James E. Kipp, Ph.D.
`
`2364 Oak Hill Rd.
`Lake Barrington, Illinois 60010
`
`
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`President/ Founder
`Kipp Pharmaceutical Consulting, Inc.
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`LinkedIn profile: www.linkedin.com/in/KippPharmCon324
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`E-Mail: jkipp324@comcast.net
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`EXECUTIVE SUMMARY
`
`
`Over 35 years of experience in parenteral product design and development. Broad
`training and detailed technical knowledge in organic chemistry, physical chemistry, and
`pharmaceutical sciences. Notable accomplishments include:
`
`
` As expert witness in patent litigation concerning formulation of injectable
`pharmaceuticals (2012-present), I have consulted in ten cases for several
`pharmaceutical companies, represented by major law firms. These included:
`
` o
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` Trade secret misappropriation (2012):
` Tekmira Pharm. Corp. v. Alnylam Pharm., Inc., et. al., Civil Action No. 11-
`1010-BLS2 (Mass.).
`
`o Hatch-Waxman litigation (2013-present)
` Cadence Pharmaceuticals Inc. et al. v. Sandoz, Inc., Civil Action No. 13-
`cv-00278
` Helsinn Healthcare SA et al. v. Cipla Ltd. et al., Civil Action No. 13-cv-
`00688
` Merck, Sharp & Dohme Corp. v. Fresenius Kabi USA, LLC, Civil Action
`No. 14-cv-03917
` Millennium Pharmaceuticals, Inc. v. Apotex Corp. et al., Civil Action No.
`13-CV-01874-GMS (D. Del.) (Consolidated)
` Pfizer Inc. et al. v. Mylan Inc. et al., Civil Action No. 15-cv-00026
` AMAG Pharmaceuticals, Inc. v. Sandoz Inc., Civil Action No. 16-cv-01508
` Hospira, Inc. v. Fresenius-Kabi, USA, LLC, Civil Action No. 16-cv-00651
`
`Inter partes review declaration (Jan 2017)
` Mylan Institutional Inc. v. Fresenius Kabi USA, LLC, Cases IPR2017-
`00643 through -00645
`
`o
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`CV (JEKIPP 190416_B)CV (JEKIPP 190416_B)
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`I have testified at deposition five times in four cases, and once at trial (July
`2018). In that case, we won a critical decision based on my testimony, and the
`judge referenced my direct and cross-examination testimony 55 times in her
`favorable decision.
`
`
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` Technical leader at Baxter in formulation of marketed pharmaceutical products,
`including premix IV infusion formulations of the phosphate ester prodrug,
`clindamycin phosphate, and premixed IV infusion formulations of vancomycin,
`fluconazole, and nitroglycerin.
`
` While at Baxter, worked on well over 100 injectable formulation projects. Expert
`in all phases of injectable pharmaceutical product development in flexible plastic
`containers, as well as rigid containers, including glass.
`
` 
`
` A technical leader, led formulation development of pharmaceuticals for
`respiratory therapy (Baxter co-development of inhaled tobramycin for cystic
`fibrosis – TOBI® in conjunction with the pharmaceutical company,
`PathoGenesis).
`
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` Scientific consultant in development of a nitrogen mustard oncology drug (2013-
`2015). As a consulting member of regulatory submission team, worked with
`Spectrum Pharmaceuticals and its corporate partner, CyDex, in the preparation
`of the 505(b)(2) filing for Spectrum Pharmaceutical’s Evomela®, a propylene
`glycol-free vial product of melphalan, a nitrogen-mustard oncolytic used to treat
`multiple myeloma. Product contains the solubilizer/stabilizer, Captisol®
`(sulfobutylether(7m)-beta-cyclodextrin).
`
` Served as formulation leader on product development teams focused on the
`development of new containers for injectable pharmaceuticals products:
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` o
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` Development of Baxter’s first sterile-fill, no freeze plastic container, Galaxy
`PL-2501. This involved years of testing various plastic film materials as well
`as identifying extractables and their degradation products from bonded
`laminates.
`o Minimization and eventual elimination of PVC, latex and DEHP from plastic
`parenteral containers. This involved at least five years of work through
`development of intermediate prototypes.
