Laura Kragie MD Bio

HIGHLIGHTS

B.S. Biology, Biochemistry & 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 & 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, McLean Hospital, Harvard Medical School

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"; "Placebo-Controlled Hypertension Trials" database project

Identified pediatric cardiovascular safety issues in ADHD drugs in 1995; antifungal reproductive toxicity in 1996

Director of Clinical Research at Pharmavene Inc. of Rockville MD; 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 & CMO Emisphere Technologies Inc.

Director of Clinical Research Shire Laboratories (Pharmavene Inc.)

Due diligence for mergers and acquisitions for multiple clients

Technology transfer and licensing for commercial and academic institutions CEO of own consulting firm

FDA Regulatory Review and Strategic Planning

Acting Team Leader Anesthesia, Critical Care

Medical Officer for: CardioRenal, Anesthesia/Analgesia, Critical Care, Addiction Therapies FDA Committees 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

Placebo-controlled hypertension trials adverse events database project

Due diligence evaluation of regulatory compliance of candidate acquisitions for firm clients

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

Bench Research

Over 2 dozen peer-reviewed publications in areas of molecular pharmacology, thyroidology, drug membrane transport, reproductive steroid metabolism and p450 drug metabolism

Over 10 years grant support for investigator-initiated research

Molecular modeling of pharmacophores for drug - hormone interactions

Validation High Throughput Aromatase assay for EPA Tier 1 Endocrine Disruptor Screening

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

Clinical Trial

Academia (as investigator): cardiovascular, gynecology, endocrine, neurology, oncology at SUNY Buffalo & 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 & Analysis (as Consultant, as FDA & NIH Medical Officer): AIDS, acetylcholinesterase inhibitors, anemia, acne, anesthetics, analgesics, antimicrobial, antivirals, antithrombotics, antiarrhythmic, anginal, anorexic agents, arthritis, asthma, autoimmune disease, biologic response modifiers, biosimilars, biologics, bipolar depression, biomarker validation, cancer, cardiovascular, complex generics, combination drug/devices, contraceptives, countermeasures, cosmetics, critical care, dengue, dementia, dermatologics, diabetes, diagnostics, disease vector controls, endocrine, eczema, epilepsy, genetic therapies, infectious diseases, immune response modifiers, infertility, inhalants (peptides/proteins/small molecules), gene therapy, GI, HRT, H1N1, HIV, HRT, hypertension, influenza, leukemia/ lymphoma, maternal-fetal, migraine, metabolic syndrome, monoclonals, Natural History studies, neuroleptic, neuromuscular blockers, NextGen DNA sequencing, nutraceuticals, orphan drugs, orthopedic therapies, partuition, personalized medicine, protein/peptide oral drug delivery, orphan drugs, polycystic ovarian syndrome, peridontal, rare diseases, reproductive, substance abuse, stem cell and transplant medicine, TB, vaccines, vaginal products, medical devices, software validation, curated knowledge databases, internet-clinical trials device and web based telemedicine, smartphone apps.

Evaluation of regulatory compliance of candidate acquisitions for clients

Evaluation of adverse events for clients; pharmacovigilance and medical monitoring; IRB; DSMB

BARDA related R&D, including: Field Stable formulations for critical care therapeutics, Medical Countermeasures, Flavivirus and Filovirus diagnostics/therapeutics/vaccines, vector mitigation.

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

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 eBook publisher and author of creative nonfiction book: Be the Rainbow * Bridge Heaven and Earth: How-to Manual for Integrating Alternative and Evidence-Based Medicine. http://www.amazon.com/dp/B0081UEYIU/ and speculative science novel: Vampire Chimeras (A Medical Thriller) http://www.amazon.com/dp/B00GKQD154

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 [http://www.epa.gov/endo/pubs/ assayvalidation/aromatase_pr.htm]

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, [www.icddrb.org] Dhaka, Bangladesh

Judge, Intel International Science and Engineering Fair

U.S. Fish & Wildlife Service Great Lakes Restoration Initiative Joint Venture grant for 120-acre property donation to the Southwest Michigan Land Conservancy

Foreign Language Skills: French