James E. Kipp, Ph.D.
`President/ Founder
`Kipp Pharmaceutical Consulting, Inc.
`
`2364 Oak Hill Rd.
`Lake Barrington, Illinois 60010
`
`Phone: 847-609-6618
`
`E-Mail: jkipp324@comcast.net
`
`LinkedIn profile: www.linkedin.com/in/KippPharmCon324
`
`EXECUTIVE SUMMARY
`
`Over 30 years of experience in parenteral product design and development. Broad training and technical
`knowledge in organic chemistry, physical chemistry, and pharmaceutical sciences. Notable
`accomplishments include:
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`Expertise in all phases of development of injectable pharmaceutical products in flexible plastic
`containers, as well as rigid containers, including glass. Technical leader at Baxter in formulation
`of several marketed pharmaceutical products, including the phosphate ester prodrug, clindamycin
`phosphate. Also led formulation of vancomycin, fluconazole, tobramycin for inhalation, and
`nitroglycerin for injection.
` Worked in organic synthesis lab (1983-84) at Baxter Travenol R&D in Morton Grove, Illinois,
`synthesized potential drug degradation products for identification of unknowns in pharmaceutical
`formulations. The Morton Grove lab originally developed Synthroid®, the first marketed fully
`synthetic oral dosage of levothyroxine.
` Developed stable formulation of meropenem, carbapenem, using carbohydrate glass-transition
`modifying agents (vitrification agents). We were able to demonstrate at least one year of stability
`frozen. Additive provided a high Tg’ (glass transition temperature with ice crystal formation).
`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.
`Scientific consultant in development of small-molecule oncology drugs (2013-2015). Wrote the
`Pharmaceutical Development Section of the 505(b)(2) filing for Evomela®, a propylene glycol-
`free vial product of melphalan. Product contains the solubilizer/stabilizer, Captisol®
`(sulfobutylether(7m)-beta-cyclodextrin). This submission was approved within a year.
`Expertise in drug delivery platform development
`o
`Lead formulator for in-line, low gravity reconstitution systems for National Aeronautics and
`Space Administration (NASA). Co-inventor of two patents, received several government
`awards.
`Formulation and delivery of poorly soluble drugs in solution, particularly by use of inclusion
`complexation with cyclodextrins
`o Research and development of injectables containing cyclodextrins (e.g., sulfobutylether-beta-
`cyclodextrin). Developed zileuton/Captisol formulation at Baxter (for Critical Therapeutics,
`Inc.)
`o Spearheaded Baxter marketing effort to acquire CyDex Inc., the developer of Captisol
`technology
`o Developed computational models for assessment of drug binding to beta-cyclodextrin based
`on molecular structure. Results were presented at national scientific meetings
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`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 on nanosuspension formulation.
`o Nanoparticle engineering by rapid solvent-antisolvent precipitation and homogenization, as
`well as dispersion lyophilization.
`o Developed nanosuspension formulations of poorly water soluble drugs, such as itraconazole
`and prednisolone.
`Experience in development of pharmaceuticals for respiratory therapy (led Baxter development of
`inhaled tobramycin for cystic fibrosis – TOBI®)
` Creative innovation in development of new drug delivery technology and intellectual property (22
`issued patents, and over 35 applications)
` Market surveillance and evaluation of new technology opportunities for Baxter. Continued this
`work for other pharmaceutical companies.
` Computational modeling to predict properties of drugs in solution, solid state and interfacial
`phenomena (QSPR/QSAR). Chemometric modeling and data mining, research presented at
`AAPS meetings. Developed QSPR neural network modeling for prediction of cyclodextrin
`complexation, solubility, and drug receptor binding (QSAR).
`Taught courses at University of Illinois, Chicago, on chemical kinetics, and ionic equilibria
`Expert witness
`o Served as expert consultant in trade secret misappropriation (2012).
`o Six Hatch-Waxman cases (clients have included medium to large generic pharmaceutical
`companies).
`o Work on claim construction and discovery
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`EMPLOYMENT HISTORY
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`Kipp Pharmaceutical Consulting, Inc.
