Leffel Consulting Group
Leffel Consulting Group, LLC specializes in strategic planning and expert consulting services for pharmaceutical and biotechnology companies, focusing on preclinical and nonclinical programs, medical countermeasures, and regulatory guidance. Led by Elizabeth Leffel, PhD, MPH, the company offers personalized support and has a strong network of experts to facilitate the transition from basic research to advanced development, with a mission to support product development from the bench to the patient.
Industries
Nr. of Employees
small (1-50)
Leffel Consulting Group
Located in central Virginia with convenient accessibility to the DC metro area, small businesses and academic interests.
Services
Consulting to plan and manage product development programs from basic research through nonclinical development toward regulatory submission.
Advisory services for navigating FDA Animal Rule requirements, preparing for INDs, and representing clients at regulatory and funding meetings.
Design of nonclinical efficacy and natural history studies, selection of endpoints, and advice on data analysis approaches.
Advisory services for aerobiology experiments and development of inhalational infectious disease models, including characterization of exposure routes.
Audit services for subcontractor compliance with Good Laboratory Practices, protocol adherence, and scientific integrity of generated data.
Support for obtaining federal funding and aligning programs to agency priorities through proposal development and program consultation.
Consulting to plan and manage product development programs from basic research through nonclinical development toward regulatory submission.
Advisory services for navigating FDA Animal Rule requirements, preparing for INDs, and representing clients at regulatory and funding meetings.
Design of nonclinical efficacy and natural history studies, selection of endpoints, and advice on data analysis approaches.
Advisory services for aerobiology experiments and development of inhalational infectious disease models, including characterization of exposure routes.
Audit services for subcontractor compliance with Good Laboratory Practices, protocol adherence, and scientific integrity of generated data.
Support for obtaining federal funding and aligning programs to agency priorities through proposal development and program consultation.
Expertise Areas
- Medical countermeasure development
- Animal model development and natural history studies
- Nonclinical study design and execution
- Aerobiology and inhalational exposure modeling
Key Technologies
- Animal model development
- Aerobiology and inhalational exposure modeling
- Natural history study design
- Preclinical toxicology and pharmacokinetics
News & Updates
Dr. Leffel was appointed by the U.S. Secretary of Health and Human Services as a special government employee to the National Biodefense Science Board in April 2018.
In June 2016, Dr. Leffel was appointed by the Governor of Virginia to the Secure Commonwealth Panel.
A case study presentation on drug development for anthrax under the Animal Rule.
A presentation on current issues in toxicology and biodefense.
A speaking engagement on the FDA Animal Rule.
A workshop organized for regulatory outsourcing.
Dr. Leffel was appointed by the U.S. Secretary of Health and Human Services as a special government employee to the National Biodefense Science Board in April 2018.
In June 2016, Dr. Leffel was appointed by the Governor of Virginia to the Secure Commonwealth Panel.
A case study presentation on drug development for anthrax under the Animal Rule.
A presentation on current issues in toxicology and biodefense.
A speaking engagement on the FDA Animal Rule.
A workshop organized for regulatory outsourcing.