Curriculum Vitae
`
`Richard N. Dalby
`
`Personal Information
`
`Qualifications
`
`Office Address
`
`Educational Summary
`
`Sept. 1984 to Oct. 1988
`
`Ph.D., B. Pharm.
`
`University of Maryland, Department of Pharmaceutical Sciences,
`20 North Pine Street, Baltimore, Maryland 21201.
`
`+1 (410) 706-3245rrdalb
`
`rx.uma landedu
`
`University of Kentucky College of Pharmacy. Ph.D.
`Sciences supervised by Dr. Peter R. Byron.
`
`in Pharmaceutical
`
`Sept. 1980 to June 1983
`
`Nottingham University School of Pharmacy, B. Pharrn. (Honors).
`
`Employment Summam
`
`July 2003 to present
`
`Sept. 1992 to present
`
`Jan 2010 to June 2016
`
`Jan. 2009 to Dec 2009
`
`May 1997 to July 2003
`
`Aug. 2001 to Jan. 2002
`
`May 1997 to Sept. 1999
`
`Dec. 1989 to Aug. 1992
`
`Oct. 1988 to Nov. 1989
`
`Oct. 1984 to Sept. 1988
`
`Sept. 1983 to Sept. 1984
`
`Jun. to Sept. 1981 & 1982
`
`Professor, Department of Pharmaceutical Sciences, University of
`Maryland (July 1996 to June 2003, Associate Professor, Sept. 1992 to
`June 1996, Assistant Professor).
`
`Affiliate Professor, School of Pharmacy, Medical College of Virginia 1
`Virginia Commonwealth University (July 1996 to June 2003, Affiliate
`Associate Professor; Sept. 1992 to June 1996, Affiliate Assistant
`Professor).
`
`Associate Dean for Academic Affairs, School of Pharmacy, University of
`Maryland. Subsumed responsibilities of Associate Dean for Curricular and
`Instructional Resources in January 2012.
`
`Graduate Program Director, Department of Pharmaceutical Sciences,
`University of Maryland.
`
`Vice Chair, Department of Pharmaceutical Sciences, University of
`Maryland.
`
`Acting Chair, Department of Pharmaceutical Sciences, University of
`Maryland.
`
`Graduate Program Director, Department of Pharmaceutical Sciences,
`University of Maryland.
`
`Research Assistant Professor at Medical College of \firginia 1 Virginia
`Commonwealth University, Department of Pharmacy and Pharmaceutics.
`
`Development Scientist, Fisons Pharmaceuticals (now sanofi aventis).
`Responsible for development of MDls & DPls. Offered promotion to
`Section Leader in 1989.
`
`Teaching and research assistant at the University of Kentucky College of
`Pharmacy.
`
`Roche
`at
`training
`pre-registration
`industry
`Pharmaceutical
`Pharmaceuticals and hospital pre-registration training at University
`College Hospital.
`
`Preregistration Pharmacy Student with the Boots Company (Community
`pharmacy).
`
`UNITED THERAPEUTICS, EX. 2022
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-01621
`Page 1 of 24
`
`

