Nahed M. Mohsen, Ph.D.

Dr. Mohsen is a bioengineer and an aerosol scientist with more than 22 years of experience in the areas of physical, chemical, and biological characterizations and analysis of polymer-based biomaterials, medical devices, and pharmaceutical drug product design and development. Dr. Mohsen has expertise in both collagen and gelatin chemistry and physics, cross-linking determination, characterization, biocompatibility, stability, and long and short durability. She also has expertise in particle design, coating technologies and powder nanotechnologies to achieve high efficiency, appropriate dissolution, and pharmacokinetic profiles and targeted drug delivery for different drug product dosage forms. She also has expertise in inhalation drug delivery systems, inhalation drug formulations design and development, aerosol plumes characterization, powder/liquid aerosolization, and drug products packaging design and development. Dr. Mohsen specializes in aerosol drug delivery systems’ development from inception to different phases of clinical and regulatory development. She has extensive experience in the design, development, and optimization of drug-device product combinations for liquid, propellant-based and dry powder-based delivery systems and formulations. Dr. Mohsen has experience in delivering pulmonary medications therapies including small molecules such vasodilators, corticosteroids, ergotamines, pain medications including fentanyl and morphine sulfate and large molecules such as insulin and gamma interferons. Dr. Mohsen’s experience includes being involved in venture initiations and start-ups. Her pharmaceutical experience is applicable to several drug dosage forms including aerosol (pulmonary and nasal), parenteral, topical ocular, and transdermal.

Dr. Mohsen has been involved in the design, development, biocompatibility and performance testing of nebulizers, insulin and pain pumps, ocular shunts, catheters, vascular stents, cardiovascular implants, implantable meshes, collagen and gelatin implants and devices and dental implants. Dr. Mohsen has expertise in developing risk assessment for single-use devices and multi-use devices to reduce products’ liabilities after reprocessing. Also, she has devised methods for medical devices’ cleanliness, sterilization, performance testing methods and usability in the hand of patients.

Dr. Mohsen has used her expertise to provide witness testimony in false advertisement and product liability cases for combination drug products, branded, generic, over-the- counter, and cosmetic drugs as well as false advertisement claims for the application of antimicrobial agents such as triclosan in consumer products.

Dr. Mohsen aerosol expertise allowed her to assist companies and provide litigation support in exposure assessment and dose reconstruction for various chemicals in different occupational environments including triclosan, dioxin, asbestos, and nanoparticles in various consumer products. Dr. Mohsen has worked on more than 70 litigation cases involving exposure assessment and dose reconstruction for asbestos.

Dr. Mohsen also has experience in regulatory strategies development for medical device and drug products registration with the FDA and quality assurance systems development. She has experience in regulatory submissions related to Chemistry, Manufacturing and Controls (CMC) sections for NDAs and ANDAs as well as 510K submissions. She has assisted companies in obtaining regulatory approval for their medical devices containing antimicrobial agents such as triclosan and devising testing strategies for color petitions in ocular drug products combination. She also has experience in quality assurance, compliance, and quality system development including reviewing and implementing current Good Manufacturing Practices (cGMP), ICH guidance, quality system regulation, design control, verification/validation testing, CAPA, quality by design and product recalls. She has experience in risk analysis and management, FMEA analysis, experimental design, and statistics.

Her doctoral preliminary qualification was on cardiophysiology and blood coagulation, blood-material interactions and transport phenomena including fluid, mass, and heat transfer. Her doctoral thesis involved design, evaluation, and optimization of organic-inorganic interphase in high performance biomaterial polymer-based composites. Her research also involved chemical and physical aging of biomaterial and implant durability in the biological environment.

