- Welcome and Board Update
- US Connect 2022: Event Summary and Best in Stream Winners! – Karen Curran, Connect Chair
- PHUSE Website and Archive Walkthrough – Anup Patel, PHUSE Technical Director
- Nonclinical Study Data Reviewer’s Guide (nSDRG) Package – Susan DeHaven, Working Group Lead
Karen Curran has over 20 years of Biometrics leadership experience providing support solutions to pharmaceutical and biotech clients that range from small start-ups to some of the largest global companies in the industry, and a track record of developing sustainable and evolving relationships with those clients.
At CSG, Karen leads the biometrics group and works with sponsors to develop customized solutions; from individual placements, staff augmentation strategies or developing customized FSP relationships, Karen brings her tenure of leadership experience to our clients for a solution that meets the needs and culture of every engagement.
Karen’s expertise includes CDISC compliant submissions planning and execution, developing KPIs and usable metrics in support of strategic partnerships and in managing sponsor relationships, project delivery and resourcing.
Prior to CSG, Karen led the global biometrics group of a large CRO with over 400 statisticians and statistical programmers worldwide and lead customized biometrics solutions for their key accounts.
PHUSE Technical Director
Anup Patel graduated with a degree in Mathematics & Statistics from De Montfort University in 1996, and has been working in the pharmaceutical industry ever since. He joined GSK in 2001, and is now the Business System Owner of GSK in-house global analysis and reporting system. Prior to joining GSK Anup worked in the Statistical Analysis & Reporting group of Pfizer in Sandwich Kent.
Director, Data Standards & Business Applications
Susan DeHaven is a veteran of SEND standard development and implementation. She and her global team manage administration of software applications used across multiple countries for data collection, analysis, visualization and reporting, along with the associated standards governance and data management for analysis and submission. Most recently, Susan and her team have implemented data systems with tools and repositories for transforming data from sources to SEND and SDTM. Susan is a co-Lead, with FDA partners, of the PhUSE Nonclinical Topics Working Group and the CDISC/FDA SEND for CBER Initiative and is a long time member of the CDISC SEND Core Team. She has represented her opinions about pharma industry perspectives on SEND in various conference panels and has been recognized with a Collaboration Award from FDA and a PhUSE/FDA Working Group Award for Achievement. Susan is based in Bridgewater, New Jersey, USA is an avid equestrian and foxhunter, and lives on a farm in Asbury, New Jersey.