throbber
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`
` IN THE UNITED STATES
` PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` CASE IPR2019-00207
` PATENT 9,517,219
` -----------------------------------x
` AMNEAL PHARMACEUTICALS LLC and
` AMNEAL PHARMACEUTICALS OF NEW
` YORK, LLC,
` Petitioners,
` -against-
` ALMIRALL, LLC,
` Patent Owner.
` -----------------------------------x
` October 4, 2019
` 8:59 a.m.
`
` Deposition of LEON H. KIRCIK, M.D., taken
` by Petitioner, held at the offices of
` Fenwick & West LLP, 902 Broadway, Suite 14,
` New York, New York 10010, before Roberta
` Caiola, a Shorthand Reporter and Notary
` Public within and for the State of New
` York.
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`AMN1039
`Amneal v. Almirall, LLC
`IPR2019-00207
`
`1
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`

`

`Page 2
`
` A P P E A R A N C E S:
`
` Attorneys for Petitioners:
` STERNE KESSLER GOLDSTEIN & FOX
` 1100 New York Avenue, NW
` Washington, DC 20005
` (202) 772-8794
` BY: ADAM C. LaROCK, ESQ.
` JOSHUA I. MILLER, ESQ.
` alarock@sternekessler.com
` jmiller@sternekessler.com
`
` Attorneys for the Patent Owner:
` FENWICK & WEST LLP
` 1191 Second Avenue, 10th Floor
` Seattle, Washington 98101
` (206) 389-4587
` BY: ELIZABETH HAGAN, Ph.D., ESQ.
` ehagan@fenwick.com
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`Page 3
`
` I N D E X
`
` WITNESS: LEON H. KIRCIK, M.D. PAGE
` EXAMINATION BY: MR. LaROCK 4
`
` EXHIBITS
` EXHIBIT DESCRIPTION PAGE
` Exhibit 1035 Poster Abstracts for the 191
` Journal of American
` Academy of Dermatology
` 2017 Annual Meeting
` Program Submissions
` (Exhibit retained by the Court Reporter to
` accompany the transcript.)
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`Page 4
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` L. Kircik, M.D.
` LEON H. KIRCIK, M.D., called as a witness,
` having been first duly sworn by a Notary
` Public of the State of New York, testifies
` as follows:
` EXAMINATION BY
` MR. LAROCK:
` Q. Good morning, Dr. Kircik.
` A. Good morning.
` Q. Have you been deposed before?
` A. Yes.
` Q. About how many times?
` A. Several times.
` Q. Are you able to quantify about
` how many times? I'm not holding you to a
` number. 10? 15? 100? 3?
` A. Less than 10.
` Q. When were those depositions?
` A. Within the last couple of
` years.
` Q. What types of cases were those
` depositions in, if you recall?
` A. Some are malpractice, some are
` expert, some are my personal cases.
` Q. What do you mean, for the
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`Page 5
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` L. Kircik, M.D.
` malpractice cases? What do you mean by
` that?
` A. I have been sued before.
` Q. Okay. And as part of that
` lawsuit, you would be deposed?
` A. Correct.
` Q. And then the other ones, you
` said, were cases where you're an expert?
` A. Correct.
` Q. What types of cases have you
` been an expert in?
` A. Malpractice.
` Q. Malpractice cases, okay.
` Have you ever been an expert --
` setting aside this case, have you ever been
` an expert in a patent case before, or a
` case involving a patent?
` A. Yes.
` Q. Okay. What case was that?
` A. I believe that's confidential.
` Q. Okay. Was it about acne?
` A. No.
` Q. Was it a case about a skin
` condition?
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`Page 6
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` L. Kircik, M.D.
` A. Correct.
` Q. Can you tell me what skin
` condition it was?
` A. Psoriasis.
` Q. And you were deposed as part of
` that case?
` A. I can't remember.
` Q. Did you go to court and testify
` in court as part of that case?
` A. No.
` Q. Okay. So it sounds like you
` have some familiarity with the deposition
` procedure, right?
` A. Yes.
` Q. You know that you're under
` oath, correct?
