Expert Details

Expert in Pharmaceuticals: Formulations, Injectables, Topicals, Analgesics, Pharmaceutical Analysis

Expert ID: 733385 Minnesota, USA

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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.

Education

Year Degree Subject Institution
Year: 1986 Degree: Ph.D. Subject: Chemical Engineering Institution: University of Minnesota
Year: Degree: Masters of Science Subject: Mathematics (Probability and Statistics) Institution: University of Minnesota

Work History

Years Employer Title Department Responsibilities
Years: to Present Employer: Undisclosed Title: Principal/ Owner/ Consultant Department: Responsibilities: Independent and collaborative work using his background in Pharmaceutical Formulations to reformulate cannabinoids, particularly CBD, hemp and cannabis oils, for improved efficacy and stability. Methods also include safe and cost-effective non-GMO manipulation of plant biosynthetic routes including the shikimic, polyphenol, terpenoid, elicitor, and cannabinoid pathways. Characterization includes HPLC and SFC (supercritical), colorimetry, microscopy, and panel evaluation.
Years: 2012 to Present Employer: Undisclosed Title: Co-founder, Consultant Department: Responsibilities: Technical— inventor and scientist in novel drug-delivery technologies including dermal, local, and transdermal delivery through articles of clothing and linens (e.g., antifungal-releasing socks, analgesicreleasing compression sleeves, etc.). Zero-order release kinetics follow from the structure of the yarn composing the textile, water-impermeable polymers and structural characteristics protect active components from release during laundering, and manufacturing conforms with standards in the textile industry. Lab develops production methodology and not only tech-transfers this to mills but also supports production-scale development, troubleshooting, and QA/QC. Related IP extends the drug-delivery approach to “depot” formulations. Instrumental in the raising of $3MM investor money as well as $900K/yr for three years from the U.S. Army and an additional $3MM in the works.
Years: 1999 to 2011 Employer: Lyotropic Therapeutics, Inc. Title: VP Technical Affairs Department: R&D Responsibilities: Technical—Led technical R&D from formulation conception through tech-transfer of product to licensing partner. Innovated a continuous stream of patent-protected D-D vehicles and processes for products with difficultly-soluble APIs, for injectable and ophthalmic routes, and drug-device combinations. Devised formulations as dispersions, solutions and lyophilized dosage forms incorporating proprietary colloidal liquid crystal solubilization technology, and novel peptide/protein-stabilizing formulations inhibiting degradative deamidation. Exploited expertise in DoE and data interpretation in analytical and stability program—microscopy (DIC, polarizing, epifluorescence), light scattering spectroscopy, HPLC for potency/ impurities/ degradants, and ELISAs were performed in-house, while Raman Confocal microscopy, rheometry, ellipsometry, SAXS, XRD, ICP and NMR were performed by myself through arrangements with outside labs. Designed novel coronary drug-eluting stents (DES) for linear release of endothelial health promoting APIs. Modeling, simulation and interpretation of NMR, UV-Vis spectroscopy, TEM, DSC, Raman confocal microscopy and sophisticated light and X-ray scattering experiment data, probing a range of phenomena and processes including chemical complexation, lipid self-assembly, solubilization, sedimentation, Ostwald ripening, diffusion, hydrolysis, adsorption, PK/PD, etc. Developed and comparison-tested formulations based on such materials as lipid nanoparticles, nanocrystals, emulsions, liposomes, cyclodextrins, micelles, microemulsions, cubosomes, polymer encapsulation, lyophilized powders, and resorbable hydrogels. Processed formulations using high-speed homogenization, microfluidization, lyophilization/freeze-drying, UF/TFF and sterile filtration, steam sterilization, gamma irradiation, centrifugation, sonication, coacervation, phase transformations, and to a lesser extent spray-drying, extrusion, chemical precipitation, interfacial reactions, and polymerization. Interfaced with raw materials suppliers and sourced excipients and APIs for GMP studies, including DMF open sections. Formulated small molecules through sale and tech transfer/CMC, as well as peptides, antibodies and siRNA’s. Wrote all patents and office action responses, and technical due diligence documents.

Managerial—In this entrepreneurial environment, managed a lab of 3-6 MS/PhD level scientists, reported directly to the CEO, and supervised internal project management as well as technical interfacing with outside collaborators and licensees. Once products were carried up the development curve to human/ animal in vivo testing with subsequent sale to industrial partners, spearheaded technical scale-up and transfer to CMO’s, and support of CMC preparation and NDA filings. Transferred products via on-site work at GMP sites, scale-up oversight, in-process QC development, equipment/vendor selection, etc.

