UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` MYLAN PHARMACEUTICALS, INC.
` Petitioner
`
` vs.
`
` YEDA RESEARCH AND DEVELOPMENT CO. LTD.,
` Patent Owner
`
` Case IPR2015-00643 (8,232,250)
` Case IPR2015-00644 (8,399,413)
` Case IPR2015-00830 (8,969,302)
`
` DEPOSITION OF DR. ARI GREEN
` San Francisco, California
` Thursday, October 22, 2015
` Volume I
`
`REPORTED BY:
`ASHLEY SOEVYN
`CSR No. 12019
`
`The Little Reporting Company
` (646) 650-5055 | www.littlereporting.com
`
`IPR2015-00644
`
`EXHIBIT NO. 1065 PAGE 1
`
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` MYLAN PHARMACEUTICALS, INC.
` Petitioner
`
` vs.
`
` YEDA RESEARCH AND DEVELOPMENT CO. LTD.,
` Patent Owner
`
` Case IPR2015-00643 (8,232,250)
` Case IPR2015-00644 (8,399,413)
` Case IPR2015-00830 (8,969,302)
`
` DEPOSITION OF DR. ARI GREEN
` San Francisco, California
` Thursday, October 22, 2015
` Volume I
`
`REPORTED BY:
`ASHLEY SOEVYN
`CSR No. 12019
`
`The Little Reporting Company
` (646) 650-5055 | www.littlereporting.com
`
`IPR2015-00644
`
`EXHIBIT NO. 1065 PAGE 1
`
`
`
` UNITED STATES PATENT AND TRADEMARK
` OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`2
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` MYLAN PHARMACEUTICALS, INC.
` Petitioner
`
` vs.
`
` YEDA RESEARCH AND DEVELOPMENT CO. LTD.,
` Patent Owner
`____________________________________________________
`
` DEPOSITION of DR. ARI GREEN, Volume I,
`taken on behalf of the Patent Owner Yeda, at Three
`Embarcadero Center, 24th Floor, San Francisco,
`California, beginning at 9:20 a.m. on October 22,
`2015, before Ashley Soevyn, Certified Shorthand
`Reporter No. 12019.
`
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` (646) 650-5055 | www.littlereporting.com
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`APPEARANCES:
`For the Patent Owner Yeda
` GOODWIN & PROCTER
` BY: ELIZABETH J. HOLLAND
` APRIL WEISBRUCH
` JOHN BENNETT
` Attorneys at Law
` 620 Eighth Avenue
` New York, New York 10018-1405
` E-mail: eholland@goodwinprocter.com
` aweisbruch@goodwinprocter.com
` jbennett@goodwinprocter.com
` Phone: (212) 813-8800
`
`For Mylan & the Deponent
` PERKINS COIE
` BY: DAVID ANSTAETT
` SHANNON M. BLOODWORTH
` Attorneys at Law
` 700 13th Street, NW
` Suite 600
` Washington, DC 20005-3960
` E-mail: danstaett@perkinscoie.com
` sbloodworth@perkinscoie.com
` Phone: (202) 654-6204
`
`The Little Reporting Company
` (646) 650-5055 | www.littlereporting.com
`
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`APPEARANCES (continued):
`For Mylan
` WILSON SONSINI GOODRICH & ROSATI
` BY: LORELEI P. WESTIN, Ph.D.
` Attorney at Law
` 12235 El Camino Real
` Suite 200
` San Diego, California 92130-3002
` E-mail: lwestin@wsgr.com
` Phone: 650-493-9300
`
`For Amneal Pharmaceuticals
` DUANE MORRIS
` BY: CHRISTOPHER S. KROON
` Attorney at Law
` 100 High Street
` Suite 2400
` Boston, MA 02110-1724
` E-mail: cskroon@duanemorris.com
` Phone: (857) 488-4276
`ALSO PRESENT: Lori Wofe, Senior Counsel, Teva
`Pharmaceuticals and Matthew Greinert, In-house
`Counsel, Mylan
`
`The Little Reporting Company
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`
`IPR2015-00644
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`EXHIBIT NO. 1065 PAGE 4
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`5
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` INDEX
`WITNESS EXAMINATION
`ARI GREEN, M.D.
`Volume I
`
`BY MS. HOLLAND 6
`
` E X H I B I T S
`No. DESCRIPTION PAGE
`Exhibit 2028 Comi Slides 99
`Exhibit 2029 Glacier Study 179
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` San Francisco, California, October 22, 2015
` 9:20 a.m.