`January 2014 - Present
`President, Founder
`As consultant for several law firms, I have been providing professional consulting and expert
`
`witness services in connection with intellectual property litigation in areas of pharmaceutical
`technology.
` Wrote CMC/PD section for FDA application for an anticancer agent for an oncology
`pharmaceutical firm (Evomela®, by Spectrum); this application for an alkylating agent was
`recently approved.
` Consulted for various pharmaceutical companies on research and development of diverse
`pharmaceutical technologies and delivery systems including one oral product.
`
`Pharmaceutical Consultant, Sole Proprietorship
`July 2013 – January 2014
`Patent litigation, generic pharmaceuticals
`As consultant for law firm based in the Midwest, I provided expert services (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
`
`an anticancer drug in solution.
` Consulting services in the development of new intellectual property. Prepared technology
`platform analysis for legal team.
` Drafted Pharmaceutical Development section of CMC for a new product submission.
`
`August 2013 - Present
`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 glass-transition modifying
`agents (vitrification agents). Proved concept by developing a stable, ready-to-use carbapenem
`(meropenem) formulation that can be frozen for up to one year.
` Developed new premix formulation for echinocandin antifungal.
` 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.
`Internal consultant for formulation of 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.
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`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.
`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.
`Invented new polymeric prodrug for treatment of Parkinson’s disease.
`
` Developed method using ultrasound for reducing particle size and potentially monitoring size
`reduction and phase transitions by simple sonocalorimetry.
` 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).
` Wrote software to predict pH and pCO2 in continuous peritoneal dialysis (CAPD) dual-container
`system. This was instrumental in development of plastic formulations and bag design (e.g.,
`thickness and headspace volume).
`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
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`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 water-insoluble drugs including iopamidol,
`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).
`Led support team in development of parenteral nutrition formulations, 3-in-1, Prosol®,
`Alphamine®, and Premasol®.
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`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.
` 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 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 (>$1 billion 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. Received two
`awards from NASA for this contribution. Two patents were filed and issued.
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`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),
`vancomycin, and RTU nitroglycerin in glass bottles.
`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. 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.
`
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`
`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 Amidori-
`rearrangement adduct of cimetidine and D-glucose. Extensive use of analytical 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 seminars at academic institutions (e.g.,
`University of Texas at Austin). Served on a dissertation committee for graduate student of
`Professor Solomon Stavchansky.
`
`Ann Arbor, MI
`The University of Michigan
`1977 – 1982
`Teaching Assistant in Chemistry
`Taught courses in Organic Chemistry and Qualitative Analysis, directed lab activities, proctored
`
`examinations, and assisted in grade assignment.
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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. Proficiency in German.
`
`EDUCATION
`University of Michigan, Ann Arbor, MI
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`
`
`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).
` MS in Chemistry (1977)
`Using GC, isolated photoproducts resulting from Type I and Type II cleavage of
`cycloalkanones. Determined quantum yields by use of chemical actinometry.
`
`Albion College, Albion, MI
`
` A.B., Cum Laude, in Chemistry (1975)
`
`University of Leiden, Leiden, The Netherlands
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`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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`Memberships
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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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`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.
`
`"Allothermal Kinetics: Mathematical Analysis", (Poster) Program and Abstract,
`Kipp, J. E.
`American Pharmaceutical Association 37th National Meeting, Philadelphia, 1984, 14(2), 187.
`
`"Nonisothermal Kinetics--Comparison of Two Methods of Data Treatment", Int. J.
`Kipp, J. E.
`Pharm., 1985, 26, 339.
`
`"Automated HPLC System for Nonisothermal Kinetic Studies:
`Kipp, J. E.; Jensen, M. M.
`Degradation of Cefotaxime Sodium", (Poster) Abstract, American Pharmaceutical Association
`133rd Annual Meeting and Exposition, San Francisco, 1986, 16(1), 142.
`
`"Automated Liquid Chromatography for
`Kipp, J. E.; Jensen, M. M.; Kronholm, K.; McHalsky, M.
