News & Events

Category: Events

Vivli webinar: Recent Developments in Data Privacy Laws and their Impact on Data Sharing

Vivli held a webinar to discuss recent developments in data privacy laws and their impact on data sharing.

The webinar was held on Monday, April 24th at 3pm CEST / 2pm BST / 9am EDT.

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The People’s Republic of China (PRC) enacted a comprehensive data privacy law called the Personal Information Protection Law (PIPL) in November 2021. This law adds to an already complex data privacy framework in the PRC, which also includes the Regulation of Human Genetic Resources, the Biosecurity Law of the PRC and the Data Security Law of the PRC. This webinar will focus on key implications of the PIPL and these other PRC laws for the sharing of clinical trials data generated in the PRC for further research purposes. The speakers will also make comparisons between PIPL and the European Union’s General Data Protection Regulation (“GDPR”), another global privacy law that has had a significant impact on the sharing of clinical trial data.

Learning objectives for this session include:
• Understand the basics of PIPL
• Understand how PIPL affects sharing of clinical trials data across international borders
• Understand key differences between PIPL and GDPR

Speakers:
• Rebecca Li, Vivli
• David Peloquin, Ropes & Gray
• Katherine Wang, Ropes & Gray

This webinar is intended for organizations and individuals that share data and will be particularly useful for those who focus on data privacy.

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Vivli Executive Director Dr. Rebecca Li Speaking at NIA-DUKE-Alzheimer’s Association Workshop

Rebecca Li will be speaking at the NIA-DUKE-Alzheimer’s Association Workshop held on March 15-16th sponsored by the National Institute on Aging.

The focus of the talk by Rebecca Li and Katherine Welsh-Bohmer (Duke University School of Medicine) is on how the Vivli platform can be used to access trials in Alzheimer’s Disease. Dr. Welsh-Bohmer will discuss the TOMMORROW trial – a large prevention study in Alzheimer’s Disease – as a specific use case.

Submitting Your NIH Data Management and Sharing Plan using Vivli

The NIH Data Management and Sharing (DMS) policy went into effect in January 2023 to promote the sharing of scientific data.

Please watch Vivli’s recent webinar and find out more about how Vivli can help you navigate the NIH Data Management and Sharing policy. Hear from academic staff on their experiences in supporting researchers with their Data Management and Sharing Plans (DMSP).

During this webinar, we:

  • Provide an overview of Vivli, including what types of data should be shared in Vivli
  • Discuss the benefits of using Vivli to meet the data sharing requirements of your NIH grant
  • Review the steps to completing the NIH DMSP and budget justification
  • Hear views from academic staff on their experiences supporting researchers to complete the new NIH DMSP

Speakers include:

  • Anne Seymour, Johns Hopkins University
  • Amy Nurnberger, Massachusetts Institute of Technology
  • John Borghi, Stanford University
  • Rebecca Li and Julie Wood, Vivli

Participants had the opportunity to ask questions. This webinar is most useful for current or prospective NIH grantees or those who support them.

View Recording

Vivli Executive Director Rebecca Li to Speak at AI-Enhanced Clinical Trials Summit in Boston

Vivli’s Executive Director, Rebecca Li, will speak at the AI-Enhanced Clinical Trials Summit in Boston on December 8th for “Unlocking Sensitive Healthcare Data To Optimize Clinical Trials And Encouraging Clinical Research Data Sharing.” Highlights will include the ethical and practical challenges of accessing patient data and how best to overcome shared challenges.

With drug development costs rapidly increasing, decision makers are right to be turning to novel AI/ML technologies to optimize clinical trial processes and de-risk drug development pipelines. Looking from both a patient-engagement and internal-process perspective, the AI-Enhanced Clinical Trials Summit takes a closer look at how available and scalable AI technologies are accelerating and improving clinical trials.

Learn more here.

Vivli webinar: “Applying the SAFE Data Standard to Securely Share Clinical Trial Data”

Vivli hosted a webinar to discuss applications of the SAFE Data Standard as defined in “Sharing Anonymized and Functionally Effective (SAFE) Data Standard for Safely Sharing Rich Clinical Trial Data.”

The webinar was held on November 29th, 4pm CET/10am EST/7am PST.

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This one-hour webinar features authors of the recently published paper “Sharing Anonymized and Functionally Effective (SAFE) Data Standard for Safely Sharing Rich Clinical Trial Data,” presenting how data transformation is measured as part of the SAFE Data Standard and how to apply the SAFE Data Standard in different security contexts. This webinar is intended to help sponsors understand how to use the SAFE Data Standard to securely share rich clinical trial data to preserve data utility and for users of data to understand how accessing data in different contexts may change the utility of the data being provided.

Read the paper here!

Speakers include:
Luk Arbuckle, Chief Methodologist, Privacy Analytics (an IQVIA company)
Stephen Bamford, Head of Clinical Data Standards & Transparency, Janssen Research and Development
Aaron Mann, CEO, Clinical Research Data Sharing Alliance

Moderated by:
Marcia Levenstein, Senior Advisor, Vivli

 

View the Recording of Vivli’s 2022 Annual Meeting

“Enabling the Data Sharing Ecosystem”

Vivli’s 2022 Annual Meeting was held on Wednesday, November 2nd, 2022, 9:00am – 12:00pm EST / 2:00  – 5:00pm CET / 10:00pm – 1:00am JST. This meeting served as a chance to allow Vivli data contributors, key collaborators and funders to discuss data sharing and its importance for furthering scientific discoveries.

