·1· ·UNITED STATES PATENT AND TRADEMARK OFFICE
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`·2· ·GRÜNENTHAL GMBH,
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`·3· · · · · · ·Petitioner,
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`·4· ·-against-· · · · · Case No.
`· · · · · · · · · · · · PGR2017-00022
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`· · ·ANTECIP BIOVENTURES II, LLC,
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`· · · · · · · ·Patent Owner.
`·7· ·- - - - - - - - - - - - - - - - - - - -x
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`· · · · · · · · · · · · 1290 Avenue of the Americas
`·9· · · · · · · · · · · New York, New York
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`10· · · · · · · · · · · January 18, 2018
`· · · · · · · · · · · · 9:04 a.m.
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`13· ·EXAMINATION BEFORE TRIAL of CLIVE GEORGE WILSON, PhD, the Expert
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`14· ·Witness herein, held at the above-mentioned time and
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`15· ·place, pursuant to Court Order, before Angela Arena, a
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`16· ·Notary Public in and for the State of New York.
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`25· ·Job No. 441885
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`ANTECIP EXHIBIT 2002
`Grunenthal GmbH v. Antecip Bioventures II LLC
`PGR2018-00001
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`·1· ·A P P E A R A N C E S:
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`·3· ·FITZPATRICK, CELLA, HARPER & SCINTO
`· · · · · Attorneys for Petitioner
`·4· · · · 1290 Avenue of the Americas
`· · · · · New York, New York 10104
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`· · ·BY:· MELINDA R. ROBERTS, ESQ.
`·6· · · · BRUCE C. HAAS, ESQ
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`· · ·MASCHOFF BRENNAN
`·8· · · · Attorneys for Patent Owner
`· · · · · 1389 Center Drive, Suite 300
`·9· · · · Park City, Utah 84098
`10· ·BY:· R. PARRISH FREEMAN, JR., ESQ.
`· · · · · BRENT A. JOHNSON, PhD
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`·1· · · ·S T I P U L A T I O N S
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`·3· · · · · · ·IT IS HEREBY STIPULATED AND AGREED by and
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`·4· ·between (among) counsel for the respective
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`·5· ·parties hereto that:
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`·7· ·All rights provided by the C.P.L.R.,
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`·8· ·including the right to object to any question, except as
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`·9· ·to form, or to move to strike any
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`10· ·testimony at this (these) examination(s), are reserved, and,
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`11· ·in addition, the failure to object
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`12· ·to any question or to move to strike any testimony
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`13· ·at this (these) examination(s) shall not be a bar
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`14· ·or waiver to make such motion at, and is reserved for the
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`15· ·trial of this action.
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`17· ·IT IS FURTHER STIPULATED AND AGREED by and between
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`18· ·(among) counsel for the respective parties hereto, that
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`19· ·this (these) examination(s)
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`20· ·may be sworn to by the witness(es) being examined,
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`21· ·before a Notary Public other than the Notary Public
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`22· ·before whom this (these) examination(s) was (were) begun;
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`23· ·but the failure to do so or to return the original of
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`24· ·this (these) examination(s)
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`25· ·to counsel, shall not be deemed a waiver of the rights
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`·1· ·provided by Rules 3116 and 3117 of the C.P.L.R., and
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`·1· ·Depositions, including the right to object to any
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`·2· ·shall be controlled thereby;
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`·2· ·question, except as to form, or to move to strike any
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`·3· ·testimony at this examination is reserved; and, in
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`·4· · · · IT IS FURTHER STIPULATED AND AGREED by and between
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`·4· ·addition, the failure to object to any question or to
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`·5· ·(among) counsel for the respective parties hereto, that
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`·5· ·move to strike any testimony at this examination shall
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`·6· ·this (these) examination(s)
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`·6· ·not be a bar or waiver to make such motion at, and is
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`·7· ·may be utilized for all purposes as provided by the
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`·7· ·reserved to, the trial of this action.
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`·8· ·C.P.L.R.;
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`10· · · · IT IS FURTHER STIPULATED AND AGREED by and between
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`11· ·(among) counsel for the respective parties hereto, that
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`12· ·the filing and certification of the original of this (these)
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`13· ·examination(s)
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`14· ·shall be and the same hereby are waived.
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`16· ·IT IS FURTHER STIPULATED AND AGREED by and
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`17· ·between (among) counsel for the respective
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`18· ·parties hereto, that a copy of the within examination(s)
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`19· ·shall be furnished to counsel representing the
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`20· ·witness(es) testifying, without charge.
