`
`Transcript of Paul A. Bunn, Jr.,
`M.D.
`
`Date: July 11, 2017
`Case: Apotex Inc., et al. -v- OSI Pharmaceuticals, Inc. (PTAB)
`
`Planet Depos
`Phone: 888.433.3767
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`WORLDWIDE COURT REPORTING | INTERPRETATION | TRIAL SERVICES
`
`APOTEX EX. 1048-001
`
`
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` APOTEX INC., APOTEX CORP., APOTEX PHARMACEUTICALS
` HOLDINGS INC., and APOTEX HOLDINGS, INC.,
` Petitioners,
` v.
` OSI PHARMACEUTICALS, INC.,
` Patent Owner,
`______________________________________________________
`
` U.S. Patent No. 6,900,221
`______________________________________________________
`
` Case No: IPR2016-01284
`______________________________________________________
`DEPOSITION OF PAUL A. BUNN, JR., M.D. - July 11, 2017
`______________________________________________________
` PURSUANT TO NOTICE, the deposition of
`PAUL A. BUNN, JR., M.D. was taken on behalf of the
`Petitioners at 1225 17th Street, Suite 2600, Denver,
`Colorado, on July 11, 2017, at 8:01 a.m., before Wendy
`C. Heath, Certified Realtime Reporter, Registered
`Professional Reporter and Notary Public within
`Colorado.
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`Transcript of Paul A. Bunn, Jr., M.D.
`Conducted on July 11, 2017
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`2
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` A P P E A R A N C E S
`For the Petitioners:
` W. BLAKE COBLENTZ, ESQ.
` ERIC J. CHOI, ESQ.
` Cozen O'Connor PC
` 1200 Nineteenth Street Northwest
` Washington, D.C. 20036
`
`For the Patent Owner:
` EMILY R. WHELAN, ESQ.
` KEVIN M. YURKERWICH, ESQ.
` Wilmer Cutler Pickering Hale and Dorr LLP
` 60 State Street
` Boston, Massachusetts 02109
`
`Also Present:
` Andrea Tiglio, Ph.D.
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`Transcript of Paul A. Bunn, Jr., M.D.
`Conducted on July 11, 2017
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`3
`
` I N D E X
`EXAMINATION OF PAUL A. BUNN, JR., M.D.: PAGE
`July 11, 2017
`By Mr. Coblentz 5
` INITIAL
`DEPOSITION EXHIBITS REFERENCE
`Exhibit 1030 Petitioners' Notice of Deposition 9
` of Paul A. Bunn, M.D., Under 37
` C.F.R., Section 42.53
`Exhibit 1031 Journal of Clinical Oncology 71
` article: Phase I and Pharmacologic
` Study of OSI-774, an Epidermal
` Growth Factor Receptor Tyrosine
` Kinase Inhibitor, in Patients With
` Advanced Solid Malignancies
`Exhibit 1032 Journal of Clinical Oncology 97
` article: A Randomized, Phase II,
` Biomarker-Selected Study Comparing
` Erlontinib to Erlotinib
` Intercalated With Chemotherapy in
` First-Line Therapy for Advanced
` Non-Small-Cell Lung Cancer
`Exhibit 1033 Article: EGF receptor gene 101
` mutations are common in lung
` cancers from "never smokers" and
` are associated with sensitivity of
` tumors to gefitinib and erlotinib
`Exhibit 1034 Article: This $7,800-a-month 107
` cancer drug caused rashes and
` rarely worked. Now Trump could
` make FDA approvals even easier
`Exhibit 1035 Summary Minutes of Oncologic Drugs 117
` Advisory Committee, December 16,
` 2009
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`4
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`DEPOSITION EXHIBITS: (Previously marked)
`Exhibit 1001 Patent No: US 6,900,221 BI 42
`Exhibit 1008 Provisional Application Cover 12
` Sheet and Provisional Application
`Exhibit 1009 Patent Number 5,747,498 54
`Exhibit 1010 Article: Anticancer drug targets: 87
` Growth factors and growth factor
` signaling
`Exhibit 1016 Article: Induction of Apoptosis 90
` and Cell Cycle Arrest by
` CP-358,774, an Inhibitor of
` Epidermal Growth Factor Receptor
` Tyrosine Kinase
`Exhibit 2021 Declaration of Dr. Paul Bunn 10
`Exhibit 2024 American Society of Clinical 76
` Oncology Thirty-Fifth Annual
` Meeting, May 15-18, 1999, Atlanta,
` GA
`Exhibit 2036 Review: Targeting the Epidermal 67
` Growth Factor Receptor in
` Non-Small Cell Lung Cancer
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`Transcript of Paul A. Bunn, Jr., M.D.
