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Nahed M. Mohsen, Ph.D.

Manager

Biomedical Engineering

Professional Profile


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.

  • Ph.D., Bioengineering, University of Michigan, Ann Arbor, 1995
  • M.S., Bioengineering, University of Michigan, Ann Arbor, 1989
  • M.S.E., Industrial and Systems Engineering, University of Michigan, Dearborn, 1989
  • B.A., Psychology, University of Michigan, Dearborn, 1985
  • B.S., Biochemistry, University of Michigan, Dearborn, 1984
  • Strategic Management of Innovation and Technology Achievement, Aeroquip Corporation, Ann Arbor, MI, 1997

  • USPTO Application 20070253913: Aerosol Formulations for Delivery of Dihydroergotamine to the Systemic Circulation Via Pulmonary Inhalation (with T.A. Armer and R.M. Pavkov).

    WO/2007/011989: Multiple Active Pharmaceutical Ingredients Combined in Discrete Inhalation Particles and Formulation Thereof, January 2007 (with T.A. Armer and R.O. Cook).

    WO/2005/025506: Aerosol Formulations for Delivery of Dihydroergotamine to the Systemic Circulation Via Pulmonary Inhalation, March 2005 (with T.A. Armer and R.M. Pavkov).

    Pub No. US 2003/0091513 A1: Method to Generate Water Soluble or Non-Water Soluble in Nanoparticulates Directly in Suspension or Dispersion Media, May 2003 (with T.A. Armer).

    Patent 6,527,151 B1: Aerosol Air Flow Control System and Method, March 2003 (with T.A. Armer and R.M. Pavkov).

    Pub No. US 2003/0026767 A1: Method to Aerosolize Interferon-Gamma for Lung Delivery for Local and Systemic Treatments, February 2003 (with T.A. Armer).

    WO/2001/038002: Aerosol Air Flow Control System and Method, May 2001 (with T.A. Armer and R.M. Pavkov).

    Patent No. 6,095,141: Methods and apparatus for delivering aerosolized medication, August 2000 (with T.A. Armer, B.B. Evans BB, R.M. Pavkov, and A.M. Sudhalker).

    Patent 6,026,808: Methods and Apparatus for Delivering Aerosolized Medication, February 2000 (with T.A. Armer, B.B. Evans BB, R.M. Pavkov, and A.M. Sudhalker).

    WO/1999/020331: Methods and Apparatus for Delivering Aerosolized Medication, April 1999 (with T.A. Armer, B.B. Evans BB, R.M. Pavkov, and A.M. Sudhalker).

    Patent 5,954,047: Methods and Apparatus for Delivering Aerosolized Medication, February 1999 (with T.A. Armer, B.B. Evans BB, R.M. Pavkov, and A.M. Sudhalker).

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