Data security is defined by the processes and mechanisms in place that prevent data misuse and identify threat risks. However, many biological research data sources, from IP to genomic to mobile, require different levels of security. The reality is that it matters not where your data exists, but the ways in which data is accessed. Track 13 addresses security services for both cloud-based systems and traditional computing.

Tuesday, April 5

7:00 am Workshop Registration and Morning Coffee

2:00 – 6:00 Main Conference Registration

5:00 – 7:00 Welcome Reception in the Exhibit Hall with Poster Viewing

Wednesday, April 6

7:00 am Registration Open and Morning Coffee

9:00 Benjamin Franklin Awards and Laureate Presentation

9:30 Best Practices Awards Program

9:45 Coffee Break in the Exhibit Hall with Poster Viewing

BUILDING A SECURE CLOUD

10:50 Chairperson’s Opening Remarks

David LaBrosse, Strategic Partner Manager, NetApp Healthcare

11:00 Building the Bionic Cloud

Michaela Iorga, Ph.D., Senior Security Technical Lead for Cloud Computing; Co-Chair, NIST Cloud Security Working Group; Co-Chair, NIST Cloud Forensic Science Working Group, National Institute of Standards and Technology

When coupling the continuously growing and changing landscape of advance persistent threats with the explosion of “pervasive computing” or “ambient intelligence” founded by the hyperconnectivity of “everyware”, we reach a technical inflection point which calls for innovative solutions to support the further development of a strong, secure backbone of the Internet of Things (IoT) – a bionic cloud.

11:30 Adopting Public Cloud at Enterprise Scale: Public IaaS at AstraZeneca

Don Barber, Infrastructure Architect, Enterprise Computing, IT Infrastructure & Operations, AstraZeneca

Public cloud adoption at scale requires significant rethinking of enterprise systems, processes and culture. This talk outlines how AstraZeneca IT has made this journey to offer public cloud as an enterprise service by tackling challenges with provisioning, management, security and qualification. Subject material will range broadly from technical issues to policy challenges and workforce education needs, concluding with a few predictions about the future.

12:00 pm Sponsored Presentation (Opportunity Available)

12:15 Bringing Data and Computing Together to Enable Research Innovation

Joe Corkery, M.D.,Senior Product Manager, Google Cloud Platform

We will discuss how the vast data storage, sharing, and computing capabilities of Google Cloud Platform have enabled numerous researchers to bring together previously unwieldy data sets to gain novel insights. We will also explore how access to Google's cloud resources enables researchers to revisit traditional approaches to data analysis and pursue new methodologies that would otherwise be out-of-reach in a traditional environment.

12:30 Session Break

12:40 Luncheon Presentation I: Making Cloud R&D Electronic Laboratory Environments a Reality

John Conway, Global Director, Strategy and Technology, Research & Development, LabAnswer

The drivers behind moving to Cloud-based, enterprise class, scientific software applications are substantial, and the trend is rapidly gaining momentum. LabAnswer will showcase examples and discuss the practical considerations of deploying electronic laboratory environments (ELE) via the Cloud, including Electronic Laboratory Notebooks, LIMS, etc. Capabilities and functionality topics to be addressed include Data Governance, Entity Registration, Request/Sample/Inventory Management, and Data Aggregation & Analytics.

1:10 Luncheon Presentation II: Large-Scale Cancer Genomics in the AWS Cloud

Brian O'Connor, Ph.D., Managing Director, Cloud Technologies, Informatics and Bio-Computing, The Ontario Institute for Cancer Research

Angel Pizarro, MSE, Technical Business Development Manager, Scientific Computing, Amazon Web Services

ICGC recently made available the genomes of approximately 1,300 cancer donors as part of the AWS Public Data Sets program. In this presentation, learn how the Ontario Institute of Cancer Research leverages the cloud to process large-scale data sets like ICGC and uniformly analyze 900 TB of data in less than four months.

1:40 Session Break

1:50 Chairperson’s Remarks

Tom Johnson, Senior Director & Product Manager, Pharma and Life Sciences Services, Exostar

1:55 Cloud Computing in a GxP Environment

Krista Woodley, Director, Digital Quality and Risk Management, Biogen

We discuss the regulatory expectations and associated challenges with moving to cloud-based solutions (SaaS, IaaS, PaaS). Discussion points include requirements for vendor oversight, validation and maintenance of cloud-based solutions.

