Transcript of Rodolfo Pinal, Ph.D.
`
`Date: April 26, 2024
`Case: Hopewell Pharma Ventures, Inc. -v- Merck Serono, S.A. (PTAB)
`
`Planet Depos
`Phone: 888.433.3767
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`
`Merck 2080
`Hopewell v Merck
`IPR2023-00481
`WORLDWIDE COURT REPORTING & LITIGATION TECHNOLOGY
`
`
`
`Date: April 26, 2024
`Case: Hopewell Pharma Ventures, Inc. -v- Merck Serono, S.A. (PTAB)
`
`Planet Depos
`Phone: 888.433.3767
`Email: transcripts@planetdepos.com
`www.planetdepos.com
`
`Merck 2080
`Hopewell v Merck
`IPR2023-00481
`WORLDWIDE COURT REPORTING & LITIGATION TECHNOLOGY
`
`
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` ___________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ___________________
` HOPEWELL PHARMA VENTURES, INC.
` Petitioner,
` v.
` MERCK SERONO S.A.,
` Patent Owner.
` ___________________
`
` IPR2023-00480
` U.S. Patent 7,713,947
` IPR2023-00481
` U.S. Patent 8,377,903
`
` Deposition of RODOLFO PINAL, PH.D.
` Washington, D.C.
` Friday, April 26, 2024
` 9:03 a.m.
`
`Job No. 534629
`Pages 1 - 134
`Reported by: Karen Young
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`2
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` Deposition of RODOLFO PINAL, PH.D., held at
`the offices of:
` STERNE, KESSLER,
` GOLDSTEIN & FOX, P.L.L.C.
` 1101 K Street, Northwest
` Washington, D.C. 20005
` (202) 371-2600
`
` Pursuant to notice, before Karen Young,
`Notary Public of the District of Columbia.
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`3
`
` A P P E A R A N C E S
`ON BEHALF OF HOPEWELL PHARMA VENTURES, INC.:
` PRATIBHA KHANDURI, PH.D., ESQUIRE
` ELDORA L. ELLISON, PH.D., ESQUIRE
` OLGA A. PARTINGTON, ESQUIRE
` STERNE, KESSLER,
` GOLDSTEIN & FOX, P.L.L.C.
` 1101 K Street, Northwest
` Washington, D.C. 20005
` (202) 371-2600
`
`ON BEHALF OF MERCK SERONO S.A.:
` SCOTT BERTULLI, ESQUIRE
` DERIC X. GENG, ESQUIRE
` WILMER CUTLER PICKERING HALE AND DORR LLP
` 60 State Street
` Boston, Massachusetts 02109
` (617) 526-6000
`
`ALSO PRESENT:
` Emil White, Remote Technician
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`4
`
` C O N T E N T S
`EXAMINATION OF RODOLFO PINAL, PH.D. PAGE
` By Mr. Bertulli......................... 5
` By Ms. Khanduri......................... 130
`
` EXHIBITS REFERRED TO
` (Retained by Counsel)
`Exhibit 1013 Paper by Stelmasiak et al...... 98
`Exhibit 1018 Paper by Rice et al............ 86
`Exhibit 1022 World Intellectual Property
` Organization Publication No. WO
` 2004/087101 A2........................... 53
`Exhibit 1080 Declaration in IPR2023-00480... 6
`Exhibit 1080 Declaration in IPR2023-00481... 6
`Exhibit 2043 Paper by Liliemark et al....... 83
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`5
`
` (Exhibits were marked prior to the deposition.)
` P R O C E E D I N G S
` RODOLFO PINAL, PH.D.,
` having been duly sworn, was examined as follows:
` - - -
` EXAMINATION BY COUNSEL FOR MERCK SERONO S.A.
`BY MR. BERTULLI:
` Q Good morning, Dr. Pinal.
` A Good morning.
` Q Thank you for joining us today.
` A Thank you.
` Q You understand that you're under oath
`today?
` A I do.
` Q Is there any reason that you cannot
`provide complete and truthful testimony today?
` A There is no reason.
` Q Okay. And -- well, let me ask you this
`question. You understand that today's deposition
`is covering two IPR proceedings, right?
` A That is my understanding.