` A. Yes.
` Q. And you know that you have to
` tell the truth today, right?
` A. Yes.
` Q. You know you have to testify
` accurately, right?
` A. Yes.
` Q. Is there any reason that you
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`Page 7
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` L. Kircik, M.D.
` can't testify truthfully and accurately
` today?
` A. No.
` Q. We have a court reporter here,
` so we're going to ask you to give audible
` answers so that she can have an accurate
` reflection of what happens.
` A. Yes.
` Q. I'll try to not talk over you.
` I hope that you will agree not to talk over
` me as we're going through our questioning
` today; is that fair?
` A. Yes.
` Q. If you have any questions for
` me, just feel free at any time to let me
` know, and I'll try to address that
` question; is that fair?
` A. Yes.
` Q. If I ask a question and you
` answer it, I'm going to assume that you
` understood the question; is that fair?
` A. Yes.
` Q. I've handed you what's been
` marked Almirall Exhibit 2055. This is the
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`Page 8
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` L. Kircik, M.D.
` Declaration of Leon Kircik, right?
` MS. HAGAN: Would you mind if
` we marked it as a deposition exhibit
` as opposed to just the Almirall
` exhibit?
` MR. LaROCK: Can we go off the
` record.
` (Off the record.)
` Q. So Almirall Exhibit 2055, this
` is the Declaration of Leon Kircik, M.D.; is
` that right?
` A. Yes.
` Q. Is this the declaration that
` you submitted as part of this case?
` A. Yes.
` Q. If you flip to the last page,
` page 55 of 66. That's your signature
` there?
` A. Yes.
` Q. When you signed it, the
` statements that you were making in this
` declaration were accurate, right?
` A. Yes.
` Q. I want to ask you about
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`Page 9
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` L. Kircik, M.D.
` paragraph 5, so if you could turn there.
` But before we get too far, are
` you aware of any changes that you would
` like to make to your opinions that are
` expressed in Exhibit 2055?
` A. No.
` Q. So you're at paragraph 5? Are
` you there, Doctor?
` A. Yes.
` Q. So you say in paragraph 5,
` "Throughout my career, I have published
` widely in peer-reviewed journals with over
` 200 publications to my name."
` Did I read that correctly?
` A. Yes.
` Q. How do you go about deciding
` what you want to publish about?
` A. Whatever is relevant to my
` work.
` Q. Some of the times, it's
` relevant to your work that a new drug was
` approved by the FDA for the treatment of a
` skin condition, right?
` A. Correct.
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`Page 10
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` L. Kircik, M.D.
` Q. And you would want to write
` about that?
` MS. HAGAN: Objection to form.
` A. I want to write about what?
` Sorry.
` Q. That a new drug was approved by
` the FDA.
` A. Okay.
` Q. I'm asking you. Is that one of
` the reasons why you publish?
` I'm trying to figure out what
` are the reasons why you're publishing over
` 200 times, just generally?
` A. Sure.
` I'm a physician. Also, medical
` education is part of my involvement with
` dermatology. So we -- I do publish
` relevant -- anything to dermatology that I
` am familiar with, that I work with.
` Q. What's the purpose of the
` publications?
` A. Medical education.
` Q. To educate your peers?
` A. I am waiting for you to finish
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`Page 11
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` L. Kircik, M.D.
` the question, I'm sorry.
` Q. Is one of the reasons that you
` want to do medical education in these
` publications is to educate your peers?
` A. Yes.
` Q. Is part of the medical
` education also to educate the public,
` non-dermatologists?
` A. Can you please clarify that,
` because public is not non-dermatologists.
` Q. Sure.
` You said that one of the
` reasons that you publish was for medical
` education. Is it to educate the people
` with acne about acne treatments, for
` example?
` A. Most public, most regular
` people don't read those journals.
` Q. So when you're publishing for
` medical education, it's mostly for
` dermatologists and people involved with
` skin conditions, treating skin conditions?
` A. Correct.
` Q. And what do you hope to
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`Page 12
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` L. Kircik, M.D.
` accomplish by writing these publications
` and educating your peers?
