`
`DAVID W. OSBORNE, Ph.D.
`
`
`DOsborne@arcutis.com
`david.wade.osborne@gmail.com
` 970-691-3452
`
`
`EDUCATION and TRAINING
`2005
`
`Professional Degree in Chemistry (Honorary)
`
`
`University of Missouri-Rolla, Rolla, Missouri
`
`1985
`
`
`
`
`
`
`
`1982
`
`Ph.D. in Physical Chemistry
`University of Missouri-Rolla, Rolla, Missouri
`Research Advisor: Professor Stig E. Friberg
`Dissertation: The interaction of a glyceridacid with lipids of the stratum corneum
`
`Bachelor of Science in Chemistry (ACS Certified), Math Minor
`Southwest Missouri State University, Springfield, Missouri
`
`
`PROFESSIONAL EXPERIENCE
`
`2017-Present
`
`2018-present
`
`2017-2018
`
`
`ARCUTIS Inc
`
`Chief Technical Officer
`
`Senior Vice President, Product Development
`Venture capital (Frazier Healthcare) funded start-up virtual company
`developing topical dermatological products. Full time employment
`began April 11, 2017.
`
`
`2016-Present
`
`2016-Present
`
`
`
`
`2008-2016
`
`
`2014-2016
`
`
`
`DAVID W. OSBORNE PHD CONSULTING INC
`
`President
`S-Corporation formed in late August of 2016 providing consulting
`and educational services in pharmaceutical product development
`including intellectual property and serving as an expert witness in
`Paragraph 4 litigations.
`
`TOLMAR Inc. (Retired in June 2016—TOLMAR had about
`650 total employees with 105 employees reporting to
`the CSO)
`
`Chief Scientific Officer
`Responsible for managing Formulation & Process Development,
`Analytical Development, Polymer Development, Clinical
`Development, and Tech Services. In addition to continuing
`development of generic topical and specialty injectable products,
`
`1 of 17
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`Almirall EXHIBIT 2058
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`Amneal v. Almirall
`IPR2019-00207
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`DAVID W. OSBORNE, Ph.D.
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`PAGE 2
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`2008-2014
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`
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`2003-2008
`
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`
`
`1993-2003
`
`
`
`2002 – 2003
`
`
`
`
`
`
`
`
`
`
`TOLMAR developed a pipeline of proprietary dermatology products
`and in-licensed a specialty injectable technology (one active
`advanced into the clinic prior to 2017). Worked closely with
`TOLMAR and external patent attorneys concerning intellectual
`property. Implemented a QbD adoption campaign.
`
`Vice President, Product Development
`Responsible for managing the Formulations Development,
`Analytical Development, Clinical Development, and Regulatory
`groups within TOLMAR. Between October 2008 and March 2010,
`this team filed five First-to-File topical product ANDAs requiring
`clinical endpoint bioequivalence studies. All five products
`successfully navigated litigation, were approved and launched. In
`addition to generic topical dermatology products (ANDAs filed: 2 in
`2009, 3 in 2009, 1 in 2010, 1 in 2011, 1 in 2012, 6 in 2013, 1 in 2014, 2
`in 2015, and 2 in 2016), generic specialty injectable product
`development was added as a second product development focus in
`2010.
`
`Dow Pharmaceutical Sciences
`
`Vice President, Product Development
`Managed Formulations & Product Development (FPD), Clinical
`Labeling, Skin Biology Laboratory, and the Internal Development
`Program (IDP) at Dow. FPD developed dermatological products
`from pre-formulation through scale-up and commercial
`manufacturing for Dow clients. Clinical Labeling provided
`randomization, labeling and product kits for clinical studies. The
`Skin Biology Lavatory completed in-vitro skin and membrane
`permeation studies to guide formulation selection. IDP selected
`development opportunities, established defendable intellectual
`property, and coordinated initial development of products that were
`then out-licensed to marketing partners (Valeant acquired DPSI and
`the IDP pipeline in 2008 for $285 million).
`
`Atrix Laboratories, ViroTex Corporation
`(ViroTex was acquired by Atrix on November 30, 1998)
`
`Vice President, Dermatology Division, Atrix
`• Responsible for establishing Atrix as a leading developer of
`generic and proprietary topical formulations and forward
`integrating this business unit to become a specialty
`pharmaceutical company focused on Dermatology.
`Operational duties include:
`• Selection and Management of generic product development
`with an ever-increasing number of annual ANDA filings (2 in
`2001, 5 in 2002, and 7 in 2003). Marketing partner for this
`program was Geneva (Sandoz/Novartis).
`• Directed all proprietary dermatology product development
`including being chairman of the Joint Development
`Management Committee between Atrix and Fujisawa that
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`DAVID W. OSBORNE, Ph.D.
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`PAGE 3
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`directed the development of 5% Aczone Topical Gel. The
`dapsone development program had a 2003 budget of $18
`Million.
`• Directed all business development activities related to
`dermatology products and provide a strategy for the creation of
`a specialty pharmaceutical company focused on Dermatology.
`• Managed both proprietary and generic analytical methods
`development and validation groups for all Atrix products
`• Responsible for overseeing worldwide patenting of all
`dermatology related Atrix intellectual property.
