IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re application of:
`
`Purdue Pharma L.P.
`
`Confirmation No.: 1091
`
`Art Unit: 1628
`
`Appl. No.: 14/500,409
`
`Examiner: Ricci, Craig D.
`
`Filed: September 29, 2014
`
`Atty. Docket: 1861.2700001/JMC/MSB
`
`For: Buprenorphine—Wafer for Drug
`Substitution Therapy
`
`Declaration under 37 C.F.R. § 1.132
`
`I, Sudip Das, hereby declare:
`
`1.
`
`I am a tenured professor of Pharmaceutical Sciences at Butler University in
`
`Indianapolis, Indiana with over 24 years of teaching experience and over 30 years
`
`of research experience, all in the area of pharmaceutical dosage forms. My filll
`
`CV is attached to this declaration as Exhibit 1.
`
`2.
`
`My research focuses on drug delivery approaches to overcome cancer multi-drug
`
`resistance, cellular delivery of interfering RNA (RNAi), sublingual drug delivery,
`
`ocular drug delivery, drug targeting with nanoparticles, and submicron emulsions.
`
`3.
`
`I have conducted extensive research in mucoadhesive sublingual drug delivery,
`
`with a particular focus on sublingual mucoadhesive buprenorphine dosage forms.
`
`As noted in my CV,
`
`I co-authored a paper entitled "Development of
`
`mucoadhesive dosage forms of buprenorphine for sublingual delivery," Drug
`
`Delivery,
`
`11
`
`(2), 89-95, 2004.
`
`This paper, and my research,
`
`focused on
`
`

`

`Purdue Pharma L.P.
`
`Appl. No. 14/500,409
`
`formulating novel mucoadhesive dosage forms that deliver buprenorphine and the
`
`properties and performance of these dosage forms.
`
`I have read and understood the description of patent Application No. 14/500,409,
`
`and the claims being examined by the USPTO.
`
`I have also read and understood
`
`the art cited by the Examiner, i.e. the Suboxone® Tablet Product Insert (PI) and
`
`Published Application US. 2007/0148097 ("Finn").
`
`In addition, I have reviewed
`
`US. provisional patent applications 60/750,191 and 60/764,619, from which Finn
`
`claims priority.
`
`I am receiving my standard consulting fees for my review and analysis of the
`
`pending application and related documents. My fees are not contingent upon a
`
`particular result and I have no financial stake in the outcome of the prosecution of
`
`this or any related applications.
`
`Additionally, I have no direct personal financial interest in, or any direct financial
`
`relationship with, the present owners of the pending patent application.
`
`As discussed with the Examiner during the telephonic interview on April 21,
`
`2015, the pending claims of the Purdue patent application have a number of
`
`differences from the Suboxone® Tablet PI and Finn.
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`Atty. Dkt. No.
`1861 .2700001/JMC/MSB
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`

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`Purdue Pharma L.P.
`
`Appl. No. 14/500,409
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`Finn is directed to a film formulation comprising an abusable drug, such as
`
`buprenorphine, and an antagonist, such as naloxone. But Finn's formulation is
`
`significantly different from the presently claimed dosage form.
`
`A key difference between Finn and the claimed invention is
`
`that both
`
`buprenorphine and naloxone in Purdue's claimed dosage form are available for
`
`transmucosal delivery.
`
`In contrast, Finn teaches the criticality of associating its
`
`antagonist, naloxone, with an "abuse-resistant matrix." See Finn, 1l [0009].
`
`10.
`
`When used as directed, Finn's abuse-resistant matrix ensures that the antagonist is
`
`"substantially transmucosally unavailable" with the abuse-resistant matrix
`
`ensuring that substantially all of the antagonist is delivered to the GI tract. Once
`
`present in the GI tract, the antagonist is absorbed and subsequently metabolized in
`
`the liver during so-called "first pass metabolism.
`
`First-pass metabolism renders
`
`H
`
`the antagonist therapeutically ineffective such that it does not interfere with the
`
`effects of the abusable drug present in the Finn formulation. See Finn, 1l [0026].
`
`ll.
`
`Finn teaches that separating the antagonist and the abusable drug is necessary in
`
`order to ensure the efficacy of the abusable drug in view of the effects of the
`
`antagonist, stating that when the antagonist is not associated with an abuse-
`
`resistant matrix, the antagonist "impairs the activity of the [abusable drug] and it
`
`often becomes necessary to increase the quantity thereof required in the dosage
`
`form for satisfactory treatment of the patients." Finn further notes that "it is
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`— 3 —
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`

