Working Group Scope
New challenges in regulatory science and drug, biologic, and device development provide new opportunities for recognising and leveraging new or emerging technologies and computational tools or under utilised existing technologies. Initiated at the 2013 PHUSE Annual CSS, the Emerging Trends & Technologies Working Group provides a forum for determining interest in specific computational science topics, tools, technologies, and approaches.
This Emerging Trends & Technologies Working Group will be an open, transparent forum for sharing pre-competitive means of applying new technologies and is being challenged with creation of well-defined collaborative projects that will describe, prioritise, assess, and assist advancement of these opportunities. Possible topics include (but are not limited to) semantic web applications, analysis metadata, modeling, simulation, and “The Cloud”. Projects incorporating these topics might include prioritisation, development, and piloting for feasibility and value.
Andy Richardson: Working Group Lead
A pharmacologist by training, Andy has worked in the pharmaceutical and CRO sectors in both senior management and consultant roles for 30 years. Based in the UK, his principal interests are in the areas of clinical data standards and clinical trial operational efficiency, with particular emphasis on data management, statistical programming, computer systems validation and systems implementation.
He is an active member of PHUSE and Co-leads the Emerging Trends & Technologies Working Group, and has contributed as a team member to many PHUSE projects, including the Key Performance Indicators (KPI), the Real-World Evidence and FHIR projects. He is also a member of the British Pharmacology Society, the ACDM, the RQA, and presents regularly at PHUSE conferences and SDEs.
Dhananjay Chhatre: Working Group Lead
DJ has over 13 years of experience in the healthcare industry, including the last 5 years with Gilead Sciences as a Director. He currently leads planning and implementation of a new development Project Management Office (PMO) overseeing departmental projects and development-wide strategic initiatives. DJ also supports Biometric projects, ranging from process improvement to tool development to systems updates, and also oversees a team of project managers with similar functions. Previously, he led a team of 10 tasked with end-to-end data standards development, implementation and governance.
He previously worked at FDA/CDER as a Study Data and CDISC Data Standards SME, as well as Project Manager. He has also represented CDER on multiple FDA-internal Working Groups tasked with drafting/updating guidance or technical specification documents to improve regulatory data submissions, and FDA data management processes. He has been active in PHUSE and CDISC, serving as Working Group and Project Lead, a member of annual conference planning committees, and steering committees.