Republican National Lawyers Association | (RNLA)
Republican National Lawyers Association | (RNLA)

Member Profile


Ms. Concetta E. Dudley

University of Maryland Baltimore County
Contributing Member
Office:
5539 Jefferson Blvd.
Frederick, MD 21703

Phone: 240-566-2781
Email: mrsrdudley@yahoo.com

Law School: Cleveland State University (1990)

Practice Areas:
 

CONCETTA E. DUDLEY, J.D.
5539 Jefferson Boulevard • Frederick, Maryland 21703
Mobile: 240-566-2781 • mrsrdudley@yahoo.com
On LinkedIn at: http://www.linkedin.com/in/concettadudley

Business mission focused attorney and technology transfer professional with broad experience expertly structuring and negotiating a wide array of technology-based transactions, and soundly handling complex issues in corporate law, contracts, healthcare and intellectual property.

PROFESSIONAL EXPERIENCE

UNIVERSITY OF MARYLAND BALTIMORE COUNTY, Baltimore, MD • 2013 – Current
Manager, Technology Transactions and Policy
Works collaboratively on executive team of Office of Research, including Vice President for Research, Associate Vice Presidents and General Counsel.
•Structures, drafts and negotiates high level agreements for technology development, data and privacy, and highly regulated compliance matters, including HIPAA, FAR/DFAR and FAA.
•Drafts and provides executive guidance on technology and research policy.
•Advise executive level stakeholders on compliance issues.
•Educates administration and staff on technology commercialization and administration issues.
Instructor: Graduate Programs in Biotechnology
•Designs coursework for and educates graduate students in Law and Ethics for Science Professions course.
•Specifically addresses issues in intellectual property law and commercialization, business law, data and privacy, torts and product liability, and research and bioethics.

LEGAL AND TECHNOLOGY TRANSFER CONSULTANT, Frederick, Maryland • 2002 – Current
Expertly advises U.S. and international private venture organizations and growing companies on legal strategy, technology development and commercialization, and enhancement of economic development opportunities.
•Provides executive legal and business expertise for several start-up companies, serving as ad hoc General Counsel, including a health informatics company and vaccine development company.
•Partnered with East Coast private equity group to in-license and manage IP portfolio for oncology therapeutics from an Israeli university, and successfully managed international clinical trial and regulatory issues.
•Partnered with The Zerhouni Group on international science policy, and worked with top foreign government officials to develop a government infrastructure framework for a country-wide research and intellectual property management agency, to enable a transition to a knowledge-based economy, whose efforts are still ongoing.
•Secured technology for and advised biotechnology start-up that has, to date, secured over $100M in private funding, and recently completed an IPO.
•Acquired multiple technologies from American universities for ophthalmic and topical therapeutics company.

WRIGHT STATE UNIVERSITY, Dayton, Ohio • 2007- 2010
Director, Office of Technology Transfer & Development: Directed and managed development and growth of technology transfer and development office from the ground up. Performed internal and external education and marketing activities related to technology transfer and regional economic development. Tripled invention disclosures and research related contracts in less than 24 months, substantially growing the university’s portfolio and increasing the university’s research revenue. Effectively managed outside counsel.
•Developed and implemented strategic plan for university IP portfolio management and development.
•Implemented and managed university’s first intellectual property case management database.
•Developed and implemented investigator education program for intellectual property protection.
•Developed export compliance program to promote compliance with federal regulations.
•Reviewed, commented on and submitted revisions of proposed legislation on behalf of university.

DIGENE CORPORATION, Gaithersburg, Maryland • 2007
Attorney (Contract): Negotiated high-level, large-scale domestic and international corporate contracts, and supported strategic alliance and technology acquisition transactions for molecular diagnostic development and manufacturing company.
•Legal lead on negotiating team that secured a nine figure long-term sales contract for medical devices.
•Served as legal partner for Business Development and Sales teams.
•Advised management in internal corporate policy development.
•Successfully structured product development and license agreements, including international agreements.

MEDIMMUNE, INC., Gaithersburg, Maryland • 2005-2007
Attorney (Contract): Negotiated high-level, large-scale domestic and international corporate contracts, agreements, and transactions for leading vaccine development and manufacturing company. Advised management on matters of internal corporate policy development.
•Profitably negotiated over 400 agreements per year, and quickly reduced large contracts backlog.
•Saved company over $500K per year by minimizing liability exposure in marketing and sales contracts.
•Served as legal partner for Business Development and MedImmune Ventures groups.
•Worked to ensure Sarbanes-Oxley compliance on internal matters.
•Conducted internal training for scientific personnel on intellectual property and contractual matters.
•Promoted export compliance awareness and initiated development of export compliance protocol.

