Kragie
BioMedWorks (R)

PHARMACEUTICAL INDUSTRY EXPERIENCE of Laura Kragie, M.D.

VP of CLINICAL DEVELOPMENT & CMO

At Emisphere Technologies Tarrytown NY; JUN 12 - DEC 21 2007

DIRECTOR of CLINICAL RESEARCH

At Pharmavene, a subsidiary of Shire Group in the Maryland-DC Metro Area; 1996-1997

MANAGEMENT RESPONSIBILITIES

Directly supervised: Pharmaceutical Sciences PhD, Clinical Development Director, PK-PD ADME PhD, PK-PD ADME MS, Clinical Research Sr. Scientist, Clinical Research Scientist, PhD Biostatistician/SAS programmer, Database Manager, Clinical Research Associate, Clinical Research Administrator, Project support staff
Staff hiring, personnel descriptions, staff evaluations and promotions
Project planning and timelines of milestones, cost assessment and budgets
Portfolio and Pipeline management contributions, Go/No Go Committee. Evaluation of potential drug products and therapeutic areas
Clinical trial design and data analyses, pharmacometric modeling of kinetics and biomarkers
Drug Development: Evaluation of potential drug products and therapeutic areas, Drug development strategy, preclinical and first in man evaluation, Regulatory strategy
Contract Research Organization selection and contract negotiator, Selection/development of animal disease model contractors
Clinical investigator recruitment and site selection, Clinical trial management
Clinical trial patient safety monitoring; Regulatory documents: preIND, IND, NDA, GRAS, FDA meetings
Presentations of research and technology to corporate clients, potential licensees, FDA. Academic publications
Inventions and patent authorship, portfolio management. Technology transfer to licensees
Investor relations and communications

MANAGED PROJECTS

Oral formulation GLP1 with functional excipient carrier (University Hospital Basel) PK-PD correlations with glucose, insulin, ghrelin. See "Pharmacokinetics and Pharmacodynamic Effects of Oral GLP-1 and PYY3-36: A Proof-of-Concept Study in Healthy Subjects", C Beglinger et al. CPT 84:468, and, "Orally Administered Glucagon-Like Peptide-1 Affects Glucose Homeostasis Following an Oral Glucose Tolerance Test in Healthy Male Subjects" RE Steinert et al. doi: 10.1038/clpt2009.159
Oral formulation development of GLP1 and analogs, interaction with DPP4 inhibitors
Evaluation product development oral heparin and oral/pulmonary insulin
GRAS status evaluation for functional carrier excipients in food supplements
Naritriptan formulation for migraine demonstrating a shortened Tmax
Development of oral formulations for osteoporosis drugs
Extended release antiepileptic product: 2 open-label clinical trials at 7 sites; NDA approved by FDA.
Extended release substance abuse product: Indications for Addiction therapy and Parkinson disease; Completed multisite trial in cocaine abusers in collaboration with NIDA
Generic version of extended release calcium channel blocker: Phase I, development of in vitro / in vivo correlations of formulation prototypes
Oral antiviral extended release product: Phase I, development of in vitro / in vivo correlations of formulation prototypes

PHARMA 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

International AIDS Society-USA CME course: Improving The Management of HIV Disease,Course in HIV Pathogenesis, Antivirals, and Other Selected Issues. Washington DC 06/2010

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

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