Christopher Drummond, PhD, DABT

Christopher Drummond, PhD, DABT

Associate Director of Toxicology @ REGENXBIO

About

At REGENXBIO Inc., my role as Associate Director of Toxicology and a board certified toxicologist (DABT) involves steering nonclinical pharmacology and toxicology studies for groundbreaking gene therapy drugs. My work is instrumental in transitioning candidates from selection to IND and BLA, showcasing my adeptness in regulatory guidelines and communication with health authorities. Serving as Project toxicologist, I support project teams in executing translational strategies, demonstrating my commitment to innovative drug development. With my proficiency in in vitro toxicology, cell biology, and in vivo pre-clinical studies, I have contributed significantly to the advancement of small molecule, oligo nucleotide, cell and gene therapy, gene editing and combination therapies targeting cardiovascular, renal, ocular, neurological and metabolic diseases. My previous experience as a Senior Research Scientist at Northern Biomedical Research has honed my skills in running studies compliant with FDA regulations, study monitoring, mentorship, and process improvement. These skills underscore my dedication to enhancing research methodologies and my pursuit of scientific excellence in the field of toxicology.

Country

-

City

United States

Industry

Biotechnology

Skill

Regulatory Toxicology, Regulatory Guidelines, Regulatory Requirements, Toxicology, Investigational New Drug Application (IND), Gene Therapy, Heart Failure, Regulatory Submissions, Pre-clinical Studies, Cell Culture, Biochemistry, Immunohistochemistry, Research, Molecular Biology, Western Blotting, Cell Biology, Chemistry, Laboratory Skills, Data Analysis, Writing

Experience

REGENXBIO

Associate Director of Toxicology

REGENXBIO

LinkedIn
2023-11 - Present · 2 yrs 11 mos

Maryland, United States

-Responsible for the nonclinical, pharmacology, and toxicology studies conducted either at or on behalf of REGENXBIO at Contract Research Organizations (CROs) or other external collaborators. -Represent Nonclinical Development on multiple project teams and/or sub-teams to support the development of gene therapy clinical candidates. -Develop nonclinical strategies to take leads from candidate selection to successful IND and subsequently BLA. -Lead Translational Sciences Teams to support project teams in execution of translational strategies. -Apply knowledge of regulatory guidelines to support submissions to worldwide health authorities and communicate with regulatory agencies to resolve nonclinical issues. -Write and review nonclinical safety documentation IBs, BBs, IMPDs, INDs & BLAs. -Serve as study monitor for the design, conduct and reporting of nonclinical Pharmacology and Toxicology studies performed at Contract Research Organizations (CROs) to ensure a quality final product. -Write and edit nonclinical study protocols. -Scientific and technical reviewer for nonclinical studies performed with external collaborators or CROs. -Review and finalize study reports {both non-GLP and GLP studies). -Build and develop partnerships with CROs. -Support Nonclinical Development SOPs and guidelines. -Present, discuss and review issues within Operations and R&ED and other stakeholders. -Work cross-functionally across the organization, including Regulatory, CMC, Clinical, Quality Assurance, Bioanalytical Sciences and other groups. -Present at and attend scientific conferences. -Build strong relationships to enable working collaboratively -Utilize clear communication to meet shared objectives.

NorthernBio

Senior Research Scientist

NorthernBio

LinkedIn
2022-2 - 2023-11 · 1 yr 10 mos

Grand Rapids Metropolitan Area

-Responsible for overall planning and conduct of non-clinical investigations in accordance with regulatory guidelines and contemporary scientific practice. -Ensured that all Good Laboratory Practices (GLP) were met and that the outcome of the study was valid and reliable. -Responsible for mentorship and actively participated in process improvement within the company. -Ran more than 60 studies evaluating the safety, toxicity, distribution, and efficacy of gene (viral vectors, LNP, etc) and cell therapies targeting the Cardiovascular, renal and metabolic disease space in accordance with FDA regulation -Enabled clients to help attain their scientific goals using existing and custom approaches to targeted delivery (surgical) and therapeutic strategies. -Supervisory responsibilities included interviewing, training, and developing employees; planning, assigning and directing work; addressing complaints and resolving problems -Scientific Expertise and Regulatory Compliance allowed me to Interpret, evaluat, and report studies, and provide peer reviews; develop protocols, remained knowledgeable of advances in field of expertise, and ensured conduct of preclinical investigations, in accordance with applicable regulatory guidelines and contemporary scientific practice. -Actively involved in Business Development: Consulted and advised Sponsors on design, pricing, and scheduling of studies; maintained market and business development with potential and future clients with a focus on customer service; established on-going repeat business with an ever-increasing number of clients. -Mentoring: Shared experiences with other Research Scientists and company staff members to enhance their knowledge and skills. -Process Improvement: Served on appropriate company process improvement teams.

