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VP Regulatory Affairs Quality Assurance Clinical Affairs

Location:
Plymouth, Michigan, 48170, United States
Posted:
January 18, 2018

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Nahed M. Mohsen

Curriculum Vitae

***** **** ***** *****

Plymouth, Michigan 48170, USA

248-***-**** (cell)

Personal Email: ac33fi@r.postjobfree.com

Biography:

Dr. Nahed Mohsen is Corporate Vice President of Regulatory Affairs and Quality Assurance. She has been a member of ISS leadership and management team since 2012 bringing over a 25 years of experience in medical products’ pre-clinical and clinical development, product regulations, re-imbursement, and commercialization, scientific and advanced technology developments. At ISS, Dr. Mohsen serves in developing regulatory strategies and submissions to gain US and European market approvals for class II and class III cardiovascular implantable wireless hemodynamic monitors (electro-mechanical based products) for congestive heart failure indications. She is the primary liaison to the regulatory authorities related to quality and compliance policies, guidelines, systems, and audits. She developed and established the quality systems and maintains quality metrics for continuous improvements. She also served as the acting VP of operation/manufacturing as well as leading the effort in initiating and managing the efforts on clinical trial conductions. Prior to joining ISS, Dr. Mohsen was the lead inventor and developer of a migraine aerosol medication product at Sheffield Pharmaceuticals, which later became MAP Pharmaceuticals (MAP stands for the initials of the 3-inventor team lead by Mohsen) prior to its purchase by Allergan for about $1 billion. Dr. Mohsen has extensive experience in design, development, and optimizations of drug-device product combinations for liquid, propellant-based and dry powder-based delivery systems and formulations. Her main area of expertise is in physical, chemical, and biological characterizations and analysis of polymer-based biomaterials. From 2007 to 2012, Dr. Mohsen was a senior medical product regulatory and quality assurance consultant and served as an aerosol expert witness for medical devices and pharmaceutics litigation cases at Exponent, Inc. Prior to joining Exponent, Dr. Mohsen was a Manager of Scientific Communications and Medical Writing at UnitedHealth Group. From 1996 to 2003, Dr. Mohsen held a series of scientific and product development positions including Chief Scientist at Sheffield Pharmaceutical and Aeroquip Corporations. Dr. Mohsen received a Ph.D. in Bioengineering, a M.S. in Bioengineering, a M.S. in Industrial and Systems Engineering, a B.A. in Psychology and a B.S. Biochemistry all from the University of Michigan. Dr. Mohsen’s areas of qualifications are cardiophysiology, blood coagulations, hemodynamic phenomenon, biomaterials long term aging and characterizations not limited to biocompatibility and hemocomaptibility. Dr. Mohsen holds 11 issued patents and has over 40 journal publications and international conference presentations.

Education

Ph.D. Bioengineering, University of Michigan, Ann Arbor, Michigan, USA (1995)

Area of concentration: biomaterials science: materials’ biocompatibility, polymer composites

physics & chemistry, polymer-powder interaction & interfacial characterization

M.S. Bioengineering, University of Michigan, Ann Arbor, Michigan, USA (1989)

Areas of qualifications: transport phenomena (fluid, mass, and heat), blood material interaction and cardiophysiology

M.S.E Industrial & Systems Engineering, University of Michigan, Dearborn, Michigan, USA (1989)

Area of concentration: statistics, experimental design & quality control

B.A. Psychology, University of Michigan, Dearborn, Michigan, USA (1985)

B.S. Biochemistry, University of Michigan, Dearborn, Michigan, USA (1984)

Professional Experience

Integrated Sensing Systems, Inc. (ISS) (11/2012 – present)

VP Regulatory Affairs, Quality Assurance and Clinical Affairs

Ypsilanti, Michigan, USA

Serving in various capacities to lead several functions as follows:

General Functions

Serve as the technical advisor to the CEO.

Assist in company’s fund raising through private investment, conventions, before strategic partners recruiting and writing governmental grants.

Tremendous flexibility in being able to adapt large company’s policies/quality systems requirements in small company’ setting.

Develop, review and maintain company business plan.

Develop pitch presentations and presented in different forums.

Speak in a public forum in front of government officials, clinical professionals and scientific conferences.