`
`Vice President, Pharmaceutical Development, Atrix
`• Transition of ViroTex technologies into Atrix following the
`November 30, 1998 acquisition. Managed product and
`analytical development groups for all products. Managed
`approximately 20-25% of Atrix Employees for this period of time
`Operational duties include:
`• Oversight of patent applications;
`• Product development from formulation selection to commercial
`scale-up
`• Analytical methods development and validation
`• Project Team Leader for Dapsone Topical Gel
`Laboratory responsibilities included:
`• New dermatological and mucosal product development
`• Novel delivery system evaluation
`• Transfer of Atrigel products from Drug Delivery to Process
`Development
`
`Vice President, Research & Development, ViroTex
` (3rd Employee, ~ 22 employees in R&D when acquired)
`• Designed and equipped a product development laboratory,
`quality control laboratory, virology/microbiology laboratory and
`a GMP manufacturing area.
`Operational duties included:
`• Oversight of patent applications, contract manufacture of both
`OTC and Rx products, contract toxicology testing, animal
`pharmacology/efficacy testing, human clinical trials.
`Laboratory responsibilities included:
`• New product research, topical drug delivery research, analytical
`methods development, product stability testing, quality control
`release of raw materials, and antiviral mechanism of action
`studies.
`
`Calgon Vestal Laboratories, Subsidiary of MERCK & CO.
`(Product Development ~45 employees)
`
`Group Leader, Skin Care
`Development of:
`• Routine and high-risk handwashing products for preventing the
`spread of infection;
`
`
`1998 – 2002
`
`
`
`
`1993 – 1998
`
`
`
`
`
`
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`
`
`
`1991 – 1993
`
`
`
`
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`PAGE 4
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`
`
`
`
`
`1985-1991
`
`1988 – 1991
`
`
`
`
`1985 – 1988
`
`
`
`
`• Development of skin conditioning products for maintaining
`healthy, normal and aging skin in hospitals and nursing homes;
`• Development of topically applied products to treat diseased skin
`or relieve skin discomfort.
`• Development efforts included evaluation of potential
`actives/products for licensing, formulation design including
`stability and efficacy testing, manufacture of GLP and GMP
`supplies for use in toxicological evaluations, and support of
`clinical studies.
`
`THE UPJOHN COMPANY (~7,000 employees)
`
`Research Scientist, Drug Delivery R&D-Specialty Products
`• Areas of specialization included: topicals, transdermal delivery
`systems (patches), and suppositories.
`• Typical activities were: pre-formulation characterization, bulk
`drug stability, formulation design, final formulation stability,
`Phase I, II and III clinical supply manufacture, GLP
`pathology/toxicology supply manufacture and preparation of the
`corresponding sections of the IND and NDA.
`Research Scientist, Pharmaceutical Manufacturing Technical
`Services--Group was reorganized into Drug Development R&D
`in January 1988
`• Areas of specialization included: topicals
`• Responsible for scale-up, manufacturing phase-in and marketed
`product support including validation of packaging and raw
`material changes.
`
`
`COMMERCIALIZED PRODUCTS
`
`Inventor/Developer
`PrimaHex Foam (Approved “NDA” marketed by CV Ltd)
`Orajel Ultra (OTC marketed by Del Laboratories)
`Eucalyptamint 2000 (OTC marketed by Heratige)
`Aczone (Approved NDA marketed by Allergan)
`Onsolis (BEMA-Fentanyl NDA marketed by Meda Pharmaceuticals)
`
`Named Inventor on Orange Book listed patent
`Bunavail (BEMA-Buprenorphine and Naloxone) US 6,159,498 and 7,579,019
`Belbuca (BEMA-Buprenorphine) US 6,159,498 and 7,579,019
`
`Developer
`Viractin Cream (OTC marketed by Combe Inc)
`Viractin Gel (OTC marketed by Combe Inc)
`Aloe Vestal Antifungal Ointment (OTC marketed by ConvaTec)
`Cleocin Vaginal Ovules (Approved NDA marketed by Pfizer)
`Eligard 1 month (Approved NDA marketed by TPI, Astellas, and others)
`Eligard 3 month (Approved NDA marketed by TPI, Astellas, and others)
`Eligard 4 month (Approved NDA marketed by TPI, Astellas, and others)
`Eligard 6 month (Approved NDA marketed by TPI, Astellas, and others)
`MetroGel 1% (Approved NDA marketed by Galderma)
`
`4 of 17
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`

`
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`PAGE 5
`
`Chair, Q3 Working Group
`
`DAVID W. OSBORNE, Ph.D.