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`22· ·IT IS FURTHER STIPULATED AND AGREED
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`23· ·by and between (among) counsel for the respective parties
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`24· ·hereto, that all rights provided by the C.P.L.R., and
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`25· ·Part 221 of the Uniform Rules for the Conduct of
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`·1· ·C L I V E· ·W I L S O N,
`·2· ·the Non-Party Witness herein, having
`·3· ·been duly sworn by the Notary Public, was· examined and
`·4· ·testified as follows:
`·5· ·EXAMINATION BY
`·6· ·MR. FREEMAN:
`·7· · · · ·Q.· · · Please state your name for the record.
`·8· · · · ·A.· · · Clive George Wilson.
`·9· · · · ·Q.· · · Please state your address for the record.
`10· · · · ·A.· · · 17 Viewfield Drive, Bishopbriggs, Glasgow,
`11· ·G64 2AQ Scotland, UK.
`12· · · · ·Q.· · · Dr. Wilson, did you do anything to prepare
`13· ·for your deposition today?
`14· · · · ·A.· · · I went through my testimony.· I went
`15· ·through some of the other exhibits.
`16· · · · ·Q.· · · Did you review any documents that were not
`17· ·exhibits in the case, to your knowledge?
`18· · · · ·A.· · · No, sir.
`19· · · · ·Q.· · · Did you meet with any people?
`20· · · · ·A.· · · I met with my counsels over the last two
`21· ·days.
`22· · · · ·Q.· · · Can you name the people with whom you met?
`23· · · · ·A.· · · I met with Mr. Haas and Ms. Roberts, who
`24· ·are here today, and also with Jim.
`25· · · · ·Q.· · · Jim Tyminski?
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`·1· · · · ·A.· · · Jim Tyminski.
`·2· · · · ·Q.· · · Did you meet with any non-lawyers regarding
`·3· ·your deposition?
`·4· · · · ·A.· · · No, I didn't.
`·5· · · · ·Q.· · · Where did you meet?
`·6· · · · ·A.· · · In these offices.
`·7· · · · ·Q.· · · About how long did you spend preparing for
`·8· ·your deposition?
`·9· · · · ·A.· · · Two days.
`10· · · · ·Q.· · · How long did you spend meeting with your
`11· ·counsel?
`12· · · · ·A.· · · Can I retract that?· I spent longer than
`13· ·two days because I spent two days with my counsel.
`14· · · · · · · · ·I also spent a day and-a-half prior to
`15· ·meeting counsel, on the plane, and obviously when I had
`16· ·the documents at home.
`17· · · · ·Q.· · · About how many hours do you think you spent
`18· ·with your counsel?
`19· · · · ·A.· · · Probably 16-to-18.
`20· · · · ·Q.· · · That was over the course of the past two
`21· ·days; is that correct?
`22· · · · ·A.· · · That's correct.
`23· · · · ·Q.· · · I'm going to hand you a copy of what's been
`24· ·previously marked in the case as Exhibit 1,005.· It's a
`25· ·copy of your declaration that you filed in this case.
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`·1· · · · ·A.· · · Thank you.
`·2· · · · ·Q.· · · I'd like to direct your attention to
`·3· ·paragraph two, please.
`·4· · · · · · · · ·Does your present position as a research
`·5· ·professor involve the study of bisphosphonates?
`·6· · · · ·A.· · · No, it doesn't.
`·7· · · · ·Q.· · · Does your present position as research
`·8· ·professor involve teaching about bisphosphonates?
`·9· · · · ·A.· · · It involves teaching about all classes of
`10· ·compounds, including bisphosphonates and any other types
`11· ·of compounds.
`12· · · · ·Q.· · · Do you teach specifically about
`13· ·bisphosphonates?
`14· · · · ·A.· · · Not specifically, no.
`15· · · · ·Q.· · · So you teach generally about
`16· ·bisphosphonates?
`17· · · · ·A.· · · I teach generally about compounds, and the
`18· ·interaction in the gut, and the idea of any physiological
`19· ·pharmaceutics.
`20· · · · ·Q.· · · Does the term bisphosphonate come up in
`21· ·your teaching at all?
`22· · · · ·A.· · · Yes.
`23· · · · ·Q.· · · In what regard?
`24· · · · ·A.· · · In regard to poorly-absorbed drugs.
`25· · · · ·Q.· · · So how much of the time would you spend on
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`·1· ·average teaching in a general way about bisphosphonates?
`·2· · · · ·A.· · · I couldn't give you a direct answer of
`·3· ·that.· I'd have to analyze my texts.
`·4· · · · ·Q.· · · Is it fair to say that to the extent you
`·5· ·teach about bisphosphonates, it is teaching that they are
`·6· ·poorly-absorbed in the gut?
`·7· · · · ·A.· · · I teach that it is an example of a drug
`·8· ·that is poorly-absorbed in the gut.
