Kragie
BioMedWorks (R)

Laura Kragie, M.D.

BRIEF BIO

CAREER HIGHLIGHTS

B.S. Biology, Biochemistry and Psychology, University of Illinois, Champaign-Urbana IL
M.D. College of Medicine, University of Iowa, Iowa City IA
Doctoral Program Biochemical Pharmacology State University of NY at Buffalo, ABD
Phase I NIH Physician Scientist Award Program and Clinical Investigator Pathway for Certification in Internal Medicine (Translational Medicine Pathway)
Director Erie County AIDS Clinic 1985-1986, Buffalo NY
Instructor, Psychiatry and Endocrine Research Fellow, Harvard Medical School, Boston
Adjunct Professor, Dept Pharmacology & Division of Clinical Pharmacology, Georgetown University Medical School, Washington DC
Research on Membrane Hormone/Drug Transporter featured as the cover of the March 1994 issue of Molecular Endocrinology
Medical Officer, FDA, CDER, Cardio-Renal Drug Products, Anesthesia, Critical Care, & Addiction Drug Products. FDA Commissioner’s Group Recognition Award as member of Gender Studies in Product Development Group
Identified pediatric cardiovascular safety issues in ADHD drugs in 1995
Director of Clinical Research at Pharmavene/Shire Labs, Antiepileptic drug product Carbatrol® FDA Approval 1997
Medical Officer, NIH NIAID Office of Clinical Research Affairs, Scientific Review Officer NIH Center for Scientific Review [Contractor]
NIH Director Group Award for Leading a Comprehensive and Coordinated Response to the H1N1 Influenza Pandemic 2010

Experience by Category

Business Management

VP Clinical Development and CMO Emisphere Technologies Inc.
Director of Clinical Research Shire Laboratories
Due diligence for mergers and acquisitions for multiple clients
Technology transfer and licensing for commercial and academic institutions
CEO of own firm

FDA Regulatory Review and Strategic Planning

Acting Team Leader Anesthesia, Critical Care
Medical Officer for CardioRenal, Anesthesia/Analgesia, Critical Care, Addiction Therapies
FDA Committee and Workshops Maternal/Fetal labeling, drug-hormone interactions and metabolism, gender differences. [http://www.fda.gov/ScienceResearch/SpecialTopics/WomensHealthResearch/ucm134470.htm]
Identified pediatric cardiovascular safety issues in ADHD drugs in 1995
Due diligence evaluation of regulatory compliance of candidate acquisitions for firm clients

Clinical Trial

Academia (as investigator) cardiovascular, gynecology, endocrine, neurology, oncology at SUNY Buffalo and Roswell Park. Addiction therapies, drug-hormone interactions at Harvard University
Industry (as Director, as VP) Phase I-III in areas of anticonvulsant, NDA approval, antiviral, antidementia, ADHD, addiction therapies, blood biotech, insulin, heparin, GLP1, PYY, cobalamin vitamin B12, functional excipients, drug delivery optimization.
Design and Analysis (as Consultant, as FDA and NIH Medical Officer) AIDS, anemia, acne, anesthetics, analgesics, antimicrobial, antivirals, antithrombotics, antiarrhythmic, anginal, anorexic agents, arthritis, asthma, autoimmune disease, biologic response modifiers, bipolar depression, cancer, cardiovascular, contraceptives, cosmetics, critical care, dengue, dementia, dermatologics, diabetes, endocrine, eczema, epilepsy, infectious diseases, immune response modifiers, infertility, inhalants (peptides/proteins/small molecules), gene therapy, GI, HRT, H1N1, HIV, hypertension, leukemia/ lymphoma, maternal-fetal, migraine, metabolic syndrome, neuroleptic, neuromuscular blockers, nutraceuticals, orthopedic therapies, partuition, protein/peptide oral drug delivery, polycystic ovarian syndrome, peridontal, partuition, reproductive, substance abuse, transplant medicine, TB, vaccines, vaginal products, medical devices, software validation, curated knowledge databases, internet based clinical trials.
Evaluation of regulatory compliance of candidate acquisitions for clients
Evaluation of adverse events for clients; pharmacovigilance and medical monitoring
BARDA and BIOSHIELD related research and development, including Field Stable formulations for critical care therapeutics

Bench Research

Over 2 dozen peer-reviewed publications in areas of molecular pharmacology, thyroidology, reproductive steroid metabolism and p450 drug metabolism
Over 10 years grant support for investigator-initiated research
Due diligence evaluation of pharm/tox regulatory compliance of candidate acquisitions for clients
Molecular modeling of pharmacophores for drug – hormone interactions

Intellectual Property

Authored several patents (own, employers, clients) for PCT and USPTO filings
Registered Trademarks and prosecuted infringement
Marketed Trade Secret Business Strategies for pharma firms
Technology transfer and patent writing for Georgetown University
Due diligence evaluations and market valuations of IP asset portfolios
Expert for Patent Examinations/Hearings

Legal Expert Witness

Expert witness USPTO hearings and pleadings
Expert witness patent and trade secret litigation in pharmaceuticals
Expert witness federal regulatory and IRB issues

Investment Services

Evaluation of business plan proposals for an angel investment group, Chicago
Setup proprietary electronic trading business, Chicago Board of Trade
Historic real estate property evaluation and renovation plans
Setup oil field leases and commodities futures contracts
Analyst/advisor for Venture Capital Investment firms

Author/Editor/ Presenter of Peer-Reviewed Research

Reviewer for numerous peer-reviewed science journals
Associate Editor for Endocrine Research
ASCPT Workshop, Interaction of Drugs with Estrogen Endocrinology March 2005
Numerous publications of original bench and clinical research, topical reviews and editorials

Nonprofit and Peer Review Work

IRB and IACUC committee for, The Institute for Genomic Research, J Craig Venter Institute
Founder and Executive Director, Endocrine Health Foundation
Scientific Review Officer NIH/CSR/HDM Challenge Grants 2009
Member NIH Study Section, Special Emphasis Panel, BioInformatics and In Vivo Imaging
Ad hoc Reviewer Reserve NSF, NIH
EPA EDSTAC Endocrine Disruptor Tier 1 Screen Peer Reviewer
Adjunct Professor Georgetown University, Depts Pharmacology and Clinical Pharmacology
Scientific advisor to Sabin Vaccine Institute
Visiting Physician/Scientist, Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders, Dhaka, Bangladesh
Judge, Intel International Science and Engineering Fair
U.S. Fish & Wildlife Service Great Lakes Restoration Initiative Joint Venture grant for 20- acre property donation to the Southwest Michigan Land Conservancy

Massachusetts State Medical Licensure – current
US Federal Security Clearance, Level 1 (NACI)- current
Foreign Language, French