Gary Herman, M.D. - October 26, 2020
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` ________________________________________
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ________________________________________
`
` MYLAN PHARMACEUTICALS INC., et al.,
`
` Petitioner,
`
` v.
`
` MERCK SHARP & DOHME CORP.,
`
` Patent Owner.
`
` __________________________________________
`
` Case IPR2020-00040
` Patent No. 7,326,708 B2
`
` __________________________________________
`
` DEPOSITION OF GARY HERMAN, M.D.
`
` APPEARING REMOTELY
`
` October 26, 2020
`
` 1:02 p.m.
`
`Reported by
`
`Rebecca J. Callow, RMR, CRR, RPR, CSR
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
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`Mylan (IPR2020-00040) Ex. 1023 p. 001
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` ________________________________________
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ________________________________________
`
` MYLAN PHARMACEUTICALS INC., et al.,
`
` Petitioner,
`
` v.
`
` MERCK SHARP & DOHME CORP.,
`
` Patent Owner.
`
` __________________________________________
`
` Case IPR2020-00040
` Patent No. 7,326,708 B2
`
` __________________________________________
`
` DEPOSITION OF GARY HERMAN, M.D.
`
` APPEARING REMOTELY
`
` October 26, 2020
`
` 1:02 p.m.
`
`Reported by
`
`Rebecca J. Callow, RMR, CRR, RPR, CSR
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1023 p. 001
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`
`
`Gary Herman, M.D. - October 26, 2020
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`Page 2
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` REMOTE APPEARANCES
`
`ON BEHALF OF MYLAN PHARMACEUTICALS, INC.:
`
` Katten Muchin Rosenman LLP
`
` 550 South Tryon Street
`
` Suite 2900
`
` Charlotte, North Carolina 28202
`
` 704-344-3185
`
` By: Lance Soderstrom
`
` lance.soderstrom@katten.com
`
` Jitendra Malik, Ph.D.,
`
` jitty.malik@katten.com
`
`ON BEHALF OF MERCK:
`
` Williams & Connolly LLP
`
` 725 Twelfth Street, Northwest
`
` Washington, D.C. 20005
`
` 202-434-5000
`
` By: Alexander S. Zolan
`
` azolan@wc.com
`
` Sahobo Zhu
`
` szhu@wc.com
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`GregoryEdwards, LLC | Worldwide Court Reporting
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`Mylan (IPR2020-00040) Ex. 1023 p. 002
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`Gary Herman, M.D. - October 26, 2020
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`Page 3
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` REMOTE APPEARANCES (CONTINUED)
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`ON BEHALF OF FOR DR. REDDY'S LABORATORIES, INC.,
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`DR. REDDY'S LABORATORIES, LTD.:
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` Lerner David Littenberg Krumholz & Mentlik
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` 20 Commerce Drive
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` Cranford, New Jersey 07016
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` (908) 654-5000
`
` By: Russell W. Faegenburg
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` rfaegenburg@lernerdavid.com
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`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
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`Mylan (IPR2020-00040) Ex. 1023 p. 003
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`Gary Herman, M.D. - October 26, 2020
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`Page 4
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` I N D E X
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` PAGE
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`GARY HERMAN, M.D.
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`Examination by Mr. Soderstrom .....................6
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`Examination by Mr. Zolan .........................39
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`Court Reporter's Certificate .....................45
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`Signature page ...................................48
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`Errata ...........................................50
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` * * * * *
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`Mylan (IPR2020-00040) Ex. 1023 p. 004
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`Gary Herman, M.D. - October 26, 2020
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`Page 5
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` E X H I B I T S
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`NO. DESCRIPTION PAGE
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` (None offered.)
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` * * * * *
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`GregoryEdwards, LLC | Worldwide Court Reporting
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`Mylan (IPR2020-00040) Ex. 1023 p. 005
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`Gary Herman, M.D. - October 26, 2020
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` Tuesday, October 26, 2020, 1:02 p.m.