Prior to joining Exponent Dr. Mohsen was an independent consultant working on issues with pharmaceutical product design and development, product performance optimization, and quality systems improvement. Prior to that she was a Principal Scientist at Sheffield Pharmaceuticals where she invented several forms of aerosol drug delivery systems and formulations that enhanced drug delivery efficiency, consistency, and ease of use using liquid, propellant and dry powder technologies to deliver small and large molecules for systemic and local delivery via the pulmonary route. She has extensive experience in aerosol science, aerosol analysis, aerosol measurements and characterizations, physical chemistry, colloidal chemistry, analytical chemistry (FTIR, UV/Vis, HPLC, GC), thermal analysis (calorimetry, microcalorimetry, dielectric measurements, dynamic mechanical testing) and fluid dynamics.

Mohsen NM, Craig RG, Filisko FE. The effects of moisture on the dielectric relaxation of urethane dimethacrylate polymer and composite. Journal of Oral Rehabilitation 2001; 28(4):376–392.

Mohsen NM, Craig RG, Filisko FE. The effects of different additives on the dielectric relaxation and the dynamic mechanical properties of Urethane Dimethacrylate. Journal of Oral Rehabilitation 2000; 27(3):250–268.

Mohsen NM, Craig RG, Filisko FE. The effects of different curing times and filler concentration on curing and post-curing of urethane dimethacrylate composites: A microcalorimetric study. Journal of Biomedical Materials Research 1998; 40:224–232.

Mohsen NM, Craig RG, Hanks CT. Cytotoxicity of urethane dimethacrylate before and after aging and leaching. Journal of Biomedical Materials Research 1998; 39:252–260.

Mohsen NM. Physical, chemical and biological characterization of urethane dimethacrylate biomaterial composite. Ph.D. Thesis; The University of Michigan, Ann Arbor, MI, 1995.

Mohsen NM, Craig RG. Effect of silanation of fillers on their dispersibility by monomer systems. Journal of Oral Rehabilitation 1995; 22:183–189.

Mohsen NM and Craig RG. Hydrolytic stability of silanated zirconia-silica urethane dimethacrylate composites. Journal of Oral Rehabilitation 1995; 22:213–220.

Presentations and Published Abstracts of Presentations

< >Mohsen NM. PMDI aerosol momentum manipulation and delivery biotargeting. Presented at Respiratory Drug Delivery VIII, Tucson, AZ, May 12–16, 2002.

Mohsen NM. Aerosol generation mechanisms. Presented at the IIR- Inhalation Technology Conference, Philadelphia, PA, July 30–August 1, 2001.

Mohsen NM. Respiratory and systemic drug delivery via the lungs from metered solution inhaler. Presented at the Novel Pain Therapeutics, Phoenix, AZ, December 5, 2000.

Mohsen NM. The use of thermodynamic and computational models to predict aerosol plume generation. Presented at the Annual Meeting and Exposition of the American Association of Pharmaceutical Scientists, Indianapolis, IN, October 29–November 2, 2000.

Mohsen NM, Craig RG, Hanks CT. Cytotoxicity of urethane dimethacrylate before and after aging and leaching. Presented at the 74th General Session and Exhibition of the IADR, 26th Annual Meeting of the AADR and Exhibition, and the 21st Annual Meeting of the CADR, Orlando, FL, March 19–23, 1997. Also, in Dental Materials III - Polymers: Biocompatibility, Toxicity, Cell Systems, Curing, Journal of Dental Research Special Issue, 76:244 Abstract No. 1981.

Mohsen NM, Filisko FE, Craig RG. The effect of moisture on the dielectric relaxation in silanated zirconia-silica-urethane dimethacrylate composite. Presented at the 24th Annual Meeting of the AADR and Exhibition and the 19th Annual Meeting of the CADR, San Antonio, TX, March 8–12, 1995. Also, in Dental Material Groups—Resin Composites: Physical Properties, Degradation, Wear. Journal of Dental Research Special Issue, 74:90 Abstract No. 631.

Mohsen NM, Filisko FE, Craig RG. Isothermal enthalpy changes of zirconium silicate-urethane dimethacrylate composite. Presented at the 72nd General Sessions & Exhibition of the IADR, the 23rd Annual Meeting of the AADR, and the 18th Annual Meeting of the CADR, Seattle, WA, March 9–13, 1994. Also, in Dental Material Groups—Resin Composites: Computer Models, Test Procedures, Test Parameters, Journal of Dental Research Special Issue, 73:294 Abstract No. 1542.

