Igor Gonda, PhD
`igonda@respidex.com
`+1 510 731 8820
`_____________________________________________________________________________________
`
`
` 
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`
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` One of the longest working pharmaceutical inhalation scientists still active – started in 1975 when
`there was practically nobody else in universities interested and very few Rx products existed; many
`former students and colleagues now in leading positions in academia, industry and CROs
`In-depth experience with pharmaceutical inhalation product development at all stages including
`regulatory interactions with FDA and EMA
` Current and past history of consulting for government, industry and pharmaceutical compendia in
`US, Australia and the UK, particularly in pulmonary and nasal inhalation products
` Experienced senior executive (CEO, CSO) and Board member of private, public and not-for-profit life
`science organizations in USA and Australia
` Stewardship of pharmaceutical industrial teams developing products from preclinical through
`commercial stages in USA, EU and Australia
` Advocate of patient-focused development of therapies for severe diseases with unmet needs,
`facilitating global cooperation between patient advocacy groups, industry and regulators
` Formation and leadership of university and industrial research and development organizations in
`the United Kingdom, Australia and USA
` Author, Inventor, expert witness in patent litigations
` Teacher, mentor and coach
` Recipient of international awards for contributions to the development of knowledge on therapeutic
`and diagnostic aerosols and products for the benefit to patients
`
`
`EMPLOYMENT HISTORY/BOARDS
`
`2020-
`Inspiring Pty Ltd (Australia)
`Non-executive Board member
`
`2020-
`Scendea (UK)
`Principal Consultant
`
`2018-
`Respidex LLC – Founder and CEO
`Consulting for pharmaceutical and medical device companies
`
`
`March 2013 – October 2019
`Board Director, The Alpha-1 Project (fully owned subsidiary of the Alpha-1 Foundation)
`Pro-bono advice for the venture philanthropy branch of this patient advocacy group
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`August 2006 – February 2018:
`Chief Executive Officer and President of Aradigm Corporation, Board Member (2001-2018), Hayward,
`CA
`Fundamentally transformed the mission and the business model that required to restructure and
`refinance the company, develop new products and new partnerships and provide vision and motivation
`for the employees. Established a culture of collaboration within and outside the company focused on
`the patients with severe rare respiratory diseases with unmet needs that included working closely with
`patient advocacy groups, key opinion leaders, regulatory authorities and contract research and
`manufacturing organizations. Provided leadership to obtain the means for the development and
`commercialization of a highly innovative treatment for severe respiratory infections through funding
`with new strategic investors, industrial partnership, government support (including funding of a
`substantial international biodefense program), sale of non-strategic assets and R&D tax rebates.
`
`
`December 2001 – 2006:
`Chief Executive Officer and Managing Director, Board Member, Acrux Limited, Melbourne, VIC,
`Australia
`Lead the development and rapid growth of the company from its university base in 2001 to become
`listed on ASX as one of the leaders in the emerging Australian life science sector. Responsible for
`building shareholders’ value through development and commercialization of multiple transdermal and
`dermal drug delivery human and veterinary healthcare products. Overall responsibility for directing the
`development, operations and quality assurance of the company and its wholly owned subsidiaries.
`Leadership in the key business development activities including partnering with other organizations.
`Securing company’s financing prior to commercial product sales through private and public equity
`raisings (IPO in 2004), funding by partners and government grants. Public and investor relationship
`management. Development of the company’s workforce by implementation of infrastructure that
`promoted alignment of personal growth with corporate goals and generation of socioeconomic value.
`
`July 2000 – December 2001:
`Chief Scientific Officer, Aradigm Corporation, Hayward, CA
`Leadership of the New Product Research Department focused on preclinical and clinical exploration of
`new therapeutic and technological opportunities. Responsible for strategic science and technology
`development, R&D alliances, public relations with the scientific and clinical communities, intellectual
`property management in a leading public pulmonary drug delivery company. Key contact for
`comparative technology assessment of Aradigm’s R&D for the investment community. Appointed to the
`Board of Directors, April 2001. Chairman of International Scientific Advisory Board of Aradigm
`Corporation until August 2006.
