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Mechanical Ventilator & Breathing Expert Witness

Provides Opinion & Testimony In:

Mechanical Ventilator, Breathing, Cardiopulmonary Monitoring, Resuscitation, Medical Device Standards, Quality Control, business development, Clinical Physiology,

Expert Witness No. 1101

PROFILE

Experienced entrepreneur, started, developed technology and served as CEO of medical device company for twenty years.  Raised capital, obtained patent, submitted IRB and 510K applications, negotiated manufacturing and licensing agreements for IP and provided leadership in a changing environment with a great support team.  Principal Investigator on many Phase 3 drug studies evaluating therapies for asthma, COPD & emphysema.

•    Planned entire organization from inception.  Raised capital and licensed
      intellectual property and provided return of equity to investors.
•    Leadership role creating need for medical device standards resulting in passage of Medical Device Act of 1976.
•    Founder and organizer of  Society on Computing in Anesthesia, Critical Care and Pulmonary Medicine and
     co-founder of Journal of Clinical Monitoring.
•    Directed and was Chairman of ANSI Z79 Committee on ‘Standards of Humidifiers & Nebulizers for Medical Use’.
•    Managed many groups with P&L responsibility both internally as CEO of a medical device company and externally serving
     as officer and member of ASTM F29 Committees on Anesthesia & Respiratory Devices for twenty-five years and member
     of NIH SBIR Grants Committee.
•    Clinical scientist, designing protocols, conducting and publishing original research results in peer review journals.

EXPERIENCE

Private Company  2009-Present
Created tech transfer agreement with a Doctor at a Private University,Virginia and State University in Michigan.  Conducted laboratory and clinical research funded by DOD developing oxygen delivery therapies to treat hemorrhagic shock in wounded soldiers.  Designed clinical protocols, obtained study subjects  and test data for analysis. Obtained method’s patent and FDA 510k approval for portable chemical oxygen generator.

Versamed/GE Healthcare.VP Business Development  2003-2009
Establishing business strategies & implementing regulatory approval for medical device manufacturer. Identifying thought leaders and developing clinical protocols for new modalities in artificial ventilation.

AstraZeneca , LP  GI/MIS  2000-2003
Medical Information Scientist for the GI therapeutic area.  Provided internal & external customer support for the launch of Nexium and Entocort EC.  Managed thought leaders’ knowledge of products. Clinical research liaison for SNDA submissions. Negotiated contracts with stakeholders and PMAs. Trained speakers and conducted consultant workshops.  Trained sales associates and presented lectures on various GI topics.
 
Pneumedics, Inc. CEO  1981- 2000
Raised $1MM, started company as an entrepreneur with full P&L responsibility, obtained FDA 510k approvals, managed FDA inspections of manufacturing facilities, designed, manufactured, marketed and sold cardiopulmonary function and exercise testing instruments.

Norwalk Hospital-Yale School Of Medicine 1970-1981
Clinical Physiologist, Director, Pulmonary Function Lab
Department Respiratory Therapy & University of Bridgeport
Associate Director, Hinds Center for Lung Research & Hyperbaric Medicine.

Union Carbide Research Institute, Tarrytown, NY  1968-1970
Research Scientist

Institute Of Environmental Medicine, NY, NY 1967-1968
NYU Medical Center
Research Instructor

Bellevue Hospital, NY, NY  1967-1968
NYU Medical Center
Research Instructor

EDUCATION

St. Peter’s University, Jersey City, NJ BS Biology 1963

New York University, NY, NY
MS Biology 1968
Ph.D. Biology 1972

PROFESSIONAL AFFILIATIONS

American Physiological Society, American Thoracic Society, Registered Respiratory Therapist, ASTM, F-29 Committee on Anesthesia Equipment, Board Member: Computing in Critical Care, Pulmonary Medicine & Anesthesia, National Emphysema Foundation.

PATENTS

Available Upon Request

PUBLICATIONS

Available Upon Request

Groups

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