Kragie
BioMedWorks (R)

REGULATORY EXPERIENCE of Laura Kragie, M.D.

GOVERNMENT POSITIONS

Medical Review Officer

FDA, CDER, Cardio-Renal Drug Products
FDA, CDER, Anesthesia, Critical Care, & Addiction Drug Products

FDA WORK EXPERIENCE

New Drug Application (NDA) & Supplemental NDA Review:

Clinical protocols
Efficacy Determination
Safety
Toxicology & Adverse Event Profile
Pharmacokinetic & Pharmacodynamic Review
Biopharmacology
Label review and editing
Integrated Summary (SBA)
Phase IV commitment protocols & Postmarketing Surveillance
Pediatric & Reproductive Label supplements

Interactive Investigational New Drug (IND):

Trial design
Clinical development program design; phase I -III
Toxicology
Safety planning and assessment
Pharmacokinetic/Pharmacodynamic relationships
Metabolism
Bioavailability

Consultative Services

Internal
External (to sponsors)
Class labeling issues
Drug abuse potential
External academic organizations
External Scientific Associations
NIH, National Institute for Drug Abuse

FDA Committee Work

Women's subcommittee, Medical Policy Coordinating Committee

Information Technology Projects

Cross platform integration
File exchange/archive
Beta test applications (esp. for Power Mac)
Placebo-controlled hypertension trial database project
Three-dimensional molecular modeling of drugs & pharmacophores

FDA/CDER Training Activities

Course development for Perinatalogy, FDA/CDER Staff College
Women's Health projects: e.g., drugs used in pregnancy
Gender guidelines in clinical trials workshop: hormonal influences in drug metabolism and effect panel member, speaker coordinator and transcript editor.

PHARMA AND FDA RELATED WORKSHOPS

Panel Member, Hormonal Influences in Drug Efficacy, Safety and Metabolism, FDA Workshop on Gender Studies in Product Development; Scientific Issues and Approaches. Editor of Executive Summary

Institute of Medicine/FDA Workshop, Roundtable on Research and Development of Drugs, Biologics, and Medical Devices. Rational Therapeutics for Infants and Children. NRC Washington DC 1999; chaired by Ron Estabrook MD and Sumner Yaffe MD

FDA-NICHD Workshop: Clinical Pharmacology during Pregnancy Washington DC 2000

FDA-BIO-PhARMA Educational Conference on the Impact of Genetics on Product Discovery and Development Rockville MD 1998

FDA-NCI Workshop On Tumor Vaccines Bethesda MD 1998

FDA-PhRMA: Workshop on the Guidance for Population Pharmacokinetics in Drug Development and Regulatory Decision Making Rockville MD; 1999

FDA-PhRMA: Workshop on Pharmacogenetics/Pharmacogenomics in Drug Development and Regulatory Decision Making Rockville MD 2002

FDA-ASH Workshop Biomarkers in Oncology Washington DC 2005

FDA Workshop: ECG Warehouse and Review Process Rockville MD 2005

FDA-ASH Workshop Clinical Endpoints in Multiple Myeloma Washington DC 2006

FDA-AHRQ Workshop: Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges. Rockville MD 2007

NIH Roadmap Workshop: Bridging the Gap between Preclinical and Clinical Evaluation of Therapeutic Candidates Bethesda MD 07/2007

DHHS: Public Health Emergency Medical Countermeasures (PHEMC) Enterprise Stakeholders Workshop Washington DC 08/2007

DHHS Workshop: Biomedical Advanced Research and Development Authority (BARDA) Industry Day Washington DC 08/2007

Uniformed Services University Center for Deployment Psychology Training: Addressing the Psychological Health of Warriors and Their Families: PTSD, Depression and TBI College Park MD Spring 2009

FDA Workshop: Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs Gaithersburg MD Spring 2009

Canada-U.S. Partners in Biomedical Defense II Conference 03/2010 Wash DC

NIH/DHS/Workshop: Vaccines or Emerging Infectious Diseases and Biothreat Agents 04/2010 Frederick MD

NIH/NIAID/DMID Workshop: Staphylococcus Vaccines, 05/2010 Washington DC

NIH/NIAID/DMID Workshop: Lyme Disease, 06/2010 Washington DC

FDA/NIH/Gates Fdn/Critical Path to TB Drug Regimens Launch Workshop; 06/2010 Wash DC

NIH/NIGMS Quantitative & Systems Pharmacology Workshop: 09/2010 Bethesda

IEEE-NIH Life Science Systems and Application Workshop (LiSSA 11) 04/2011 Bethesda MD

FDA CDER Small Business Assistance Program, Clinical Trials Forum 04/2011 Silver Spring MD

AFMS-CTSA Collaboration Workshop: Opportunities in Translational Science Research. Bethesda MD 05/2011

Endocrine Society Meeting and Presentation, Washington DC 06/95; San Francisco CA 06/1996

Generic Pharmaceutics Industry Association, Boca Raton FL 03/1996

Society for Neuroscience, Washington DC 11/1996

American Society for Clinical Pharmacology and Therapeutics: San Diego 03/1997; Atlanta 03/2002, 03/2010; Orlando 03/2005; Baltimore 03/2006; Orlando 04/2008, Washington DC 03/2009

Regulatory Affairs Professionals Society, Washington DC 9/1997; Washington DC 10/1998

American Association of Pharmaceutical Scientists, Boston MA 11/1997

American Association for the Advancement of Science, Washington DC 02/2000 Drug Metabolism: Innovations in Discovery and Development Philadelphia PA 03/2000

American Association of Orthopaedic Medicine Annual Conference: New Treatments for Sports Injuries Washington DC 04/2006

DC Science Writers Association Professional Development Day, Washington DC 04/2011

American Medical Informatics Association Annual Conference, Washington DC 10/2011