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`Purdue Pharma L.P.
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`Appl. No. 14/500,409
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`desirable not to filrther increase the stress on the patient by release a large
`
`proportion of opioid antagonist. . .", making it clear that it is preferable to have the
`
`antagonist sequestered and substantially transmucosally unavailable. See Finn 11
`
`[0010].
`
`12.
`
`Finn's abuse-resistant matrix does not effectively release the antagonist when the
`
`device is used in a non-abusive manner, but releases the antagonist when the
`
`dosage form is used in an abusive manner (i.e. dissolved in a solvent, opened,
`
`chewed, and/or cut apart). See, Finn 11 [0034].
`
`In contrast, the antagonist in the
`
`instant application is released along with the buprenorphine such that both are
`
`available for transmucosal absorption.
`
`See, Oksche, et 01] pg. 16,
`
`third full
`
`paragraph as well as pending claims 1 and 24.
`
`13.
`
`As discussed in Finn 11 [0013], the abuse-resistant matrix itself is a layer or
`
`coating, such as a water-erodable coating or layer at least partially disposed about
`
`the antagonist. Alternatively, it can be a water-hydrolyzable, water erodible, or
`
`water soluble matrix, such as an ion exchange polymer.
`
`14.
`
`The Finn device can comprise two or three layers. Finn's layers are generally
`
`referred to as a "mucoadhesive layer," a "backing layer," and a "third layer" which
`
`is disposed in between the mucoadhesive layer and the backing layer. See, for
`
`example, Finn 11 [0050].
`
`_ 4 _
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`Atty. Dkt. No.
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`

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`Purdue Pharma L.P.
`
`Appl. No. 14/500,409
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`15.
`
`16.
`
`Finn describes various permutations of his device noting, for example, that the
`
`abusable drug can be in the mucoadhesive layer while the abuse-resistant matrix
`
`can be in the backing layer. See, Finn 11 [0050].
`
`But in each of the embodiments supported as of Finn's provisional filing dates, the
`
`antagonist is associated with the abuse-resistant matrix such that the antognist is
`
`substantially transmucosally unavailable. Instead, the antagonist is only delivered
`
`to the GI tract, where the antagonist is safely metabolized and therapeutically
`
`inactivated.
`
`17.
`
`In summary, Finn teaches a device for transmucosally delivering an abusable drug
`
`while incorporating an antagonist
`
`in an abuse-resistant matrix such that
`
`the
`
`antagonist is substantially transmucosally unavailable. But as noted earlier, both
`
`buprenorphine M naloxone in the claimed dosage form are substantially
`
`available for transmucosal delivery.
`
`18.
`
`19.
`
`Although I am an expert in sublingual formulations, I have supervised and taught
`
`those of ordinary skill in the art, i.e. individuals with not more than a master's
`
`degree in pharmaceutical formulations.
`
`Based on my review, and for the reasons noted herein, it is my conclusion that a
`
`person of ordinary skill in the art would not have found the present claim obvious
`
`in view of the Suboxone® Tablet PI and Finn.
`
`- 5 -
`
`Atty. Dkt. No.
`1861.2700001/JMC/MSB
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`

`

`Purdue Pharma L.P.
`
`Appl. No. 14/500,409
`
`20.
`
`All statements made herein of my own knowledge are true and all statement made
`
`on information and belief are believed to be true. Further, these statement are
`
`made with the knowledge that willful false statements and the like are punishable
`
`by fine or imprisonment, or both, under Section 1001 of Title 18 of the United
`
`States Code and that such willful false statements may jeopardize the validity of
`
`this application or any patent issuing thereon.
`
`May 25“, 2015 Date:
`
`Sudip Das, Ph. D.
`
`199373873
`
`— 6 —
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`Atty. Dkt. No.
`1861 .2700001/JMC/MSB
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`

`

`EXHIBIT 1
`
`

`

`
`Butier University, Coiiege oi Pharmacy a Heaith Sciences
`Phone:
`317.:948-9134
`n
`.i.4600 Sunset Avenue, indianaoeiis. ii\i 45208—3485
`E-mail:
`
`
`
`Ind-iv
`
`
`
`
`TEACHiNG:
`
`Professionai HiHhiihts
`
`as
`
`Professional pharmacy program
`
`0
`25 ears of teacnin ex erience — 23 ears in US PharmD‘i 2 ears in Canada ’88 Pharmi
`
`o Developed problem~based and seif~directed learning moduies in dosage form courses {PharmD}.
`o Restructured drug forrriuiation design courses (iecture and lab) at three institutions.
`
`0 Nominated for the Distinguished Teacher Award (ldaho State University, 2003).
`
`o Obtained student training grant from the ldaho State Board of Education (Co a l).
`
`a Graduate program
`
`0
`
`19 years of graduate (MS 8: PhD) teaching experience.
`
`0 Redeveloped the ceased graduate program in pharmaceutics at idaho State University in 1999.
`0
`Re—ihstated the graduate program in pharmaceuticai sciences at Butler University in 2005.
`
`RESEARCH:
`
`:9
`
`Experience
`0 Over 30 years of research experience in drug formulation design, drug targeting and RNAi.
`
`0 Major areas of research:
`
`Formulation of drugs, nanomedicine, anticancer drug deiivery, delivery of siRNA and
`microRNA, ocular drug
`delivery, vaccine
`delivery,
`pooriy soiuhie drugs,
`and
`pharmacoitinetics.
`
`s
`
`Extramural funding
`
`0 Obtained individual and collaborative Nit-l grants in the area of drug deiivery.
`0 Obtained a research grant from Parenteral Drug Association (FDA) Foundation (Pi).
`
`0 Obtained undergraduate research grants from PhRiviA (co—Pi), Pfizer (Pi) and AFPE Gateway
`(Pi).
`
`o Obtained pharmaceutical company contracts on formulation deveiopment and drug analysis (Pl).
`
`in
`
`Scholarly achievements
`Extensive publications in the broad area of ciru delive. I as of Februar 2015
`0
`
`as
`
`a
`
`a
`
`as
`
`s
`
`Peer reviewed journal articies: 48
`
`US patent :
`
`’t
`
`Book chapters: 8
`
`Peer reviewed extended (two page) proceedings: 2?
`
`Peer reviewed conference presentations: 93
`
`o Developed research projects in the interdisciplinary areas oi physicai cherriistry, hiomateriais,
`moiecuiariceli piciogy, cancer biology, and ciinicai sciences.
`
`is
`
`infrastructure development
`
`0 Research i'aciiities (inciuding design of open structure research tab) in drug deiivery and celi
`bioiogy at Butler University, starting from ground zero.
`
`0
`
`0
`
`Pharmaceutics research facilities at idaho State University. starting from ground zero.
`
`Pharmaceutics research facilities at Nova Southeastern University.
`
`ADMiNiSTRATiGN: (Chair, Department of Pharmaceutical Sciences, Butier University. June 2004 a May 2009)
`
`is
`
`a
`
`a
`
`«1
`
`a
`
`a
`
`Deveioped a state of the art research faciiity from scratch.
`
`Deveiooed the graduate program curriculum and guideiines.
`
`Deveiopeo' the strategic plan, goals and mission for the department foiiowing a SWOT anaiysis.
`
`viotivated faculty to enhance researchlschoiarship activities.
`
`initiated a culture of pedagogical schoiarship and exceiience in teaching
`
`Deveiopeo' a mentoring program foriunior faculty
`
`«1 Organized yearly dept. retreats comprising of workshops on teaching and scholarship
`
`at Organized the recruitment of three open facuity positions in pharmaceuticai sciences department.
`
`

