Hugh Smyth, Ph.D.
`
`Curriculum Vitae
`
`Hugh David Charles Smyth, Ph.D.,
`Delgado Endowed Professorship,
`Associate Professor with Tenure, UT-Austin.
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`The University of Texas at Austin
`College of Pharmacy
`Division of Pharmaceutics
`University Avenue, PHR 4.214E
`1 University Station, A1920
`Austin, Texas 78712-0126
`Tel (512) 471 3383
`Fax: (512) 471 7474
`Email: hsmyth@mail.utexas.edu
`
`B.Pharm., Ph.D.
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`NAME/TITLE
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`ADDRESS
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`DEGREES
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`PRIMARY APPOINTMENTS
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`2011 – Present
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`The University of Texas at Austin
`College of Pharmacy, Division of Pharmaceutics
`Associate Professor with Tenure
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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, NC.
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`Auckland Hospital, Auckland Healthcare, New Zealand, Pharmacist
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`2009 – 2011
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`2005 – 2009
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`2004 – 2005
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`2000
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`1998 – 1999
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`1996
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`ADJUNCT APPOINTMENTS
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`2006 – Present
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`2006 – 2009
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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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`Curriculum Vitae
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`1
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`MYLAN EX 1012, Page 1
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`

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`Hugh Smyth, Ph.D.
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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)
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`University of Otago, Dunedin, New Zealand
`School of Pharmacy, Department of Pharmaceutical Sciences
`Bachelor of Pharmacy
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`AWARDS AND HONORS
`2014
`Editor-in-Chief, Drug Development and Industrial Pharmacy, Informa Press
`(September, 2014).
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`EDUCATION
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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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`2013
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`2012
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`2008
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`2007
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`2007
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`2007
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`American Association of Colleges of Pharmacy, Academic Research Fellow
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`Nominee for 2014 Edith and Peter O'Donnell Engineering Award, The Academy
`of Medicine, Engineering & Science of Texas
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`Nominee for 2014 Edith and Peter O'Donnell Technology Innovation Award,
`The Academy of Medicine, Engineering & Science of Texas
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`Bergen-Brunswig Fellow, University of Texas at Austin.
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`Best Poster, Respiratory Drug Delivery 2008, Scottsdale, AZ
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`New Investigator Award in Pharmaceutics,
`Drug Delivery, and Pharmaceutical Technologies
`American Association of Pharmaceutical Scientists
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`New Investigator in Pharmaceutics Award,
`Pharmaceutical Research and Manufacturers of America (PhRMA)
`Foundation
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`Winning Team, Second Annual Technology Business Plan Competition
`University of New Mexico
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`Vernon Tews - GlaxoWellcome Inc. Education Scholarship
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`American Chemical Society
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`Curriculum Vitae
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`2
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`1997 – 1999
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`PROFESSIONAL SOCIETIES
`2004 – Present
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`International Society for Aerosols in Medicines
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`2005 – 2008
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`MYLAN EX 1012, Page 2
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`2001 – 2005
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`2001 – Present
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`1998 – Present
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`1997 – Present
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`1996 – 2004
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`SCHOLARLY REVIEW
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`Ad Hoc Review
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`2000 – Present
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`Hugh Smyth, Ph.D.
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`North Carolina Pharmaceutical Discussion Group
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`American Association of Pharmaceutical Scientists
`Inhalation Technology Focus Group
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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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`European Journal of Pharmaceutics and Biopharmaceutics
`Molecular Pharmaceutics
`Journal of Microencapsulation
`Nature Reviews Drug Discovery
`International Journal of Pharmaceutics
`Journal of Pharmaceutical Sciences
`Journal of Aerosol Medicine
`Journal of Controlled Release
`AAPS PharmSciTech
`Journal of Pharmacy and Pharmacology
`Pharmaceutical Research
`Drug Development and Industrial Pharmacy
`Langmuir
`Powder Technology
`Journal of Environmental Management
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`Editorial Review
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`2014 – Present
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`2012 – Present
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`2010 – Present
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`2010
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`2008 – 2012
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`2007 – 2010
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`2007 – Present
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`Editor-in-Chief, Drug Development and Industrial Pharmacy.
`Drug Development & Delivery Editorial Advisory Board
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`Editorial Board Member, Journal of Bioequivalence & Bioavailability
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`Editorial Advisory Board, Drug Delivery Letters
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`Guest Editor, Journal of Nanomaterials, Special Issue Nanostructured Aerosol
`Particles: Fabrication, Pulmonary Drug Delivery, and Controlled Release
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`Editorial Advisory Board for Books
`Controlled Release Society
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`Editorial Advisory Committee for Books
`American Association of Pharmaceutical Scientists
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`Reviewer, Annual Meeting
`American Association of Pharmaceutical Scientists
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`Curriculum Vitae
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`3
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`MYLAN EX 1012, Page 3
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`2006 – 2014
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`Editorial Board Member
`Drug Development and Industrial Pharmacy
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`National / International Grant Review
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`2013-Present
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`Hugh Smyth, Ph.D.