`·9· · · · ·Q.· · · Do you teach any other aspect of
`10· ·bisphosphonates?
`11· · · · ·A.· · · I teach that the early bisphosphonates
`12· ·cause problems of esopheagal ulceration and I worked on
`13· ·that as a problem.
`14· · · · ·Q.· · · Do you teach any aspect of bisphosphonate
`15· ·pharmacology?
`16· · · · ·A.· · · No.
`17· · · · ·Q.· · · That would include pharmacokinetics?
`18· · · · ·A.· · · (No verbal response given.)
`19· · · · ·Q.· · · I'll ask that differently.· Do you teach
`20· ·any aspect of bisphosphonate pharmacokinetics?
`21· · · · ·A.· · · No.
`22· · · · ·Q.· · · Did your former position as chair of
`23· ·pharmaceutics involve a study of bisphosphonates?
`24· · · · ·A.· · · During that period, I was involved in the
`25· ·design of Risedronate, known in the USA as Actonel,
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`·1· ·formulations for a company called Proctor & Gamble, which
`·2· ·you probably know.
`·3· · · · ·Q.· · · So I'm speaking just in your capacity of
`·4· ·chair of pharmaceutics, did you study bisphosphonates?
`·5· · · · ·A.· · · As I just told you, I conducted experiments
`·6· ·on bisphosphonate-based formulations over a period of
`·7· ·three years during my time as J P. Todd Chair of
`·8· ·Pharmaceutics, specifically with my particular interest
`·9· ·in upper GI irritation.
`10· · · · ·Q.· · · You're speaking there about your work on
`11· ·Risedronate for Proctor & Gamble?
`12· · · · ·A.· · · Specifically Risedronate.
`13· · · · ·Q.· · · Oral applications of Risedronate?
`14· · · · ·A.· · · Oral applications.
`15· · · · ·Q.· · · And you worked with Zoledronic Acid?
`16· · · · ·A.· · · None, to my knowledge.
`17· · · · ·Q.· · · When we spoke a moment ago about your
`18· ·teaching work as a research professor, was any of your
`19· ·teaching directed specifically to Zoledronic Acid?
`20· · · · ·A.· · · Not specifically, no.
`21· · · · ·Q.· · · You said you assisted with Risedronate
`22· ·development during a three-year period; is that correct?
`23· · · · ·A.· · · At least three years continuously and then
`24· ·on and off after that.
`25· · · · ·Q.· · · What was the three-year span?
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`·1· · · · ·A.· · · P-H-A-R-M-A-C-O-S-C-I-N-T-I-G-R-A-P-H-Y.
`·2· · · · ·Q.· · · What does that word mean?
`·3· · · · ·A.· · · It's the relationship between where a
`·4· ·formulation is, or how it disperses, and the blood
`·5· ·levels, or effects that drug causes.
`·6· · · · ·Q.· · · Is that related to bioavailability studies?
`·7· · · · ·A.· · · It's related to bioavailability studies and
`·8· ·to studies where you are interested in LALAs, locally
`·9· ·acting, locally administered drugs.
`10· · · · ·Q.· · · Like a patch?
`11· · · · ·A.· · · No.· Like Mesalazine, or like steroids that
`12· ·are taken orally where you are deliberately trying to get
`13· ·a good average of the GI tract, but not necessarily
`14· ·bioavailability.
`15· · · · ·Q.· · · Did your work with Risedronate for P&G
`16· ·while you were Chair of Pharmaceutics involve any aspect
`17· ·of Risedronate pharmacology?
`18· · · · ·A.· · · In addition, I suppose, because I was
`19· ·constantly exposed to my colleagues working on
`20· ·Risedronate connecteds, and also on different aspects
`21· ·of -- so I became aware of some of the actions,
`22· ·obviously, of Risedronate, and how it helps mobilize
`23· ·calcium for remodelling of bone.
`24· · · · ·Q.· · · So to the extent that -- strike that.
`25· · · · · · · · ·Your exposure to Risedronate pharmacology
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`·1· · · · ·A.· · · I think in the 90's.· I'd have to go back
`·2· ·to my CV to look.
`·3· · · · ·Q.· · · So I understand that your work for Proctor
`·4· ·& Gamble happened at the same time that you were chair of
`·5· ·pharmaceutics.
`·6· · · · · · · · ·I want to get a clear understanding of was
`·7· ·that work that you conducted in your capacity as chair of
`·8· ·pharmaceutics or was it work on the side?
`·9· · · · ·A.· · · It was part of my research work.
`10· · · · ·Q.· · · So it was in your capacity as chair?
`11· · · · ·A.· · · My capacity as chair is administrative.
`12· ·I'm allowed to do any appropriate research program that I
`13· ·want to pursue.