`Nonisothermal Kinetic Studies", Int. J. Pharm., 1986, 34, 1.
`
`"Estimation of pH Changes in Frozen
`Kipp, J. E.; Bueno, C.; Vieira, M.; Comer, G.; Ludwig, S.
`and Thawed Cephalothin I.V. Formulations", (Poster, American Association of Pharmaceutical
`Scientists, Third Annual Meeting, Orlando, 1988). Pharm. Res., 1988, 5(10), S-91.
`
`"Linear Algebraic Method for the Calculation of pH and Ionic Species
`Kipp, J. E.; Patel, B.
`Concentrations in Aqueous Solution" (Poster, Abstract: American Association of Pharmaceutical
`Scientists, Fourth Annual Meeting, Atlanta, 1989). Pharm. Res., 1989, 6(9), S-140.
`
`"Nonisothermal Stability Assessment of Stable Pharmaceuticals:
`Kipp, J. E.; Hlavaty, J. J
`Testing of a Clindamycin Phosphate Formulation", Pharm. Res., 1991, 570-575.
`
`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.
`
`"PHCALC: A Computer Program for Acid/Base Equilibrium Calculations", J.
`Kipp, James E.
`Chem. Educ., 1994, 71(2), 119-121.
`
`“Compatibility Issues in Total Nutrition Admixtures” (Podium Presentation,
`Kipp, James E.
`Abstract:
`37th Annual
`International
`Industrial Pharmaceutical Research and Development
`Conference, Merrimac, Wisconsin, June 5-9, 1995).
`
`Kipp, James E.; Schuck, D. F. “Computer Simulation of the Effect of Temperature on pH” J.
`Pharm. Sci., 1995, 84(11), 1347-1352.
`
`Kipp, J. E., Bosco, P. J. “Estimation of Calcium Phosphate Solubility in Amino Acid
`Formulations.” (Poster presentation: AAPS Annual Meeting and Exposition, Seattle,
`Washington, 1996), Pharm. Res., 1996, 13(9), 336.
`
`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 presentation: 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 presentation: AAPS Annual Meeting
`and Exposition, Toronto, Canada, 2002).
`
`Chaubal, M., Doty, M., Kipp, J., Papadopoulos, P., Rebbeck, C., Werling, J., Wong, J., 2003.
`Preparation of stable, sterile nanosuspensions for intravenous administration. Controlled
`Release Society Meeting (Salt Lake City, Utah, US), March 2003.
`
`Kipp, J. The role of solid nanoparticle technology in the parenteral delivery of poorly water-
`soluble drugs.
`Int. J. Pharm., 2004, 284, 109-122.
`
`Kipp, J. AAPS Short Course - Particle Engineering: Engineering Friable Particles by Rapid
`Precipitation, AAPS Annual Meeting, Baltimore, November 2004
`
`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.
`
`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.
`
`Dou, H., Limoges, J., Ellison, B., Kingsley, J.D., Zhou, Y., Destache, C.J., Chaubal, M., Werling,
`J., Kipp, J., Rabinow, B. and Gendelman, H.E. Macrophage-based delivery system for anti-
`retroviral therapy. J. Virol., submitted 2005.
`
`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. A macrophage nanoparticle system for anti-retroviral drug delivery: Pharmacokinetic,
`immune, and anti-viral responses in a murine model of HIV-1 disease, submitted, Nature
`Medicine, 2006.
`
`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).
`
`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.
`
`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.
`
`Dou H, Destache CJ, Morehead JR, Mosley RL, Boska MD, Kingsley J, Gorantla S, Poluektova L,
`Nelson JA, Chaubal M, Werling J, Kipp J, Rabinow BE, Gendelman HE Dou, H., et al., A
`macrophage nanoparticle system for anti-retroviral drug delivery: Pharmacokinetics, immune, and
`anti-viral responses in a murine model of HIV-1 disease. J Clin Inv (submitted).
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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.
`
`Kipp J Solubilizing systems for parenteral formulation development - small molecules . In
`“Solvent Systems and Their Selection in Pharmaceutics and Biopharmaceutics”, 2007.