2:25 Case Study: How Merck Is Leveraging Information Security to Enable & Accelerate Clinical Trials

Andrew K. Porter, Director, Enterprise Architecture, IT Planning & Innovation, Merck & Co.

Bringing data, applications and people together for clinical trials takes too long, costs too much and leaves security gaps that threaten intellectual property and regulatory compliance. Merck explains its cloud-based solution to close these gaps and mitigate risks by leveraging entitlements management and fine-grained provisioning to automate partner onboarding, connect required applications and data, assign permissions and control access by authenticating identities.

2:55 Why Would You NOT Use Public Clouds for Your Big Compute Workloads?

Jason Stowe, CEO, Cycle Computing

Up to now there’s been resistance to leveraging the cloud for the compute and data intensive workloads that historically run on in-house HPC environments. But genomics, computational chemistry, and other data collection and analytics have outpaced internal capacity. The lure of zero queue times, unlimited amounts of processing, and the ability to directly fit jobs to budget/value instead to available capacity is proving impossible to resist. This talk will highlight the risks and rewards of doing science in the cloud.

3:25 Refreshment Break in the Exhibit Hall with Poster Viewing

GENOMIC DATA SECURITY AND PRIVACY

4:00 The Next Phase for Healthcare Privacy and Security - Information Governance

Katherine Downing, Director, Practice Excellence, American Health Information Management Association

Security and privacy are of huge importance in business as our organizations continue to be the target of attack. Taking a holistic approach using Information Governance is the next generation for privacy and security. Information Governance is an organization-wide framework for managing information throughout its lifecycle and for supporting the organization’s strategy, operations, regulatory, legal, risk, and environmental requirements.

4:30 Securing Personal Genomic Data: The Potential of the Blockchain

Richard Shute, Ph.D., Consultant, Curlew Research

More people are having their genomes sequenced and letting sequencing companies use their data for research. What if people want to take back control of their own data? How would they confidently and securely manage their most highly personalized information? Blockchain technology (the global ledger behind Bitcoin) could be the answer to securely protecting genomic information and managing transactions associated with personal genomic data.

5:00 FEATURED PRESENTATION: The Role of Cybersecurity Leadership in This New World

Mansur Hasib, D.Sc., CISSP, PMP, CPHIMS, Cybersecurity Professor and Author, University System of Maryland

The world has changed. Technology drives the mission of the bio-IT world today. Yet this world has been the subject of some of the most sensational data breaches and even ransomware. What are we doing wrong? Technology certainly does not appear to be the answer. Yet, organizations appear prepared to dump money on the problem. In a highly interactive session, Dr. Hasib shares his views and analysis on the importance of people, leadership, and culture in cybersecurity.

5:30 – 6:30 Best of Show Awards Reception in the Exhibit Hall with Poster Viewing

Thursday, April 7

7:00 am Registration and Morning Coffee

10:00 Coffee Break in the Exhibit Hall and Poster Competition Winners Announced

PRACTICES AND POLICIES TO PROTECT SENSITIVE DATA

10:30 Chairperson’s Opening Remarks

Dinesh Vandayar, Vice President, Personalized Medicine, SAP SE

10:40 Standardized Security Systems: How They Protect Pharmaceutical Data from Breaches

Mollie Shields-Uehling, President, SAFE-BioPharma Association

Information security breaches are a problem. Globalization and digitization of drug development relies on the Web to share information, exposing patient data and scientific intellectual property to hacks. The session reviews standardized security systems, and their use allowing the secure free flow of information across firewalls among collaborating parties. It includes best practices used by stakeholders such as Merck, GSK and Pfizer.

11:00 Possession is 9/10ths of the Law; Considerations and Evaluations for IT Security Policies

Brian Bissett, Senior Member, Baltimore Section, Institute of Electrical and Electronic Engineers (IEEE)

High-level IT security breaches have made the news numerous times over the past year. Despite the awareness of the risks security breaches pose to organizations, they are still occurring with alarming frequency across all enterprises in both the public and private sector. Is this to become the new norm or has it ushered in a catalyst for change?

11:20 Accessing and Utilizing Public Genomic Data: How Hard Can It Be?