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`Ad-Hoc Study Section Member
`Center for Scientific Review
`National Institutes of Health
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`Ad-Hoc Study Section Member (2 Study Sections)
`Center for Scientific Review
`National Institutes of Health
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`Panelist SBIR/STTR Program
`National Science Foundation
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`Reviewer
`Ohio Cancer Research Associates Foundation
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`Panelist SBIR/STTR Program
`National Science Foundation
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`Reviewer
`North Carolina Biotechnology Center
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`Panelist “Drug Discovery and Development”
`National Science Foundation
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`Panelist “Drug Delivery in Biotechnology”
`National Science Foundation
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`Special Emphasis Panel: “Delivery Systems and Nanotechnology”
`Center for Scientific Review
`National Institutes of Health
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`Reviewer
`Alberta Heritage Foundation for Medical Research, Canada
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`Panelist “Drug Delivery in Biotechnology”
`National Science Foundation
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`2012
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`2010
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`2010
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`2009
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`2009
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`2007
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`2006
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`2005
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`2004
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`2001
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`SERVICE
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`The University of Texas at Austin
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`2014
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`2012 - Present
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`Co-Chair, Faculty Retreat Committee, College of Pharmacy.
`Member, Center for Infectious Diseases, UT-Austin
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`Chair, Faculty Search Committee, Pharmaceutics (2013).
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`Steering Committee, Improving Course Outcome and Student Achievement,
`(ICOSA)
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`Curriculum Vitae
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`4
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`MYLAN EX 1012, Page 4
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`

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`Hugh Smyth, Ph.D.
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`Continuing Education Committee
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`Graduate Studies Administrative Sub-Committee*
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`Teaching Credentials & Assignments Committee*
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`Division of Pharmaceutics Graduate Advisor.
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`2010 – 2013 Steering Committee, TherapUTex, Drug Dynamics Institute
`College of Pharmacy
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`2010 – present
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`2010 – present
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`2010 – present
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`2010
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`University of New Mexico
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`2009
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`2007 – 2008
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`Curriculum Committee
`College of Pharmacy
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`Program Assessment Team
`College of Pharmacy
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`Accreditation Self-Study Committee 5
`College of Pharmacy
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`Seminar Coordinator
`Division of Pharmaceutics
`College of Pharmacy
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`Faculty Advisor for Pharm.D. Class of 2012
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`University of New Mexico Intellectual Property Policy Committee
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`Organizational Planning & Evaluation Committee
`College of Pharmacy
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`Faculty Search Committee, Pharmacokinetics
`College of Pharmacy
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`Steering Committee Member, Biomedical Sciences Graduate Program
`The Biomedical Sciences Graduate Program is the graduate program for the
`entire Health Sciences Center. The steering committee has members from
`each participating unit and oversees the graduate program from admissions,
`qualifying exams, assessment, etc.
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`Lung Cancer Working Group
`Cancer Research and Treatment Center
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`Phase 1 Working Group
`Cancer Research and Treatment Center
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`Assessment Task Force
`College of Pharmacy
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`Scholarships, Student Loans and Awards Committee
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`Curriculum Vitae
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`5
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`2007 – 2009
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`2007
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`2006 – 2009
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`2006 – 2009
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`2006 – 2009
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`2006 – 2007
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`2005
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`MYLAN EX 1012, Page 5
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`

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`College of Pharmacy
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`Hugh Smyth, Ph.D.
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`Professional Leadership
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`2014
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`Professional Development
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`2013
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`Founder, Via Therapeutics, Austin, TX
`Founder, SpinDrift Therapeutics, Austin, TX
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`Member of Organizing Committee, International Society of Microencapsulation
`International Meeting 2015.