`o Developed glass container system for Baxter’s nitroglycerin injection. This
`involved the testing of many elastomeric closures including EPDM, butyl
`rubber, and Teflon-coated stoppers such as Daikyo and West Fluorotec,
`Helvoet Omniflex, etc.
`o Studied the migration of drug into plastic containers and elastomeric closures
`(e.g., nitroglycerin, bupivacaine) and developed mathematical models for
`container sorption.
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`o Work on development and troubleshooting teams for numerous parenteral
`products. Examples: anti-“blooming” project for haze prevention in
`autoclaved plastic containers, particularly PVC; identification of container
`extractables, minimization of water-vapor transmission through plastics,
`modeling of formulation changes (e.g., pH) caused by container leachables.
`o Developed mathematical models and computer simulations for predicting the
`effect of plastic container parameters (e.g., film thickness, plastic type and
`blend, volume and configuration of inner bag and overpouch, overwrap
`material and thickness, etc.) on formulation stability. Example:
`PHYSIONEAL container modification and effects on formulation such as pH
`and pCO2.
`
` Expertise in physical chemistry of colloidal dispersions.
`
` o
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` While at Baxter, I led the development of nanoparticulate pharmaceutical
`dispersions, in particular itraconazole, and was a key scientist in the
`development of paclitaxel/albumin microspheres and antiretroviral agents for
`HIV (HAART). Many patents were generated from my work on
`nanosuspensions.
`o Designed custom coatings for colloid stabilization, including poloxamer
`butanesulfonate (US Patent 7,776,360).
`o Developed concepts for novel iron oxide sols in iron supplementation for renal
`therapy.
`
`
` Worked in organic synthesis (1983-84) at Baxter Travenol R&D in Morton Grove,
`Illinois; synthesized potential drug degradation products for identification of
`unknowns in pharmaceutical formulations.
`
` 
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` Developed a stable frozen formulation of the carbapenem antibiotic, meropenem,
`using 2-hydroxypropyl beta-cyclodextrin, which served a dual function as an
`inclusion complexation host and glass-transition modifier (high Tg’ vitrification
`agent). We were able to demonstrate at least one year of stability in the frozen
`state (Wong J, Kipp JE, Miller RL, Nair LM, Ray GJ. Mechanism of 2-
`hydroxypropyl-beta-cyclodextrin in the stabilization of frozen formulations. Eur. J.
`Pharm. Sci., 2014, 62:281-292).
`
` Use of 2-hydroxypropyl beta-cyclodextrin in stabilizing meropenem in the frozen
`state was patented (US Patent 8,183,233. Stable pharmaceutical formulations.
`Kipp, James E..; Wong, Joseph C-T; Nair, Lakshmy; Miller, Reagan; Rabinow,
`Barrett E. Issued May 22, 2012).
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` 
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` Formulation and delivery of poorly soluble drugs in solution, particularly by use of
`inclusion complexation with cyclodextrins
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`o Research and development of injectables containing cyclodextrins (e.g.,
`sulfobutylether-beta-cyclodextrin).
`o Developed zileuton/cyclodextrin formulation at Baxter (for Critical
`Therapeutics, Inc.), and submitted patent application (US2007 0111965A1.
`COMPOSITIONS COMPRISING LIPOXYGENASE INHIBITORS AND
`CYCLODEXTRIN. Kipp; James E.; Gupta; Pramod. May 17, 2007.
`
`
`Inventor of two lyophilization processes: “Preparation of submicron sized
`nanoparticles via dispersion lyophilization”, 2014, US Patent 8,722,091;
`“Preparation of submicron sized nanoparticles via dispersion lyophilization”,
`2004, US Patent 6,835,396.
`
` Expertise in drug delivery platform development
`
` o
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` Lead formulator for in-line, low gravity reconstitution systems for National
`Aeronautics and Space Administration (NASA). Co-inventor in two patents;
`received several U.S. government awards.
`o Developed computational models for assessment of drug binding to beta-
`cyclodextrin based on molecular structure. Results were presented at several
`national scientific meetings.
`o Lead scientist and inventor of Baxter’s nanoparticulate drug delivery platform
`(NANOEDGETM) – led research and development of nanoparticulate
`suspensions. Wrote review articles, taught AAPS short course (Baltimore,
`2004) on nanosuspension formulation.