UNIVERSITY OF MARYLAND UNIVERSITY COLLEGE, Adelphi, Maryland • 2007
Adjunct Assistant Professor, Graduate School of Management & Technology
•Educated graduate level students in fundamentals of basic contract law, detailed federal contracting processes, and procurement issues.
•Specific topics covered included FARS/DFARS, intellectual property, and anti-trust.

TECHNICAL RESOURCES INTERNATIONAL, Bethesda, Maryland • 2003-2004
Chief Counsel, Regulatory Compliance Center: Served as lead attorney for regulatory compliance center of contract research organization. Negotiated clinical trial and other agreements for the Division of AIDS of the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.
•Worked on executive team responsible for major clinical trial safety compliance, FDA and HIPAA issues.
•Safeguarded the company and agency by ensuring compliance in the areas of government contracting and procurement, intellectual property, and human subjects protection in international clinical trials.
•Successfully negotiated high volume of multi-phase international clinical trial agreements.
•Procured high volume of doses of study and supportive therapy drugs.

PANACEA PHARMACEUTICALS, INC., Gaithersburg, Maryland • 2003
Vice President, Legal Affairs: Served as General Counsel and member of executive management team, managing all corporate legal matters including research and licensing agreements, technology transfer activities, financing development, litigation management, real estate law, and general business activities, including management of outside counsel for patent and litigation matters.
•Successfully established new subsidiary for company to focus on new product pipeline.
•Established and implemented employee invention reporting process.
•Worked with CFO to manage international shareholder interests.
•Managed litigation and outside counsel

NATIONAL HEART, LUNG & BLOOD INSTITUTE (NIH), Bethesda, Maryland • 2001-2002
Director, Technology Transfer and Development: Managed administrative workflow, trained staff and supervised technology transfer operations for 7 institutes within the National Institutes of Health. Educated scientific and professional staff on technology transfer processes. Promoted services internally and externally, and advised and supported the extramural federal grants and contracts division.
•Managed Technology Review Committees for NHLBI and other serviced institutes.
•Improved collaborative efforts by implementing the organization’s first case tracking database.
•Maintained personal caseload of research contracts including CRADAs, MTAs, and other associated transactions.

JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE, Baltimore, Maryland • 2000-2001
Associate Director, Office of Technology Licensing: Identified and evaluated new intellectual property, oversaw patent prosecution by outside counsel, and managed transactional aspects of research and licensing activities including contract development, negotiation, and contract compliance. Performed educational and marketing activities related to technology transfer process.
•Worked closely with university’s foreign campus personnel to support technology transfer and development, as well as non-US regional economic investment.
•Trained and developed a team of talented staff members to handle specialized agreements.
•Managed diverse invention portfolio that included medical devices and imaging technology as well as therapeutics, and that spanned the School of Medicine, Applied Physics Laboratory and Main Campus.

CELERA GENOMICS, Rockville, Maryland • 2000
Attorney: In-house counsel that successfully negotiated high value database license contracts and general corporate matters.
•Worked closely with business development unit to effectively close deals
•Trained business development team members on intellectual property and working with academic customers.

CASE WESTERN RESERVE UNIVERSITY, Cleveland, Ohio • 1998-2000
Licensing Associate: Solicited and managed intellectual property developed by university researchers and handled preliminary patentability and marketability assessments. Identified and negotiated with domestic and international licensees and research sponsors.
•Managed transactional aspects of research sponsorship and licensing including contract development & compliance.
•Reviewed and negotiated federal prime and sub-prime research contracts.
•Successfully negotiated research contracts with major foreign governments and commercial entities.

PRIVATE PRACTICE, Cleveland, Ohio • 1991-1998
Attorney: Private legal practitioner engaged in business development, litigation and general business law. Services encompassed transactional work, licensing, negotiation, litigation and real estate issues.
•Worked successfully on team negotiating agreement between major regional healthcare organization and foreign government.
•Taught Real Estate Law on an ad hoc basis at Hondros College.

EDUCATION

Juris Doctor Degree
Cleveland-Marshall College of Law, Cleveland State University, Cleveland, Ohio

Bachelor of Arts Degree
Case Western Reserve University, Cleveland, Ohio

BAR MEMBERSHIPS

Supreme Court of the United States
Supreme Court of the State of Ohio

PUBLICATIONS

Bartosh, C. and K. Sybert. 2006. Cooperative Research and Development Agreements (CRADAs). In Research Administration and Management. Jones and Bartlett. E. Kulakowski and L. Chronister (eds.).

Bartosh, C. and J. Drake. 1990. Lake Eutrophication in Northeastern Ohio, In Environment Cleveland.




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