Hugh David Charles Smyth, Ph.D.
`Professor with Tenure
`Alcon Centennial Professor
`The University of Texas at Austin
`Curriculum Vitae
`
`Address: Division of Molecular Pharmaceutics and
`Drug Delivery
`University Avenue, PHR 4.214E
`1 University Station, A1920
`Austin, Texas 78712-0126
`
`Office phone:(512) 471 3383
`Office Fax: (512) 471 7474
`Email: hugh.smyth@austin.utexas.edu
`Website: https://site.utexas.edu/smyth/
`
`EDUCATION AND TRAINING
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`2001 – 2003
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`1998 – 2000
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`1997
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`1992 – 1995
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`University of North Carolina at Chapel Hill
`School of Pharmacy, Division of Drug Delivery and Deposition
`Post-Doctoral Fellow
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`University of Otago, Dunedin, New Zealand
`School of Pharmacy, Department of Pharmaceutical Sciences
`Doctor of Philosophy
`Thesis: Investigation of Electrically Assisted Drug Delivery in the Percutaneous
`Delivery of Peptides
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`University of Otago, Dunedin, New Zealand
`School of Pharmacy, Department of Pharmaceutical Sciences
`Post Graduate Diploma in Pharmaceutics (with Distinction)
`
`University of Otago, Dunedin, New Zealand
`School of Pharmacy, Department of Pharmaceutical Sciences
`Bachelor of Pharmacy
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`PROFESSIONAL APPOINTMENTS
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`PRIMARY APPOINTMENTS
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`2020 – Present
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`2018 – Present
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`2016 – 2020
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`2014 – 2016
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`2012 – 2014
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`The University of Texas at Austin, College of Pharmacy
`Alcon Centennial Professorship
`
`Full Professor
`The University of Texas at Austin, College of Pharmacy
`
`The University of Texas at Austin, College of Pharmacy
`Alan W Hamm Centennial Fellow in Pharmacy
`
`The University of Texas at Austin, College of Pharmacy
`Fellow to the Jaime N Delgado Endowed Professorship
`
`The University of Texas at Austin, College of Pharmacy,
`Bergen Brunswig Corporation Centennial Fellow
`
`Hugh D C Smyth, Ph.D. Curriculum Vitae
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`1
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1506-0001
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`2011 – Present
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`Associate Professor with Tenure
`The University of Texas at Austin
`College of Pharmacy, Division of Molecular Pharmaceutics
` and Drug Delivery
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`2009 – 2011
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`2005 – 2009
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`2004 – 2005
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`2016 – Present
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`2010 – 2021
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`2014 – 2022
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`2006 – Present
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`2006 – 2009
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`The University of Texas at Austin
`College of Pharmacy, Division of Pharmaceutics
`Assistant Professor
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`University of New Mexico
`Health Sciences Center, College of Pharmacy
`Assistant Professor
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`University of North Carolina at Chapel Hill
`School of Pharmacy, Division of Drug Delivery and Deposition
`Research Assistant Professor
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`Knox Pharmacy, Dunedin, New Zealand, Pharmacist
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`GlaxoWellcome, Research Triangle Park, Durham, NC.
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`Auckland Hospital, Auckland Healthcare, New Zealand, Pharmacist
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`Co-Founder and Chief Scientific Officer, Cloxero Therapeutics, Austin, TX.
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`Co-Founder, Via Therapeutics, Austin, TX (Start-up from technology developed
`in my lab)
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`2000
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`1998 – 1999
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`1996
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`ADJUNCT AND OTHER APPOINTMENTS
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`2020 – Present
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`2017 – Present
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`Consulting Chief Technology Officer, Nob Hill Therapeutics, San Diego, CA
`(Start-up from technology developed in my lab)
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`Consulting Chief Scientist, Respira Therapeutics, (Start-up from technology
`developed in my lab, now in clinical development)
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`Editor-in-Chief, Drug Development and Industrial Pharmacy.
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`Lovelace Respiratory Research Institute, Albuquerque, NM
`Adjunct Associate Scientist
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`University of New Mexico Cancer Research and Treatment Center
`Member
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`PROFESSIONAL SOCIETIES
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`2004 – 2016
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`2005 – 2008
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`2001 – 2005
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`International Society for Aerosols in Medicines
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`American Chemical Society
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`North Carolina Pharmaceutical Discussion Group
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`Hugh D C Smyth, Ph.D. Curriculum Vitae
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`2
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1506-0002
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`2001 – Present
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`American Association of Pharmaceutical Scientists Inhalation and Nasal
`Community (Previously named: Inhalation and Nasal Technology Focus
`Group)
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`1998 – Present
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`1997 – Present
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`1996 – 2004
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`PUBLICATIONS
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`PEER REVIEWED PAPERS (in reverse chronological order)
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`Professor, at The University of Texas at Austin
`(September 2018 – Present)
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`American Association of Pharmaceutical Scientists
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`Controlled Release Society
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`Member Pharmaceutical Society of New Zealand
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`1. Ren A, Koleng III JJ, Costello M, Spahn JE, Smyth HD, Zhang F. Twin-screw continuous
`mixing can produce dry powder inhalation mixtures for pulmonary delivery. Journal of
`Pharmaceutical Sciences. 2022 Oct 11.