` MS. HAGAN: Objection;
` relevance.
` You can answer.
` A. Medical education.
` Q. So you're trying to inform them
` of whatever it is that you're writing about
` and educate them to whatever it is that
` you're writing about; is that fair?
` A. Yes.
` Q. Besides medical education, is
` there any other reason why you would
` publish?
` A. No.
` Q. As part of the publications, do
` you ever work with companies to write a
` publication and get it published? Strike
` that.
` In your career have you ever
` worked with drug companies to publish
` articles about their drugs?
` A. I think you have to specify
` that a little better when you say "work."
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`Page 13
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` L. Kircik, M.D.
` Q. Well, as part of the
` publication process, they're either authors
` or somehow involved in the process --
` right? -- there's instances of that in your
` career?
` A. Sometimes we get the
` information relevant to that publication
` from the sponsors.
` Q. What do you mean information
` that's relevant to the publication?
` A. For example, a clinical study,
` we need to get that information.
` Q. Like the data for the study?
` A. Correct.
` Q. So some of your publications
` you've -- besides getting data from a drug
` manufacturer as part of the publication
` process, is there any other way that, in
` your publications, the drug manufacturer is
` involved in your publications?
` A. Sure, because I am part of the
` clinical studies. When we do clinical
` studies, the study results become
` publications, and of course, the sponsor or
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`Page 14
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` L. Kircik, M.D.
` the pharmaceutical company is involved.
` Q. Besides you and the drug
` company working together for a clinical
` study, or besides you getting the data from
` the drug company as part of the publication
` process, is there any other involvement by
` the drug company in the publication
` process?
` A. I cannot think of any. Maybe
` you can give an example.
` Q. I'm just asking. Right now you
` can't think of any other involvement,
` besides the two instances you previously
` talked about?
` A. I cannot think of it.
` Q. When there's a drug
` manufacturer that's involved in one of your
` publications, is it you who approaches the
` drug company to be involved or does the
` drug company approach you to be involved?
` A. Usually it's a coordinated
` effort.
` Q. Between what?
` A. Between the parties involved.
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` L. Kircik, M.D.
` Q. But at some point in time,
` someone has to approach someone else to
` start that coordination, right?
` A. Not necessarily.
` Q. Were you finished?
` A. Yes.
` Q. How does that coordination
` happen, I guess, is my question?
` A. Sometimes third-party
` involvement will coordinate those things.
` Q. Has it ever been the case that
` a drug company approached you to ask you to
` be involved in writing and publishing an
` article?
` A. When I did the clinical studies
` for that particular drug company as an
` investigator, they included me as a part of
` it.
` Q. Besides you being involved in
` the clinical study that's being published
` about, is there any other instance where a
` drug company would approach you to publish
` an article?
` A. There may be, but I cannot
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`Page 16
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` L. Kircik, M.D.
` think of any.
` Q. As part of your work on the
` clinical study with the drug manufacturer,
` you are a clinical investigator?
` A. Yeah.
` Q. Is that like a consulting
` arrangement, or how is that arrangement
` organized?
` MS. HAGAN: Objection to form.
` You can answer.
` A. Clinic -- clinical study is not
` consultant.
` Q. Okay. It's something separate?
` A. It is separate.
` Q. Okay. As part of the clinical
` study work where you're a clinical
` investigator, are you compensated in any
` way by the drug company whose drug you're
` studying?
` A. Yes.
` Q. What compensation do you
` receive for that work as a clinical
` investigator?
` A. Every clinical study has a
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`Page 17
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` L. Kircik, M.D.
` budget.
` Q. What's the budget for?
` A. Can you specify, please. What
` do you mean "what's the budget for?"
` Q. Yes. You receive a budget,
` what is the budget?
` A. The budget is for the clinical
` study work that we do.
` Q. You use that budget for
` expenses?
` A. No. That budget is used for
` everything, for the work that we do.
` Q. But is there a -- so I guess
` the answer to my question would be yes, the
` budget is used for expenses?
` A. Maybe you can be more specific.
` When you say "expenses," expenses may be
` rent?
` Q. Um-hum.
