UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________________________________
`
`HOPEWELL PHARMA VENTURES, INC.,
`Petitioner,
`v.
`MERCK SERONO SA,
`Patent Owner.
`_________________________________________________
`Case IPR2023-00480
`Patent 7,713,947
`
`Case IPR2023-00481
`Patent 8,377,903
`____________________________________________________
`
`DECLARATION OF NICHOLAS BODOR, Ph.D., D.Sc., d.h.c. (multi), HoF
`(multi)
`
`Merck 2054
`Hopewell v Merck
`IPR2023-00480
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`

`

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`I, Nicholas Bodor, declare as follows:
`
`IPR2023-00480, IPR2023-00481
`U.S. Patent Nos. 7,713,947, 8,377,903
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`I.
`
`INTRODUCTION
`
`1.
`
`I am over eighteen years of age, and I am competent to testify as to
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`the matters set forth herein if I am called upon to do so.
`
`2.
`
`I have prepared this Declaration for consideration by the Patent Trial
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`and Appeal Board in the following Inter Partes Review proceedings: IPR2023-
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`00480 (“’480 IPR”) and IPR2023-00481 (“’481 IPR”). I understand that the
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`subject of the ’480 IPR is U.S. Patent No. 7,713,947 (“the ’947 patent”) and the
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`subject of the ’481 IPR is U.S. Patent No. 8,377,903 (“the ’903 patent”).
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`3.
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`I am a named inventor of the PCT Application, WO 2004/087101,
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`“Oral Formulations of Cladribine” (“BODOR PCT”), which I understand has been
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`numbered Ex. 1022 in the ’480 IPR and in the ’481 IPR. I have been asked to
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`provide a declaration as an inventor of the BODOR PCT.
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`4.
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`I am being compensated for my time in preparing this declaration at
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`my usual consulting rate of $1250.00/hour. My compensation is in no way
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`contingent on the substance of my testimony or the outcome of this or any other
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`proceeding. I have no interest in this proceeding.
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`5.
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`I have personal knowledge of the facts stated herein and can testify
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`competently to those facts.
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`II. BACKGROUND
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`IPR2023-00480, IPR2023-00481
`U.S. Patent Nos. 7,713,947, 8,377,903
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`6.
`
`I am currently a Graduate Research Professor Emeritus in the College
`
`of Pharmacy, University of Florida. My professional qualifications are stated more
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`fully in my curriculum vitae, which is attached as Appendix A. Below is a brief
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`summary of my relevant education, work experience, and other qualifications.
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`7.
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`I received my B.S./M.S. degree in Organic Chemistry in 1959 from
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`Bolyai University in Transylvania, and my Ph.D. degree in 1965 from the
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`University of Babes-Bolyai, Cluj and the Romanian National Academy of
`
`Sciences.
`
`8.
`
`I served as a Group Leader at the Pharmacochemical Research
`
`Institute in Romania until 1968. Thereafter, I received the R.A. Welch Fellowship
`
`at the University of Texas in Austin. From 1972 until 1978, I worked at the ALZA
`
`Laboratories in Lawrence, Kansas, which later became INTERx Research
`
`Corporation. During this time, I also served as an adjunct professor at the
`
`University of Kansas.
`
`9.
`
`In 1979, I joined the University of Florida as Professor and Chairman
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`of the Medicinal Chemistry Department. During my time at the University of
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`Florida, I have held many appointments and served in many positions across the
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`University, including Executive Director of the Center for Drug Discovery in the
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`College of Pharmacy, Graduate Research Professor in the College of Pharmacy,
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`and Affiliate Graduate Research Professor in the Department of Chemistry in the
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`IPR2023-00480, IPR2023-00481
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`College of Liberal Arts and the Department of Ophthalmology in the College of
`
`Medicine at the University.
`
`10.
`
`In 2000, I accepted the role of Senior Vice President of Basic
`
`Research and Drug Discovery at IVAX Research, Inc. From 2000 to 2006, I
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`served in various managing capacities at IVAX, including as Chief Scientific
`
`Officer of the IVAX Corporation, Managing Director of the IVAX Drug Research
`
`Institute, Budapest, Hungary, as well as President of the IVAX Research Institute.
`
`In 2006, after IVAX merged with Teva, I returned to the University of Florida and
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`started Bodor Laboratories Inc., where I manage a small team who use a
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`proprietary approach to drug design that leverages retrometabolic processes to
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`create drugs that are safer, less toxic, and intrinsically better targeted than
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`traditional drugs.