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`2. Brunaugh AD, Walz A, Warnken Z, Pearce C, Munoz Gutierrez J, Koleng JJ, Smyth HD,
`Gonzalez-Juarrero M. Respirable Clofazimine Particles Produced by Air Jet Milling Technique
`Are Efficacious in Treatment of BALB/c Mice with Chronic Mycobacterium tuberculosis
`Infection. Antimicrobial Agents and Chemotherapy. 2022 Aug 9:e00186-22.
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`3. Hefnawy, A., Herpin, M.J., Easton, M., Joshi, S., Jordan, D., Smyth, H.D.C., Tarpy, J., Design
`Validation of a Smart Inhaler Device with an Integrated Spacer for Enhanced Aerosolization
`Performance. J Pharm Innov (2022). https://doi.org/10.1007/s12247-022-09673-7
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`4. Spahn JE, Hefnawy A, Smyth HD, Zhang F. Development of a novel method for the
`continuous blending of carrier-based dry powders for inhalation using a co-rotating twin-screw
`extruder. International Journal of Pharmaceutics. 2022 Jun 16:121914.
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`5. Spahn JE, Zhang F, Smyth HD. Mixing of dry powders for inhalation: A review. International
`Journal of Pharmaceutics. 2022 Apr 8:121736.
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`6. Trementozzi AN, Zhao C, Smyth H, Cui Z, Stachowiak JC. Gap Junction-Mediated Delivery of
`Polymeric Macromolecules. ACS Biomaterials Science & Engineering. 2022 Mar 10;8(4):1566-
`72.
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`7. Brunaugh AD, Ding L, Wu T, Schneider M, Khalaf R, Smyth HD. Identification of stability
`constraints in the particle engineering of an inhaled monoclonal antibody dried powder.
`Journal of Pharmaceutical Sciences. 2022 Feb 1;111(2):403-16.
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`Hugh D C Smyth, Ph.D. Curriculum Vitae
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`3
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1506-0003
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`8. Zhu Y, Gu Z, Liao Y, Li S, Xue Y, Firempong MA, Xu Y, Yu J, Smyth HD, Xu X. Improved
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`intestinal absorption and oral bioavailability of astaxanthin using poly (ethylene glycol)‐graft‐
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`chitosan nanoparticles: preparation, in vitro evaluation, and pharmacokinetics in rats. Journal
`of the Science of Food and Agriculture. 2022 Feb;102(3):1002-11.
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`9. Domínguez-Delgado CL, Akhtar Z, Awuah-Mensah G, Wu B, Smyth HD. Effects of Process
`and Formulation Parameters on Submicron Polymeric Particles Produced by a Rapid
`Emulsion-Diffusion Method. Nanomaterials. 2022 Jan 11;12(2):229.
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`10. Ding L, Brunaugh AD, Thakkar R, Lee C, Zhao QJ, Kalafat J, Maniruzzaman M, Smyth HD.
`Comparison of HPMC Inhalation-Grade Capsules and Their Effect on Aerosol Performance
`Using Budesonide and Rifampicin DPI Formulations. AAPS PharmSciTech. 2022 Jan;23(1):1-
`3.
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`11. Ceschan NE, Montoto SS, Sbaraglini ML, Ruiz ME, Smyth HD, Bucalá V, Ramírez-Rigo MV.
`Nebulization of a polyelectrolyte-drug system for systemic hypertension treatment. European
`Journal of Pharmaceutical Sciences. 2021 Dec 26:106108.
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`12. Ding L, Cai S, Wang J, Smyth H. 481: PEGylated tobramycin significantly improves anti-biofilm
`activity in vitro and in vivo. Journal of Cystic Fibrosis. 2021 Nov 1;20:S226-8.
`
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`13. Arafa KK, Smyth HD, El-Sherbiny IM. Mitotropic triphenylphosphonium doxorubicin-loaded
`core-shell nanoparticles for cellular and mitochondrial sequential targeting of breast cancer.
`International Journal of Pharmaceutics. 2021 Sep 5;606:120936.
`
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`14. Brunaugh AD, Ding L, Wu T, Schneider M, Khalaf R, Smyth HD. Identification of Stability
`Constraints in the Particle Engineering of an Inhaled Monoclonal Antibody Dried Powder.
`Journal of Pharmaceutical Sciences. 2021 Aug 26.
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`15. Zhu Y, Gu Z, Liao Y, Li S, Xue Y, Firempong MA, Xu Y, Yu J, Smyth HD, Xu X. Improved
`
`intestinal absorption and oral bioavailability of astaxanthin using poly (ethylene glycol)‐graft‐
`
`chitosan nanoparticles: preparation, in vitro evaluation, and pharmacokinetics in rats. Journal
`of the Science of Food and Agriculture. 2021 Aug 13.
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`16. Zhang H, Zhang Y, Williams III RO, Smyth HD. Development of PEGylated chitosan/CRISPR-
`Cas9 dry powders for pulmonary delivery via thin-film freeze-drying. International Journal of
`Pharmaceutics. 2021 Aug 10;605:120831.
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`17. Ding L, Brunaugh AD, Stegemann S, Jermain SV, Herpin MJ, Kalafat J, Smyth HD. A Quality
`by Design Framework for Capsule-Based Dry Powder Inhalers. Pharmaceutics. 2021
`Aug;13(8):1213.