` A. No.
` Q. But there are expenses that are
` associated with running the clinical study
` site?
` A. Of course.
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` L. Kircik, M.D.
` Q. And the budget is applied to
` those expenses?
` A. The expenses is applied for the
` work that we do, and the work may include
` the expenses.
` Q. Besides expenses, what else
` would the budget be used for?
` A. For the work that I do.
` Q. Just for your time, your
` effort?
` A. It's not calculated per time,
` per hour.
` Q. Is the budget per patient or
` does the budget have a lump sum?
` A. Usually the budget is per
` patient.
` Q. Okay. So, for example, as part
` of a clinical study, you would be a
` clinical investigator; and as part of that,
` the drug company would say, here's X amount
` of dollars to run the clinical study for us
` at the site per patient?
` MS. HAGAN: Objection to form.
` You can answer.
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`Page 19
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` L. Kircik, M.D.
` A. Correct.
` Q. Looking back at paragraph 5.
` It says you also -- and I'm paraphrasing --
` presented hundreds of posters at industry
` meetings, and you are frequently invited to
` give talks on new and emerging treatments
` in dermatology, including acne and rosacea
` treatments.
` Is that a fair summary of the
` second sentence of paragraph 5?
` A. Yes.
` Q. Similar to what we talked about
` with the publications, the posters at the
` industry meetings, and the talks that you
` would give, the purpose is medical
` education, right?
` A. Yes.
` Q. Okay. Are those poster
` presentations or talks, are they for any
` other reason besides medical education?
` A. No.
` Q. The last sentence on paragraph
` 5 says, "I have given hundreds of talks at
` industry meetings and symposia, as well as
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`Page 20
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` L. Kircik, M.D.
` local seminars." Is that right?
` A. Yes.
` Q. And again, there, the purpose
` there is medical education?
` A. Yes.
` Q. The talks at industry meetings,
` the symposia, and the local seminars, is
` that to -- the audience for those is your
` peers?
` A. Yes.
` Q. Is the audience for those
` meetings also the patients with acne?
` A. No.
` Q. Going back to the poster
` presentations and the talks that you give.
` Is there compensation associated with those
` talks or poster presentations?
` A. The answer is yes and no,
` depending on the meetings.
` Q. Okay. I'll start with no. So
` what types of meetings would it be where
` there's no compensation involved?
` A. So meetings such as American
` Academy of Dermatology, or any meetings
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` L. Kircik, M.D.
` that is CME, continuing medical education,
` is not compensated meetings.
` Q. Got it. And those are --
` that's like the industry group, right?
` That's like the board certification, those
` are the people who are regulators of your
` field?
` A. It has nothing to do with board
` certification.
` Q. So at those meetings where --
` what do you talk about at those types of
` meetings where there's no compensation
` involved?
` A. Anything related to
` dermatology.
` Q. The purpose of those meetings
` is kind of the CME, the continuing medical
` education?
` A. Correct.
` Q. And those are to get some sort
` of credit for -- the CME credits to kind of
` like continue on being registered to be a
` doctor?
` A. Not to be a doctor, but CME is
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` L. Kircik, M.D.
` a part of a requirement in some states, for
` example, to renew your license.
` Q. Got it. Okay.
` A. But CME is part of basically
` being a professional to keep a license, and
` those are what we call CME meetings, but
` it's not only for CME, it's also for
` medical education.
` Q. Got it. Understood.
` And some of these talks and
` poster presentations are talks where you're
` compensated for your time, right?
` A. Non-CME ones.
` Q. The non-CME, okay. For those
` meetings, the non-CME ones, how is it that
` you become involved in doing one of those
` talks?
` A. You are asked for it.
` Q. So the company or someone in
` the industry asks you to do the talk?
` A. Yes.
` Q. Do you ever approach the drug
` company or industry person and say, I want
` to do a talk on X, Y, and Z topic?
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` L. Kircik, M.D.
` A. I don't need to.
` Q. Even earlier in your career
` that was not a situation that came about?
` A. I can't remember.
` Q. So the non-CME meetings where
` you're compensated -- and again, that's
` compensation for your time?