Establish company policies.

Exhibited in several medical conventions and venues.

Negotiate contracts with CROs, vendors and raw materials suppliers.

Lead and managed a team of engineering, quality and regulatory personnel.

Tremendous experience in cardiovascular medical products development.

Act as the liaison and spokesperson on quality and regulatory issues before FDA and European Authorities as well as the lead management representative for external audits.

Tremendous experience working with Contract Research Organizations (CROs) related to clinical affairs, product’s scale up and manufacturing, sterilization and packaging as well as testing.

Regulatory Affairs Functions

Experienced in adults, pediatrics and orphan diseases medical products developments and regulatory submissions.

Extensive experience of EU medical device directives including Active Implantable Medical Directives (AIMD) 90/385/EEC, Medical Device Directives (MDD) 93/42/EEC and In Vitro Diagnostic Directive (IVDD) 98/79/EEC.

Experience in all phases of regulatory submissions and direct experience with FDA and European notifying bodies interactions.

Develop regulatory strategies and timelines and act as the primary liaisons with the US Food and Drug Administration (FDA) and European Notifying Bodies for cardio -implantable medical/diagnostic device products (class I, II and III).

Lead the efforts and prepared successful submissions including Pre-subs, IDEs and HUDs.

Lead the efforts with European Notifying Bodies interactions for CE Marking requirements, submissions and approvals.

Developed, authored and prepared successful design/technical dossiers submissions according to Active Implantable Medical Directives (AIMD) 90/385/EEC, and Medical Device Directives (MDD) 93/42/EEC.

Develop products that handle patients’ data according to Health Insurance Portability and Accountability Act (HIPAA) requirements and Data Protection Directive (DPD) 95/46/EC.

Expert in developing and preparing FDA 510Ks and PMAs for medical device and NDA, ANDA and 505b2 combination drug product applications submissions and documentations.

Develop, compile and maintain products’ Instruction(s) for Use and labeling.

Responsible for ensuring product labeling meets regulatory requirements for FDA and European notifying bodies including products labeling, external labeling (market brochures, publications, conferences materials and etc.).

Developed company’s product surveillance system.

Expert in regulatory guidelines including FDA, cGMPs, GLPs, GCPs, ICH, EPA, UL/cUL.

Quality Assurance Functions

Lead the efforts on taking the company’s certifications through external audits with observations- free twice.

Ensure internal audits are conducted and executed incompliance with regulatory requirements

Review Quality performance metrics to improve and monitor performance.

Ensure compliance, maintain and continuously improve the company’s quality management system according to FDA QSR including 21 CFR 820, CMDR, ISO 13485:2003, ISO 13485:2016, ISO 9001:2008 and ISO 9001:2016, cGMP and ICH guidance.

Developed and implemented companies’ systems including; risk management and risk analysis according to ISO 14971, CAPAs systems, complaints handling and adverse events reporting.

Established receiving/inspection/release systems and manufacturing quality control plans.

Developed several procedures and processes according to applicable standards including design control 21 CFR 820, usability (IEC 62366), verification/validation testing procedures, quality by design, software validation (IEC 62304) and automated software production equipment and process validation.

Act as primary liaison with regulatory authorities related to quality and compliance policies, guidelines, systems, and audits.

Direct accumulation, assimilation, analysis, communication/distribution of all quality, regulatory scientific and engineering data, and provide trend data tools for product field information, and recalls.

Perform root cause analysis, and manage and lead closure of preventative and corrective actions (CAPAs) cases.

Implement training program for all employees.

Clinical Affairs Functions

Initiate and manage clinical trials in human and manage clinical supplies.

Designed, developed and authored several pilot and pivotal studies designs and protocols according to GCP and EN ISO 14155 requirements including studies for device performance, accuracy, reliability as well as safety and efficacy for more than 500 patients multi-centers studies.

Designed, developed and Authored post-marketing clinical studies protocols.

Authored and prepared clinical trials reports for pilot and pivotal studies according to FDA and MEDDEV 2.7.1 requirements.

Authored and maintained successful clinical evaluation plans and clinical evaluation reports (CERs) as part of CE marking design dossiers according to MDDEV 2.7/1 Rev 4, June 2016.