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`Co-Chair, Workshop on: Developing Pharmaceutical Products for Controlled
`Pulmonary Delivery, October 23, 2011, Walter E. Washington Convention
`Center, Washington, D.C., U.S.A. Controlled Release Society & American
`Association of Pharmaceutical Scientists
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`Chief Scientist, Consultant
`Respira Therapeutics
`Start-up company based on intellectual property and patents licensed from my
`laboratory
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`Programming Committee
`“Lactose as a Carrier for Inhalation Products” Conference
`Parma, Italy
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`Pulmonary Advisory Board
`Mannkind Corporation, Danbury, Connecticut
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`Member Business Advisory Board
`Zia Scientific, Albuquerque, New Mexico
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`Scientific Consultant to various Law Firms
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`Scientific Analyst, Evaluation of Existing Inhaler Products in Developing Nations
`United Nations Development Program
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`Member of University of Texas at Austin learning community program on
`“Flipping the Classroom”
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`College Wide Workshop on Objective Writing, Speaker: Dr. John Littlefield
`Director of the Academic Center for Excellence in Teaching (ACET) at the UT
`Health Science Center, San Antonio
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`Teaching Conversations, The University of Texas at Austin,
`College of Pharmacy
`Coordinator: Patrick Davis, Senior Associate Dean
`
`Faculty Development Series, College of Pharmacy, University of New Mexico
`Coordinators: Craig Marcus, Division Chair, Laurie Hudson, Regents Professor
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`Curriculum Vitae
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`6
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`2011
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`2010-Present
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`2010
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`2008
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`2007
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`2005 – Present
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`2003
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`2011
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`2009 – Present
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`2006 – 2009
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`MYLAN EX 1012, Page 6
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`

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`TEACHING
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`Professional Curriculum, Pharm.D.
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`The University of Texas at Austin
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`2014-Present
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`Teaching Methods and Teaching Enhancement
`Center for Teaching and Learning / Center for Faculty Excellence
`University of North Carolina at Chapel Hill
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`Hugh Smyth, Ph.D.
`
`PHR356C Pharmaceutics (Spring).
`Transformed didactic course into a team-based flipped class room model with
`Dr Williams. Approximately 14 modules x 3 hours per week. Co-developed all
`new syllabus, course materials, quizzes, exams, assignments.
`
`PHR 156P (Spring)
`Pharmaceutics Laboratory and Lectures
`Course Coordinator: Hugh Smyth
`Lecture course on pharmaceutical calculations to 1st year Pharm.D. students.
`Developed new syllabus, generated new course handouts, study guides, and
`participated in electronic “lecture capture” to enable students to remotely
`access the lecture audio and visual materials to supplement lectures.
`Approximately 130 students, 12 lectures
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`2004 – 2005
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`2010-2013
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`Laboratory compounding course for 1st year Pharm.D. students. Includes
`introductory presentations in lab and directing practical demonstrations of
`compounding techniques.
`Approximately 25 students per lab, 5 labs per week, 10 weeks.
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`PHR 356.
`Lecture course on pharmaceutics.
`Approximately 130 students, 2-3 lectures (Team Taught Course).
`Course Coordinator: R O Williams
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`2010-Present
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`University of New Mexico
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`2006 - 2009
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`2006 - 2009
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`PHARM 701: Pharmaceutics I, Fall Semester
`Course Coordinator: Linda Felton
`Study of pharmaceutical dosage forms and relevant physico-chemical and
`biopharmaceutical principles. Introduction to the metrology and calculations
`involved in the compounding and dispensing of pharmaceutical preparations.
`Dosage forms discussed include ophthalmics, otics, nasal products, aerosols,
`and transdermal products.
`Approximately 85-90 students, 12 lectures
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`PHARM 702: Pharmaceutics II, Spring Semester
`Course Coordinator: Hugh Smyth
`Study of pharmaceutical dosage forms and relevant physico-chemical and
`biopharmaceutical principles. Introduction to the metrology and calculations
`involved in the compounding and dispensing of pharmaceutical preparations.
`Dosage forms discussed include ophthalmics, otics, nasal products, aerosols,
`and transdermal products.
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`Curriculum Vitae
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`7
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`MYLAN EX 1012, Page 7
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`

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`Approximately 85-90 students, 14 lectures
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`The University of North Carolina at Chapel Hill
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`2003
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`Pharm 411, Basic Pharmaceutics 2
`Course Coordinator: Anthony Hickey
`2 Lectures, Inhalation Aerosols
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`Hugh Smyth, Ph.D.
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`University of Otago, New Zealand
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`2000
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`Pharmaceutics I,
`Course Coordinator: Nigel Davies
`2 Lectures, Transdermal Drug Delivery
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`Graduate Curriculum
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`The University of Texas at Austin
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`2011 - Present
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`PHR 380Q, Fall
`Advanced Manufacturing Pharmacy
`Approximately 12 Students, 3 x 4 hr Lectures
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`2010 - Present
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`PHR 382, Summer
`Recent Advances in Pharmaceutics
`Course Coordinator: Hugh Smyth
`Approximately 10 Students, 6 x 4 hr Lectures
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`The University of New Mexico
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`2007 – 2008
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`PHARM/BIOMED 576: Molecular and Cellular Pharmacology, Fall Semester,
`Course Coordinator: Joe Masserano
`The course reviews general principles of pharmacology, including receptor
`interaction and signaling, ADME, drug design, pharmacogenomics, and
`toxicology. One lecture was provided on the Respiratory Pharmacology
`Approximately 5 students
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`PHARM/BIOMED 581: General Toxicology
`Course Coordinators: Mary Walker/Craig Marcus
`An in-depth introduction to the basic principles and concepts of toxicology.
