"Dr. Kragie's rich experience as a Medical Officer with the FDA and the Center for Drug Evaluation and Research (CDER) working on regulatory review on a wide array of drug products, along with her deep knowledge of the many facets of biotech, are among the many skills Dr. Kragie brings to Emisphere," said Mr. Novinski. "Dr. Kragie also brings a real sense of business management, deep clinical trial experience and varied pharmaceutical development skills. We are very excited to have her bring this wealth of experience to Emisphere."
At BioMedWorks, Dr. Kragie specialized in pipeline and drug development strategies, efficacy and safety determination, biomarker/surrogate endpoints, intellectual property portfolio development, and regulatory strategies. She guided clients at all stages of their regulatory processes, from pre-IND through to launch and post-approval phases. Dr. Kragie also investigated unmet clinical needs and new indications for approved drugs. Dr. Kragie's research and nonprofit efforts worked to generate and communicate knowledge regarding food, drug and environmental interactions with endocrine systems and their impact on health and disease.