`o Nanoparticle engineering by rapid solvent-antisolvent precipitation and
`homogenization, as well as dispersion lyophilization.
`o Lead development of nanosuspension formulations of poorly water soluble
`drugs, such as itraconazole and prednisolone.
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` Led exploratory formulation of cell expansion media in conjunction with the
`Immunotherapy group at Baxter. This entailed the application of iron dextran
`(colloidal iron oxide in dextran) as a nutrient iron source. This therapy
`incorporated use of Baxter’s cell isolation technology, the ISOLEX 300i Magnetic
`Cell Selection System. The ISOLEX system used superparamagnetic iron
`microbeads coated with murine anti IgG to effect separation of hematopoietic
`stem cells.
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`Innovative creativity in the development of new drug delivery technology and
`intellectual property (22 issued patents, and over 35 patent applications).
`
` Market surveillance and evaluation of new technology opportunities for Baxter.
`Continued this work as a consultant for other pharmaceutical companies.
`
` Expert in modeling physical and chemical processes
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`o Developed computational modeling techniques to predict properties of drugs
`in solution, solid state and interfacial phenomena (QSPR/QSAR).
`Chemometric modeling and data mining, research presented at AAPS
`meetings.
`o Developed QSPR neural network modeling (US Patent Application US2008
`0104001A1) for prediction of cyclodextrin complexation, solubility, and drug
`receptor binding (QSAR).
`o Developed models and computer programs to predict chemical kinetics under
`non-isothermal conditions. This enabled rapid assessment of thermal
`stability.
`o As part of inventing a magnetic filtration device, I modeled magnetic flux, a
`priori, in 2D cross-sections of potential magnetic arrays using conventional
`software (VIZIMAG). Results were verified using magnetometry.
`
`
` Taught courses at University of Illinois, Chicago, on chemical kinetics, and ionic
`equilibria.
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` Presented seminar on non-isothermal kinetics (Univ. of Texas at Austin)
`
` Conducted site inspection of an analytical laboratory used in a regulatory
`submission for a pharmaceutical firm under contract with a contract research
`company in San Diego, CA.
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`EMPLOYMENT HISTORY
`
`
`Kipp Pharmaceutical Consulting, Inc.
`
`
`President, Founder
`
` 
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` As consultant, served as expert witness in patent litigation.
` Provided support in writing the CMC/PD section of 505(b)(2) application for an
`anticancer injectable (the nitrogen mustard, melphalan) for an oncology
`pharmaceutical firm (Evomela®, by Spectrum); this application for an alkylating
`agent was approved. Evomela utilizes the modified beta-cyclodextrin, Captisol®,
`as a stabilizer.
`
` Consulted for various pharmaceutical companies on research and development
`of diverse pharmaceutical technologies and delivery systems. Developed new
`product concepts and research plans.
`
` 
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` Worked on new product ideas for oncology drugs (Spectrum Pharmaceuticals,
`Inc.)
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`January 2014 – Present
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`In conjunction with a regulatory batch production for a new drug product, I
`conducted a site inspection of an analytical services lab for a contract research
`organization.
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`Pharmaceutical Consultant, Sole Proprietorship
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`July 2013 – January 2014
`Patent litigation, generic pharmaceuticals
` As consultant for law firm based in the Midwest, I acted as outside expert witness
`(case discovery, issuance of expert report) in regard to intellectual property
`litigation.
`
`
`March -December 2012
`Patent litigation, biotechnology
` As consultant for a patent law firm based in San Francisco area, I worked for
`Plaintiff on a trade secret misappropriation case (Alnylam v. Tekmira). This case
`was favorably settled, and our client was awarded damages of $65 million, with
`milestone payments going forward.
`
`
`March 2012 – December 2014
`Small molecule pharmaceutical development
` As consultant for a drug company in southern California, I assisted in R&D efforts
`in formulating anticancer drugs in solution (e.g., l-folinic acid).
`
` Consulting services in the development of new intellectual property. Prepared
`technology platform analysis for legal team.
`
` Supported writing Pharmaceutical Development section of CMC for a new
`product submission.