`
`6
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` ARI GREEN, M.D.,
`having been administered an oath, was examined and
`testified as follows:
`
` MS. HOLLAND: Elizabeth Holland of Goodwin
` Proctor for Patent Owner, Yeda, and with me
` today is John Bennett and April Weisbruch and
` Lori Wolfe of Teva.
` MR. ANSTAETT: David Anstaett of Perkins
` Coie on behalf of Mylan. And since we have a
` number of people here, I'm going to let each of
` them make their own introduction.
` MS. BLOODWORTH: Shannon Bloodworth with
` Perkins Coie on behalf of Mylan.
` MR. KROON: Christopher Kroon, Duane
` Morris, LP.
` MS. WESTIN: Lorelei Westin of Wilson,
` Sonsini, Goodrich & Rosati on behalf of Mylan.
` MR. GREINERT: Matt Greinert with Mylan.
` EXAMINATION
`BY MS. HOLLAND:
` Q Good morning, Dr. Green.
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` A Good morning.
` Q What is your area of expertise?
` A I'm a clinician scientist who has a focus
`in multiple sclerosis. Also, my clinical activity
`also focuses on neuro ophthalmology and neurological
`conditions. And I have a laboratory that focuses on
`repair and neuro-degeneration in MS and therapies
`intended to help with repair in the disease.
` Q Okay. So you said you're a clinician
`scientist?
` A I did.
` Q With a focus on multiple sclerosis?
` A Yes.
` Q Do you have an area of specialty within
`multiple sclerosis?
` A Within multiple sclerosis?
` Q Yeah.
` A I have some clinical activity that focuses
`on neuro-ophthalmologic manifestations of the
`disease, but I'm a clinician that cares for patients
`with MS.
` Q Okay. Do you have any expertise in
`pharmacokinetics?
` A Do I have a expertise in pharmacokinetics?
`No.
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` Q Do you have expertise in pharmacology?
` A No.
` Q Do you have expertise in immunology?
` A I have training in neuro immunology,
`clinical immunology, but I am not an immunologist.
` Q What do you mean by training in neuro
`immunology?
` A Clinical neuro immunology.
` Q Can you explain what you mean by that?
` A Sure. So clinical neuro immunology
`deals -- intended for treatment and care for
`patients with inflammatory conditions of the central
`nervous system.
` Q How does that distinct from neurology?
` A It a subspecialty of neurology.
` Q And what exactly does the neuro immunology
`deal with as a subspecialty of neurology?
` A We care for patients with multiple
`sclerosis and other neuro inflammatory conditions of
`the central nervous system.
` Q Do you have any special training in
`immunology?
` A Part of that training includes training in
`immunology, but we are not -- we're not
`immunologists. I'm not a laboratory immunologist.
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` Q What type of training do you have in
`immunology?
` A We have weekly conferences dealing with
`neuro-immunological issues. I have -- I spent years
`in the laboratory dedicated to genetics and neuro
`immunology, so the training is not around all of
`immunology. It's around specific areas of
`immunology that are pertinent to the care of
`patients with these conditions.
` Q And is it a clinical training?
` A Well, it's both. You can't separate so
`clearly between clinical training and the scientific
`basis for understanding the relationship between
`immune dis-regulation and the disease, but I
`wouldn't classify myself as a immunologist.
` Q Have you taken course work in immunology?
` A Not course work, no.
` Q Have you performed any dose ranging
`studies?
` A With regards to what in particular?
` Q Any pharmaceutical or therapeutic agent?
` A In what role specifically are you asking
`me about that I would have played a role in? You
`mean directly changing doses in a human patient or
`in an animal?
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` Q I'm asking very broadly at the beginning.
`Have you had any involvement in dose ranging
`studies?
` A I have.
` Q What has your involvement been?
` A Some of that is confidential information
`related to research that I do that is -- that is --
`that is bound by confidentiality agreements.
` Q This is current research?
` A It is.
` Q When did you start doing that research?
` A I've been doing that research for about
`the last three to four years.
` Q So it was about 2012-ish you started doing
`the dose ranging research?
` A Well, started to investigate particular
`compounds in that time range, and the dose ranging
`investigations would have followed on afterwards.
` Q Did you have any involvement with dose
`ranging investigations prior to this research that
`started in about 2012?
` A No.
` Q I understand that the -- you said that the
`compound you're investigating is confidential; is
`that right?