`Augustijns P (Ed.), Springer - AAPS Press, Washington DC.
`
`Wong J, Papadopoulos P, Werling J, Rebbeck C, Doty M, Kipp J, Konkel J, Neuberger D.
`Itraconazole suspension for intravenous injection: Determination of the real component of
`complete refractive index input for static light scattering particle sizing instrument. Tenth Annual
`Drug Delivery Partnerships, January 2006 (Phoenix, Arizona).
`
`Kipp J, “Kinetics of Chemical Reactions in Solution”, Graduate School Symposium June 2006,
`School of Pharmacy, University of Illinois, Chicago.
`
`Kipp J, “Effect of Temperature on pKa and pH, and Implications in Stability Assessment”,
`Graduate School Symposium June 2006, School of Pharmacy, University of Illinois, Chicago.
`
`M. Chaubal, M. Doty, R. Garcia, J. Kipp, P. Papadopoulos, C. Rebbeck, J. Werling, and J. Wong.
`Preparation of Stable, Sterile Nanosuspensions for Intravenous Administration. Proceed. Intern.
`Symp. Control Rel. Bioact. Mater. 30 (227) 2003.
`
`Rabinow B, Kipp J, Papadopoulos P, Wong J, Glosson J, Gass J, Sun C-S, Wielgos T, White R,
`Cook C, Barker K, Wood K . Itraconazole IV nanosuspension enhances efficacy through altered
`pharmacokinetics in the rat. International Journal of Pharmaceutics 339 (2007) 251–260.
`
`Wong J, Brugger A, Khare A, Chaubal M, Papadopoulos P, Rabinow B, Kipp J, Ning J.
`Suspensions for Intravenous (IV) Injection: A Review of Development, Preclinical and Clinical
`Aspects. Advanced Drug Delivery Reviews 60 (2008) 939–954.
`
`Kipp J. Ensemble-based Descriptor Selection in Neural Network Modeling—Application in
`Predicting Inclusion Complexation Equilibria. AAPS Annual Meeting, November 10-14, 2013.
`
`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.
`
`Kipp J. Ensemble-based genetic optimization for selection of neural network inputs – application
`in melting point estimation (poster T2013). AAPS Annual Meeting, November 3, 2014.
`
`Kipp J. Prediction of Relative Estrogen Receptor Binding Using an Ensemble Kernel Regression
`with Genetic Optimization. Accepted for publication at AAPS Annual Meeting, 2015.
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`Patents (Issued):
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`U.S. Patent 5,484,431, System For Creating At a Site, Remote From A Sterile Environment, A
`Parenteral Solution. Scharf, M.; Finley, Mike; Veillon, J.; Kipp, J.; Dudar, T.; Owens, J.; Ogle, J.
`
`U.S. Patent 5,490,848, System For Creating On Site, Remote From A Sterile Environment,
`Parenteral Solutions. Finley, M.; Scharf, M.; Packard, J.; Kipp, J.; Dudar, T.; Owens, J.;
`Bindokas, Al.
`
`U.S. Patent 6,221,222: A Reference Electrode Solution Containing Organic Ammonium and
`Phosphonium Salts for Potentiometric Measurement of pH.
`Issued Apr 24, 2001. Kipp, J.;
`Wehrmann, G.; Hammond, R.; Rebbeck, C.
`
`U.S. Patent 6,479,541 Amiodarone-containing parenteral administration.
`Kipp, James E.; Doty, Mark J.; Rebbeck; Christine L.; Eilert, Jan Y.
`
`Issued Nov 12, 2002.
`
`Issued
`U.S. Patent 6,607,784 Microprecipitation method for preparing submicron suspensions.
`Aug 19, 2003. Kipp, James E.; Wong, Joseph Chung Tak; Doty, Mark J.; Rebbeck, Christine L.
`
`US Patent 6,835,396 Preparation of submicron sized nanoparticles via dispersion lyophilization,
`issued Dec 28, 2004, Brynjelsen, S.; Doty, M.; Kipp, J.; Jayswal, N.; Narayanan, K.
