Publications

2024

Tully, J., Saggar, R., Prabel, J., Garcia, A., Patel, S., Chen, K., Kan, P. Clinical Pharmacokinetics of an Extended-Release Formulation of Inhaled Liposomal Treprostinil (L606) to Reduce Dosing Frequency [POSTER]. Pulmonary Vascular Research Institute (PVRI) 2024 Annual Congress; 2024 Feb 2, London.

2023

Burger, C.D., Sahay, S., Patel, S., Galloway, A., MacLennan, D., Elwing, M., Exploratory Efficacy Analysis of INSPIRE Open-Label Extension Study With Inhaled Treprostinil (YUTREPIA™) [POSTER]. 2023 American Thoracic Society International Conference, May 22, Washington D.C.

2022

Simon, M., Shapiro, S., Sahay, S., et al. Clinical Outcomes of YUTREPIA™ Dose in 6MWD and Quality of Life [Poster]. CHEST 2022 Annual Meeting, October 18, Nashville, TN

Patel, S., Prabel, J., MacLennan, D., Rosen, G. Robustness of YUTREPIA™, a Dry-Powder Inhaled Formulation of Treprostinil, in Patient Misuse Scenarios [Poster]. CHEST 2022 Annual Meeting, October 18, Nashville, TN

Hill N.S., et al. INSPIRE: Safety and Tolerability of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (PAH) [publication]. Pulmonary Circulation; 2022 Jul 26; doi.org/10.1002/pul2.12119

Kingman, M and Patel, S. Quality of Life (QoL) in PAH Patients Receiving an Inhaled Dry Powder Treprostinil (LIQ861) in the INSPIRE Study [Poster]. PHA International Conference; 2022 June 9, Atlanta, GA   

Hill N. S., et al. Safety and Tolerability of LIQ861 in Pulmonary Arterial Hypertension (PAH): Results from INSPIRE Study at 1 Year [Mini-symposium Presentation]. ATS Annual Meeting; 2022 May 15, San Francisco, CA

Hill N. S., et al. Safety and Tolerability of LIQ861 in Pulmonary Arterial Hypertension (PAH): Results from INSPIRE Study [Poster]. ATS Annual Meeting; 2022 May 16, San Francisco, CA

Sahay, Sandeep, “Risk Assessment in Pulmonary Arterial Hypertension (PAH): Insights From the INSPIRE Study With LIQ861” [Presentation]. 42nd Annual Meeting of International Society for Heart and Lung Transplant (ISHLT), 2022 April 27, Boston, MA

2021

Roscigno RF, Vaughn T, Parsley E, Hunt T, Eldon MA, Rubin LJ. Comparative bioavailability of inhaled treprostinil administered as LIQ861 and Tyvaso® in healthy subjects. Vascul Pharmacol. 2021;138:106840. doi: 10.1016/j.vph.2021.106840.

2020

Dumont E.F., et al. A Novel Inhaled Dry-Powder Formulation of Ribavirin Allows for Efficient Lung Delivery in Healthy Participants and Those with Chronic Obstructive Pulmonary Disease in a Phase 1 Study [publication]. Antimicrobial Agents and Chemotherapy; 2020 Feb 18; DOI: 10.1128/AAC.02267-19

Hill N. S., et al. INSPIRE: A Phase 3 Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of LIQ861in Pulmonary Arterial Hypertension (PAH) – Exploratory Efficacy Endpoints Analysis at Month 2 [Poster]. American Thoracic Society Annual Meeting – Virtual, 2020 Aug 5.