`
`III. CLADRIBINE FORMULATION RESEARCH
`
`11. When I joined IVAX in 2000, IVAX had obtained the rights to
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`develop cladribine for the treatment of multiple sclerosis (“MS”), which had
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`previously belonged to the SCRIPPS Research Institute (“SCRIPPS”) and Johnson
`
`& Johnson (“J&J”).
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`12. Cladribine is a chlorinated purine analog, 2-chloro-2’-deoxyadenosine
`
`(“2-CdA”) compound. When I joined IVAX in 2000, cladribine was FDA
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`approved for the treatment of patients with hairy cell leukemia. It had not yet been
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`IPR2023-00480, IPR2023-00481
`U.S. Patent Nos. 7,713,947, 8,377,903
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`approved for the treatment of other diseases, like multiple sclerosis.
`
`13. As part of my role at IVAX, I was responsible for leading a team to
`
`investigate and develop an oral cladribine formulation suitable for use in Phase III
`
`clinical trials for MS patients.
`
`14. My team at IVAX included my co-inventor of the BODOR PCT,
`
`WO2004/087101, Dr. Yogesh Dandiker, Dr. Stephen Marcus, and other team
`
`members.
`
`15.
`
`In researching a potential cladribine formulation, my team at IVAX
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`investigated different methods to maximize incorporation of cladribine into
`
`complexes with cyclodextrins. We had identified hydroxypropyl-(cid:533)-cyclodextrin as
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`a promising cyclodextrin for cladribine-cyclodextrin complexes for oral delivery of
`
`cladribine. My team focused on studying the conditions that would incorporate the
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`most cladribine into the resulting complex as well as whether other cyclodextrins
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`might form a complex that incorporated more cladribine.
`
`16. The work that my team and I performed on cyclodextrin-cladribine
`
`complexes would ultimately result in our invention of an oral formulation of
`
`cladribine including a cladribine-cyclodextrin complex, as described in the
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`BODOR PCT, WO 2004/087101.
`
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`5
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`IPR2023-00480, IPR2023-00481
`U.S. Patent Nos. 7,713,947, 8,377,903
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`17. After developing the cladribine-cyclodextrin complex described in the
`
`BODOR PCT, my team at IVAX performed pharmacokinetic and bioavailability
`
`studies of that oral formulation in non-human and human subjects. We conducted
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`these studies using single doses of the oral cladribine formulation we developed, to
`
`compare its pharmacokinetic properties and bioavailability against prior
`
`intravenous formulations. My team at IVAX never treated a patient using multiple
`
`doses of cladribine. ’480 Ex. 1022, 36:10-39:19; ’481 Ex. 1022, 36:10-39:19.
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`Thus, we never used or studied anything that could be described as a “dosing
`
`regimen.”
`
`A.
` IVAX AND SERONO PARTNERSHIP
`18. Around 2002, IVAX entered into an exclusive worldwide product
`
`development and license agreement with Ares Trading, S.A., an affiliate of Serono,
`
`S.A., (collectively, “Serono”) for the development and commercialization of an
`
`oral formulation of cladribine for the treatment of multiple sclerosis. Under this
`
`joint research and development agreement with Serono, IVAX was responsible for
`
`developing an oral formulation of cladribine. While IVAX developed an oral
`
`formulation of cladribine, Serono would develop a potential dose and dosing
`
`regimen, design and conduct Phase III clinical trials, obtain regulatory approval,
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`and market and sell the final product for treating multiple sclerosis.
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`IPR2023-00480, IPR2023-00481
`U.S. Patent Nos. 7,713,947, 8,377,903
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`B.
`
`INVENTION OF THE COMPLEX CLADRIBINE-
`CYCLODEXTRIN COMPLEX
`19. After my team and I began developing different oral formulations of
`
`cladribine, we first filed for a U.S. provisional patent application, U.S. Patent
`
`Application No. 60/458,922 (“’922 Provisional”), on March 24, 2003. The ’922
`
`Provisional was directed to particular cladribine-cyclodextrin complexes that
`
`IVAX had in development, including complexes isolated by freeze-drying
`
`(lyophilizing) cladribine and cyclodextrin. Ex. 2044, 1.1 The ’922 Provisional did
`
`not contain any proposed or suggested dosing regimen using cladribine
`
`formulations for treating MS. Ex. 2044, 1-18. I am the sole named inventor of the
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`’922 Provisional.
`
`20.