`

`Richard Dalby, PhD.
`
`Membership of Professional Organizations
`
`Fellow of the American Association of Pharmaceutical Scientists and member of the Royal Pharmaceutical
`
`Society of Great Britain (M.R. Pharm. 8., Registered Pharmacist in United Kingdom, License Number
`78009, not current),.
`
`Research Interests
`
`Formulation and evaluation of pressurized metered dose inhaler, dry powder, nebulizer, and nasal spray
`products. Development and evaluation of existing and proposed test methods for inhalation products.
`Laboratory testing and patient evaluation of novel pulmonary and nasal delivery devices. Design of patient
`education aids.
`
`Papers
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`10.
`
`11.
`
`implications of the Stiolto® Respimat® Soft MistT” inhaler for patients with chronic
`Clinical
`obstructive pulmonary disease. Gary T. Ferguson and Richard N. Dalby. Journal of Postgraduate
`Medicine (Submitted).
`
`Automated Actuation of Nasal Spray Products: Effect of Hand Related Variability on the In Vitro
`Performance of Flonase® Nasal Spray; Diane V. Doughty, Wenchi Hsu and Richard N. Dalby. Drug
`Development and Industrial Pharmacy, Vol. 40, No.
`6, Pages 711-718,
`June 2014.
`DOI:10.3109l03639045.2013.777735.
`
`Methodology for the In Vitro Evaluation of the Delivepg Efficiency from Valved Holding Chambers
`with Facemasks; Zhen Xu, Wenchi Hsu, Dirk von Hollen, Ashwin Viswanath, Kurt Nikander and
`Richard Dalby Journal of Aerosols in Medicine and Pulmonary Drug Delivery, Volume 2?,
`Supplement 1, 844-54, 2013. DOI: 10.1089ljamp.2013.1074. PMID: 24219816.
`
`Development of Respimat and its Clinical Utility in Respiratopg Disorders, R N Dalby, J Eicher and
`B Zierenberg, Medical Devices: Evidence and Research. Medical Devices: Vol 1, No 4, pages 145—
`155, 2011.
`
`Effect of Various Formulation and Administration Related Factors on Deposition Pattern of Nasal
`Spray Pumps. Vipra Kundoor and Richard N. Dalby. Pharmaceutical Research, Volume 28,
`Number 8, 1895—1904, 2011. PMID: 21499839.
`
`Automated Actuation of Nasal Spray Products: Determination and Comparison of Adult and
`Pediatric Settings. D. V. Doughty, C. Vibbert, M. E. Bollinger, A. Kewalramani and R. N. Dalby.
`Drug Development and Industrial Pharmacy. Vol. 37, No. 3, pages 359-366, 2010.
`
`imaging and
`Thousand Years of Pharmaceutical Aerosol’s Conference Paper. Deposition,
`clearance: What remains to be done? Aerosol Medicine and Pulmonary Drug Delivery, Volume 23,
`Suppl 2, pages 1—19, 2010.
`
`Assessment of Facial and Ocular Deposition of Nebulized Aerosol Using a Color Based Method.
`Vipra Kundoor and Richard N. Dalby. Drug Development and Industrial Pharmacy, Pages 1-5, June
`2010. PMID: 20545511.
`
`Demonstrating Bioeguivalence of Locally Acting Orally Inhaled Drug Products {OIPsl: Workshop
`Summary Report, Cosponsored by Product Quality Research Institute (PQRI) and Inhaiation and
`Nasal Technology Focus Group ([NTFG). Wallace P. Adams, Richard C. Ahrens, Mei—Ling Chen,
`David Christopher, Badrul A. Chowdhury, Dale P. Conner, Richard Dalby, Kevin Fitzgerald, Leslie
`Hendeles, Anthony J. Hickey, Gunther Hcchhaus, Beth L. Laube, Paul Lucas, Sau L. Lee, Svetlana
`Lyapustina, Bing Li, Dennis O'Connor, Neil Parikh, David A. Parkins, Prasad Peri, Gary R. Pitcairn,
`Michael Riebe, Partha Roy, Tushar Shah, Gur Jai Pal Singh, Sandra Suarez Sharp, Julie D.
`Suman, Marjolein Weda, Janet Woodcock and Lawrence Yu. J. Aerosol Medicine and Pulmonary
`Drug Delivery. Volume 23, Number 1, pp. 1—29, 2010.
`
`Assessment of Nasal Spray Deposition Pattern In A Silicone Human Nose Model Using A Color
`Based Method. Vipra Kundoor and Richard Dalby. Pharmaceutical Research, Volume 27, Number
`1, Pages 30—36. January, 2010. DOI: 10.100'fls11095—009—0002—4.
`
`Effect of Flexible Dip—tubes and Shaking on Spray Weight Consistency in Nasal Sprays. Diane
`Doughty, Lei Li and Richard N. Dalby. J. Aerosol Medicine and Pulmonary Drug Delivery, Volume
`23, Number 2, pages 69—75, 2010.
`
`Page 2 of 24
`
`UNITED THERAPEUTICS, EX. 2022
`WATSON LABORATORIES V. UNITED THERAPEUTICS, |PR201?-01621
`Page 2 of 24
`
`