`
`
`
`Clobex Spray (Approved NDA marketed by Galderma)
`Desonate Gel (Approved NDA marketed by Bayer AG)
`Ziana Gel (Approved NDA marketed by Medicis)
`Acanya Gel (NDA marketed by Arcutis/Valeant)
`Erythromycin Benzoyl Peroxide Gel (Approved ANDA marketed by Sandoz)
`Fluticasone Cream (Approved ANDA marketed by Sandoz)
`Lidocaine/Prilocaine Cream (Approved ANDA marketed by Impax)
`Mometasone Ointment (Approved ANDA marketed by Impax)
`Betamethasone Dipropionate Cream (Approved ANDA marketed by Impax)
`Ketoconazole Shampoo (Approved ANDA marketed by Sandoz)
`Metronidazole Topical Gel (Approved ANDA marketed by Impax)
`Metronidazole Vaginal Gel (Approved ANDA marketed by Sandoz)
`Mometasone Cream (Approved ANDA marketed by Impax)
`Mometasone Lotion (Approved ANDA marketed by Impax)
`Orajel Protective Mouth Sore Discs (OTC marketed by Del Laoratories)
`Clindamycin Benzoyl Peroxide Gel (Approved ANDA-BenzaClin marketed by Mylan)
`5% Imiquimod Cream (Approved ANDA marketed by Impax)
`Calcipotriene Cream (Approved ANDA marketed by Sandoz)
`Diclofenac Gel, 3% (Approved ANDA marketed by Impax)
`Calcipotriene 0.005% and Betamethasone Dipropionate Ointment
`(Approved ANDA marketed by Sandoz)
`Adapalene Gel, 0.03% (Approved ANDA marketed by Sandoz)
`Jublia (efinaconazole) Topical Solution 10% (Approved NDA marketed by Valeant)
`Clindamycin Benzoyl Peroxide Gel (Approved ANDA-Duac marketed by Impax)
`Naftifine Cream 2% (Approved ANDA marketed by Impax)
`Clindamycin Benzoyl Peroxide Gel (Approved ANDA-BenzaClin marketed by Impax)
`Acyclovir Ointment 5% (Approved ANDA marketed by Impax)
`Azeleic Acid 15% (Approved ANDA marketed by Impax)
`
`Combined annual sales of developed products exceeded $1.2 billion in 2015
`
`PROFESSIONAL SOCIETIES
`
`American Chemical Society
`American Academy of Dermatology
`American Association of Pharmaceutical Scientists (inactive)
`The Society for Investigative Dermatology (inactive)
`Skin Pharmacology Society (inactive)
`
`PROFESSIONAL ACTIVITIES AND HONORS
`
`2016-2019
`
`2015-2016
`
`CSU Advisory Board Member for developing a Professional Science
`Master’s degree in Biodata Analytics in the Department of Biochemistry and
`Molecular Biology
`
`
`2011-present Member of the UMKC School of Pharmacy Research Advisory Council
`
`2005
`
`
`Chair AAPS Dermatopharmaceutics Focus Group
`
`
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`DAVID W. OSBORNE, Ph.D.
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`
`
`2004
`
`
`
`
`
`PAGE 6
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`Faculty for the “Society for Investigative Dermatology Basics of Skin:
`Pharmaceutics and Pharmacology” Course.
`
`
`2003-present Founding Member of the Missouri State University Chemistry Department
`Board of Advisors
`
`
`2002
`
`1995
`
`
`
`
`
`
`1993-1998
`
`
`1992-1995
`
`
`1992-1994
`
`
`1992
`
`
`1992
`
`
`1991
`
`
`1990
`
`
`1990
`
`
`1987
`
`
`1986-1989
`
`
`PATENTS
`
`10,172,841
`
`
`10,111,956
`
`
`10,105,354
`
`Outstanding Young Alumni Award, Southwest Missouri State University.
`
`Organizer of the COLL Division Symposium “Surfactants and Association
`Colloids: Symposium in Honor of Stig Friberg”, Anaheim ACS Meeting.
`
`Adjunct Associate Professor of Pharmaceutics, University of Houston,
`College of Pharmacy.
`
`Founding North American Editor of the Elsevier Journal Colloids & Surfaces
`B: Biointerfaces Editor of Volumes 1-4.
`
`Adjunct Assistant Professor of Pharmaceutics, Saint Louis College of
`Pharmacy.
`
`Co-Organizer of the 66th Colloid and Surface Science Symposium symposia
`on “Surfactants: Isotropic Solutions and Liquid Crystals.”
`
`Chairman of the American Chemical Society Division of Colloid and Surface
`Science
`
`Chairman Elect of the American Chemical Society Division of Colloid and
`Surface Science.
`
`Vice Chairman of the American Chemical Society Division of Colloid and
`Surface Science.
`
`the COLL Division Symposium “Surfactants and
`Co-Chairman of
`Association Colloids: Zwitterionic Surfactants,” Boston ACS Meeting.
`
`Co-Organizer of the 61st Colloid and Surface Science Symposium symposia
`on “Topical Drug Delivery Formulations.”
`
`National Meeting Secretary (Program Chairman) for the American Chemical
`Society Division of Colloid and Surface Science.
`
`29 Issued US Patents
`
`Inhibition of Crystal Growth of Roflumilast. Inventor: David
`W. Osborne. Assignee: Arcutis.
`
`Corticosteroid Compositions. Inventors: Robert W. Lathrop,
`David W. Osborne. Assignee: TOLMAR.
`
`Inhibition of Crystal Growth of Roflumilast. Inventor: David
`W. Osborne. Assignee: Arcutis.
`
`6 of 17
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`DAVID W. OSBORNE, Ph.D.
`
`
`
`
`9,907,788
`
`
`
`PAGE 7
`
`Inhibition of Crystal Growth of Roflumilast. Inventor: David
`W. Osborne. Assignee: Arcutis.