Hill N. S., et al. INSPIRE: Final Results from a Phase 3, Open-Label, Pivotal Study to Evaluate the Safety and Tolerability of LIQ861 in Pulmonary Arterial Hypertension [ePresentation]. ISHLT Annual Meeting; 2020 Apr 30. (link to audio ePresentation)

Maynor B., et al Nonclinical, In-silico, and Clinical Evaluation of LIQ861 Inhalation Powder Deposition and Pharmacokinetics Digital Respiratory Drug Delivery 2020; 2020 Apr 26 [Poster]

Maynor B., et al Nonclinical, In-silico, and Clinical Evaluation of LIQ861 Inhalation Powder Deposition and Pharmacokinetics Digital Respiratory Drug Delivery 2020; 2020 Apr 26 [Full Abstract]

Roscigno R, et al. Pharmacokinetic (PK) performance of LIQ861 and evaluation of comparative bioavailability with Tyvaso® in healthy subjects (Study LTI-102) [poster]. 14th Pulmonary Vascular Research Institute (PVRI) Annual World Congress on Pulmonary Vascular Disease; 2020 Jan 31; Lima, Peru.

Roscigno R.,et al. Pharmacokinetics and tolerability of LIQ861, a novel dry-powder formulation of treprostinil. Pulmonary Circulation 2020; 10(4) 1–9; DOI: 10.1177/2045894020971509

2019

Hill N. S., et al. INSPIRE: A Phase 3, Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of LIQ861 in PULMONARY ARTERIAL HYPERTENSION (PAH) (Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil NCT03399604)[poster]. American Thoracic Society (ATS) Conference 2019; 2019 May 21; Dallas, TX.

Hofmann C. L., et al. PRINT® Particle Design Improves Skin Penetration in a Topical Formulation [poster]. 77th annual Society for Investigative Dermatology (SID) Annual Meeting; 2019 May 8-11; Chicago, IL.

Hill N. S., et al. INSPIRE: A Phase 3 Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of LIQ861 in Pulmonary Arterial Hypertension (PAH) [presentation]. ISHLT 39th Annual Meeting & Scientific Sessions; 2019 Apr 3; Orlando, FL.

2018

Vaughn T, et al. A Phase 1 Randomized, Controlled, Double-Blind, Single Ascending Dose Safety and Pharmacokinetic/Pharmacodynamic Study in Healthy Adult Males after LIQ865 Injection [poster]. In: ASRA’s Annual Pain Medicine; 2018 Nov 15-18; San Antonio, TX.

Roscigno R, et al. Phase 1 Safety and Pharmacokinetic Study of Inhaled LIQ861, a New Dry Powder Formulation of Treprostinil [poster]. In: PHA’s International PH Conference; 2018 June 28-July 1; Orlando, FL.

Anderson S, et al. LIQ865A Produces a Slow Controlled Release of Bupivacaine after Subcutaneous Dosing in Rats and Minipigs [poster]. In: SOT Annual Meeting; 2018 March 11-15; San Antonio, TX.

Wilson SD, et al. LIQ865A, a Slow Release Microparticle Formulation of Bupivacaine, is Well-Tolerated and Does Not Interfere with Wound Healing after Subcutaneous Dosing in Rats and Minipigs [poster]. In: SOT Annual Meeting; 2018 March 11-15; San Antonio, TX.

Royal M, Roscigno R, et al. Preclinical and Phase 1 Clinical Characterization of LIQ861, a New Dry Powder Formulation of Treprostinil [poster]. In: World Symposium on Pulmonary Hypertension; 2018 February 27-March 1; Nice, France.

Royal M, Roscigno R, et al. Preclinical and Phase 1 Clinical Characterization of LIQ861, a New Dry Powder Formulation of Treprostinil [poster].  In: Pulmonary Vascular Research Institute (PVRI) Annual World Congress; 2018 January 21-24; Singapore, Asia.

2017

Billiard J, et al.  Dry Powder Inhaled Ribavirin in Healthy Volunteers: Safety, Tolerability, Lung and Systemic Pharmacokinetics [poster].  In: European Respiratory Society International Congress; 2017 September 9-13; Milan, Italy.