`

`Richard Datby, PhD.
`
`12.
`
`13.
`
`14.
`
`15.
`
`16.
`
`17.
`
`18.
`
`19.
`
`20.
`
`21.
`
`22.
`
`23.
`
`24.
`
`25.
`
`26.
`
`27.
`
`28.
`
`29.
`
`30.
`
`Phospholipid Induced In Vivo Particle Migration to Enhance Pulmonapy Deposition. Sudipta
`Ganguly, Vikas Moolchandani, Natalie Eddington, Joseph Roche, Paul S. Shapiro, Shailaja
`Somaraju and Richard N. Dalby. J. Aerosol Medicine and Pulmonary Drug Delivery, Vol. 21, No. 4:
`343-350, Dec 2008.
`
`in Healthy Female
`Phase I Clinical Trial of Repeat Dose Terameprocol Vaginal Ointment
`Volunteers. Niharika Khanna, Richard Dalby, Alyson Connor, Ann Church, Jennifer Stern and Neil
`Frazer. Sexually Transmitted Diseases. 35(6):577—582, 2008.
`
`Phase IIII Clinical Safety Studies of Terameprocol Vaginal Ointment. Niharika Khanna, Richard
`Dalby, Ming Tan, Stephanie Arnold, Jennifer Sternand & Neil Frazer. Gynecologic Oncology,
`Volume 107, Issue 3, 554—562, 2007.
`
`The Analysis and Prediction of Functional Robustness of Inhaler Devices. Pallavi Nithyanandan,
`Stephen W. Hoag and Richard N. Dalby. Journal of Aerosol Medicine, 20 (1), 19—37, 2007.
`
`Validity of In Vitro Tests on Aqueous Spray Pumps as Surrogates for Nasal Deposition, Absorption
`and Biologic Response. Julie D. Suman, Beth L. Laube and Richard Dalby, J. Aerosol Medicine,
`19 (4), 510-521, 2006.
`Positive Expiratory Pressure Changes Aerosol Distribution in Patients with Cystic Fibrosis. Beth L.
`Laube, David E. Geller, Ta-Chun Lin, I Richard N. Dalby, Marie Diener—West and Pamela L. Zeitlin.
`Respiratory Care, 50 (11), 1438—1444, November 2005.
`
`The Effect of Formulation Variables and Breathing Patterns on the Site of Nasal Deposition in an
`Anatomically Correct Model. Yang Guo, Beth Laube and Richard Dalby. Pharmaceutical Research
`22 (11), 1871—1878, November 2005.
`Who Nose, Richard Dalby, Yang Guo and Julie Suman. European Pharmaceuticai Review, 10 (1),
`96-100, 2005.
`
`A Review of the Development of Respimat® Soft Mist Inhaler. Dalby, R, Spallek, M and Vcshaar,
`T. International Journal of Pharmaceutics, Volume 283, Issues 1-2 , 1-9, 2004.
`
`Drug Delivery to the Nasal Cavity: In Vitro And In Vivo Assessment. Stephen P. Newman, Gary R
`Pitcairn and Richard N. Dalby. Critical Reviews in Therapeutic Drug Carrier Systems, 21 (1), 21-
`66, 2004.
`
`Inhalation Therapy: Technical Milestones in Asthma Treatment, Richard Dalby and Julie Suman.
`Advanced Drug Delivery Reviews, 55 (T), 779—791, 2003.
`
`Pulmonary Drug Delivery — What’s Next, Richard Dalby. European Pharmaceutical Review, 2,
`73, June 2003
`
`70—
`
`Allergen Challenge and Deposition of Nedocromil Sodium in Asthma, B.L. Laube, T. Lin, A.
`Valleteau, R.N. Dalby, F.B. Diemer and AG. Togias. Journal of Aerosol Medicine, 15(4), 415-426,
`2002.
`
`Predicting the Quality of Powders for Inhalation from Surface Energy, David P. Cline and Richard
`N. Dalby. Pharmaceutical Research, 9 (19), September 2002.
`
`Novel system to investigate the Effects Of Inhaled Volume And Rates Of Rise In Simulated
`Inspiratcry Air Flow 0n Fine Particle Output From A Dry Powder Inhaler [DPIL Varsha Chavan and
`Richard Dalby. AAPS PharmSci; 4 (2) article 6 (2002).
`Relevance of In Vitro Tests of Nasal Solutions to Predict In Vivo Deposition., J.D. Suman, B.L.
`Laube, T. Lin, G. Brouet, and R. Dalby. Pharmaceutical Research, 19 (1): 1-6 (2002).
`Targeting Aerosol Deposition In Patients With Cystic Fibrosis: Effects Of Alterations In Particle Size
`And Inspiratogg Flow Rate, Beth L. Laube, Rajkumari Jashnani, Richard N. Dalby and Pamela
`Zeitlin. Chest :11821069 -1076 (2000).
`
`Effect Of Rise In Simulated Inspiratogg Flow Rate And Carrier Particle Size On Powder Emptying
`From DD: Powder
`Inhalers, Varsha Chavan and Richard Dalby, American Association Of
`Pharmaceutical Scientists, AAPS PharmSci; 2 (2) article 10 (2000).
`
`Inhaled ATP Causes Mucin Release From Goblet Cell Of Intact Rat, Chan Young Shim, K. Chul
`Kim, Mi-Jeong Jo, Kyu Hwan Park, Richard Dalby and Kwang Ho Kc. Journal of Experimental Lung
`Research, 26: 1—11 (2000).
`
`Page 3 of 24
`
`UNITED THERAPEUTICS, EX. 2022
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-01621
`Page 3 of 24
`
`