`
` P R O C E E D I N G S
`
` - - - - -
`
` GARY HERMAN, M.D.,
`
` called as a witness herein, having
`
` been first duly sworn by a Notary Public,
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` was examined and testified as follows:
`
` EXAMINATION
`
` BY MR. SODERSTROM:
`
` Q. Good afternoon, Dr. Herman.
`
` A. Hello.
`
` Q. Can you, please, state your full name for
`
`the record?
`
` A. Gary Alan Herman.
`
` Q. And we're in different times here, but just
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`because I can't be there, do you have any documents
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`that are in front of you?
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` A. I do.
`
` I have the binder that is labeled
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`"Herman IPR Depo Prep." And I'm in my home office,
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`so my wife's got some papers around that are
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`irrelevant.
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`Gary Herman, M.D. - October 26, 2020
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`Page 7
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` Q. I can promise you I won't ask you about
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`those.
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` But in terms of the binder that you do
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`have in front of you, can you just let me know what
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`documents you have in there?
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` A. Okay. I have document 2109, my
`
`declaration; 1001, the patent, the '708; 2106, the
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`protocol 005, the clinical study report; 2107,
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`protocol 6, the clinical study report; 2108, the
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`batch analysis module from the NDA.
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` 2110, the summary of the product
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`development team for DPP-IV; 2111, draft preliminary
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`interim analysis email; 2112, the Demuth 2000
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`article. 2113, the Popisilik 2002 article; 2114 is
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`the Thornberry 2007 article; 2115 is the Rothenberg
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`2000 abstract; and 2158 is the DPP-IV background
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`that is an email from me. And --
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` Q. And is it fair -- yes. Sorry.
`
` A. And I have not written in this binder at
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`all.
`
` Q. You at least guessed one of my question to
`
`come.
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`Gary Herman, M.D. - October 26, 2020
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`Page 8
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` The other one I had for you was, are
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`there any documents other than those that are in your
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`binder that you considered in putting together your
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`declaration in this matter?
`
` A. No.
`
` Q. And just to keep things clean, and to help
`
`me, do you mind refraining from accessing or
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`consulting certain of those materials unless I'm
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`specifically asking you a question on that document?
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` Or, to the extent that you need to
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`reference another document, if you'd just let me know
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`which one you're looking at as we go through the
`
`questions.
`
` A. Sure.
`
` Q. I'm going to go through and ask you a
`
`series of questions today. I'd ask that you answer
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`fully and truthfully.
`
` Is there anything that would prevent
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`you from doing so today?
`
` A. No.
`
` Q. You understand that you're under oath?
`
` A. Yes, I do.
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`Gary Herman, M.D. - October 26, 2020
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`Page 9
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` Q. If you don't understand a question, please,
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`just let me know, I'll do my best to rephrase it.
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`If you need a break, please also let me know.
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` I know you are a busy man and I'm going
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`to do everything in my power to get you out of here
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`in fairly short order.
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` A. Thank you.
`
` Q. Have you been deposed before?
`
` A. I've not been deposed before.
`
` I have been a witness testifying in a
`
`trial in a child abuse case when I was a practicing
`
`physician.
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` Q. And, just roughly, how long ago was that?
`
` A. It would have been around 1994.
`
` Q. Are you being compensated for your time
`
`here today?
`
` A. I am not.
`
` Q. What did you do, to the extent that you did
`
`anything, in preparing for today's deposition?
`
` MR. ZOLAN: Dr. Herman, let me just
`
`remind you not to reveal the contents of any
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`communications that you and I have had. But,
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`Gary Herman, M.D. - October 26, 2020
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`Page 10
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`otherwise, go ahead and answer the question.
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` A. I have had conversations with Alex. I have
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`reviewed all of the documents that were provided,
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`and I collaborated on the drafting of the
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`declaration.
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` BY MR. SODERSTROM:
`
` Q. And, roughly, how long did you spend
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`meeting or speaking with Alex?
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` A. Maybe a total of ten hours, something like
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`that.
