1. 1st BSMA/MassBIO Conference Boston Marriott Cambridge, MA April 26
 “Driving Innovation in the global bio-pharma supply chain”
3:00-3:30 Panel:
Benefits and Best Practices for GxP Data Management in the Cloud
The ascension of the patient-centric supply chain, omni-channel e- commerce, mobile computing, and big data analytics promise significant business benefits; however, they rely more and more on an enterprise level approach to providing a single point of access and control and for your GxP-critical data. The strategic opportunity, best practices, technical roadmap and validation considerations of a cloud transformation of GxP data will be discussed on this panel.
Panel Moderator: Todd Hein Sr. Director – Oracle Life Sciences
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2. Panelist:
Chandra Pandey, Supply Chain / ERP Thought Leader at Biogen Idec
Chandra is Supply Chain / ERP Thought Leader for Biogen and has been playing a key role in Supply Chain Transformation and ERP Roadmap at Biogen. He has over 20 years of experience in supply chain, & Manufacturing across various industries. He also brings in more than 15 years of experience managing sales, global engagements and solution engineering with focus in the area of Oracle ERP & Supply Chain. He has worked with several global organizations in the past to assist them in their supply chain transformations especially in the area of Global Supply Chain Planning and S & OP. He holds a Bachelor of Technology in Mechanical Engineering from IIT Bombay.
Sophia Hannay, Associate Director, Global Supply Master Data at Celgene Corporation  
Sophia has spent the last 10 plus years centralizing product master data for both the medical device and now pharma industry. She has overcome organizational challenges, regulatory requirements, disparate ERP/PLM systems, and has established data governance capabilities and processes across divisions and enterprise levels. In her current role, she is introducing the value of Data Governance and establishing an enterprise data council for the product domain as well as strategizing a roadmap for a hub implementation for the Corporation.
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3. Panelist: Joe McGrath MVP, Information Technologies -SAGE Therapeutics
Joe has been in leader in Life Sciences IT for almost 30 years, and joins us from SAGE Therapeutics, where he is the Vice President of IT. Prior to SAGE, Joe was VP of IT and CIO for FORUM Pharmaceuticals, a position he took in after a year of life-science consulting, and 19 years as Sr. VP of IT at Sunovion (nee Sepracor) Pharmaceuticals.
John Danese, Senior Director – Life Sciences at KPIT
John’s experience spans over 25 years working with global companies, bringing new digital products and services to market to address the needs of the life sciences industry segments. He's held various leadership roles in consulting, product development, strategy and sales.  As Senior Director of Life Sciences in KPIT's Industry Business Unit, he remains dedicated to interpreting the needs of and defining KPIT’s strategic solution direction for the life science industries.
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4. Panel Discussion Outline:
What is the perceived value and strategy of cloud software at your company?
What is your cloud roadmap considerations – ie what is your initiation point use case?
How is your organization transforming to manage the higher frequency of SaaS upgrades, and on-going validation compliance
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5. “Cloud Strategy & Governance is an outsourcing model”
Panel Discussion Outline:
 1 What is the perceived value and strategy of cloud software at your company?
Speed of deployment, scale & elasticity of SaaS
Enable mobile/connected use model
Leverage current S/W release
Provides big data analytics
“Cloud Strategy & Governance is an outsourcing model”
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6. Leveraging the CMC eco-system in the cloud
Panel Discussion Outline: 2 What is your cloud roadmap considerations – ie what is your initiation point use case and what is the impact on existing on- premise S/W (ie hybrid model)?
Life Science Use-Cases in PLM
CMC (Chemical-Mfg-Control) mgmt
DHF & DMR content & Mgmt
CMO/CRO Collaboration & management
Tech Transfer
UDI/IDMP submittals and attribute mgmt
Clinical Trial Inventory Mgmt
Variation/Jurisdiction mgmt
Leveraging the CMC eco-system in the cloud
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7. Panel Discussion Outline: 3 How is your organization transforming to manage the higher frequency of SaaS upgrades, and on-going validation compliance (ie best practice of establishing a vendor/IT- Partner/Q-A/Business user team)?
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8. Call to action:
BSMA will be establishing a Steering Committee to define upgrade management and validation best practices for cloud software. If you are interested in participating please contact me at
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