` Q And it's not a quiz, but one of them is
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`6
`
`IPR2023-00480. Does that sound right?
` A That sounds right.
` Q And I see that you've consulted a
`document to answer my question. What is that
`document you've got there with you?
` A The document I'm holding in my hands
`right now is a copy of my declaration on
`IPR2023-00480.
` Q And does that copy of your declaration
`have an exhibit number in the bottom right-hand
`corner on the cover?
` A It does.
` Q And what's that number?
` A The number is EX1080.
` Q Okay. And then the other proceeding that
`we're covering today is IPR2023-00481. Is that
`also your understanding?
` A That is also my understanding.
` Q Okay, and you've also consulted a hard
`copy of your declaration in that second proceeding;
`is that right?
` A Correct.
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`7
`
` Q And does it have an exhibit number in the
`lower right-hand corner?
` A It does.
` Q And what's that number?
` A EX1080.
` Q Do you have any other hard copies of
`documents with you today?
` A The only hard copies of documents that I
`have with me today are the two documents for which
`I read the exhibit number for you.
` Q Your declarations.
` A That is correct.
` Q Are those clean copies of your
`declarations?
` A Both copies are clean. There are no
`annotations by anyone on either of them.
` Q Great. Do you recall when you were
`contacted to participate in this case?
` MS. KHANDURI: Objection. Dr. Pinal, I
`will remind you to -- I will caution you to not
`divulge the substance of communications with
`counsel. Subject to that instruction, you can
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`8
`
`answer the question.
` A I have a recollection of being contacted
`for the first time to work on this case.
` Q Do you recall when that was?
` A Not precisely.
` Q Do you have an estimate of when that was?
` A A good estimate that I would give is a
`few months ago.
` Q A few months ago? And that's a few
`months ago from today, April 26th, 2024.
` A A few months prior to April 26th, 2024.
` Q And without sharing any content of any
`privileged communications, do you recall who
`reached out to you to participate in this case?
` A I do.
` Q Who was that?
` A Ms. Bond.
` Q Who is Ms. Bond?
` A Ms. Bond is a person that works at the
`firm that I'm working with.
` Q Okay, and that firm's Sterne Kessler?
` A That is correct.
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`9
`
` Q Okay. How many times have you provided a
`declaration in an inter partes review proceeding
`before this case?
` A I cannot give you a precise number, but I
`know that there is at least one.
` Q Less than ten times?
` A Less than ten times would be an adequate
`estimate.
` Q And do you recall how many times, if any,
`you've given deposition testimony before today?
` A Deposition testimony in general or for
`IPR proceedings?
` Q That was going to be my next question.
`So you can answer in general, and then we can break
`it up if that would be helpful, but how about
`generally first, how many times have you sat for a
`deposition?
` A In general, about 15 times.
` Q And to your point of clarification, how
`many of those times were for an inter partes review
`proceeding?
` A To the best of my recollection, this is
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`10
`
`the first time that I'm deposed on a IPR
`proceeding.
` Q Okay, so for the rest of those 15
`depositions, were those District Court litigations
`that you gave testimony for?
` A I don't know the specific legal
`situations, but I would say that I believe so.
` Q Has every deposition that you've
`participated in been with regard to a patent
`dispute?
` A I believe so.
` Q Let's -- I'm going to ask you questions
`about your declaration shortly, but some more
`housekeeping. Did you prepare for today's
`deposition?
` MS. KHANDURI: I will caution the witness
`not to divulge the substance of the communications
`with counsel. Subject to that instruction, you can
`answer the question.
` A I did.
` Q Yes or no, did you prepare with counsel?
` A My preparation for this deposition
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`11
`
`included meeting with counsel.
` Q The part of your preparation that
`included meeting with counsel, did that take place
`in one meeting?
` A It did not.
` Q How many meetings did your -- strike
`that. How many times did you meet with counsel to
`prepare for your deposition?
` A My estimate is about five times.
` Q Did all five meetings with counsel take
`place in person?
` A They did not.
` Q How many of the five meetings with
`counsel took place in person?
` A Three.
` Q Without disclosing any privileged
`communications or the content of your discussions,
`which counsel was present for your preparation for
`this deposition?
