News & Events

Category: Events

Synthetic Data Webinar: How to preserve privacy of participants when sharing clinical data

September 3 at 11AM ET

This 60-minute webinar will explore the emergence of synthetic data, a privacy preservation approach to protect individual patient data. Top experts will explain what synthetic data is, when and how to deploy this approach and share case studies about the successful utilization of using synthetic data and future applications of synthetic data.

RECORDING

Topics include:
• Highlight issues faced by data contributors wishing to share data from rare diseases concerned about privacy issues
• Putting synthetic data in context with other privacy preservation approaches
• Case studies of successful use of synthetic data and how it applies to clinical research

Webinar attendees will have the opportunity to ask questions of the panelists.

Moderators:
Ida Sim and Marcia Levenstein, Vivli

Presenters:
Patrick Cullinan, Bluebird Bio
Khaled El Emam, Replica Analytics
Michael Lesh, Syntegra

RECORDING

Vivli Executive Director to take part in panel at Duke-FDA event on rare diseases and data sharing

Vivli Executive Director, Rebecca Li, will take part in a panel discussion as part of Data Sharing to Accelerate Therapeutic Development for Rare Diseases hosted by Duke and the FDA. Her session will focus on platform analytics tools to support data sharing and drug development for rare diseases.

The Duke-Margolis Center for Health Policy, through a cooperative agreement with the U.S. Food & Drug Administration, is convening a two-day public meeting on August 18th and 19th, to discuss the importance of data sharing for accelerated therapeutic development in rare disease as well as considerations for sustaining and leveraging a robust data sharing infrastructure to support innovative rare disease trial design. The meeting will explore several topics including:

  • The importance of shared data to support innovation and quality in the drug development pipeline for rare diseases
  • Approaches and challenges to ensuring data quality, standardization, and interoperability in shared data resources
  • The role of regulatory agencies in strengthening rare disease data collection and shared data resources

Please see the event page for more details and to register for the event.

Ida Sim to present at NIH webinar for COVID-19 Data Sharing

Vivli’s co-founder Ida Sim to speak at a webinar hosted by the National Library of Medicine (NLM) at the National Institutes of Health (NIH) for researchers to learn how to share, discover, and cite COVID-19 data and code in generalist repositories. Dr. Sim will speak to Vivli’s involvement in supporting discoverability and reusability of COVID-19 data on Friday, April 24th at 2:10 pm ET.

View Dr. Sim’s slides from the presentation.

Webinar: Data Sharing and Data Anonymization–the Vivli-Privacy Analytics Partnership

Join Vivli and Privacy Analytics for a discussion of how both organizations help data contributors to share their data securely and protect patient’s privacy. The webinar will include discussions about the different approaches to anonymization and the value of a risk-based, quantitative anonymization approach. Learn more about how together we are building research communities to advance scientific research and creating trustworthiness through transparency. The webinar will be held on April 2nd at 10 am ET.

Our key topics include:
• Overview of the regulatory landscape
• Importance of data-sharing and secondary-use of data
• The fundamentals of anonymization

RECORDING 

Presenters:
Rebecca Li, Vivli
Niamh McGuinness, Privacy Analytics

Future Directions: Real-World Data (RWD), Real-World Evidence (RWE) and Clinical Trials

VIEW HERE

Join Vivli for a webinar discussing the differences between Real-World Data (RWD) and Real-World Evidence (RWE), and clinical trials. Different types of study designs can help answer different questions and this webinar will explore when these different approaches are deployed. The panelists will provide an overview of the RWD and RWE landscape, the regulatory perspectives and a case study on how RWE and RWD have been used in regulatory submissions. Join us as we explore where RWD and RWE fit in and how we can optimize its role in answering various questions. The webinar will be held on February 20 at 12 pm ET.