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`5
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` WHEREUPON, the following proceedings
`were taken pursuant to 37 C.F.R., Section 42.53
` * * * * *
` PAUL A. BUNN, JR., M.D.,
`having been first duly sworn to state the whole truth,
`testified as follows:
` (Deponent's reply to oath: "I do.")
` EXAMINATION
`BY MR. COBLENTZ:
` Q. Good morning, Dr. Bunn.
` A. Good morning.
` Q. I'm going to start out with some
`introductions just so you know who everyone is. My
`name is Blake Coblentz. I'm from the firm Cozen
`O'Conner, here on behalf of the petitioner, Apotex.
`Along with me is my colleague Eric Choi, who is also
`with Cozen O'Connor as well.
` MS. WHELAN: Emily Whelan and Kevin
`Yurkerwich of Wilmer Hale for the patent owner. And
`with us is Andrea Tiglio of Astellas.
` Q. (BY MR. COBLENTZ) If you could state
`your full name for the record for us, please.
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`6
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` A. Paul A. Bunn, Jr.
` Q. And if you could give us the city and
`state where you live.
` A. Denver, Colorado.
` Q. Dr. Bunn, have you ever been deposed
`before?
` A. I have.
` Q. How many times?
` A. Probably five.
` Q. When was the last time that you were
`deposed?
` A. More than three years ago. Couldn't say
`for sure. Probably four or five years ago.
` Q. Did any of those involve patent
`litigation in any sense?
` A. No. One of them was about a drug. And
`it was a case between Dana-Farber cancer center,
`Novartis, and a small company whose name I don't know
`over -- I think the main issue -- sometimes legally
`it's hard to know what the issue is. But it seems
`like the issue was who owned a patent.
` Q. Got it. Is that your only involvement
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`Transcript of Paul A. Bunn, Jr., M.D.
`Conducted on July 11, 2017
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`7
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`in a patent litigation or have you been involved in
`other patent litigations?
` A. No, I think that's it.
` Q. Have you ever been involved in an
`inter partes review proceeding before, except for this
`one obviously?
` A. Not that I'm aware of. I had to try to
`figure out what it was.
` Q. That's okay. I think a lot of people
`outside the patent world try to figure out what it is.
` Now you understand that your testimony
`here today is under oath; is that correct?
` A. That's correct.
` Q. Is there any reason why you can't
`testify truthfully here today, any medical conditions
`or drugs that would prevent you from testifying
`truthfully?
` A. No, sir.
` Q. Now, since it's been a couple of years
`since you've been deposed, let me go through just a
`couple of brief ground rules so that we're on the same
`page.
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`Transcript of Paul A. Bunn, Jr., M.D.
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`8
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` I'm going to be asking you questions.
`If you are at all unclear about my question, please
`let me know, and I'll do my best to clarify that
`question. Do you understand that?
` A. Yes, sir.
` Q. Your counsel may object to some of my
`questions, but unless your counsel instructs you not
`to answer, you still need to answer my question. Do
`you understand that?
` A. Yes, sir.
` Q. I ask that you please let me finish my
`question before you answer the question, just so the
`court reporter has a clear record. Do you understand
`that?
` A. Yes, sir.
` Q. Also, if you could make sure that your
`answers are audible answers, no head nods or uh-huhs
`so, again, we get a clear record. Do you understand
`that?
` A. I do, and I'll do my best.
` Q. And I'll do my best. If I see you doing
`it, I'll do my best to try to correct that.
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`Transcript of Paul A. Bunn, Jr., M.D.
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`9
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` The last thing is that if you need a
`break, we can take a break at any time. The only
`thing that I ask is that if there is a question
`pending that you answer that question before we take a
`break. Just to let you know, we'll take periodic
`breaks throughout the deposition. Do you understand
`that?
` A. Yes, sir.
` Q. Dr. Bunn, I'm handing you what has been
`marked Exhibit 1030.
` (Deposition Exhibit 1030 was marked.)