` A The three attorneys here present.
` Q Was anyone else who was not an attorney
`present for your preparation?
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`12
`
` A There was no one else other than the
`three attorneys here present.
` Q And is that true for all five meetings
`that you conducted to prepare for today's
`deposition?
` A It is true for the three meetings we had
`in person. To the best of my knowledge, it was
`also true for the meetings we have video
`conference.
` Q Understood. And so what preparation did
`you do for your deposition that did not include
`meeting with counsel?
` A It included reading my declaration and
`reviewing the materials considered for the most
`part.
` Q What do you mean by for the most part?
` A It also involved thought process of
`connecting concepts.
` Q Did you speak with anyone besides counsel
`during your preparation?
` A I have not spoken with any person other
`than counsel as part of my preparation.
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`13
`
` Q Have you ever spoken with anyone other
`than counsel about this case at all since you've
`begun working on it?
` A I have not spoken about this case with
`anybody outside counsel.
` Q Why don't you pick up your copy of
`Exhibit 1080, which I think is your declaration in
`the IPR2023-00480 proceeding.
` A I have it in front of me.
` Q And if I could ask you to please turn to
`page 45? That's the very end. Are you there?
` A I am there.
` Q Okay, and page 45 of your declaration
`shows your signature. Do you see that?
` A I see it.
` Q Is that your signature?
` A That is my signature.
` Q And you signed this declaration on April
`3rd, 2024.
` A That is correct.
` Q Okay, and I'm hoping to just have us
`stick with one declaration so you're not jumping
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`14
`
`back and forth all day, but if you go to your other
`declaration in the 00481 proceeding --
` A I have it in front of me.
` Q Can you please go to the last page there?
` A I am on the last page.
` Q And does the last page of your second
`declaration also bear your signature?
` A This is also my signature.
` Q And you signed it?
` A I did sign it.
` Q And you signed it on April 3rd, 2024.
` A I signed it on April 3rd, 2024.
` Q And you said you reviewed your
`declarations as part of your preparation; is that
`right?
` A That is correct.
` Q Are there any opinions in either of your
`declarations that you'd like to change today?
` A The opinions presented in my declarations
`have not changed as of this moment.
` Q So each of your opinions contained in
`your declarations are true and correct to the best
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`15
`
`of your understanding.
` A To the best of my understanding, they are
`true and correct.
` Q Are you equally confident in every one of
`your opinions?
` A Could you clarify the question?
` Q Sure. So each of your declarations
`includes more than one of your opinions. Is that
`fair?
` A My declaration contains different aspects
`of my general opinion.
` Q And are you equally confident in every
`aspect of your opinions in your declarations?
` A All the opinions that I present as part
`of my general opinion represent my level of
`confidence on them.
` Q Why don't we stick with the Exhibit 1080
`declaration in the 00480 case, okay?
` A Okay.
` Q Could you please turn to page 8?
` A I am on page 8.
` Q At paragraph 21, you write, "In
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`16
`
`formulating my opinions, I considered the following
`documents." Do you see that?
` A I see it.
` Q And then there is a table that reads from
`the bottom of page 8 it looks like all the way
`through pages 9, 10 and 11. Do you see that table?
` A I do.
` Q Did you consider any documents in
`formulating your opinions that are not included in
`this table?
` A The documents considered in forming my
`opinion are listed on this document.
` Q And you considered every document that's
`listed in this table?
` A I read and considered every document in
`forming my opinion.
` Q Okay, so looking at the bottom of page 8,
`do you see an Exhibit Number 1002?
` A I see it.
` Q And the description of that exhibit
`reads, "Declaration of Aaron Miller, M.D." Did I
`read that correctly?
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`17
`
` A You did.
` Q So in formulating your opinions in your
`declaration, you considered Dr. Miller's
`declaration, Exhibit 1002; is that right?
` A I did consider Dr. Miller's declaration.
` Q Did you agree with all of the opinions
`that Dr. Miller set forth in Exhibit 1002?
` MS. KHANDURI: Objection, scope.
` A My opinion as per what I was asked to
`opine on refer to the formulation and the dosage
`form and the times of treatment regimen without
`extending to the therapy of multiple sclerosis.