`

`Curriculum vitae — Sudip K. Das
`
`SERVECE:
`a
`
`Accreditation Councii tor Pharmacy Education
`
`0
`
`0
`
`0
`0
`
`o
`
`o
`
`0
`
`Site Visitation Team Member, April 2014, Ciinton, SC
`it
`S e Visitation Team Member, February 2013, Gainesviile, Ft.
`it
`C e Visitation Team Member, April 2012, Hartford, CT
`C
`ite Visitation Team Member, Aprii 2011, Louisviiie, KY
`it
`C e Visitation Team Member, November 2010, Hartford, CT
`it
`S e Visitation Team Member, May 2010, Baitimore, MD
`
`Self—Study:
`
`o
`
`a
`
`Federai
`
`Co—Chair, Standards for Physicai and Practice Faciiities, Butter University, 2005
`
`Chair, Standards for Physicai and Practice Faciiities, idaho State University, 2003
`
`0 Center for Scientific Review/NiE-i
`
`o
`
`pharmacoiogy,
`cancer
`deiivery,
`drug
`on
`sections
`severai
`reviewer,
`Panei
`bioengineering/biomateriais, and feliowship w Served on 34 Nit-l studv sections from
`2004 to Feb 2015
`
`o
`
`o
`
`Reviewer, Gene and Drug Deiivery ((3130) Study Section, 2004 m 2008
`a
`Reviewer of National Defense Science and Engineering Graduate Feiiowships (000), 2014 —
`
`Civiiian Research & Deyeiopment Foundation (an agency of the US Department of State) Expert
`reviewer participated in the on-site deiegation team in 'i'biiisi, Georgia (Former USSR).
`
`GrantiFeiiowship Appiication Reviewer for Foondaticnsiflrganizations
`
`0 Kentucky Science and Engineering Foundation, 2005. 2000, 2007, 2000, 2011
`
`o Nationat Defense Science and Engineering Graduate Feilowship, 2012-1, 2015
`
`Editoriai Board Memberships
`
`0
`
`Therapeutic Deiivery {Future Science Group, UK), 2009 —
`
`0 American Journai oi' Pharmaceuticai Education (AACP), 2006 _ 15
`
`o
`
`o
`u
`
`<
`
`Ciinicai Pharmacoiogy & Biooharmaceutics
`
`Journai of Pharmaceutical Technology & Drug Research
`
`internationai Journai of Tumor Therapy
`
`United States Pharmacopeia
`
`0
`
`2005, 2010 and 2015 USP Convention deiegate
`
`American Association of Cottages of Pharmacy (AACP, member since 1003—04)
`0 Member, Research and Graduate Affairs Committee, 2014-15
`
`0
`0
`
`0
`0
`
`0
`
`0
`0
`
`o
`
`Reviewer‘tor New investigator and Medoo awards, 2011, 2012, 2018, 2014
`Board 01’ Directors, 2008 — 11
`
`Chair, Annuai Meeting Programming Committee, 2010
`Chair, Council oi Sections, 2008—00
`
`Chair, Pharmaceutics Section, 2007—08
`
`Chair, Steering Committee, New Pharmacy Faculty Research Awards Pro-gram, 2010—11
`immediate Past Chair, Councii of Sections, 2009 — 11
`
`immediate Past Chair, Pharmaceutics Section, 2008—00
`
`0 Member, 800 Task Force on Volweiier and Dawson award criteria, 2010
`
`0 Member, Research and Graduate Affairs Committee, 2010-11
`
`0 Member, investment Committee, 2000-11
`
`0 Member, COP Task Force on Pharmaceuticai Sciences and Research Education, 2007—08
`
`0 Member, Byiaws and Poiicy Development Committee, 2004—05, 2005-00, 2006-07
`
`20117
`
`

