Melanie Ufkin, Ph.D, PPM,PMP
Associate Director Clinical Science at Regeneron- Claim this Profile
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Bio
Experience
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Regeneron
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United States
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Biotechnology
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700 & Above Employee
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Associate Director Clinical Science
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Jan 2022 - Present
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Senior Manager Oncology and Translational Sciences
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Jan 2020 - Jan 2022
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Manager Oncology and Translational Sciences
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Jan 2018 - Jan 2020
Tarrytown, NY
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Clinical Science Oncology
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Jan 2015 - Dec 2017
Tarrytown, NY •Actively involved in initiation activities of First in Human studies in immune therapy in hematologic malignancies and solid tumors •Development of CRF pages, investigator brochure, study reference manuals, pharmacy manual, and cross functional study meetings and activities •Review clinical data and patient monitoring in both hematological malignancies and solid tumors •Data visualization and analysis with QlikView and Spotfire
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Regeneron
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United States
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Biotechnology
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700 & Above Employee
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Translational Science Clinical Development and Regulatory Affairs Intern
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Jun 2014 - Aug 2014
Tarrytown, NY • Actively involved in initiation activities of First in Human studies in immune therapy in hematologic malignancy by developing CRF pages, investigator brochure, study reference manuals, pharmacy manual, and cross functional study start-up meetings and activities • Prepared draft manuscript based on Clinical Study Report of Phase 1 study in advanced solid tumor setting • Reviewed clinical data of ongoing Phase 1 studies in advanced solid tumor, summarized clinical data and prepared… Show more • Actively involved in initiation activities of First in Human studies in immune therapy in hematologic malignancy by developing CRF pages, investigator brochure, study reference manuals, pharmacy manual, and cross functional study start-up meetings and activities • Prepared draft manuscript based on Clinical Study Report of Phase 1 study in advanced solid tumor setting • Reviewed clinical data of ongoing Phase 1 studies in advanced solid tumor, summarized clinical data and prepared presentation material for executive and senior management study review meetings • Actively involved in clinical trial management and clinical science aspects for several Phase 1 oncology projects including budget review Show less
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Keck Graduate Institute
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United States
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Higher Education
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200 - 300 Employee
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Applied Entrepreneurishment - Business Plan Development
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Jan 2014 - May 2014
• Produced business plan to establish a new company based on new in situ sequencing scientific method and technology produced at Caltech • Gained experience in market analysis, patents, and sales forecasting • Received first place in Business Plan Competition at KGI
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Pfizer Team Masters Project - Development of a Rare Disease Database
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Jan 2014 - May 2014
• Developed a searchable rare disease database with team members which included ~3000 fields added to FDA’s provided table • Completed landscape analysis of the rare disease field utilizing information gained from completed database leading to a future manuscript currently under development • Received the Collaborative Excellence Award and first place in Team Masters Project at KGI
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Maine Medical Center
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United States
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Hospitals and Health Care
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700 & Above Employee
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Doctoral Candidate
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Oct 2010 - Dec 2013
University of Maine My doctoral thesis had two aims focusing on characterizing the role of miR-125a in Acute Myeloid Leukemia. AIM 1: Identify the mechanism of molecular silencing of microRNA-125a in Acute Myeloid Leukemia (AML) where I discovered that miR-125a was transcriptionally suppressed by methylation in AML through de-methylating drugs, bisulfite sequencing, and expression analysis. Aim 2: Dissect the functional role of miR-125a in AML. From collaborations, microRNA expression via small RNA… Show more My doctoral thesis had two aims focusing on characterizing the role of miR-125a in Acute Myeloid Leukemia. AIM 1: Identify the mechanism of molecular silencing of microRNA-125a in Acute Myeloid Leukemia (AML) where I discovered that miR-125a was transcriptionally suppressed by methylation in AML through de-methylating drugs, bisulfite sequencing, and expression analysis. Aim 2: Dissect the functional role of miR-125a in AML. From collaborations, microRNA expression via small RNA sequencing in bone marrow samples identified miR-125a to be low in multiple AML subtypes, which were confirmed through bioinformatic analysis of data provided on NCI TCGA Data Portal. Through RNA expression profiling and comprehensive bioinformatics analysis of miR-125a transduced cells, potential new targets of miR-125a were discovered as well as a potential new therapeutic therapies from pathway analysis. Collaborations: ● Study the role of Sprouty 1 in erythropoiesis: Identified a novel regulator of red blood cell development that has potential implication in advancing anti-anemia therapy. ● Role of Podxl in breast cancer migration and metastasis Show less