`
`
`August 2013
`New product opportunity surveillance
` As consultant for a major drug company in the Chicago area, I evaluated
`physical-chemical properties of over 250 candidate pharmaceuticals for suitable
`match to parenteral delivery systems, such as prefilled syringes or flexible,
`sterile-filled IV bags.
`
`
`Baxter Healthcare Corporation
`
`2009 – Dec 2011
`Principal Scientist
` Developed technology platform for formulation of unstable drugs using high Tg’
`glass-transition modifying agents (vitrification agents). This platform used 2-
`hydroxypropyl beta-cyclodextrin (2-HPbCD) as both a glass transition point
`modifier and inclusion complexing agent. Proved concept by developing a
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`stable, ready-to-use carbapenem (meropenem)/2-HPbCD formulation that can be
`frozen for up to one year.
`o Research was published (Wong J, Kipp JE, Miller RL, Nair LM, Ray GJ.
`Mechanism of 2-hydroxypropyl-beta-cyclodextrin in the stabilization of frozen
`formulations. Eur. J. Pharm. Sci., 2014, 62:281-292).
`o Use of 2-hydroxypropyl beta-cyclodextrin as stabilizing agent was patented
`(US Patent 8,183,233. Stable pharmaceutical formulations. Kipp, James E..;
`Wong, Joseph C-T; Nair, Lakshmy; Miller, Reagan; Rabinow, Barrett E.
`Issued May 22, 2012).
`
` Developed new premix formulation for the echinocandin antifungal, caspofungin.
`
` Developed modified method for non-isothermal stress testing of pharmaceuticals.
`The shelf life of caspofungin at -20 °C was predicted to be greater than 2 years
`using 6-month accelerated isothermal data. The same estimate could be
`obtained in 1 day in nonisothermal testing with a linear temperature ramp.
`Results were presented at 2011 AAPS meeting in Washington D.C.
`
` Worked at Baxter on formulation of a parenteral tetracycline analog.
`
` Worked on development of HAART (Highly Active Antiretroviral Therapy)
`nanoparticles for the NANOEDGE platform. This therapy used nanoparticles to
`target hard to reach reservoirs of HIV virus. Colloidal dispersions of the protease
`inhibitors ritonavir, indinavir, tenofovir, lopinavir, and the non-nucleotide reverse
`transcriptase inhibitor, efavirenz, were prepared.
`
` As part of Baxter’s Physioneal container modification for continuous peritoneal
`dialysis (CAPD), I modeled the effects of container changes (e.g., thickness of
`films for inner chambers and overpouch) on pH before and after mixing as well
`as final pCO2. Wrote software to predict pH and pCO2 in continuous peritoneal
`dialysis (CAPD) dual-container system. This was instrumental in development of
`plastic container formulations and bag design (e.g., thickness and headspace
`volume).
`
`
`
`2003 – 2009
`Senior Baxter Research Scientist
` Led research and development of a cyclodextrin (Captisol®)-based formulation
`(zileuton with sulfobutylether beta-cyclodextrin).
`
` Directed research on premixed carbapenem in frozen, flexible containers (Baxter
`Galaxy® system). We were successful in developing a method of choosing
`additives that provided aqueous solutions with high glass transition temperatures
`(Tg). This allowed storage of frozen drug below Tg, thereby favoring high
`stability.
`
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`
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` Led research on feasibility of developing of premixed echinocandins for
`intravenous infusion, including caspofungin, frozen in Galaxy containers.
`Demonstrated use of non-isothermal kinetic experiments to rapidly predict long-
`term stability.
`
` Developed proprietary methods for nanoparticle drug formulation.
`
`In concert with collaborative team from University of Nebraska and Baxter,
`demonstrated that HAART nanoparticles could be trafficked, in-vivo, to sites of
`inflammation. Mononuclear phagocytes acted as vehicles for dissemination to
`reservoirs of HIV infection, and thus phagocytic cells could be ideal drug carriers,
`particularly for brain targeting.
`
` Developed QSPR methods for prediction of physical and chemical properties of
`pharmaceuticals in solution and suspension (e.g., solubility in various solvents,
`binding constants to cyclodextrins). Applied these techniques in product
`development for internal and external customers. Presented results for neural
`net model at AAPS meeting in San Antonio (2006).