`14· · · · · · · · ·My expertise is in gamma scintigraphy and I
`15· ·set up a unit at Nottingham University, which I still
`16· ·continue, because I was working with
`17· ·pharmacoscintigraphy.· After I'd become the J P. Todd
`18· ·Professor, I had a grant.
`19· · · · · · · · ·Then I essentially carried on investigating
`20· ·another of my interests, which is esophageal irritation
`21· ·and reflux disease.
`22· · · · ·Q.· · · You said a word a moment ago,
`23· ·pharmacoscintigraphy?
`24· · · · ·A.· · · Pharmacoscintigraphy.
`25· · · · ·Q.· · · Can you spell that?
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`·1· ·during your work on Risedronate, is that best
`·2· ·characterized as an indirect exposure?
`·3· · · · ·A.· · · It depends whether you regard making a
`·4· ·successful formulation of Risedronate an indirect
`·5· ·exposure.
`·6· · · · · · · · ·It is essentially getting the formulation
`·7· ·right is the most important thing you can do in designing
`·8· ·a drug which is poorly-absorbed.
`·9· · · · ·Q.· · · Was your work with Risedronate directed to
`10· ·pharmacology of Risedronate in any way?
`11· · · · ·A.· · · My work with Risedronate was directed
`12· ·towards not the pharmacology of Risedronate directly, but
`13· ·more the toxicology associated with drugs, which are very
`14· ·acidic and which cause esophageal ulceration.
`15· · · · ·Q.· · · Did your former position as Chair of
`16· ·Pharmaceutics involve teaching about bisphosphonates?
`17· · · · ·A.· · · In that I took part in conferences
`18· ·discussing the actions of bisphosphonates, for example,
`19· ·Intrento, as a JP Todd Professor of Pharmaceutics, which
`20· ·was a two-day course organized by the Italian
`21· ·Gastroenterology Society, and by the fact that I am a
`22· ·member of the British Society of Gastroenterologists.
`23· · · · ·Q.· · · When you were chair of pharmaceutics did
`24· ·your job as chair of pharmaceutics entail teaching a
`25· ·course about bisphosphonates?
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`·1· · · · ·A.· · · Not specifically to pharmacists, no.
`·2· · · · ·Q.· · · When you say not specifically to
`·3· ·pharmacists?
`·4· · · · ·A.· · · I taught medics.
`·5· · · · ·Q.· · · You taught medics?
`·6· · · · ·A.· · · Yes.
`·7· · · · ·Q.· · · You taught a course in bisphosphonates to
`·8· ·medical students?
`·9· · · · ·A.· · · I contributed to courses on the GI effects
`10· ·of bisphosphonates to medical students, yes.
`11· · · · ·Q.· · · So the GI effects of bisphosphonates?
`12· · · · ·A.· · · Yes.
`13· · · · ·Q.· · · Not the pharmacology?
`14· · · · ·A.· · · Not the pharmacology.· It was related to my
`15· ·research work.
`16· · · · ·Q.· · · Did any of your work as Chair of
`17· ·Pharmaceutics involve Zoledronic Acid?
`18· · · · ·A.· · · No.
`19· · · · ·Q.· · · Looking at paragraph three, in obtaining
`20· ·your BSC degree in applied biology, did you take any
`21· ·courses that covered bisphosphonates?
`22· · · · ·A.· · · No.
`23· · · · ·Q.· · · What's a PhD in biochemistry (drug
`24· ·metabolism)?· What does that mean?
`25· · · · ·A.· · · It means a higher doctorate obtained by
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`·1· · · · ·A.· · · Metabolized and excreted, yes.
`·2· · · · ·Q.· · · When we say metabolized, we're talking
`·3· ·about uptake of a drug by the gut?
`·4· · · · ·A.· · · You're talking about not just uptake of the
`·5· ·drug by the gut, but catabolism by the liver and
`·6· ·excretion in the urine and bile.
`·7· · · · ·Q.· · · Does that PhD cover any aspect of
`·8· ·pharmacology?
`·9· · · · ·A.· · · A little bit in that the drug I was working
`10· ·on was an antiparasitic.· So you're interested in the
`11· ·pharmacology in the host, as well as the effect on the
`12· ·parasite.
`13· · · · ·Q.· · · In working for your PhD in biochemistry
`14· ·drug metabolism, did you work with bisphosphonates?
`15· · · · ·A.· · · No.
`16· · · · ·Q.· · · Referring to paragraph four of exhibit
`17· ·1,005, did your former position as professor involve the
`18· ·study of bisphosphonates?
