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Dr. DeWyngaert has provided operational clinical managerial consulting and litigation services to various segments of the health care industry. He trained as a molecular biologist and has been actively involved in both research and business development roles for the past 25 years. Mark specializes in assisting pharmaceutical manufacturers biotechnology and medical device companies with identifying and mitigating regulatory risks and valuing intellectual property.
Professional Experience
Mark regularly leads teams in the assessment of medical affairs and clinical development activities and assists companies in the redesign of business practices to comply with applicable regulations and standards. He also serves clients and their legal counsel in fraud investigations compliance inquiries litigation strategy issues and acting as an expert witness.
Representative examples of Mark's engagement experience include:
Reviewed sponsored clinical research protocols for intellectual property concerns and ensured compliance with institution's policies for research agreements such as investigator conflict of interest.
Assisted in developing new procedures policies and forms to ensure compliance with institutional and external regulatory requirements.
Reviewed reporting procedures and payments made in compliance with license agreement.
Assisted major insurance company with significant claims analysis related to biomedical technology dispute valued over $200 million.
Assisted board of a failed medical device company to extract value from residual intellectual property for a gain of $1 million.
Assisted major pharmaceutical companies with independent assessments of their clinical trials registry process and procedures.
Negotiated international joint ventures and licensing programs for several biotechnology firms.
Provided compliance systems reviews to several major Pharmaceutical companies related to GXPs.
Education & Certifications
Master of Business Administration Stern School of Business New York University
Doctor of Philosophy Molecular Biology University of Rochester
Recipient of NIH pre-doctoral fellowship
Master of Arts Biology University of Rochester
Bachelor of Arts Neurochemistry University of Rochester
Professional Associations
New York State Biotechnology Association Member
Licensing Executives Society Member
Association of University Technology Transfer Managers Member
International Consortium for Blood Safety Co-founder
CT Venture Group State Board Member
Speaking Engagements
Mark is a frequent speaker on the management of regulatory risks associated with promotional education research and clinical development activities as well as in valuation practices and intellectual property matters. | 