`
`October 1995 – June 2000:
`Vice President, Research and Development, Aradigm Corporation, Hayward, CA
`Leading the R&D organization containing initially 12 people. In 5 years, R&D and engineering parts of
`the organization grew to ~100 people engaged in multidisciplinary research and development of
`products for major pharmaceutical markets such as diabetes and pain management. Provided
`challenging career development programs for the R&D employees. Key technical person for forming
`strategic business alliances with major pharmaceutical and biotechnology companies. Essential member
`of the executive team in successful mezzanine financing, the initial public offering and subsequent public
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`and private financing rounds. Principal Investigator on a National Institute of Health/National Cancer
`Institute Small Business Industrial Research Grant for gene therapy.
`
`January – September 1995:
`Senior Scientist and Group Leader, Pharmaceutics, Pharmaceutical R&D, Genentech, Inc., South San
`Francisco, CA
`Responsible for the development of non-parenteral delivery of protein, peptides and gene products.
`Supervised 15 scientists and technicians.
`
`February 1992 – December 1994:
`Senior Scientist and Group Leader, Aerosol Drug Delivery Group, Pharmaceutical R&D, Genentech,
`Inc., South San Francisco, CA
`Prepared and executed the development plan for pulmonary delivery of the first human recombinant
`protein administered by inhalation (rhDNase, brand name Pulmozyme). The product went in record
`time (4.5 years) from cloning to FDA approval and is now used globally as a major part of therapy of
`cystic fibrosis. Founded and led a multidisciplinary group (protein and peptide formulation and analysis,
`aerosol physics and engineering, pulmonary disease and absorption models, lung delivery of viral gene
`vectors) that provided key techniques and findings for one of the most rapidly growing branches of the
`biotech industry. Involved in partnering between Genentech and other companies. Facilitated
`development of people who now play leading roles in industrial and academic R&D.
`
`September 1983 – January 1992:
`Senior Lecturer/Lecturer, Department of Pharmacy, University of Sydney
`
`January – July 1990:
`Visiting Associate Professor, School of Public Health, Johns Hopkins University, Baltimore, MD
`
`July – December 1989:
`Visiting Scientist, Advanced Drug Delivery Research, Ciba-Geigy, Horsham, England
`
`1982 – 1983:
`Research Scholar, School of Mathematics, Physics and Chemistry, Macquarie University, Sydney,
`Australia
`
`Summer 1978:
`Senior Visiting Research Fellow, Department of Chemistry, Clarkson College of Technology, Potsdam,
`NY
`
`October 1975 – August 1982:
`Lecturer, Department Pharmacy, University of Aston in Birmingham, UK
`
`October 1974 – September 1975:
`Project Chemist, Nicholas Research Laboratories, Slough, UK
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`Degrees
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`BSc (Chemistry) and PhD (Physical Chemistry), University of Leeds, England
`
`
`KEY PROFESSIONAL EXPERIENCE AND ACHIEVEMENTS
`
`Invited speaker and session chairperson at many national and international scientific, business
`development and investor conferences, member of editorial boards of several journals in the areas of
`pharmaceutical sciences and drug delivery.