`19· · · · ·A.· · · As I've said, during that time I conducted
`20· ·studies with Proctor & Gamble at the University of
`21· ·Nottingham working on the pharmacoscintigraphy, looking
`22· ·at formulation effects relative to esophageal ulceration.
`23· · · · ·Q.· · · Would you say ulcerative effects?
`24· · · · ·A.· · · Yes.
`25· · · · ·Q.· · · Esophageal, what was the other word?
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`·1· ·research, where specifically I was looking at the
`·2· ·metabolism of drugs in hosts and -- in parasites and also
`·3· ·in hosts animals, such as pigs and cows.
`·4· · · · · · · · ·I was also working on drug metabolism in
`·5· ·man and in rats, and generally looking at the actions of
`·6· ·cytochrome P450 isoforms.
`·7· · · · ·Q.· · · Is that what pharmacoscintigraphy is?
`·8· · · · ·A.· · · Absolutely not.
`·9· · · · ·Q.· · · Absolutely not.· Help me understand the
`10· ·difference, please.
`11· · · · ·A.· · · Scintigraphy is a clinical technique where
`12· ·you administer a radiopharmaceutical.· The
`13· ·radiopharmaceutical contains within it's makeup a
`14· ·gamma-emitting isotope, specifically technetium 99M, or
`15· ·Indian 113, or Indian 111, or even a gas.
`16· · · · · · · · ·The idea of this being that you can look at
`17· ·the distribution of the radiopharmaceutical, and from
`18· ·that you can sometimes infer how formulations deliver and
`19· ·why you get certain kinds of pharmacokinetic effects.
`20· · · · · · · · ·For example, the failure to deliver a drug
`21· ·in the colon, or the failure to achieve group dispersion
`22· ·where you have no blood or urine surrogates.
`23· · · · ·Q.· · · So the PhD in biochemistry drug metabolism,
`24· ·that means a specialization in how drugs are metabolized;
`25· ·is that correct?
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`·1· · · · ·A.· · · Esophageal irritation.· I was interested
`·2· ·particularly in esophageal retention.
`·3· · · · ·Q.· · · That's with regard to Risedronate?
`·4· · · · ·A.· · · That was with regard to the potential
`·5· ·Actonel formulation.
`·6· · · · ·Q.· · · Actonel is Risedronate?
`·7· · · · ·A.· · · Actonel is the currently-marketed
`·8· ·Risedronate formulation in the US.
`·9· · · · ·Q.· · · That's an oral application?
`10· · · · ·A.· · · It's an oral.
`11· · · · · · · · ·MR. FREEMAN:· I know you've had your
`12· · · · ·deposition taken before, but I will just remind
`13· · · · ·you we have to be careful not to talk over one
`14· · · · ·another.· I have to remind myself.
`15· · · · · · · · ·So I'm saying it for both our benefits.
`16· · · · ·Let's not talk over one another, or cut each other
`17· · · · ·off, even if we think where the other one is
`18· · · · ·going.
`19· · · · · · · · ·Enunciate as best you can verbally with
`20· · · · ·your answers, yes, no.· Don't nod.· Don't say
`21· · · · ·uh-huh, uh-uh, that kind of thing.· I know you
`22· · · · ·knew that, but now we both know.
`23· · · · · · · · ·THE WITNESS:· It's always good to be
`24· · · · ·reminded.
`25· · · · ·Q.· · · That work was in the mid-90's, you think?
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`·1· · · · ·A.· · · 90's through to 2000.
`·2· · · · ·Q.· · · Aside from the Risedronate work, did your
`·3· ·former position as professor that you refer to in
`·4· ·paragraph four of your declaration involve the study of
`·5· ·bisphosphonates?
`·6· · · · ·A.· · · Prior to that.
`·7· · · · ·Q.· · · I'm referring to the period of time that
`·8· ·you discuss in your declaration of paragraph four, 1990
`·9· ·to 2016 professor?
`10· · · · ·A.· · · Right.
`11· · · · ·Q.· · · I'm treating these as separate, two, three
`12· ·and four, these are all separate engagements,
`13· ·chronologically or otherwise.· If they're overlapping,
`14· ·then let me know.
`15· · · · ·A.· · · I will let you know.· Now.
`16· · · · ·Q.· · · They are overlapping?
`17· · · · ·A.· · · The overlapping one is the research
`18· ·professor.· I retired for tax reasons.· I was in the next
`19· ·day.· I still have a team.
`20· · · · ·Q.· · · Say that again.
`21· · · · ·A.· · · I retired for tax reasons.· I still have my
`22· ·team.· I still have my full tenured position at
`23· ·Strathclyde University.· I'm not an honoree.· I'm a
`24· ·tenured member of staff.
`25· · · · ·Q.· · · So the work in paragraph four overlaps
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`·1· ·part in administrative roles.