` A. I'm sorry, can you repeat your
` question.
` Q. The non-CME meetings, the
` compensation was for your time?
` A. For your services.
` Q. To help do the medical
` education, to put the time and effort into
` the presentation, and to give it, right?
` A. Yes.
` Q. Are those call branded
` presentations, is that like a terminology
` that you're familiar with?
` A. Yes. But I do want to go back
` and correct one thing that you said just a
` minute ago, to prepare those lectures.
` Q. Okay.
` A. Those lectures are already
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` L. Kircik, M.D.
` prepared.
` Q. Okay. By the drug company?
` A. By the drug company.
` Q. Okay.
` A. It's an important thing because
` those have to be approved by regulatory
` bodies, so I don't prepare those lectures.
` Q. The reason is because they need
` to make sure that they're not going to say
` anything as part of that presentation that
` goes off label, the FDA-approved label?
` A. Yes.
` Q. And that's important, to make
` sure that that doesn't happen?
` A. Yes.
` Q. So as part of those meetings,
` you're handed the presentation, you review
` it, and then you give it. That's kind of
` generally how it goes?
` A. We actually get trained on
` those lectures at what we call speaker
` training programs.
` Q. And that's part of, like, a
` speakers bureau that a company may have, a
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` L. Kircik, M.D.
` drug company may have?
` A. Yes.
` Q. So there's training on what you
` can say and what not to say, to make sure
` that you're going to say things that are
` approved by the regulatory authorities?
` A. Yes.
` Q. And as part of those, have you
` ever encountered a situation where you
` didn't agree with something that was in the
` presentation or something that was part of
` the speaker training?
` A. It's irrelevant.
` Q. Okay. Why is it irrelevant?
` A. Because this is approved by
` compliance, by regulatory bodies.
` Q. So the fact that it's approved,
` it's kind of not relevant that you disagree
` with it?
` A. I don't understand the
` question.
` Q. I'm just trying to understand
` why you think that a situation where you
` disagreed with something wasn't relevant?
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` L. Kircik, M.D.
` A. It's not about disagreement or
` agreement.
` Q. Whatever the presentation says,
` it says, and you're going to give it?
` A. Because those are fair and
` balanced presentations prepared by -- and
` people spend a lot of time to prepare those
` to be fair and balanced.
` Q. And because you know that, you
` know that you're not going to disagree with
` anything that's part of those
` presentations?
` A. I really don't understand your
` question.
` Q. Well, you answered my question
` previously that it's irrelevant that you
` may disagree with something because the
` presentations are fair and balanced?
` MS. HAGAN: Objection;
` mischaracterized his prior testimony.
` A. That's not what I said. What I
` said is those presentations are very
` carefully prepared with the approval of the
` regulatory bodies in this country that
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` L. Kircik, M.D.
` oversee the pharmaceutical companies, and
` the data in those presentations is the
` data. Agreement with the data is
` irrelevant. The data is the data.
` Q. Is there anything in those
` presentations -- is there anything that's
` part of those presentations, beyond just
` the data?
` A. It can discuss disease state.
` Q. Are there conclusions drawn
` from the data, I guess, is my question?
` A. Yes.
` Q. And those conclusions drawn
` from the data are the ones that you're
` presenting as part of the presentation?
` A. There might be a slide about
` the conclusion.
` Q. Are there situations where you
` disagree with a conclusion that's being
` drawn from the data?
` A. The conclusion is the data,
` it's from the data.
` Q. So that's a no?
` A. This is not about my agreement
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` L. Kircik, M.D.
` or disagreement. The slide decks are
` carefully prepared by regulatory bodies in
` this country, with the oversight of the
` FDA.
` Q. As part of your work or
` training in the speakers bureau, are you
` compensated for that time as well?
` A. Yes.
` Q. Because it's taking you away
` from your services that you could otherwise
` be providing, so they wanted to compensate
` you for that time?
` A. We get compensated.
` Q. I want to direct you to
` paragraph 6 of your declaration, and I want
` to ask you about the part -- so paragraph 6
` starts on page 5 of 66 and goes to page 6
` of 66. So I want to ask you about the
` first full sentence of paragraph 5 on page
` 6 of 66.