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`Hugh D C Smyth, Ph.D. Curriculum Vitae
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`4
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1506-0004
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`18. Hall MD, Anderson JM, Anderson A, Baker D, Bradner J, Brimacombe KR, Campbell EA,
`Corbett KS, Carter K, Cherry S, Chiang L, omas Cihlar, Emmie de Wit, Mark Denison,
`Matthew Disney, Courtney V Fletcher, Stephanie L Ford-Scheimer, Matthias Götte, Abigail C
`Grossman, Frederick G Hayden, Daria J Hazuda, Charlotte A Lanteri, Hilary Marston, Andrew
`D Mesecar, Stephanie Moore, Jennifer O Nwankwo, Jules O’Rear, George Painter, Kumar
`Singh Saikatendu, Celia A Schiffer, Timothy P Sheahan, Pei-Yong Shi, Hugh D Smyth,
`Michael J Sofia, Marla Weetall, Sandra K Weller, Richard Whitley, Anthony S Fauci,
`Christopher P Austin, Francis S Collins, Anthony J Conley, Mindy I Davis. Report of the
`National Institutes of Health SARS-CoV-2 Antiviral Therapeutics Summit. The Journal of
`Infectious Diseases. 2021 Jun 10.
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`19. Hewavitharana, Amitha K., Shaw, P. Nicholas, Smyth, H. D.C., Samaranayake, L. P., and
`Bandara, H. M.H.N. (2021). The importance of complete overlapping of analyte and internal
`standard peaks in eliminating matrix effects with liquid chromatography–mass spectrometry
`(Lc–ms). LC-GC North America 39 (7) 335-338..
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`20. Ding L, Wang J, Cai S, Smyth H, Cui Z. Pulmonary Biofilm-Based Chronic Infections and
`Inhaled Treatment Strategies. International Journal of Pharmaceutics. 2021 Jun 3;604:120768.
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`21. Wang JL, Hanafy MS, Xu H, Leal J, Zhai Y, Ghosh D, Williams Iii RO, Smyth HD, Cui Z.
`Aerosolizable siRNA-encapsulated solid lipid nanoparticles prepared by thin-film freeze-drying
`for potential pulmonary delivery. International Journal of Pharmaceutics. 2021 Mar
`1;596:120215.
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`22. Brunaugh AD, Sharma S, Smyth H. Inhaled fixed-dose combination powders for the treatment
`of respiratory infections. Expert Opinion on Drug Delivery. 2021 Feb 27:1-5.
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`23. Brunaugh AD, Seo H, Warnken Z, Ding L, Seo SH, Smyth HD. Development and evaluation of
`inhalable composite niclosamide-lysozyme particles: A broad-spectrum, patient-adaptable
`treatment for coronavirus infections and sequalae. PloS one. 2021 Feb 11;16(2):e0246803.
`
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`24. Shah SM, Shah SM, Khan S, Ullah F, Shah SW, Ghias M, Shahid M, Smyth HD, Hussain Z,
`Sohail M, Elhissi A. Efficient design to fabricate smart Lumefantrine nanocrystals using
`DENA® particle engineering technology: Characterisation, in vitro and in vivo antimalarial
`evaluation and assessment of acute and sub-acute toxicity. Journal of Drug Delivery Science
`and Technology. 2021 Feb 1;61:102228.
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`25. Armijo LM, Wawrzyniec SJ, Kopciuch M, Brandt YI, Rivera AC, Withers NJ, Cook NC, Huber
`DL, Monson TC, Smyth HD, Osiński M. Antibacterial activity of iron oxide, iron nitride, and
`tobramycin conjugated nanoparticles against Pseudomonas aeruginosa biofilms. Journal of
`nanobiotechnology. 2020 Dec;18(1):1-27.
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`26. Anzueto A, Smyth HD. Letter to the Editor in response to the article:“Nebulization: A potential
`source of SARS-CoV-2 transmission”. Respiratory Medicine and Research. 2020 Nov 17.
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`Hugh D C Smyth, Ph.D. Curriculum Vitae
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`5
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1506-0005
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`27. Zhang H, Leal J, Soto MR, Smyth HD, Ghosh D. Aerosolizable Lipid Nanoparticles for
`Pulmonary Delivery of mRNA through Design of Experiments. Pharmaceutics. 2020
`Nov;12(11):1042.
`
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`28. Brunaugh AD, Seo H, Warnken Z, Ding L, Seo SH, Smyth HD. Broad-spectrum, patient-
`adaptable inhaled niclosamide-lysozyme particles are efficacious against coronaviruses in
`lethal murine infection models. bioRxiv. 2020 September.
`
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`29. Andrea N. Trementozzi, Stephanie Hufnagel, Haiyue Xu, Mahmoud S. Hanafy, Felipe Rosero
`Castro, Hugh D.C. Smyth, Zhengrong Cui, and Jeanne C. Stachowiak, Gap Junction
`Liposomes for Efficient Delivery of Chemotherapeutics to Solid Tumors ACS Biomaterials
`Science & Engineering 2020 6 (9), 4851-4857, DOI: 10.1021/acsbiomaterials.0c01047
`
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`30. Xu H, Alzhrani RF, Warnken ZN, Thakkar SG, Zeng M, Smyth HD, Williams III RO, Cui Z.