Devise post marketing surveillance and vigilance plans and infrastructures according to FDA and MEDDEV 2.12-1requirments.

Pre-clinical Functions

Served as the Acting VP of Manufacturing/Operations from 11/2012 to 11/2014.

Developed and maintained Risk Management File(s) for several medical products.

Performed gap analysis for the product essential requirements.

Developed and authored animal safety, functionality and reliability protocols, managing, and coordinating GLP/non GLP safety and reliability studies for cardio medical devices.

Lead the efforts of conducting pre-clinical studies including bio/hemo-compatibility according to all parts of ISO 10993.

Developed and maintained procedures and records for products sterilization validations, routine sterilizations, annual process assessments, re-validations and re-qualifications all according to the applicable standards including ISO 11135, ISO 11138, and ISO 11737.

Developed sterile and sales packaging for the various medical products according to ISO 11607.

Developed protocols and executed internal and external studies to support MRI compatibility claims.

Nooryn Group (4/2012 – present)

Pharmaceutical consulting firm

Founder & Partner

Plymouth, Michigan, USA

Consult and advise clients in technology transfers, regulatory affairs and quality control in medical devices and pharmaceutical drug products from inception to commercialization to ensure compliance with ISO 13485, cGMP and CFR 820.

Exponent (Failure Analysis Associates) (11/2007 – 3/2012)

Managing Engineer/Manager

Biomedical Engineering Practice and Pharmaceutical Sectors

Farmington Hills, Michigan, USA

Lead managers for corporate-client teams in R&D activities including directing new technologies’ development, technology transfer, regulatory, quality assurance, scientific, and engineering strategies and tasks in pharmaceutical and medical device companies including the following:

Management & Leadership

Developed pharmaceutical and medical devices products from inception to commercialization.

Positioned and adapted consumer products to medical products.

Worked with key opinion leaders and investigators on research concepts, including supporting potential investigator’s concept development and submissions; reviewing study design, contracting, and overseeing study progression.

Assessed product opportunities, conducted initial market surveys, identified differentiable new therapies, performed benchmarking studies, and developed regulatory strategies, established budgets and resources.

Evaluated technologies for patentability and licensing potentials including reviewing invention disclosures and guide patenting decisions, liaising with outside counsel in preparation, filing and prosecution of patent applications, initiating patentability, and performing patent searches.

Project management and administration including planning and proposals, budgets and resources, execution and timeliness, delivery and compliance.

Developed and maintained necessary team/individual training programs as required by local, state, federal, corporate and project/client requirements.

Developed and implemented safety programs in compliance with governmental regulations (OSHA) and corporate policies.

Led investigations, root-cause analysis and implementing CAPA according to clients’ quality management system and corporate policies.

Presented and frequently interacted with corporate executive leadership and management teams and provided progress updates and reports.

Negotiated contracts, agreements and T&Cs with executive leaderships and legal counsel.

Served as an expert witness in court of law for OTC cosmetic products.

Regulatory Affairs and Quality Assurance

Developed regulatory strategies, developed timelines and directed interaction with the US Food and Drug Administration (FDA) for pharmaceutics and medical device products registrations including NDAs, 505b2s and ANDAs, DMF’s and color additive petitions for drugs as well as IDEs and 510Ks for medical devices.

Lead and prepared US regulatory product submissions 510ks, IDEs, NDAs, 505b2s and ANDAs technical files.

Lead the design and development of In Vitro Diagnostic Medical Directive (IVDD) surveillance system to a major client according to FDA and EU IVDD 98/79/EEC regulatory requirements.

Audited, developed and implemented quality assurance systems including USP, ISO 9001, ISO 13485, ISO 17025, FDA QSR 21 CFR 820, cGMP, 21 CFR 58, 210 and 211, and ICH Q7, Q8, Q 9 and Q 10.

Audited and developed systems for FDA 21 CFR Part 803 Medical Device Reporting, FDA 21 CFR Part 806 Corrections and Removals.

Audited and developed process validations/qualifications (IQ, OQ and PQ).

Audited and developed companies’ systems including; quality, management, risk management, CAPA, complaints handling and adverse events reporting.