`
`IVAX also filed U.S. Application No. 60/484,756 (“’756
`
`Provisional”) on July 2, 2003. The ’756 Provisional was directed to particular
`
`cladribine-cyclodextrin complexes that IVAX had in development. Ex. 2045, 1-2.
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`The ’756 Provisional did not contain any proposed or suggested dosing regimen
`
`using cladribine formulations for treating MS. Ex. 2045, 1-15. I am the sole
`
`named inventor of the ’756 Provisional.
`
`
`1 All citations to Patent Owner’s Exhibits are in reference to Patent Owner’s
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`exhibits filed contemporaneously in IPR2023-00480 and IPR2023-00481.
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`IPR2023-00480, IPR2023-00481
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`21.
`
`IVAX additionally filed U.S. Application No. 60/541,247 (“’247
`
`Provisional”) on February 4, 2004. The ’247 Provisional was directed to oral
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`formulations of cladribine that IVAX had in development. Ex. 2046, 1:3-5. In
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`particular, it was directed to solid oral dosage forms containing an amorphous
`
`mixture of different cladribine-cyclodextrin complexes. Ex. 2046, 4:25-27. I am
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`the sole named inventor of the ’247 Provisional.
`
`22.
`
`I understand that on March 25, 2004, IVAX also filed two provisional
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`patent applications, both entitled “Cladribine Regimen for Treating Multiple
`
`Sclerosis.” Both applications were cited in the BODOR PCT. ’480 Ex. 1022,
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`23:24-29; ’481 Ex. 1022, 23:24-29. I do not believe I or Dr. Dandiker are named
`
`as an inventor on either. I am not aware of the subject matter of either application.
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`I am not aware of anyone at IVAX who was working on developing or researching
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`a cladribine dosing regimen for treating MS, nor anyone at IVAX who invented a
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`cladribine dosing regimen for treating MS. Counsel have provided me with an
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`amendment from the prosecution history of U.S. Patent No. 8,785,415, which is a
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`U.S. patent corresponding to the BODOR PCT. The amendment says:
`
`These were provisional applications which were abandoned without
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`the filing of non-provisional applications based thereon. Further, they
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`were not for inventions of the present inventors and belonged to a
`
`former assignee. They were not made available to the public. In the
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`IPR2023-00480, IPR2023-00481
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`parent case, now patented (Application No. 12/986, 310), the sentence
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`in question was deleted during prosecution, by an amendment made
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`October 3, 2008. Accordingly, page 23 of the specification has been
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`amended to delete the final sentence on page 23, consistent with the
`
`parent.
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` Ex. 2047, 10. I have no reason to doubt the amendment is accurate.
`
`23. On March 26, 2004, IVAX filed the BODOR PCT Application, WO
`
`2004/087101. The BODOR PCT named me and my colleague Dr. Dandiker as
`
`inventors. The BODOR PCT was directed to oral formulations of cladribine that
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`IVAX had in development. In particular, it was directed to solid oral dosage forms
`
`containing an amorphous mixture of cladribine-cyclodextrin complexes.
`
`24. The amorphous cladribine-cyclodextrin complexes described in the
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`BODOR PCT contain an “amorphous admixture of (a) an amorphous inclusion
`
`complex of cladribine with an amorphous cyclodextrin and (b) amorphous free
`
`cladribine associated with amorphous cyclodextrin as a non-inclusion complex.”
`
`’480 Ex. 1022, 14:12-14; ’481 Ex. 1022, 14:12-14. Because this formulation
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`contains both an inclusion complex and a non-inclusion complex of cladribine, it
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`can be called a “complex cladribine-cyclodextrin complex.” ’480 Ex. 1022, 16:27;
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`’481 Ex. 1022, 16:27. This complex cladribine-cyclodextrin complex can “be
`
`saturated with cladribine.” ’480 Ex. 1022, 14:16; ’481 Ex. 1022, 14:16. This
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`allows “cladribine [to cyclodextrin] weight-ratios of from about 1:10 to 1:16.”
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`IPR2023-00480, IPR2023-00481
`U.S. Patent Nos. 7,713,947, 8,377,903
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`’480 Ex. 1022, 31:18-20; ’481 Ex. 1022, 31:18-20. This composition can be
`
`created, for example, by adding cladribine to a dilute solution of cyclodextrin at
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`elevated temperature until it is saturated and then freeze drying (lyophilizing) it.
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`’480 Ex. 1022, 12-21, 26-33; ’481 Ex. 1022, 12-21, 26-33.
`
`25.