`
`
`
`1978
`
`
`
`External Examiner in Pharmaceutics, University of Dar-es-Salaam, Tanzania
`
`1979 -1981
`
`Course Tutor (Chemistry), Open University, UK
`
`1982 -1988
`
`Member of the `Ad Hoc' Committee on Standards for Aerosol Inhalations, British
`Pharmacopoeia Commission
`
`1986 & 1987
`
`
`
`
`Visiting Research Professor, Department of Pharmaceutics, Hoshi
`University, Tokyo, Japan
`
`1986 - 1992
`
`
`
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`External Evaluator for the Drug Marketing Approval Submissions to
`NBSL, Canberra
`
`
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`
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`1986 & 1987
`
`Examiner for PhD students, University of Queensland, St. Lucia
`
`1989 - 91
`
`1990/91
`
`
`
`
`
`Member of the Working Party on Metered Dose Aerosols,Australian Drug
`Evaluation Committee
`
`
`Co-organizer of the Satellite Symposium, "Aerosols for 1990's -Putting
`Respiratory Therapy in the Right Place", organized by the Thoracic Society of
`Australia and New Zealand and the Australian Society of Respiratory
`Technology, April 1990, Lorne, Victoria
`
`1990 - 91
`
`Member of the Working Party on the Therapeutic Goods Order for Metered
`Dose Pressurized Inhalations, Therapeutics Goods Administration, Canberra,
`Australia
`
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`1990- 92
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`1991-92
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`1991-95
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`Convenor of an international symposium on "Advances in Delivery of
`Therapeutic and Diagnostic Agents" sponsored by the Australian Pharmaceutical
`Sciences Association, Controlled Release Society, the Australasian Society for
`Clinical and Experimental Pharmacology and the Royal Australian Chemical,
`Institute - Polymer Division
`
`President, the Australasian Pharmaceutical Science Association
`
`Member of the International Board, International Society for
`Aerosols in Medicine
`
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`1991-92
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`1997
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`2001-2
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` Representative on the International Membership Committee, The
`Controlled Release Society
`
`Co-organizer with M. Newhouse and A.R. Clark of ISAM Focus Symposium
`“Towards meaningful laboratory tests for evaluation of pharmaceutical
`aerosols”, San Juan, Puerto Rico
`
`Founding Member of the Board of Directors, International Pharmaceutical
`Aerosols Consortium – Regulatory Science
`
`2001 Astra-Zeneca Industrial Achievement Award
`
`2004
`
`2004 - 2006
`
`2013
`
`2018 –
`
`
`
`
`The Thomas T. Mercer Joint Prize of the International Society for Aerosols in
`Medicine and the American Association for Aerosol Research, for Excellence in
`Pharmaceutical Aerosols and Inhalable Materials
`
`Member of the Australian Stock Exchange/Ausbiotech working group for the
`development of the Code of Best Practice of Reporting by Life Science
`Companies
`
`Member of the External Advisory Panel, California Institute of
`Regenerative Medicine, San Francisco, CA, USA
`
`
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`California Life Sciences Institute Advisor
`
`
`PATENTS and PUBLICATIONS
`
`More than 120 issued patents and patent applications in USA, plus a large number of issued and pending
`patents in other countries.
`
`Author of well over 100 research articles, invited reviews and book chapters in the areas of treatment of
`respiratory diseases, pulmonary drug delivery and other aspects of clinical and pharmaceutical sciences.
`
`Selection of publications:
`
`I.Gonda "A Semi-Empirical Model of Aerosol Deposition in the Human Respiratory Tract for Mouth
`Inhalation", J.Pharm. Pharmacol., 1981 33 692-696.
`
`I. Gonda, J.B. Kayes, C.V. Groom and F.J.T. Fildes "Characterisation of Hygroscopic Inhalation Aerosols",
`Particle Size Analysis 1981 (conference organised by the Royal Society of Chemistry), September 1981,
`N. Stanley-Wood and T. Allen, Eds., Heyden, London, 1982, pp. 31-43.
`
`I. Gonda and A.F.K. El Khalik "On the Calculation of Aerodynamic Diameters of Fibres", Aerosol Sci. Tech.,
`1985 4 233-238.
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`I. Gonda "Development of a Systematic Theory of Suspension Inhalation Aerosols. I. A Framework to
`Study the Effects of Aggregation on the Aerodynamic Behaviour of Drug Particles", Int. J. Pharmaceut.
`1985 27 99 - 116.
`
`P.R. Phipps, P. Borham,I.Gonda, D.L.Bailey, G.J. Bautovich and S.D. Anderson, "A Rapid Method for the
`Evaluation of Diagnostic Radioaerosols", Eur. J. Nucl. Medicine, 1987 13 183-186.
`
`I. Gonda, "Drugs Administered Directly into the Respiratory Tract: Modeling of the Duration of Effective
`Drug Levels", J. Pharm.Sci 1988 77 340-346.
`
`P.R.Phipps, I.Gonda, D.L.Bailey, P.Borham, G.Bautovich and S.D. Anderson,"Comparison of Planar and
`Tomographic Gamma Scintigraphy to Measure the Penetration Index of Inhaled Aerosols", Amer.
`Rev.Resp.Dis. 1989, 139, 1516 - 1523.
`
`P.R. Phipps and I. Gonda, "Droplets Produced by Medical Nebulizers: Some Factors Affecting their Size
`and Solute Concentration", Chest 1990 97 1327-1332.