NorthernBio

Senior Study Director

NorthernBio

LinkedIn
2021-4 - 2022-2 · 11 mos

Grand Rapids Metropolitan Area

-Responsible for overall planning and conduct of non-clinical investigations in accordance with regulatory guidelines and contemporary scientific practice. -Ensured that all Good Laboratory Practices (GLP) were met and that the outcome of the study was valid and reliable. -Responsible for mentorship and actively participated in process improvement within the company. -Ran more than 60 studies evaluating the safety, toxicity, distribution, and efficacy of gene (viral vectors, LNP, etc) and cell therapies targeting the Cardiovascular, renal and metabolic disease space in accordance with FDA regulation -Enabled clients to help attain their scientific goals using existing and custom approaches to targeted delivery (surgical) and therapeutic strategies. -Supervisory responsibilities included interviewing, training, and developing employees; planning, assigning and directing work; addressing complaints and resolving problems -Scientific Expertise and Regulatory Compliance allowed me to Interpret, evaluat, and report studies, and provide peer reviews; develop protocols, remained knowledgeable of advances in field of expertise, and ensured conduct of preclinical investigations, in accordance with applicable regulatory guidelines and contemporary scientific practice. -Actively involved in Business Development: Consulted and advised Sponsors on design, pricing, and scheduling of studies; maintained market and business development with potential and future clients with a focus on customer service; established on-going repeat business with an ever-increasing number of clients. -Mentoring: Shared experiences with other Research Scientists and company staff members to enhance their knowledge and skills. -Process Improvement: Served on appropriate company process improvement teams.

NorthernBio

Study Director

NorthernBio

LinkedIn
2020-11 - 2021-4 · 6 mos

Grand Rapids, Michigan, United States

-Responsible for overall planning and conduct of non-clinical investigations in accordance with regulatory guidelines and contemporary scientific practice. -Ensured that all Good Laboratory Practices (GLP) were met and that the outcome of the study was valid and reliable. -Responsible for mentorship and actively participated in process improvement within the company. -Ran more than 60 studies evaluating the safety, toxicity, distribution, and efficacy of gene (viral vectors, LNP, etc) and cell therapies targeting the Cardiovascular, renal and metabolic disease space in accordance with FDA regulation -Enabled clients to help attain their scientific goals using existing and custom approaches to targeted delivery (surgical) and therapeutic strategies. -Supervisory responsibilities included interviewing, training, and developing employees; planning, assigning and directing work; addressing complaints and resolving problems -Scientific Expertise and Regulatory Compliance allowed me to Interpret, evaluat, and report studies, and provide peer reviews; develop protocols, remained knowledgeable of advances in field of expertise, and ensured conduct of preclinical investigations, in accordance with applicable regulatory guidelines and contemporary scientific practice. -Actively involved in Business Development: Consulted and advised Sponsors on design, pricing, and scheduling of studies; maintained market and business development with potential and future clients with a focus on customer service; established on-going repeat business with an ever-increasing number of clients. -Mentoring: Shared experiences with other Research Scientists and company staff members to enhance their knowledge and skills. -Process Improvement: Served on appropriate company process improvement teams.

Charles River Laboratories

Senior Research Scientist (Senior Study Director)

Charles River Laboratories

LinkedIn
2019-11 - 2020-11 · 1 yr 1 mo

Mattawan, Michigan

As a Study Director I am responsible for the overall planning and conduct of non-clinical investigations in accordance with applicable regulatory guidelines and contemporary scientific practice. In this role I primarily concentrate on internal/external communications, and providing scientific expertise, and regulatory compliance, as well as other essential functions, such as business development with a focus on customer service. My specific expertise is in running studies evaluating the safety. toxicity, distribution, and efficacy of gene and cell therapies targeting the Cardiovascular, renal and metabolic disease space in accordance with FDA regulation. I work with clients to help attain their scientific goals using existing and custom approaches to targeted delivery (surgical) and therapeutic strategies. My essential responsibilities are as follows: • Supervisory responsibilities in accordance with the organization’s policies and applicable laws to include interviewing, hiring and, training, and developing employees; planning, assigning and directing work; rewarding and disciplining employees; addressing complaints and resolving problems. • Scientific Expertise and Regulatory Compliance: Interprets, evaluates, and reports studies, and provides peer reviews; develops protocols, remains knowledgeable of advances in field of expertise, and ensures conduct of preclinical investigations, in accordance with applicable regulatory guidelines and contemporary scientific practice. • Business Development: Consults and advises Sponsors on design, pricing, and scheduling of studies; maintains market and business development with potential and future clients with a focus on customer service; establishes on-going repeat business with an ever-increasing number of clients. • Mentoring: Shares experiences with other Study Directors and company staff members to enhance their knowledge and skills. • Process Improvement: Serves on appropriate company process improvement teams.

Charles River Laboratories

Senior Study Director

Charles River Laboratories

LinkedIn
2019-8 - 2019-11 · 4 mos

Mattawan, Michigan

• Led teams in planning and conducting non-clinical investigations, ensuring regulatory compliance and scientific expertise. • Collaborated with clients to achieve efficacy and safety goals in cardiovascular and renal studies. • Mentored staff members to enhance their knowledge and skills in preclinical investigations.