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` A It is.
` Q Okay. But don't tell me the name of the
`compound, but just tell me what your role is in the
`research.
` A I'm a scientific founder of a company
`dedicated to investigating a class of compounds.
`And I'm also involved on a scientific advisory for a
`company that is investigating other compounds.
` Q So what is your particular role with
`respect to the dose ranging studies?
` A Some of that is confidential, but as far
`as I can disclose to you, it would be as a
`clinician, providing guidance, in terms of what we
`would look for, what we would want to see as an
`outcome, but then also as a translational scientist,
`thinking about the outcomes that may be relevant in
`animal models that might help us inform us for
`future human studies.
` Q Have you ever had any involvement in the
`selection of the appropriate dose that a
`pharmaceutical company would use to develop a
`pharmaceutical product?
` A If you can clarify what you mean by "any
`role," it would be helpful.
` Q Again, I'm asking very broadly.
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` A So if you're asking very broadly, yes,
`because oftentimes in regards to either consulting
`arrangements or advisory participation that I've had
`with them, or the number of companies, there would
`be questions raised about dosing, and those
`questions would be broadly discussed both within the
`advisory capacity as well as more specifically
`following on in private discussions with people from
`the company.
` Q When did these consulting and advisory
`positions take place?
` A Well, that's been over the course of my
`career.
` Q Beginning when?
` A Well, it's not something I've reviewed. I
`don't know if I could give you exact date, but
`sometime in the last ten years.
` But that's, again, speaking broadly. If
`you're asking more specifically about that
`scientific advisory work, that's more in the last
`four years, three or four years, as we've covered.
` Q What did you mean when you said that's
`"speaking broadly"?
` A Well, you used the term "broadly."
` Q No, I understand that, but you
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`differentiated the prior consulting work from what
`you've been doing in the last four years. Can you
`explain the difference between --
` A Sure.
` Q -- what you were doing then and what
`you're doing now?
` A Sure. So in the past, that role was much
`more broad advisory discussions surrounding
`development of a compound or maybe late-stage
`development of a clinical program.
` More recently, it's much and earlier-stage
`development that we're talking about.
` Q In the -- in the earlier years that you
`were just referring to, what exactly was your role
`on the consulting or advisory boards with respect to
`dose selection?
` A It would have just been part of the broad
`discussion about clinical trial development, and it
`would have been discussions around dosing, but it
`would not be characterized as a focus of the
`discussion.
` Q Do you consider yourself an expert in
`preclinical research?
` A I consider myself a translational
`scientist, yes.
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` Q Do you consider yourself an expert in
`preclinical research? And then we'll get to the
`next question.
` A Sure. That's preclinical. So
`translational science is part preclinical.
` Q If I understand your answer, are you
`saying that you're an expert in the subspecialty
`within preclinical research that is translational
`research?
` A If you could clarify -- clarify your
`question, please.
` Q I will try. You said -- I asked you if
`you were an expert in preclinical research, and then
`you said you're an expert in translational science.
` A Yes.
` Q Does that mean that translational science
`is one aspect of preclinical research?
` A No. I mean more that they're overlapping.
`Preclinical research could be everything going all
`the way back to basic, fundamental molecular
`biology, and translational science can be all the
`way into early-phase studies with the patient. So
`there's overlap -- overlap between preclinical
`research and translational science. Neither one is
`a subset of the other.
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` Q The early-phase studies with patients is
`clinical research, right?
` A It depends on the context. Depends on
`what you're trying to learn. Some of it's
`translational.
` Q What do you mean by translational then?
` A Well, so there's a number of different
`types of translational research. There's what's
`referred to as T1, T2, and T3 by some people. So T3
`is actually implementation research. It's actually
`taking something that's been discovered in the
`clinic and figuring out how you deliver it to
`patients.
` T1, on other hand, is that very early
`phase, which is early development that may have
`implications for patients, but focusing not just on
`broad scientific questions, but focusing on how do
`you apply a discovery in the laboratory, how do you
`plan discoveries in the laboratory in order to
`deliver them to patients. And T2 is between those
`two, and my focus of research is largely in T2.
` Q What is -- describe your research that you
`say is in T2.
` A So it's research intended to help
`accelerate the development of therapeutics by coming
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`up with measures that can be used in animal models
`that would hopefully translate into application in
`patients once the drug is used in patients.
` Q How long have you been working in
`translational science?
` A That's my career.