` Q. (BY MR. COBLENTZ) If you could take a
`look at that for me. For the record, Exhibit 1030 is
`the Petitioners' Notice of Deposition of Paul A. Bunn,
`M.D. under 37 C.F.R., Section 42.53.
` A. I see it.
` Q. Dr. Bunn, have you seen this deposition
`notice before?
` A. Not to my knowledge.
` Q. But you do understand you are here
`pursuant to this deposition notice, correct?
` A. Correct.
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`Transcript of Paul A. Bunn, Jr., M.D.
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`10
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` Q. You can put that aside.
` So I'm handing you what has already been
`marked as OSI Exhibit 2021. For the record, this is
`the declaration of Dr. Paul Bunn. Do you recognize
`this?
` A. I do.
` Q. What is it?
` A. It's a declaration by me regarding this
`case.
` Q. I'll ask you to turn to page 56 of your
`declaration. And you will see that there is a
`signature there. Is that your signature?
` A. Yes, sir.
` Q. And this is dated April 24, 2017.
` A. Correct.
` Q. Now, I would like to go to page 4 of
`your declaration. And I'm looking at section Roman
`numeral II, which says, Overview, and specifically
`paragraph 16 where it says, I have reviewed.
` Do you see where I'm at?
` A. I do.
` Q. Now, if we look at page 4 all the way
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`Transcript of Paul A. Bunn, Jr., M.D.
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`11
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`through page 9, I believe this represents the
`references that you reviewed in preparation for this
`deposition; is that correct?
` A. That's correct.
` Q. Is this a full list of the materials you
`considered when preparing this declaration?
` A. Yes, sir.
` Q. Did you review any publications or
`materials, other than materials listed here, in
`preparing your opinions in this case? Feel free to
`take your time and look at the references you cite.
` A. This would be complete.
` Q. Now, this declaration, does this contain
`all of the opinions that you have put forth in this
`case?
` A. Yes, sir.
` Q. Is there any edits you need to make to
`this particular declaration?
` A. No, sir.
` Q. Let's go to paragraph 22 of your
`declaration; that would be on page 10. Now, looking
`at paragraph 22, in the second sentence you say, I
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`12
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`have been asked to assume a priority date for the
`claimed invention of March 30th, 2000. Do you see
`that?
` A. I do.
` Q. Do you know why you were asked to assume
`a priority date of March 30, 2000?
` MS. WHELAN: I'll object and instruct
`you not to reveal any communications with attorneys.
` A. My answer would be, I read the patent
`and that's one of the dates on the patent.
` Q. (BY MR. COBLENTZ) Did you do any
`independent analysis of the provisional application,
`that was submitted on March 30 of 2000, to determine
`whether that was the correct priority date?
` A. It says I've been asked to assume a
`priority date. That's my factual -- I was asked to
`assume that date.
` Q. Now I'm handing you what has been marked
`previously as Exhibit 1008. For the record, this is a
`copy of the provisional application, 60/193,191. If
`you look towards the end of the page you will see it's
`dated March 30, 2000. Do you see that, Dr. Bunn?
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`13
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` A. Right here, you are talking about?
` Q. Yes.
` A. I do see that, yes.
` Q. Okay. I would like you to take a look
`through this application -- it's not very long -- and
`tell me whether you see any clinical trial data
`relating to erlotinib in the 191 application.
` MS. WHELAN: Objection, beyond the
`scope.
` A. I'm supposed to answer the question,
`right?
` Q. (BY MR. COBLENTZ) Yes.
` A. (Deponent perused the document.) Can
`you repeat the question, just so I get it right now?
` Q. You would agree with me, Dr. Bunn, there
`is no clinical trial data relating to erlotinib in the
`101 application; is that correct?
` MS. WHELAN: I'll object as beyond the
`scope of Dr. Bunn's declaration.
` A. In my rapid review of these eight pages
`I don't see any clinical trial information, correct.
` Q. (BY MR. COBLENTZ) So you can put that
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`14
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`aside.
` Now, I would like to go back to your
`declaration, which is Exhibit 2021, and I want to go
`back to paragraph 22.
` A. Correct.
` Q. In the middle of paragraph 22 you state,
`In my view, one of ordinary skill in the art as of
`that time would be a medical oncologist who would hold
`an M.D. degree and who would have completed several
`years of practice in the field of oncology.
` Do you see where I'm at?
` A. I do.
