Cytel and Sunesis Pharmaceuticals' Experts Host Educational Session December 14, 11:00 AM EST on DMC/DSMB and Adaptive Trial Regulatory Compliance

Cambridge, Massachusetts, December 8, 2011 - Cytel Inc., the leading provider of adaptive clinical trial services and biostatistical software, announced an webinar that examines the increasing use of Data Monitoring Committees (DMC or DSMB) for monitoring safety or for interim analyses and adaptive changes.

The program’s premise is that DMC trials - both conventional and adaptive - are increasingly prevalent, and the costs to administer independent committees is becoming prohibitive.  Sponsors need new tools to automate committee support and satisfy regulators that interim analysis (IA) are kept secure and confidential. The webinar will feature a pointed discussion of how new technology is helping companies meet expectations of data committees in compliance with the FDA’s Guidance and the EMA’s Guidelines.

Cytel has introduced ACES® (Access Control Execution System), purpose-built to manage the many committee-sponsor interactions and to safeguard the integrity of trials with interim analyses in pivotal studies leading to an NDA.  Developed in collaboration with Wyeth initially, the ACES system is being deployed by a growing number of biotechs, specialty pharmas and just recently, a top 5 global pharmaceutical corporation.

About the Session
Preserving Trial Integrity When Utilizing DMCs/DSMBs and Interim Analyses
Using examples from actual ongoing trials, the webinar will provide insights into:

• How to build data-protection firewalls to satisfy regulators
• What to consider when forming information paths for committee communications
• When best to schedule interim analyses for safety concerns or adaptive designs
• The potential to automate generation of supporting documentation: medicinal, statistical and operational

Wednesday, December 14th, 2011
11:00 AM - 12:00 PM  EST
Free registration link:
http://www.cytel.com/News/Webinars.aspx

Presenters
Cytel Enterprise Solutions Manager, Eric Silva, and Sunesis Vice-President for R&D, Steven Ketchum interactive explore regulatory considerations, sponsor experience and demonstrate the ACES® system.

Steven B. Ketchum, Ph.D.
Sunesis Pharmaceuticals Sr. Vice President, Research & Development

Steven Ketchum is a Research and Development leader at Sunesis with a marked experience in late-stage product development and regulatory strategy, having led to the successful filings of multiple NDAs.

Eric J. Silva
Cytel Inc. Enterprise and Hosted Solutions Manager

Eric oversees the development and deployment of Cytel’s ACES®. The ACES system is fully validated and is already deployed in numerous ongoing pivotal and confirmatory adaptive studies.

ACES Systems in Use Today
Read about Sunesis Pharmaceutical’s VALOR trial utilizing an adaptive sample size re-estimation design. The interim analysis and DSMB work will be managed by the ACES system.

About Cytel
Cytel Inc. is a leading provider of clinical research services and trial design and analysis software for the biopharmaceutical, medical device, academic and government research markets.

All 25 leading global biopharmaceutical companies use Cytel technology to design, simulate and analyze their clinical studies. Pioneers of the supporting statistical methods, every adaptive trial designed by Cytel has been accepted by international regulators.

Interview requests/more info:
Michael Weitz
+1 617 528 7132
mike@cytel.com