` Q Have you ever performed research on
`therapeutic agents in any animal models?
` A I have.
` Q When was that?
` A I think I just clarified that's been what
`I've done for a number of years, but I've been -- my
`laboratory has worked with animal models -- my
`laboratory has worked with animal models for at
`least the last five years.
` Q Has your laboratory worked -- withdrawn.
` Did you work with animal models prior to
`that time?
` A Yes. Going back to when I did laboratory
`science, during training, I worked with animal
`models.
` Q What is the current focus of your
`research?
` A I think I answered, but can you further
`clarification.
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` Q Are you working on any specific drugs at
`the current time?
` A I am, but I think I described that some of
`those are bound by confidentiality. However, what I
`can tell you is we've -- a large focus on my current
`research is on re-myelination and repair of multiple
`sclerosis.
` Q Are you working with new therapeutic
`agents for that purpose?
` A Yes.
` Q And are these things that were developed
`as part of the company that you've founded?
` A Yes. In part. It is my academic
`laboratory that's not dedicated to research solely
`around what the company is focused on.
` Q Let me see if I understand this. So you
`do some research in an academic setting, and then
`other research outside the academic setting for the
`company you founded; is that accurate?
` A I participated in that research and,
`provide supervisory function for that research and
`advice as the company moves forward.
` Q What's the focus of your research in the
`academic setting?
` A Exactly what I just told you.
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`Re-myelination and repair of multiple sclerosis,
`understanding how we can use animal models in MS to
`develop better therapeutics.
` Q And what therapeutic agents do you use in
`your academic laboratory?
` A Some of those are still unpublished
`material, and I wouldn't -- I don't think are
`pertinent to the discussion here today.
` Q Are there any that are published?
` A We have in collaboration a paper published
`in the last few years in Nature Medicine that
`focuses on screening methods for looking for
`compounds capable of inducing repair in multiple
`sclerosis.
` Q Do you consider yourself an expert in
`conducting clinical trial?
` A I do. I have training in that area.
` Q What type of training do you have in that
`area?
` A I have a Master's in clinical research
`from UCSF I was awarded in 2007 that focused on
`clinical research, clinical trials, and
`translational research.
` Q Have you ever designed any clinical
`trials?
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` A I have.
` Q Which clinical trials?
` A I have an ongoing clinical trial right now
`that's just completed that I designed and fully
`executed.
` Q Can you describe that trial?
` A It's a trial around just what we just
`spoke about, re-myelination and repair.
` Q Has it been published?
` A It has not.
` Q Was that first clinical trial that you
`designed?
` A Designed on my own?
` Q Yes?
` A Yes.
` Q And when did you design that clinical
`trial?
` A In around 2013.
` Q Prior to that time, did you participate in
`the design of any clinical trials?
` A I did.
` Q Which clinical trial?
` A So I participated in design for a number
`of companies, but, for example, for the Phase III
`clinical trials for Ocreluzimab -- I'll spell it for
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`you. O-C-R-E-L-U-Z-I-M-A-B.
` THE REPORTER: Thank you.
` THE WITNESS: That's a humanized model
` clone antibody that is intended for the
` treatment of patients with multiple sclerosis
` recently released its results in the last two
` weeks.
`BY MS. HOLLAND:
` Q When did you participate in the design of
`that trial?
` A Again, some of this is confidential
`between me and the company that I provided advice
`to, but timing would have been during the period of
`planning. I don't remember the years. It was
`around 2010, '11. I don't know for sure.
` Q Have you participated in the design of any
`other clinical trials?
` A I have.
` Q Which trials?
` A So I also worked in the capacity as a
`member of the scientific advisory board for another
`company, Bionore, that's focused on repair molecules
`for treatment of multiple sclerosis, and provided
`them advice in that regard.
` Q What type of advice did you provide?
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`The Little Reporting Company
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`IPR2015-00644
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`EXHIBIT NO. 1065 PAGE 20
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` A The design of the clinical trials.
` Q What aspect of the clinical trials?
` A All aspects?
` Q Statistics? Did you provide advice on
`statistics?
` A Ultimately, on what you would look at in
`the analysis. That could include statistics.
`Statistics is a pretty broad concept.
` Q Do you consider yourself an expert in
`statistics?
` A I do not.
` Q What was the first clinical trial that
`you -- where you participated in the design of the
`trial?