`Immunogenicity of Antigen Adjuvanted with AS04 and Its Deposition in the Upper Respiratory
`Tract after Intranasal Administration. Molecular Pharmaceutics. 2020 Aug 10;17(9):3259-69.
`
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`31. Armijo LM, Wawrzyniec SJ, Kopciuch M, Brandt YI, Rivera AC, Withers NJ, Cook NC, Huber
`DL, Monson TC, Smyth HD, Osiński M. Antibacterial activity of iron oxide, iron nitride, and
`tobramycin conjugated nanoparticles against Pseudomonas aeruginosa biofilms. Journal of
`Nanobiotechnology. 2020 Dec;18(1):1-27.
`
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`32. Davis DA, Martins PP, Zamloot MS, Kucera SA, WilliamsIII RO, Smyth HD, Warnken ZN.
`Complex Drug Delivery Systems: Controlling Transdermal Permeation Rates with Multiple
`Active Pharmaceutical Ingredients. AAPS PharmSciTech. 2020 Jun 4;21:165.
`
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`33. Tewes F, Bahamondez-Canas TF, Moraga-Espinoza D, Smyth HD, Watts AB. In vivo Efficacy
`of a Dry Powder Formulation of Ciprofloxacin-Copper Complex in a Chronic Lung Infection
`Model of Bioluminescent Pseudomonas aeruginosa. European Journal of Pharmaceutics and
`Biopharmaceutics. 2020 May 20.
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`34. Sahakijpijarn S, Smyth HD, Miller DP, Weers JG. Post-inhalation cough with therapeutic
`aerosols: Formulation considerations. Advanced Drug Delivery Reviews. 2020 May 14.
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`35. Leal J, Peng X, Liu X, Arasappan D, Wylie DC, Schwartz SH, Fullmer JJ, McWilliams BC,
`Smyth HD, Ghosh D. Peptides as surface coatings of nanoparticles that penetrate human
`cystic fibrosis sputum and uniformly distribute in vivo following pulmonary delivery. Journal of
`Controlled Release. 2020 Mar 31.
`
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`36. Bandara HM, Hewavitharana AK, Shaw PN, Smyth HD, Samaranayake LP. A novel, quorum
`sensor-infused liposomal drug delivery system suppresses Candida albicans biofilms.
`International Journal of Pharmaceutics. 2020 Mar 30;578:119096.
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`Hugh D C Smyth, Ph.D. Curriculum Vitae
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`6
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1506-0006
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`37. Gu J, Clegg JR, Heersema LA, Peppas NA, Smyth HD. Optimization of Cationic Nanogel
`PEGylation to Achieve Mammalian Cytocompatibility with Limited Loss of Gram-Negative
`Bactericidal Activity. Biomacromolecules. 2020 Mar 24;21(4):1528-38.
`
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`38. Zhang X, Yue X, Cui Y, Zhao Z, Huang Y, Cai S, Wang G, Wang W, Hugh S, Pan X, Wu C. A
`Systematic Safety Evaluation of Nano-porous Mannitol Material as a Dry Powder Inhalation
`Carrier System. Journal of Pharmaceutical Sciences. 2020 Jan 24.
`
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`39. Jasmim Leal, Tony Dong, Feng Gao, Melissa Soto, Hugh D.C. Smyth, Debadyuti Ghosh, M13
`phage display to identify a permeating peptide against hyperconcentrated mucin, bioRxiv
`659573; doi: https://doi.org/10.1101/659573 (Pre-print)
`
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`40. Smyth HD, Koleng J, Brunaugh AD. Inhaled Delivery of Clofazimine – A High Efficiency, Flow
`Independent, Cellular-Targeted System for Mycobacterial Infections Respiratory Drug Delivery
`2020. Volume 1, 2020: 35-46
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`41. Jasmim Leal, Xinquan Liu, Xiujuan Peng, Rashmi P. Mohanty, Dhivya Arasappan, Dennis
`Wylie, Sarah H. Schwartz, Jason J. Fullmer, Bennie C. McWilliams, Hugh D. C. Smyth,
`Debadyuti Ghosh, A combinatorial biomolecular strategy to identify peptides for improved
`transport across the sputum of cystic fibrosis patients and the underlying epithelia, bioRxiv
`659540; doi: https://doi.org/10.1101/659540 (Pre-print)
`
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`42. AD Brunaugh, T Wu, SR Kanapuram, HDC Smyth, Effect of Particle Formation Process on
`Characteristics and Aerosol Performance of Respirable Protein Powders, Molecular
`Pharmaceutics (2019) 16(10) p 4165-4180
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`43. Patricia P. Martins, Hugh D.C. Smyth, Zhengrong Cui, Strategies to facilitate or block nose-to-
`brain drug delivery, International Journal of Pharmaceutics, Volume 570, 2019, 118635, ISSN
`0378-5173, https://doi.org/10.1016/j.ijpharm.2019.118635.