` Q Did Dr. Miller's declaration of Exhibit
`1002 include any opinions as to formulation?
` A Could I have a copy of Dr. Miller's
`declaration?
` Q I'm just asking you questions about your
`review. You reviewed it, right?
` A I review it. I did not memorize it.
` Q Okay. Do you recall if Dr. Miller
`provided any opinions about formulation in his
`declaration?
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`18
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` A Could I have a copy of Dr. Miller's
`declaration?
` Q I just asked if you recalled, and I hear
`you requesting a copy, but your deposition's not
`about Dr. Miller's declaration. It's about your
`declaration and your review of Dr. Miller's
`declaration.
` A As I sit here right now, I cannot give
`you a precise recollection of what I read in
`Dr. Miller's declaration.
` Q Do you think that if you had read
`something in Dr. Miller's declaration that you
`disagreed with, you would have remembered it?
` MS. KHANDURI: Objection, form,
`foundation.
` A I don't understand your question.
` Q Well, you read Dr. Miller's declaration,
`Exhibit 1002; is that right?
` A That is correct.
` Q So in your reading it, if you had
`encountered something that you disagreed with in
`his declaration, would that have stuck with you?
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`19
`
` MS. KHANDURI: Objection, form,
`foundation.
` A Dr. Miller's declaration bases on the
`therapy of multiple sclerosis for a person of skill
`in the art who had chosen to utilize cladribine. I
`have not been asked to opine on that subject, and
`as such, I don't disagree. I have no reason to
`disagree with Dr. Miller's opinion.
` Q Okay, so that's fair. So then let me ask
`it this way. You don't have any reason to dispute
`anything that was included in Dr. Miller's
`declaration of Exhibit 1002. Is that fair?
` A I have found no reason to dispute the
`opinions of Dr. Miller.
` Q What is your understanding of
`Dr. Miller's expertise?
` A Could I have a copy of Dr. Miller's
`declaration?
` Q Do you need a copy of Dr. Miller's
`declaration to identify your understanding of his
`expertise?
` A I have not memorized Dr. Miller's
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`20
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`declaration.
` Q Dr. Miller's a neurologist; is that
`right?
` A I have not memorized the career path of
`Dr. Miller.
` Q Have you ever talked to Dr. Miller?
` A I have not.
` Q Have you ever communicated with
`Dr. Miller through other electronic means like
`e-mail or text message?
` A I have not.
` Q Has Dr. Miller ever consulted with you
`with respect to this case?
` A He has not.
` Q Are you aware if Dr. Miller has submitted
`any other declarations in support of this case?
` A I am aware that Dr. Miller submitted, to
`the best of my knowledge, two declarations.
` Q Have you ever seen Dr. Miller's second
`declaration in this case?
` A I have not.
` Q So you did not see Dr. Miller's second
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`21
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`declaration at the time that you signed your
`declaration in this case.
` A I did not.
` Q Do you know if Dr. Miller has ever
`reviewed your declaration in this case?
` A I don't have direct or firsthand
`knowledge on the answer to that question.
` Q And that's totally fair. I just want to
`know if you know. Who knows what he's done on his
`own or otherwise. Just you, do you know if
`Dr. Miller has ever reviewed your declaration in
`this case?
` A To my knowledge, I don't know.
` Q In your declaration, can you please turn
`to paragraph 13?
` A I have paragraph 13 in front of me.
` Q You are an expert in the field of
`pharmacology; is that right?
` A I refer to myself as a pharmaceutical
`scientist, and as such, pharmacology is one of the
`subjects of my expertise, but it is not the only
`one.
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
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`22
`
` Q Is pharmacokinetics an aspect of your
`expertise in pharmacology?
` A Pharmacokinetics is a subset of the
`pharmaceutical sciences, like pharmacology. It is
`part of the expertise of a pharmaceutical
`scientist.
` Q Are you comfortable if I refer to
`pharmacokinetics today as PK?
` A I will be comfortable with that.
` Q Is formulation an aspect of PK?
` A Formulation is another subject that falls
`under pharmaceutical sciences.
` Q So -- so that I understand, so
`formulation falls outside the scope of PK
`specifically?