`·2· · · · ·Q.· · · So with regard to your work as professor
`·3· ·from 1990 to 2016, and putting aside the Risedronate
`·4· ·work, did any of that work involve the study of
`·5· ·bisphosphonates?
`·6· · · · ·A.· · · After -- no, it didn't.
`·7· · · · ·Q.· · · Referring to paragraph five of your
`·8· ·declaration, is your current role as chairman of
`·9· ·biological sciences limited, have you working with
`10· ·bisphosphonates in any way?
`11· · · · ·A.· · · Only in the regards of this case.
`12· · · · ·Q.· · · When you say this case, you're acting as an
`13· ·expert in three different PGR proceedings; is that
`14· ·correct, all involving -- is that right?
`15· · · · · · · · ·MS. ROBERTS:· I think it's two PGR.
`16· · · · · · · · ·MR. FREEMAN:· Pardon me, strike that.
`17· · · · ·Q.· · · I just want to clarify, in this case you
`18· ·mean generally the work for Grünenthal; is that correct?
`19· · · · ·A.· · · Yes.
`20· · · · ·Q.· · · Involving the PGR proceedings that
`21· ·Grünenthal is involved in relating to Zoledronate?
`22· · · · ·A.· · · That's correct.
`23· · · · ·Q.· · · Did your previous role as Chief Scientific
`24· ·Officer for BioImages Research Limited have you working
`25· ·with bisphosphonates in any way?
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`·1· ·somewhat with the work in paragraph two; is that correct?
`·2· · · · ·A.· · · Effectively could do, yes.
`·3· · · · ·Q.· · · Currently it doesn't?
`·4· · · · ·A.· · · No.
`·5· · · · ·Q.· · · So as far as the work at Strathclyde, I'm
`·6· ·seeing professor, research professor, Chair of
`·7· ·Pharmaceutics.· Can you help me understand the
`·8· ·chronology?
`·9· · · · ·A.· · · From 1990 I took the post up at Strathclyde
`10· ·University in 1990.· In the same year I was awarded an
`11· ·MRC Grant at the University of Nottingham where I was
`12· ·formally Reader.
`13· · · · · · · · ·So what happened is that I was then made an
`14· ·honorary professor in medical physics at the University
`15· ·of Nottingham during the 1990's, which allowed me to be
`16· ·insured, to continue the work in patients and in
`17· ·volunteers on the Risedronate project.
`18· · · · · · · · ·Two years ago I retired.· I formally
`19· ·retired and gave up the chair in order to free it up for
`20· ·someone else to occupy it.· That hasn't happened.
`21· · · · · · · · ·Then I had a contract from the University
`22· ·of Strathclyde, which continued my position, which
`23· ·allowed me -- which essentially covered my insurance,
`24· ·which allowed me to have a laboratory, which allowed me
`25· ·to supervise, teach, examine, and if I so wished, to take
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`·1· · · · ·A.· · · I don't recall working with bisphosphonates
`·2· ·at that time.
`·3· · · · ·Q.· · · Do you think it's possible that you did?
`·4· · · · ·A.· · · I'm trying to recall.· I was still in
`·5· ·contact with Proctor & Gamble, but they sort of divested
`·6· ·a lot of their interest in that area.· So I don't think
`·7· ·during that time we did work on bisphosphonates.
`·8· · · · ·Q.· · · You say in paragraph five that you're a
`·9· ·member of the Steering Committee of the European
`10· ·Federation of Pharmaceutical Sciences.· It is unclear to
`11· ·me whether you mean former or current member.
`12· · · · ·A.· · · I was the President of the European
`13· ·Federation of Pharmaceutical Sciences.
`14· · · · · · · · ·After that capacity you become the past
`15· ·president and serve on the committee.· After that you
`16· ·serve on senate for a period of time.
`17· · · · · · · · ·I'm still on senate with responsibility for
`18· ·education, and overseas liaison, particularly with the
`19· ·new Europe.
`20· · · · ·Q.· · · So you're currently a member of the
`21· ·Steering Committee?
`22· · · · ·A.· · · I'm currently a member of senate.
`23· · · · ·Q.· · · You are formally a member of the Steering
`24· ·Committee?
`25· · · · ·A.· · · I'm formally a member.
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`·1· · · · ·Q.· · · Of the Steering Committee?
`·2· · · · ·A.· · · Yes.
`·3· · · · ·Q.· · · Did your work as a former member of the
`·4· ·Steering Committee have you working with bisphosphonates
`·5· ·in any way?
`·6· · · · ·A.· · · Specifically, no, because that's not the
`·7· ·nature of the organization.