`

`Richard Dalby, PhD.
`
`31.
`
`32.
`
`33.
`
`34.
`
`35.
`
`36.
`
`37.
`
`38.
`
`39.
`
`40.
`
`41.
`
`42.
`
`43.
`
`44.
`
`45.
`
`46.
`
`47.
`
`48.
`
`49.
`
`Nasal Nebulizers Versus Nasal Spray Pumps: An Investigation Of Deposition And Mucociliary
`Clearance. Julie Suman, Beth L. Laube and Richard N. Dalby. Pharmaceutical Research, 16 (10):
`1648-1652 (1999).
`The Efficacy 0f Slow Vs. Faster Inhalation Of Cromolyn Sodium In Protecting Against Allergen
`Challenge In Patients With Asthma, Beth L. Laube, Alan M. Edwards, Richard N. Daiby, Peter
`Creticos and Philip Norman. J. Allergy and Clinical Immunology, 101 (4) Part 1, 475-483 (1998).
`
`Evaluation Of Aerosol Drug Output From The Optichamber Spacer : Comparison To The
`Aerochamber In A Model System, Richard N. Dalby, Shailaja Somaraju, Varsha Chavan and Dayna
`Jarvis. Journal of Asthma, 35(2), 173—177 (1998).
`
`Predicting In Vivo Lung Deposition Of Cromolyn Sodium From In Vitro Estimates, Beth L. Laube,
`Rajkumari Jashnani and Richard N. Dalby. J. Aerosol Medicine, 11 (Supplement 1), 35—42 (1998).
`Also presented at the international Society for Aerosols in Medicine Focus Symposium, Towards
`meaningful laboratory tests for evaluation of pharmaceutical aerosols, San Juan, PR, January,
`1997.
`
`Liquefied Propellant Density - Measurement And Utility, Shailaja Somaraju, Richard N. Dalby and
`Michael Pierpont. Pharmaceutical Technology, 21(10) (1997).
`
`Semi-Automated Spray Pattern Testing Of Nasal Sprays, Shailaja Somaraju, Julie Suman, Richard
`Dalby and Walter Stridick. Pharmaceutical Technology, 21 (5), 58—64 (1997).
`
`Comparison Of A Respiratory Suspension Aerosolized By An Air Jet And Ultrasonic Nebulizer,
`Susan L. Tiano and Richard N. Dalby. Pharmaceutical Development and Technology, 1 (3), 261-
`268 (1996).
`Testing 0f Dry Powder Aerosol Formulations In Different Environmental Conditions, Rajkumari N.
`Jashnani, Peter R. Byron and Richard N. Dalby. International Journal of Pharmaceutics, 113, 123-
`130 (1994).
`
`Pitfalls And Opportunities In The Inertial Sizing And Output Testing Of Nebulizers, Richard N. Dalby
`and Susan L. Tiano. Pharmaceutical Technology, 17 (9), 144-156 (1993).
`
`Preparation, Characterization, And Dissolution Kinetics Of Two Novel Albuterol Salts; Rajkumari
`N. Jashnani, Peter R. Byron and Richard N. Dalby. Journal of Pharmaceutical Science, 82 (6),
`613—616 (1993).
`
`Validation Of An Improved Rotating Disk Dissolution Apparatus; Rajkumari N. Jashnani, Peter R.
`Byron and Richard N. Dalby. Journal of Pharmaceutical Science, 82 (6), 670—871 (1993).
`Axial Ratio Measurement For Early Detection Of Crystal Growth In Suspension Type Metered Dose
`Inhalers; Elaine M. Phillips, Peter R. Byron and Richard N. Dalby. Pharmaceutical Research, 10
`(3), 454-456 (1993).
`
`Droplet Drying And Electrostatic Collection - A Novel Alternative To Conventional Comminution
`Techniques; Richard N. Dalby, Venkatesh Naini and Peter R. Byron. Journal of Biopharmaceutical
`Sciences, 3(1), 91-99 (1992).
`
`Safety Assessment Of MDls Containing Flammable Propellants; Richard N. Dalby. Journal of
`Biopharmaceutical Sciences, 3 (1), 49—57 (1992).
`
`Prediction And Assessment Of Flammability Hazards Associated With Metered Dose Inhalers
`Containing Flammable Propellants; Richard N. Dalby. Pharmaceutical Research, 9 (5), 636-642
`(1992).
`Metered Dose Inhalers Containing Flammable Propellants: -Perspectives And Some Safety
`Evaluation Procedures; Richard N. Dalby and Peter R. Byron. Pharmaceutical Technology, 15 (10),
`54-66 (1991).
`
`Determination Of Drug Solubility In Aerosol Propellants; Richard N. Dalby, Elaine M. Phillips and
`Peter R. Byron. Pharmaceutical Research, 8(9), 1206-1209 (1991).
`
`Possible Replacements For CFC—Propelled Metered—Dose Inhalers; Richard N. Dalby. Medical
`Device Technology, 21 —25 (1991).
`
`Special Considerations In The Formulation Of Suspension Type Metered Dose Inhalers; Richard
`N. Dalby. Aerosol Age, 22—89 (1990).
`
`Page 4 of 24
`
`UNITED THERAPEUTICS, EX. 2022
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR2017-01621
`Page 4 of 24
`
`

