Greetings NMusers, A fellowship opportunity is currently available in the Division of Pharmacometrics within the Office of Clinical Pharmacology (OCP) at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA). OCP's mission is to assure the safety and effectiveness of new drugs through the evaluation of clinical pharmacology and biopharmaceutics data in support of CDER's Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA) review programs.
The initial appointment will be for one year which can be extended depending on availability of funds. Brief description of the fellowship: There are several biologics approved for Crohn's Disease (CD) and Ulcerative Colitis (UC) in adults. There is little quantitative understanding on the discriminatory power of endpoints for dose selection or to assess treatment effect, adequate duration of clinical trials, timing of assessment of induction of response or remission or the appropriate early predictors of long term response. The goal of this project is to systematically evaluate the data available from in-house biologic license applications (BLAs) for UC and CD with an aim of streamlining the clinical trials and improve clinical trial outcomes with respect to the following goals : * Identify and propose 'More discriminatory' endpoints for dose selection and/or approval. This will provide good quantitative rationale of the endpoints that should be used for dose selection and/or approval. * Evaluate approaches that could reduce the duration of registration trials where possible thus shortening the drug development cycle. * Identify adequate endpoint-assessment time points for induction of response or remission. * Identify early predictors/indicators of long-term response/remission to aid in treatment decisions. This will allow the reassessment of benefit/risk in a patient early on to make treatment discontinuation decision preventing unnecessary exposure of drug to the patient. Interested candidates should apply using the following link: https://www.zintellect.com/Posting/details/1327 Please contact me if you have any questions or need additional information regarding the fellowship. Best Regards Nitin ************************************************************ Nitin Mehrotra, M.Pharm., Ph.D. Pharmacometrics Team Leader Hematology, Medical Imaging, Metabolic & Endocrinology and Gastroenterology & Inborn Error Products Division of Pharmacometrics, Office of Clinical Pharmacology, OTS, CDER, FDA 10903 New Hampshire Ave, Bldg 51, Rm 3199 Silver Spring, MD-20993 E-mail: [email protected]<mailto:[email protected]> Phone: 301-796-0976 Cell: 301-802-5329 Pharmacometrics@FDA: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm167032.htm ************************************************************ The contents of this message are mine personally and do not necessarily reflect any position of the Government or the Food and Drug Administration. This message, including attachments, is for the sole use of the intended recipient(s) and may contain confidential and privileged information. Any unauthorized use, disclosure, or distribution is prohibited. If you are not the intended recipient, please contact the sender and destroy all copies of the original message