`
`I understand that certain disclosures in the ’247 Provisional and the
`
`BODOR PCT are at issue in the inter partes review proceedings. Specifically, the
`
`BODOR PCT states:
`
`At the present time, it is envisioned that, for the treatment of multiple
`
`sclerosis, 10 mg of cladribine in the instant complex cladribine-
`
`cyclodextrin complex in the instant solid dosage form would be
`
`administered once per day for a period of five to seven days in the
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`first month, repeated for another period of five to seven days in the
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`second month, followed by ten months of no treatment.
`
`’480 Ex. 1022, 23:15-20; ’481 Ex. 1022, 23:15-20. The ’247 Provisional
`
`contains similar language:
`
`At the present time, it is envisioned that, for the treatment of multiple
`
`sclerosis, 10 mg of cladribine in the instant complex cladribine-
`
`cyclodextrin complex in the instant solid dosage form would be
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`administered once per day for one week in the first month, repeated
`10
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`IPR2023-00480, IPR2023-00481
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`for another week in the second month, followed by ten months of no
`
`treatment.
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`Ex. 2046, 20:6-10.
`
`26. Neither myself nor my team, including Dr. Dandiker, developed,
`
`researched, or invented the above dosing regimen. Indeed, no one on my team at
`
`IVAX developed, researched, or invented any cladribine dosing regimen for
`
`treating MS. I do not consider this regimen to be my invention, and it was not
`
`claimed in the BODOR PCT or the corresponding U.S. patents, Nos. 7,888,328
`
`and 8,785,415. Ex. 2069; Ex. 2029.
`
`27. To the best of my knowledge, pursuant to the joint research and
`
`development agreement, Serono was responsible for any research and development
`
`regarding proposed dosing regimens to be used in Phase III clinical trials of the
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`oral cladribine formulation that my team and I developed.
`
`28.
`
`I understand that from 2002 to 2004, teams at IVAX and Serono
`
`regularly held joint team meetings discussing the progress of the cladribine project,
`
`and also communicated about the project via e-mail. Because Serono researchers
`
`were the only group in the IVAX-Serono collaboration working on proposed
`
`dosing regimens of cladribine for treating MS, it is highly likely that, prior to
`
`February 4, 2004, Serono communicated the above dosing regimen disclosed in the
`
`’247 Provisional and BODOR PCT to other people at IVAX, including Dr.
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`IPR2023-00480, IPR2023-00481
`U.S. Patent Nos. 7,713,947, 8,377,903
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`Dandiker, Dr. Marcus, and others, through meetings and emails pursuant to the
`
`joint research and development agreement.
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`29.
`
`I am not aware of any evidence suggesting anyone at IVAX
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`developed the regimen in the ’247 Provisional and BODOR PCT. Nor am I aware
`
`of any evidence suggesting Serono did not communicate these regimens to other
`
`people at IVAX before February 2004.
`
`30.
`
`In signing this declaration, I understand that the declaration will be
`
`filed as evidence in a contested case before the Patent Trial and Appeal Board of
`
`the United States Patent and Trademark Office. I acknowledge that I may be
`
`subject to cross-examination in this case and that cross-examination will take place
`
`within the United States. If cross-examination is required of me, I will appear for
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`cross-examination within the United States during the time allotted for cross-
`
`examination.
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`IPR2023-00480, IPR2023-00481
`U.S. Patent Nos. 7,713,947, 8,377,903
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`31.
`
`I declare that all statements made herein of my knowledgearetrue,
`
`and thatall statements made on information and belief are believed to be true, and
`
`that these statements were made with the knowledgethat willful false statements
`
`and the like so madeare punishable by fine or imprisonment, or both, under
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`Section 1001 of Title 18 of the United States Code.
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`Dated: December 21, 2023
`
`By:
`
`Lawsbaw
`
`Nicholas Bodor, Ph.D., D.Sc., d.h.c., HoF
`
`

`

`APPENDIX A
`APPENDIX A
`
`

`

`Curriculum Vitae
`
`Nicholas Bodor, Ph.D., D.Sc., d.h.c. (multi), HoF (multi)
`
`Page 1 of 144
`Page | of 144
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`Nicholas Bodor, Ph.D., D.Sc., d.h.c., HoF (multi)
`
`CURRICULUM VITAE
`
`Date ofBirth:
`
`February 1, 1939
`
`Address:
`
`Telephone:
`
`10225 Collins Avenue, Apt. 1002-04
`Bal Harbour, Florida 33154 USA
`
`(305) 868-8250 (residence)
`(305) 571-8490 (office; Bodor Laboratories, Inc.)
