Kragie BioMedWorks (R)
GOVERNMENT CONTRACT ASSISTANCE, BioMedWorks® helps firms with
NIH contract proposals in areas related to Infectious Diseases, Addiction
Therapies and Medical Informatics.
Dr. Kragie works as a federal contracted Medical Officer, Medical Monitor and Scientific Review Officer in areas of health care delivery, bioemergent infections and neglected tropical diseases.
ENHANCED ORAL FORMULATION VITAMIN B12: BioMedWorks® utilized novel carrier molecules in a coformulation with cyanocobalamin (B12) to create an enhanced formulation that provides rapid and dramatic enhancement of oral B12 - indicating absorption via an alternative pathway to the usual receptor mediated process requiring intrinsic factor production and intact ileum.
IND and NDA REGULATORY STRATEGIES for drug and biologic products in areas of (e.g.) immunology, reproduction, oncology, endocrinology, pediatric formulations: BioMedWorks® advises many different clients on clinical trial protocols, preclinical toxicology and the risks and benefits of pursuing ANDA versus NDA 505(b)2 regulatory strategies and the issues involved.
CLINICAL TRIAL DESIGN and MANAGEMENT In conjunction with NIDA and a commercial partner, BioMedWorks® assisted in conducting, evaluating, and monitoring of ongoing clinical trials of an addiction therapy, including the overall design of the NDA and drug development strategy. Other areas include: anginal, anorexic agents, arthritis, asthma, autoimmune disease, biologic response modifiers, bipolar depression, cancer, cardiovascular, contraceptives, cosmetics, critical care, dementia, dermatologics, diabetes, endocrine, eczema, epilepsy, infectious diseases, immune response modifiers, infertility, inhalants (peptides/proteins/small molecules), gene therapy, GI, HRT, 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, vaccines, vaginal products, medical devices.
INTERNAL REVIEW BOARD Review of protocols and applications for adherence to guidelines and codes for patient and animal safety and ethical treatment.
INTELLECTUAL PROPERTY LITIGATION Expert witness testimony and consulting in areas of pharmaceutical product development and regulation.
TECHNOLOGY EVALUATION and market development of the patent portfolio for Georgetown University, and other commercial clients. BioMedWorks® evaluated emerging technologies and helped to craft their patent claims for broader scope and market impact, identified market targets, quantified their commercial potential, and participated in forging partnerships and joint ventures.
SCIENCE ADVISOR to ALBERT B. SABIN VACCINE INSTITUTE, on institute policy and mission; Special Awards Judge for International Science and Engineering Fair; medical writing related to vaccine technologies and development history.
EDITORIAL WRITER for HEALTHCARE TRENDS REPORT of Chevy Chase MD, a monthly digest of Business and Public Policy News headed by Sylvia Fubini PhD. Dr. Kragie updates readers on breakthroughs in the biotechnology inductry and their impact on healthcare delivery. Her most recent feature, "Today's Telemedicine" described current ventures in home nursing telemedicine as well as interactive video encounters.
INTERNET-BASED PHARMACEUTICAL/ HEALTHCARE VENTURES Designed protocols for internet market research with Robbin Zeff PhD of Zeff Group, dealing with investigating the impact of the internet on pharmaceutical usage and physician prescribing practices. Assisted companies in their strategic planning and partnering.