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` Q. Have you spoken with any other
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`individual -- or let me rephrase that.
`
` Have you spoken with any individuals at
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`Merck in preparing for this deposition?
`
` A. I have not spoken to any individuals other
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`than -- other than Alex and his team.
`
` Q. When did Alex or someone from his team
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`first contact you in connection with this matter?
`
` A. I can't remember exactly. This year feels
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`like ten years.
`
` I was first approached through the
`
`assistant general counsel, I think it was, in
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`Mylan (IPR2020-00040) Ex. 1023 p. 010
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`Gary Herman, M.D. - October 26, 2020
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`Page 11
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`August, something like that. But I could be wrong
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`about that.
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` Q. If I've done this correctly, I've uploaded
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`a document that you're able to download. I assume
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`it's the same as what you have in your binder as
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`Merck Exhibit 2109.
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` But if you're able to just download it
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`and confirm it so that I know that we're looking at
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`the same document, I'd appreciate that.
`
` A. How do I do that?
`
` Q. I think if you're able to click on the
`
`chat -- there should be a chat option when you hit
`
`"More" at the bottom of your screen, possibly?
`
` A. Oh, okay.
`
` Q. And then in the chat, you'll see,
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`hopefully, something titled EX2109 and the option to
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`download.
`
` A. Yes. It's downloading.
`
` (Pause in proceedings.)
`
` A. What I'm looking at, it says -- okay. Yes.
`
`This is the -- this is the same document.
`
`\\\
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`Mylan (IPR2020-00040) Ex. 1023 p. 011
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`Gary Herman, M.D. - October 26, 2020
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`Page 12
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` BY MR. SODERSTROM:
`
` Q. Okay. And this is your declaration that
`
`was submitted with --
`
` A. Right.
`
` Q. Okay.
`
` A. So do you want me to be looking at this or
`
`the hard copy of it? It's a little bit easier for
`
`me to look at the hard copy.
`
` Q. Whatever you're comfortable with,
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`Dr. Herman, is fine. I just wanted to make sure
`
`that what I have here is the same as what you have.
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`I don't doubt that it is, but I just want to --
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` A. Okay. So it's okay for me to close this
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`out now then.
`
` Q. That's fine.
`
` A. Okay.
`
` Q. I just want to confirm, on page 11 of that
`
`is your signature?
`
` A. This is my signature on page 11.
`
` Q. I believe you noted earlier that you worked
`
`in collaboration in drafting this declaration.
`
` Were there certain parts that you
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`Gary Herman, M.D. - October 26, 2020
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`Page 13
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`drafted and others that were drafted by others?
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` A. So in the drafting of the declaration, I
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`had conversations. Someone else wrote the words on
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`here. I reviewed carefully every word and signed
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`the document.
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` Q. Did you select the documents that are
`
`referenced in your declaration?
`
` A. I did not select the documents. It was not
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`my choice which documents weren't in here.
`
` Q. And prior to someone reaching out to you
`
`regarding this declaration, when was the last time
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`that you would have seen the documents that are
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`cited in your declaration?
`
` A. Some of these documents I have never seen.
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` The last time would have been the two
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`clinical study reports, protocol 5 and protocol 6,
`
`which would have been in early 2006.
`
` Q. And can you just identify which documents
`
`you're referring to that you had never seen?
`
` A. I never saw the patent, 1001. And I had
`
`never seen 2108, the batch analysis. And I had
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`never seen the -- 2110, the email there. And let me
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`
`Mylan (IPR2020-00040) Ex. 1023 p. 013
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`Gary Herman, M.D. - October 26, 2020
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`Page 14
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`just make sure.
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` I believe I have seen the remaining
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`documents prior.
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` Q. Have you seen anybody else's declaration
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`that has been submitted in connection with this
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`matter?
`
` A. I have not seen anybody else's declaration.
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` Q. And with respect to your declaration, are
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`there any corrections or changes that you would like
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`to make, having reviewed it again more recently?