`
`Married To:
`
`Sheryl Lee Bodor
`
`Children:
`
`Nicole and Erik (Miami); Miklés (Debrecen, Hungary)
`
`EDUCATION:
`
`“* R.A. Welch Postdoctoral Fellow
`by invitation ofProf. Michael J. S. Dewar;
`University of Texas at Austin, 1968-1969; 1970-1972
`
`“* Ph.D. (Doctor in Chemistry)
`Babes-Bolyai University, and Supreme Council of Scientific Titles of the Romanian
`National Academy of Science, 1965
`
`«* Diplomain Science (B.S., M.S., Organic Chemistry)
`with special honors - straightA's throughoutthefive years;
`Bolyai University (Cluj, Romania), 1959
`
`EMPLOYMENT:
`
`«* Founder and CEO, Bodor Laboratories,Inc.
`Miami, Florida; Founded in 2006
`
`“* Graduate Research Professor Emeritus (active), University of Florida
`Gainesville, Florida; since 2003
`
`«* Executive Director, University of Florida Center for Drug Discovery
`J. Hillis Miller Health Science Center, Gainesville, Florida; since 1990
`
`Page 2 of 144
`Page 2 of 144
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`Nicholas Bodor Curriculum Vitae
`Career Summary
`
`Affiliate Graduate Research Professor, Dept. of Ophthalmology
`University of Florida College of Medicine, Gainesville, Florida; since 1991
`
`Affiliate Professor, Dept. of Chemistry
`University of Florida College of Liberal Arts & Sciences
`Gainesville, Florida; since 1990
`
`,~
`
`o,
`“ye
`
`Previous:
`2,
`“
`Chief Scientific Officer,VAX Corporation
`Miami, Florida; 2003-2006
`
`Managing Director, IVAX Drug ResearchInstitute, Ltd.
`Budapest, HUNGARY;1999-2006
`
`President, [VAX Research Institute, Inc.
`Miami, Florida; 2002-2006
`
`Senior Vice President, Basic Research & Drug Discovery, [VAX Research, Inc.
`Miami, Florida; 2000-2006
`
`Graduate Research Professor, Dept. of Pharmaceutics, University of Florida
`College of Pharmacy, Gainesville, Florida; 1991-2003
`
`Graduate Research Professor, Dept. of Medicinal Chemistry, University of Florida
`College of Pharmacy, Gainesville, Florida; 1983-2003
`
`V Ravi Chandran PhD Professor in Drug Design and Targeting, University of Florida
`College of Pharmacy, Gainesville, Florida; 2000-2003
`
`Vice President and Director, Pharmatec, Inc.
`Alachua, Florida; 1983-1992
`
`Director, Center for Drug Design and Delivery, University of Florida
`J. Hillis Miller Health Science Center, Gainesville, Florida; 1986-1990
`
`Chairman, Dept. of Medicinal Chemistry, University of Florida
`College of Pharmacy, Gainesville, Florida; 1989-1990
`
`Professor (1979-1983) and Chairman (1979-1984), University of Florida
`Dept. of Medicinal Chemistry, J. Hillis Miller Health Center, Gainesville, Florida
`
`Adjunct Professor of Pharmaceutical Chemistry, University of Kansas
`Lawrence, Kansas; 1978-1980
`
`o,
`“
`
`,“
`
`Page 3 of 144
`Page 3 of 144
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`Nicholas Bodor Curriculum Vitae
`Career Summary
`
`,
`~~
`
`2.
`“
`
`0
`~~
`
`2
`“~
`
`o
`~~
`
`oO,
`“
`
`Adjunct Professor of Medicinal Chemistry, University of Kansas
`Lawrence, Kansas; 1974-1978
`
`Associate Director of Medicinal Chemistry, INTERx Research Corporation
`Lawrence, Kansas; 1973-1979
`
`Senior Research Scientist, ALZA Corporation
`Lawrence, Kansas; 1972-1973
`
`R.A. Welch Postdoctoral Fellow, University of Texas at Austin
`1968-1969 and 1970-1972
`
`Principal Investigator and Group Leader, Chemical-Pharmaceutical Research Institute
`Cluj, Romania; 1961-1968 and 1969-1970
`
`Research Investigator and Group Leader, “| September” Factory
`Satu Mare, Romania; 1959-1961
`
`ELECTED TO:
`
`Fellow, Council for Human Dignity (Hungary); 2005
`
`Fellow, the World Innovation Foundation; 2002
`
`Member, Dermatology Advisory Board, Glaxo Wellcome; 1997
`
`Member, Hungarian Academyof Sciences; 1995
`
`Fellow, American College of Clinical Pharmacology; 1991
`
`Fellow, American Association for the Advancement of Science; 1989
`
`Honorary Member, Panhellenic Association of Pharmacists; 1989
`
`Honorary Member, Hungarian Chemical Society; 1988
`
`Fellow, American Association of Pharmaceutical Scientists; 1986
`
`Fellow, Academy of Pharmaceutical Research and Science; 1983
`
`\?
