Lisa Cooper, Ph.D.
Assistant Professor
Department: Health Informatics
Phone: (973) 972-5503
Email: blanchld@rutgers.edu
Office location:
65 Bergen Street , Room 171
Newark, NJ 07107
About
Dr. Lisa Cooper is currently an Associate Professor within the Clinical Research Management master’s program within the Rutgers School of Health Professions. Prior to joining Rutgers as a full-time faculty member in August 2020, Lisa supported the program as an adjunct faculty member since 2017.
Lisa brings over 20 years of industry sponsor regulatory affairs experience, spanning from the pre-IND stage through post-market life-cycle management. Some of Lisa’s industry achievements include the successful opening of multiple INDs, navigating strategic regulatory development pathways, leading the market application submission and product launch of an oncology product as project lead, and chairing advertising and promotion review committees.
Lisa’s undergraduate and master’s degree are in biology, and her PhD, earned from Alvernia University, is in Corporate Leadership. In addition, Lisa is Regulatory Affairs Certified by RAPS and is a certified medical writing professional (CMWP).
Education
BSc, York College of PA
MSc , Fairleigh Dickinson University
Ph.D., Alvernia University
Professional Achievements
Ikaria Research and Development Big Six On the Spot Award: Pediatric Extension of INOmax Ikaria, December 2010
Ikaria Research and Development Big Six On the Spot Award: Orphan Drug Grant Application for Lucassin, February 2011
Ikaria Research and Development Big Six On the Spot Award: IND Application development for PAH (iNO/INOpulse DS Combination Product), December 2011
Ikaria Research and Development Big Six On the Spot Award: Orphan Drug Application for PAH (iNO/INOpulse DS Combination Product), April 2012
Ikaria Research and Development Big Six On the Spot Award: BPD, PAH, and COPD Projects, June 2012
Ph.D. Director’s Award, School of Graduate and Adult Education, Alvernia University, December 2014
Research
Research Interests
Regulatory Affairs
Pharmaceutical Development
Clinical Trials
Oncology Drug Development
Orphan Drugs
Publications
| Title | Authors | Where and When | ||
Changes in Companion Diagnostic Labelling: Implementation of FDA’s April 2020 Guidance for Industry for In Vitro CDx Labeling for Specific Oncology Therapeutic Groups |
Cooper, L., Chen J. |
Ther Innov Regul Sci. 2022 Jun 10 |
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COVID-19 Pandemic Response Varies by Clinical Trial Sponsor Type |
Cooper, L., Lee, I., & Waldron Lechner, D |
Journal of Clinical and Translational Science, 2021 |
||
The economic impact of Alvernia University |
Tiglioglu, T., Cooper, L., Dzomba, B., Gifford, R., & Hess, J. |
Pennsylvania Economic Review, 2012 |
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Therapeutic Class Labeling of FDA-Approved Epidermal Growth Factor Receptor (EGFR) Companion Diagnostics |
Chen, Joyce & Cooper, Lisa |
Presented at Translational Science 2022 Conference by Association for Clinical and Translational Science, 2022 |
||
Trends in Oncology Companion Diagnostic Labeling: An Evaluation of FDA-Approved Companion Diagnostics |
Chen, Joyce & Cooper, Lisa |
Presented at 2021 ASHP Mid-Year Clinical Meeting & Exhibition, 2021 |
||
Pandemic Response Time Varies by Study Sponsor and Collaborator Pairing |
Lee, Irene & Cooper, Lisa |
Presented at 2021 ASHP Mid-Year Clinical Meeting & Exhibition, 2021 |
||
15 Year Review (2006-2020) of Patient-Reported Outcomes Labeling for Oncology Products Approved by the Center of Drug Evaluation and Research (CDER) |
Wo, Emily & Cooper, Lisa |
Presented at Rutgers Pharmacy Research Day Ernesto Mario School of Pharmacy at Rutgers University, 2021 |
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Study Collaborators and Product Status of US interventional COVID-19 studies listed in ClinicalTrials.gov |
Lee, Irene & Cooper, Lisa |
Presented at Rutgers Pharmacy Research Day Ernesto Mario School of Pharmacy at Rutgers University, 2021 |
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Sponsor types of US interventional COVID-19 studies listed in ClinicalTrials.gov |
Lee, Irene, Cooper, Lisa & Waldron Lechner, Doreen |
Presented at Translational Science 2021 Conference by Association for Clinical and Translational Science, 2021 |
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Rutgers, The State University of New Jersey, an equal opportunity, affirmative action institution. All rights reserved.
Rutgers is an equal access/equal opportunity institution. Individuals with disabilities are encouraged to direct suggestions, comments, or complaints concerning any accessibility issues with Rutgers web sites to: accessibility@rutgers.edu or complete the Report Accessibility Barrier or Provide Feedback Form.