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Wayfinder School at Camden and New Gloucester
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Jan 2011 - Nov 2013
New Gloucester, ME • Tutored students on various subject matters dependent on need (Science, Math, English, college applications, SAT) • Mentored students on future goals post-graduation or conflicts they had within personal lives
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Assistant Rowing Coach
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2010 - 2010
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Medical College of Wisconsin
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Higher Education
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700 & Above Employee
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Graduate Student
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Sep 2007 - Jul 2009
Milwaukee, WI Thesis project prior to transferring to University of Maine ● Designed diagnostic protocol to subtype Human Herpes Virus 8 between individuals by utilizing previously published work ● Initiated correlation analysis of HHV8 infection in individuals with lung disease and common variable immune disorder
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Medical College of Wisconsin
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Higher Education
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700 & Above Employee
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Lab Technician
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Jun 2006 - Jul 2007
Milwaukee, WI ● Produced gene mutations necessary for protein folding analysis on electronic paramagnetic resonance (EPR) ● Initiated temperature-sensitive protein analysis ● Aided graduate students and post-doctoral fellows on research projects ● Organized, completed ordering, and maintained solutions necessary, such as buffers
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Lawrence University
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Higher Education
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500 - 600 Employee
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Professor's Lab Assistant
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Sep 2004 - Jun 2006
Appleton, WI Three different semesters: Fall 2004, Spring of 2005 and 2006 ●Aided professor during labs for Zoology and intro to Chemistry ●Guided students to conduct the various experiments during the term ●Advised students on how to analyze lab data and write lab reports
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Residence Life Advisor
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Sep 2003 - Jun 2006
Appleton, WI ● Worked in three distinct communities, currently a 25 female, upper class small house, and previously a 40 mostly freshman female floor, and 40 mixed class female floor ● Served on Residence Life Advisor Council ● Gained administrative skills from desk working ● Used interactive bulletin boards and active programs in order to foster a close community within the floor or house ● Served in buildings with on-duty rotation
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Summer Residence Life Advisor
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Jun 2004 - Aug 2004
Appleton, WI ●Worked with the Assistant Dean of Students and three fellow students to run and organize building operations ●Ran the desk on weekly bases using an on-duty rotation ●Planned/ carried-out programs to build a community within the diverse 100 summer students
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Summer Internship
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Jun 2004 - Aug 2004
Appleton, WI ●Conducted research under the Merck Scholarship ●Produced and worked with gold nanoparticles, DNAzyme systems, and lead system ●Photographed gold nanoparticles, DNAzyme systems, and lead system utilizing Transmission Electron Microscope ●Preliminary work on the effects of nanoparticles (gold nanoparticles and PMMA nanospheres) on RAW cells (macrophages) aided in development for current research being conducted
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Summer Internship
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Jun 2005 - Aug 2005
Scarborough, ME ●Worked in lab in determining Epo-dependent mechanisms for erythroblast survival through the stat-5 pathway ●Generated protocol for erythroblast expansion and edited previous lab protocols ●Analyzed data and prepared graphs for future published articles
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Education
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Keck Graduate Institute
Postdoctoral Professional Masters in Bioscience Management -
University of Maine
Doctor of Philosophy (Ph.D.), Cell/Cellular and Molecular Biology -
Lawrence University
Bachelor of Arts, Biochemistry with and Interdisciplinary Major in Neuroscience -
University of Maine
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Medical College of Wisconsin