`

`Curriculum vitae — Sudip K. Das
`
`a American Association of Phermeceuticei Scientists (AAPS, member since 1991)
`
`0
`
`0
`0
`
`Chair, Abstracts Screening for BiOTEC section, Annual Meeting 209? - 98
`
`Chair, Abstracts Screening for BiOTEC section, Nationai Biotechnoiogy Conference 2097—08
`Eiected executive committee member of the indianaItho Discussion Group of AAPS, 2905—07,
`
`0 Member, AAPS Student and Postdoc Outreach Development Committee, 2003 — 2008,
`
`0 Abstract reviewer of PT, PUD and BIOTEC sections of AAPS, 1995 - present.
`
`0 Organized symposia and roundtabies at nationai/internationai meetings,
`AACP,
`
`inciuding AAPS and
`
`s Contreiied Reiease Society (CR3, member since 198?}
`
`0 Young Scientists Mentoring Committee, 2009
`
`2013
`
`s
`
`R a [31%
`
`0
`
`Judge for the Annuai Awards, 1994, 1995, 199.7, 1998, 1999, 2010, 2011, 2912, 2013, 2914,
`2015
`
`Education and Academic Training
`
`1990 - 91
`
`1986
`1983 _ 88
`
`1981 _ 83
`
`1976 _ 81
`
`Postdoctoral Research Feiiow, The University of Queensiand, Austraiia
`
`Postgraduate Schoiar in Pharmaceuticai Technoiogy, State University of Ghent, Beigium
`Phi]. in Pharmaceutics, Jadavpur UniversitV, india
`
`MPharm. in Pharmaceutics, Jadavpur UniversitV, india
`
`BPharm. in Pharmacy, Jadavpur University, india
`
`Experience:
`Professor of Pharmaceuticai Sciences (Pharmaceutics, Tenured)
`Associate Professor of Pharmaceuticai Sciences (Pharmaceutics, “tenured;
`[Iiirector of Graduate Program and Research in Pharmaceuticai Sciences
`Cottage of Pharmacy and Heaith Sciences, Butter University, indianapoiis, indiana, USA
`Research: Drug deiivery approaches to overcome MGR, ceiiuiar deiivery for RNAi, ccuiar drug deiivery,
`mucoadhesive suhiinguai drug deiivery, drug targeting with haneparticies and suhmicron emuisiens
`Teaching: PharmD. and graduate ievei advanced drug deiivery and formuiation deveiopment, Ethics in
`Research, Criticai Thinking and Prohiem Soivihg
`Administration: Administration of graduate curricuium and admission. coordination of research activities and
`infrastructure and graduate curricuium deveiopment
`
`2/2015 -
`6/2004 w 2/2015
`
`Chair, Department of Pharmaceuticai Sciences,
`Cottage of Pharmacy and i-teaith Sciences, Butter University, indianapoiis, indiana, USA
`
`8/2004 m 5/2909
`
`Associate Professor of Pharmaceutics (“tenured on Feb. 24. 2993)
`Coiiege of Pharmacy, idaho State University, idaho, USA
`Teaching: PharmD. and graduate ievei pharmaceutics courses, pharmaceuticai biotechhoiogy, medicinai
`chemistry (1998'), case studies in pharmaceutics reiated ciinicai prohiem soivihg and pharmacotherapeutics
`Research: Biodegradabie rnicroparticuiate deiivery systems for proteins, vaccines and oiigcnucieotides,
`deiivery of peony soiuhie anticancer drugs, mucoadhesive suhiinguai drug deiivery
`
`771998 -- 6/2004
`
`Assistant Professor of Pharmaceutics (his tenure system)
`Coiiege of Pharmacy, Nova Southeastern University, Fiorida, USA
`Teaching: Pharmi). ievei pharmaceutics and pharmacokinetics
`Research: Bicdegradabie micrcparticuiate deiivery oi proteins, vaccines and ciigonucieotides
`
`12/1993 — 711998
`
`Assistant Professor of Pharmaceutics (Tenure track}
`Schcoi of Pharmacy, Memoriai University of Nevvioundiand, CANADA
`Teaching: BS. (Pharm) ievei pharmaceutics
`Research: Bioadhesive ocuiar drug deiivery, deveiepment ei controiied reiease microcarticies for orai deiivery
`
`8.11991 -- 12/1993
`
`30117
`
`

