSS. DURING THE CROSS-EXAMINATION, FOR EXAMPLE, THE LENGTHY DISCUSSION OF VALIDATION REPORTS, THEIR CONTENT, THE VALIDATION PROCESS, THAT DOES NOT BEAR A CLOSE NEXUS TO THE SUBSTANCE OF THE DIRECT IS THE GOVERNMENT'S POSITION. WHEN WE GET INTO THOSE AREAS, OUR VIEW IS THAT WE'RE ENTERING THE DEFENSE CASE-IN-CHIEF TERRITORY, AND THAT'S PROBABLY WHY WE'RE RAISING THE ISSUE NOW.
JUDGE DAVILA: OKAY.
MR. WADE: WITH ALL DUE RESPECT, WE COULDN'T AGREE MORE STRONGLY GIVEN THE SCOPE OF THE GOVERNMENT'S DIRECT EXAMINATION. THEY PUT AT ISSUE ALL OF THESE ASSAYS AND THE TESTS PERFORMED ON THE EDISON DEVICES THROUGH DR. ROSENDORFF. HE MADE BROAD STATEMENTS, BROAD INDICTMENT, FRANKLY, OF HIS OWN WORK AT TIMES. WE HAVE TO UNPACK THAT, AND THAT'S NOT EASY BECAUSE THE LAB IS COMPLICATED. AND I DON'T THINK IT'S LIMITED TO CROSS-EXAMINING HIM ON THE EMAIL. THEY WENT THROUGH A LOT OF DIFFERENT ASSAYS, THEY WENT THROUGH A LOT OF GENERAL PRACTICES, AND I THINK IT'S NECESSARY FOR THE JURY TO BE ABLE TO UNDERSTAND THE CONTEXT IN WHICH THAT IS OFFERED, OTHERWISE, OTHERWISE THE EVIDENCE THAT WAS OFFERED BY THE GOVERNMENT IS VERY MISLEADING.
JUDGE DAVILA: ALL RIGHT. WELL, THANK YOU FOR THE DISCUSSION. WELL, IT SOUNDS LIKE WE WILL HAVE DR. ROSENDORFF BACK ON TUESDAY NEXT AND HE'LL FINISH, OF COURSE, FRIDAY, BUT WE WON'T FINISH WITH HIS EXAMINATION FRIDAY WITH THAT LIMITED TIME. AND IT SOUNDS LIKE HE MIGHT BE HERE FOR THE ENTIRETY OF TUESDAY. IS THAT A FAIR ASSESSMENT DO YOU THINK?
MR. WADE: I'LL HAVE A BETTER SENSE OF THAT. AND I'M INFERRING FROM MR. BOSTIC THAT HE MAY HAVE SOME REDIRECT. SO WE'LL MEET AND CONFER, AND WE'LL KEEP THE COURT APPRISED ON FRIDAY AT THE END OF THE DAY AS TO WHERE WE STAND.
JUDGE DAVILA: OKAY. THAT'S GREAT. AND THEN YOU'RE ADJUSTING, MR. BOSTIC, YOUR TEAM IS ADJUSTING YOUR WITNESS SCHEDULES ACCORDINGLY? ON EITHER SIDE IF THERE ARE ANY -- YOU'LL LET ME KNOW IF YOU HAVE ANY WITNESS ISSUES AND THEN WE CAN CALENDAR ACCORDINGLY.
MR. BOSTIC: WE WILL, THANK YOU.
JUDGE DAVILA: AND THAT'S ON BOTH SIDES.
JUDGE DAVILA: GREAT. THANKS. HAVE A GOOD EVENING, AND WE'LL SEE YOU ON FRIDAY. THANK YOU.
COURT CLERK: COURT IS ADJOURNED.
(COURT ADJOURNED AT 4:30 P.M.)