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Division of Pharmacometrics has an opening for a Fellowship: "Quantitative assessment of endpoints in Inflammatory Bowel Diseases"

From: Mehrotra, Nitin <Nitin.Mehrotra>
Date: Wed, 18 Nov 2015 20:53:23 +0000

Greetings NMusers,

A fellowship opportunity is currently available in the Division of Pharmaco=
metrics within the Office of Clinical Pharmacology (OCP) at the Center for =
Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administratio=
n (FDA). OCP's mission is to assure the safety and effectiveness of new dr=
ugs through the evaluation of clinical pharmacology and biopharmaceutics da=
ta in support of CDER's Investigational New Drug (IND), New Drug Applicatio=
n (NDA), and Biologics License Application (BLA) review programs.

The initial appointment will be for one year which can be extended dependin=
g on availability of funds.

Brief description of the fellowship:
There are several biologics approved for Crohn's Disease (CD) and Ulcerativ=
e Colitis (UC) in adults. There is little quantitative understanding on the=
 discriminatory power of endpoints for dose selection or to assess treatmen=
t effect, adequate duration of clinical trials, timing of assessment of ind=
uction 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 f=
rom in-house biologic license applications (BLAs) for UC and CD with an aim=
 of streamlining the clinical trials and improve clinical trial outcomes wi=
th respect to the following goals :

* Identify and propose 'More discriminatory' endpoints for dose selection a=
nd/or approval. This will provide good quantitative rationale of the endpoi=
nts 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 respon=
se or remission.
* Identify early predictors/indicators of long-term response/remission to a=
id in treatment decisions. This will allow the reassessment of benefit/risk=
 in a patient early on to make treatment discontinuation decision preventin=
g unnecessary exposure of drug to the patient.

Interested candidates should apply using the following link: https://www.zi=
Please contact me if you have any questions or need additional information =
regarding the fellowship.

Best Regards

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, FD=
10903 New Hampshire Ave, Bldg 51, Rm 3199
Silver Spring, MD-20993
E-mail: Nitin.Mehrotra
Phone: 301-796-0976
Cell: 301-802-5329
The contents of this message are mine personally and do not necessarily ref=
lect any position
of the Government or the Food and Drug Administration. This message, includ=
ing attachments,
is for the sole use of the intended recipient(s) and may contain confidenti=
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Any unauthorized use, disclosure, or distribution is prohibited. If you are=
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Received on Wed Nov 18 2015 - 15:53:23 EST

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