Historical 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. |
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| Announcement: New Name and Scope for the ET&T Working Group! |
ET&T has changed its name and scope. It will now be called "Emerging Trends and Innovation" (ET&I). Hear from the Working Group Lead Mike Hamidi on why the name and scope has changed for this working group: "The proposed name change from Emerging Trends & Technologies to Emerging Trends & Innovation reflects a broader focus beyond just technological enablement. This shift encompasses not only ongoing developments in areas such as AI/ML, digital health technologies, and healthcare standards but also aims to provide deeper insights into these and other evolving topics. We believe this adjustment will preserve the emphasis on emerging trends while enhancing our commitment to delivering valuable industry insights and innovations." |
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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 and Technology workgroup, and has contributed as a team member to many PHUSE projects including the key performance indicators (KPI) project, 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
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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 Biometrics 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.
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Resources |
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mike.hamidi.standards@gmail.com Mike Hamidi has an MSHS in Clinical Research Administration from George Washington University and an MSc in Information & Knowledge Strategy from Columbia University. He has over 17 years of industry experience in consulting, operations, technology, data sciences, and healthcare standards. Mike’s passion revolves around bridging the healthcare ecosystem regarding clinical care and research. He is actively involved in several initiatives and organizations, including but not limited to:
When Mike is not busy with internal and external duties, he uses the time to continuously learn and increase his knowledge regarding healthcare. He also enjoys relaxing at the beach with his family. | Stuart Malcolm is Head of Standards, Efficiency and Automation at Veramed where his focus is the delivery of a software platform, tools and techniques to optimise the delivery of clinical trial analysis projects. He has a lifelong interest in computing with over 25 years’ experience developing software, including 10 years in clinical trials, and previously in a range of industries including telecommunications, finance and media. Stuart lives in the Scottish Highlands, and outside work he enjoys running in the mountains. |
Mark Bynens is Director and Scientific Computing Operations (SCO) Head within Statistics & Decision Sciences (SDS), Global Development, Johnson & Johnson. In this role, he, together with his team, is responsible and accountable for amongst other: change management, project management and end-to-end management of software applications for statistical evaluation or for business processes, education in-classroom and e-learning, knowledge sharing, software/application acquisition and high-performance computing for intensive data evaluation, simulations, and statistical research. He is one of the main authors of the SCE White Paper and is an R-Consortium ISC member. Fun facts: | |
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