`Categories of chemicals causing toxic effects, the manner of exposure to toxic
`substances, the environmental and biological effects, and the laws and
`regulations will be considered. Two lectures on Respiratory Toxicology
`Approximately 5 students
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`2006 – 2009
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`2007
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`Other Courses Taught
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`2005
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`ECE 590 Graduate Seminar (Electrical and Computer Engineering):
`Course Coordinator: Marek Osinski
`One lecture, Nanocrystals and Nanoparticles for Drug Delivery
`Approximately 10 students.
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`Workshop “Sustained Pulmonary Drug Delivery”
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`Curriculum Vitae
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`8
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`MYLAN EX 1012, Page 8
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`

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`Hugh Smyth, Ph.D.
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`The Institute of Validation Technology
`Drug Delivery Systems conference, September 20-23
`San Francisco
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`Department of Biomedical Engineering, University of North Carolina at Chapel
`Hill; Undergraduate lectures on “Drug Delivery”
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`Faculty Speaker
`Pharmaceutical Inhalation Aerosol Technology Course and Colloquia
`September 29-30
`Research Triangle Park, North Carolina
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`Teaching Assistant
`Biopharmacy, Physical Pharmacy, & Aseptic Dispensing
`School of Pharmacy, University of Otago, NZ
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`Teaching Assistant
`Biopharmacy, Physical Pharmacy, & Aseptic Dispensing
`School of Pharmacy, University of Otago, NZ
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`Dr. Silvia Ferrati, “Biomimetic Vesicles for Drug Delivery”
`
`Dr Xianfei Xie, “Controlled pulmonary drug delivery to alter and optimize the
`pharmacokinetics of therapeutic molecules”
`
`Dr Xin Li “Microfluidic Synthesis of Shape Controlled Particles”
`
`Dr Nihal Bandara, Ph.D. (University of Hong Kong, Microbiology and Oral
`Biosciences).
`“Drug Delivery in Biofilms”
`
`Roger Andrew Maloney, Ph.D. (University of New Mexico, Physics)
`“Particle Adhesion and Detachment”
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`Aileen Gibbons, Ph.D. (Royal College of Surgeons, Dublin, Ireland)
`“Dry Powder Inhaler Formulations”
`Current Position, Senior Scientist, Respira Therapeutics.
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`Stephen Marek, Ph.D. (The University of Texas)
`“Interparticulate Forces”
`Current Position, Lecturer, Biomedical Engineering, Univ. of Texas at Austin
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`Ibrahim El-Sherbiny, Ph.D. (Massey University, New Zealand)
`“Hydrogels for Drug Delivery”
`Current Position: Associate Professor, Mansoura University Egypt.
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`Parthiban Selvam, Ph.D. (Wayne State University)
`“Dry Powder Inhaler Development”
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`Curriculum Vitae
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`9
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`2004
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`2003
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`2000
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`1997
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`2013 – Present
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`2012 – 2014
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`2011 – 2014
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`2011-2012
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`2009 – 2011
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`2008 – 2010
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`2008 – 2010
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`Students Supervised
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`Post-Doctoral Fellows
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`2014 – Present
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`2014 – Present
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`MYLAN EX 1012, Page 9
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`

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`Hugh Smyth, Ph.D.
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`Current Position: Scientist, Savara Pharmaceuticals
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`Satya Singh, Ph.D., (Indian Institute of Technology, Kanpur, India)
`“Computational Fluid Dynamics for Inhalers”
`Current Position: Scientist, Indian Institute of Technology
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`Imran Saleem, Ph.D. (Aston University, United Kingdom)
`“Inhalation Aerosols for Lung Cancer Treatment”
`Current Position: Faculty at John Moores University, Liverpool, United Kingdom
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`2008 – 2009
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`2006 – 2008
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`Graduate Students (* in candidacy, + graduate)
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`2014 – Present
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`2013 – Present
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`2013 – Present
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`2012 – Present
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`2011 – Present
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`2010 – Present
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`2010 – Present
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`Zachary Warnken, Pharm.D., Ph.D. Graduate Student
`Pharmaceutics Ph.D. Graduate Program, The University of Texas at Austin
`Co-Supervised with Dr Williams.