Charles River Laboratories

Study Director 2

Charles River Laboratories

LinkedIn
2018-4 - 2019-11 · 1 yr 8 mos

Mattawan, Michican

• Managed non-clinical investigations in compliance with regulatory guidelines and scientific practices. • Provided scientific expertise, regulatory compliance, and focused on customer service for business development. • Conducted large and small animal cardiovascular, renal, and cardiorenal studies to achieve efficacy and safety goals.

MPI Research

Study Director 2

MPI Research

LinkedIn
2017-1 - 2018-4 · 1 yr 4 mos

Mattawan, MI

• Managed non-clinical investigations in compliance with regulatory guidelines, focusing on client communication and scientific expertise. • Conducted large and small animal cardiovascular, renal, and cardiorenal studies to help clients achieve efficacy and safety goals. • Collaborated with clients to develop surgical and therapeutic strategies, leading to successful study outcomes.

The University of Toledo

Postdoctoral Research Fellow in Medicinal Chemistry

The University of Toledo

LinkedIn
2011-6 - 2017-1 · 5 yrs 8 mos

Toledo, Ohio Area

•Coached 10 medical and graduate students and technicians •Creatively managed an annual budget of $75K for purchasing supplies and equipment, provide funds for meeting registration and travel •Optimized compliance with accounting and lab safety guidelines and perform necessary documentation •Curate detailed laboratory records •Establish and cultivate relationships with junior and senior researchers both internally and externally resulting in novel inhalation toxicology expertise resulting in 3 publications and grant applications totaling more than $150,000 •Designed experiments using hiPSCs, BMSCs, and hiPSC-derived cardiomyocytes to study CKD •Lead studies on role of NaK-ATPase signaling in chronic kidney disease induced Cardiac disease •Anti-fibrotic micro RNA, miR-29b-3p in cardiac tissues, using primary cells and cell lines culture and small animal methods resulting in 12 peer-reviewed publications, 18 presentation and published abstracts at national and international meetings •Developed methodology to isolate and reliably measure non-coding RNA biomarkers including miRNA in plasma and plasma-derived exosomes for biomarker identification in cardio-renal disease in human and rodent plasma. In addition to molecular analysis of non-coding RNAs in animal tissues. •Developed and directed innovative research leading to a three-year Individual National Research Service Award of $173K from the National institute of Health (NIDDK) F32 Grant. •Selected to be one of nine scientists to participate in the UAB-UCSD O’Brien Center Rodent Physiology and Injury Workshop, developing rodent surgical skills, metabolic analysis, and multisystem injury analysis. •Engaged in “Genome Access Course” provided by Cold Spring Harbor in association with the focus on Bioinformatic, RNA-seq, microarray and other bioinformatic based data analysis resulting in a new project directed at the development of intellectual property surrounding a novel non-coding RNA.

Bowling Green State University

Research and Teaching Assistant

Bowling Green State University

LinkedIn
2006-5 - 2009-12 · 3 yrs 8 mos

Bowling Green, OH

• Conducted laboratory evaluations of a key enzyme regulating the molting process in insects and parasitic invertebrates. • Instructed anatomy and physiology courses, developing instructional plans and assessing student work. Supervised lab activities, advising and assisting students. Served as senior graduate mentor to undergraduate students. • Nominated for Outstanding Teaching Assistant Award. • Effectively communicated results of my research as the only graduate student keynote speaker at the 2009 Annuals Department of Biological Sciences Research Retreat. • Developed radioimmunoassay and radioenzymological assays coupled to Thin Layer Chromatography (TLC) to measure the function of an important enzyme mediating insect development resulting in 3 peer-reviewed publications and 15 presentations and published abstracts at regional and national meetings. • Awarded small research grants like the Katzner/University Bookstore Research Grant, Sigma Xi Grant-in-Aid of research, and Office of Undergraduate Research grants totaling more than $2,000 • Established collaborations within diverse areas of my institute (College of Pharmacy, College of Medicine multiple departments with multidisciplinary expertise physicians and basic researchers) and at the University of California-San Diego to direct development of a project to evaluate the comparative cardiorenal toxicity of e-cigarettes and combustible cigarettes. Resulting in development of novel methodology and equipment, 2 peer review papers currently under review, 4 presentations at National meetings, 1 hosted seminar speaker, and 2+ grants submitted for external funding.

Medical College of Ohio (Now University of Toledo Health Science Campus)

Summer Undergraduate Research Fellowship

Medical College of Ohio (Now University of Toledo Health Science Campus)

2005-5 - 2005-8 · 4 mos

Toledo, Ohio Area

Selected as a participant in the SURF program worked in the laboratory of Dr. Joseph I. Shapiro, M.D., developing an Enzyme linked immunosorbent assay (ELISA) to analyze circulating levels of the cardiotonic steroid Marinobufagenin in plasma samples.

Education

Bowling Green State University

Bowling Green State University

LinkedIn

Pre-Medicine/Biology Minor in Chemistry

Engaged in undergraduate research, took course work in chemistry (organic and biochemistry), biology, general education.

Bowling Green State University

Bowling Green State University

LinkedIn

Biological Sciences, Concentration Molecular and cellular Biochemistry

Christopher Drummond, PhD, DABT's Contact Information

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