` Q. Now, throughout the deposition I may
`refer to "one of ordinary skill in the art" as a POSA
`for short. That stands for a Person of Ordinary Skill
`in the Art. I just want to make that clear in case I
`mess up, you understand what I'm saying. But you can
`ask for clarity if you don't understand what I'm
`saying.
` I may also refer to non-small cell lung
`cancer as NSCLC. Do you understand that?
` A. Yes, sir.
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`15
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` Q. Now, you understand that one of the
`claims of the 221 patent that is at issue in this
`proceeding is directed to treatment solely of NSCLC;
`is that correct?
` A. Correct.
` Q. And you would agree with me that in your
`declaration you have only opined about the treatment
`of NSCLC, not the other cancers that were present in
`claim 44; is that correct?
` A. That's correct.
` MS. WHELAN: Object to form.
` Q. (BY MR. COBLENTZ) And you would agree
`with me, Dr. Bunn, that there are oncologists that
`specialize specifically in treating lung cancer; isn't
`that correct?
` A. There are -- probably not correct.
` Q. That's not correct? So there are
`doctors that are general oncologists but do not
`specialize in treating lung cancer?
` A. No, no. Most thoracic oncologists would
`see lung cancers, mesothelioma, thymomas. Cancers in
`the chest, not just lung cancer. Any cancer in the
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`16
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`chest, so that would be a thoracic oncologist.
` Q. So a patient that has non-small cell
`lung cancer would go to a thoracic oncologist for
`treatment; is that a fair assessment?
` A. They might.
` Q. But there are specific --
` A. Many general oncologists in the
`community will see lung cancer patients and they
`wouldn't consider themselves thoracic oncologists.
` Q. But there are thoracic oncologists that
`specifically treat lung cancer --
` A. Correct.
` Q. -- is that correct?
` A. Correct.
` Q. Thoracic oncologists, do they specialize
`in using medications in therapies effective for
`treating lung cancer?
` A. Yes, sir.
` Q. I would like to go to paragraphs 24
`through 26 of your declaration, and that starts at
`page 11. If you need to take the clip off of that to
`make it easier --
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`17
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` A. It's okay for now.
` Q. Now, I'm looking at paragraphs 24
`through 27. I know I said 26 earlier. But those are
`where you give -- come to the introduction and summary
`of your opinions. Do you see that?
` A. Yes, sir.
` Q. And you understand that claims 44, 45,
`46, and 53 of the 221 patent are involved in this
`proceeding; is that correct?
` A. Correct.
` Q. Dr. Bunn, did you offer any opinions on
`claims 45 and 46 that are independent of the opinions
`that you gave on claims 44 and 53?
` MS. WHELAN: Object to form.
` A. Not to my knowledge.
` Q. (BY MR. COBLENTZ) Now, I would like to
`specifically look at paragraph 26 of your declaration,
`which is on page 12 of your declaration. You say here
`at paragraph 26 that a skilled artisan also would not
`have had a reasonable expectation of success in
`achieving the claimed invention by combining OSI 10-K,
`or Gibbs with Schnur, because none of the references
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`18
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`describes treatment of NSCLC with erlotinib or any
`efficacy data relating to such treatment.
` Do you see where I'm at?
` A. I do.
` Q. Now, Dr. Bunn, in your opinion do these
`references that you are referring to here in
`paragraph 26, do they need to show Phase II or
`Phase III clinical data in order to describe treatment
`of NSCLC with erlotinib?
` MS. WHELAN: Objection.
` A. Can you repeat the question?
` Q. (BY MR. COBLENTZ) Sure. In your
`opinion do the prior references that you are referring
`to in paragraph 26 of your declaration here need to
`show Phase II or Phase III clinical data in order to
`describe treatment of NSCLC with erlotinib?
` MS. WHELAN: Objection.
` A. None of the references describe any
`treatment efficacy in preclinical models or in people.
`So I guess your question is not important, because
`there isn't any clinical data and there is no
`preclinical data in any of these papers or any of
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`these documents.
` Q. (BY MR. COBLENTZ) Would you need to see
`that clinical data, Phase II or Phase III trials, in
`order to determine whether these references describe a
`treatment of an NSCLC with erlotinib?
` MS. WHELAN: Objection.
` A. These references could have described
`preclinical data, but they don't.