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` A. I have reviewed all of the declaration and
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`have signed off because I attest that this is true
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`and accurate.
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` Q. And that's fair. And I won't get bogged
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`down in this, but my question is just to ensure
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`that, when you signed it -- between when you signed
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`it on August 19th, 2020, and sitting here today,
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`that there aren't any changes that you would like to
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`make to the declaration, or corrections or anything
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`of the sort?
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` A. Not at this time.
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` Q. And your declaration was meant to be a
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`Mylan (IPR2020-00040) Ex. 1023 p. 014
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`Gary Herman, M.D. - October 26, 2020
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`Page 15
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`complete statement for issues that you are offering
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`testimony on. Is that correct?
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` A. This is intended to be a complete
`
`statement.
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` Q. And if you turn to page 2 of your
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`declaration, you reference Claim 17, and then in
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`paragraph 3, you reference Claim 19 of the
`
`'708 patent.
`
` I think you said earlier that you
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`hadn't seen the patent before, but in preparing this,
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`did you look at any other claims of the '708 patent?
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` A. In preparation, to understand -- fully
`
`understand the context, I read the document from
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`beginning to end of the '708. But I will say that
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`the first time I read it, I'm not an author. I
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`would consider myself an extreme novice in IP.
`
` Q. Did you find it exciting?
`
` A. I did not.
`
` Q. Is it fair to say, though, that, sitting
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`here today, your testimony is limited to these two
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`claims?
`
` A. I think that's a fair statement.
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`Gary Herman, M.D. - October 26, 2020
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`Page 16
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` Q. And is it fair to say that -- well, let me
`
`ask you.
`
` Do you have any experience in salt
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`formation?
`
` A. I'm not a chemist. I sat on teams where my
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`colleagues were responsible for delivering those.
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`But, you know, again, I would say I know enough to
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`ask somebody questions, like "why is that good," but
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`I would, again, consider myself an extreme novice in
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`this.
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` Q. And I suppose -- a slightly related
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`question -- then, would you consider yourself a
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`novice in process chemistry?
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` A. I would answer that very similarly. I had
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`colleagues; that was part of the deliverable. They
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`needed to deliver a good amount of suitable drug
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`that we could test in the clinic.
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` Q. But in terms of your personal experience,
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`you would agree with me that you have no personal
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`experience in process chemistry. Is that fair?
`
` A. That is correct.
`
` Q. And is it also fair that -- again, limited
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`Gary Herman, M.D. - October 26, 2020
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`Page 17
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`to personal experience, that you have no personal
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`experience in formulation?
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` A. That is correct.
`
` Q. Looking back at those two claims that are
`
`referenced in paragraphs 2 and 3 of your
`
`declaration, they both use the phrase
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`"therapeutically effective." Do you see that?
`
` And what does that mean to you?
`
` MR. ZOLAN: Object to form.
`
` A. Could you be more precise in what it is
`
`that you're looking for in your question?
`
` BY MR. SODERSTROM:
`
` Q. Sure.
`
` I'm just looking at paragraphs 2 and 3
`
`of your declaration. And you use the words
`
`"therapeutically effective" in each paragraph. I'm
`
`just trying to understand what that means to you.
`
` MR. ZOLAN: Object to form.
`
` Go ahead.
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` THE WITNESS: Should I answer?
`
` MR. ZOLAN: Yes. Yeah. The
`
`objections are for the record. But go ahead and
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`Gary Herman, M.D. - October 26, 2020
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`Page 18
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`answer.
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` THE WITNESS: Okay.
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` A. Again, with the understanding that I'm
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`not -- you know, I'm a novice in looking at patents.
`
` What it means to me, okay, is that the
`
`composition is going to have a benefit clinically,
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`meaningful beneficial effect, in the disease in
`
`question; in this case, type 2 diabetes.
`
` BY MR. SODERSTROM:
`
` Q. Okay. Is that -- is it fair -- or I
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`suppose, correct me if I'm going too far with it.