Audited, developed and implemented design control, verification/validation testing, CAPA, quality by design, product recalls, risk analysis and management, and FMEA analysis.

Implemented quality systems according to GLP, cGMP and ICH guidance.

Audited, developed and implemented raw, intermediate in –process sampling and release testing, verification/validation testing, and validations of analytical procedures.

Audited, developed and implemented CAPA, product recalls, and management risk analysis.

Conducted internal audits and led management review meetings.

Audited suppliers and venders and developed and implemented laboratory control.

Developed and implemented operational environmental safety, building and facilities, sanitary, water and containment programs in compliance with cGMP.

Devised verification and validation testing programs and protocols for several medical devices to support 510Ks and PMAs submissions.

Performed software validations including test cases creation, test plans creation, actual tests execution in simulated and in the hand of user environments, data analysis, and mentoring tests and colleagues.

Research and Development

Directed development of new drug products and new technologies including drug formulation process developments, tech transfer from bench to scale up and commercial manufacturing.

Directed innovative research and novel scientific ideas, developed and provided strategies and directions for the scientific team, and analyzed and interpreted data.

Developed risk assessment programs for DPIs and MDIs drug products.

Assisted clients in combination drug products design and development programs.

Led the efforts of developing and implementing stability programs for several drug products in different dosage forms.

Led the efforts of developing drug packaging for several dosage forms.

Assisted companies in drug formulations’ particle design, coating technologies and powder nanotechnologies to achieve high efficiency, appropriate dissolution and pharmacokinetic profiles and targeted drug delivery for several dosage forms.

I3 StatProbe, United Health Group (11/2006 – 10/2007)

Scientific Communication Specialist

Ann Arbor, Michigan, USA

Medical writing and scientific communication including

Developed and wrote aerosol drug products clinical trials protocols for Phase I and Phase II.

Developed and wrote peer-reviewed articles in the areas of women and men health.

Responded to medical/scientific/technical information requests from external customer groups including healthcare professionals.

Developed and maintained scientific expertise and familiarity with literature regarding assigned products portfolio, including competitor products.

Independent Consultant (1/2004 – 10/2006)

Consulted and advised clients in pharmaceutical products development and technology transfer including:

Evaluated technologies, conducted bench marking, assessed technologies for patentability and licensing potentials.

Developed and managed drug products programs including development (regulatory, clinical and technical), marketing and commercialization.

Led the efforts in technology transfers from bench to manufacturing.

Involved in products management at different stages in the development.

Audited, developed and implemented quality systems regulations and requirements.

Advised on regulatory strategies, prepared testing strategies/programs for deficiency letter responses to FDA and prepared documentation for regulatory submissions including NDAs, 505b2s, and ANDAs,

Developed and implemented testing programs and strategies to answer FDA’s questions, inquiries and deficiencies in submissions.

Provided expertise to regulatory and product development teams for regulatory requirements, quality assurance and marketing.

Audited companies’ systems including; quality management systems, risk management, CAPA and complaints handling and adverse events reporting.

Sheffield Pharmaceuticals, Inc. (9/1998 – 12/2003)

Principal Scientist/Group Leader

Ann Arbor, Michigan, USA

Led and headed the R & D division involving oversight of all the scientific, technical, operations and resources including staff, equipment and supplies, managed and provided directions and training of scientists and engineers, and worked in several areas of drug product development including the following:

Business Development, Regulatory Affairs and Quality Control

Assessed product opportunities, conducted initial market surveys, identified differentiable new therapies, performed benchmarking studies, developed regulatory strategies, established budgets and resources, and interacted with external regulatory and marketing consultants, intellectual property and patent lawyers.

Evaluated technologies, for patentability and licensing potentials, oversaw patents filing and managed patent applications. Reviewed invention disclosures and guide patenting decisions, liaising with outside counsel in preparation, filing and prosecution of patent applications, initiating patentability, and performing patent searches.

Created marketing, product developments, licensing and programs funding strategies for products.

Involved in negotiations, drafts, terms and conditions for technology agreements and licensing deals.

Led management review meetings and updated development progress to executive management and chairman of the board.

Led products’ quality reviews.

Developed and managed drug products programs including development (regulatory, clinical and technical), marketing and commercialization.