Mohsen NM, Filisko FE, Craig RG. Dielectric relaxation of zirconium silicate-urethane dimethacrylate interfaces. Presented at the 71st General Session and Exhibition of the IADR, the 22nd Annual Meeting of the AADR, and the 17th Annual Meeting of the CADR, Chicago, IL, March 10–14, 1993. Also, in Dental Material Group—Polymer and Resin Composite Analysis with Advanced Instrumentation, Journal of Dental Research Special Issue, 72:198 Abstract No.754.

Mohsen NM, Craig RG. Hydrolytic stability of silanated zirconium silicate-urethane dimethacrylate interfaces. Presented at the 21st Annual Meeting and Exhibition of the AADR, Boston, MA, March 11–15, 1992. Also, in Dental Material Groups—Composites: Monomer/Silanization/O2 Inhibition, Journal of Dental Research Special Issue, 71:240 Abstract No. 1075.

Mohsen NM, Craig RG. Effectiveness of silanation of fillers using flow point test. Presented at the 21st Annual Meeting of the AADR and Exhibition, Boston, MA, March 11–15, 1992. Also, in Dental Material Groups—Composites: Monomer, Silanation/ O2 Inhibition, Journal of Dental Research Special Issue, 71:240 Abstract No. 1076.

Merz S, Mohsen NM. Evaluation of utilizing heated gas for ECMO thermal regulation. Presented at the 7th Annual Spring Conference for Neonatal ECMO, Ann Arbor, MI, April 10–13, 1988.

Published Abstracts and Posters

Mohsen NM, Beussink D, Steiger B, Gustow G, Ryde T. Safety and pharmacokinetic study of a unit dose nanocrystal budesonide. Presented at Respiratory Drug Delivery VIII, Tucson, AZ, May 12–16, 2002.

Mohsen NM. The stability of proprietary HFA steroid formulation delivered from the Aerosol Drug Delivery System (ADDS). Presented at the Annual Meeting and Exposition of the American Association of Pharmaceutical Scientists, Denver, CO, October 21–25, 2001.

Jayamaha M, Mohsen NM. The stability of two proprietary nano-steriod formulations delivered from the Multidose Solution Inhaler (MSI). Presented at the Annual Meeting and Exposition of the American Association of Pharmaceutical Scientists, Denver, CO, October 21–25, 2001.

Mohsen NM, Byron DA, Pavkov RM. Improvement of drug products delivery efficiency with Aerosol Drug Delivery System (ADDS). Presented at the Annual Meeting and Exposition of the American Association of Pharmaceutical Scientists, Indianapolis, IN, October 29–November 02, 2000.

Newman SP, Hirst PH, Bacon RE, Mohsen NM, Armer TA, Byron DA. Delivery of inhaled ergotamine tartrate to man using a novel inhaler device. Presented at the World Conference on Clinical Pharmacology and Therapeutics-Division of Clinical Pharmacology and the 4th Congress of the European Association For Clinical Pharmacology and Therapeutics, Florence, Italy, July 15–20, 2000, Abstract No.2114.

Hirst PH, Bacon RE, Newman SP, Armer TA, Mohsen NM, Pavkov RM, Byron DA. Deposition, absorption and bioavailability of aerosolized morphine sulfate delivered by a novel hand-held device, the Metered Solution Inhaler (MSI). Presented at the Respiratory Drug Delivery VII, Tarpon Springs, FL, May 14–18, 2000.

Newman SP, Hirst PH, Bacon RE, Mohsen NM, Pavkov RM, Armer TA, Byron DA. Pulmonary delivery of ergotamine tartrate using a new breath-actuated pressurized aerosol device, the Aerosol Delivery System (ADDS). Presented at the Respiratory Drug Delivery VII, Tarpon Springs, FL, May 14–18, 2000.