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`44. Kuehl, P.J., Smyth, H.D., Stein, S.W. et al. In Memoriam: Dr. Paul B. Myrdal
`
`AAPS PharmSciTech (2019) 20: 211. https://doi.org/10.1208/s12249-019-1430-z
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`45. Tewes, F., Bahamondez-Canas, T.F. & Smyth, H.D.C. Efficacy of Ciprofloxacin and Its Copper
`Complex against Pseudomonas aeruginosa Biofilms, AAPS PharmSciTech (2019) 20: 205.
`https://doi.org/10.1208/s12249-019-1417-9
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`46. Patricia P. Martins, Arnold D. Estrada, Hugh D.C. Smyth, A human skin high-throughput
`formulation screening method using a model hydrophilic drug, International Journal of
`Pharmaceutics, Volume 565, 2019, Pages 557-568, ISSN 0378-5173,
`https://doi.org/10.1016/j.ijpharm.2019.05.044.
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`Hugh D C Smyth, Ph.D. Curriculum Vitae
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`7
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1506-0007
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`47. Bahamondez-Canas, T.F.; Heersema, L.A.; Smyth, H.D.C. Current Status of In Vitro Models
`and Assays for Susceptibility Testing for Wound Biofilm Infections. Biomedicines 2019, 7, 34.
`
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`48. Heersema, L.A.; Smyth, H.D.C. A Multispecies Biofilm In Vitro Screening Model of Dental
`Caries for High-Throughput Susceptibility Testing. High-Throughput 2019, 8, 14.
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`49. Mohadeseh Hashemi, Javad Mohammadi, Meisam Omidi, Hugh D.C. Smyth, Bharadwaj
`Muralidharan, Thomas E. Milner, Amir Yadegari, Davoud Ahmadvand, Mohammad Shalbaf,
`Lobat Tayebi, Self-assembling of graphene oxide on carbon quantum dot loaded liposomes,
`Materials Science and Engineering: C, Volume 103, 2019,109860, ISSN 0928-4931,
`https://doi.org/10.1016/j.msec.2019.109860.
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`50. Moon C, Smyth HDC, Watts AB, Williams RO 3rd. Delivery Technologies for Orally Inhaled
`Products: an Update. AAPS PharmSciTech. 2019 Feb 19;20(3):117. Doi:10.1208/s12249-019-
`1314-2. PubMed PMID: 30783904.
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`51. Brunaugh A, Smyth HDC. Process optimization and particle engineering of micronized drug
`powders via milling. Drug Deliv Transl Res. 2018 Dec;8(6):1740-1750. Doi: 10.1007/s13346-
`017-0444-x. Review. PubMed PMID: 29134556.
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`52. Nazareth Eliana Ceschan, Verónica Bucalá, Melina Valeria Mateos, Hugh David Charles
`Smyth, María Verónica Ramírez-Rigo, Carrier free indomethacin microparticles for dry powder
`inhalation, International Journal of Pharmaceutics, Volume 549, Issues 1–2, 2018, Pages 169-
`178, ISSN 0378-5173, https://doi.org/10.1016/j.ijpharm.2018.07.065.
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`53. Silvia Ferrati, Tian Wu, Sekhar R. Kanapuram, Hugh D.C. Smyth, Dosing considerations for
`inhaled biologics, International Journal of Pharmaceutics, Volume 549, Issues 1–2, 2018,
`Pages 58-66, ISSN 0378-5173, https://doi.org/10.1016/j.ijpharm.2018.07.054.
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`54. Jasmim Leal, Tony Dong, Amber Taylor, Emily Siegrist, Feng Gao, Hugh D.C. Smyth,
`Debadyuti Ghosh, Mucus-penetrating phage-displayed peptides for improved transport across
`a mucus-like model, International Journal of Pharmaceutics, Volume 553, Issues 1–2, 2018,
`Pages 57-64, ISSN 0378-5173, https://doi.org/10.1016/j.ijpharm.2018.09.055.
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`55. Hairui Zhang, Tania F. Bahamondez-Canas, Yajie Zhang, Jasmim Leal, and Hugh D.C. Smyth
`PEGylated Chitosan for Nonviral Aerosol and Mucosal Delivery of the CRISPR/Cas9 System
`in Vitro, Molecular Pharmaceutics Article ASAP, DOI: 10.1021/acs.molpharmaceut.8b00434
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`56. Moraga-Espinoza, D.F., Eshaghian, E., Shaver, A, Hugh D. C. Smyth, Effect of Inhalation Flow
`Rate on Mass-Based Plume Geometry of Commercially Available Suspension pMDIs AAPS J
`(2018) 20: 84. https://doi.org/10.1208/s12248-018-0241-6
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`Hugh D C Smyth, Ph.D. Curriculum Vitae
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`8
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1506-0008
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`57. Mohadeseh Hashemi; Bharadwaj Muralidharan; Meisam Omidi; Javad Mohammadi; Yahya
`Sefidbakht; Eun Song Kim; Hugh D. C. Smyth; Mohammad Shalbaf; Thomas E. Milner, Effect
`of size and chemical composition of graphene oxide nanoparticles on optical absorption cross-
`section, J. of Biomedical Optics, 23(8), 085007 (2018).
`https://doi.org/10.1117/1.JBO.23.8.085007
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`58. Brunaugh AD, Smyth HDC. Formulation techniques for high dose dry powders. Int J Pharm.