`

`Curriculum vitae — Sudip K. Das
`
`UQ ~ Postdoctorai Research Feiiew in Pharmaceutics
`Department of Pharmacy. The University of Queensiano‘, AUSTRALiA
`Research: Tcoicai and site specific ccuiar drug oeiivery, physicochemicat characterization of oetymers,
`chromatography and surface anaiyticat
`techniques, carticie characterization by etectron microscopy and
`ctyhamic/iaser tight scattering
`
`1/1900 — 7/1991
`
`Executive, Quality Assurance
`Deyis Medical Manufacturing Limited, iNDiA
`Responsihitity; Quaiity Assurance oi Soiict Dosage Forms
`
`4/1988 — 1/t990
`
`Postgraduate Schciar
`Soeciaiizaticn Training in Pharmaceuticai Technoiogy
`Sponsored by UNEDQ — WHO — Government of Beigium, State University of Gent, BELGEUM
`Training: Pharmaceutical technotogy and targe—scaie manuiacturing oi pharmaceuticai products
`
`1986 Summer
`
`Senior Research Feiicw (University Grants Commission, Council of Sci. and ino'. Res.)
`Department of Pharmaceuticai Technoiogy, Jadavpur University, ENDEA
`Research: Centrctted reiease microscheres
`tor
`crai drug
`pharmacokinetic evaiuation
`
`3/1983 ~ 4/1988
`
`deiiyery — design, physiccchemicai
`
`and
`
`Junior Research Fetiow (University Grants Commission)
`Department of Pharmaceuticai Technoiogy, Jadavpur University, iNDiA
`Research: Controiieo' reiease rnicrospheres for orai drug detivery - design and physicochemicai evaluation
`
`. I1981 — 2/1983
`
`Biographicai
`Recognition
`
`Who‘s Who in America 2015, 80th ed, (in press)
`Who‘s Who in America 2014, 68th ed, Voi. i, p. 9??—078
`Who's Who in America 20t3, 67th ed., 2013, Vet. i, p. 082
`Who's Who in Science and Engineering, 11th ect, 2011—12
`American Men 3;. Women of Science, 28th ec'., 2010, vci 2, p. 034
`Who‘s Who in America, 64th eo'., 2010, voi. 1, p. 1058
`American Men 8: Women of Science, 26th ect., vot 2, p. 611
`Who's Who Among America‘s Teachers, 8th ect, 2004
`American Men 8: Women of Science, 24th ed. voi 2, p. 508
`Who‘s Who in Medicine & Heaithcare, 4th ect, 2002-2003
`American Men 8‘ Women of Science, 20th eo'., 1998—90, voi. 2, 33. 04-4-
`Who‘s Who in Science 8; Engineering, 3rd ect, 1996-97, p. 2‘17
`Who's Who Among America‘s Teachers, 4th ect, 1090
`
`Visiting Scientist/Lecturer
`May 1995
`May 1994
`
`Awards and Honors
`
`2005 — 06
`1990
`1989
`
`1088
`1988
`1986
`
`Memhership in
`Professions!
`Societies
`
`Trainees Supervised
`
`Department oi Medicai Microhioiogy, University of Sheffieid, UK
`Facuitao' tie Farmacia, Universidad Centrai o'e Venezueia
`Deiivered a course on Advances in Orai Drug Deiivery to Schooi of Pharmacy iacutty
`
`Academic Leadership Feiiow, American Association of Cottages of Pharmacy
`USA—Postdoctoral Research Feiiowshio, The University of Queensiand. Austraiia
`The Ycung Scientist Award, The indian Science Congress
`(The highest honor for indian scientists below the age of 30 years
`presented by The Prime Minister of indie)
`Research Associateshio, Councii of Scientific and industriai Research, india
`Senior Research Feiiowship, indian Councii of Medicai Research
`Postgraduate Schotarship, UNiDC} - WHQ -- Government at Beigium
`
`American Association of Pharmaceuticai Scientists (since 1991)
`Controiiec Retease Society, t SA (since 198?)
`American Association of Coiieges of Pharmacy (since 190394)
`institution of Chemists, india (Feiiow) (since 1089)
`
`Post - doctoral fei/ows
`5/08), Assistant Professor of Pharmaceutics. U. of S. Fioricta. Tampa
`Vijay Sutariya, PhD (4/07
`F’rabhakarVeera Redcty, PhD. (10/05 ., 9/06), F’rincipai, St Peter's Cottage of Pharmacy, indie
`Sarat C. Chattaraj, Phi"). (1/90 — 8197), Director for Permutation Dev, Mytan Corporation, WV
`Ahmed Ei-Genc‘y, PhD. (11/01 _- 5/02)
`
`401 17
`
`