2016

PRINT nanoparticle-based delivery of immunostimulants and the MAGE-A3 antigen induces high IgG, CD4 +, & CD8+ T cell responses in swine” ; Michele Stone, Katie Horvath, Ashley Galloway, Christina Hofmann, Lara Kelly, Akihisa Nonoyama, Sean Meng, Andy Murphy, Loïc Le Gourrierec1, Pol Harvengt1, Christelle Langlet, Stéphane Temmerman1, Joelle Renneson, Nathalie Vanderheyde, Abdelatif Elouahabi, Sandra Morel. ImVacs abstract and poster presentation, Advances in Vaccine Technologies & Vaccine Adjuvant sessions, December 2016.  1 Liquidia Technologies;  2 GSK Vaccines, Belgium

PRINT Particles Enable Liquid Storage of Incompatible Components:  A case study with HibTT and DTaP” ; Ashley Galloway, Laurent Strodiot, Nadia Ouaked, Jin Lee, Patrick Pohlhaus, Ramya Yadavalli, Gabe Fawcett, Meredith Earl, Joseph Marchand, Marie-Noëlle Donner, Stéphane Temmerman, Nathalie Garçon, Eric De Buyl, Fabrice Godfroid, Abdelatif Elouahabi, and Michele Stone. ImVacs abstract and poster presentation, Advances in Vaccine Technologies & Vaccine Adjuvant sessions, December 2016.  1 Liquidia Technologies;  2 GSK Vaccines, Belgium

Precisely Molded Nanoparticle Displaying DENV-E Proteins Induces Robust Serotype-Specific Neutralizing Antibody Responses“; Stefan W. Metz , Shaomin Tian , Gabriel Hoekstra, Xianwen Yi, Michelle Stone, Katie Horvath, Michael J. Miley, Joseph DeSimone, Chris J. Luft , Aravinda M. de Silva; October 20, 2016; DOI: 10.1371/journal.pntd.0005071

2013

Morton, S. W., Herlihy, K. P., Shopsowitz, K. E., Deng, Z. J., Chu, K. S., Bowerman, C. J., DeSimone, J. M. and Hammond, P. T. (2013), Scalable Manufacture of Built-to-Order Nanomedicine: Spray-Assisted Layer-by-Layer Functionalization of PRINT® Nanoparticles. Adv. Mater.. doi: 10.1002/adma.201302025

Maynor, B.; Garcia, A.; Tully, J.; Yerxa, B. “Application of PRINT® Microparticle and Nanoparticle Technology – Toward Preparation of Ophthalmic Suspension Formulations with Improved Tolerability and Efficacy”. ARVO abstract and poster presentation, Drug Delivery I session, May 2013.

Garcia, A.; Tully, J.; Maynor, B.; Yerxa, B. “Precisely Engineered Biodegradable Intraocular Implants for the Sustained Release of Dexamethasone”. ARVO abstract and poster presentation, Drug Delivery I session, May 2013.

Development of a Nanoparticle-Based Iinfluenza Vaccine using the PRINT® Technology”; Galloway, A. L.; Murphy, A.; DeSimone, J. M.; Di, J.; Herrmann, J. P.; Hunter, M. E.; Kindig, J. P.; Malinoski, F. J.; Rumley, M. A.; Stoltz, D. M.; Templeman, T. S.; & Hubby, B. Nanomedicine: Nanotechnology, Biology and Medicine, May 2013, 9(4), pp. 523–531.

2012

“Particle Engineering for Inhalation Formulation and Delivery of Biotherapeutics”; Mack, P.; Horvath, K.; Garcia, A.; Tully, J.; and Maynor, B. Inhalation. August 2012. www.inhalationmag.com.

PEGylated PRINT® Nanoparticles: The Impact of PEG Density on Protein Binding, Macrophage Association, Biodistribution, and Pharmacokinetics”; Perry, J. L.#; Reuter, K. G.#; Kai, M. P.; Herlihy, K. P.; Jones, S. W.; Luft, J. C.; Napier, M. E.; Bear, J. E.; DeSimone, J. M.; Nanoletters, 2012, 12, 5304.

Rendering Protein-based Particles Transiently Insoluble for Therapeutic Applications”; Xu, J.; Wang, J.; Luft, J. C.; Tian, S.; Owens, G.; Pandya, A.; Berglund, P.; Pohlhaus, P. D.; Maynor, B. W.; Napier, M. E.; DeSimone, J. M. J. Am. Chem. Soc. 2012, DOI: 10.1021/ja302363r.