Dianne Pacheco, Information Security Officer, The Jackson Laboratory

Gregg TeHennepe, IT Project Manager, The Jackson Laboratory

The world is awash in Big Data, including large public genomic data sets such as TCGA. Access to these data sets is cited as a high-priority need for research programs; however, the technical and administrative logistics can be daunting. In this talk we will cover the security policies and practices needed to satisfy the data use requirements associated with major public genomic data sets.

11:40 Innovating, Reimaging, and Digitally Transforming Personalized Medicine

David Delaney, Ph.D., CMO, SAP SE

With a flexible platform and advanced analytics, new digital solutions from SAP are uniquely positioned to help advance personalized medicine. The SAP Foundation for Health and applications such as SAP Health Engagement support deeper insights and connect data silos. Bring together your mission-critical structured, unstructured, public private, and experimental health data to provide better patient outcomes.

12:10 pm Session Break

12:20 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:20 Dessert Refreshment Break in the Exhibit Hall with Poster Viewing

BIG DATA: SHARING VS. PRIVACY VS. SECURITY IN HEALTHCARE

1:55 Chairperson’s Remarks

John M. Conley, J.D., Ph.D., William Rand Kenan, Jr. Professor of Law, University of North Carolina, Chapel Hill; Counsel, Robinson Bradshaw & Hinson

2:00 FEATURED PRESENTATION: precisionFDA

Taha A. Kass-Hout, M.D., MS, Chief Health Informatics Officer & Director, Office of Health Informatics, FDA

precisionFDA is an informatics cloud-based platform for ensuring the accuracy of Next-Generation Sequencing (NGS) tests by crowdsourcing reference material and data. A key part of President Obama’s Precision Medicine Initiative, it serves as a collaborative research effort that will inform later regulatory pathways and decision making. During this talk, Dr. Taha Kass-Hout, FDA’s Chief Health Informatics Officer, describes the platform and its successes since the December 2015 beta release. 

2:30 FEATURED PRESENTATION: How the Plecosystem, Blockchain, and Federated Data Enclaves will Shape Genomics Innovation and Application: Emerging Initiatives from the Global Alliance for Genomics and Health

John E. Mattison, M.D., Chief Medical Information Officer, Assistant Medical Director, Southern California Medical Group, Kaiser Permanente; Co-Chair, eHealth Workgroup, Global Alliance for Genomics and Health GA4GH

How can we maximize genomic research for the good of all citizens without violating their privacy? We need powerful new approaches to ensure ethical research without unwarranted risk to citizens who consent to use of personal data. The Global Alliance for Genomics and Health includes worldwide institutions seeking consensus on policy frameworks supported by creative technical solutions to achieve these paired goals of higher value and lower risk. I discuss progress to date.

3:00 FEATURED PRESENTATION: Large-Scale Data Commons for Genomic and Clinical Data and the Changing Landscape for Sharing Research Data

Robert Grossman, Ph.D., Director, Center for Data Intensive Science (CDIS); Core Faculty, Institute for Genomics & Systems Biology and Computation Institute, Professor of Medicine, Section of Genetic Medicine, University of Chicago

Open commons containing large amounts of public biomedical data from the research community can potentially dramatically speed up medical research. We describe our experiences developing large-scale open source data commons for genomic and associated clinical data. We also discuss options for integrating and interoperating in-house genomic and clinical data with public data commons and private data partnerships.

3:30 PANEL DISCUSSION: How Will Data Sharing Innovations Fare in the Regulatory Environment?

Moderator: John M. Conley, J.D., Ph.D., William Rand Kenan, Jr. Professor of Law, University of North Carolina, Chapel Hill; Counsel, Robinson Bradshaw & Hinson

Panelists:

Robert Grossman, Ph.D., University of Chicago

Taha A. Kass-Hout, M.D., MS, FDA

John E. Mattison, M.D., Kaiser Permanente

Andrew K. Porter, Merck & Co.

Mollie Shields-Uehling, SAFE-BioPharma Association

The growth in patient healthcare and life sciences innovations can be attributed to technology enhancements like cloud computing, big data analytics and mobile applications, but may conflict with increasing regulatory compliance demands to ensure protection of healthcare life and quality as well as patient data privacy and security. This panel of esteemed technology solution providers and regulators debates real-world challenges and how regulation must also innovate at technology’s pace.

4:00 Conference Adjourns