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`Tania Bahamóndez, Graduate Student
`Pharmaceutics Ph.D. Graduate Program, The University of Texas at Austin
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`Daniel F Moraga-Espinoza, Graduate Student
`Pharmaceutics Ph.D. Graduate Program, The University of Texas at Austin
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`*Ashkan Yazdi, PharmD, Graduate Student
`Pharmaceutics Ph.D. Graduate Program, The University of Texas at Austin
`
`*Ping Du, Graduate Student
`Pharmaceutics Graduate Program, The University of Texas at Austin
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`*Matt Herpin, Graduate Student
`Pharmaceutics Graduate Program, The University of Texas at Austin
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`*Ju Du, Graduate Student
`Pharmaceutics Graduate Program, The University of Texas at Austin
`“Novel Therapeutics Delivered as Inhalation Aerosols”
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`Srimahitha Kaliki, Graduate Student
`Biomedical Engineering Graduate Program, The University of Texas at Austin
`Graduated 2014
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`Diana Guzman, Graduate Student at Facultad de Farmacia
`Universidad Autonoma Del Estado De Morelos
`Co-Advisor: Dr Dea Herrara Ruiz
`Graduated 2013
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`Martin Donovan, Graduate Student
`Awarded NSF IGERT scholarship for Nanoscience and Microsystems
`Biomedical Sciences Graduate Program, UNM, transferred to:
`Pharmaceutics Graduate Program, The University of Texas at Austin
`Graduated August 2011
`Current Position, Senior Scientist, Xeris Therapeutics, Austin Texas
`
`Shayna McGill, Graduate Student
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`Curriculum Vitae
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`10
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`2011 – 2014
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`2010 – 2013
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`2006 – 2011
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`2007 – 2011
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`MYLAN EX 1012, Page 10
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`

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`Hugh Smyth, Ph.D.
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`Biomedical Sciences Graduate Program, UNM, transferred to:
`Pharmaceutics Graduate Program, The University of Texas at Austin
`Awarded NSF IGERT fellowship for “Integrating Nanotechnology with Cell
`Biology and Neuroscience”
`Winner of International Society for Aerosols in Medicine, Biennial Student
`Research Award
`Graduated, August 2011
`Current Position, Postdoctoral Fellow, University of North Carolina, Chapel Hill
`
`+Leah Mitchell, Ph.D. Biomedical Sciences, University of New Mexico
`“Mechanisms of Inhaled Multiwalled Carbon Nanotube-Induced
`Immunosupression in Mice”
`Major Advisor: Scott Burchiel
`Graduated May 2009
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`Sonya Flores, Graduate Student, Biomedical Sciences Graduate Program
`On Rotation
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`+Michelle B. Gallegos, Masters Student,
`Mechanical Engineering Program, University of New Mexico
`Major Advisor: C Randall Truman
`Graduated 2008
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`2007 – 2009
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`2007
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`2005 – 2008
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`Pharm. D. Students (Research)
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`2014
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`Ashlee Brunaugh, Pharm.D., Ph.D. Student, Research Rotations.
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`Maliha Ahmed, Pharm.D. Student, Research Rotations, Honors Program
`The University of Texas at Austin
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`Sarah Hallowell, Pharm.D. Student, Research Rotations, Honors Program
`The University of Texas at Austin
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`Stephanie Hufnagel, Pharm.D. Student, Research Rotations, Honors Program
`The University of Texas at Austin
`
`Lucy Gong, Pharm.D. Student, Research Rotations, Honors Program
`The University of Texas at Austin
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`Scott Mosley, Pharm.D. Student, Research Rotations, Honors Program
`The University of Texas at Austin
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`Tommy Cai, Student, Research Rotation, The University of Texas at Austin
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`Nicola Maynard, Pharm.D. Student, College of Pharmacy
`University of New Mexico
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`Samantha Torres, Pharm.D. Student, College of Pharmacy
`University of New Mexico
`Summer Fellow
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`Vincent Agustin, Pharm.D. Student, College of Pharmacy
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`Curriculum Vitae
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`2013
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`2010 – 2013
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`2010 – 2012
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`2010 – 2012
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`2009 – 2012
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`2009
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`2008
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`MYLAN EX 1012, Page 11
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`University of New Mexico
`Summer Fellow
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`Hugh Smyth, Ph.D.
