Speaker Lineup.
Al Pacheco
Al Pacheco is a seasoned pharmaceutical and biotech professional with a proven track record in project management and strategic implementation. He is deeply committed to driving transformation and operational excellence in the delivery of life-
Amanda Langel
With over two decades of experience spanning biotech, CROs, medical devices, and big pharma, Amanda Langel is a recognised leader in clinical data strategy and innovation. As Co-Founder of Better Clinical Trial (BCT)...
Antonia Witten
Antonia Witten is the Customer Delivery Manager here at Arkivum. Antonia has built a successful track record of onboarding clients into the solution through the use of structured onboarding sessions and helping customers...
Ashley Avery
Ashley Avery is a Senior Specialist, Quality Documents and Archival at a global biopharmaceutical company. She sits on the HSRAA Operations Committee as the Training Coordinator and the ARMA Kansas City Chapter Engagement Director...
Bob Thompson
Bob is a GxP Archivist and has an Archives and Records Management Post Graduate Diploma from Dundee University. Bob has a background in programming and database administration, as well as knowledge and understanding of Computer Systems Validation.
Cornelia Baumgartner
Cornelia founded Cetacea Clinical GmbH in 2022 to support biotech start-ups as they launch their first clinical trials. With over two decades of experience in clinical operations, her mission is to guide companies through the complex landscape of trial planning, execution, and regulatory compliance...
Dawn Niccum
Dawn Niccum heads Quality Assurance at the inSeption Group. She is an expert in the development, management, and implementation of clinical trial systems including the TMF. Dawn is a Steering Committee Member for the CDISC TMF Reference Model, Chair of the Educational Governance Committee, and is a Steering Committee Liaison for the ISF Reference Model initiative.
James Baker
Professor James Baker is Director of Digital Humanities at the University of Southampton and academic lead of Digital Preservation Southampton. A historian by training, he works at the intersection of history, cultural heritage, and digital technologies. James is a Software Sustainability Institute Fellow, a Trustee of the Programming Historian, and a founding member of the Digital Humanities Climate Coalition.
Jamie Toth
Jamie Toth is Global Head, Trial Master File Management & Records at BeOne Medicines USA Inc (formerly BeiGene USA Inc.), home based in New Jersey, USA.
Jamie is a Steering Committee member for the CDISC TMF Reference Model Working Group and the Incoming Chair Elect. She is on the Board of Directors for the Health Sciences Records and Archives Association (HSRAA) and on the Board of Directors for the Association for GxP Excellence (AGxPE). Read more.
Jean Maxime Pommery
Jean-Maxime Pommery began his career as an IT engineer in the pharmaceutical industry in 1999. Since joining Actelion-Idorsia in 2008, he has had the opportunity to broaden his knowledge by working with regulated GxP computerised systems.
Jenny Mitcham
Jenny Mitcham is Chief Digital Preservation Officer at the Digital Preservation Coalition. She works closely with the members of the Coalition on their digital preservation challenges, as well as facilitating good practice in digital preservation by organising events and...
Kaan Volkan
Kaan Volkan has read over 20,000 technical pages on IG technologies and helped numerous organisations clean up file shares. Now, he focuses on sharing his findings to help more organisations overcome data challenges. His unique take on technology and vendors combined with his brief engaging style makes for some of the most entertaining and educational webinars.
Karen Roy
Karen Roy was jointly responsible for the development of the CDISC TMF Reference Model, an industry driven initiative to standardize the content, naming and structure of Trial Master Files. She chairs the management of the Model and is currently working for CDISC supporting the transition of the Model to becoming a CDISC Standard.
Kateryna Oliinyk
Kateryna has worked in Clinical Development and Research since 2008, with experience spanning both CROs and sponsor organizations. Her background includes Development, Project Management, TMF Leadership, and in-house CRA roles.
Katherine Chorley
Katherine is an Archivist with over 10 years’ experience working in business archives. She has a keen interest in digital preservation and experience working with a variety of digital collections and solutions in the heritage sector. As part of her current role at The Macallan, Katherine leads...
Laurisa Sastoque
Laurisa Sastoque is the Digital Preservation Training Officer at Digital Preservation Southampton. In her role, she works to develop training and strategic guidance to inform partnerships in the digital cultural heritage sector. Her background is in Digital Humanities and History.
Martin Kunze
Martin is a Founder and Marketing lead at Cerabyte. He is a silicate technologist, long-term information storage pundit and visionary inventor. He is the inventor of modern ceramic data carriers, drawing from his expertise in silicate technology.
Matthew Addis
Matthew is the co-founder and CTO of Arkivum. Over the last fifteen years, Matthew has worked with a wide range of organisations in the UK, Europe and US on solving the challenges of long-term data retention and access.
Roberta Svanetti
Roberta Svanetti has a degree in Information Science from the Università degli Studi of Milan, Italy. For over 20 years, expert of Life Sciences Industry and R&D Information management including data curation, valorization and archiving and digital preservation...
Sandra Blake
Sandra Blake is the Corporate Records Manager at Barts Health NHS Trust and has managed the long-term storage of research records since 2018. She is responsible for ensuring Trust records are managed according to legislation, national guidelines, and Trust policy.
Sarah Hitching
Hedian Records Management (HRM) was set up in 2018 by Sarah Hitching after many years in clinical research. Sarah is a member of Clinical Data Interchange Standards Consortium (CDISC) which manages the TMF Reference Model, and the Health Science Records Archiving Association (HSRAA).
Sarah Middleton
Sarah is a marketing and communications professional and the Chief Community Officer for the Digital Preservation Coalition (DPC). She started work at the DPC in 2013 as part of the 4C Project (Collaboration to Clarify the Cost of Curation) and is now responsible for...
Suzanne Turner
Suzanne Turner is a Trial Master File (TMF) Consultant and expert who’s spent over a decade helping sponsors maintain inspection readiness and strengthen their TMF processes. She’s worked across CROs and sponsors, managing everything from paper TMFs to full eTMF transitions...
Tony Hewer
Tony Hewer has an IT career of over 35 years with the past 20+ years in the life sciences sector.
After his BSc and PhD in astrophysics at University College London, Tony moved into software engineering and various IT management roles with business areas including the travel industry and wholesale financial services front office systems....
Lauren Alani
Lauren Alani is the Director Digital Innovation at Seuss+, where she bridges emerging technologies with clinical development strategies to help biotech and pharmaceutical sponsors strengthen compliance, data integrity, and operational efficiency.
Julia Bonder-Le Berre
Julia Bonder-Le Berre is a Legal Counsel and Head of Global Privacy at Iron Mountain. Before that, Julia was Global Privacy Counsel at Hewlett-Packard Enterprise, Senior Privacy Counsel at MasterCard and Senior Associate at Baker&McKenzie.
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