Accomplishments:
• Ryanodex® Dantrolene Sodium Injectable Suspension hospital drug formulation (see www. Ryanodex.com), FDA-approved (NDA 205579) on July 22, 2014, marketed Q4 2014, revenues currently ~$10MM and rising.
• Double-digit royalty rate realized for core products → successful exit strategy.
• Led in the development and tech-transfer of both ANDA and 505(b)(2) products.
• Seven (7) international patents issued with expiration as late as 2028.
• Tech-transferred patents, methods and compositions to CRO for ongoing application.
Years: to Present Employer: Undisclosed Title: Department: Responsibilities: Startup venture, three people, precursor company to Lyotropic Therapeutics. Several thrusts including novel filtration/ separations materials, colloidal microencapsulation formulations, and defense contract work in bioanalytics/ aerobiology. Developed surfactant- and lipid-based formulations for personal care/cleaning, nutritional/nutriceutical, cosmetic/ cosmeceutical, OTC pharmaceutical, and food/ beverage products using my proprietary technology for solubilization of poorly-soluble actives. Actives encapsulated include capsaicin, Coenzyme Q10, vitamins, herbal extracts, benzoyl peroxide, bacteriostats, Photofrin, antibodies, and the N-acetylcholine receptor. Particular application areas included acne/skin treatment, dietary supplements, rodent deterrents, and also clinical diagnostics. Focus was on implementation of controlled-release / encapsulation. Additionally, work funded by the Army on the design of instrumentation for isolating and identifying viruses in environmental samples continued, resulting in the design and construction of novel ultrafiltration housings, and of aggregate systems incorporating UF, ultracentrifugation, and state-of-art aerosol characterization instruments. Work included the first reported detection and sizing of virus particles using aerosol methods.
Responsibilities: Performed all hands-on experimental work and oversight of research and development activities, analysis and report/proposal writing. Also provided input into strategic planning, intellectual property and contracting, and technology acquisition.
Accomplishments: Built the technology, patent base, and the funding and executive team that became Lyotropic Therapeutics. In particular, the pharmaceutical rights to the technology and employ were acquired by Lyotropics in 1999.
Years: to Present Employer: Undisclosed Title: Assistant Professor Department: Responsibilities: Responsibilities:
Teaching—Taught Biophysics, Biomaterials, and a post-graduate Polymer Chemistry course of my own design and implementation. Supervisor for two graduate students. Also taught summer course for inner-city high school students.
Research—Led a research group focused on the formation of nanoporous materials through the polymerization of lyotropic (lipid-based) liquid crystals, typically based on lipids with polyunsaturated and/or conjugated fatty acyl chains, with subsequent post-processing including electroplating at the nanostructured level. Advanced the application of these nanostructured polymers for bioseparations—ultrafiltration, chromatography, other bio- and immunoassays—and for encapsulation and superporous / superabsorbent hydrogels as well as biodegrable/bioresorbable polymer based depot formulations. Siloxanes (aliphatic and aromatic), acrylates, olefins, PUFAs, epoxides, polyesters, alkyd resins, gelatins and other gelling biomacromolecules, hydrogel polymers such as polyHEMA, etc., were all adapted to the proprietary liquid crystal polymerization technology pioneered in lab.
Accomplishments:
• Awarded SBIR grants from DoD and NIH, and the NSF/Industry Center for Biosurfaces.
• Implemented a graduate Polymers course with a particular emphasis on biomacromolecules.
• Graduated two Masters degree students.
• Contract research at the Army Edgewood Research Development and Engineering Command on detection of viral warfare threats resulted in U.S. patent, later sold.

Career Accomplishments

Associations / Societies
Member: American Association of Pharmaceutical Scientists (AAPS)
Member: American Chemical Society (ACS)
Awards / Recognition
OTHER AFFILIATIONS AND AWARDS
Graduation with high distinction Tau Beta Pi, Phi Kappa Phi
Runner-up in Niagara Frontier Inventor of the Year Award
Finalist in Richmond's New Technology of the Year
Runner-up in Swedish "Innovation Cup" invention contest (Dagens Industri)
Strathmore’s Who’s Who, Virginia Academy of Science, National Directory of Scientific Experts
Publications and Patents Summary
Publications: 18
Patents and Patent Applications: 15

Additional Experience

Expert Witness Experience
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.

Fields of Expertise

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