A Case Study of a Mid-Size Pharmaceutical Company's Biostatistics and Data Management Group with NDA Submissions: Past, Recent and Future-- Biostatistics and Data Management Committee

Wed, August 22 12:00 pm – 2:00 pm

Type of Event Committees & Forums

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Committee Biostatistics/Data Management

<link media="all" type="text/css" href="http://massbio.org/sup/css/content.css" rel="stylesheet"> You are invited to join the MBC Biostatistics and Data Management Committee for a presentation on "A Case Study of a Mid-Size Pharmaceutical Company’s Biostatistics and Data Management Group with NDA Submissions: Past, Recent and Future"

When: Wednesday, August 22, 2007

Time: 12:00-2:00 PM

Where: MBC Office, One Cambridge Center, 9th Floor, Cambridge, MA

Overview:

Cubist Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing antiinfective therapies for the acute care environment. Cubist has reengineered its biostatistics and data management processes to be more efficient, streamlined, and scalable to meet the evolving data and regulatory standards for a New Drug Application (NDA) since its first approval in 2003 and recent sNDA approval in 2006. Changes include development of Biostatistics and Data Management focused operational guidelines and procedures, implementation of CDISC and moving from eNDA to the eCTD format. Come hear about Cubist’s journey, the lessons learned and current plans for future submissions

Speakers:

Jameelah Aziz- Sr. Manager, Clinical Data Management, Cubist Pharmaceuticals

Ted Trost- Manager, Regulatory Information Systems, Cubist Pharmaceuticals

We look forward to seeing you there!

Lunch will be served.

TO REGISTER:
email your name, title and company to register@massbio.org. Please include "BDM 8/22" in the subject line.

This event is free of charge and open to MBC Member companies and their employees only.

For more information on Membership, contact Lori Gold at lori.gold@massbio.org or 617-674-5149.

About MBC

The Massachusetts Biotechnology Council, founded in 1985, is a not-for-profit organization committed to advancing the development of critical new science, technology and medicines that benefit people worldwide.

Our Vision

We provide services and support to foster the biotechnology industry in Massachusetts and sustain our position as a world leader.

Membership

There are more than 550 members in the MBC representing all facets of the industry. Our membership includes biotechnology companies, businesses related to the industry, major teaching hospitals and world-leading academic institutions.

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