プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Dr. Scott F.に依頼

United States

Freelance Expert in Oncology, SARS-CoV-2, Orphan Drugs/Rare Diseases, Regulatory Intelligence, & Clinical Trial Design

プロフィール概要

Biomedical professional with a multifaceted background in research in an academic setting, 5-years at the FDA in the Office of Orphan Products Development (OOPD), regulatory consulting, working in industry in regulatory affairs, intelligence, and research, as well as being actively involved in SARS-CoV-2 research. I have a PhD in Cancer Biology based on research I conducted in the Molecular Oncology Program at the Moffitt Cancer Center (also where I subsequently completed a 2-year postdoctoral fellowship in the Department of Experimental Therapeutics); was accepted into (and completed) the extremely competitive FDA Commissioner's Fellowship Program; reviewed over 100 orphan drug designation (ODD) requests and over 10 humanitarian use device (HUD) (and numerous amendments of each), served as the Scientific Review Administrator for the neuro-oncology review panel for the OOPD clinical grants program, and was the Project Manager for multiple grants funded through the program; spent time as a regulatory consultant as well as did medical writing; served as the Regulatory Intelligence & Research Lead for Shire; served as a Global Regulatory Team Lead for Rare Diseases at Sanofi; left science (formally) to open my own music studio; and finally was brought back into science via involvement with SARS-CoV-2. Through these experiences, I have gained a plethora of knowledge that has endowed me with the ability to effectively interrogate clinical trial designs regardless of disease state or condition or phase of study, how to effectively communicate with regulatory agencies, how to conduct intelligence on regulatory activities broadly or against competitors (and in the clinical trial space), write effective orphan drug designation or HUD requests, optimize research programs, write content, and multiple other functions. I look forward to seeing how I can help advance your needs.

専門分野

• ★ Oncology
• ★ Severe Acute Respiratory Syndrome (SARS)
• ★ Rare Diseases
• ☆ STEM
• ☆ Separation & Purification
• ☆ Peptide Synthesis
• ☆ Biology/Life Sciences
• ☆ Evolutionary Biology
• ☆ Biochemistry
• ☆ Molecular Biology
• ☆ Biomarkers
• ☆ Genetics
• ☆ Kinases
• ☆ Cell Biology
• ☆ Cell Signaling Pathways
• ☆ Stem Cell Research
• ☆ Biotechnology & Bioengineering
• ☆ Protein/Enzyme Engineering
• ☆ Health Policy
• ☆ Music
• ☆ Music Industry
• ☆ Digital Music Production
• ☆ Music Composition
• ☆ Small Molecule Drug Development
• ☆ Biologic & Biosimilar Development
• ☆ Medicine
• ☆ Clinical Trials
• ☆ Hematology
• ☆ Leukemia & Lymphoma
• ☆ Medical Affairs
• ☆ Regulatory Affairs
• ☆ Gene Therapy
• ☆ Medical Sciences
• ☆ Spinal Cord Injury
• ☆ Research
• ☆ Research Methodology
• ☆ PreMarket Approval (PMA) Applications
• ☆ Technical & Scientific Writing

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Technical Writing, Newswriting

Research Market Research, Feasibility Study, Fact Checking, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Consulting Scientific and Technical Consulting

Product Development Formulation

職務経験

Owner/Chief Sound Engineer

Freeman Sound Works

12月 2019 - 12月 2020

Associate Director

Sanofi Genzyme

5月 2018 - 1月 2019

Associate Director, Regulatory Intelligence & Research Lead

Shire Pharmaceuticals Human Genetic Therapies Inc

9月 2016 - 5月 2018

Senior Medical Writer

Shire Pharmaceuticals Human Genetic Therapies Inc

6月 2015 - 9月 2016

Senior Regulatory Specialist

Voisin Consulting Life Sciences

1月 2015 - 6月 2015

Health Science Administrator

US Food and Drug Administration

4月 2011 - 8月 2014

Commissioner's Fellow

US Food and Drug Administration

9月 2009 - 9月 2011

Postdoctoral Fellow

Moffitt Cancer Center

11月 2007 - 8月 2009

学歴

Doctor of Philosophy (Ph.D)

University of South Florida

7月 2002 - 12月 2007

BS, Biology (mj) Chemistry (mn)

Central Michigan University

9月 1999 - 5月 2002

Bachelor of Science in Biological Sciences

Central Michigan University

1月 1999 - 1月 2002

認定資格

• 認定資格の詳細は未入力です。

出版物

PREPRINT

Fricke, I., & Freeman, S. N. (2020, September 17). A new vaccine approach and convalescent plasma until its development. https://doi.org/10.31219/osf.io/msu98 .

BOOK CHAPTER

The Development of Orphan Drugs /Users/mystuff/Downloads/FDA_Regulatory_Affairs.bibtex. FDA Regulatory Affairs, 3rd Edition.

JOURNAL ARTICLE

Thorat C, Xu K, Freeman SN, Bonnel RA, Joseph F, Phillips MI, Imoisili MA(2012). What the Orphan Drug Act has done lately for children with rare diseases: a 10-year analysis . Pediatrics.

Freeman SN, Cress WD(2010). RhoBTB2 (DBC2) comes of age as a multifunctional tumor suppressor . Cancer biology & therapy.

Burke KA, Freeman SN, Imoisili MA, Coté TR(2010). The impact of the Orphan Drug Act on the development and advancement of neurological products for rare diseases: a descriptive review . Clinical pharmacology and therapeutics.

Freeman SN, Burke KA, Imoisili MA, Coté TR(2010). The Orphan Drug Act and the development of stem cell-based products for rare diseases . Cell stem cell.

Freeman SN, Bepler G, Haura E, Sutphen R, Cress WD(2005). Re: Prognostic significance of a short sequence insertion in the MCL-1 promoter in chronic lymphocytic leukemia . Journal of the National Cancer Institute.

Ma Y, Freeman SN, Cress WD(2004). E2F4 deficiency promotes drug-induced apoptosis . Cancer biology & therapy.

ONLINE RESOURCE

http://atlasgeneticsoncology.org//Genes/RRM1ID42174ch11p15.html .