Lead the efforts and managed technical, methods and manufacturing technologies transfer.

Developed regulatory strategies and action plans to gain market approval for 9 drug combination products in the USA & Europe, prepared CMC sections to support INDs, NDAs, 505b2s and ANDAs submissions, provided responses to regulatory queries, solved CMC related-issues, summarized pre-clinical & clinical studies, managed document and represented the company before the FDA.

Developed, implemented and maintained quality assurance systems in compliance and in accordance with cGMP, 21 CFR 210 and 211, and ICH Q7, Q8, Q 9 and Q 10.

Developed and implemented cGMP laboratory controls.

Audited suppliers and venders and procured and managed raw materials and supply chain.

Developed and maintained quality records and documentations, process equipment records, material management systems and records, packaging and labeling systems, laboratory control, validation and verification records and testing.

Developed and maintained personnel safety and training programs, employees’ performance evaluation and goals setting and career empowerment.

Developed and maintained operational environmental safety, building and facilities, sanitary, water and containment programs.

Project Management

Managed multiple projects including developing and tracking projects (time, resources and budget), intellectual properties, and publications using computer based project management software and tools.

Worked with multiple partners and multi-disciplinary groups.

Wrote summaries, technical reports, presentations and recommendations.

Research, Development and Manufacturing

Invented, designed and managed the development of 5 novel aerosol drug delivery systems (one pMDI, two DPIs and two nebulizers) to deliver respiratory and systemic formulations through the pulmonary route from proof-of-concept to different stages of clinical development including mechanical, functional, and ergonomic designs, as well as industrialization and packaging of the delivery systems.

Managed the efforts of particles/powder design using different powder technology techniques (e.g., Super Critical Fluids (SCF), Spray Drying, Precipitation) to control powder size, morphologies and shapes to produce crystalline, amorphous, micro and nano-crystal particles, and developed studies, protocols, specifications and ICH stability programs for reformulated powder.

Invented, developed and produced bio-batches for 9 different aerosol formulations (liquid and suspension) including 2 steroidal anti-asthma, 2 anti-migraine, 4 non-steroidal asthma drugs, and one pain formulation.

Developed and validated methods, product specifications, protocols and procedures to evaluate drug product performance and implemented testing programs for CMC and stability according to FDA/ICH/GMP guidelines.

Designed, coordinated, and conducted process development activities for manufacturing of different drug formulations for clinical supplies at various CMOs and managed all resources, SOPs, batch cards, supplies and bio-batches scale-ups.

Implemented and developed quality by design, devised products manufacturing attributes, implemented raw materials, intermediates, in-process and release testing.

Negotiated contracts and deals with contract manufacturing sites and contract labs.

Identified and managed sites for preclinical testing programs including toxicology studies and analytical testing.

Laboratory & Analytical

Started, built and managed the corporate analytical laboratories including equipment and quality systems.

Developed, validated and maintained testing methods’ protocols, SOPs and documentation procedures, and implemented the infrastructure for cGMP.

Established and lead the efforts of maintaining records of inventories for raw materials, laboratory supplies, drug supplies, equipment and their calibration, preventative maintenance and operational procedures.

Lead the effort of establishing safety and environmental procedures.

Identified, sourced and procured APIs and suppliers for manufacturing of clinical and commercial drug liquid, suspension, sterile, non-sterile and aerosol drug products.

Lawrence Technological University (8/1999 – 5/2000)

Adjunct Professor

Department of Natural Science, Southfield, Michigan, USA

Teaching undergraduate chemistry courses

Aeroquip Corporation (3/1996 – 8/1998)

Associate Research Engineer

Corporate Technology Organization, Ann Arbor, Michigan, USA

Started The Aerosol Drug Delivery Corporate Venture and accomplished the following:

Business Development

Performed strategic planning, market analysis, competition and product opportunities assessment, and developed business plans for novel aerosol drug delivery system business.

Evaluated technologies, conducted bench marking, assessed technologies for patentability and licensing potentials, oversaw patents filing and managed patent applications.

Created marketing, product developments, licensing and programs funding strategies for products.

Involved in negotiations, drafts, terms and conditions for technology agreements and licensing deals.

