This year, Lead positions became available within two of the PHUSE Working Groups: Data Transparency and Emerging Trends & Technologies. We are very pleased to introduce you to the new Working Groups Leads, who have taken on these vital roles. Their breadth of valuable experience will be a great asset to the team.
You can find out more about our new Working Groups Leads below and what they are most looking forward to in their new roles. We look forward to their contributions within PHUSE.
Data Transparency
Devaki Thavarajah partners with pharmaceutical clients and members of the research and healthcare community globally, to help meet their clinical trial transparency and disclosure requirements. She has eight years’ experience within the pharmaceutical and healthcare industry.
Devaki’s journey in the transparency and disclosure space first began in 2016 at Eisai, where she led the first three EMA Policy 0070 submissions, the coordination of activities for plain language summary development, the release of patient-level data to qualified external researchers, and new and upcoming health authority requirements. She also had exposure to governmental sector data sharing in identifying and implementing process improvements during the critical transitionary period of organisational change for the UK’s public health reform initiative. Devaki has an understanding of multiple areas in the pharmaceutical and healthcare industry through her previous roles, including medical information and drug safety.
As part of the response to the global pandemic, Devaki contributed to the transparency project for one of the leading COVID-19 vaccines to receive approval, providing guidance to the marketing authorisation holder on the operational elements for the EMA and Health Canada’s request for publication of the full clinical data used to support their authorisations of this vaccine.
“Over the years, having met so many inspirational people within the field of Data Transparency who helped me to learn and grow, I wanted to give back to our community and joined PHUSE in January 2021 which has been an incredible experience being part of a welcoming and thoughtful industry platform whereby ideas no matter how big or small are always valued. I look forward to continuing to work with the team in my new role and serving our community across the industry, building upon the great work already accomplished by PHUSE in delivering high-quality project outcomes, bridge the gap and increase outreach across different sectors for us to continue creating a diverse discussion.”
Muhammed Oneeb Rehman Mian is a Senior Manager of Privacy and Data Enablement for the Clinical Trials Transparency (CTT) business stream at Privacy Analytics. He provides technical leadership and subject-matter expertise for privacy methodology and solutions. Muhammad has over four years of experience developing scalable risk-based anonymisation technologies for clinical trial data, evolving privacy threat modelling and identifiability metrics, and exploring solutions to practical challenges faced in the field of privacy and data protection engineering. Previously, Muhammad worked in biomedical research, applying statistics and big data analytics to solve novel problems. Muhammad draws from his prior experience in medical research to enable privacy programmes that ensure data are useful and accurate.
"Advancing the objectives of Data Transparency initiatives at scale require strong collaboration and dedicated focus, given the varying regulatory landscape globally. I am very much looking forward to engaging with my fellow data transparency experts to produce outcomes that are applicable and relevant to real-world use cases, in a manner that will facilitate greater adoption."
Find out more about the Data Transparency Working Group here.
Emerging Trends & Technologies
Mike Hamidi is a Director, Data Standards Strategy Lead at Pfizer. Mike’s work involves Pfizer’s global initiatives involving eSource, governance, technology, regulatory intelligence and data standards. He has an MSHS in Clinical Research Administration from George Washington University and an MSc in Information and Knowledge Strategy from Columbia University.
“I am most looking forward to supporting future innovation through a collaborative knowledge-sharing network.”
Stuart Malcolm is Head of Standards, Efficiency and Automation at Veramed, where his focus is the delivery of a software platform, tools and techniques for optimising the delivery of clinical trial analysis projects. He has a lifelong interest in computing, with over 25 years’ experience developing software.
"I believe the Emerging Trends & Technologies Working Group can play a key role in helping to ‘de-risk the future’ through projects that help us to understand what is on our technology roadmap and make it easier to prioritise, pilot and adopt new technologies and techniques. I have a particular interest in standards-based metadata-driven automation, and so also hope to be able to indulge that passion as one of the Working Groups Leads!”
Find out more about the Emerging Trends & Technologies Working Group here.
Do You Want to Get Involved with the PHUSE Working Groups?
Participation to the PHUSE Working Groups is open to anyone who wants to contribute and there are several ways in which you can get involved.
Our Hot Topics page has all the latest information for each of our Working Groups and Working Groups related events. Fast approaching is the PHUSE/FDA Computational Science Symposium 2022, where you can hear from presenters across industry, academia and health authorities. Involvement in the PHUSE Working Groups gives you the opportunity to either attend or present at our events.
With multiple active Working Groups covering key industry topics, our projects are always seeking new members. Be sure to check out our Volunteers Board or, if you would like to join a project, please contact workinggroups@phuse.global.