`2018, 17;547(1-2):489-498. Doi: 10.1016/j.ijpharm.2018.05.036.
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`Associate Professor with Tenure at The University of Texas at Austin
`– Aug 2018)
`(2011
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`59. Herpin MJ, Ebi D, Clemens NT, Smyth HDC. Production and characterization of drug-loaded
`toroidal vortices from a novel ocular drug delivery device. Drug Deliv Transl Res. 2018 Jul 2.
`Doi: 10.1007/s13346-018-0553-1.
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`60. Moraga-Espinoza D, Warnken Z, Moore A, Williams RO 3rd, D C Smyth H. An Modified USP
`Induction Port To Characterize Nasal Spray Plume Geometry And Predict Turbinate
`Deposition Under Flow. Int J Pharm. 2018 Jun 27. Pii:nS0378-5173(18)30458-7. Doi:
`10.1016/j.ijpharm.2018.06.058.
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`61. Takabe H, Warnken ZN, Zhang Y, Davis DA, Smyth HDC, Kuhn JG, Weitman S, Williams Iii
`RO. A Repurposed Drug for Brain Cancer: Enhanced Atovaquone Amorphous Solid
`Dispersion by Combining a Spontaneously Emulsifying Component with a Polymer Carrier.
`Pharmaceutics. 2018 May 19;10(2). Pii: E60. Doi:10.3390/pharmaceutics10020060
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`62. Tania F. Bahamondez-Canas, Silvia Ferrati, Daniel F. Moraga-Espinoza, Hugh D.C. Smyth,
`Development, characterization, and in vitro testing of co-delivered antimicrobial dry powder
`formulation for the treatment of Pseudomonas aeruginosa biofilms, Journal of Pharmaceutical
`Sciences , Accepted 2018
`
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`63. Xu Liu, Mingshuang Li, Hugh Smyth, Feng Zhang, Otic Drug Delivery Systems: Formulation
`Principles and Recent Developments, Drug development and industrial pharmacy, Accepted
`2018
`
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`64. Daniel Moraga-Espinoza, Eli Eshaghian, Hugh D.C. Smyth, Mass Median Plume Angle: A
`novel approach to characterize plume geometry in solution based pMDIs, International
`Journal of Pharmaceutics, Volume 543, Issues 1–2, 2018, Pages 376-385,
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`65. Tania F. Bahamondez-Canas, Hairui Zhang, Frederic Tewes, Jasmim Leal, and Hugh D.C.
`Smyth Molecular Pharmaceutics, PEGylation of Tobramycin Improves Mucus Penetration and
`Antimicrobial Activity against Pseudomonas aeruginosa Biofilms in Vitro, Article ASAP, DOI:
`10.1021/acs.molpharmaceut.8b00011
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`Hugh D C Smyth, Ph.D. Curriculum Vitae
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1506-0009
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`66. Zachary N. Warnken, Hugh D.C. Smyth, Daniel A. Davis, Steve Weitman, John G. Kuhn,
`and Robert O. Williams, III, Personalized Medicine in Nasal Delivery: The Use of Patient-
`Specific Administration Parameters To Improve Nasal Drug Targeting Using 3D-Printed Nasal
`Replica Casts Molecular Pharmaceutics Article ASAP DOI:
`10.1021/acs.molpharmaceut.7b00702
`
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`67. Ferrati, S., Wu, T., Fuentes, O., Brunaugh AD., Kanapuram SR., Smyth, HDC., Influence of
`Formulation Factors on the Aerosol Performance and Stability of Lysozyme Powders: a
`Systematic Approach, AAPS PharmSciTech (2018). https://doi.org/10.1208/s12249-018-
`0980-9
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`68. Bahamondez-Canas T. and Smyth HDC. Influence of excipients on the antimicrobial activity
`of tobramycin against Pseudomonas aeruginosa biofilms. Pharmaceutical Research.
`Accepted (Manuscript ID: PHAM-D-17-00484)
`
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`69. Herpin, M.J. & Smyth, H.D.C. Super-heated aqueous particle engineering (SHAPE): a novel
`method for the micronization of poorly water soluble drugs, Journal of Pharmaceutical
`Investigation (2017). https://doi.org/10.1007/s40005-017-0368-y
`
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`70. Brunaugh, A. & Smyth, H.D.C., Process optimization and particle engineering of micronized
`drug powders via milling Drug Deliv. And Transl. Res. (2017).
`https://doi.org/10.1007/s13346-017-0444-x
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`71. Smyth Hugh D., Colthorpe Paul, George Maureen, Jansen Paul, Fuglsang Anders, Armstrong
`Katherine E., and Lyapustina Svetlana., Highlights from the 2017 IPAC-RS/ISAM Joint
`Workshop “New Frontiers in Inhalation Technology” Journal of Aerosol Medicine and
`Pulmonary Drug Delivery. November 2017, ahead of print.
`https://doi.org/10.1089/jamp.2017.1425
`
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`72. Mohadeseh Hashemi; Meisam Omidi; Bharadwaj Muralidharan; Lobat Tayebi ; Matt Herpin;
`Mohammad Ali Mohagheghi ; Hugh D Smyth ; Thomas E Milner, Javad Mohammadi, Layer-
`by-layer assembly of graphene oxide on thermosensitive liposomes for photo-chemotherapy,
`Acta Biomaterialia, Accepted.