`

`Richard Dalby, PhD.
`
`50.
`
`51.
`
`52.
`
`53.
`
`54.
`
`CFC Propellant Substitution: P—134a As A Potential Replacement For P-12 In MDls; Richard N.
`Dalby, Peter R. Byron, H.R. Shepherd and Elaine Papadopoulos. Pharmaceutical Technology,
`14,(3), 26-33 (1990).
`Optimized Inhalation Aerosols. l. The Effect Of Spherical Baffle Size And Position Upon The Output
`Of Several Pressurized Nonaqueous Suspension Formulations; Peter R. Byron, Richard N. Dalby
`and Anthony J. Hickey. Pharmaceutical Research, 6 (3), 225-229 (1989).
`
`Effects Of Surfactants On Aerosol Powders In Suspension. Implications For Airborne Particle Size;
`Anthony J. Hickey, Richard N. Dalby and Peter R. Byron. International Journal of Pharmaceutics,
`4, 267—270 (1988).
`
`Comparison Of The Output Particle Size Distributions From Pressurized Aerosols Formulated As
`Solutions Or Suspensions, Richard N. Dalby and Peter R. Byron. Pharmaceutical Research, 5 (1),
`36—39, January (1988).
`
`Effects Of Heat Treatment On The Permeability Of Polyvinylalcohol Films To A Hydrophilic Solute;
`Peter R. Byron and Richard N. Dalby. Journal of Pharmaceutical Sciences, 76 (1), 6567 (1987).
`
`Miscellaneous (Unreviewed) Papers
`1.
`
`Sparking Innovation in Drug Delivery. Richard N. Dalby. The Medicine Maker (November 2015).
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`The Respiratory Drug Delivery (RDD®) Conferences. Richard Dalby and Pierre Carlotti. Inhalation,
`9(5), pages 6—8, October 2015.
`
`In vitro Bioeguivalence Testing of Nasal Sprays, Diane V. Doughty, Vipra Kundoor, Feiyan Jin,
`Wenchi Hsu and Richard Dalby, Inhalation, 3(1) 22-26, 2009.
`
`How to Participate in Respiratory Drug Delivery Meetings, Richard N. Dalby, Joanne Pearl and
`Peter R. Byron. Inhalation, October 2007.
`
`Letter to the Editor. J. Aerosol Med. Concerning "Validity of In Vitro Tests on Aqueous Spray Pumps
`as Surrogates for Nasal Deposition, Absorption and Biologic Response. Julie D. Suman, Beth L.
`Laube and Richard Dalby, J. Aerosol Medicine, 19 (4), 510—521, 2006.
`
`Meeting Report. The Annual Respiratory Drug Delivery® Symposium, Richard Dalby. Touch
`Briefings, June 2007.
`
`Meeting Report. Respiratory Drug Delivery Europe 2007. Peter R. Byron, Richard N. Dalby and
`Joanne Peart. Expert Reviews in Respiratory Medicine, 1(1), 2007.
`
`M 1
`
`.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`Creating a Comprehensive Exam to Prepare Students for the PCOA. Andrew Coop, Lisa
`Lebovitz, Shannon R. Tucker, George Anagnostou, Christopher Klimas and Richard N. Dalby.
`AACP Annual Meeting, Anaheim, CA, (July 2016).
`Recruiting Allies - Kids, Colleges, and Communities. Helping Win the Battle for the Best
`Pharmacy Applicants. Richard Dalby, Cherokee Layson Wolf, Lisa Lebovitz, Shannon R. Tucker,
`Margaret Hayes & Alexander Wong. AACP Annual Meeting, Anaheim, CA, (July 2016).
`Potentially Bioactive or Toxic Metals in E-cigarette Materials of Construction. Sarah L. J. Michel,
`Maureen A. Kane, Abraham Schneider, Thao Vo, Geoffrey Shimberg and Richard N. Dalby. ln
`Respiratory Drug Delivery 2016, Richard N. Dalby, Peter R. Byron, Joanne Peart, Julie Suman,
`Paul Young and Daniela Traini, Editors, Book 3, ISBN 1-933722-96-7, p583-586; Davis
`Healthcare International Publishing, River Grove, Illinois (April 2016).
`Plume Geometry Evaluation of Solution—type Metered Dose Inhalers Formulated Using
`Effervescent Aerosol Technology. Muku] S. Kelkar and Richard N. Dalby. In Respiratory Drug
`Delivery 2016, Richard N. Dalby, Peter R. Byron, Joanne Peart, Julie Suman, Paul Young and
`Daniela Traini, Editors, Book 3, ISBN 1-933722-96-7, p579-582; Davis Healthcare International
`Publishing, River Grove, Illinois (April 2016).
`
`It’s Reguired! Richard
`Pharmacy Curriculum Outcomes Assessment (PCOA). Love it or Hate it,
`Dalby, Lisa Lebovitz, Shannon Tucker, Cherokee Layson Wolf, Andrew Coop, Joey Mattingly and
`Nicki Brandt. AACP Annual Meeting, National Harbor, DC (July 2015).
`How PharmD Students Perceive and Reflect on Direct and Sometimes Uncomfortable
`
`Conversations About Professionalism. Cherokee Layson—Wolf and Richard Dalby. AACP Annual
`Meeting, National Harbor, DC (July 2015).
`
`Page 5 of 24
`
`UNITED THERAPEUTICS, EX. 2022
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-01621
`Page 5 of 24
`
`