` Are you there?
` A. I'm sorry, you said paragraph
` 5? We went over paragraph 5 already.
` Q. Sorry. So I want to direct you
`
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`Page 29
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` L. Kircik, M.D.
` to the portion of paragraph 6 that's on
` page 6 of 66.
` A. Yes.
` Q. So you say, "I am also sought
` out by and serve as a consultant for Phase
` II through Phase IV clinical study design
` and marketing for numerous pharmaceutical
` companies," and the sentence continues,
` right?
` A. Yes.
` Q. What are Phase II through Phase
` IV clinical studies?
` A. So in order for a drug to get
` approved in this country, they go all the
` way from Phase I to Phase III studies.
` Phase I, it's mostly very basic science
` that are sometimes on animals in very
` limited numbers. Phase II is those finding
` studies, trying to find the exact dose or
` appropriate dose to balance for a
` particular drug, which are smaller studies.
` Then Phase III studies are
` randomized, double-blind, clinical trials.
` Usually they are parallel run, multicenter,
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`Page 30
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` L. Kircik, M.D.
` that basically gets the approval for that
` particular drug from the FDA.
` And Phase IV studies are after
` the approval, most likely for use of the
` drug, how to use it, or more of a
` post-marketing studies.
` Q. Thank you.
` It says that you were a
` consultant for Phase II through Phase IV
` clinical study design.
` Can you tell me about your
` experience designing Phase II through Phase
` IV clinical study?
` A. Sure.
` Because I do a lot of clinical
` studies, I also learn from my experience;
` and so sometimes the drug companies come
` and say, "How should we design a study for
` that particular molecule?"
` Q. Okay. Understood.
` So you would be involved in,
` for example, determining the primary
` endpoints for a study?
` A. Yes and no, depending on the
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` L. Kircik, M.D.
` study, but usually there are standards for
` primary endpoints.
` Q. Okay. And what about secondary
` endpoints?
` A. Secondary endpoints are more
` flexible.
` Q. So you would be involved in
` determining which ones you were going to
` look for as part of the study?
` A. Part of it, but not only that,
` it's an overall general fashion.
` Q. As part of that clinical study
` design work, does it also include figuring
` out how to appropriately power the study in
` order to show endpoints or not?
` A. The answer is yes and no
` because that's more of a statistician's
` job, not my job, but I do have a general
` idea. A small number of an end is not
` going to give you statistical significance.
` Sometimes you need a higher number of ends
` to reach the statistical significance.
` Q. Are you able to say what --
` strike that.
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` L. Kircik, M.D.
` For the Dapsone molecule, were
` you involved in any Phase II through Phase
` IV clinical study designs?
` A. Can you specify which Dapsone
` molecule?
` Q. So the answer to my question
` was yes, one -- one of the Dapsone
` molecules? Well, the answer to the
` question was yes for the Dapsone molecule,
` you were involved.
` I'm just talking about the
` molecule, not any particular product.
` MS. HAGAN: Objection;
` mischaracterized his testimony.
` A. I didn't say yes. I asked
` which Dapsone molecule.
` Q. What does "Dapsone molecule"
` mean to you?
` A. The Dapsone molecule, Dapsone
` is an oral medication that has been around
` for a very long time. I have not been
` involved with any clinical studies of oral
` Dapsone molecule.
` Q. Have you been involved in, as a
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` L. Kircik, M.D.
` consultant, Phase II through Phase IV
` clinical study design for Aczone 5%?
` A. No.
` Q. Have you been involved as a
` consultant in any Phase II through Phase IV
` clinical study design for Aczone 7.5%?
` A. No.
` Q. Okay. Have you been involved
` as a consultant in any Phase II through
` Phase IV clinical study design for any use
` of Dapsone?
` A. No.
` Q. Have you been involved in any
` clinical studies involving Aczone 5%?
` A. Yes.
` Q. Were you an investigator for
` those studies?
` A. You have to be specific. Which
` studies?
` Q. T

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