`

`Curriculum vitae — Sudip K. Das
`
`Symposia Organized
`
`A dvr'sor of graduate students (BUTLER)
`Sheetai D'Meiio (MS July 20-39), PhD student, University oi iowa
`’atri Patel, (MS December 2012) Senior Associate Scientist, Pfizer inc, Andover, MA
`Shounak Bose, (MS March 2014), Formulation Scientist, Sanciilio, FL
`Puja Kanvinde, (MS tentative fall 2014}, Anatyticai Chemist, Hosoira, Austin, TX
`Raishekhar Kammari, (MS tentative 2015)
`Nikeeta Kheradia, (MS tentative 2018)
`Ryan Dimmitt, PharmD/MS 2017
`
`Research Coilahorator of graduate students (Advisor: Dr, N. Das, BU)
`
`Kanaito Somatsu, (MS July 2007), Clinical Research Scientist, Boston Scient 3, Tokyo, Japan
`Shamieen (Ratioue) Kotwani, (MS June 2008}, CEO, Lamrnos Laboratories Pvt. Ltd, Mumbai, india
`Arnit Kunrar (MS Juiy 2009), PhD student, University of Texas at Austin
`‘atwati Shukia (MS June 20’: t)
`Ruchi Kapoor, (MS Juiy 261 i), Scientist. Novartis Biosciences, San Francisco, CA
`Jainik Pancnal, (MS April 2G‘l3), PhD student, Purdue University
`Neeiima Mantha, (MS August 20‘i3), Senior Scientist, Genentech—Roche
`Rameez Kagdi, (MS tentative December 2014), R&D Scientist, Fr‘esenius Kahi, lL
`Sanika Rege, (MS tentative December 20%)
`Rukmini Lac'i, (MS tentative 2016)
`
`Advisor or' graduate students (lSU)
`Swathi Pinnamaneni, (MS February 2002), Research Scientist, Bristoi Myers Squibb, NJ
`Madhu S. Suraoenani, (MS February 2094), MBA, Globai Business Management Lead, Pfizer, NY
`PharmD. research students (Butler)
`Samreen Khatri (Pfizer UG and AFPE fellow), Brenda Greenen, Ryan Dimmitt
`PharmD. research students (’iSU)
`Brenik Kuzmic (ESU — UG award), Jerry Hoiiand (PhRMA award), Sherry Borchert (iSU — UG Award),
`Eiton Schmidt (lSlJ Research Symposia - Best Poster Award), Andrew Morgan (ESU — UG Award;
`iSU Research Symposia — Best Poster Award), Mathew Marziock (iSU — UG Award“), Shawn
`Sorensen, Brent Dance
`Pham‘iD. research students (Nova)
`Poilyanna Goons, .lu'oy Thomas, Elizabeth Aiegret, Shalita Pahaian,
`Charierre Griffith, Brian Saide, Jon Wirnbisn, Susan Batcheiier,
`Antonia Zapantis (Assoc. Dean, Nova SE)
`MRC -- PMAC research students (Merricriar’)
`Stancy Singh, Cynthia Tuik, Etizabeth Gardiner
`Challenge ’93 summer student (Mamet-tau — Gregory Peddle
`UQ -- FDA summer research student (Queerisiaritii -- Cameron Tolemy
`
`Organizer and Moderator of Session "'i'echnoiogy in Teaching", Annual Meeting of American Association of
`Coileges of Pharmacy, Boston, MA, 2005":
`Organizer, Moderator and Speaker oi Session “integrating the Scholarship of Teaching and Learning into your
`Teaching”, Annuai Meeting oi American Association of Colieges of Pharmacy, Chicago, lL, ZQGS
`Organizer and Moderator of Session “Pharmaceuticai Compounding: Opportunities and Chailenges", Annual
`Meeting oi American Association of Colleges of Pharmacy, Lake Buena Vista, FL, 2007
`Organizer and i'ioo'erator oi Student & Postdoc Session, “Scientific Research integrity", Annuai Meeting of
`American Association of Pharmaceutical Scientists, can Diego, CA, 2007
`Organizer and Moderator of Roundtabie Session, “impact of Etiiux Transporters in Drug Deiivery”, Annuai
`Meeting of American Association of Pharmaceutical Scientists, San Diego, CA, 2007
`Organizer and Moderator of Sunrise Session, “Mass Spectroscopy techniques for biophamtaceuticals", Annuai
`Meeting of American Association of Pharmaceutical Scientists, San Antonio, TX, 2006
`Organizer and Moderator of Sunrise Session, "F’harmacogenomics and Significance of ShiP”, Annual Meeting
`ct American Association of Pharmaceutical Scientists, San Antonio, TX, 2006
`Organizer and Moderator of Student & Postdoc Session, “Career Options: Academia, industry or FDA”, Annuai
`Meeting of American Association of Pharmaceutical Scientists, San Antonio, TX, 2006
`Organizer and Moderator of Session, "The Future oi Graduate -<iucation in Pharmaceutics and Academia",
`Annual Meeting ct American Association oi Coiieges oi Pharmacy, Salt Lake City, UT, Juiy 2GO4
`Organizer and Moderator oi Roundtable, “Graduate Education in Pharmaceutics and Future oi Academic
`Pharmaceutics”, Annuai Meeting of American Association oi Pharmaceutical Scientists, Salt Lake City, UT,
`October 30, 2003
`Jlate Systems for Targeted Drug Deiivery”,
`Organizer and Moderator of Symposium, “Surface Modified Parti
`Annual Meeting ct American Association oi Pharmaceuticai Scientists, Toronto, Canada, November 12, 20:62
`Organizer and Moderator of Roundtabie, "Recent Deveiooments in Antisense Delivery", Annuat Meeting of
`American Association of Pharmaceutical Scientists, New Orieans, LA, November “:8, 1999
`.,
`,
`1h
`.
`.
`..i_
`.
`.
`.
`\
`.
`.
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`Program committee member oi 1998 Conterence on Pharmaceuticai Science and Techhoiogy (in conjunction
`‘rrth 28 Annual Meeting ot the Fine Partrcre Socrety) also organizer, chair and speaker of the symposium on
`“Delivery Systems for Proteins, Vaccines and Oligonucieotides”, Dallas, TX, Anrii 33,1998
`
`
`
`Sol 17
`
`