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`HongChao Liu, Pharm.D. Student, College of Pharmacy
`University of New Mexico
`Pfizer Fellow, UNM 2007-2008
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`Undergraduate Students (Research)
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`2014
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`Alejandro Harb
`David Kolacny
`Heather Klein (BME)
`Jessica Musler (BME)
`Kevin Gandingco (BME)
`Jeanette Lee (Intellectual Entrepreneurship Program)
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`Danielle Stolley,
`Tyler Fields
`Damian Jimenez
`Sarah D Labianca
`Giovanni A Campagna
`Khurram Qazi
`Jihyun Yoo
`Howard Lin
`Joiesah Sunga
`Samantha Salcedo
`Alejandro Harb
`David Kolacny
`Johnny Thai
`
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`Johnny Thai - Biochemistry Major
`Stivaly Gomez - Biomedical Engineering
`Michael Huang - Pre-Med
`Kunnel Zachariah - Chemical Engineering
`Mashal Awais - Chemistry
`David Yang - Biomedical Engineering
`Charlie Nguyen - Biology
`Kevin Zhao - Intellectual Entrepreneurship Program, Pre-Pharm
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`Y Vo, Chemical Engineering, University of Texas at Austin
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`Kristi Mascarenas, McNair Scholar, University of New Mexico
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`2007 – 2008
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`2012 – 2013
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`2011 – 2012
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`2010 – 2012
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`2009
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`2008 – 2009
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`Abdullah Feroz, Regents Scholar, Undergraduate, University of New Mexico
`Carla Cuylear, Minority Access to Research Careers (MARC) Scholar
`Undergraduate, University of New Mexico
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`Poonam Patil, Pre-Pharmacy Student, University of New Mexico
`Laura Rogers, Pre-Pharmacy Student, University of New Mexico
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`2007 – 2008
`2006 – 2007
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`Student Committees
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`Doctoral Thesis Committees (* denotes chair of committee)
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`Curriculum Vitae
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`Hugh Smyth, Ph.D.
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`Leah Mitchell
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`*Martin Donovan
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`*Shayna McGill
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`Thiago Carvalho
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`Kevin O’Donnell
`Stephanie Bosselmann
`Justin Hughey
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`Javier Morales
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`Yi-Bo Wang
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`*Ju Du
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`*Matt Herpin
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`Xinran Li
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`Amit Kumar
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`Ryan Bennett
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`Simone Carvalho
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`*Ping Du
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`*Ashkan Yazdi
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`*Srimahitha Kaliki
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`Youssef Naguib
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`Leena Prasad
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`Justin Lafontaine
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`Zachary Warnken
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`Biomedical Sciences (UNM)
`Pharmaceutics (UT)
`Pharmaceutics (UT)
`Pharmaceutics (UT)
`Pharmaceutics (UT)
`Pharmaceutics (UT)
`Pharmaceutics (UT)
`Pharmaceutics (UT)
`Pharmaceutics (UT)
`Pharmaceutics (UT)
`Pharmaceutics (UT)
`Pharmaceutics (UT)
`Pharmaceutics (UT)
`Pharmaceutics (UT)
`Pharmaceutics (UT)
`Pharmaceutics (UT)
`Pharmaceutics (UT)
`Biomedical Engineering (UT)
`Pharmaceutics (UT)
`Pharmaceutics (UT)
`Pharmaceutics (UT)
`Pharmaceutics (UT)
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`Mechanical Engineering, UNM
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`2009
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`2011
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`2011
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`2011
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`2011
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`2012
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`2012
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`2012
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`2013
`Pending
`Pending
`2013
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`2013
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`Pending
`2013
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`Pending
`Pending
`Pending
`Pending
`Pending
`Pending
`Pending
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`Masters Thesis Committees
`2008
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`Michelle Gallegos
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`Student Awards (under my direct supervision)
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`2011
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`2010
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`2009
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`2009
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`2009
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`2008
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`Matthew Herpin, Graduate Student
`Pharmaceutical Researchers and Manufacturers Association (PhRMA)
`Foundation, Graduate Student Fellowship in Pharmaceutics (Full Stipend
`Support, 2 years)
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`Shayna McGill, Graduate Student
`Dr. Bill and Jill Williams and Dr. Jim and Kitty McGinity Graduate Fellowship
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`Shayna McGill, Graduate Student
`Nominee, Teaching Excellence Award
`College of Pharmacy, The University of Texas at Austin
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`Martin Donovan, Graduate Student
`Nominee, Teaching Excellence Award
`College of Pharmacy, The University of Texas at Austin
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`Shayna McGill, Graduate Student
`Winner of the International Society for Aerosols in Medicine, Biennial Student
`Research Award
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`Hongchao Liu, Pharmaceutical Sciences Pharm.D. Research Award
`University of New Mexico, College of Pharmacy
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`Curriculum Vitae
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`MYLAN EX 1012, Page 13
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`Hugh Smyth, Ph.D.