`

`Richard Dalby, PhD.
`
`7.
`
`8.
`
`9.
`
`10.
`
`11.
`
`12.
`
`13.
`
`14.
`
`15.
`
`16.
`
`17.
`
`18.
`
`19.
`
`20.
`
`21.
`
`22.
`
`23.
`
`Physics for Pre—pharmacy: Is a Spirometer Faster than a Racecar? Alexander Wong, Richard Dalby
`and Kathleen J Pincus. American Association of Physics Teachers (AAPT), College Park, Maryland
`(July 2015).
`Formulation of Suspension-type Pressurized Metered Dose Inhalers Using Effervescent Aerosol
`Technology. Mukul S. Kelkar and Richard N. Dalby. In Respiratory Drug Delivery Europe 2015,
`Richard N. Dalby, Peter R. Byron, Joanne Peart, Julie Suman, Paul Young and Daniela Traini,
`Editors, Book 2, ISBN 1—933722—88—6, p493—496; Davis Healthcare International Publishing, River
`Grove, Illinois (May 2015).
`
`Formulation of Solution—type Pressurized Metered Dose Inhalers Using Effervescent Aerosol
`Technology. Mukul S. Kelkar and Richard N. Dalby.
`In Respiratory Drug Delivery Asia 2014,
`Richard N. Dalby, Peter R. Byron, Joanne Peart, Paul Young and Daniela Traini, Editors, Davis
`Healthcare International Publishing, River Grove, Illinois (November 2014).
`
`Child and Caregiver Reaction to Use of a Prototype Inhalation Monitor as a Training Tool. Mona G
`Tsoukleris, Jill Morgan, Francoise Pradel, Mary E Bollinger, Richard Dalby and Wenchi Hsu.
`Association of Asthma Educators Annual Meeting, San Antonio, TX. August 2014. Accepted as a
`top abstract to be presented from the podium.
`
`Career Preparation. The Final Frontier: Maintaining Student Attention During Off Campus
`Experiences. Richard Dalby, Shannon Tucker, Lisa Lebovitz and Cherokee Layson Wolf. AACP
`Annual Meeting, Dallas, TX, July 2014.
`
`Contrasting Approaches and Experiences with Electronic Examinations. Richard Dalby, Veronica
`Shuford, Shannon Tucker and Brigitte Sicat. AACP Annual Meeting, Dallas, TX, July 2014.
`A Simple and Effective Programmatic Assessment Process for Continuous Quality Improvement.
`Lisa Lebovitz and Richard Dalby. AACP Annual Meeting, Dallas, TX, July 2014. Abstract received
`the 2014 AACP Award for Excellence in Assessment.
`
`Planning an IPE Day, Lebovitz L, Congdon H, Dalby R, Mallott, D and Pecukonis E. All Together
`Better Health, Pittsburgh, PA, June 2014.
`
`Effervescent Aerosols: A Novel Formulation Technology for Pressurized Metered Dose Inhalers.
`Mukul S. Kelkar and Richard N. Dalby. In Respiratory Drug Delivery 2014, Richard N. Dalby, Peter
`R. Byron, Joanne Peart, Julie Suman, Paul Young and Daniela Traini, Editors, Davis Healthcare
`International Publishing, River Grove, Illinois Vol 3, pp 669—672 (2014). Selected for Posters on
`the Podium presentation.
`
`Does Tmst in the Pharmacist Correlate with Improved Asthma Outcomes, a Pilot Study. Jill Morgan,
`Mona Tsoukleris, Richard Dalby, Wenchi Hsu and Francoise Pradel. The 23rd Pediatric Pharmacy
`Advocacy Group Annual Meeting, Nashville, TN, April 2014.
`
`Child and Caregiver Reaction to Use of a Prototype Inhalation Monitor as a Training Tool. Mona G
`Tsoukleris, Jill Morgan, Francoise Pradel, Mary E Bollinger, Richard Dalby and Wenchi Hsu. ASHP
`Midyear Meeting, Orlando, FL. December 2013.
`In vitro Delivery Efficiency of Valved Holding Chambers with or without Facemasks. Z Xu, M Kelkar,
`D von Hollen, A Viswanath, K Nikander and R Dalby. Drug Delivery to the Lungs, Edinburgh,
`Scotland, December 2013.
`
`Novel Approach to an Assessment Committee. Lisa Lebovitz, Fadia T. Shaya and Richard N.
`Dalby. AACP Annual Meeting, Chicago, IL. July 2013.
`
`Relationship between Student Confidence and Cumulative GPA Upon Completion of Didactic
`PharmD Coursework. Lisa Lebovitz, Stuart T. Haines, Deborah A. Sturpe, David S. Roffman and
`Richard N. Dalby. AACP Annual Meeting, Chicago, IL. July 2013.
`
`Valved Holding Chambers and Facemask Systems: The Relationship of Facemask Leakage and
`in vitro Dmg Delivery Efficiency. Zhen Xu, Wenchi Hsu, Dirk von Hollen, Ashwin Viswanath, Kurt
`Nikander and Richard Dalby. American Association of Pharmaceutical Scientists Annual Meeting,
`Chicago, IL, October 2012.
`
`Assessment of Facemask Seal Leakage from Six VHC Systems on Two Pediatric Simulated
`Anatomical Models Under Simulated Breathing Conditions. 2. Xu, D. von Hollen, W.Hsu, K.
`Nikander and R. Dalby. European Respiratory Society, Vienna, Austria. September 2012.
`
`Delivery Efficiency from Valved Holding Chambers with Facemasks: A Comparative Study Using
`Soft Anatomical Face Models. Zhen Xu, Wenchi Hsu, Dirk von Hollen, Ashwin Viswanath, Kurt
`
`Page 6 of 24
`
`UNITED THERAPEUTICS, EX. 2022
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-01621
`Page 6 of 24
`
`