`
` Modeled the effects of plastic processing on container extractables (from plastic)
`and formulation pH.
`
` Studied and modeled the effects of gamma irradiation of water and saline
`solutions on pH and species concentrations (e.g., hydrogen peroxide and
`hypochlorite)
`
` Taught course in chemical kinetics at University of Chicago, College of
`Pharmacy.
`
` Presented short course: Particle Engineering -- Engineering Friable Particles by
`Rapid Precipitation, AAPS Annual Meeting, Baltimore, November 2004
`
` Developed zileuton injectable formulation, solubilized with sulfobutylether(7m)
`beta-cyclodextrin (Captisol®). Submitted patent application (US2007
`0111965A1. COMPOSITIONS COMPRISING LIPOXYGENASE INHIBITORS
`AND CYCLODEXTRIN. Kipp; James E.; Gupta; Pramod. Published May 17,
`2007. Utility patent issued: US 8,183,233.
`
` Developed small particle suspensions for zileuton using microprecipitation and
`homogenization in the presence of surfactants. Patent application: US2007
`0134341A1. COMPOSITIONS OF LIPOXYGENASE INHIBITORS. Kipp, J.E.;
`Werling, J; Gupta, P; Buresh, R. Published June 14, 2007).
`
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` Developed and submitted a patent application (US 2009 0152176A1) for a
`magnetic filtration device. This was based on a double Halbach array of
`neodymium-iron-boron split-ring magnets arranged in a stacked column so that a
`porous tube could be passed through the central core. We demonstrated that
`ferromagnetic, ferrimagnetic, or paramagnetic contaminants could be effectively
`removed from liquids passed through the central core of the magnetic column.
`Total iron levels were monitored by emission spectroscopy.
`
`
`1996 – 2003
`Baxter Scientist
` Lead inventor and developer of Baxter’s NANOEDGETM technology platform,
`designed to address the formulation of water insoluble drugs (“brick dust”).
`
` Co-developed microprecipitation and comminution methods for preparing small
`drug particles, 200-300 nm. Either ultrasonication or piston-gap homogenization
`could be employed for particle size reduction.
`
` Led R&D group to develop injectable formulations for poorly soluble drugs
`including ACEA-1021 (licostinel), and RSR-13 (efaproxiral).
`
` Developed in-silico screening methods for evaluating early proprietary pipeline
`drugs for which physical or chemical data are sparse or entirely lacking.
`Examples include solubility, pKa, and particle size and stability of drug
`nanoparticles produced by the NANOEDGE process.
`
` Spearheaded intellectual property development for the Product Development
`group -- organized legal team and scientific staff to coordinate the development
`of patents for core technologies.
`
` Assembled cross-functional team between Business Development, Marketing,
`and R&D, for development of new product database for selection of late-stage
`drugs for potential premix infusion products.
`
` Developed and patented a surfactant-free formulation of amiodarone, a poorly
`water soluble drug. A US patent was issued (U.S. Patent 6,479,541).
`
`
`
`1990 – 1996
`Senior Research Scientist
` Technical Leader: Directed development of IV premix products within
`Pharmaceutical Sciences R&D. Examples: fluconazole (Diflucan®),
`vancomycin. Responsibilities focused on coordination and technical consultation
`in all aspects of parenteral development from preformulation through stability
`batch production, NDA submission and approval.
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` Devised method of determining realistic storage effects in various product
`warehouses. This enabled simple laboratory experimentation to calculate
`combinations of “virtual” relative humidity and temperatures that could be applied
`to predict shelf life in any environment.
`
` Lead technical leader for formulation development of Tobramycin for Inhalation
`(TOBI®):
`o Worked with PathoGenesis (now part of Novartis) as technical leader (with
`Dr. Bruce Montgomery at PathoGenesis) in the development of Tobramycin
`for Inhalation, for treatment of cystic fibrosis.
`o Lucrative product (>$300 million globally) for Novartis.
`
` Directed development of fluid reconstitution system for NASA space shuttle and
`proposed space station. This system enabled formulation of infusion solutions in
`zero gravity. One invention was based on development of a plastic bag that
`contained baffles that induced fluid vortexing when flowing water was introduced.
