Boston SDE 2014

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This page is used to plan the upcoming Boston SDE in 2014.

Tentative Agenda:

Time What Who
8:30-9 Breakfast Example
9-9:10 Intro TC,SS,DB
9:10-9:30 Dataset Validation Majdoub, Biogen Idec
9:30-10:00 Dataset Validation Paul Bukowiec, Takeda
10:00-10:30 Break
10:30-11:00 Dataset/Program Submission Ram Govindaraju (small molecule) /Mominul Islam (experience based for Vaccine studyfrom Vertex –probably large molecule)
11:00-11:30 Dataset/Program Submission  ????
11:30-12:00 Submission Documentation Sally Cassells
12:00-1:00 Lunch
1:00-1:30 Submission Documentation  ????? DB looking
1:30-3:00 Discussion
3:00 - 4:00 Wrap Up


Data set submissions are an integral component of successful drug development. Serving as the basis for clinical approval, data provides the means in which the Agency can confirm the results as presented in the Clinical Study Report. Yet, data set submissions are a very misunderstood process with each company doing it differently and each FDA reviewer requesting it differently. At the PhUSE Boston Single Day Event on May 7th we will dive into three topics which cause confusion in the data set submission process; Dataset Validation, Submission of Data sets/Programs, Submission Documentation. The morning will be devoted to presentations from industry experts spanning large and small companies. In the afternoon we will benefit from the collective experience of the attendees and have open discussion on these three topics. Join us for an exciting day of learning, discussion and networking.

Biogen Idec, 14 Cambridge Center, Building 8 Auditorium, Cambridge MA 02142