`

`Richard Dalby, PhD.
`
`Nikander and Richard N Dalby. In Respiratory Drug Delivery 2012, Richard N. Daiby, Peter R.
`Byron, Joanne Peart, Julie Suman, Stephen Farr and Paul Young, Editors, Davis Healthcare
`International Publishing, Vol 3, pp 809-814 (2012).
`Statistically Significant Improvement in Inhaler Technique Among Patient Volunteers Using an
`Instrumented Inhaler. Wenchi Hsu, Lin Hao, Mona Tsoukleris, Jill Morgan, Mary Bollinger,
`Francoise Pradel & Richard Dalby. American Association of Pharmaceutical Scientists Annual
`Meeting, Washington, DC, October 2011.
`
`Preliminary Evaluation of an Automated Andersen Cascade Impactor - The “ABC". Zhen Xu, Rajesh
`Maheshwari, Krishna Maheshwari & Richard Dalby. American Association of Pharmaceutical
`Scientists Annual Meeting, Washington, DC, October 2011.
`
`Breath by Breath Delivered Dose Comparison from Three Valved Holding Chambers with
`Facemasks Under Simulated Pediatric Breathing Conditions. W. Hsu, D von Hollen, Z. Xu, T Bei,
`K Nikander and R Dalby. European Respiratory Society, Amsterdam, The Netherlands. September
`2011.
`
`Does an Integrated Curriculum Lead to Improved Confidence to Practice? Raymond C. Love
`University of Maryland; Lisa Lebovitz, Yunting Fu, and Richard Dalby, University of Maryland
`School of Pharmacy. AACP Annual Meeting. San Antonio, Texas. July 2011.
`
`Evaluation of Delivery Efficiency from a Valved Holding Chamber with Facemask under Simulated
`Conditions. Wenchi Hsu, Zhen Xu, Dirk von Hollen, Tao Bai, Kurt Nikander and Richard Dalby. In
`Respiratory Drug Delivery Europe 2011, Richard N. Dalby, Peter R. Byron, Joanne Peart, Julie
`Suman and Paul Young, Editors, Davis Healthcare International Publishing, May 2011.
`Comparative Analysis of ln-use Actuation Parameters with In Vitro Performance of Nasal Spray
`Pumps. Gerallt Williams, Richard N. Dalby and Diane V. Doughty. In Respiratory Drug Delivery
`Europe 2011, Richard N. Dalby, Peter R. Byron, Joanne Peart, Julie Suman and Paul Young,
`Editors, Davis Healthcare International Publishing, May 2011.
`The Effect of Particle Size and Shape on Drug Uptake and Release of Nasal Suspension
`Formulations. Feiyan Jin and Richard N. Dalby. American Association of Pharmaceutical Scientists
`Annual Meeting, New Orleans, LA, November 2010.
`
`Using an Instrumented Inhaler as a Training Aid to Improve Inhaler Technique Among Patient
`Volunteers. Wenchi Hsu, Mona Tsoukleris, Jill Morgan, Mary E. Bollinger & Richard N. Dalby.
`American Association of Pharmaceutical Scientists Annual Meeting, New Odeans, LA, November
`2010.
`
`Cross-Course Testing — Concept and Implementation of Coordinated Quizzes at the University of
`Maryland School of Pharmacy. Lisa Lebovitz, Douglas A. Nutter, Yunting Fu, David S. Roffman &
`Richard Dalby. AACP Annual Meeting, Seattle, WA, July 2010.
`In Vitro Beclomethasone Dipropionate Dissolution and Uptake Rates From Nasal Suspensions
`Comprised of Differing Primary Drug Particle Sizes. Feiyan Jin and Richard Dalby. Richard N.
`Dalby, Diane Doughty and Vipra Kundoor. In Respiratory Drug Delivery 2010, Orlando, FL. Richard
`N. Dalby, Peter R. Byron, Joanne Peart, Julie Suman and Paul Young, Editors, Davis Healthcare
`International Publishing, April 2010.
`
`Realistic Evaluation of a Valved Holding Chamber with Facemask — Using a Soft Anatomical Model
`Face to Evaluate Aerosol Output Under Simulated Use Conditions. Wenchi Hsu, Tao Bai, Dirk von
`Hollen, Kurt Nikander and Richard Dalby. In Respiratory Drug Delivery 2010, Orlando, FL. Richard
`N. Dalby, Peter R. Byron, Joanne Peart, Julie Suman and Paul Young, Editors, Davis Healthcare
`International Publishing, April 2010.
`
`Validation of a Method to Visualize the Effect of Cascade Impactor Operating Temperature on
`Stage Deposition. Wenchi Hsu, Vipra Kundoor and Richard N. Dalby. American Association of
`Pharmaceutical Scientists Annual Meeting, Los Angeles, CA. November 2009.
`
`Influence of Adult and Pediatric Hand-Related Variability on in vitro Performance of Flonase® Nasal
`Spray. D. V. Doughty, C. Vibbert, M. E. Bollinger, A. Kewalramani and R. N. Dalby. American
`Association of Pharmaceutical Scientists Annual Meeting, Los Angeles, CA. November 2009.
`
`In Vitro Uptake of Nasal Sprays Containing Suspension Formulations in Calu—3 Human Ainivay
`Cells. Feiyan Jin and Richard N. Dalby. American Association of Pharmaceutical Scientists Annual
`Meeting, Los Angeles, CA. November 2009.
`
`24.
`
`25.
`
`26.
`
`27.
`
`28.
`
`29.
`
`30.
`
`31.
`
`32.
`
`33.
`
`34.
`
`35.
`
`36.
`
`37.
`
`Page 7 of 24
`
`UNITED THERAPEUTICS, EX. 2022
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-01621
`Page 7 of 24
`
`