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`Shayna McGill, Graduate Student
`Awarded NSF IGERT fellowship for “Integrating Nanotechnology with Cell
`Biology and Neuroscience”
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`Martin Donovan, Graduate Student
`Awarded NSF IGERT scholarship for Nanoscience and Microsystems
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`2007 – 2009
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`2006 – 2009
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`PUBLISHED / ISSUED PATENTS
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`
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`Issued Patents
`1. Apparatuses and methods for microparticle dry coating of surfaces, Inventors: Parthiban
`Selvam, Hugh D.C. Smyth, Martin Donovan, United States Patent 8715770
`2. Aerosol-mediated particle synthesis, Inventors: Hugh D.C. Smyth, Ibrahim M. El-Sherbiny,
`United States Patent 8652366
`3. Bead-containing dry powder inhaler, Inventors: Martin J. Donovan, Jacques Pappo, Hugh
`Smyth, United States Patent 8651104
`4. Swellable particles for drug delivery, Inventors: Hugh D. Smyth, Martin J. Donovan, United
`States Patent 8440231
`5. Dry powder inhaler, Inventors: Martin J. Donovan, Jacques Pappo, Hugh Smyth, United
`States Patent 8561609
`6. Swellable particles for drug delivery, Inventors: Hugh D. Smyth, Martin J. Donovan, United
`States Patent 8257685
`7. Dry powder aerosol generator, Inventors: Hickey, Anthony J., Smyth, Hugh D. C., Telko,
`Martin J. United States Patent 8205612
`8. Coated filament for evaporation/condensation aerosol generation of therapeutic agents
`and methods for using, Inventors: Hickey, Anthony J., Smyth, Hugh D. C., United States
`Patent 8165460
`9. Methods of acoustic measurement and control of pharmaceutical sprays, Inventors:
`Hickey, Anthony J., Smyth, Hugh D. C., Mitran, Sorin, United States Patent 8156829
`10. Dry powder inhaler with aeroelastic dispersion mechanism, Inventors: Hugh Smyth,
`Randall Truman, United States Patent 8127763
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`Patent Applications
`
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`1. SOLID COMPOSITIONS FOR PHARMACEUTICAL USE, Inventors: Hugh D.C. Smyth,
`Ibrahim M. El-Sherbiny, United States Patent Application 20140141094
`2. TOROIDAL PHARMACEUTICAL FORMULATIONS, Inventors: Hugh D C Smyth, Matthew
`Herpin, United States Patent Application 20130012893
`3. Dry powder nebulizer, US20130000640, Inventors: Nicola Jeanne Maynard, Hugh D. Smyth.
`1. Dry powder inhaler with flutter dispersion member, US 20120234322 A1, Inventors: Parthiban
`Selvam, Hugh D.C. Smyth, Charles Randall Truman
`2. Dry powder inhaler with aeroelastic dispersion mechanism, US 2012/0125331 A1, Inventors:
`Hugh Smyth, Charles Randall Truman
`3. Methods And Systems For Dosing And Coating Inhalation Powders Onto Carrier Systems, US
`2012/0207913 A1, Inventors: Hugh D. Smyth, Martin J. Donovan
`4. DPI Formulation Containing Sulfoalkyl Ether Cyclodextrin, Us 2007/0175472 A1, Inventors:
`James D. Pipkin, Rupert O. Zimmerer, Anthony J. Hickey, Diane O. Thompson, Hugh D.C.
`Smyth
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`Curriculum Vitae
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`MYLAN EX 1012, Page 14
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`5. Formulations Containing Large-Size Carrier Particles For Dry Powder, US 2011/0253140 A1,
`Inventors: Hugh D.C. Smyth, Martin Donovan
`6. Active nanoparticles and method of using, US 2009/0226521 A1, Inventors: Hugh D. Smyth,
`Marek Osinski, Shayna L. McGill
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`Hugh Smyth, Ph.D.
`
`PUBLICATIONS (* denotes corresponding author)
`
`A. Original Research Papers
`
`
`1. Xin Hua, Shengnan Tan,H. M. H. N. Bandara, Yujie Fu, Siguo Liu mail, Hugh D. C. Smyth,
`Externally Controlled Triggered-Release of Drug from PLGA Micro and Nanoparticles, PLoS
`ONE 9(12): e114271. doi:10.1371/journal.pone.0114271
`
`2. H. M. H. N. Bandara, A. Harb, D. Kolacny Jr., P. Martins, H. D. C. Smyth, Sound Waves
`Effectively Assist Tobramycin in Elimination of Pseudomonas aeruginosa Biofilms In vitro,
`AAPS PharmSciTech, Accepted DOI: 10.1208/s12249-014-0200-1
`
`3. Diana Guzman-Villanueva, Ibrahim M El-Sherbiny, Alexander V Vlassov, Dea Herrera-Ruiz,
`Hugh DC Smyth, Enhanced cellular uptake and gene silencing activity of siRNA molecules
`mediated by chitosan-derivative nanocomplexes, International Journal of Pharmaceutics,Vol
`473, 1 October 2014, Pages 579–590
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`4. Ju Du, Ibrahim M. El-Sherbiny and Hugh D. Smyth, Swellable Ciprofloxacin-Loaded Nano-in-
`Micro Hydrogel Particles for Local Lung Drug Delivery, AAPS PharmSciTech, Published
`online: 31 July 2014
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`5. Du, Ping, Du, Ju, Smyth, Evaluation of Granulated Lactose as a Carrier for DPI Formulations
`1: Effect of Granule Size, AAPS PharmSciTech, Published online: 25 June 2014
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`6. Leisha M. Armijo ; Michael Kopciuch ; Zuzia Olszόwka ; Stephen J. Wawrzyniec ; Antonio C.
