Law Office of Concetta E. Dudley, JD

Corporate and Business Practice with emphasis on Life Science and Technology, and VC/PE

Founder; Managing Attorney

The Johns Hopkins University

Graduate adjunct faculty teaching Technology Transfer & Commercialization, and Ethical, Legal and Regulatory Aspects of Biotechnology.

Lecturer

Gertsburg Licata Co., LPA

Of Counsel

Freedom and Growth for Entrepreneurs and Their Ventures

Partner

MEDA Angels, LLC

Due diligence advisor evaluating life science and medical investment opportunities.

Advisor

Fauver Co, LPA

Ohio Business Practice - Litigation, M&A, Business & Corporate Transactions & Estate Planning

Shareholder

University of Maryland Baltimore County

•	Designed and taught in-person and hybrid coursework for graduate students in law and ethics for scientists.
•	Specifically addresses issues in law, research development, bioethics and related outcomes and economics

Graduate Faculty – Biotechnology 

Graduate Program Director , Biotechnology 

•	Legal advisor on executive team of Office of the Vice President for Research, providing high level support on contracts, transactional law, research administration, compliance and regulatory matters.
•	Managed high level agreements for data and privacy, health informatics, innovation development and highly compliance matters, including HIPAA/HI-TECH/Privacy Act, FOIA, FCPA, FAR/DFAR, and COI/OCOI.
•	Drafted and provided executive guidance on university policies and procedures.
•	Developed and managed all DUAs, BAAs, and other data and privacy matters for state and CMS data.
•	Handled FOIA and other records requests.

Manager, Technology Transactions & Policy

Inspirion Biosciences

General Counsel for emerging global biorisk management and strategy company.  Primary legal resource and advisor on executive management team.  Highly skilled advising on a variety of complex issues, including corporate law, transactional law, strategic customer contracts, risk management, compliance, regulations and employment law.
•	Leading strategic corporate turnaround.
•	Responsible for drafting, reviewing, and negotiating contracts, providing general corporate and legal analysis.
•	Maintains updates and changes in relevant laws, regulations, industry standards and emerging trends.

General Counsel

Legal, Business & Compliance Advisor

Advises U.S. and international private venture organizations and growing companies on legal transactions, strategy and commercialization of new technologies.
•	Serves as Board Secretary for advanced carbon company.
•	Served four years as fractional General Counsel for private equity group in oncology therapeutics, handling multi-national clinical trial agreements and licensing matters.
•	Served as advisor with The Zerhouni Group, private advisory group directed by Elias Zerhouni, former Director of NIH and President for Global Research and Development with Sanofi-Aventis, advising nation of Qatar, to develop a research and development infrastructure framework for health and technology research and investment.
•	Served as senior health law & policy team for gubernatorial candidate.  Evaluated current law and drafted applicable state waivers to ACA (1115 and 1332).  Developed strategic approach to new healthcare models, including models for high risk pools, wellness and direct primary care.

Mount St. Mary's University

•	Spearheaded development of Research Compliance, Sponsored Research and Intellectual Property policies.
•	Developed new graduate programming in Quality Assurance and Regulatory Science.

Director, Graduate Programs in Science

Trulogix Analytics

Fractional General Counsel to start-up data analytics research and development company focused on healthcare fraud detection for CMS and private insurance markets.  Worked collaboratively with leadership to handle governance, intellectual property, and general corporate matters; managed outside counsel.

Experienced, mission driven, CCEP-certified attorney and strategic business leader with broad experience and a commitment to high standards of professionalism and integrity.  High impact member of executive leadership.  Strong corporate law, contract law, transactional law, negotiations, intellectual property and compliance expertise. Skilled at creating collaborative relationships with key cross-functional stakeholders.  Proven leader in a fast-paced, diverse, changing, energetic team environment.


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