Our key topics include:
• The Real-World Evidence and Real-World Data landscape
• What kinds of questions RWE and RWD can help answer
• FDA perspective on the value created by using RWE
• Case Study on using RWD and RWE in a regulatory submission

Presenters:
Ida Sim, Vivli and UCSF
Marcia Levenstein, Vivli
Jack Mardekian, Rutgers University
Gregory Pappas, Food & Drug Administration

Credit for Data Sharing Webinar

Vivli, the Multi-Regional Clinical Trials Center (MRCT Center) and Association of American Medical Colleges (AAMC) present a discussion on methodologies for appropriating credit in data sharing. Dr. Barbara Bierer, MRCT Center Faculty Director, and Heather Pierce, Senior Director of Science Policy for AAMC share how purpose-driven data sharing both enhances scientific discovery and ensures data generators receive credit for their work. The webinar will be held Tuesday, November 12th at 11am EST.

Topics include:
• Methods for leveraging existing initiatives to track, use, and reuse impactful scientific data
• Benefits of purpose-driven data sharing to both public and scientific community
• Recommended policy and practice changes
• Role of journals, funders, and academic institutions

RECORDING

Presenters
Barbara E. Bierer, MD
Faculty Director, the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center)
Co-Founder and Board Member, Vivli
Heather Pierce, JD, MPH
Senior Director – Science Policy, Regulatory Counsel, Scientific Affairs. Association of American Medical Colleges

Vivli Executive Director and Special Advisor presenting at NIH Grand Rounds

Vivli Executive Director Rebecca Li and Frank Rockhold, Vivli Special Advisor and Professor of Bioinformatics at Duke Clinical Research Institution, will present at the NIH Grand Rounds on September 27 from 1-2pm EST on Preparing for Clinical Trial Data Sharing and Re-use: The New Reality for Researchers.

Li discusses datathon outcomes at RWE workshop

Vivli Executive Director Rebecca will present at the Drug Information Association’s (DIA) Future of Evidence Workshop session on Real World Evidence (RWE), Data Sharing and Data Transparency. Dr. Li’s presentation on “Finding New Solutions to Problems and Concerns in Clinical Data Sharing – Outcomes from Datathon” will speak on October 25. The Switzerland based event runs October 24 – October 25, 2019 from 9:00am – 5:30pm. The workshop agenda includes three separate sessions on the important components in maximizing clinical utility, and the role of willingness to share data in this initiative.

Vivli Executive Director to Share Experience with Synthetic Data

Dr. Rebecca Li will discuss how Vivli used synthetic datasets as part of its data challenge with Microsoft on a webinar entitled An Introduction to Synthetic Clinical Trial Data. The webinar will be on October 4 at 11am-12pm EDT and is hosted by Replica Analytics. Sign up to the webinar today to find more about how synthetic data can be used to share clinical trial date while protecting participant privacy.

Register for Vivli’s Annual Meeting on September 18

“Working Together to Transform Data Sharing” 

The Vivli Annual Meeting event will be held at the DoubleTree by Hilton Hotel Bethesda.

The event is free but registration is mandatory, please register as soon as possible as space is limited.

Date: Wednesday, September 18, 2019. 

11:30 – 4:00 pm EST.

Location: DoubleTree Hilton – 8120 Wisconsin Avenue. Bethesda, MD 20814

If you are unable to attend in person, a livestream of the meeting is available. Sign up to attend the meeting virtually.

                                                         Agenda

Welcome remarks

Vivli Update for 2019 and Vision for 2020

Working lunch

Invited Speaker: Informed consent and secondary use of data for data sharing – David Peloquin, Ropes & Gray

Panel Discussion: Challenges of sharing small datasets and rare disease data

  • Patrick Cullinan, Takeda
  • Edith Eby, Pfizer
  • Robyn Himick, Amyloidosis Research Consortium
  • David Peloquin, Ropes & Gray
  • Susan Ward, cTAP

Lightning Rounds–Brief updates from Vivli stakeholders

  • Tianjing Li, Johns Hopkins University – Meta-analysis Utilizing IPD
  • Quan Chen, ImmPort, NIH – Data reuse partner
  • Gaurav Luthria and Qingbo Wang, Harvard University – Vivli Microsoft 2019 Datathon Grand Prize Winners
  • Heather Pierce and Anurupa Dev, Association of American Medical Colleges – Credit for data sharing
  • Pam Miller, New England Journal of Medicine – NEJM Experience with Data-Sharing Statements

Wrap-up and Next steps

Reception to follow.

Space is limited, reserve your seat today by registering.