`Rivera ; John B. Plumley ; Nathaniel C. Cook ; Yekaterina I. Brandt ; Dale L. Huber ; Gennady
`A. Smolyakov ; Natalie L. Adolphi ; Hugh D. C. Smyth ; Marek Osiński, Delivery of tobramycin
`coupled to iron oxide nanoparticles across the biofilm of mucoidal Pseudonomas aeruginosa
`and investigation of its efficacy, Proc. SPIE, Colloidal Nanoparticles for Biomedical
`Applications IX, 2014, doi:10.1117/12.2043340
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`7. IY Saleem, HDC Smyth, Tuning Aerosol Particle Size Distribution of Metered Dose Inhalers
`Using Cosolvents and Surfactants, BioMed Research International, Volume 2013 (2013),
`Article ID 574310, 7 pages, http://dx.doi.org/10.1155/2013/574310
`
`8. D Guzman-Villanueva, IM El-Sherbiny, D Herrera-Ruiz, HDC Smyth, Design and In Vitro
`Evaluation of a New Nano-Microparticulate System for Enhanced Aqueous-Phase Solubility of
`Curcumin, BioMed Research International, Volume 2013 (2013), Article ID 724763, 9 pages
`http://dx.doi.org/10.1155/2013/724763
`
`9. Patrick J. Wayne, Peter Vorobieff, Hugh Smyth, Tennille Bernard, Clint Corbin, Andy Maloney,
`Joseph Conroy, Ross White, Michael Anderson, Sanjay Kumar, C. Randall Truman, Deepti
`Srivastava, Shock-Driven Particle Transport Off Smooth and Rough Surfaces, Journal of
`Fluids Engineering, (2013) Vol 135, number 6, Article 061302.
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`Curriculum Vitae
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`MYLAN EX 1012, Page 15
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`Hugh Smyth, Ph.D.
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`10. Leisha M. Armijo ; Brian A. Akins ; John B. Plumley ; Antonio C. Rivera ; Nathan J. Withers ;
`Nathaniel C. Cook ; Gennady A. Smolyakov ; Dale L. Huber ; Hugh D. C. Smyth and Marek
`Osiński (2013) Highly efficient multifunctional MnSe/ZnSeS quantum dots for biomedical
`applications ", Proc. SPIE, 8595, Colloidal Nanocrystals for Biomedical Applications VIII,
`859517; doi:10.1117/12.2009563
`
`11. Yekaterina I. Brandt ; Leisha M. Armijo ; Antonio C. Rivera ; John B. Plumley ; Nathaniel C.
`Cook ; Gennady A. Smolyakov ; Hugh D. C. Smyth and Marek Osiński, (2013) Effectiveness of
`tobramycin conjugated to iron oxide nanoparticles in treating infection in cystic fibrosis ", Proc.
`SPIE, 8595, Colloidal Nanocrystals for Biomedical Applications VIII, 85951C (February 22,
`2013); doi:10.1117/12.2009549
`
`12. Guzman-Villanueva D., El-Sherbiny IM, Herrera-Ruiz D, Vlassov AV, Smyth HDC,* (2012)
`Formulation approaches to short interfering RNA and MicroRNA: Challenges and implications,
`Journal of Pharmaceutical Sciences, 101(11), pages 4046–4066, DOI: 10.1002/jps.23300
`a. In Top 10 downloaded articles for Journal of Pharm. Sci. Oct-Dec 2012.
`
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`13. Beinborn NA, Du J, Wiederhold NP, Smyth HD, Williams RO 3rd., (2012) Dry powder
`insufflation of crystalline and amorphous voriconazole formulations produced by thin film
`freezing to mice. Eur J Pharm Biopharm. May 1. [Epub ahead of print] PMID: 22569473
`
`14. Armijo, L.M.; Brandt, Y.I.; Mathew, D.; Yadav, S.; Maestas, S.; Rivera, A.C.; Cook, N.C.;
`Withers, N.J.; Smolyakov, G.A.; Adolphi, N.; Monson, T.C.; Huber, D.L.; Smyth, H.D.C.;
`Osiński, M. (2012) Iron Oxide Nanocrystals for Magnetic Hyperthermia Applications.
`Nanomaterials 2, 134-146.
`
`15. Donovan MJ*, Kim S, Raman V, and Smyth, HD (2012), Dry Powder Inhaler Device Influence
`on Carrier Particle Performance, Journal of Pharmaceutical Sciences, Vol. 101