Project Management
Resume:
John S. Lopez
Tempe, Arizona 85281
E-mail: abl2ge@r.postjobfree.com
Mobile: 805-***-****
Facsimile: 602-***-****
Arizona Bar No. 026740
LEGAL EXPERIENCE
Jennings, Strouss & Salmon, PLC 9/08 - 3/10
Phoenix, Arizona
Associate Attorney
Intellectual Property Department
Life Science & Biotechnology Industry Practice Group
. Draft and negotiate licensing agreements and provide patent licensing
counseling to a variety of bioscience and technology clients.
. Draft and negotiate clinical trial agreements, complex research
collaboration agreements, and alliance agreements.
. Draft and negotiate material transfer agreements, non-disclosure
agreements, distribution agreements and evaluation agreements for a
variety of bioscience entities.
. Provide trademark registration and conflicts counseling, and prepare
office action responses.
. Provide copyright registration and conflicts counseling.
. Provide internet domain name conflict counseling and prepare UDRP
complaints.
. Perform intellectual property and FDA regulatory due diligence for merger
and acquisition transactions.
. Provide FDA regulatory counseling to research institutes and other
entities related to in vitro diagnostic devices and drug products.
. Provide CMS regulatory counseling to research institutes related to high-
complexity laboratory testing.
. Counsel pharmaceutical company through federal and state statutory and
regulatory requirements.
. Provide counseling for responding to FDA untitled letters.
. Review drug product labeling for FDA and FTC regulatory compliance.
. Prepare motions for summary judgment, discovery motions, disclosure
statements, and assist with assorted commercial and intellectual property
litigation.
Jennings, Strouss & Salmon, PLC 5/07 - 8/07
Phoenix, Arizona
Summer Associate
. Prepared research memoranda related to intellectual property issues
including patentability, patent licensing, right of publicity conflicts,
and trademark conflicts.
. Prepared research memoranda on issues relating to employment
relationships, business interference torts, negligence torts, and agency
relationships.
. Assisted in preparing an intellectual property protection evaluation.
Hall, Vande Sande, & Pequignot, LLP
Patent, Trademark, and Copyright Attorneys 12/06; 06/06 - 08/06
Washington, D.C.
Law Clerk
. Prepared research memoranda on issues pertaining to patent infringement,
patent validity, misappropriation torts, rules and sanctions, choice of
law, and unfair competition.
. Outlined and drafted intellectual property litigation motions and
prepared deposition digests.
. Assisted in preparing trademark applications.
. Assisted in formulation of patent litigation strategy.
. Assisted in various phases of litigation discovery.
. Docketed patent and trademark action dates.
. Maintained patent and trademark files.
PHARMACEUTICAL INDUSTRY EXPERIENCE
ISTA Pharmaceuticals, Inc.
Irvine, California 01/05 - 06/05
Specialist, Regulatory Affairs
. Advised cross-functional departments on current regulations, potential
regulatory issues, and regulatory strategies through ophthalmic drug
development cycle.
. Ensured project deadlines and performance standards were established and
achieved across cross-functional departments to ensure regulatory
compliance and regulatory filing timeliness.
. Composed, reviewed, and compiled scientific documentation in support of
Investigational New Drug Applications; New Drug Applications; Annual
Reports; Periodic Safety Reports; and other reports submitted to the FDA.
. Reviewed and approved drug product advertising and promotional materials,
and continuing medical education materials in accordance with federal
regulation.
. Provided critical review of scientific and regulatory documentation for
due diligence assessment considering international marketing
requirements, licensing, and technology transfer.
. Provided critical review of pre-clinical, clinical, analytical protocols,
and chemistry, manufacturing, and controls documentation for satisfaction
of regulatory requirements.
. Reviewed, compiled, and presented scientific documentation to support
formal meetings with the FDA.
. Guided publishing group to track, compile, and inspect final regulatory
submissions for accuracy, completeness, and quality.
Watson Laboratories, Inc.
Corona, California 06/03 - 12/04
Associate, Research and Development Regulatory Affairs
. Provided critical review of analytical protocols and chemistry,
manufacturing, and controls documentation for satisfaction of FDA
regulations and requirements.
. Advised cross-functional departments on current regulations, potential
regulatory issues and regulatory strategies.
. Provided critical review of scientific and regulatory documentation for
due diligence assessment considering associated with technology licensing
and transfer.
. Reviewed and compiled scientific documentation in support of Abbreviated
New Drug Applications.
. In collaboration with Project Management, ensured project deadlines and
performance standards were established and achieved.
EDUCATION
Sandra Day O'Connor College of Law
Arizona State University
Tempe, Arizona
Juris Doctor, Class of 2008
Honors: High Technology Licensing Grade: 95
FDA Regulation Grade: 96
University of Southern California, School of Pharmacy
Los Angeles, California
Master of Science, Regulatory Science, Class of 2005
University of California, Santa Barbara
Santa Barbara, California
Bachelor of Science, Microbiology, Emphasis in Genetic Engineering
Bachelor of Arts, Law and Society
Minor in Professional Writing, Emphasis in Technical Communication
PUBLICATIONS AND PAPERS
Curci, Frank X., Lopez, John S., "How Secure is Your Intellectual
Property? Maintaining Your Ownership Rights," District Energy
Magazine (January 15, 2010).
Lopez, John S., "Should Genetic Code Be Patented?" Law and Society
Review at the University of California, Santa Barbara 1 (2002): 57-62.
Lopez, John S., "The Competitive Effects of Non-Compete and Licensing
Agreements in the Pharmaceutical Industry: Reaching and Resisting
Interpretation under the Sherman Antitrust Act and the Federal Food,
Drug and Cosmetic Act."
Lopez, John S., "Regulation and Enforcement of Prescription Drug
Advertising and Promotion: An Exploration from Legislation through
Litigation."
Lopez, John S., "Nanopharmaceuticals: Mitigating Intellectual Property
and Regulatory Issues."
PRESENTATIONS
Moderator, "Business Track Session: A New Washington - The Impact on
the Bioscience Industry," BIOZONA 2009, Arizona's Annual Bioscience
Industry Conference (April 2009).
Moderator, "Regulatory Session: Incorporating and Executing Efficient
Regulatory Strategy," Commercializing Life Sciences Forum (October
2008).
ACADEMIC EXPERIENCE
Law & Society Review at University of California, Santa Barbara
Santa Barbara, California 01/01-06/03
Editor
. Founding member and inaugural editor for undergraduate sociolegal
journal.
. Created legacy documents including quantitative and qualitative
submission assessment matrices, fundraising script and information
packages, and journal project management tools.
. Performed copyediting, citation verification, grammatical and syntactical
editing.
Diane Eardley, Professor of Immunology
University of California, Santa Barbara 03/03-06/03
Undergraduate Teaching Assistant
. Assisted graduate teaching assistants in demonstration of laboratory
techniques, and assisted students with laboratory technique and
manipulations.
. Assisted graduate students with experiment instruction and lecture of
laboratory course concepts and curriculum.
Barbara Kerr, Pharmacology, and Immunology Laboratory
University of California, Santa Barbara 09/02-06/03
Laboratory Research Assistant
. Assisted laboratory coordinator in preparation, production, assessment,
and maintenance of undergraduate pharmacology, cell development, and
immunology laboratory.
PROFESSIONAL AFFILIATIONS
Arizona BioIndustry Association
Sandra Day O'Connor Inn of Court
American Bar Association
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