`
`
`9,895,359
`
`
`9,884,050
`
`
`8,143,227
`
`
`8,124,123
`
`
`7,704,959
`
`
`7,579,019
`
`
`7,399,462
`
`
`7,326,408
`
`
`7,252,816
`
`
`6,620,435
`
`
`6,432,415
`
`
`
`Inhibition of Crystal Growth of Roflumilast. Inventor: David
`W. Osborne. Assignee: Arcutis.
`
`Inhibition of Crystal Growth of Roflumilast. Inventor: David
`W. Osborne. Assignee: Arcutis.
`
`Azithromycin for Treatment of Skin Disorders. Inventors:
`Gordon J. Dow, Bhaskar Chaudhuri, David W. Osborne, Barry
`Calvarese. Assignee: Dow Pharmaceutical Sciences.
`
`Controlled Release Azithromycin Solid Dosage Forms.
`Inventors: Radhakrishnan Pillai, Pramod Sarpotdar, David W.
`Osborne, Gordon J. Dow. Assignee: Valient.
`
`Azithromycin for the treatment of nodular acne. Inventors:
`David W. Osborne, Gordon J. Dow, Bhaskar Chaudhuri, Barry
`Calvarese. Assignee: Valient.
`
`for Delivery of
`Pharmaceutical Carrier Device Suitable
`Pharmaceutical Compounds to Mucosal Surfaces. Inventors:
`Gilles H. Tapolsky, David W. Osborne. Assignee: Arius Two
`Inc.
`
`Protectant for UV-induced skin damage. Inventor: David W.
`Osborne. Assignee: QLT, USA.
`
`Topical Acne Vulgaris Medication with a Sunscreen.
`Inventors: Arturo Angle, David W. Osborne, Gordon J. Dow.
`Assignee: Dow Pharmaceutical Sciences.
`
`Topical Acne Vulgaris Medication with a Sunscreen.
`Inventors: Arturo Angle, David W. Osborne, Gordon J. Dow.
`Assignee: Dow Pharmaceutical Sciences.
`
`Compositions for Topical Application of Therapeutic Agents.
`Inventor: David W. Osborne. Assignee: ViroTex Corporation.
`
`Pharmaceutical Gel and Aerosol Formulations and Methods to
`Administer the Same to Skin and Mucosal Surfaces.
`Inventors: David W. Osborne, Russell J. Mumper. Assignee:
`Atrix Laboratories.
`
`7 of 17
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`DAVID W. OSBORNE, Ph.D.
`
`
`
`6,355,657
`
`
`
`PAGE 8
`
`System for Percutaneous Delivery of Opioid Analgesics.
`Inventor: David W. Osborne. Assignee: Atrix Laboratories
`
`
`6,290,984
`
`
`6,159,498
`
`
`6,103,266
`
`
`6,060,085
`
`
`5,955,097
`
`
`5,906,808
`
`
`5,905,092
`
`
`5,863,560
`
`
`5,800,832
`
`
`5,776,430
`
`
`5,762,917
`
`Pharmaceutical Preparation Applicable to Mucosal Surfaces
`and Body Tissues. Inventors: Gilles H. Tapolsky and David
`W. Osborne. Assignee: ViroTex Corporation.
`
`Bioerodible Film for Delivery of Pharmaceutical Compounds
`of Mucosal Surfaces. Inventors: Gilles H. Tapolsky, David W.
`Osborne. Assignee: ViroTex Corporation
`
`Pharmaceutical Gel Preparation Applicable to Mucosal
`Surfaces and Body Tissues. Inventors: Gilles H. Tapolsky,
`David W. Osborne. Assignee: ViroTex Corporation
`
`Compositions and Methods for Topical Application of
`Therapeutic Agents. Inventor: David W. Osborne. Assignee:
`ViroTex Corporation
`
`Pharmaceutical Preparation Applicable to Mucosal Surfaces
`and Body Tissues. Inventors: Gilles H. Tapolsky, David W.
`Osborne. Assignee: ViroTex Corporation.
`
`Process of Preparing a Topical Antimicrobial Cleanser.
`Inventors: David W. Osborne, Fred Kirchner. Assignee:
`Calgon Vestal, Inc.
`
`Topical Antibiotic Composition Providing Optimal Moisture
`Environment for Rapid Wound Healing that Reduces Skin
`Contraction. Inventors: David W. Osborne, Meidong Yang.
`Assignee: ViroTex Corporation
`
`for Topical Application of
`Composition and Methods
`Therapeutic Agents. Inventor: David W. Osborne, Assignee:
`ViroTex Corporation
`
`Bioerodible Film for Delivery of Pharmaceutical Compounds
`to Mucosal Surfaces. Inventors: Gilles H. Tapolsky, David W.
`Osborne, Assignee: ViroTex Corporation.
`
`Topical Antimicrobial Cleanser Containing Chlorhexidine
`Gluconte and Alcohol. Inventors: David W. Osborne, Fred
`Kirchner, Assignee: Calgon Vestal, Inc.
`
`Method and Composition for Cleansing Wounds with Minimal
`Cytotoxicity for Minimal Scarring.
`
`Inventor: David W.
`Osborne, Assignee: ViroTex Corporation.