`This resulted in mixing with minimal formation of dispersed air bubbles.
`Received two awards from NASA for this contribution. Two patents were filed
`and issued.
`
`
`1985 – 1990
`Research Scientist
` Technical Leader: Headed development of premixed infusion products
`(antibiotics, antifungals, cardiovascular agents) for intravenous therapy. Directed
`formulation, and helped craft CMC section of NDA files. Examples: clindamycin
`phosphate (CLEOCIN® PHOSPHATE) in sterile-fill/no-freeze PL2501 plastic
`bags, vancomycin in frozen Galaxy PL2040 bags, fluconazole in PL 2408
`(Intravia®) containers, and RTU nitroglycerin in glass bottles.
`
` Lead formulation scientist in the development of Galaxy sterile-fill, no-freeze
`plastic container system. Worked on identification of plastic container
`extractables.
`
` Led formulation development of the poorly water-soluble antibiotic, clindamycin,
`as its phosphate ester prodrug. The phosphate ester has a much higher solubility
`making it safer to inject.
`
` Developed methods for calculation of complex solution equilibria, including the
`effect of temperature and electrolytes. Wrote a program (PHCALC and
`PHTEMP) to determine equilibrium concentrations of up to 105 species in
`solution, given equilibrium and mass constraints. Articles were published in the
`Journal of Pharmaceutical Sciences and Journal of Chemical Education.
`
` Developed Baxter nitroglycerin injectable in glass containers as lead formulation
`scientist. Studied drug sorption into plastics and rubber closures.
`
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`CV (JEKIPP 190416_B)CV (JEKIPP 190416_B)
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` Studied effects of autoclaving and product transport on haze formation in plastic
`parenteral containers.
`
`
`1983 – 1985
`Senior Research Associate (Travenol Laboratories)
` Project management and support: Organic synthesis, isolation, identification and
`characterization of degradation products from product formulations. Was able to
`synthesize an Amadori-rearrangement/ Maillard adduct of cimetidine and D-
`glucose. Extensive use of analytical techniques (FT-IR, NMR, mass
`spectrometry) and preparative HPLC and TLC.
`
` Developed software for analysis of nonisothermal stress testing data. Published
`several articles in Int. J. Pharm. and J. Pharm. Sci., and presented seminar at
`University of Texas at Austin. Served on a dissertation committee for graduate
`student of Professor Solomon Stavchansky (Univ. of Texas).
`
` Researched oxidation of amino acids and carbohydrates.
`
`Ann Arbor, MI
`
`
`The University of Michigan, Rackham Graduate School
`
`1977 – 1982
`Teaching Assistant in Chemistry
` Taught courses in Organic Chemistry and Qualitative Organic Chemical Analysis
`(including use of FT-IR, NMR, mass spectrometry, and wet chemical
`identification methods), directed lab activities, proctored examinations, and
`assisted in grade assignment.
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`CV (JEKIPP 190416_B)CV (JEKIPP 190416_B)
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`COMPUTER and LANGUAGE SKILLS
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` Computer programming in FORTRAN, PASCAL, Visual Basic, Visual Basic for
`Applications (Microsoft Excel®)
` Can speak and read Dutch. Reading proficiency in German.
`
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`EDUCATION
`
`
`University of Michigan, Ann Arbor, MI
`
`
` Ph.D. in Chemistry (1983)
`Ph.D. Thesis:
`"The Photochemistry of Bicyclo[3.3.1]non-1-ene and 9-
`Oxabicyclo[3.3.1]non-1-ene” (John R. Wiseman, advisor). Research included
`new synthesis of strained bridgehead olefins, and study of their thermal and
`photochemical reactivity. New synthetic methods were developed in the
`course of this work.
`
` MS in Chemistry (1977)
`Using GC, isolated photoproducts resulting from Norrish Type I and Type II
`cleavage of cycloalkanones. Determined quantum yields by use of chemical
`actinometry. (Advisor: David S. Weiss)
`
`Albion College, Albion, MI
`
`
` A.B., Cum Laude, in Chemistry (1975)
`
`
`University of Leiden, Leiden, The Netherlands
`
`
` Student exchange program with Chemistry Department of Albion College (1973-
`1974).
