プロフィール詳細

プロジェクトを作成

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Dr. Millissia B.に依頼

United States

Regulatory Affairs & Clinical Research Consultant | IND/CTA, FDA Meeting Packages, Scientific Writing

プロフィール概要

I am a regulatory affairs and clinical research professional with experience supporting FDA-facing development programs across early clinical stages. My work focuses on producing high-quality, submission-ready scientific and regulatory documents and helping teams align their strategies with regulatory expectations. I have contributed to IND/CTA packages, FDA meeting materials (including Type D, pre-IND, and scientific advice interactions), protocol and nonclinical document review, and cross-functional data integration across clinical, pharmacology, and translational disciplines. I am particularly skilled at synthesizing complex scientific information into clear, structured narratives that withstand regulatory scrutiny. My core strengths include: • IND/CTA document development and review (CTD Modules 2 & 5) • FDA meeting briefing packages and strategic responses • Clinical and nonclinical data synthesis • Protocol critique against FDA guidance • Literature reviews and scientific positioning • Medical and regulatory writing (CSRs, IBs, summaries, slide decks) Clients value my attention to detail, strong scientific rigor, and ability to anticipate regulatory questions before they arise. I work efficiently, communicate clearly, and treat every project as if it were submission-critical. I am available for short-term consulting, document review, scientific writing projects, and expert input on regulatory strategy.

専門分野

• ★ Developmental Biology
• ★ Epigenetics
• ★ In vivo Preclinical Toxicology
• ☆ Embryology
• ☆ Molecular Biology
• ☆ Biomarkers
• ☆ Genetics
• ☆ PCR
• ☆ Next Generation Sequencing (NGS)
• ☆ DNA Sequencing
• ☆ ChIP-Seq
• ☆ Cell Biology
• ☆ Histology
• ☆ Cell Culture
• ☆ Immunohistochemistry
• ☆ Drug Development

サービス

• Writing
• Research
• Consulting

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing

Research Feasibility Study, Scientific and Technical Research, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting

職務経験

Regulatory Affairs Associate and Scientist

TekTeam

1月 2022 - 現在

Research Associate

Washington State University

9月 2016 - 現在

Research Associate / Lab Manager

Washington State University

1月 2019 - 2月 2022

Postdoctoral Resarcher

Washington State University

9月 2016 - 12月 2018

PhD Student

IRSET

10月 2012 - 9月 2015

学歴

Ph.D., Biology

Université Rennes I - France

10月 2012 - 12月 2015

PhD Student (Viral and chemical environment and reproduction)

IRSET

10月 2012 - 9月 2015

Masters of Science

Université de Tours

9月 2010 - 6月 2012

Bachelor’s in Biological sciences

Université de Rouen - Haute Normandie - France

9月 2007 - 6月 2010

認定資格

• Research with data or laboratory specimens- ONLY

  CITI

  https://www.citiprogram.org/verify/?w3b88553d-0795-46d9-ae01-e775af691760-31627192

  7月 2021 - 7月 2026

• GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) Course

  CITI

  https://www.citiprogram.org/verify/?w05b070df-3e7a-42c1-ad55-d0defa76455f-67008474

  6月 2025 - 6月 2026

出版物

JOURNAL ARTICLE

Ben Maamar M, Sadler-Riggleman I, Beck D, Skinner MK(2021). Genome-Wide Mapping of DNA Methylation 5mC by Methylated DNA Immunoprecipitation (MeDIP)-Sequencing . Methods in molecular biology (Clifton, N.J.).

Beck D, Ben Maamar M, Skinner MK(2021). Integration of sperm ncRNA-directed DNA methylation and DNA methylation-directed histone retention in epigenetic transgenerational inheritance . Epigenetics & chromatin.

Garrido N, Cruz F, Egea RR, Simon C, Sadler-Riggleman I, Beck D, Nilsson E, Ben Maamar M, Skinner MK(2021). Sperm DNA methylation epimutation biomarker for paternal offspring autism susceptibility . Clinical epigenetics.

Nilsson EE, Maamar MB, Skinner MK(2020). Environmentally Induced Epigenetic Transgenerational Inheritance and the Weismann Barrier: The Dawn of Neo-Lamarckian Theory . Journal of developmental biology.

Nilsson EE, Thorson JLM, Ben Maamar M, Beck D, Skinner MK(2020). Epigenome-wide association study (EWAS) for potential transgenerational disease epigenetic biomarkers in sperm following ancestral exposure to the pesticide methoxychlor . Environmental epigenetics.