`
`US Patent 6,869,617 Microprecipitation method for preparing submicron suspensions, issued
`3/22/2005, Kipp, J.; Wong, J.; Doty, M.; Rebbeck, C.
`
`US Patent 6,884,436 Method for preparing submicron particle suspensions, issued 4/26/2005,
`Kipp, J.; Wong, J.; Doty, M.; Rebbeck, C.
`
`US Patent 6,951,656 Microprecipitation method for preparing submicron suspensions, issued
`10/4/2005; Kipp, J.E.; Wong, J.C-T.; Doty, M.J.; Rebbeck, C.L.; Brynjelsen, S.
`
`US Patent 6,977,085 Method for preparing submicron suspensions with polymorph control.
`Issued December 20, 2005. Werling, Jane; Kipp, James E.; Sriram, Rajaram; Doty, Mark J.
`
`US Patent 7,037,528 Microprecipitation method for preparing submicron suspensions. Issued
`May 2, 2006. Kipp James E.; Wong, Joseph Chung Tak; Doty, Mark J.; Rebbeck, Christine L.
`
`US Patent 7,067,143 Premixed amiodarone parenteral solution and method for making the
`same.
`Issued June 27, 2006. Doty; Mark J.; Rebbeck; Christine L.; Kipp; James E.; Raghavan;
`Neervalur V.
`
`US Patent 7,112,340. Compositions of and method of preparing stable particles in a frozen
`aqueous matrix.
`Issued September 26, 2006. Kipp, J.E.; Doty, M.J.; Rebbeck, C.L.; Brynjelsen,
`S.; Konkel, J.T.
`
`US Patent 7,193,084. Polymorphic form of itraconazole.
`Doty MJ; Rebbeck CL; Wong J C-T, Kipp JE.
`
`Issued March 20, 2007. Werling J;
`
`US Patent 7,511,079. Methods and apparatuses for the comminution and stabilization of small
`particles. Kipp JE, Wong J C-T, Wisler M, Garcia R.
`Issued March 31 2009.
`
`(Polyalkoxy)sulfonate surface modifiers. Kipp, James E.; Hai, Ton That;
`US Patent 7,776,360.
`Melnick, Bennett P.
`Issued Aug 17, 2010.
`
`JEKIPP CV (161220)
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`Mylan Ex 1005, Page 10
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`
`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.
`
`US Patent 8,263,131. Method for treating infectious organisms normally considered to be
`resistant to an antimicrobial drug. Rabinow B, White R, Sun C-S, Wong J C-T, Kipp JE, Doty M,
`Rebbeck CL, Papadopoulos P. Issued September 11, 2012.
`
`US Patent 8,333,959. Ex-vivo application of solid microparticulate therapeutic agents. James E.
`Kipp, Barrett E. Rabinow. Issued December 18, 2012.
`
`US Patent 8,722,091. Preparation of submicron sized nanoparticles via dispersion lyophilization.
`Sean Brynjelsen, Mark Doty, James E. Kipp, Nailesh Jayswal, Krishnaswamy Narayanan. Issued
`May 13, 2014.
`
`US Patent 8,986,736. Method for delivering particulate drugs to tissues. Barrett E. Rabinow,
`Howard E. Gendelman, James E. Kipp, Issued March 24, 2015.
`
`US Patent 9,044,381. Method for delivering drugs to the brain. Barrett E. Rabinow, James E.
`Kipp, Howard E. Gendelman, issued June 2, 2015.
`
`Patent Applications:
`
`US Patent Application, US2002 0127278A1. Microprecipitation method for preparing submicron
`suspensions, published 9/12/2002. Kipp, James E.; Wong, Joseph Chung Tak; Doty, Mark J.;
`Rebbeck, Christine L.
`
`US Patent Application, US2002 0143050A1. Premixed amiodarone parenteral solution and
`method for making the same, published 10/3/2002. Doty, Mark J.; Rebbeck, Christine L.; Kipp,
`James E.; Raghavan, Neervalur V.