`
` But to you -- and, again, I realize
`
`that you -- you don't spend a lot of time creating
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`patents.
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` But for "therapeutically effective," is
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`it eliciting some response based on taking a
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`particular drug?
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` MR. ZOLAN: Object to form.
`
` A. I'm not sure what it is that you're looking
`
`for.
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` Clearly, it is -- it references
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`amount. And so there -- it has a drug concentration
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`Gary Herman, M.D. - October 26, 2020
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`Page 19
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`and a dose that matter. It's not like you can just
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`give any amount. But beyond that, I'm not really
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`sure what you're looking for from me.
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` BY MR. SODERSTROM:
`
` Q. And I appreciate that. And to be fair,
`
`you'll see this. You are undoubtedly far smarter
`
`and I. And it will be rare that I am looking for
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`something in particular, other than to get your
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`thoughts on any of these questions that I have here
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`today. But I do appreciate that.
`
` If you look down at paragraph 4 in your
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`declaration, do you see it says, "I did not invent
`
`the subject matter claimed in the '708 patent."
`
` Do you see that?
`
` A. Yes.
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` Q. And, again, I'm just curious as to what you
`
`mean by that.
`
` A. I'm just rereading paragraph 4, because I
`
`want to make sure that I'm complete here.
`
` Q. By all means. Take your time and review
`
`anything that you need to.
`
` (Document review.)
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`Gary Herman, M.D. - October 26, 2020
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`Page 20
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` A. So as I stated, I -- I was not involved in
`
`the drafting or authorship of the patent. I was not
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`responsible for the determination of the salt form,
`
`nor the formulation; but I was the clinical team
`
`lead -- well, actually, it was the product team
`
`lead, what we called a PDT, and was the physician
`
`responsible for the design and oversight and
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`drafting of the studies that are relevant to this.
`
` And I was there at the time that these
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`things happened, and so I can talk -- I can speak to
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`when these things happened and what's in those
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`studies.
`
` BY MR. SODERSTROM:
`
` Q. And so for -- when you're referring to
`
`those studies and the relevant -- I think you said
`
`relevant aspect of it, you're talking about
`
`Claims 17 and 19 of the patent that you have
`
`pertinent information on. Is that correct?
`
` A. I am speaking about the clinical studies
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`that I was responsible for, yes.
`
` Q. And the subject matter of Claim 17 and
`
`Claim 19, again, you refer to those in paragraphs 2
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`Gary Herman, M.D. - October 26, 2020
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`Page 21
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`and 3 in your declaration.
`
` Who were the inventors responsible for
`
`that particular subject matter?
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` A. I'm going to just open up and make sure
`
`that -- can I just pull out Claim 17? Is that okay
`
`with you?
`
` Q. Of course.
`
` A. I don't know any of the inventors. I
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`didn't recollect any of their names.
`
` My understanding, though, is that they
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`were in the process research and pharmaceutical
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`research and development organizations. And more
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`senior individuals that they would have been working
`
`with were on the team that I cochaired. The DPP-IV
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`product development team.
`
` Q. If you go back to your declaration, in
`
`paragraph 12, there you reference protocol 005. And
`
`I think you mentioned that earlier today in your
`
`testimony as well.
`
` Do you see that in paragraph 12?
`
` A. I'm looking at paragraph 12.
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` Q. And do you see the reference to
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`Gary Herman, M.D. - October 26, 2020
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`Page 22
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`protocol 005 there?
`
` A. I do see the reference to protocol 005.
`
` Q. I'm going to try to do this again, and
`
`bother you with this for one second just to try to
`
`download the exhibit that I have, hopefully,
`
`uploaded into the chat.
`
` And I understand you may have the paper
`
`copy in front of you. I don't necessarily need you,
`
`unless you feel the need, to go through each page to
`
`confirm that what I have just uploaded is the same as
`
`what you have in front of you.