`·8· · · · ·Q.· · · Did your previous role as President of the
`·9· ·European Federation of Pharmaceutical Sciences have you
`10· ·working with bisphosphonates in any way?
`11· · · · ·A.· · · If I can explain?
`12· · · · ·Q.· · · Sure.
`13· · · · ·A.· · · My previous role as a member of the
`14· ·Steering Committee involved me organizing collaboration
`15· ·between scientists across Europe.
`16· · · · · · · · ·It involved the setting up of specifically
`17· ·discussion groups, including those which discussed
`18· ·bisphosphonates, and I'm still a member of one of those
`19· ·groups called Bioavailability and Biopharmaceutics
`20· ·Network, which I serve on.
`21· · · · · · · · ·So periodically I would say that you dip in
`22· ·and out of drugs, such as bisphosphonates.
`23· · · · ·Q.· · · The way I understood your answer is to say
`24· ·that you are involved in the sense that you help people
`25· ·organize meetings or presentations regarding them; is
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`·1· ·that fair to say?
`·2· · · · ·A.· · · That's one of the roles I have.· I also act
`·3· ·as a European ...· so what we do is we get the great and
`·4· ·the good together and we condense their knowledge and
`·5· ·then report it back to the FDA and to the EMA.
`·6· · · · ·Q.· · · Do you recall doing that for
`·7· ·bisphosphonates?
`·8· · · · ·A.· · · Not specifically, though I may do it in the
`·9· ·future.
`10· · · · ·Q.· · · Do you regard yourself as a laboratory
`11· ·chemist?
`12· · · · ·A.· · · Not particularly.· I regard myself as
`13· ·someone with a good working knowledge who still goes into
`14· ·the laboratory to perform experimentation, who has an
`15· ·interest in novel technology associated with the
`16· ·solution.
`17· · · · · · · · ·I work on trying to improve those robotized
`18· ·systems.· I have an interest in building prototype
`19· ·devices for flow in implants, for example.
`20· · · · · · · · ·At the moment I am leading a team looking
`21· ·at ways of measuring the behavior of interocular
`22· ·implants, which are very, very small.
`23· · · · · · · · ·I look at the design of devices which
`24· ·attempt to go beyond the existing dissolution apparatus
`25· ·and mimic the actions of the stomach, and I published on
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`·1· ·that.
`·2· · · · · · · · ·I look at the behavior of simulators, which
`·3· ·simulate the whole of the GI tract, and with that I work
`·4· ·with a Deutsch group called TNO.· Am I going too fast for
`·5· ·you?
`·6· · · · ·Q.· · · No, but we're getting a little off of where
`·7· ·we started.· I'll ask another question.· I don't want to
`·8· ·cut you off, though.
`·9· · · · ·A.· · · Those are things which I do.· I was trying
`10· ·to give you an idea of my sort of interactions in this
`11· ·field.
`12· · · · ·Q.· · · Okay.· Do you think you're capable of
`13· ·synthesizing compounds in a lab?
`14· · · · ·A.· · · I have certainly had to do that with
`15· ·radiopharmaceuticals, which require quite delicate and
`16· ·careful manipulation.
`17· · · · ·Q.· · · So in general, if somebody said I want you
`18· ·to go synthesize compound A, here is the recipe,
`19· ·so-to-speak could you do that?
`20· · · · ·A.· · · Absolutely.
`21· · · · ·Q.· · · Referring to paragraph six of your
`22· ·declaration, did you learn anything about bisphosphonates
`23· ·in connection with your membership in the British Society
`24· ·of Gastroenterology?
`25· · · · ·A.· · · Absolutely.
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`·1· · · · ·Q.· · · What have you learned?
`·2· · · · ·A.· · · Generally, because we get continually
`·3· ·informed through our membership to the Journal of Gut, we
`·4· ·learn a lot about essentially the absorption
`·5· ·characteristics of bisphosphonates.
`·6· · · · · · · · ·We learn a little bit about other aspects
`·7· ·of immunology associated with inflammation, which is
`·8· ·relevant.
`·9· · · · ·Q.· · · Anything about the pharmacology of
`10· ·bisphosphonates?
`11· · · · ·A.· · · There certainly would have been some. I
`12· ·can't recall the exact issue and date, but there would
`13· ·have been some.
`14· · · · ·Q.· · · So you're referring to things that you
`15· ·would have read in the Journal of Gut?
`16· · · · ·A.· · · Among other things, yes.
`17· · · · ·Q.· · · What are the other things?
`18· · · · ·A.· · · I can't recall.· I do read more than the
`19· ·Journal of Gut.
`20· · · · ·Q.· · · Did you learn anything about
`21· ·bisphosphonates in connection with your membership in the
`22· ·Controlled Release Society?