`“
`
`?,
`“~
`
`+o,
`~
`
`,“
`
`ye
`
`Page 4 of 144
`Page 4 of 144
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`Nicholas Bodor Curriculum Vitae
`Career Summary
`
`AWARDS AND HONORS:
`
`Arany Janos Lifetime Achievement Award of the Hungarian Academyof Sciences, 2022.
`
`Inducted into the Academy of Science, Engineering & Medicine of Florida (ASEMFL)
`inaugural membership class; 2020
`
`Inducted into the Florida Inventors Hall of Fame; 2020
`
`Inducted into the American Chemical Society Hall of Fame (Medicinal Chemistry
`Division); 2012
`
`Commander’s Cross of the Order of Merit of the Hungarian Republic - presented at the
`Hungarian Parliament during the national celebration of over 1,000 years of statehood
`and its Canonizedfirst king, St. Stephen; 2010
`
`Fabinyi Prize, awarded by the Hungarian Chemical Society (given to eminentscientists
`living outside Hungary); 2010
`
`Distinguished Pharmaceutical Scientist Award, American Association of Pharmaceutical
`Scientists; 2007
`
`Honorary Doctor of Science Degree, University of Florida; 2005
`
`Gold Cross of Merit of the Hungarian Republic, awarded by Ferenc Madl, President of
`Hungary; March 31, 2004
`
`Volwiler Research Achievement, American Association of Colleges of Pharmacy; 1997
`
`Professorial Excellence Program Award, University of Florida; 1996
`
`o,
`~~
`
`?
`~
`
`o,
`~
`
`Leo Friend Award, American Chemical Society; 1996
`
`The Nagai Foundation Tokyo Fellowship; 1994
`
`University of Florida Research Achievement Award; 1991
`
`Doctor Honoris Causa, Medical University of Debrecen, Hungary; 1990
`
`University of Florida Research Achievement Award; 1990
`
`Doctor Honoris Causa, Technical University of Budapest, Hungary; 1989
`
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`Nicholas Bodor Curriculum Vitae
`Career Summary
`
`«* American Pharmacists Association (APhA) Research Achievement Award in
`Pharmaceutical and Medicinal Chemistry; 1989
`
`«* American Association of Pharmaceutical Scientists Research Achievement Award (the
`first) in Medicinal and Natural Product Chemistry; 1988
`
`“* “The 1984 Florida Scientist of the Year”
`
`OTHER ACADEMIC AND SCIENTIFIC RECOGNITIONS:
`
`2,
`“ The Nicholas Bodor Distinguished Lectureship, University of Florida;
`established 2014
`
`“* The Nicholas Bodor Professor in Drug Discovery, University of Florida;
`established 2007
`
`«* Appointed as Graduate Research Professor Emeritus upon retirement from the
`University of Florida; 2003
`
`o,
`~~ Targeted brain delivery of neuropeptides (as published in Science, 257, 1698-1700, 1992)
`cited as one ofthe top 10 medical advances of 1992 by the Harvard Health Letter, March
`1993 issue
`
`2°,
`Sg Appointed Graduate Research Professor, University of Florida; 1983
`
`SERVICE TO ACADEMIA AND INDUSTRY:
`
`“* Nominator of numerous successful award recognitions for international leaders in the
`pharmaceutical industry, including:
`> Prof. Yuichi Sugiyama, recipient of University of the Florida Doctor of Science
`degree honoris causa, 2012.
`> Dr. Phillip Frost, recipient of the University of Florida Doctor of Science degree
`honoris causa, 2015.
`>» Prof. Thorsteinn Loftsson, recipient of the American Association of
`Pharmaceutical Scientists’ Research Achievement Award in Physical Pharmacy
`and Biopharmaceutics, 2016.
`
`«* Organizing Memberof the Association of Hungarian-American Academicians (AHAA),
`established in 2015 for US external members of the Hungarian Academy of Sciences
`(HAS)
`
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`Nicholas Bodor Curriculum Vitae
`Career Summary
`
`o,
`“
`
`2,
`~~
`
`%,
`“~~
`
`o,
`“
`
`o,
`“
`
`Member, Board of Directors, ALCHEM Laboratories Corp.; 1997-2015 (from inception,
`to sale to anotherentity)
`
`Member, Scientific and Medical Advisory Board, Oculis ehf.