`
`
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`73. Mohadeseh Hashemi, Meisam Omidi, Bharadwaj Muralidharan, Hugh Smyth, Mohammad A.
`Mohagheghi, Javad Mohammadi, and Thomas E. Milner, Evaluation of the Photothermal
`Properties of a Reduced Graphene Oxide/Arginine Nanostructure for Near-Infrared
`Absorption, ACS Applied Materials & Interfaces 2017 9 (38), 32607-32620 DOI:
`10.1021/acsami.7b11291
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`74. Ashlee D. Brunaugh, Syed Umer Jan, Silvia Ferrati, and Hugh D. C. Smyth, Excipient-Free
`Pulmonary Delivery and Macrophage Targeting of Clofazimine via Air Jet Micronization,
`Molecular Pharmaceutics, DOI: 10.1021/acs.molpharmaceut.7b00690
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`Hugh D C Smyth, Ph.D. Curriculum Vitae
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1506-0010
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`75. Jasmim Leal, Hugh D.C. Smyth, Debadyuti Ghosh, Physicochemical properties of mucus and
`their impact on transmucosal drug delivery, In International Journal of Pharmaceutics, Volume
`532, Issue 1, 2017, Pages 555-572, ISSN 0378-5173,
`https://doi.org/10.1016/j.ijpharm.2017.09.018.
`
`
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`76. Gadok A., Zhao C., Meriwether A., Rowley T. G., Ferrati S., Smyth H. D. C., Stachowiak J*.
`Display of Single-Domain Antibodies on the Surfaces of Connectosomes Promotes Efficient
`and Specific Drug Delivery Through Gap Junctions, Biochemistry 2017, Accepted
`(Manuscript ID: bi-2017-00688n).
`
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`77. Ferrati S, Gadok AK, Brunaugh AD, Zhao C, Heersema LA, Smyth HD, Stachowiak JC*.
`Connexin membrane materials as potent inhibitors of breast cancer cell migration. J R Soc
`Interface. 2017 Aug; 14 (133).
`
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`78. Herpin J. M., Smyth HD*. Precision Ocular Drug Delivery via Aerosol Ring Vortices. Pharm.
`Res. 2017 Aug 7
`
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`79. Javier O. Morales*, Kristin R. Fathe, Ashlee Brunaugh, Silvia Ferrati, Song Li, Miguel
`Montenegro-Nicolini, Jason T. McConville, Mark R. Prausnitz, Hugh D.C. Smyth*. Challenges
`and Future Prospects for the Delivery of Biologics: Oral Mucosal, Pulmonary, and Transdermal
`Routes, AAPS Journal, Accepted.
`
`
`80. Yin* J, Bovet J, Smyth HD, Clark AR, Hannon J, An Add-on to a Dry Powder Inhaler Device
`that Can Improve Dose Delivery to the Lungs, RDD Europe 2017. Volume 2, 2017: 185-188.
`
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`81. Xin Hua, Wanjiang Zhang, Zhimin Dong, Jiashuo Zhang, Shengnan Tan & Hugh Smyth*
`Magnetically Triggered Drug Release from Nanoparticles and Its Applications in Anti-Tumor
`Treatment, Drug Delivery, Accepted, DOI:10.1080/10717544.2016.1256001
`
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`82. Gema Alas ; Ronald E. Pagano ; Jane Q. Nguyen ; H. M. H. Nihal Bandara ; Sergei A. Ivanov ;
`Gennady A. Smolyakov ; Dale L. Huber ; Hugh D. C. Smyth ; Marek Osiński*; Effects of iron-
`oxide nanoparticles and magnetic fields on oral biofilms. Proc. SPIE 10078, Colloidal
`Nanoparticles for Biomedical Applications XII, 1007806 (February 22, 2017);
`doi:10.1117/12.2256221.
`
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`83. Ashkan K. Yazdi, Hugh D.C. Smyth*, Implementation of design of experiments approach for
`the micronization of a drug with a high brittle–ductile transition particle diameter, Drug
`Development and Industrial Pharmacy, Accepted, Published online: 14 Nov 2016
`
`
`84. Smyth HD*, Heersema LA, Moon C, Watts AB, Williams III RO, Amorphous or Crystalline?
`Evaluating Particle Engineering Approaches for Inhalation Products, RDD Asia 2016. Volume
`1, 2016: 163-176.
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`Hugh D C Smyth, Ph.D. Curriculum Vitae
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1506-0011
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`85. Nazareth Eliana Ceschan, Verónica Bucalá, María Verónica Ramírez-Rigo*, Hugh David
`Charles Smyth. Impact of feed counterion addition and cyclone type on aerodynamic
`behavior of alginic-atenolol microparticles produced by spray drying, European Journal of
`Pharmaceutics and Biopharmaceutics, Volume 109, December 2016, Pages 72-80, ISSN
`0939-6411, http://dx.doi.org/10.1016/j.ejpb.2016.09.020.