` A It's not something I've thought about
`lately, or reviewed, but I think it would probably
`be related to either Ocreluzimab, the compound we
`just spoke about, or Ritoximab, the precursor
`compound that was evaluated by Genentech, which is a
`subsidiary of Roche.
` Q Have you ever used an animal model to test
`a therapeutic agent?
` A I have.
` Q Is that work that you've done since 2012?
` A Again, the challenge, I find here is that
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`The Little Reporting Company
` (646) 650-5055 | www.littlereporting.com
`
`IPR2015-00644
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`EXHIBIT NO. 1065 PAGE 21
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`these are broad concepts. Do you mean any
`participation on my part, or do you mean strictly
`out of my own laboratory?
` Q Well, let's start with your own
`laboratory.
` A So since 2012, that work has come out of
`my laboratory.
` Q Does that -- withdrawn.
` Prior to 2012, have you ever used an
`animal model to test the therapeutic agent in your
`own laboratory?
` A No.
` Q You were talking about the Ritoximab
`clinical trial for Genentech. When did that take
`place?
` A I think those were published in around
`2008 or so.
` Q What was your role in the design of that
`trial?
` A I was asked to provide advice while the
`trials were being designed. So it was an advisory
`board capacity, invited to provide advice and
`consulting.
` Q Do you recall what specific type of advice
`you provided to Genentech?
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`The Little Reporting Company
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`IPR2015-00644
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`EXHIBIT NO. 1065 PAGE 22
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` A I can't disclose that.
` Q I'm not asking for the advice you gave,
`but was it with respect to a specific aspect of the
`clinical trial?
` A I would -- I was -- I would often be
`consulted on issues like outcomes, what would you
`look at as an outcome for a clinical trial. But,
`again, these are broad-ranging discussions. They
`involve lots of people. Some of them are many years
`ago.
` Q Are there standard endpoints that you look
`for in an MS clinical trial?
` A If you could clarify the question. If
`you're asking, are there standard endpoints that
`have been used for agents intended for the treatment
`of -- for the use of immunomodulatory agents for the
`treatment of MS, or agents that address immune
`dis-regulation of the disease, the answer would be
`yes.
` Q What are those standard endpoints?
` A So the most prominent ones would be
`relapse rate, sustained disability progression,
`which would include disability score like EDSS, MRI
`outcomes, including the presence of new lesions,
`glatiramer-enhanced lesions, changes in the brain
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`The Little Reporting Company
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`IPR2015-00644
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`EXHIBIT NO. 1065 PAGE 23
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`atrophy.
` But if there is a portion in my report
`that you're referring to that might be illuminating
`to us as we continue this conversation, it might be
`good if we could point to it.
` Q This is illuminating to me right now.
`Thank you.
` Have you ever participated in a trial
`where MRI was the endpoint?
` A I have.
` Q Which trial was that?
` A All the trials I just spoke to you about.
`MRI would have been one of the endpoints.
` Q Was MRI the primary endpoint in any of
`those trials?
` MR. ANSTAETT: Objection. Form.
` THE WITNESS: So you're asking if MRI was
` the primary endpoint in any clinical trials
` that I've -- that I've looked at? Yeah.
`BY MS. HOLLAND:
` Q Yes, that you've participated in.
` A I don't believe so, no.
` Q In the clinical trials you've participated
`in, what was the primary endpoint?
` A It would depend on the trial. So there's
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`The Little Reporting Company
` (646) 650-5055 | www.littlereporting.com
`
`IPR2015-00644
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`EXHIBIT NO. 1065 PAGE 24
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`been a broad range of trials, and you've used the
`word that I've "participated" in. Now we're not
`talking about the trials I've designed, but we're
`talking about the trials I've participated in. It
`would help if you could clarify.
` Q Sure. Let's start with the trials you've
`testified earlier that you helped designed. What
`were the primary endpoints in those trials?
` A Most of those were phase -- late Phase II
`or phase III clinical trials, so in that context the
`clinical outcome would typically -- I mean, the
`primary outcome would be typically be a clinical
`outcome. MRI would be a secondary outcome.
` Q What's the difference between a primary
`outcome and a secondary outcome?
` A Primary outcome is the outcome that you're
`going to use with a regulatory body to say this
`shows evidence of effect. Secondary outcomes are
`sometimes characterized as exploratory. In other
`instances, they are there to support what
`conclusions you reach by looking at the primary
`outcome.
` MS. HOLLAND: This is off the record.
` (Off the record.)