`
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`Honors and Awards (non-corporate)
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`OTHER ACHIEVEMENTS
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`AOAC International, Southern California Section, Certificate of Appreciation,
`March 15, 2002.
`Marquis Who’s Who in Science and Engineering, 1996-1999
`American Men and Women of Science, 1992-1998
`NASA Technical Contribution Awards, 1991
`Phi Lambda Upsilon, 1978
`University of Michigan, Teaching Scholarship, 1977-1982.
`Phi Eta Sigma, 1972
`Dean's List, Albion College, 1971-1975
`Albion Presidential Scholarship Awards, 1971-1973
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`CV (JEKIPP 190416_B)CV (JEKIPP 190416_B)
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`American Chemical Society, 1977-Present
`American Association of Pharmaceutical Scientists, 1986-Present
`Controlled Release Society
`Chicagoland Pharmaceutical Discussion Group (Publicity Chairman, 1985-86)
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`Memberships
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`Publications and presentations
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`Wiseman, J. R.; Kipp, J. E. (E)-Bicyclo[3.3.1]non-1-ene, J. Amer. Chem. Soc.,
`1982, 104, 4688.
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`Kipp, J. E. Allothermal Kinetics: Mathematical Analysis (Poster). Program and
`Abstract, American Pharmaceutical Association 37th National Meeting,
`Philadelphia, 1984, 14(2), 187.
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`Kipp, J. E. Nonisothermal Kinetics--Comparison of Two Methods of Data
`Treatment, Int. J. Pharm., 1985, 26, 339.
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`Kipp, J. E.; Jensen, M. M. Automated HPLC System for Nonisothermal Kinetic
`Studies: Degradation of Cefotaxime Sodium (Poster). American Pharmaceutical
`Association 133rd Annual Meeting and Exposition, San Francisco, 1986, 16(1),
`142.
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`Kipp, J. E.; Jensen, M. M.; Kronholm, K.; McHalsky, M. Automated Liquid
`Chromatography for Nonisothermal Kinetic Studies. Int. J. Pharm., 1986, 34, 1.
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`Kipp, J. E.; Bueno, C.; Vieira, M.; Comer, G.; Ludwig, S. Estimation of pH
`Changes in Frozen and Thawed Cephalothin I.V. Formulations (Poster).
`American Association of Pharmaceutical Scientists, Third Annual Meeting,
`Orlando, 1988. Pharm. Res., 1988, 5(10), S-91.
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`Kipp, J. E.; Patel, B. Linear Algebraic Method for the Calculation of pH and Ionic
`Species Concentrations in Aqueous Solution (Poster). American Association of
`Pharmaceutical Scientists, Fourth Annual Meeting, Atlanta, 1989). Pharm. Res.,
`1989, 6(9), S-140.
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`Kipp, J. E.; Hlavaty, J. J. Nonisothermal Stability Assessment of Stable
`Pharmaceuticals: Testing of a Clindamycin Phosphate Formulation, Pharm.
`Res., 1991, 570-575.
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`Kipp, J. E.; Smith, Walter, J., Myrdal, P. B. "Determination of Phosphate
`Functional Group Acid Dissociation Constants of Clindamycin-2-Phosphate
`Using 31P Fourier Transform NMR Spectrometry", Int. J. Pharm., 1991, 215-220.
`Kipp, James E. "PHCALC: A Computer Program for Acid/Base Equilibrium
`Calculations", J. Chem. Educ., 1994, 71(2), 119-121.
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`Kipp, James E. Compatibility Issues in Total Nutrition Admixtures (Abstract).
`37th Annual International Industrial Pharmaceutical Research and Development
`Conference, Merrimac, Wisconsin, June 5-9, 1995).
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`Kipp, James E.; Schuck, D. F. Computer Simulation of the Effect of Temperature
`on pH. J. Pharm. Sci., 1995, 84(11), 1347-1352.
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`Kipp, J. E., Bosco, P. J. Estimation of Calcium Phosphate Solubility in Amino
`Acid Formulations. (Poster). AAPS Annual Meeting and Exposition, Seattle,
`Washington, 1996, Pharm. Res., 1996, 13(9), 336.