Developed and managed drug products programs including development (regulatory, clinical and technical), marketing and commercialization.

Involved and managed technical, methods and manufacturing technology transfers.

Identified the functional arms of the business including consultants, personnel, CROs, and testing labs.

Presented Aeroquip’s new aerosol drug delivery technology to potential buyers and venture capitalists.

Research & Development

Invented aerosol drug delivery concepts, designs and models and established proof-of-concept using imaging and aerosol measurement techniques.

Developed correlation criteria between optimum atomization conditions and optimum inhalation delivery using CFD simulations and experiments.

The University of Michigan (1/1990 – 5/1995)

Graduate Research Assistant

Joint appointment with the Department of Material & Biological Sciences, School of Dentistry, Department of Material Science & Engineering and the Department of Bioengineering, Ann Arbor, Michigan, USA

Researched several topics including:

Evaluated biocompatibility and cytotoxicity of biomaterial polymer-based composites.

Identified chemicals leached from polymer-based composite.

Developed methods for coating of inorganic phases (powder) in polymer-based composites and evaluating their stability, property-structure relationships, and their impact on the physical properties of these composites.

Characterized the interface & evaluating polymer-powder interaction w/wo coupling agents in these composites using unique techniques.

Examined effects of the biological environment on these interactions.

Examined effects of different additives on molecular mobility of polymers in polymer-based composites.

Examined continual chemical and physical aging of polymers using spectroscopical & thermodynamic approaches.

The University of Michigan (1/1987 – 5/1988)

Research Assistant

The Extracorporeal Membrane Oxygenation (ECMO) Laboratory, Department of Surgery, Medical School, Ann Arbor, Michigan, USA

Conducted several tasks including:

Collected samples & perform data analysis from in vivo experiments in dogs and sheep, including blood & urine samples.

Improved the thermal regulation of ECMO system.

Therapeutic Experience

Pulmonary/respiratory (asthma and COPD), diabetes, CNS (pain management & migraines), women’s health (osteoporosis and breast cancer), and drug delivery systems (aerosol, pulmonary, nasal, ocular, transdermal and parenteral), and Cardiovascular medical devices.

Laboratory & Computer Skills

Molecular & Conformational Characterization of Macromolecules: Dielectric Measurements Methods

Analytical Methods: UV/Vis., HPLC, FT-IR, Karl Fischer coulometry

Enthalpy Measurements Methods: Microcalorimetry, Dynamic Mechanical Testing (Torsion Pendulum) & DSC

Mechanical Strength Tests: Tensile, 3-Point Bending, Modulus & Knoop Hardness

Aerosol Measurement: laser diffraction particle analyzer, Cascade Impactors, & Dose Unit Sampling Apparatus (DUSA)

Surface Measurements: Contact Angle

In vitro Cell Culture Testing

MS Office: Word, Excel, Powerpoint & Project, Sigma Plot and RefMan; UNIX operating system

Professional Affiliations & Awards

American Association of Pharmaceutical Scientists (AAPS), 1999–present

Chair of Pharmaceutical Packaging Development Focus Group, 2009–2012

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

“Strategic Management of Innovation and Technology” Certificate of Achievement from Aeroquip Corporation on 12/19/1997

Continued Educational Courses

Advances in Proteins and Gene Therapy (11/14/1999)

The Annual meeting and Exposition of the American Association of Pharmaceutical Scientists, Ernest N. Morial Convention Center, New Orleans, LA, USA

Advances in Controlled Release Technology: Polymeric Delivery Systems for Pharmaceuticals, Proteins and Other Agents (6/17/1996 – 6/21/1996)

Massachusetts Institute of Technology, Cambridge, MA, USA

Good Manufacturing Practice GMP/GLP (12/10/1996)

Aeroquip Corporate Technology Organization, Ann Arbor, MI, USA

Summary of Patents, ROIs, & Publications

o13 Patents granted including: EP 0911048A2 and WO 9920331A1,

o18 Records of Inventions (Aeroquip Corp., and Sheffield Pharmaceuticals, Inc.),

o7 Publications,

o1 Webinar,

o13 Presentations and Published Abstracts of Presentations, and

o13 Published Abstracts and Posters.



Contact this candidate