` Q. (BY MR. COBLENTZ) So I'm just
`specifically talking about Phase II and Phase III
`data. Is Phase -- would Phase II and Phase III data
`be needed in order to describe, in your opinion, a
`treatment of NSCLC with erlotinib?
` MS. WHELAN: Objection.
` A. One could describe treatment with the
`erlotinib in a human tumor in a mouse, but none of
`these describe that, so I don't understand what your
`question is getting at.
` Q. (BY MR. COBLENTZ) But would that be
`enough to describe, if they contained information
`about treatment in a mouse of NSCLC with erlotinib,
`would that be enough for you to determine that that is
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`a treatment of NSCLC with erlotinib?
` MS. WHELAN: Objection, beyond the
`scope.
` A. Again, that's a hypothetical, because
`none of these do, so I'm not sure I understand the
`intent of your question. But if you treated a human
`tumor in a mouse, that might be some evidence of
`whether that treatment would work in a person. But
`mouse experiments are not good predictors of what is
`going to happen in people.
` Q. (BY MR. COBLENTZ) What about Phase I
`trials?
` A. Phase I trials are safety trials.
` Q. Are there any instances where there is
`efficacy data taken in a Phase I trial?
` A. In 2017 Phase I trials are different
`than they were in 1999 and 2000. So some Phase I
`trials now have expansion cohorts that didn't exist
`previously.
` Q. So in 1999, 2000, there were not Phase I
`trials that had efficacy data for a specific drug?
` A. Response data were reported but it
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`wasn't the goal of the studies.
` Q. But there was response data that was
`reported?
` A. Correct.
` Q. And do you know if any such response
`data was recorded in a Phase I trial with erlotinib as
`it relates to treatment of NSCLC?
` A. In November of 2000, yes. In March of
`2000, no.
` Q. So specifically I'm talking about
`Phase I data. Is there any Phase I data where there
`was response data recorded for erlotinib in the
`treatment of --
` A. Not until November of 2000.
` Q. I would like to go to paragraph 29 of
`your declaration, which is on page 13. Now, in
`paragraph 29 you state, In the 1990s the standard of
`care for NSCLC was chemotherapy.
` Do you see that?
` A. Yes, sir.
` Q. And you cite a paper that is authored by
`you and Dr. Herbst from 2003?
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` A. Correct.
` Q. That's Exhibit 2036?
` A. Correct.
` Q. Now, what is the standard of care for a
`patient diagnosed with NSCLC now?
` A. You will have to clarify stage and a few
`other factors, whether it's the first treatment, so
`on. You will need to tell me the stage and situation.
` Q. So that's a great question. You are the
`doctor. I'm not. So can you tell me a little bit
`about that?
` A. Well, okay, so mostly here we're talking
`about stage IV. And I'm going to assume for a moment
`that we're talking about 2017.
` Q. Yes.
` A. So 2017, you would determine whether the
`patient's tumor had a molecular abnormality and you
`would determine whether the tumor expresses an immune
`protein called PD-L1. So if they had a high
`expression of PD-L1, you would treat with a drug
`called pembrolizumab, p-e-m-b-r-o-l-i-z-u-m-a-b.
` If they had one of several molecular
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`abnormalities, you would give them --
` (Reporter requests clarification.)
` A. If they had one of several molecular
`abnormalities, you would treat with a tyrosine kinase
`inhibitor specific for that abnormality. And if you
`had neither an immune marker or a molecular marker,
`you would generally treat with a platinum doublet
`chemotherapy.
` Q. (BY MR. COBLENTZ) Now, you referenced
`treatment of patients with abnormalities. Can you
`explain what those abnormalities are?
` A. So some cancers have genetic alterations
`that activate a receptor, tyrosine kinase pathway,
`that can be inhibited with a pill. So one of those is
`the epidermal growth factor receptor that can be
`mutated. And if it's mutated, it's highly likely that
`a tyrosine kinase inhibitor binding to that receptor
`will be effective.
` Q. What percentage of NSCLC patients have
`these abnormalities?
` MS. WHELAN: Object to form.
` A. Again, would you give me the stage and
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`the country of origin of the patient?
` Q. (BY MR. COBLENTZ) So stage IV in the
`U.S.
` A. 15 percent.
` Q. And the other 85 percent of those
`divided among the other two conditions you discussed?
` MS. WHELAN: Object to form.
` A. 85 percent of non-small cell patients
`won't have that mutation, if that's what you mean.