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`Kipp J. E.; Rebbeck, C., Hammond, R.; Eilert J. (Baxter Healthcare Corporation,
`Pharmaceutical Sciences R&D 60073). Lucero, J.C.; Kerkhof, N.J. (CoCensys,
`Inc., Pharmaceutical Sciences, 201 Technology Drive, Irvine, CA 92618). The
`Effect of Amine Solubilizers on the Solubility of ACEA 1021 (Poster). AAPS
`Annual Meeting and Exposition, San Francisco, California, 1998, PharmSci,
`1998, 1(1), S-265.
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`Kipp, J. E. Prediction of Aqueous Solubility Using a Theoretical Descriptor Model
`and Genetic Optimization With Kernel Regression Estimator. (Poster). AAPS
`Annual Meeting and Exposition, Toronto, Canada, 2002.
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`Chaubal, M., Doty, M., Kipp, J., Papadopoulos, P., Rebbeck, C., Werling, J.,
`Wong, J. Preparation of stable, sterile nanosuspensions for intravenous
`administration. Controlled Release Society Meeting (Salt Lake City, Utah, US),
`March 2003.
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`Kipp, J. The role of solid nanoparticle technology in the parenteral delivery of
`poorly water-soluble drugs. Int. J. Pharm., 2004, 284, 109-122.
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`Kipp, J. Particle Engineering: Engineering Friable Particles by Rapid
`Precipitation (AAPS Short Course), AAPS Annual Meeting, Baltimore, November
`2004
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`Kipp, J.; Werling, J.; Buresh, R., 2005. Mathematical modeling of solid
`comminution in high-shear fluid processing in the production of submicron
`particles for drug delivery. Controlled Release Society Meeting (Miami, FL, US),
`June 2005.
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`Dou H, Morehead J, Destache CJ, Kingsley JD, Shlyakhtenko L, Zhou Y,
`Chaubal M, Werling J, Kipp J, Rabinow BE, Gendelman HE. Laboratory
`investigations for the morphologic, pharmacokinetic, and anti-retroviral properties
`of indinavir nanoparticles in human monocyte-derived macrophages. Virology
`358(1):148-58, 2007.
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`Dou, H., Destache, C.J., Morehead, J.R., Mosley, R.L., Boska, M.D., Kingsley, J.,
`Gorantla, S., Poluektova, L., Nelson, J.A., Chaubal, M., Werling, J., Kipp, J.,
`Rabinow, B.E., and Gendelman, H.E. Development of a macrophage-based
`nanoparticle platform for antiretroviral drug delivery. Blood 2006; 108(8).
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`Mosley RL, Gorantla S, Dou H, Destache CJ, Nelson JA, Kingsley, Poluektova L,
`Boska M, Chaubal M, Werling J, Kipp K, Rabinow B, Gendelman HE,
`Macrophage tissue migration: A novel platform for anti-retroviral delivery, 2005,
`Abs 235, Keystone Symposium, Leukocyte Trafficking: Cellular and Molecular
`Mechanisms Keystone.
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`Dou H, Destache CJ, Kingsley J, Mosley RL, Nelson JA, Morehead JR,
`Poluektova L, Boska M, Gorantla S, Chaubal M, Werling J, Kipp J, Rabinow BE,
`Gendelman HE, A novel platform for anti-retroviral delivery: Implications for HIV-
`1 associated dementia, 2005, Abs 338.19, Society for Neuroscience.
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`Dou H, Grotepas CB, McMillan JM, Destache CJ, Chaubal M, Werling J, Kipp J,
`Rabinow B, Gendelman HE, Macrophage Delivery of nanoformulated
`antiretroviral drug to the brain in a murine model of neuroAIDS. J Immunology
`2009 183(1):661-669.
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`Rabinow B, Glosson J, Sun C, Papadopoulos P, Kipp J, Wong J.
`Nanosuspension Formulation of Itraconazole Increases Survival Relative to
`Solution Formulation in Immunocompromised Rat Model of Itraconazole-
`Resistant C. albicans. December 16-19, 2005 45th Annual Interscience
`Conference on Antimicrobial Agents and Chemotherapy (ICAAC) Washington,
`DC.
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`Kipp J Solubilizing systems for parenteral