`
`E. Daviskas, I. Gonda and S.D. Anderson, "Mathematical Modelling of the Heat and Water Transport in
`the Human Respiratory Tract", J. Appl. Physiol. 1990 69 362-372.
`
`A.J. Hickey, I. Gonda, W.J.Irwin and F.J.T.Fildes, "The Effect of Hydrophobic Coating Upon the Behaviour
`of a Hygroscopic Aerosol Powder in an Environment of Controlled Temperature and Relative Humidity",
`J. Pharm Sci. 1990 79 1009-1014.
`
`I.Gonda, "Therapeutic and Diagnostic Aerosols for Delivery of Agents to the Respiratory Tract", CRC
`Critical Reviews of Therapeutic Drug Carrier Systems 1990, 6, 273-313.
`
`I.Gonda, "Physico-chemical Principles in Aerosol Delivery", ch.7 in "Topics in Pharmaceutical Sciences
`1991" (Eds. D.J.A. Crommelin and K.K.Midha), Medpharm Scientific Publishers, Stuttgart (1992), pp.95-
`115.
`
`E. Daviskas and I.Gonda, "Heat and Water Transport in the Respiratory Tract", Comments in Theoretical
`Biology 1992 2 335-355.
`
`Regnis, J.A., Robinson, M., Bailey, D.L., Cook, P., Hooper, P., Chan, H.-K., Gonda, I., Bautovich, G. and
`Bye, P.T.P., Mucociliary clearance in patients with cystic fibrosis and in normal subjects, Am. J.
`Respir.Crit.Care Med., 150, 66-71 (1994)
`
`Phipps, P. R., Gonda, I., Anderson, S. D., Bailey, D., and Bautovich, G. Regional deposition of saline
`aerosols of different tonicities in normal and asthmatic subjects. Eur. Respir. J., 7, 1474-1482 (1994).
`
`Cipolla, D., Gonda, I., and Shire, S. J. Characterization of aerosols of human recombinant
`deoxyribonuclease I (rhDNase) generated by jet nebulizers. Pharm. Res., 11(4), 491-498, (1994).
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`Gonda I, Cipolla DC, Shire SJ, Meserve K, Weck, S, Clark AR, Chan H-K. A Case Study in Aerosol Protein
`Drug Development: Aqueous Solution Aerosols of rhDNase. In: Respiratory Drug Delivery IV. 1994:47-53.
`Editors, Richard N. Dalby, Peter R. Byron, Stephen J. Farr, Published by Interpharm Press, Buffalo Grove,
`IL, Richmond, VA. May 1-6, 1994.
`
`Cipolla DC, Clark AR, Chan H-K, Gonda I, Shire SJ. Assessment of aerosol delivery systems for
`recombinant human deoxyribonuclease. STP Pharm Sciences. 1994;4(1):50-62.
`
`Cipolla D, Gonda I. Method for Collection of Nebulized Proteins. In: ACS Symposium Series #567,
`Formulation and Delivery of Proteins and Peptides. Editors, Cleland JL & Langer R. 1994; 20:343-352.
`
`Cipolla D, Gonda I, Meserve K, Weck S, Shire SJ. Formulation and Aerosol Delivery of Recombinant
`Deoxyribonucleic Acid Derived Human Deoxyribonuclease I. In: ACS Symposium Series #567,
`Formulation and Delivery of Proteins and Peptides. Editors, Cleland JL & Langer R. 1994;19:322-342.
`
`Fiel, S.B., Fuchs., H., Sinicropi, D., Gonda, I., Clark, A.R. and the Pulmozyme rhDNase Study Group. A
`randomized, open-label comparison of three jet nebulizer aerosol delivery systems to administer
`recombinant human DNase I to cystic fibrosis patients, Chest 108:153-156 (1995).
`
`Daviskas, E., Anderson, S.D., Gonda, I., Chan, H.-K., Cook, P. and Fulton, R., Changes in mucociliary
`clearance during and after isocapnic hyperventilation in asthmatic and healthy subjects, Eur.Resp. J.
`8:742-751 (1995)
`
`Finlay, W.H., Stapleton, K.W., Gonda, I., Chan, H.-K., Zuberhuler, P., Regional deposition of inhaled
`hygroscopic aerosols: in vivo SPECT compared with mathematical deposition modeling, J. Appl. Physiol.