`
`8 of 17
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`DAVID W. OSBORNE, Ph.D.
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`
`
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`5,631,301
`
`
`
`PAGE 9
`
`Topical Antibiotic Composition Providing Optimal Moisture
`Environment. Inventor: David W. Osborne, Assignee: ViroTex
`Corporation.
`
`
`DO350601
`
`
`
`
`AU 784,676
`
`
`AU 768,046
`
`
`AU 746,339
`
`
`AU 737,365
`
`
`AU 731,645
`
`
`AU 729,516
`
`
`CA 2329128
`
`
`CA 2268187
`
`
`
`Vaginal Drug Delivery Insert. Inventor: David W. Osborne,
`Charles R. Whitman. Assignee: The Upjohn Company
`
`Over 83 Issued National Patents from PCT Filings
`
`Pharmaceutical Gel and Aerosol Formulations and Methods to
`Administer the Same to Skin and Mucosal Surfaces.
`Inventors: David W. Osborne, Russell J. Mumper. Assignee:
`Atrix Laboratories.
`
`Compositions and Methods for Topical Application of
`Therapeutic Agents. Inventor: David W. Osborne. Assignee:
`ViroTex Corporation.
`
`Pharmaceutical Carrier Device Suitable for Delivery of
`Pharmaceutical Compounds to Mucosal Surfaces. Inventors:
`Gilles H. Tapolsky, David W. Osborne. Assignee: ViroTex
`Corporation.
`
`Compositions and Methods for Topical Application of
`Therapeutic Agents. Inventor: David W. Osborne. Assignee:
`ViroTex Corporation.
`
`Pharmaceutical Gel Preparation Applicable to Mucosal
`Surfaces and Body Tissues. Inventors: Gilles H. Tapolsky,
`David W. Osborne. Assignee: ViroTex Corporation.
`
`Pharmaceutical Carrier Device Suitable for Delivery of
`Pharmaceutical Compounds to Mucosal Surfaces. Inventors:
`Gilles H. Tapolsky, David W. Osborne. Assignee: ViroTex
`Corporation
`
`Pharmaceutical Carrier Device Suitable for Delivery of
`Pharmaceutical Compounds to Mucosal Surfaces. Inventors:
`Gilles H. Tapolsky, David W. Osborne. Assignee: ViroTex
`Corporation
`
`Pharmaceutical Carrier Device Suitable for Delivery of
`Pharmaceutical Compounds to Mucosal Surfaces. Inventors:
`Gilles H. Tapolsky, David W. Osborne. Assignee: ViroTex
`Corporation
`
`9 of 17
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`DAVID W. OSBORNE, Ph.D.
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`
`
`CA 2268140
`
`
`
`PAGE 10
`
`Pharmaceutical Gel Preparation Applicable to Mucosal
`Surfaces and Body Tissues. Inventors: Gilles H. Tapolsky,
`David W. Osborne. Assignee: ViroTex Corporation.
`
`
`CA 2265461
`
`
`CA 2250117
`
`
`EU 1 210 934
`
`
`EU 0 973 497
`
`
`
`EU 0 957 900
`
`
`EU 0 930 873
`
`Compositions and Methods for Topical Application of
`Therapeutic Agents. Inventor: David W. Osborne. Assignee:
`ViroTex Corporation.
`
`Method and Composition for Cleansing Wounds with Minimal
`Cytotoxicity for Minimal Scarring.
`
`Inventor: David W.
`Osborne, Assignee: ViroTex Corporation.
`
`(WO/1998/018605) Pharmaceutical Carrier Preparation
`Applicable to Mucosal Surfaces and Body Tissues. Inventors:
`Gilles H. Tapolsky, David W. Osborne. Assignee: ViroTex
`Corporation. Designated in AT BE CH DE DK ES FI FR GB GR
`IE IT LI LU MC NL PT and SE.
`
`(WO/1999/055312) Pharmaceutical Carrier Device Suitable for
`Delivery of Pharmaceutical Compounds to Mucosal Surfaces.
`Inventors: Gilles H. Tapolsky, David W. Osborne. Assignee:
`ViroTex Corporation. Designated in AT BE CH DE DK ES FR
`GB GR IE IT NL and SE. In Germany P 697 17 862.5-08 and in
`Greece 20030400713.
`
`(WO/1998/010746) Compositions and Methods for Topical
`Application of Therapeutic Agents. Inventor: David W.
`Osborne. Assignee: ViroTex Corporation. Designated in AT
`BE CH DE DK ES FI FR GB GR IE IT LI LU MC NL PT and SE.
`
`(WO/1998/017252) Pharmaceutical Gel Preparation Applicable
`to Mucosal Surfaces and Body Tissues. Inventors: Gilles H.
`Tapolsky, David W. Osborne. Assignee: ViroTex Corporation.
`33 international patents issued having the numbers 930873 in
`Austria, Belgium, Switzerland, Germany, Denmark, Spain,
`Finland, France, UK, Greece, Ireland, Italy, Luxembourg,
`Monaco, Netherlands, Portugal, Sweden; E338537T1 in
`Belgium; 69736641.3-08 in Germany; 20060404188 in Greece;
`1210934 in Belgium, Switzerland, Denmark, Spain, Finland,
`France, UK, Ireland, Italy, Luxembourg, Netherlands, Portugal,
`Sweden.
