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CORE SKILLS
Instrumentation skills.
APIs/preformulation: X-ray diffraction; Raman spectroscopy; HPLC (potency, degradants, purity, linearity, accuracy, precision, LOQ, LOD) with detection via UV-Vis, fluorescence, and conductivity; content uniformity, dissolution/elution incl. sustained- and immediate release formulations, paddle wheel apparatus; forced degradation incl. gamma irradiation stability; moisture content from Karl-Fisher; salt forms; etc., etc. Colloids/interfaces/adsorption: Ellipsometry and optical response modeling including ultrathin films and multistack composites, DSC/TGA, fluorescence microscopy (both confocal and epifluorescence), adsorption of nanoparticles, as well as viruses and bacteria, as a function of surface treatment, light-scattering based particle sizing and zeta potential measurements and interpretation; drug elution from particulate formulations with paddle wheel apparatus; ultrafine particle production methods including micronization and high-pressure homogenization (“microfluidization”), electrospray nebulizers, condensation particle counters, differential mobility analyzers, impactors, etc. On an informal basis served as consultant to Beckman-Coulter in the evaluation of new particle sizing/zeta instruments.

Colloids/interfaces/adsorption: Ellipsometry and optical response modeling including ultrathin films and multistack composites, DSC/TGA, fluorescence microscopy (both confocal and epifluorescence), adsorption of nanoparticles, as well as viruses and bacteria, as a function of surface treatment, light-scattering based particle sizing and zeta potential measurements and interpretation; drug elution from particulate formulations with paddle wheel apparatus; ultrafine particle production methods including micronization and high-pressure homogenization (“microfluidization”), electrospray nebulizers, condensation particle counters, differential mobility analyzers, impactors, etc. On an informal basis served as consultant to Beckman-Coulter in the evaluation of new particle sizing/zeta instruments.

Nanotech/microporous materials: Extensive studies of nanostructured materials with small- and wideangle X-ray diffraction (SAXS, XRD), TEM, SEM, EDX, thermoporometry, polarizing and DIC optical microscopy, and high-resolution Raman spectroscopic confocal microscopy. The first to publish and patent isoporous polymers produced from lattice-ordered nanostructured liquid crystals, and application thereof in separations with characterization by porosimetry, enzyme ELISA and RIA assays, protein adsorption and absorption, and MW cut-off determinations; also developed functional housings for rapid UF in virus detection; employed sterile filtration (0.2 micron) in both solution and colloidal dispersion formulations, and in both cartridge and tangential-flow filtration (TFF) modes. Polymers: Seminal work in the polymerization of lipid- and terpenoid-based natural materials, as well as synthetics such as acrylates, styrenes, norbornenes, epoxies, lactones, crosslinkable polysiloxanes, etc.; polymerization methods included radical, autoxidative, e-beam, epoxide and ring-opening metathesis polymerizations, the latter through work in Robert Grubbs’ Caltech lab; decoration and post-treatments included membrane protein incorporation, conducting polymer formation within porespace, templating via electroless plating and mineralization; traditional processing methods such as screw-extrusion, coacervation, spray-drying, critical point drying, melt-blowing, 2-phase aqueous equilibria, and to a lesser extent spincoating and roll-coating. General: NMR, ICP, IR, UV-Vis, liquid chromatography (HPLC), electro/electroless plating, anodizing, etc. Short course certifications in rheology, DSC, XRD, and laser particle sizers.

Polymers: Seminal work in the polymerization of lipid- and terpenoid-based natural materials, as well as synthetics such as acrylates, styrenes, norbornenes, epoxies, lactones, crosslinkable polysiloxanes, etc.; polymerization methods included radical, autoxidative, e-beam, epoxide and ring-opening metathesis polymerizations, the latter through work in Robert Grubbs’ Caltech lab; decoration and post-treatments included membrane protein incorporation, conducting polymer formation within porespace, templating via electroless plating and mineralization; traditional processing methods such as screw-extrusion, coacervation, spray-drying, critical point drying, melt-blowing, 2-phase aqueous equilibria, and to a lesser extent spin-coating and roll-coating.

General: NMR, ICP, IR, UV-Vis, liquid chromatography (HPLC), electro/electroless plating, anodizing, etc. Short course certifications in rheology, DSC, XRD, and laser particle sizers.

Mathematics/modeling/computer skills: Strong mathematical, modeling, and computing skills, with implementation ranging from PC's to mainframes to supercomputers, including innovative state-of-art technical graphics. Sophisticated finite element analyses, including 3D graphics representations of solutions, supported by direct analytical calculations including published methods for a wide range of applied mathematics problems relating to nanostructured materials. Analytical and FEM solutions of flow patterns, diffusion profiles, scattering/diffraction phenomena, etc. Modeled structure-property relations in polymers. Modeling of thermodynamics, microstructures, spectroscopic and other measurements of complex structures.

Languages/programs used include FOTRAN, Unix, Mathematica, Excel, SEDFIT, ACDlabs, Aspen Plus, Design-Expert, and numerous instrument control/analysis software programs, etc., executed on laptops to mainframes to Cray supercomputers. Areas of particular expertise include: probability and statistics; differential geometry; analysis including differential forms; calculus of variations; solution of nonlinear differential equations; abstract algebra including Galois Theory; ensemble averaging; solution of nonlinear differential equations; number theory; Monte Carlo simulation including simulated annealing; FEM; spectral/Fourier analysis, etc. My modeling achievements in the field of liquid crystal nanostructures—including thermodynamic, microstructural, transport/diffusion, and scattering, spectral and TEM-ultrastructural—are known worldwide and have transformed the field from what had been semiquantitative at best, to, in many cases, what I have
transformed into fully quantitative.

Areas of particular expertise include: probability and statistics; differential geometry; analysis including differential forms; calculus of variations; solution of nonlinear differential equations; abstract algebra including Galois Theory; ensemble averaging; solution of nonlinear differential equations; number theory; Monte Carlo simulation including simulated annealing; FEM; spectral/Fourier analysis, etc.

Expert's modeling achievements in the field of liquid crystal nanostructures—including thermodynamic, microstructural, transport/diffusion, and scattering, spectral and TEM-ultrastructural—are known worldwide and have transformed the field from what had been semiquantitative at best, to, in many cases, what he has transformed into fully quantitative.

EXPERT WITNESS / DEPOSITION
- Expert witness (2016, ongoing) in a patentability dispute over the scope of U.S. Patent. Deposition recorded 2018.
- Expert witness (2016) in a patentability dispute over a formulation of bendamustine, centered around patent and chemistry issues.
- Expert witness in 2010 in litigation relevant to U.S. Patent.


SELECTIVE CONSULTING EXPERIENCE EXAMPLES:
Deep consultant on any investment due diligence, particularly any investment where a (re)-formulation is pivotal to success.
- Consultant and engineer for DuPont spin-off company producing specialty polymers and next-generation nonwoven polymer and composite fibers from novel, high-throughput, “green” processes incorporating sonic and supersonic fluid flows informed by combustion science. Product areas include medicated wound dressings; methods include polymer extrusion, spray-coating, melt-blown nanofiber spinning, polymer microencapsulation; authored patents.
- Training and consulting for PSI personnel in formulation and production of polymer/lipid nanoparticles of my invention for oral and injectable drug-delivery. Specific subject matter is proprietary.