`
`Chairman, Policy Committee of the Florida Center for Heterocyclic Compounds
`
`Member, Board of Trustees; ARKAT-USA
`
`Consultant, advisor or Board of Directors member for numerous major pharmaceutical
`companies and law firms (Taft Law, Schering-Plough, ONO Pharmaceutical Co., Otsuka
`Pharmaceutical Co., Xenon Vision, Inc., Oculis, Inc., Helene Curtis, Inc., etc.)
`
`Principal Investigator of numerous National Institutes of Health research grant awards
`
`Visiting Professor, Hoshi University, Tokyo Japan; 1995
`
`Visiting Professor, Assiut University, Assiut Egypt; 1984
`
`LECTURES AND CONFERENCES:
`
`2
`“~ Invited speaker of more than 430 national and international symposia and special lectures
`(please see separatelisting).
`
`Founder and Organizer of the Retrometabolism Based Drug Design and Targeting
`Conference; international series of symposia held biennially from 1997-2015 (atotal of
`10 events).
`
`NameLectureships given: Hoechst-Roussel Lectureship in Chemistry, Somerville NJ,
`1983; Hoshi University Diploma, Tokyo Japan, 1983; Bombay College of Pharmacy
`Silver Medal, BombayIndia, 1984; Nichols Distinguished Symposium, American
`Chemical Society, Tarrytown NY, 1986; Sigma Xi Lectureship, 1987; University of
`Saskatchewan College of Pharmacy, Canada, 1998; The Hégyes Lecture, Semmelweis
`University of Medicine, Budapest Hungary, 2000.
`
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`Nicholas Bodor Curriculum Vitae
`Career Summary
`
`EDITORIAL BOARDS:
`
`AAPS Journal
`Advanced Drug Delivery Reviews
`American Journal ofDrug Delivery
`Burger’s Medicinal Chemistry, 6" Edition
`Current Drugs
`Current Medicinal Chemistry
`Drug Design & Discovery
`Expert Opinion on Drug Delivery
`Journal of Ocular Pharmacology and Therapeutics
`Journal ofPharmacology & Clinical Toxicology
`Journal ofPharmacy and Pharmacology
`Magyar Kemiai Folyoirat
`Open Medicinal Chemistry Journal
`Pharmaceutical Research
`Pharmaceutical Science Communications
`Pharmacy and Pharmacology Communications
`STP Pharma Sciences
`
`MEMBERSHIPS:
`
`Academyof Pharmaceutical Scientists (APS)
`American Association for the Advancementof Science (AAAS)
`American Association of Colleges of Pharmacy (AACP)
`American Association of Pharmaceutical Scientists (AAPS)
`American Chemical Society (ACS)
`American College of Clinical Pharmacology (ACCP)
`American Epilepsy Society (AES)
`American Pharmacists Association (APhA)
`Association of Hungarian-American Academicians
`Association for Ocular Pharmacology and Therapeutics (AOPT)
`Controlled Release Society (CRS)
`Hungarian National Academyof Sciences
`International Council of Scientific Unions (ICSU)
`International Scientific Advisory Panel of Oxford Molecular Group, PLC
`International Union of Pure and Applied Chemistry (IUPAC)
`New York Academyof Sciences
`Sigma Xi
`Worldwide Hungarian Medical Academy (WHMA)
`
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`Nicholas Bodor Curriculum Vitae
`Career Summary
`
`PUBLICATIONS:
`
`“* Author/co-author of more than 530 publications (please see separatelisting)
`
`PATENTS:
`
`“* Inventor on more than 325 patents (please see separate listing)
`
`GRADUATE AND POSTDOCTORAL SUPERVISON:
`
`“* Has supervised more than 50 doctoral students and 100 postdoctoral research
`fellows/associates
`
`LANGUAGES:
`
`“* Fluent in English, Hungarian and Romanian;
`Read and write in French, Russian and German
`
`LISTED IN:
`
`American Scientist
`
`Who’s Who in America
`Who’s Who in Frontiers ofScience
`Who’s Whoin Science and Technology
`Who’s Who in Technology Today
`Who’s Who Worldwide (Platinum Edition)
`Ki Kicsoda (Who’s Who Worldwide — Hungarian Edition)
`
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`Nicholas Bodor, Ph.D., D.Sc., d.h.c. (multi), HoF (multi)
`
`BIOGRAPHICAL SKETCH
`
`Dr. Nicholas Bodoris a Graduate Research Professor Emeritus (active) at the University of Florida
`(UF) College of Pharmacy, Gainesville. He joined the university in 1979 as Professor and
`Chairman of the Medicinal Chemistry Department and was promoted to Graduate Research
`Professor in 1983. He was the Executive Director of the college’s Center for Drug Discovery,
`founded by him in 1986. During his tenure at UF, Dr. Bodor has supervised the training of more
`than 50 doctoral students and over 100 postdoctoral level research associates and fellows. In
`February 2000, he took a leave of absence from his academic posts in order to accept a position as
`Senior Vice President of Basic Research and Drug Discovery at the IVAX Corporation. Dr. Bodor
`then served as Chief Scientific Officer of the IVAX Corporation, as well as President of the IVAX
`Research Institute. Duringthis period, he simultaneously led Hungary’s Institute for Drug Research
`(some 450 researchers) as its Managing Director until his retirement from ITVAX in October 2005.
