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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.

Current Projects

Cloud Adoption in the Life Sciences Industry

Digital Biomarkers in Clinical Submissions

Investigating the Use of FHIR in Clinical Research

Real World Evidence

Best Data Practices for Rare Disease Patient Foundations and Researchers

Resources

Click here to search for all Emerging Trends & Technologies deliverables, past projects are housed under the archived section. 

Mike Hamidi: Working Group Lead 

Kamiar.Hamidi@pfizer.com

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 & 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:

  • PHUSE Emerging Trends & Technologies and Optimizing the Use of Data Standards volunteer;
  • CDISC Submission Data Standards (SDS) and Operational Data Model (ODM) volunteer;
  • CDISC Advisory Council (CAC) member;
  • OHDSI OMOP Clinical Trials Working Group co-lead;
  • HL7 Biomedical Research & Regulation (BR&R) member;
  • HL7 Vulcan Operations Committee co-chair;
  • TransCelerate member

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: Working Group Lead 

stuart.malcolm@veramed.co.uk

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.

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