`
`
`PUBLISHED PATENT APPLICATIONS
`
`20110196040
`
`for Polar Drugs.
`Skin Penetration Enhancing Systems
`Inventors: David W. Osborne, Pramod P. Sarpotdar, Arturo J.
`
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`PAGE 11
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`20100304426
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`20090182004
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`20080268021
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`20070207192
`
`
`20070207107
`
`
`20070122435
`
`
`20060204526
`
`
`20030194420
`
`Angel, Inigo Saenz De Tegada, Maria Luisa Krauel. Filed
`February 17, 2009.
`
`Analytical Methods for Measuring Synthetic Progesterone.
`Inventors: David Osborne, Paul Winkler. Filed May 26, 2010.
`
`Imiquimod Formulation. Inventors: Gareth Winckle, David W.
`Osborne. Filed January 14, 2009.
`
`Adhesive bioerodible ocular drug delivery system. Inventors:
`Stephen L. Warren, David W. Osborne, Richard Holl. Filed
`June 24, 2008.
`
`Adhesive bioerodible transmucosal drug delivery system.
`Inventors: Richard J. Holl, David W. Osborne, Assignee: QLT,
`USA. Filed December 22, 2006. (11/645,091)
`
`Silicone based emulsions for topical drug delivery. Inventors:
`Gareth Winkle, David W. Osborne, Gordon J. Dow, Assignee:
`Not Disclosed. Filed January 30, 2007.
`
`Topical dapsone treatment for acne. Inventor: David W.
`Osborne, Assignee: QLT, USA. Filed December 12, 2006.
`
`Emulsive composition containing Dapsone. Inventors: Robert
`W. Lathrop, David W. Osborne. Assignee: Atrix Laboratories.
`Filed February 13, 2006. (11/352,935)
`
`Process for loading a drug delivery device. Inventor: Richard
`Holl, Kasey Kravig, Scott Jefers, David W. Osborne, Gerald A.
`Boaudoin, and Amy Poshusta. Assignee: Not Disclosed. Filed
`April 11, 2002. (10/121,430)
`
`
`
`FEDERAL GRANT SUPPORT
`
`SBIR Grant No. R44 AI058358-02 (NIAID). Topical Use of TEAC to Treat
`Cutaneous Viral Infection. $915,160 grant awarded
`August 2005.
`
`
`SBIR Grant No. R43 AI63706-01 (NIAID). P-113: A Novel Peptide Therapy for
`Vaginal Candidiasis. $86,650 grant awarded March 2005.
`
`
`SBIR Grant No. R43 AR43531-0IAI (NIAMS). 1% Dapsone Topical Gel for
`Dermatitis Herpetiformis. $99,844 grant awarded April
`1997.
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`11 of 17
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`DAVID W. OSBORNE, Ph.D.
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`SBIR Grant No. R43 AI38158-01 (NIAID). Optimized Dermal Delivery of
`Tetracaine for HSV-2 Lesions. $99,970 grant awarded
`October 1995.
`
`PAGE 12
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`GRADUATE COMMITTEE MEMBER
`
`Rush University Medical Center, Clinical Pharmacology
`Kathleen C. Heneghan, PhD
`Topical Loperamide for Pain Reduction.
`
`
`June 2015.
`
`University of Houston, College of Pharmacy
`Adwoa O. Nornoo, PhD
`Microemulsion formulations of Paclitazel.
`August,1998.
`
`
`Robert O. Kumi, PhD
`
`Preclinical
`Development,
`Formulation
`Phamacokinetics and Efficacy of Liposomes
`Incorporating Annamycin, a Lipophilic Analog
`of Doxorubicin.
`November 1997.
`
`
`
`
`
`
`
`
`
`
`Liposomal Formulation of Cefazolin.
`June 1995.
`
`
`Dong Liang, PhD
`
`
`
`PUBLICATIONS
`
`1.
`
`“Solubilization of Calcium Dodecyl Sulfate in a Micellar Solution and in Lamellar
`Liquid Crystal,” S.E. Friberg and D.W. Osborne, Colloids and Surfaces, 12, 357-365
`(1984).
`
`
`
`2.
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`
`
`3.
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`
`
`4.
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`
`
`5.
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`
`6.
`
`“X-Ray Diffraction Study of Human Stratum Corneum,” S.E. Friberg, D.W. Osborne
`and T.L. Tombridge, J. Society Cosmetic Chemists, 36, 349-354 (1985).
`
`“Cooperative Education – A New Perspective,” David Osborne, ACS Co-Op
`Newsletter, 6(1), 5 (1985).
`
`“Diacid – A Non-Traditional Hydrotrope,” S.E. Friberg, D.W. Osborne and T.D.
`Flaim, Symposium Proceedings, XVI Congress of the Spanish Committee on
`Surfactants, Barcelona, Spain, 1985.
`
`“Small Angle X-ray Diffraction Patterns of Stratum Corneum and a Model Structure
`For Its Lipids,” S.E. Friberg and D.W. Osborne, Journal of Dispersion Science and
`Technology, 6(4), 485-495 (1985).