`
`Dr. Bodor's main research interests include design of drugs with improved therapeutic index, design
`of new chemical delivery systems, computer-assisted drug design, drug transport and metabolism,
`and theoretical and mechanistic organic chemistry. He has published more than 530 research
`articles, has over 310 patents, andis on the editorial boards ofnumerousinternational scientific
`journals. An internationally recognized leaderin drug discovery, design and delivery, he has
`introduced revolutionary, general, comprehensive drug design and drug targeting concepts known
`as retrometabolic drug design approaches. These conceptsstrategically combine chemical and
`enzymatic (metabolic) processes to achieve drug targeting and to producesafe drugs and safe
`environmental chemicals. The two majorclasses of the retrometabolic drug design concepts contain
`“chemicaldrug targeting systems” (CDS) and the “soft drugs” (SD). Each ofthese large classes
`contains various subclasses, based on the different design rules. The design concepts incorporated
`in the soft drug approaches were used by Dr. Bodor to develop a general and comprehensive
`program, including a computerized expert system which can be usedto design all potential and
`possible metabolites and the correspondingsafe active soft drugs or chemical delivery systems. The
`soft steroid Loteprednol Etabonate, designed by Dr. Bodor, is on the market in the U.S. and other
`countries. Other drugs designed by him using the retrometabolic concepts are in advanced clinical
`development.
`
`Dr. Bodorreceived his B.S./M.S. degree in Organic Chemistry in 1959 at Bolyai University in
`Transylvania, and his Ph.D. degree in 1965 from the University of Babes-Bolyai, Cluj and the
`Romanian National Academy of Sciences. He was a Group Leaderat the Pharmacochemical
`ResearchInstitute in Romania until 1968, when he was offered an R. A. Welch Fellowship at the
`University of Texas in Austin, where he worked in thefield of theoretical organic chemistry with
`Dr. Michael J. S. Dewar, the first Robert A. Welch Research Chair. In 1972 he became a Senior
`Research Scientist at ALZA Laboratories in Lawrence, Kansas, which later became INTERx
`Research Corporation, where he was Director of Research, as well as an Adjunct Professorat the
`University of Kansas until 1978.
`
`Amonghis many honors, Dr. Bodoris an elected Fellow of the Academy of Pharmaceutical
`Sciences, American Association of Pharmaceutical Scientists, American Association for the
`Advancement of Science, and American College of Clinical Pharmacology. Heis also an Honorary
`Memberof the Hungarian Chemical Society and the Panhellenic Society of Pharmacists. Among
`other honors, Dr. Bodor has been named "The 1984 Florida Scientist of the Year" and received the
`
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`Nicholas Bodor Curriculum Vitae
`Biographical Sketch
`first AAPS Research Achievement Award in Medicinal and Natural Product Chemistry in 1988, as
`well as the APhA Research Achievement Award in Pharmaceutical and Medicinal Chemistry in
`1989. In 1994 he was namedthefirst recipient of the Nagai Foundation TokyoInternational
`Fellowship. He was named by the American Chemical Society as the 1996 recipient of the Leo
`Friend Awardin recognition ofhis article entitled, "Design of Biologically Safer Chemicals,"
`published in Chemtech, October 1995. Heis the first College of Pharmacy faculty memberto
`receive a Professorial Excellence Award, given by the University of Florida in 1996. The AACP
`selected Dr. Bodoras the recipient of the 1997 Volwiler Research