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`The Little Reporting Company
` (646) 650-5055 | www.littlereporting.com
`
`IPR2015-00644
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`EXHIBIT NO. 1065 PAGE 25
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`BY MS. HOLLAND:
` Q Have you ever been involved with a
`clinical trial in which MRI was the primary
`endpoint?
` A No.
` If I could clarify again. You've used the
`word "involved." So you -- earlier, we were talking
`about helped in design. I'd have to think more
`about whether or not I've been involved in any way
`with a trial in which MRI was the primary outcome.
` Q Can you think of any as you sit here right
`now?
` A I could. I don't know I don't recall the
`primary outcome in some of these trials, but in the
`early stage Daclizumab clinical trials. So that's
`D-A-C-L-I-Z-U-M-A-B.
` THE REPORTER: Thank you.
` THE WITNESS: I suspect that MRI was the
` primary outcome, but I don't recall.
`BY MS. HOLLAND:
` Q What do you mean by "early-stage" trials?
` A Not Phase III registration trials, but
`Phase II clinical trials.
` Q Do you have an understanding one way or
`the other about whether a -- an MS drug could be
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`The Little Reporting Company
` (646) 650-5055 | www.littlereporting.com
`
`IPR2015-00644
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`EXHIBIT NO. 1065 PAGE 26
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`approved based only on a trial where MRI was the
`primary endpoint?
` MR. ANSTAETT: Objection. Form.
` THE WITNESS: I do.
`BY MS. HOLLAND:
` Q What is your understanding?
` A It would require typically that you have a
`clinical endpoint. The clinical endpoint that's
`accepted by the FDA is generally been annualized
`relapse rate.
` Q What is an open label study?
` A An open label study? An open label study
`is a study in which both the investigator and the
`patient may be aware of their exposure to a
`compound, as distinct from a study in which the
`investigator and/or the patient are blinded to which
`therapy they're receiving.
` Q What kind of information can you get from
`an open label study?
` MR. ANSTAETT: Objection. Form.
` THE WITNESS: You can get information that
` would help you to determine if something would
` be worth pursuing in the future; as in, you
` might -- it might be worth putting the
` resources into. You may have a reasonable
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`The Little Reporting Company
` (646) 650-5055 | www.littlereporting.com
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`IPR2015-00644
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`EXHIBIT NO. 1065 PAGE 27
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` expectation that what you do in a future study
` that's going to be more resource intensive or
` more costly will yield results that are
` promising or help with the advancement of a
` therapy.
`BY MS. HOLLAND:
` Q How do Phase II and Phase III trials
`differ from each other?
` A Phase II trials are typically still in the
`range of looking at safety outcomes. They may be
`looking at adverse events, but they also will look
`at clinical endpoints for -- to help a company or a
`sponsor figure out if this is something worthy of
`continued pursuit with a much more expensive and
`larger scale Phase III study.
` Q Are Phase III trials better powered than
`Phase II trials?
` MR. ANSTAETT: Objection. Form.
` THE WITNESS: That's -- I think that's --
` the simple answer to that question is no.
`BY MS. HOLLAND:
` Q What -- let me withdraw that. Sorry.
` Can you conform conclusions concerning
`efficacy or safety based on the results of a Phase
`II trial?
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`The Little Reporting Company
` (646) 650-5055 | www.littlereporting.com
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`IPR2015-00644
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`EXHIBIT NO. 1065 PAGE 28
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` MR. ANSTAETT: Objection. Form.
` THE WITNESS: You can form some
` conclusions. The question is, are they
` definitive conclusions? So, of course, there
` would be no point to them if you couldn't form
` some conclusion from them.
` So Phase II clinical trials are useful for
` forming conclusions that help you with making
` decisions about whether or not to proceed with
` a Phase III clinical study, or they create
` motivation for further research.
`BY MS. HOLLAND:
` Q Just to be clear, do you agree that you
`can't form definitive conclusions from the results
`of Phase II trials?
` MR. ANSTAETT: Objection. Form.
` Objection. Asked and answered.
` THE WITNESS: When you ask about
` definitive conclusions, if you're asking, can
` you gain regulatory approval from the FDA from
` a Phase II clinical study, in most instances
` the answer is no; although, there are
` exceptions that the FDA grants in which they
` allow for what are called sometimes Phase
` II/III clinical studies. However, the general
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` concept is the phase -- at least two Phase III
` clinical studies are required for registration.
` That is entirely distinct from the notion of
` formation of a conclusion, and I think the
` terminology being used here could so
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