Eck CR, Armer TA, Bauer A, Byron DA, Mohsen NM. Reformulation and stability testing of an ergotamine tartrate MDI based on Hydrofluoroalkanes (HFAs). Presented at the Respiratory Drug Delivery VII, Tarpon Springs, FL, May 14–18, 2000.

Hirst PH, Bacon RE, Newman SP, Armer TA, Mohsen NM, Pavkov RM, Byron DA. Deposition of ergotamine tartrate in the human respiratory tract from a novel inhaler device, the Aerosol Drug Delivery System (ADDS). Presented at the World Millennial Congress of Pharmaceutical Sciences, San Francisco, CA, April 16–20, 2000.

Byron DA, Bacon RE, Mohsen NM. Deposition and systemic absorption of morphine sulfate delivered by a ‘soft mist’ Multidose Solution Inhaler (MSI). Technical Paper, 1999.

Eck CR, Armer TA, Bauer A, Helm M., Mohsen NM Newman SP, Pavkov RM. In-vitro and in-vivo characterization of an Ergotamine Tartrate pMDI suspension formulation in P227 using a novel Aerosol Drug Delivery System (ADDS). Presented at the Annual Meeting and Exposition of the American Association of Pharmaceutical Scientists, New Orleans, LA, November 14–18, 1999, Abstract No.2690.

Byron DA, Pallotta T, Bacon R, Mohsen NM. Correlation between pharmacodynamic effect and lung deposition of salbutamol. Presented at the Annual Meeting and Exposition of the American Association of Pharmaceutical Scientists, New Orleans, LA, November 14–18, 1999, Abstract No.3674.

Mohsen NM, Pallotta T, Bacon R, Byron DA, Armer TA, Pavkov RM. Correlation between in-vitro and in-vivo lung deposition of salbutamol sulfate. Presented at the Annual Meeting and Exposition of the American Association of Pharmaceutical Scientists, New Orleans, LA, November 14–18, 1999, Abstract No. 2541.

Mohsen NM, Filisko FE, Craig RG. Dielectric behavior of zirconia-filled urethane dimethacrylate restorative dental composite: Organic-inorganic interface. Presented at the 34th Annual Meeting of Continuing Education of the Dental School and the 4th Annual Meeting of Specialized Materials Science Research Center of The University of Michigan, Ann Arbor, MI, October 11–12, 1993.

Mohsen NM, Filisko FE, Craig RG. Dielectric behavior of zirconia-filled urethane dimethacrylate restorative dental composite: Organic-inorganic interface. Presented at the Thirty Years of Bioengineering Michigan Symposium at the University of Michigan, Ann Arbor, MI, November 11–13, 1993.

• Scientific Communication Specialist, I3 Stateprobe, United Health Group, 2006–2007
• Independent Consultant, specializing in pharmaceutical drug product development and optimization, 2004–2007
• Principal Scientist, Research and Development, Sheffield Pharmaceuticals Inc., 1998–2003
• Associate Engineer, Corporate Technology Organization, Aeroquip Corporation, 1996–1998
• Research Assistant, Joint appointments with the Departments of Bioengineering, Materials and Biologic Sciences,
• School of Dentistry, and Material Science and Engineering, The University of Michigan, 1990–1995
• Research Assistant, Department of Surgery, Medical School, The University of Michigan, 1987–1988

• American Association of Pharmaceutical Scientists (AAPS), 1999–present
  • Chair of Pharmaceutical Packaging Development Focus Group, 2009–present
• Food and Drug Law Institute (FDLI), 2007–present
  • Medical Devices and Diagnostics Committee member, 2011
• Regulatory Affairs Professional Society (RAPS), 2007–present
• Drug Information Association (DIA), 2007–present
• International Society For Aerosol in Medicine (ISAM), 2007–2010
• American Chemical Society (ACS), 2009–2010
• American Association of Dental Research (AADR), 1991–1998
• Material Research Society (MRS), 1993–1997
• Engineering in Biology and Medicine (EBM), 1992–1997
• Institute of Electrical and Electronic Engineers (IEEE), 1992–1997