`

`Curriculum vitae — Sudip K. Das
`
`Reviewer for Journats
`
`Program committee member of 1996 Conference on Pharrnaceuticat Science and Ter:h11olo1'11r (111 cc junction
`with 27‘h Annuat Meeting of the Fine Particle Society) atso organizer,
`c—cchair of the symposium on
`“Methodologies in Percutaneous Absorption”, Chicago. it. August 08 1996
`(111 co111ur1ctior1
`Program committee member of 1995 Conference on Pb arma'e-itcalocience and Teethnotog;r
`With 26‘“ Annuat Meeting of the Fine Particle Society) atso organizer, ccchair of the symposium on
`“Formuiation and Beth/cry of Proteins and Peptides”, Chicaoo, 9.. August 24. 1995
`Program committee member of 1994 Conference on Pharmaceutical Science and Technology (in conjunction
`With 25‘” Ann-11a! Meeting of the Fine Particie Society) aiso organizer, chair and speaker oi the symposium on
`“Modular Drug Deiivery”. East Brunswick, NJ, Juty 28. 1994
`Program committee member of 1993 Conference on Pharmaceutical Science and Technoiegy (in conjunction
`with 24‘” Annuat Meeting of the Fine Particie Society) aiso organizer chair and speaker of the symposium on
`“Modulated anti iranscterrnat Drug Deti-1/ery” Chicago EL Aug-95:127. 1993
`
`F’narmaceuticei Reseaich., Journal of Pharmaceuticai Sciences, Current Eye Research, Cciioids and
`Soriaces, Journai of Conceited Retease, internationat Jonrnai of Pharmaceutics, Drug Deveiopment and
`
`tndusi
`i Pharmacy, Criticai Reviewe in Therapeut.ic Drug Carrier Svssetme, Journai (at Pharmacy it
`Pharmacotogy Cancer Gene Therapy, internat-tor5.11 Journal of Pharmaceuticai Compounding, Journa i
`of Pharmacoiogy 23: Experiments-11 Therapeutics, American Journat of Pharmaceut cat Education, indian
`Journai of Experimentai Bioiogy
`
`Externai Reviewer of
`951.0. {tissertaticns
`
`Schooi of Pharmacy, Universit y of Otago, New Zeaiantt
`M G R l‘v’iedicai Universny, Chennai, inoia,
`Jadavpur University. Caicutia, tndia
`
`Reviewer of
`Research Grants
`
`Center for Scientific Review — Nit—i Study Section meetings
`‘ 0 Section & SiEttR/SETT." ZRGi (EDD (01). Nov. 18—19. 2004-
`
`
`
`cSBiR/STTR, ZRGi 8 112.110), Mar. 14, S 05
`eonaeolian Nov. 1748,2005
`one seiR/srrn. 212131 SST-21:10) (13), Nov. 213. 2005
`.. Mar. 2-3. 20013
`
`(53), Way 2‘5-
`
`(R1 Jun. 15.2
`2126113511132;
`
`
`
`, November 02
`
`
` d Nanotecu iology, ZRG. BSTZ '
`SBiR/u] T R, ZRGt ESST—Zi1018.(
`'
`
`
`
`Nannies:iriology, ZRG‘.32010)
`
`;.10 2009
`
`-D (13) 8, November 2009
`
` D: rectors Opuortu ' ,. nsl (,. nicsl Oncology. t.
`
`
`- (551 R, May 201(1-
`
`Line 201 ‘1
`2011/10 ZRG‘ F04
`Fellowship: Biopuysoai and Biochemical Sofie '
`
`
`
`8, 2011
`s, 1..J31 OTC.-X 1'90), Sept2!
`Canoe: Therape
`
`,ZRGtI liviSTA (12) 8, Nov 05, 20.1 (ma:lift): Nov 0,2011 meeting
`
`university Committees
`
`,
`(es Gra App cations. 06/24/2014
` J OTC-N (34111111.; ’
`
`
`.d integlativ'e Bio
`10/15/2014:VAM‘.
`
`. ore-111 (801A
`tM-ST~S (121.3. s
`
`
`01/29/2015
`mom .i sciences 9.
`2/26/2015
`1d integ
`
`
`.ogicel sciences gren- appi. 10.1 13, 06/, 12015
`. December 20 i4
`
`Material 8- '
`cc: Di‘
`
` of Canada
`Medicai Research Cou
`Kent"
`,
`.
`ce and Engineering l'onniation
`
`
`US; (,1
`'1 Research it [)evecument.-ou--rtation forthe independent States of the Former Soviet Union
`
`Butter University. Cottage of Fharmacy 81 Heaith Sciences
`
`Academic Aft:
`'s Committee of Faculty Senate 201446. Universfiy Accreditation Committee. 2011—13. Pharmacy Dean
`
`Search Committee 2006. College Executive Co1. 1.
`tea 20011 — 009 Administrative 2004 - 00. Academic Affairs 2004- -
`
`08, Assessment 2004 -- 08, 2014-15.Re~3earch &'raduate(-:hair) 2004-
`
`iciaho State University
`
`
`ACF’E Accreditation Self—Study: Chair, Sta 'o‘a ‘
`’1 tor F‘hysicai and Practice Fec"‘ties 2004— 2005 F‘ ‘1 'ity Afie.it's (F'&T)
`
`
`
`
`1999 ~ 2001,
`ncil 01 Teaching and t.
`11:1 1998 ~ 2002.. Undergradrate Research Committee 1999 - 2003
`(secretary), Assessment 1999 — 2003. Technology 1998 - “00" Professionai Achievement Awe/d Committee 2000 ~
`
`
`2001. Curriculum Affairs 2001 - 200 , Facuity Search 2001 .. 2002.
`1
`(3 Standards 2002- 2005 Advisor.
`Association of indian Students ilSU) 200... Graduate Educ tion and Facuity R9586}l.1 Affairs 2003 - 2.004
`
`Nova Southeastern University
`Memories! University
`
`Promotions 1998 Facuity search 1997~98
`Facuity search. t_i.'1dergrariuate 8: Graduate studies. Seminar coordinator
`
`601 ‘17
`
`