`23· · · · ·A.· · · The Controlled Release Society examines
`24· ·methodologies associated with sustained release and with
`25· ·presentation to different issues.
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`·1· · · · · · · · ·Therefore, inevitably it covers all aspects
`·2· ·of drugs used in the treatment of man.· In that time I
`·3· ·served in the membership, I will have seen papers, and
`·4· ·posters, and even adjudicated posters, which associated
`·5· ·with Zoledronate and the modern bisphosphonates.· I can't
`·6· ·recall them exactly because there are so many of them.
`·7· · · · ·Q.· · · There are many involving Zoledronate?
`·8· · · · ·A.· · · Zoledronate is not really a unique compound
`·9· ·and therefore many would -- it doesn't sort of stand out
`10· ·as a paper because I see so many, but I will have seen
`11· ·some for sure.
`12· · · · ·Q.· · · Specifically mentioning Zoledronate?
`13· · · · ·A.· · · I would imagine so, yes.
`14· · · · ·Q.· · · But you can't specifically recall them
`15· ·right now?
`16· · · · ·A.· · · I would challenge anybody that looks at
`17· ·1,000 posters to pick out the poster.
`18· · · · ·Q.· · · But you didn't participate in preparing any
`19· ·of the posters; is that correct?
`20· · · · ·A.· · · That is correct.
`21· · · · ·Q.· · · The material that you said you read in the
`22· ·Journal of Gut and other sources that you can't recall,
`23· ·you didn't participate in preparing any of those writings
`24· ·either, did you?
`25· · · · ·A.· · · No, I did not.
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`·1· · · · ·Q.· · · Did you learn anything about
`·2· ·bisphosphonates in connection with your membership in the
`·3· ·American Association of Pharmaceutical Sciences?
`·4· · · · ·A.· · · The same applies in that's a meeting of
`·5· ·6,000 pharmaceutics people, and without a doubt there
`·6· ·will be something there, which I can't recall, on
`·7· ·Zoledronate without a doubt.
`·8· · · · ·Q.· · · You're referring to things that you would
`·9· ·have read; is that correct?
`10· · · · ·A.· · · Read and seen.
`11· · · · ·Q.· · · Read and seen.
`12· · · · ·A.· · · And attended lectures as well.
`13· · · · ·Q.· · · But you didn't prepare any writings
`14· ·yourself; is that correct?
`15· · · · ·A.· · · That's correct.
`16· · · · ·Q.· · · Did you learn anything about
`17· ·bisphosphonates in connection with your membership in the
`18· ·Academy of Pharmaceutical Sciences?
`19· · · · ·A.· · · The same type of organization.· Therefore,
`20· ·the same applies.
`21· · · · ·Q.· · · Did you learn anything about
`22· ·bisphosphonates in connection with your membership in any
`23· ·other organization not identified in paragraph six?
`24· · · · ·A.· · · In the Italian Society of
`25· ·Gastroenterologists, for example, which I mentioned
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`·1· ·before, which I attended.
`·2· · · · ·Q.· · · What did you learn about bisphosphonates in
`·3· ·connection with the Italian Society of Gastroenterology?
`·4· · · · ·A.· · · I would have to go back to my notes to see.
`·5· ·I presented at that Society.· It was specifically looking
`·6· ·at GI, or my interest with GI irritation.
`·7· · · · · · · · ·I learned some of the problems that the
`·8· ·modern bisphosphonates did cause.· I learned about some
`·9· ·of the limitations and was asked my opinion about things
`10· ·like bioavailability, so lots of things with regard to
`11· ·this.
`12· · · · ·Q.· · · Was it about oral bisphosphonates?
`13· · · · ·A.· · · It was about oral bisphosphonates.
`14· · · · ·Q.· · · Was it about Zoledronate?
`15· · · · ·A.· · · It included Zoledronate and others.
`16· · · · ·Q.· · · Did it specifically mention Zoledronate?
`17· · · · ·A.· · · It included Zoledronate and others.
`18· · · · ·Q.· · · Did it state the word Zoledronate?
`19· · · · ·A.· · · Yes.
`20· · · · ·Q.· · · It didn't involve the pharmacology of
`21· ·Zoledronate, however?
`22· · · · ·A.· · · In passing, it could have been.· I can't
`23· ·recall.· I may have been lecturing.· It was a
`24· ·multisession thing, so there would be other things going
`25· ·on.· I can't remember whether I attended those or not. I
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`·1· ·think I did.
`·2· · · · ·Q.· · · So others would have been speaking to the
`·3· ·pharmacology?
`·4· · · · ·A.· · · At the same time I was speaking, it's quite
`·5· ·possible.· There were things going on, yes.
`·6· · · · ·Q.· ·