`
`US Patent Application, US2002 0143051A1. Premixed amiodarone parenteral solution and
`method for making the same, published 10/3/2002. Doty, Mark J.; Rebbeck, Christine L.; Kipp,
`James E.; Raghavan, Neervalur V.
`
`US Patent Application, US2002 0168402A1. Microprecipitation method for preparing submicron
`suspensions, published 11/14/2002. Kipp, James E.; Wong, Joseph Chung Tak; Doty, Mark J.;
`Rebbeck, Christine L.
`
`US Patent Application, US2002 0176935A1. Microprecipitation method for preparing submicron
`suspensions, published 11/28/2002. Kipp, James E.; Wong, Joseph Chung; Doty, Mark J.;
`Rebbeck, Christine L.
`
`US Patent Application, US2003 0003155A1. Microprecipitation method for preparing submicron
`suspensions, published 1/2/2003. Kipp, James E.; Wong, Joseph Chung Tak; Doty, Mark J.;
`Rebbeck, Christine L.; Brynjelsen, Sean.
`
`US Patent Application, US2003 0044433A1. Method for preparing submicron suspensions with
`polymorph control, published 3/6/2003. Werling, Jane; Kipp, James E.; Sriram, Rajaram; Doty,
`Mark J.
`
`US Patent Application, US2003 0059472A1. Preparation of submicron sized nanoparticles via
`dispersion lyophilization, published 3/27/2003. Brynjelsen, Sean; Doty, Mark; Kipp, James E.;
`Jayswal, Nailesh; Narayanan, Krishnaswamy.
`
`JEKIPP CV (161220)
`
`11
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`Mylan Ex 1005, Page 11
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`

`
`US Patent Application, US2003 0072807A1. Solid particulate antifungal compositions for
`pharmaceutical use, published 4/17/2003. Wong, Joseph Chung-Tak; Kipp, James E.; Doty,
`Mark J.; Rebbeck, Christine; Papadopoulos, Pavlos.
`
`US Patent Application, US2003 0077329A1. Composition of and method for preparing stable
`particles in a frozen aqueous matrix, published 4/24/2003. Kipp, James E.; Doty, Mark J.;
`Rebbeck, Christine L.; Brynjelsen, Sean; Teresa Konkel, Jamie.
`
`US Patent Application, US2003 0096013A1. Preparation of submicron sized particles with
`polymorph control, published 5/22/2003. Werling, Jane; Kipp, James E.; Sriram, Rajaram; Doty,
`Mark J.
`
`itraconazole, published
`US Patent Application, US2003 0100568A1. Polymorphic form of
`5/29/2003. Werling, Jane; Doty, Mark J.; Rebbeck, Christine L.; Wong, Joseph Chung Tak; Kipp,
`James E.
`
`US Patent Application, US2003 0206959. Method for preparing submicron particle suspensions,
`published 11/6/2003. Kipp, James E.; Wong, Joseph Chung Tak; Doty, Mark J.; Werling, Jane;
`Rebbeck, Christine L.; Brynjelsen, Sean.
`
`US Patent Application, US2003 0232887A1. Preparation and use of a stable formulation of
`allosteric effector compounds, published 12/18/2003. Johnson, Douglas Giles; Doty, Mark; Kipp,
`James E.
`
`US Patent Application, US2004 0022862A1. Method for preparing small particles, published
`2/5/2004. Kipp, James E.; Wong, Joseph Chung Tak; Doty, Mark J.; Werling, Jane; Rebbeck,
`Christine L.; Brynjelsen, Sean.
`
`US Patent Application, US2004 0266890A1. Methods and apparatuses for the comminution and
`stabilization of small particles, published 12/30/2004. Kipp, James E.; Wong, Joseph Chung Tak;
`Wisler, Monte; Garcia, Rhonda.
`
`US Patent Application, US2005 0013868A1. Preparation of submicron sized nanoparticles via
`dispersion lyophilization, published 1/20/2005. Brynjelsen, Sean; Doty, Mark; Kipp, James E.;
`Jayswal, Nailesh; Narayanan, Krishnaswamy.
`
`US Patent Application, US2005 00480