`
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`86. Avinash K Gadok, David J Busch, Silvia Ferrati, Brian Li, H.D.C. Smyth, and Jeanne C
`Stachowiak*, 
Connectosomes for Direct Molecular Delivery to the Cellular Cytoplasm

`Journal of the American Chemical Society, Accepted, September 2016 
DOI:
`10.1021/jacs.6b05191
`
`
`87. Ping Du, Ju Du, Hugh D. C. Smyth* Evaluation of Granulated Lactose as a Carrier for Dry
`Powder Inhaler (DPI) Formulations 2: Drugs and Drug Loading, Journal of Pharmaceutical
`Sciences, Accepted. August 31, 2016
`
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`88. Francesca Buttini , James Hannon, Kristi Saavedra, Irene Rossi, Anna Giulia Balducci, Hugh
`Smyth, Andy Clark, Paolo Colombo*. Accessorized DPI: a shortcut towards flexibility and
`patient adaptability in dry powder inhalation. Pharmaceutical Research. Accepted, August 16,
`2016
`
`
`89. Zachary N. Warnken, Hugh D.C. Smyth*, Alan B. Watts, Steve Weitman, John G. Kuhn,
`Robert O. Williams III*, Formulation and device design to increase nose to brain drug delivery,
`Journal of Drug Delivery Science and Technology, Volume 35, October 2016, Pages 213-222,
`ISSN 1773-2247, http://dx.doi.org/10.1016/j.jddst.2016.05.003.
`
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`90. H. M. H. N. Bandara, M. J. Herpin, D. Kolacny, Jr., A. Harb, D. Romanovicz, and H. D. C.
`Smyth*, Incorporation of Farnesol Significantly Increases the Efficacy of Liposomal
`Ciprofloxacin against Pseudomonas aeruginosa Biofilms in Vitro, Molecular
`Pharmaceutics Article ASAP, DOI: 10.1021/acs.molpharmaceut.6b00360
`
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`91. J Kaushik KS, Stolhandske J, Shindell O, Smyth HDC, Gordon VD* (2016) Tobramycin and
`bicarbonate synergise to kill planktonic Pseudomonas aeruginosa, but antagonize to promote
`biofilm survival. Biofilms and Microbiomes. 2: 16006.
`
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`92. Justin S. LaFountaine, Kristin Fathe, Hugh D.C. Smyth*, Delivery and therapeutic applications
`of gene editing technologies ZFNs, TALENs, and CRISPR/Cas9, International Journal of
`Pharmaceutics 494(1): 180-194.
`
`
`93. Ashkan K. Yazdi, Hugh D.C. Smyth*, Carrier-free high-dose dry powder inhaler formulation of
`ibuprofen: Physicochemical characterization and in vitro aerodynamic performance,
`International Journal of Pharmaceutics, Available online 24 June 2016, ISSN 0378-5173,
`http://dx.doi.org/10.1016/j.ijpharm.2016.06.061.
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`Hugh D C Smyth, Ph.D. Curriculum Vitae
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1506-0012
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`94. Fathe, Kristin; Ferrati, Silvia; Moraga-Espinoza, Daniel; Yazdi, Ashkan; D.C. Smyth, Hugh*,
`Inhaled Biologics: From Preclinical to Product Approval, Current Pharmaceutical Design,
`Volume 22, Number 17, May 2016, pp. 2501-2521(21)
`
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`95. Hannon J, Donovan M, Gibbons A, Xu Z, Curtis R, Smyth HD*, Clark AR, Novel High
`Efficiency Inhaler for PDE5i Lung Delivery, Respiratory Drug Delivery 2016. Volume 3, 2016:
`519-522.
`
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`96. Leena Kumari Prasad*, Hugh Smyth, 3D Printing technologies for drug delivery: a review,
`Drug Development and Industrial Pharmacy, Vol. 42, Iss. 7, 2016
`
`
`97. Ashkan K. Yazdi*, Hugh D.C. Smyth, Hollow crystalline straws of diclofenac for high-dose and
`carrier-free dry powder inhaler formulations, International Journal of Pharmaceutics, Volume
`502, Issues 1–2, 11 April 2016, Pages 170-180, ISSN 0378-5173,
`http://dx.doi.org/10.1016/j.ijpharm.2016.02.030.
`
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`98. Thakkar SG, Fathe K, Smyth HD*. Amorphous or crystalline? A comparison of particle
`engineering methods and selection. Curr Pharm Des. 2015 Oct . PMID: 26446464.
`
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`99. H.M.H.N. Bandara , D. Nguyen , S. Mogarala , M. Osiñski , H.D.C. Smyth*, Magnetic fields
`suppress Pseudomonas aeruginosa biofilms and enhance ciprofloxacin activity, Biofouling Vol.
`31, Iss. 5, 2015
`
`
`Ju Du, H. M. H. N. Bandara, Ping Du, Hui Huang, Khang Hoang, Dang Nguyen, Sri
`100.
`Vasudha Mogarala, and Hugh D. C. Smyth*, Improved Biofilm Antimicrobial Activity of
`Polyethylene Glycol Conjugated Tobramycin Compared to Tobramycin in Pseudomonas
`aeruginosa Biofilms, Molecular Pharmaceutics 2015 12 (5), 1544-1553, DOI:
`10.1021/mp500846u
`
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`Leisha M. Armijo ; Priyanka Jain ; Angelina Malagodi ; F. Zuly Fornelli ; Allison Hayat ;
`101.
`Antonio C. Rivera ; Michael Fre