` Q. (BY MR. COBLENTZ) Yes. And the
`mutations that -- the abnormalities that you
`discussed, those are the patients that you treat with
`the tyrosine kinase inhibitors; is that correct?
` MS. WHELAN: Object to form.
` A. Right, stage IV patients who have an
`EGFR mutation, an activating one, would be treated
`with an EGFR TKI such as erlotinib today.
` Q. (BY MR. COBLENTZ) But not just
`erlotinib? There's other TKI inhibitors; is that
`correct?
` A. There are.
` Q. What are those?
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` A. Gefitinib, afatinib are approved for the
`first-line treatment. Osimertinib is approved for
`second-line treatment. And several others are in
`Phase III clinical trials that might or might not lead
`to approval.
` Q. So of the TKI inhibitors, which one is
`the predominant one that is given to treat a NSCLC
`patient with stage IV cancer that has one of these
`abnormalities?
` MS. WHELAN: Object to form.
` A. You will have to tell me the country.
` Q. (BY MR. COBLENTZ) U.S.
` A. Tarceva would be the most commonly
`prescribed first-line treatment for such patients in
`the U.S.
` Q. And do you know what percentage in the
`U.S. of patients, approximately, would be treated by
`Tarceva?
` A. I do not. I could make a guess, if you
`wish.
` Q. Sure.
` A. 80 percent.
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` Q. 80 percent of the patients have these
`abnormalities?
` A. Correct.
` Q. Which is 15 percent of the NSCLC
`population, correct?
` A. Correct.
` Q. I would like to go to paragraph 32 of
`your declaration. And your declaration, for the
`record, is Exhibit 2021. And if we look at
`paragraph 32, you are discussing that in the 1990s
`several types of growth factor receptors were
`described, including the epidermal growth factor
`receptor, which is abbreviated EGFR.
` Do you see that?
` A. I do.
` Q. The last sentence in paragraph 32 you
`say that EGFR was frequently overexpressed on
`epithelial cancers -- in parentheses you have
`carcinomas -- including lung cancers.
` Do you see that?
` A. I do.
` Q. When you say epithelial cancers, in
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`parentheses, carcinomas, what cancers does this
`include?
` A. This includes any cancer that has its
`origin in epithelial tissue. That would be prostate
`cancer, breast cancer, colon cancer, lung cancer,
`several skin cancers, head and neck cancers.
`Carcinomas are the most frequent cancers in humans.
` Q. Now I would like to go to page 16 of
`your declaration, specifically starting at
`paragraph 35.
` Q. You say in paragraph 35 that, Despite
`their potential promise, the overwhelming majority of
`investigational therapies, including monoclonal
`antibodies to EGFR and TKIs like EGFR inhibitors,
`failed in clinical trials.
` Do you see that?
` A. I do.
` Q. So I would like to talk a little bit
`about drug development and these failures that you
`discussed here. Now, when a specific company comes up
`with a new drug candidate they first do plea -- pre --
` A. Preclinical.
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` Q. Let me start over. When you come up
`with a new drug candidate, the company first does
`preclinical studies,; is that correct?
` A. Well, generally that's not correct.
` Q. Okay. Well, correct me.
` A. Well, if you are trying to inhibit EGFR,
`okay, you do studies which are enzymatic studies to
`see if you actually inhibited the enzyme. So that
`wouldn't -- that would just be an enzyme in a test
`tube. But that would be done first.
` So you show that your drug inhibits the
`target, okay? There is no cells or cancer involved
`there. You are just seeing if the drug does what it's
`supposed to do.
` Q. And so those are in vitro studies,
`correct?
` A. Yes, those are in vitro studies.
`They're not necessarily even with cell lines; it may
`just be with an enzyme in a tube.
` Q. Okay. I understand. So after --
` A. After that --
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`simultaneously.)
` MS. WHELAN: Wait for the question
`first.
` Q. (BY MR. COBLENTZ) So after that, if
`they pass through the in vitro studies, what's the
`next step?
` A. So generally you would be testing your
`compound against the model disease that you are
`interested in.
` Q. And would that test or the model disease
`be done in mammals?
` A. Well, first you would usually use
`in vitro testing of cells, not an animal. Generally
`you would do cells before an animal.
` Q. So after they have passed the cell line
`studies then you would move on to studies in mammals;
`is that correct?
` A. Well, i
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