`

`Curriculum vitae — Sudip K. Das
`
`EXTRAMURAL GRANTS FUNQEE)
`
`1 Redox protein APE-Z‘i/REF-1 as a target for age-reiated macuiar degeneration (AME), (1R41EY019784-0’i), September 2009 --
`September 2010, $ 5,100.00 to Dr. 03s, Martin 1'-' Hasianger, (Pi
`- Apex Therapeutics, inc), Mark Keiiey,
`(Co-1w itiPUi),
`Sudip K. Das (Coiiabcratcr)
`
`a.
`
`Lymphatic targeted tamoxiien for breast cancer therapy, (1R15 (50100843001) 0 123,820, N111 -- Nationai institute of Generai
`iv‘iedicai Sciences, August 2003 —~ February 2008, Nandita G. Das (Pi), Studio K. Qas (CovPi), Cindy M. Wiison (Co—Pi)
`
`3. Mucoadhesive huprenorphine for opioid addiction therapy (1R150A01535801, 5R150A015358—02), $ 121,0?4, Nit—i _
`Nationai institute on Drug Abuse, August 2002 w Juiy 2006, Sudip K. Bas (Pi), Nandita G. Das (Cat-ti)
`
`4.
`
`Stahiiity of Drugs. Baxter Heaithcare Corporation. September 2005 ~— Decemher 2008, $ 125,000, Sudip K. Das (Pi), Nano‘ita
`G. Das (Co~P1)
`
`5. Ceiiuiar uptake of methotrexate encapsuiated in dendritic nanoo'evices,
`June 2000 — duty 2007, Sudip K. Das (Pi & Mentor) and Sarnreen Khatri
`
`it 5,000, AFPE Gateway to Research Feiiowship,
`
`0.
`
`.7.
`
`8.
`
`Stabiiization of a modei protein in piodegradabie nanoparticies, is 5,000 ~ Pfizer Undergraduate Summer Research Program,
`May -- August. 2005. Samreen Khatri (P1) and Sudip K. Das (Mentor)
`
`Surface modified nanoemuisions for reversai of muitidrug resistance in cancer chemotherapy, $ 15,000, Parenterai Drug
`Association Foundation for Pharmaceuticai Sciences, Aprii 2001
`March 2002, Sudip K. Elias (Pt), Nandita G. Das
`(Coiiaborator)
`
`Enhancing probiem soiving skiiis in pharmacy education. is 48,050, idaho State Board of Education, Juiy 2000 m June 2001,
`Paui S. Cady (Pi), Suctip K. Gas (CovPi), Wendy Force (Co~Pi), Sandra Jue ((301%), Barbara G. Weiie (Co-Pi‘,
`
`0. Nanoemuision deiivery system for pooriy soiupie antineopiastic agents, $ 5000, Pharmaceuticai Research and Manufacturers
`eiArnerica Foundation, January, 2000 — December, 2000, Nandita G. Das (Pi), Sudip K. Elias (Co-Pi)
`
`10 Surface modified nanoemuisions for reverse! of muitidrug resistance in cancer chemotherapy. $ 15,000, Parenterai Drug
`Association Foundation for Pharmaceuticai Sciences, Aprii 2001
`March 2002, Sudip K. Elias (Pt), Nandita G. Das
`(Coiiaborator)
`
`1t.
`
`iv‘iedicai Research Councii of Canada, 1003-04
`
`12. Medicai Research Councii of Canada, 1092—03
`
`5:3. The Generai i-iospitai Foundation, Memoriai University of Newtoundiand, Canada, 1002—03.
`
`14. Deveiopment oi bioadhesive poiymers for site specific ocuiar deiivery, Sudip K. Das, ian G. Tucker, David J. T. Hiii, Lawrence
`W. Hirst, University of Queensiand Speciai Project Grant, AU$ 18,101
`
`15. Deveiopment and preiimihary evaiuation of hioadhesi