Jeff Engelhardt Email and Phone Number
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Key ExperienceAn author of the NDA/MAA toxicology section or the preclinical expert and author of the nonclinical overview for 25 marketed small molecules, biologics, and antisense oligonucleotides.Specialties: Renal pathology, Primate pathology, Pathology peer review, Primary histopathology, and Interpretation of pathology data from toxicology studies.Scientific review of general toxicology study reports.Preparation of expert reports, specialized overviews, and integrated summaries. Strategies for nonclinical development programs.
Engelhardt Consulting
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Engelhardt ConsultingAiken, Sc, Us
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ConsultantEngelhardt Consulting Jul 2022 - PresentConsulting in nonclinical safety of nucleic acid therapeutics, especially pertaining to renal safety.
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Vice PresidentIonis Pharmaceuticals, Inc. Dec 2013 - Jun 2022Carlsbad, Ca, UsOversight of anatomic and clinical pathology sections of toxicology studies including primary histopathology and peer review of critical studies. Provide scientific and regulatory leadership for the design and interpretation of toxicology studies, preparation of key regulatory documents (IND/IMPD, CTD) and conduct gap analyses and safety reviews for antisense oligonucleotide drug candidates. -
Vice PresidentEpl, Inc. Apr 2012 - Dec 2013Sterling, Virginia, UsResponsible for EPL’s further expansion in the western United States and Asia-Pacific region. Serve as the primary contact for new and current clients in the region and provide general pathology support (e.g., study pathologist, peer review, etc.), as well as pathology and regulatory consultation to clients requesting these services. -
PresidentEpl, Inc. Jun 2010 - Mar 2012Sterling, Virginia, UsResponsible for overall management and direction of contract research pathology laboratories in Virginia and North Carolina. Pathology evaluation of government and university research and safety assessment programs of the pharmaceutical, chemical, and cosmetic industry. Pathology peer review, pathology working groups, general consultation in toxicologic pathology, non-clinical drug safety, and preclinical development.
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Consultant In Toxicologic Pathology And Nonclinical Drug SafetyEngelhardt Consulting, Inc. Jan 2009 - Dec 2013General consultant in nonclinical drug development and pathology including pathology peer review, primary histopathology, and interpretation of pathology data from toxicology studies, scientific review of general toxicology study reports, authoring expert reports and specialized overviews, and development and implementation of strategies for nonclinical development programs.
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Director Pathology Services/Senior Toxicologic PathologistSnbl Usa Aug 2009 - Jun 2010Kagoshima, Kagoshima, JpDirection of anatomic and clinical pathology laboratories and supervision of 5 pathologists; Bench pathologist responsible for anatomic pathology evaluation of toxicity studies. -
Executive Director ToxicologyAmgen Mar 2004 - Jan 2009Thousand Oaks, Ca, UsToxicologic pathology evaluation of nonclinical safety studies of biologics and small molecules, project team representative for development projects, responsibile author for nonclinical expert report/module 2 components for marketing applications, representative for the company at oral hearings with regulatory authorities. -
Preclinical Expert And Pathology AdvisorEli Lilly Jun 1985 - Feb 2004Indianapolis, Indiana, UsToxicologic pathology evaluation of nonclinical safety studies of small molecules, project team representative for development projects, responsibile author for nonclinical expert report/module 2 components for marketing applications, representative for the company at oral hearings with regulatory authorities.
Jeff Engelhardt Skills
Jeff Engelhardt Education Details
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Purdue UniversityVeterinary Pathology -
Purdue UniversityVeterinary Medicine
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University Of Notre DameMicrobiology
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University Of Illinois Urbana-ChampaignMicrobiology
Frequently Asked Questions about Jeff Engelhardt
What company does Jeff Engelhardt work for?
Jeff Engelhardt works for Engelhardt Consulting
What is Jeff Engelhardt's role at the current company?
Jeff Engelhardt's current role is Consultant in nonclinical safety of nucleic acid therapeutics.
What is Jeff Engelhardt's email address?
Jeff Engelhardt's email address is je****@****rma.com
What schools did Jeff Engelhardt attend?
Jeff Engelhardt attended Purdue University, Purdue University, University Of Notre Dame, University Of Illinois Urbana-Champaign.
What skills is Jeff Engelhardt known for?
Jeff Engelhardt has skills like Toxicology, Drug Development, Clinical Development, Ind, Glp, Pathology, Biotechnology, Oncology, Life Sciences, Drug Discovery, Pharmaceutical Industry, Biologics.
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