Reductively-Responsive siRNA-Conjugated Hydrogel Nanoparticles for Gene Silencing”; Dunn, S. S.; Tian, S.; Blake, S.; Wang, J.; Galloway, A. L.; Murphy, A.; Pohlhaus, P. D.; Rolland, J. P.; Napier, M. E.; and DeSimone, J. M. J. Am. Chem. Soc., Just Accepted Manuscript • DOI: 10.1021/ja300174v • Publication Date (Web): 05 Apr 2012.

Delivery of Multiple siRNAs Using Lipid-coated PLGA Nanoparticles for treatment of Prostate Cancer”; Hasan, W.; Chu, K.; Gullapalli, A.; Dunn, S. S.; Enlow, E.; Luft, J. C.; Tian, S.; Napier, M.E.; Pohlhaus, P. D.; Rolland, J. P.; DeSimone*, J. M. NanoLetters 2012, 12, 287-292.

Microfabricated Engineered Particle Systems for Respiratory Drug_Delivery and Other Pharmaceutical Applications” ;Garcia, A.; Mack, P.; Williams, S.; Fromen, C.; Shen, T.; Tully, J.; Pillai, J.; Kuehl, P.; Napier, M. E.; DeSimone, J. M.; and Maynor, B. Journal of Drug Delivery. 2012

2011

Engineering Nanomedicines Using Stimuli-responsive Biomaterials”; Wang, Y.; Byrne, J. D.; Napier, M. E.; DeSimone*, J. M. Advanced Drug Delivery Reviews 2011, in press.

“Microfabricated, Engineered Particles for Efficient Inhalation Drug Delivery”; Maynor, B. W.; Presented at Drug Delivery to the Lungs 22, December 2011.

PRINT®: A Novel Platform Toward Shape and Size Specific Nanoparticle Theranostics”; Perry, J. L.; Herlihy, K. P.; Napier, M. E.; DeSimone*, J. M. Accounts of Chemical Research 2011, 44(10), 990-998.

Engineering More Effective Nanomedicines Through Particle Design”; Wang, J.; Byrne, J. D.; Napier, M. E.; DeSimone*, J. M. Small 2011, 7(14), 1919-1931.

Ashley L. Galloway, Andrew Murphy, Jason P. Rolland, Kevin P. Herlihy, Robby A. Petros, Mary E. Napier, and Joseph M. DeSimone; “Micromolding for the Fabrication of Biological Microarrays” in Biological Microarrays: Methods and Protocols; Eds A. Khademhosseini; K.-Y Suh; M. Zourob; 2011; pp. 249-260.

Novel Platforms for Vascular Carriers with Controlled Geometry”; Pillai, J.; Dunn, S. S.; Napier, M. E.; DeSimone*, J. M. International Union of Biochemistry and Molecular Biology: Life 2011, 63(8), 596-606.

Control of Nano- and Micro-Particle Size, Shape, Dispersity and Elasticity: Development of Vaccine and Therapeutic Particles for Use in Parenteral and Inhalation Routes of Administration. Presented at SMART Drug Delivery Workshop , Washington, DC.DeSimone, J.M.; Mack, P.D. (2011, August).

PRINT® Particles and Well Arrays for Next Generation Sequencing; Knutson, T.; Maynor, B.; Nijhawan, A. 2011

Using mechanobiological mimicry of red blood cells to extend circulation times of hydrogel microparticles“; Merkel, T. J.; Jones, S. W.; Herlihy, K. P.; Kersey, F. R.; Shields, A. R.; Napier, M.; Luft, J. C.; Wu, H.; Zamboni, W. C.; Wang, A. Z.; Bear, J. E.; and DeSimone, J. M., Proceedings of National Academy of Sciences 2011, 108(2) 586-591.

Potent Engineered PLGA Nanoparticles by Virtue of Exceptionally High Chemotherapeutic Loadings“; Enlow, E.M.; Luft, J.C.; Napier, M.E.; DeSimone, J.M., Nano Letters 2011, (DOI: 10.1021/nl104117p).