`

`Richard Dalby, PhD.
`
`38.
`
`39.
`
`40.
`
`41.
`
`42.
`
`43.
`
`44.
`
`45.
`
`46.
`
`47.
`
`48.
`
`49.
`
`50.
`
`51.
`
`52.
`
`53.
`
`Visualization of Facial and Ocular Deposition Using a Color Based Technique. Vipra Kundoor and
`Richard Dalby. American Association of Pharmaceutical Scientists Annual Meeting, Los Angeles,
`CA. November 2009.
`
`Visualizing the Effect of Cascade lmpactor Operating Temperature on the Size and Evaporation
`Rate of Nebulized Droplets. Wenchi Hsu, Vipra Kundoor and Richard N. Dalby. In Respiratory Drug
`Delivery Europe 2009, Richard N. Dalby, Peter R. Byron, Joanne Peart, Julie Suman and Paul
`Young, Editors, Davis Healthcare International Publishing, May 2009.
`
`In vitro and in vivo Terameprocol efficacy studies in HPV infection models. Christensen N, Dalby
`R, Khanna N. The 25th International Papillomavirus Conference, Malmr‘j, Sweden, May 2009.
`
`Uptake and local metabolism of beciomethasone dipropionate in Calu—3 human airway cells. Feiyan
`Jin and Richard N. Dalby. American Association of Pharmaceutical Scientists Annual Meeting,
`Atlanta, GA. November 2008.
`
`Comparison of Deposition Patterns of Nasal Nebulizers and Aqueous Nasal Spray Pumps Using a
`Colorimetric Technique. Vipra Kundoor
`and Richard Dalby. American Association of
`Pharmaceutical Scientists Annual Meeting, Atlanta, GA. November 2008.
`Determination of Patient-Relevant Settings for In Vitro Evaluation of Flonase Using Automated
`Actuation Stations. Diane Doughty and Richard Dalby. American Association of Pharmaceutical
`Scientists Annual Meeting, Atlanta, GA. November 2008.
`
`The accuracy of Ventolin® dose counters using a force—instrumented pressurized metered dose
`inhaler under simulated use conditions. Wenchi Hsu and Richard Dalby. American Association of
`Pharmaceutical Scientists Annual Meeting, Atlanta, GA. November 2008.
`Assessment of Nasal Spray Deposition in a Nose Model Using a Colorimetric Technique —
`Influence of Formulation and Airflows, Vipra Kundoor and Richard N. Dalby. In Respiratory Drug
`Delivery 2008, Richard N. Dalby, Peter R. Byron, Joanne Peart, Julie Suman and Paul Young,
`Editors, Davis Healthcare International Publishing, May 2008.
`
`Assessment of Nasal Spray Deposition in a Nose Model Using Colorimetric Techniques. Vipra
`Kundoor and Richard N. Dalby. American Association of Pharmaceutical Scientists Annual
`Meeting, San Diego, CA. November 2007.
`
`The Effect of Volunteer Study—derived Actuation Parameters on Sprayed Droplet Size.
`Wenchi Hsu, Diane V. Doughty and Richard N. Dalby. American Association of Pharmaceutical
`Scientists Annual Meeting, San Diego, CA. November 2007.
`Handedness and Gender Effects on the Derivation of Machine Actuation Parameters for Nasal
`
`Sprays. Diane Doughty and Richard N. Dalby. American Association of Pharmaceutical Scientists
`Annual Meeting, San Diego, CA. November 2007.
`
`Preliminary Study on the Bioequivalence in Nasal Sprays Containing Suspension Formulations.
`Feiyan Jin and Richard N. Dalby. American Association of Pharmaceutical Scientists Annual
`Meeting, San Diego, CA. November 2007.
`
`Influence of Shaking on the Spray Weight of Nasal Spray Pumps; Lei Disc and Richard N. Dalby.
`American Association of Pharmaceutical Scientists Annual Meeting, San Diego, CA. November
`2007.
`
`Characterization of Delivered Dose and Droplet Size Distribution of Flovent HFA Utilizing the Next
`Generation lmpactor (NGI) and Breath Simulation with OptiHaler. Tao Bai and Richard N. Dalby,
`American Association of Pharmaceutical Scientists Annual Meeting, San Diego, CA. November
`2007.
`
`Phospholipid Induced ln-Vivo Particle Migration To Enhance Pulmonary Deposition. Sudipta
`Ganguly, Vikas Moolchandani, Joseph Roche, Paul S. Shapiro, Shailaja Somaraju, Natalie
`Eddington and Richard N. Dalby. American Association of Pharmaceutical Scientists Annual
`Meeting, San Diego, CA. November 2007.
`
`Determination of Automated Nasal Actuator Parameters Based on a Twenty Volunteer Study.
`Diane V. Doughty and Richard N. Dalby. In Respiratory Drug Delivery Europe 2007, Richard N.
`Dalby, Peter R. Byron, Joanne Pearl and Julie Suman, Editors, Davis Healthcare International
`Publishing, April 200?.
`
`Page 8 of 24
`
`UNITED THERAPEUTICS, EX. 2022
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-01621
`Page 8 of 24
`
`

`

`Richard Dalby, PhD.
`
`54.
`
`55.
`
`56.
`
`57.
`
`58.
`
`59.
`
`60.
`
`61.
`
`62.
`
`63.
`
`64.
`
`65.
`
`66.
`
`67.
`
`68.
`
`69.
`
`Modification of Nasal Spray Dip Tubes to Decrease Formulation Waste and Improve Content
`Uniformity by Decreasing the Number of Sprays in the Tail—Off Period. Diane Doughty and Richard
`N. Dalby. Parenteral Drug Association National Meeting, Las Vegas, NV. March 2007.
`A Novel Way to Increase the Efficiency of Nasal Spray Pumps. Diane Doughty and Richard N.
`Dalby. American Association of Pharmaceutical Scientists Annual Meeting, San Antonio, TX.
`October 2006.
`
`The Influence of Tilt Angles on the Efficiencies of Jet Nebulizers. Feiyan Jin and Richard N. Dalby.
`American Association of Pharmaceutical Scientists A