`
`“Viscosities of Solutions of Lithium Chloride in Water-Dimethyl Sulfoxide Mixtures
`at 25, 35 and 45 C,” D.W. Osborne and James F. O’Brien, J. Chemical Engineering
`Data 31, 317-320 (1986).
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`12 of 17
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`PAGE 13
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`DAVID W. OSBORNE, Ph.D.
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`
`
`
`7.
`
`“A Lamellar Liquid Crystal As An In Situ Surface Balance II. The Conformation of 2-
`(alkoyloxy)-1[(alkoyloxy)methyl] – ehtyl-7-(4-heptyl-5, 6dicarboxyl-2-cyclohexene-2-
`yl)heptanoate,” S.E. Friberg and D.W. Osborne, Colloid and Polymer Sci. 264, 182-
`184 (1986).
`
`
`8.
`
`
`9.
`
`
`
`10.
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`11.
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`12.
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`13.
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`14.
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`15.
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`16.
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`17.
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`18.
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`19.
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`20.
`
`
`
`“The Mechanism of Hydrotrope Action of a Dicarboxylic Acid,” S.E. Friberg, S.B.
`Rananavare and D.W. Osborne, J. Colloid Interface Sci., 109, 487-492 (1986).
`
`“Interactions of a Model Skin Surface Lipid with a Modified Triglyceride,” S.E.
`Friberg and D.W. Osborne, J. American Oil Chemical Society, 63, 123-126 (1986).
`
`“Computational Methods for Predicting Skin Permeability,” D.W. Osborne,
`Pharmaceutical Manufacturing, 3(4), 41-48 (1986).
`
`“The Structure of Stratum Corneum Lipids and its Cosmetical Implications,” S.E.
`Friberg, D.W. Osborne and L. Goldsmith, Symposium Proceedings I.F.S.C.C. 14th
`Congress – Barcelona, Spain, 208 (1986).
`
`“Interaction of a Model Epidermal Lipid with a Vegetable Oil Adduct,” S.E. Friberg
`and D.W. Osborne, J.Disp.Sci.Tech., 8(3), 249-258 (1987).
`
`“Role of Stratum Corneum Lipids as Moisture Retaining Agent,” D.W. Osborne and
`S.E. Friberg, Journal of Dispersion Science and Technology, 8(2), 173-179 (1987).
`
`“Evaluation of the Usefulness of Cloud Point Elevation to Predict Transdermal
`Delivery Enhancers,” D.W. Osborne. Drug Development and Industrial Pharmacy,
`13(3), 391-403 (1987).
`
`“Hard Water and Skin Irritation,” D.W. Osborne, J. Amer. Acad. Dermatol., 16(6),
`1263-1264 (1987).
`
`“Automation of Surfactant Phase Behavior Determination by Laboratory Robotics,”
`C.V.Pesheck, K.J. O’Neill and D.W. Osborne, J. Colloid Interface Sci. 119, 289-290
`(1987).
`
`“A Small-Angle Neutron-Scattering Study of a Non-Aqueous Three Component
`Microemulsion,” S.B. Rananavare, A.J.I. Ward, D.W. Osborne, S.E. Friberg and H.
`Kaiser, J. Phys. Chem., 92, 5181–5183 (1988).
`
`“The Penetration of 2-(alkoyloxy)-1[(alkoyloxy)methyl]-ethyl-7-(4-heptyl-5, 6-
`dicarboxyl-2-cyclohexene-2-yl) heptanoate into Human Stratum Corneum,” S.E.
`Friberg, L.B. Goldsmith, D.W. Osborne and R. Brown, J.Soc.Cosmet.Chem., 39, 283-
`290 (1988).
`
`“Alcohol-free Microemulsions,” D.W. Osborne, C.A. Middleton and R.L. Rogers,
`J.Disp.Sci.Tech., 9, 415-423 (1988).
`
`“The Effect of the Monosodium Salt of a C21 Dicarboxylic Acid Hydrotrope on
`Biosurfactant Bilayers: Transdermal Delivery Considerations,” D.W. Osborne,
`Colloids & Surfaces, 30, 13-23 (1988).
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`PAGE 14
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`DAVID W. OSBORNE, Ph.D.
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`
`
`21.
`
`“Microemulsions as Topical Drug Delivery Vehicles. I. Characterization of a Model
`System,” D.W. Osborne, A.J.I. Ward and K.J. O’Neill, Drug Development and
`Industrial Pharmacy, 14, (9), 1203-1219 (1988).
`
`
`
`22.
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`23.
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`24.
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`25.
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`26.
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`27.
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`28.
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`29.
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`30.
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`31.
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`32.
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`33.
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`
`
`“Laboratory Robotics for the Personal Care Industry: Phase Behavior Studies,”
`D.W. Osborne, C.V. Pesheck, K.J. O’Neill, A.J.I. Ward and M. El-Nokaly. Cosmetics
`and Toiletries, 103 (November), 53-62 (1988).
`
`“The Skin Softening Properties of Maleated Soybean Oil,” D.W. Osborne,
`Cosmetics & Toiletries, 103 (August), 57-70 (1988).
`
`“Phase Behavior and Viscosity Studies of the Microemulsion System AOT-
`75/Arlacel 20/Hexadecane/Water.” D.W. Osborne, R.J. Chipman and C.V. Pesheck,
`Int.J.Pharm. Tech. & Prod. Manufact., (1989).