2010 and earlier

Tunable Bi-functional Silyl Ether Cross-Linkers for the Design of Acid Sensitive Biomaterials”; Parrott, M. C.; Luft, J. C.; Byrne, J. D.; Fain, J. H.; Napier, M. E.; DeSimone*, J. M. J. Am. Chem. Soc. 2010, 132(50), 17928-17932.

“Microfabricated, Shape-Specific Particles and Engineered Aerosols for Efficient Aerosol Delivery to the Lung”;Maynor B.W.; Garcia, A.; Duong, H.; Mack, P. Respiratory Drug Delivery 2010 , 2010 Vol 2, pp 619-622

“PRINT® Technology: Enabling Next Generation Sequencing“; Knutson, T.; Maynor, B.; Zhou, Z.; Chenet, K. 2010.

The Complex Role of Multivalency in Nanoparticles Targeting the Transferrin Receptor for Cancer Therapies“; Wang, J.; Tian, S.; Petros, R. A.; Napier, M. E.; DeSimone*, J. M. J. Am. Chem. Soc. 2010, 132 (32), pp 11306–11313 (DOI: 10.1021/ja1043177)

Nanomanufacturing: The Missing Link between Discovery and Products [White Paper]. Rothrock, G., Pishny,E., & DeSimone, J. 2009.

Top-down Particle Fabrication: Control of Size and Shape for Diagnostic Imaging and Drug Delivery“; Canelas, D. A.; Herlihy, K. P.; DeSimone*, J. M. Advanced Reviews Wiley 2009, 1 (4), 391-404.

The Effect of Particle Design on Cellular Internalization Pathways“; Gratton, S. E. A.; Ropp, P. A.; Pohlhaus, P. D.; Luft, J. C.; Madden, V. J.; Napier, M. E.; DeSimone*, J. M. Proceedings of the National Academy of Sciences2008, 105(33), 11613-11618.

Shape-specific, Mono-disperse Nano-molding of Protein Particles“; Kelly, J. Y.; DeSimone*, J. M. J. Am. Chem. Soc. 2008, 130, 5438-5439.

Microfabricated Particles for Engineered Drug Therapies: Elucidation into the Mechanisms of Cellular Internalization of PRINT® Particles“; Gratton, S. E. A.; Napier, M. E.; Ropp, P. A.; Tian, S. DeSimone*, J. M.Pharm. Res. 2008, 25, 2845-2852.

Reductively Labile PRINT® Nanoparticles for the Delivery of Doxorubicin to HeLa Cells“; Petros, R. A.; Ropp, P. A.; DeSimone*, J. M.; J. Am. Chem. Soc. 2008, 130, 5008-5009.

The Pursuit of a Scalable Nano-fabrication Platform for Use in Material and Life Science Applications“; Gratton, S. E. A.; Williams, S. S.; Napier, M. E.; Pohlhaus, P. D.; Zhou, Z.; Wiles, K. B.; Maynor, B. B.; Shen, C.; Olafsen, T.; Samulski, E. T.; DeSimone*, J. M. Accounts of Chemical Research 2008, 41, 1685-1695.

“Nanoparticle Drug Delivery Platform“; Napier, M. E.; DeSimone*; J. M. Polymer Reviews 2007, 47, 321-327

Nanofabricated Particles for Engineered Drug Therapies: A Preliminary Biodistribution Study of PRINT® Nanoparticles“; Gratton, S. E. A.; Pohlhaus, P. D.; Lee, J.; Guo, J.; Cho, M. J.; DeSimone*, J. M. J. Controlled Release 2007, 121, 10-18.

Imparting Size, Shape, and Composition Control of Materials for Nanomedicine“; Eulis, L.; DuPont, J.; DeSimone*, J. M. Chem. Soc. Rev. 2006, 35, 1095-1104.

Direct Fabrication and Harvesting of Monodisperse, Shape Specific Nano-Biomaterials“; Rolland, J. P.; Maynor, B. W.; Euliss, L. E.; Exner, A. E.; Denison, G. M.; DeSimone*, J. M J. Am. Chem. Soc. 2005, 127, 10096-10100.