`81:374-383 (1996)
`
`Daviskas, E., Anderson, S.D., Gonda, I., Eberl, S., Meikle, S., Seale, J.P., and Bautovich, G. Inhalation of
`hypertonic saline aerosol enhances mucociliary clearance in asthmatic and healthy subjects, Eur.Resp. J.
`9:725-732 (1996)
`
`Anderson SD, Brannan J, Spring J, Spalding N, Rodwell LT, Chan K, Gonda I, Walsh and Clark A, A new
`method for bronchial provocation testing in asthmatic subjects using a dry powder of mannitol, Am J
`Respir Crit Care Med, 156:758-765 (1997)
`
`I. Gonda, Mathematical modeling of deposition and disposition of drugs administered via the nose, Adv
`Drug Deli Rev 1998 29 179-184
`
`Gonda I, Schuster J, Rubsamen R, Lloyd P, Cipolla D and Farr SJ, Inhalation delivery systems with
`compliance and disease management capabilities, J Contr Rel 53: 269-274 (1998)
`
`S.J. Farr, I. Gonda, and V. Licko, Physicochemical and physiological factors influencing the effectiveness
`of inhaled insulin, In: Respiratory Drug Delivery VI, 25-53 (1998), Eds. R.N.Dalby, P.R.Byron and S.J.Farr,
`Interpharm Press, Inc., Buffalo Grove, IL
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`Schuster JA, Farr SJ, Cipolla D, Wilbanks T, Rosell J, Lloyd P, Gonda I. Design of a Highly Efficient and
`Reproducible Compact Aerosol Delivery System: AERx. In: Respiratory Drug Delivery Vl. 1998:83-90.
`Editors, Richard N. Dalby, Peter R. Byron, Stephen J. Farr, Published by Interpharm Press, Buffalo Grove,
`IL, Hilton Head, SC. April 28-May 2, 1998.
`
`Harvey B-G, Leopold PL, Hackett NR, Grasso TM, Williams PM, Tucker AL, Karner RJ, Ferris B, Gonda I,
`Sweeney TD, Ramalingam R, Kovesdi I, Shak S and Crystal RG, Airway epithelial CFTR mRNA expression in
`cystic fibrosis patients after repetitive administration of a recombinant adenovirus, J Clin Invest
`104:1254-1255 (1999)
`
`Cipolla D.C., Gonda I., Shak S., Kovesdi I., Crystal R. and Sweeney T.D., Coarse spray delivery to a
`localized region of the pulmonary airways for gene therapy, Human Gene Ther 11:361-371 (2000)
`
`I.Gonda, The Ascent of pulmonary drug delivery, J Pharm Sci 2000 89 940-945
`
`Cipolla D, Farr S, Gonda G, Otulana B. Delivery of Biologics to the Lung. In: New Drugs for Asthma,
`Allergy and COPD. 2001;30: 20-23. Editors TT Hansel and PJ Barnes. Published by S. Karger AG, Basel,
`Switzerland.
`
`Deshpande D, Blanchard J, Srinivasan S, Fairbanks D, Fujimoto J, Sawa T, Wiener-Kronish J, Schreier H,
`Gonda I. Aerosolization of lipoplexes using AERx Pulmonary Delivery System. AAPS PharmSci.
`2002;4(3):E13
`
`Okumu FW, Lee RY, Blanchard JD, Queirolo A, Woods CM, Lloyd PM, Okikawa J, Gonda I, Farr SJ,
`Rubsamen R, Adjei AL, Bertz RJ. Evaluation of the AERx pulmonary delivery system for systemic delivery
`of a poorly soluble selective D-1 agonist, ABT-431. Pharm Res. 2002 19(7):1009-12.
`
`Boyd B, Noymer P, Liu K, Okikawa J, Hasegawa D, Warren S, Taylor G, Ferguson E, Schuster J, Farr S,
`Gonda I. Effect of gender and device mouthpiece shape on bolus insulin aerosol delivery using the AERx
`pulmonary delivery system. Pharm Res. 2004 21(10):1776-82.