`
` But I would like to ask you a few
`
`questions about this document. And so if you'd
`
`prefer to use the paper copies in front of you, I'll
`
`just ask that you confirm that it's the same as what
`
`I have uploaded in the chat.
`
` A. Okay. I have protocol 005, Clinical Study
`
`Report, in front of me and it's downloading now.
`
`And I'll let you know when it completes.
`
` Q. Okay. Thank you.
`
` (Document review.)
`
` A. Okay. This is the same document.
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`Gary Herman, M.D. - October 26, 2020
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`Page 23
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` BY MR. SODERSTROM:
`
` Q. And is it correct that you are one of the
`
`authors of this report. Is that right?
`
` A. I was the principal author on this clinical
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`study report.
`
` Q. And this is a true and correct copy of
`
`protocol 005, as far as you can tell?
`
` A. The document appears to be a true and
`
`correct copy.
`
` Q. On page 17 of that protocol, do you see
`
`where it says "Primary Therapy Period," sort of like
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`the fourth main row under "Synopsis."
`
` Do you see that?
`
` A. I'm right there at the period of 14th
`
`October 2002 to 16th of March. Yeah. I see that.
`
` Q. And then just after what you read, it says
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`the frozen file date was December 3rd, 2003.
`
` What's the frozen file date?
`
` A. So the frozen file date is the penultimate
`
`step before the data is locked and analyzed.
`
` So any data cleaning or any
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`reconciliation -- so there was a lot of sampling,
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`Gary Herman, M.D. - October 26, 2020
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`pharmacokinetics, et cetera. Any questions that
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`anybody wanted to ask verifying, say, did that
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`sample really get taken at 9 a.m., or was it
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`9:05 a.m. Those can happen. But once it's locked,
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`that's it. Or once it's frozen, that's it.
`
` Q. And so, I suppose, just what happens during
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`that period of -- we have the primary therapy period
`
`that's ending March 16th, 2003.
`
` What happens between that date and --
`
`and the frozen file date being selected or enforced
`
`or executed?
`
` A. Once the last patient has finished their
`
`visit, which would have been 16th of March 2003, the
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`clinical team has an opportunity to go back and
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`review all of the source documentation, the data,
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`where it came from, because it all has to be
`
`reconstructed after the fact, and to make sure that
`
`it looks perfect.
`
` And if something looks -- if there's
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`any question about anything in the dataset, that
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`they have an opportunity to go back and ask the
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`study side's investigator, please verify this date,
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`Gary Herman, M.D. - October 26, 2020
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`Page 25
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`before they actually run the final analysis.
`
` Q. If you would turn to page 26 of that same
`
`protocol.
`
` A. I'm on page 26.
`
` Q. Yeah. Hopefully, you're seeing a title,
`
`"Rationale for the Present Study," at the top. Is
`
`that right?
`
` A. I do see that.
`
` Q. At the end of the third paragraph there, it
`
`looks like it is one somewhat long sentence that
`
`reads:
`
` "One or both doses of MK-0431 were
`
`hypothesized to reduce post-OGTT glucose by at least
`
`10 percent as compared to placebo.
`
` "The rationale for this target was
`
`based on the observation that other oral
`
`antihyperglycemic agents that target post-prandial
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`glucose" -- I won't be able to pronounce these next
`
`couple words, so I'll rely on you for that one to the
`
`extent we need it -- "achieve reductions of at least
`
`10 percent or greater."
`
` Can you just explain to me what those
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`Gary Herman, M.D. - October 26, 2020
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`Page 26
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`two sentences mean?
`
` A. First off, I apologize for my lengthy
`
`prose.
`
` At the beginning, we had to decide and
`
`reason what a clinically meaningful, therapeutically
`
`effective amount of glucose lowering following a
`
`glucose tolerance test would be.
`
` And OGTT is -- you ask somebody to
`
`drink glucose, their glucose goes up, you measure
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`the reduction by your treatment.
`
` And we looked at examples of other
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`agents that did this that were meaningful and led to
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`beneficial outcomes. And those all had at least a
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`10 percent or greater effect. That's where that
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`came from.