Thorson JLM, Beck D, Ben Maamar M, Nilsson EE, McBirney M, Skinner MK(2020). Epigenome-wide association study for atrazine induced transgenerational DNA methylation and histone retention sperm epigenetic biomarkers for disease . PloS one.

Ben Maamar M, Beck D, Nilsson EE, Kubsad D, Skinner MK(2020). Epigenome-wide association study for glyphosate induced transgenerational sperm DNA methylation and histone retention epigenetic biomarkers for disease . Epigenetics.

Thorson JLM, Beck D, Ben Maamar M, Nilsson EE, Skinner MK(2020). Epigenome-wide association study for pesticide (Permethrin and DEET) induced DNA methylation epimutation biomarkers for specific transgenerational disease . Environmental health : a global access science source.

Ben Maamar M, Nilsson E, Thorson JLM, Beck D, Skinner MK(2020). Transgenerational disease specific epigenetic sperm biomarkers after ancestral exposure to dioxin . Environmental research.

Ben Maamar M, Nilsson E, Thorson JLM, Beck D, Skinner MK(2020). Epigenome-wide association study for transgenerational disease sperm epimutation biomarkers following ancestral exposure to jet fuel hydrocarbons . Reproductive toxicology (Elmsford, N.Y.).

Ben Maamar M, Beck D, Nilsson E, McCarrey JR, Skinner MK(2020). Developmental origins of transgenerational sperm histone retention following ancestral exposures . Developmental biology.

Lecluze E, Rolland AD, Filis P, Evrard B, Leverrier-Penna S, Maamar MB, Coiffec I, Lavoué V, Fowler PA, Mazaud-Guittot S, et al.(2020). Dynamics of the transcriptional landscape during human fetal testis and ovary development . Human reproduction (Oxford, England).

Nilsson E, Thorson J, Ben Maamar M, Beck D, Skinner M(2020). Epigenome-wide association study (EWAS) for potential transgenerational disease epigenetic biomarkers in sperm following ancestral exposure to the pesticide methoxychlor . Environmental epigenetics.

Ben Maamar M, King SE, Nilsson E, Beck D, Skinner MK(2019). Epigenetic transgenerational inheritance of parent-of-origin allelic transmission of outcross pathology and sperm epimutations . Developmental biology.

Skinner MK, Nilsson E, Sadler-Riggleman I, Beck D, Ben Maamar M, McCarrey JR(2019). Transgenerational sperm DNA methylation epimutation developmental origins following ancestral vinclozolin exposure . Epigenetics.

Ben Maamar M, Nilsson E, Sadler-Riggleman I, Beck D, McCarrey JR, Skinner MK(2018). Developmental origins of transgenerational sperm DNA methylation epimutations following ancestral DDT exposure . Developmental biology.

Ben Maamar M, Sadler-Riggleman I, Beck D, McBirney M, Nilsson E, Klukovich R, Xie Y, Tang C, Yan W, Skinner MK(2018). Alterations in sperm DNA methylation, non-coding RNA expression, and histone retention mediate vinclozolin-induced epigenetic transgenerational inheritance of disease . Environmental epigenetics.

Ben Maamar M, Sadler-Riggleman I, Beck D, Skinner MK(2018). Epigenetic Transgenerational Inheritance of Altered Sperm Histone Retention Sites . Scientific reports.

Skinner MK, Ben Maamar M, Sadler-Riggleman I, Beck D, Nilsson E, McBirney M, Klukovich R, Xie Y, Tang C, Yan W(2018). Alterations in sperm DNA methylation, non-coding RNA and histone retention associate with DDT-induced epigenetic transgenerational inheritance of disease . Epigenetics & chromatin.

(2017). Ibuprofen results in alterations of human fetal testis development . Sci Rep.

Ben Maamar M, Lesné L, Desdoits-Lethimonier C, Coiffec I, Lassurguère J, Lavoué V, Deceuninck Y, Antignac JP, Le Bizec B, Perdu E, Zalko D, Pineau C, Chevrier C, Dejucq-Rainsford N, Mazaud-Guittot S, Jégou B, PloS one, 2015, vol. 10, no. 2, pp. e0117226 .

Mazaud-Guittot S, Nicolas Nicolaz C, Desdoits-Lethimonier C, Coiffec I, Ben Maamar M, Balaguer P, Kristensen DM, Chevrier C, Lavoué V, Poulain P, Dejucq-Rainsford N, Jégou B, The Journal of clinical endocrinology and metabolism, 2013, vol. 98, no. 11, pp. E1757-67 .