View the Recording

Agenda

Welcome remarks
Vivli Update for 2022, Rebecca Li, Executive Director, Vivli

Sharing COVID-19 Clinical Trial Data on Vivli
Reflecting on best practices and current experience

  • Julie Holtzople, Senior Director Clinical Transparency and Data Sharing, AstraZeneca
  • Steve Kern, Interim CEO, Global Health Labs
  • Ben Rotz, Associate Vice President – Global Medical Policy Strategy and Operations, Lilly
  • David Leventhal, Enterprise Clinical Trial Data Sharing Lead, Pfizer
  • Rebecca Sudlow, Global Lead Patient Level Data Sharing, Roche

Q&A

NIH Data Sharing Policy Changes in 2023

  • Dr. Susan Gregurick, Associate Director for Data Science and Director of the Office of Data Science Strategy (ODSS), NIH

Q&A

Data Challenges
Spotlighting data challenges Vivli is embarking on with key partners in 2022-2023

  • Deniz Dalton, Program Officer, The Leona M. and Harry B. Helmsley Charitable Trust, presenting “Moving Type 1 Diabetes and Exercise Data to Solutions”
  • Tetsuyuki Maruyama, Executive Director, Alzheimer’s Disease Data Initiative (ADDI), presenting “ADDI/Vivli Data Challenge in Alzheimer’s Disease”

Next Steps and Discussion

Vivli Program Manager Catherine D’Arcy Speaks at DIA Global Clinical Trial Disclosure & Transparency Conference

Vivli’s Program Manager, Catherine D’Arcy, spoke at DIA Global Clinical Trial Disclosure & Transparency Conference on October 18th in Amsterdam, presenting “Clinical Research Data Use: Insights From Vivli’s Experience Of Data Sharing.” More than 140 delegates attended from 16 countries.

The 2022 Global Clinical Trial Disclosure and Data Transparency Conference builds on prior successful conferences to leverage learnings from regulators and international experts in the field. This event will provide essential, timely information about global clinical trial disclosure, data transparency, data sharing for secondary research, and the EU Clinical Trial Information System (CTIS) with the focus on transparency in relation to the protection of personal data and commercially confidential information. It brings leading study sponsors from industry and academia together with regulators and other players to exchange knowledge and share their experiences with the implementation of Clinical Trial Disclosure and Data Transparency from various viewpoints.

Vivli Senior Director Julie Wood Speaks at 19th Annual DIA Japan Annual Meeting 2022

Vivli’s Senior Director, Julie Wood, spoke at the 19th Annual DIA Japan Annual Meeting in Tokyo, Japan on October 11th for “Implementing Data Sharing in a Time of Pandemic.” The panel also included chair Azusa Tsukida, senior advisor to Vivli, and Dr. Oladayo Oyelola, Senior Director of Clinical Trial Information Disclosure at Daiichi Sankyo, Inc.

The theme of the 19th DIA Japan Annual Meeting is “New ‘Quest for the future’- Moving Creativity and Innovation Forward in ‘New Normal.’” Now that the world has experienced COVID-19, all will explore the future in a new normal environment. COVID-19 has brought about dramatic changes in our lives and activities. While face-to-face work declined dramatically, digital transformation accelerated quickly. This also promoted extremely rapid development of vaccines and therapeutic agents, as well as new clinical trial models including telemedicine. In addition, the importance of self-care associated with refraining from visiting medical institutions and the importance of addressing the issue of infodemics were reaffirmed.

Vivli webinar with CRDSA: “Mind the Data Sharing Gap: Navigating sponsor policies and data protection methodologies.”

Vivli hosted CRDSA to explore findings of their newly published whitepaper, “A Review of BioPharma Sponsor Data Sharing Policies and Protection Methodologies.”

The webinar was held on October 6th, 11am EDT/8am PDT/5pm CEST.

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This one-hour webinar featured the authors from the CRDSA’s new white paper “A Review of BioPharma Sponsor Data Sharing Policies and Protection Methodologies” in a lively a moderated discussion with CRDSA’s CEO, Aaron Mann. This webinar explored findings from the white paper that examines sponsor’s data sharing policies and protection methodologies as well as reflections on actionable steps for sponsors and secondary analysis researchers alike.

  • For Researchers: Understand the policy and privacy elements that can impact research utility
  • For Data Contributors: Identify meaningful benchmarks to help guide policy development

Read the whitepaper here!

Speakers include:
Luk Arbuckle, Chief Methodologist, Privacy Analytics (an IQVIA company)
Liz Roberts, Senior Director, Data Policy and Privacy Lead, UCB

Moderated by:
Aaron Mann, CRDSA CEO

 

Vivli Executive Director Dr. Rebecca Li Speaking at 2022 Biomedical Transparency Summit

Vivli’s Executive Director, Dr. Rebecca Li, will be speaking at the Center for Biomedical Research Transparency’s 2022 Biomedical Transparency Summit on September 7th for “NIH Data Sharing Policy  – What you need to know!” Dr. Li will speak alongside NIH’s Active Director of the Office of Science Policy, Dr. Lyric Jorgenson and NIH’s Associate Director for Data Science, Dr. Susan K. Gregurick.

Dr. Li will be speaking at the Wednesday, September 7, session. Register today.

The 2022 Biomedical Transparency Summit is a virtual program of 2 webinars that brings together leaders in publishing, private and publicly funded research, policymakers and technology to share the latest transparency developments impacting research practice.

Webinar 1 will take place Wednesday, September 7 at 3pm EDT/NY, 8pm BST/London. Webinar 2 will take place Wednesday, September 14 at 3pm EDT/NY, 8pm BST/London. Attendees can expect to hear thought-provoking presentations, panel discussions and Q&A sessions around each of the day’s topics. Learn more information here.