`
` And so we were looking for at least a
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`10 percent reduction in glucose excursion following
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`this test in the presence of MK-0431.
`
` Q. And then on the next page, sort of, I
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`suppose, in the conclusory paragraph, or at least
`
`the last paragraph of this section, it says:
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` "In order to corroborate estimates
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`Gary Herman, M.D. - October 26, 2020
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`(based on preclinical data) of the relationship
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`between near-maximum glucose lowering and MK-0431
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`plasma concentrations, plasma DPP-IV activity and
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`augmentation of active GLP-1 levels, preliminary
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`information on the PK/PD relationship of MK-0431 was
`
`also sought."
`
` And, again, I'm just hoping that you
`
`can explain to me what is meant by this sentence.
`
` A. So there's an interrelationship between
`
`giving the drug, inhibiting the DPP-IV enzyme. And
`
`the DPP-IV enzyme normally cleaves these incretin
`
`hormones. GLP-1 being the key one.
`
` And so it stabilizes and prevents the
`
`degradation, meaning augmentation of active GIP to
`
`prevent degradation between more GLP-1 that's
`
`uncleaved.
`
` And by putting together the
`
`interrelationship between drug concentration, how
`
`much we're inhibiting the enzyme, how much we're
`
`stabilizing the GLP-1, and looking at relationship
`
`between that and glucose lowering, we believed, at
`
`the time that we wrote this, that we would be able
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`Gary Herman, M.D. - October 26, 2020
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`to predict those that would work over long-term
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`trials.
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` And we intended to go directly from
`
`this trial into a large Phase IIb dose-ranging
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`finding study, which is what was written there in
`
`the document. And that is, in fact, what happened.
`
` Q. And so just turning back to sort of the
`
`beginning of that sentence where it's corroborating
`
`estimates based on preclinical data, can you just
`
`let me know sort of how that process works?
`
` A. Well, there were --
`
` MR. ZOLAN: Objection to form.
`
` A. There were preclinical models, in this case
`
`rodents, that went through all these same things.
`
`And we have initial estimates of how much inhibition
`
`of the enzyme, how much augmentation we give to the
`
`glucose lowering. And that's what guided the sample
`
`size here, and what we'd been looking for initially.
`
` BY MR. SODERSTROM:
`
` Q. If you would turn to page 155 of that same
`
`protocol.
`
` A. I'm looking at page 155.
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`Gary Herman, M.D. - October 26, 2020
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`Page 29
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` Q. Okay. And just under the point 9
`
`"Discussion," it opens up by saying, "DPP-IV
`
`inhibitors are expected to promote efficacy in
`
`glycemic control in patients with type 2 diabetes by
`
`inhibiting the degradation of the incretin hormones
`
`GLP-1 and GIP" -- and in possibly others -- "thereby
`
`stabilizing the active intact form of the hormones
`
`to enhance incretin action."
`
` And so, I guess, my question is
`
`twofold. Is this sort of what you were just
`
`explaining to me or is this something slightly
`
`different?
`
` A. I believe you could have read this section
`
`and then you wouldn't have had to ask me the
`
`question.
`
` Q. Well, that's fair. But luckily for you,
`
`and I suppose for me, is I still get to ask the
`
`questions and we can see where it goes. Let me
`
`rephrase it then, based on that.
`
` Why was it expected?
`
` A. Why was what expected?
`
` Q. I'm sorry.
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` That DPP-IV inhibitors are expected to
`
`promote efficacy in glycemic control in patients with
`
`type 2 diabetes?
`
` Is it strictly what follows?
`
` A. This is a weight-of-evidence argument. And
`
`it was a hypothesis at the time that we started down
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`this track that turned out to be true.
`
` There was preclinical data for a
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`couple of other molecules that had been in the
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`clinic that also showed that the hypothesis was
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`likely to be true, which showed glucose lowering in
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`the clinic. And our job was to nail it. But at the
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`time that we started this, I would sa
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