` A In the pharmaceutical sciences, the
`different subjects or sub-subjects are
`interconnected, but they have somewhat different
`focus because each one covers a slightly different
`aspect.
` Q So what is, in your words, formulation?
` MS. KHANDURI: Objection, form.
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`23
`
` A Formulation in the pharmaceutical context
`is the design of -- the design, preparation,
`manufacture of compositions used in pharmaceutical
`processes.
` Q And how does formulation factor into the
`design, preparation and manufacture of compositions
`used in pharmaceutical processes?
` A Can you repeat your question please?
` Q Sure. How does formulation factor into
`the design, preparation and manufacture of
`compositions used in pharmaceutical processes?
` MS. KHANDURI: Objection, form, scope.
` A I absolutely don't understand your
`question.
` Q Okay. What is drug absorption in the
`context of pharmaceutical sciences?
` A In the context of pharmaceutical
`sciences, drug absorption is the process that
`follows administration of a drug into a subject or
`patient such that the drug, for lack of a better
`term, gets incorporated, not to be redundant with
`the word "absorption," into the body of the
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`24
`
`subject.
` Q And you looked at drug absorption as part
`of your analysis in this case; is that right?
` A Drug absorption is one of the phenomena
`involved in considering the attributes of
`pharmaceutical formulations and pharmaceutical
`products.
` Q In the context of pharmaceutical
`sciences, what is solubility?
` A Solubility is a property of chemical
`substances that refers to the maximum concentration
`that can be achieved for a given substance in a
`liquid solution.
` Q And you looked at solubility as part of
`your analysis in this case. Is that true?
` A The solubility phenomenon is part of the
`parameters that are taken into account when
`considering pharmaceutical products or
`pharmaceutical dosage forms.
` Q And you would have taken solubility into
`account in your analysis in this case.
` A Solubility is one of the parameters that
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`25
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`is taken into account.
` Q Is permeability another parameter that
`would have been taken into account in your analysis
`in this case?
` A Permeability is another parameter that is
`taken into account when considering pharmaceutical
`products or pharmaceutical dosage forms.
` Q And what is permeability in this context?
` A Permeability can be put as the ability of
`a molecule, in this case a drug molecule, to
`penetrate tissues of the body of the subject to
`whom a drug has been administered.
` Q Is dosage form another parameter that you
`would have taken into account in your analysis in
`this case?
` A Could you clarify your question?
` Q Sure. Well, are you familiar with the
`phrase "dosage form"?
` A I am, and that is why I'm asking you to
`clarify your question.
` Q Well, what does dosage form mean to you
`in the context of pharmaceutical sciences?
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`26
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` A Dosage form is the physical form, for
`example, a tablet or a capsule, which is used to
`administer a formulation to a patient or subject.
` Q Were you consulting a particular
`paragraph of your declaration while arriving at
`your answer?
` A I was consulting a footnote.
` Q Which footnote was that?
` A It is footnote number 2.
` Q You mentioned tablets and capsules as
`examples of dosage form; is that right?
` A In my previous answer, those are the two
`terms that I used.
` Q Is a solution another example of dosage
`form?
` MS. KHANDURI: Objection, form.
` A Dosage forms include solutions.
` Q Is sublingual film an example of a dosage
`form?
` MS. KHANDURI: Objection, form.
` A Dosage forms include sublingual films.
` Q Did you analyze any examples of
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`27
`
`sublingual films as part of your analysis in this
`case?
` A I have no precise recollection of that.
` Q Can you describe what a sublingual film
`is?
` A I can.
` Q Could you please?
` A A sublingual film in general terms is a
`thin layer of a material, typically polymeric
`material or a material that has the ability to form
`films, and in that thin layer, a drug is embedded,
`and that piece of material is placed in the mouth
`cavity, and if it is sublingual, it is under the
`tongue, and when placed in there, that is how it is
`administered.
` Q Do you recall when you first encountered
`sublingual films in your work in the field?
` MS. KHANDURI: Objection, scope.
` A I don't recall when I first encountered
`sublingual films in my work.
` Q Do you have any understanding of when
`sublingual films were first developed in
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`28
`
`pharmaceutical sciences?
` MS. KHANDURI: Objection, scope.