`
`“Phase Studies of Zwitterionic Surfactants: Alkyl Sulphobetaines,” P.G. Faulkner,
`A.J.I. Ward and D.W. Osborne, Langmuir 5(4), 924-926 (1989).
`
`“Theoretical Considerations of Transdermal Drug Delivery,” D.W. Osborne, Drug
`News & Perspectives, 2(6), 329, (1989).
`
`“Influence of Skin Surface Lipids on Topical Formulations,” D.W. Osborne and D.A.
`Hatzenbuhler, in Topical Drug Delivery Formulations, D.W. Osborne and A.H.
`Amann eds., Marcel Dekker, New York, 69-86 (1990).
`
`“Computational Methods that Aid Topical Drug Design,” D.W. Osborne, in Topical
`Drug Delivery Formulations, D.W. Osborne and A.H. Amann eds., Marcel Dekker,
`New York, 109-126 (1990).
`
`“Surfactant Association Colloids as Topical Drug Delivery Vehicles,” D.W. Osborne
`and A.J.I. Ward, in Topical Drug Delivery Formulations, D.W. Osborne and A.H.
`Amann eds., Marcel Dekker, New York, 349-379 (1990).
`
`“The Use of Phase Behavior and Laboratory Robotics For The Optimization of
`Pharmaceutical Topical Formulations,” D.W. Osborne, Topical Drug Delivery
`Formulations, D.W. Osborne and A.H. Amann eds., Marcel Dekker, New York, 143-
`195 (1990).
`
`“Stratum Corneum Structure and Transport Properties,” S.E. Friberg, I. Kayali, M.
`Margosiak, D.W. Osborne and A.J.I. Ward, in Topical Drug Delivery Formulations,
`D.W. Osborne and A.H. Amann eds., Marcel Dekker, New York, 29-45 (1990).
`
`“Microemulsions as Topical Drug Delivery Vehicles: In-Vitro Transdermal Delivery
`Studies of a Model Hydrophilic Drug,” D.W. Osborne, A.J.I. Ward, and K.J. O’Neill.
`J. Pharm. Pharmacol. 43, 451-454 (1991).
`
`“Use of a Lamellar Liquid Crystal as a Matrix to Follow Free Radical Initiated Lipid
`Peroxidation,” D.W. Osborne, O.C. Donoghue, J.M. Braughler, A.J.I. Ward.
`Langmuir, 7, 323-326 (1991).
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`14 of 17
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`PAGE 15
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`DAVID W. OSBORNE, Ph.D.
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`
`
`34.
`
`“Evaluation of Cefmetazole Rectal Suppository Formulations,” E. Novak, D.W.
`Osborne, L.E. Matheson, E.L. Parrott, J.L. Lach, W.B. Morrison, Drug
`Dev.Ind.Pharm. 17(3), 373-389 (1991).
`
`
`
`35.
`
`
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`36.
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`
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`37.
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`38.
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`39.
`
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`40.
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`41.
`
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`42.
`
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`43.
`
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`44.
`
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`45.
`
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`46.
`
`
`
`“Dioctyl Sodium Sulfosuccinate-Sorbitan Monolaurate Microemulsions,” D.W.
`Osborne, C.V. Pesheck, R.J. Chipman, in Microemulsions and Emulsions In Foods,
`M. ElNokaly, and D. Cornell eds., ACS Symposium Series 448, American Chemical
`Society, Washington DC, 62-79 (1991).
`
`“Symposium on Zwitterionic Surfactants: Preface,” D.W. Osborne, A.J.I. Ward,
`Langmuir, 7, 840-841 (1991).
`
`“Phase Behavior Characterization of Propylene Glycol, White Petrolatum,
`Surfactant Ointments,” D.W. Osborne, Drug Development and Industrial Pharmacy,
`18, 1883-1894 (1992).
`
`“A Computational Method for Predicting Optimization of Prodrugs or Analogs for
`Percutaneous Delivery,"” D.W. Osborne, W.J. Lambert, in Prodrugs for Dermal
`Delivery, K.B. Sloan ed., Marcel Dekker, New York, 163-178 (1992).
`
`“Hydrotropy and Skin Penetration Enhancement,” A.J.I. Ward and D.W. Osborne, in
`Pharmaceutical Skin Penetration Enhancement, J. Hadgraft and K.A. Walters eds.,
`Marcel Dekker, New York, 365-388 (1993).
`
`“Phase Behavior Characterization of Ointments Containing Lanolin or a Lanolin
`Substitute,” D.W. Osborne, Drug Development and Industrial Pharmacy, 19, 1283-
`1302 (1993).
`
`“Preformulation characterization of Topical Ibuprofen Piconol”, C.V. Pesheck, D.W.
`Osborne, Drug Dev. Ind. Pharm. 19, 1889-1902 (1993).
`
`“Lyotropic Liquid Crystals as Topical Drug Delivery Vehicles”, D.W. Osborne, A.J.I.
`Ward, Int’l J. of Pharm Advances 1 (1), 38-45 (1995).
`
`“A Listing of Skin Penetration Enhancers Cited in t