`
`Davison S, Thipphawong J, Blanchard J, Liu K, Morishige R, Gonda I, Okikawa J, Adams J, Evans A, Otulana
`B, Davis S. Pharmacokinetics and acute safety of inhaled testosterone in postmenopausal women. J Clin
`Pharmacol. 2005 45(2):177-84.
`
`Deshpande DS, Blanchard JD, Schuster J, Fairbanks D, Hobbs C, Beihn R, Densmore C, Farr S, Gonda I.
`Gamma scintigraphic evaluation of a miniaturized AERx pulmonary delivery system for aerosol delivery
`to anesthetized animals using a positive pressure ventilation system. J Aerosol Med. 2005 18(1):34-44.
`
`Gonda I. Systemic delivery of drugs to humans via inhalation. J Aerosol Med. 2006 Spring;19(1):47-53.
`
`Gonda I., Bruinenberg, P., Mudumba, S. and Cipolla D. Smoking Cessation Approach via Deep Lung
`Delivery of ‘Clean’ Nicotine, Respiratory Drug Delivery Europe 2009 (printed symposium publication and
`online at www.rddonline.org)
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`Cipolla DC, Redelmeier, Eastman S, Bruinenberg P, Gonda I. Liposomes, Niosomes and Proniosomes –A
`Critical Update of Their Development as Inhaled Products. Respiratory Drug Delivery Europe. 2011;41-
`54.
`
`Bruinenberg P, Blanchard JD, Cipolla DC, et al. Inhaled liposomal ciprofloxacin: once a day management
`of respiratory infections. Respiratory Drug Delivery 2010, 73-81
`
`Cipolla D, Gonda I. Formulation Technology to Repurpose Drugs for Inhalation Delivery. Drug Discovery
`Today: Ther Strategies. 2011;8(3-4):123-130. doi:10.1016/j.ddstr.2011.07.001.
`
`Ong HX, Williams SP, Svolos M, Cipolla D, Gonda I, Young PM, Traini D. Inhaled Liposomal Ciprofloxacin
`Nanoparticles for the Treatment of Respiratory Biofilm Infections. In: Respiratory Drug Delivery 2018.
`2018:TBD-TBD. Editors, Richard N. Dalby, Peter R. Byron, Joanne Peart, Julie D. Suman, Stephen J. Farr,
`Paul M. Young. Davis Healthcare Int’l Publishing, River Grove, IL. Phoenix, AZ, May 13-17, 2012.
`
`Ong HX, Traini D, Cipolla D, Gonda I, Bebawy M, Agus H, Young PM. Liposomal Nanoparticles Control the
`Uptake of Ciprofloxacin Across Respiratory Epithelia. Pharm Research. 2012;29(12):3335-3346. doi:
`10.1007/s11095-012-0827-0.
`
`Hui Xin Ong, David Cipolla, Igor Gonda, Daniela Traini, Mary Bebawy, Helen Agus, Paul M Young. Inhaled
`Liposomal Ciprofloxacin Nanoparticles Control the Release of Antibiotic at the Bronchial Epithelia. In:
`Respiratory Drug Delivery 2012. 2012:851-854. Editors, Richard N. Dalby, Peter R. Byron, Joanne Peart,
`Julie D. Suman, Stephen J. Farr, Paul M. Young. Davis Healthcare Int’l Publishing, River Grove, IL.
`Phoenix, AZ, May 13-17, 2012.
`
`Cipolla D, Gonda I, Chan H-K. Liposomal Formulations for Inhalation. Ther Delivery. 2013;4(8):1047-1072.
`doi: 10.4155/tde.13.71.
`
`Ong HX, Benaouda F, Traini D, Cipolla D, Gonda I, Forbes B, Young PM. In vitro and ex vivo methods
`predict the enhanced lung residence time of liposomal ciprofloxacin formulations for nebulisation. Eur J
`Pharm Biopharm. 2013;86(1):83-89. http://dx.doi.org/10.1016/j.ejpb.2013.06.024
`
`Cipolla D, Wu H, Chan J, Chan H-K, Gonda I. Liposomal Ciprofloxacin for Inhalation Retains Integrity
`Following Nebulization. Respiratory Drug Delivery Europe 2013. 2013:237-242. Editors, Richard N. Dalby,
`Peter R. Byron, Joanne Peart, Julie D. Suman, Stephen J. Farr, Paul M. Young. Davis Healthcare Int’l
`Publishing, River Grove, IL. Berlin, Germany, May 21-24, 2013.