` A The subject of sublingual -- sublingual
`films has been around for many years in the
`pharmaceutical sciences, so if you can be more
`specific in your question, I may be able to answer.
` Q What do you mean by many years in your
`answer?
` A The reason I do not recall exactly when I
`first encountered sublingual films is that to the
`best of my recollection, it happened at some time
`when I was a student, so your question about some
`specific development of films, if I'm able to
`answer it, I need you to be more precise in your
`question.
` Q Okay. Well, we can come back to that
`because I have a few other parameters that I want
`to cover. What does it mean if a drug or a
`compound is in an amorphous form?
` MS. KHANDURI: Objection, form,
`foundation.
` A The amorphous form of a material is one
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`29
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`in which the crystalline composition of that
`material has been disrupted.
` Q What do you mean when you say the
`crystalline composition of that material has been
`disrupted?
` A When a material such as a drug substance,
`which almost as a rule are produced in crystalline
`form, meaning as crystals, when that crystalline
`arrangement is ameliorated so that it's no longer
`present, the material takes the amorphous form.
` Q Is stability another parameter considered
`in the pharmaceutical sciences?
` MS. KHANDURI: Objection, form,
`foundation.
` A The stability of drugs is one
`consideration in the development of pharmaceutical
`drugs.
` Q In the context of pharmaceutical drugs,
`what is stability?
` A In the context of the pharmaceutical
`sciences and the pharmaceutical field, stability is
`the capacity of a drug in a drug product to remain
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`30
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`chemically intact for a prolonged period of time.
` Q Is higher stability for a drug
`preferable?
` MS. KHANDURI: Objection, form,
`foundation.
` A With everything else equal, if the drug
`lasts longer chemically intact in one product as
`opposed to another product, the one that lasts
`chemically intact longer would be preferable.
` Q Which form of drug has a hire stability,
`amorphous or crystalline?
` MS. KHANDURI: Objection to form.
` A It depends.
` Q On what?
` A It depends on what the environment of the
`amorphous drug happens to be.
` Q What aspects of the environment of the
`amorphous drug are considered when looking at
`stability?
` A One of the aspects that is considered
`when looking at a stability is the presence and
`effect of other ingredients in the formulation.
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
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`31
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` Q And what do you mean by other
`ingredients?
` A Pharmaceutical products contain an active
`compound, which is the drug. It is the main use in
`the field. They also contain other ingredients
`which are not pharmacologically active.
` Q So you called the -- the drug in a -- I'm
`sorry, strike that. You called the drug the active
`compound? Am I following that correctly?
` A That is a common term used in the
`pharmaceutical field, so can be used with the word
`"drug" or the word "active compound" to refer to
`the pharmacologically active compound, which is the
`drug.
` Q Is there a common term used in the
`pharmaceutical field to refer to the other
`ingredients which are not pharmacologically active?
` A There is.
` Q What's that term?
` A The term used for non-pharmacologically
`active ingredients in pharmaceutical products is
`excipient.
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`32
`
` Q A few moments ago, you talked about
`tablets. When -- when studying dosage form, does
`the size of a tablet matter?
` A Can you clarify your question please?
` Q Sure. Well, let me ask it differently.
`I guess if all else being equal, if a
`pharmacologist is developing a tablet, do they --
`does that person consider the size of the resultant
`tablet at all?
` MS. KHANDURI: Objection, form,
`foundation.
` A With everything else equal, tablets are
`made taking into consideration the person who is
`going to use them. In that sense, the size of the
`tablet is something that can be handled by the
`patient with ease, and it can also be swallowed by
`the patient with ease.
` Q So that's a helpful clarification. I was
`going to ask you if when you said handled by the
`patient with ease, if you meant swallowing it, but
`I think it means something different.
` A Patients, when they have to take
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
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`33
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`medication, they need to grab with their hands
`their medication, and subsequently, take it, ingest
`it. So aspects of holding them in hand is
`something that is relevant to the use of
`medications.
` Q So it seems like a smaller sized tablet
`could be harder to handle for certain types of
`patients.
` MS. KHANDURI: Objection, form.
`BY MR. BERTULLI:
` Q Is that fair?
` A
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