Beth (Elizabeth) Leffel work email
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Life science executive with 19 years of experience in leading preclinical and nonclinical drug development programs including: the development and characterization of animal models, advancement of aerosol research of biothreat and infectious agents and progressing medical countermeasures for licensure by the FDA Animal Rule. Primary specialization is in animal model selection and vaccine/therapeutic development for biodefense and emerging infectious disease indications.Accomplished in strategic portfolio management; translational medicine; FDA Animal Rule; aerobiology; directing research, development and commercialization programs; Good Laboratory Practices; and promoting responsible science in all stages of product development for corporate and government programs.Specialties: biodefense; animal models of infectious disease and radiation-induced syndromes; medical countermeasure (MCM) development; pre-IND packages; government contracting; contract research organization oversight; liaison between company and customer.
Leffel Consulting Group, Llc
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PresidentLeffel Consulting Group, Llc Jan 2014 - PresentWashington D.C. Metro AreaLeffel Consulting Group provides translational medicine services to pharmaceutical and biotechnology companies desiring external assistance in preclinical and nonclinical programs. We provide expertise in the area of developing vaccines and therapeutics for emerging infectious diseases as well as medical countermeasures (MCMs) for biological, chemical or radiation/nuclear disasters. Scientific and regulatory guidance is provided in the areas of: drug/vaccine development & strategic planning, FDA Animal Rule navigation including model development, inhalation routes of exposure, appropriate designs for successful efficacy studies, interpretation of data, and preparing documents suitable for both government and investor audiences.
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Vice President, Preclinical And Nonclinical ProgramsTerapio Corporation Jul 2012 - Apr 2014Key member of executive team with specific leadership responsibilities for: nonclinical/preclinical, bioanalytical assays, and regulatory affairs. Drug development programs required CRO identification, contracting, and management. Contributed to commercialization strategies, market analyses, preparation of investor-relations documents and plan for engagements. Key planner for financial strategies, including program management for government contracts, venture capital and private investments – for several clinical indications to FDA licensure. Serve as primary liaison and key program and scientific contact for the company with the FDA, NIH/NIAID, NIH/NCI, BARDA, and DoD.
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Senior Director Of Nonclinical SciencesPharmathene Jun 2009 - Jun 2012Responsible for strategic planning and management of the nonclinical development of biodefense medical countermeasures, to include: design, oversight, and execution of the nonclinical program; coordination of clinical and manufacturing activities with nonclinical schedule; manage nonclinical operational components of study execution, account management, and scheduling activities; and interaction with DoD, FDA, CDC, BARDA, and NIH. Primary author for peer-reviewed manuscripts and scientific presentations.
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Senior AerobiologistNational Biodefense Analysis And Countermeasure Center (Nbacc) Mar 2008 - May 2009Planned the Bioaerosol Research Center for the Federally Funded Research and Development Center/Department of Homeland Security; wrote the mission and strategic plan to include staffing and research projects out 5yrs. Designed aerosol lab space and equipment requirements. Advised on IACUC, science, security and safety processes for BSL-3 and BSL-4 labs during final phases of laboratory construction. Project manager for external contracts. Represented the NBACC at the National Interagency Confederation of Biodefense Research initiatives (Fort Detrick Campus) and on subcommittees of the Frederick County Chamber of Commerce. Held security clearances.
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Chief, Aerosol Research CenterUsamriid 2002 - 2008Managed the Aerosol Service Center personnel and resources. Contributing scientist for research leading to the licensure of levofloxacin, via the FDA Animal Rule, for the treatment of inhalational plague. Principal Investigator for research conducted in BSL-3 and BSL-4 laboratories and Study Director for research conducted under GLP regulations. Research interests focused on inhalation models of infectious and emerging diseases.
Beth (Elizabeth) Leffel Skills
Beth (Elizabeth) Leffel Education Details
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Pharmacology And Toxicology -
Environmental And Occupational Health -
Biochemistry
Frequently Asked Questions about Beth (Elizabeth) Leffel
What company does Beth (Elizabeth) Leffel work for?
Beth (Elizabeth) Leffel works for Leffel Consulting Group, Llc
What is Beth (Elizabeth) Leffel's role at the current company?
Beth (Elizabeth) Leffel's current role is President at Leffel Consulting Group, LLC.
What is Beth (Elizabeth) Leffel's email address?
Beth (Elizabeth) Leffel's email address is ek****@****ail.com
What schools did Beth (Elizabeth) Leffel attend?
Beth (Elizabeth) Leffel attended Virginia Commonwealth University School Of Medicine, The George Washington University, Virginia Tech.
What skills is Beth (Elizabeth) Leffel known for?
Beth (Elizabeth) Leffel has skills like Vaccines, Science, Research, Infectious Diseases, Toxicology, Glp, Program Management, Animal Models, R&d, Immunology, Fda, Assay Development.
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