`
`Serisier DJ, Bilton D, De Soyza A, Thompson PJ, Kolbe J, Greville HW, Cipolla D, Bruinenberg P, Gonda I.
`Inhaled, Dual-Release Liposomal Ciprofloxacin in Non-Cystic Fibrosis Bronchiectasis (ORBIT-2) – a
`Randomised, Double-Blind, Placebo-Controlled Trial. Thorax. 2013;68(9):812-817. doi:
`10.1136/thoraxjnl-2013-203207.
`
`Cipolla D, Wu H, Gonda I, Chan HK. Aerosol Performance and Long Term Stability of Surfactant-
`Associated Liposomal Ciprofloxacin Formulations with Modified Encapsulation and Release Properties.
`AAPS PharmSciTech, 2014;15(5):1218-1227. doi: 10.1208/s12249-014-0155-2.
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`Cipolla D, Wu H, Eastman S, Redelmeier T, Gonda I, Chan HK. Modifying the Release Properties of
`Liposomes toward Personalized Medicine. J. Pharm Sci. 2014;103(6):1851-1862. doi:10.1002/jps.23969.
`
`Cipolla D, Wu H, Eastman S, Redelmeier T, Gonda I, Chan HK. Development and Characterization of an In
`Vitro Release Assay for Liposomal Ciprofloxacin for Inhalation. J. Pharm. Sci. 2014;103(1):314-327.
`doi:10.1002/jps.23795
`
`Cipolla D, Froehlich J, Gonda I. Emerging Opportunities for Inhaled Antibiotic Therapy. Journal of
`Antimicrobial Agents 2015; 1 (1) 1-5.
`
`Cipolla D, Wu H, Gonda I, Chan HK. Aerosol Performance and Stability of Liposomes Containing
`Ciprofloxacin Nanocrystals. J Aer Med Pulm Drug Del. 2015;28(6):411-422. doi:10.1089/jamp.2015.1241.
`
`Cipolla D, Gonda I. Inhaled Nicotine Replacement Therapy. Asian J Pharm Sci. 2015;10(6)472-480. doi:
`10.1016/j.ajps.2015.07.004.
`
`Cipolla D, Blanchard J, Gonda I. Development of Liposomal Ciprofloxacin to Treat Lung Infections.
`Pharmaceutics. 2016;1-31.
`
`D. Cipolla, H. Wu, S. Salentinig, B. Boyd, T. Rades, D. Vanhecke,FA. Petri-Fink, B. Rothin-Rutishauser, S.
`Eastman, T. Redelmeier, I. Gonda and H. K. Chan, Formation of drug nanocrystals under
`nanoconfinement afforded by liposomes, Royal Society of Chem. Adv., 2016, 6, 6223-6233
`
`Cipolla D, Wu H, Eastman S, Redelmeier T, Gonda I, Chan H-K. Tuning Ciprofloxacin Release Profiles from
`Liposomally Encapsulated Nanocrystalline Drug. Pharm Research. 2016;33(11):2748-2762.
`doi:10.1007/s11095-016-2002-5
`
`Haworth CS, Bilton D, Chalmers JD, Davis AM, Froehlich J, Gonda I, Thompson B, Wanner A,, O'Donnel
`AE. Inhaled liposomal ciprofloxacin (ARD-3150) in patients with non-cystic fibrosis bronchiectasis and
`chronic lung infection with Pseudomonas aeruginosa: results of two phase III randomized controlled
`trials (ORBIT-3 and ORBIT-4). Lancet Respir Med. 2019 Mar;7(3):213-226.
`
`VanDevanter DR, Gonda I, Dahms J, Cipolla D, Davis AM, Chalmers JD, Froehlich J. Microbiological
`changes observed over 48 weeks of treatment with inhaled liposomal ciprofloxacin in individuals with
`non-cystic fibrosis bronchiectasis and chronic Pseudomonas aeruginosa lung infections Clin Microbiol
`Infect. 2019 Apr 26. pii: S1198-743X(19)30194-6. doi: 10.1016/j.cmi.2019.04.017.
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`10
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`Liquidia's Exhibit 1005
`Page 10
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