PHUSE

The APAC SDE in Hyderabad, India has achieved a monumental milestone! We are proud to share that this event, which will be taking place on 8 June, has reached the highest number of sponsors EVER for a Single Day Event – an astounding 27 sponsors! “In the spirit of collaboration and progress, we extend our deepest gratitude to all the sponsors for your commitment to bringing together the brightest minds in the healthcare data science community, to foster an environment where ideas flourish, tools are shared and learning is accelerated. Together, we are not just expediting clinical trials; we are revolutionising the journey of bringing life-saving medicines to patients at unprecedented speed. Thank you for being an integral part of this transformative endeavour.” – Ravichandra Venkata B & Anuradha Tirumalaraju, SDE Chairs  A big thank you to our sponsors: SDE Host: Bristol Myers Squibb Gold Sponsors: AstraZeneca, Johnson & Johnson, SAS Silver Sponsors: Algorics, Clinvia, Inductive Quotient Analytics, K3-Innovations, Inc., Navitas Life Sciences, Saama Bronze Sponsors: Bayer, Clinovo, Cognizant, Cytel, Endpoint Data Analytics Pvt. Ltd., Ephicacy, Hexaware Technologies, INLINE CONSULTANTS, Novartis, Phastar, PPD, princeps technologies , SENSAN BIOSCIENCES, SCL IT TECHNOLOGIES PVT LTD, Symbiance, VAICS Consulting, Veranex Biocompatibility Your support is the driving force to delivering successful and impactful SDEs. #PHUSE | Sarvesh Singh, Shrishaila Patil K, Mamta G.

What do our attendees love about PHUSE Connects? Find out in our blog! From diverse networking opportunities to high-quality content, discover why PHUSE Connects are a must-attend for industry individuals worldwide. In addition to testimonials, highlights and achievements since 2022, the blog also recognises the invaluable contributions of first-time attendees, whose fresh insights and enthusiasm infuse new energy into the PHUSE community. Read Now: https://lnkd.in/evmdM5mK Join us at the upcoming Connects: EU Connect 2024 | 10–13 November | Strasbourg, France Register Now: https://lnkd.in/eptASh_V Early Bird registration closes on 19 July! US Connect 2025 | 16–19 March | Orlando, Florida Call for Papers and Registration will open on 1 July! #PHUSE

Live from the PHUSE Utrecht Single Day Event! Attendees are having a brilliant time so far, enjoying a line up of presentations on the theme of 'AI and ML in Life Sciences and Healthcare: Enhancing Clinical Research & Data Analysis'. PHUSE would like to give a huge thank you to all our presenters, attendees and sponsors. #PHUSE | Jules van der Zalm Paul Vervuren

Join PHUSE's new Working Group Project! Under the Real World Evidence Working Group, we have a new project 'Estimands for RWD/RWE' which is calling for volunteers. The focus of this project is on best practices of RWD Estimands, not on their implementation using data standards. Email [email protected] by the closing date of 14 June to seize this opportunity. Find Out More: https://lnkd.in/gPWnM6_q #PHUSE

The EU Connect 2024 has broken PHUSE's record for abstract submissions for Call for Papers! We closed on an outstanding 435 submissions, so the Connect Stream Chairs had a lot to run through in last weeks Paper Review Meeting – which ran for 7 hours. Attendees are in store for some truly insightful presentations that include though-provoking topics. So, if you haven't already, register your place now and do so before the Early Bird discount closes on 19 July. Find Out More: https://lnkd.in/eptYgWXS Register Now: https://lnkd.in/eptASh_V #PHUSE

An exciting opportunity awaits those passionate about data transparency… Call for Speakers is open for the Data Transparency Autumn Event, taking place 17–19 September. Now is your chance to share your knowledge and ideas with the PHUSE Community! Your contributions are instrumental in helping shape the conversation around data transparency in our ever-evolving industry. For your chance to become an esteemed speaker, all you need to do is submit a 150-word abstract by 14 June. In need of some inspiration? Explore a list of curated topics from the PHUSE Data Transparency Leads: https://lnkd.in/eyjAWS4H Submit Abstract: https://lnkd.in/e2Yw5sy9 #PHUSE

Are you based in Ontario, Canada? Then we may have your next presenting opportunity! The PHUSE Mississauga Single Day Event, taking place on 13 September is calling for speakers. In the rapidly evolving statistical programming landscape, the tools and technologies we adopt today will shape the future of data analysis in the pharmaceutical industry. Therefore, this event will be based on the theme 'Coding the Future: Tomorrow’s Statistical Programming Toolset'. Which will explore emerging tools that can help us streamline and automate workflows, enhance reproducibility and support the complex demands of drug development. Submit your 150-word abstract by 28 June: https://lnkd.in/gZ5k7xpv #PHUSE

Have you seen PHUSE's latest blog? 'A PHUSE India Single Day Event Experience' written by Santosh Karthikeyan Viswanathan, Ph.D., provides great insight into the experience you could have as a PHUSE India Single Day Event attendee. "The day was fully packed with a comprehensive agenda covering multiple tracks on the most happening topics in our industry. I connected with industry leaders and innovators and discussed challenges and experiences, which has opened up avenues for potential collaborations and partnerships." Read it now: https://lnkd.in/gqfi-qCA Registration is now closed for our next India SDE, but keep your eyes peeled via the SDE Calendar (https://lnkd.in/e3ATjNB6) for registration opening for the Chennai SDE later this Summer. #PHUSE

PHUSE has some exciting Working Group news to announce… The Safety Analytics Working Group has welcomed two new Leads to the team! Robert "Mac" Gordon, MS Robert has a master’s in statistics and graduate certificates in public health, pharmacovigilance and pharmacoepidemiology and has been with Johnson and Johnson for 15 years and in the industry for 20 years. He has been heavily involved in pharmacovigilance, signal detection and safety data visualisation for most of his career, including membership in several multi-disciplinary industry/regulatory working groups. Ellis Unger Ellis is a Principal Drug Regulatory Expert at Hyman, Phelps & McNamara, a leading consulting FDA law firm. He is a board-certified cardiologist, who retired from the US Food and Drug Administration following a 24-year career, where he served in senior leadership roles in the Office of New Drugs, Center for Drug Evaluation and Research (CDER). Robert and Ellis will be joining the current leads Mary Nilsson, Greg Ball and Scott Proestel. To learn more about the leads, visit the Safety Analytics page of the Advance Hub: https://lnkd.in/e6EBwwfp #PHUSE

The PHUSE/FDA Computational Science Symposium offers a plethora of collaboration opportunities, notably through the Working Group Breakout Sessions spread across Tuesday and Wednesday. Let’s take a look at the topics the Optimizing the Use of Data Standards, Real World Evidence, Risk Based Quality Management and Safety Analytics Working Groups will be exploring. Optimizing the Use of Data Standards: ·      SDTM ADaM Implementation FAQ ·      CDM Models and Standards for Submitting Real-World Data (in collaboration with Real World Evidence) ·      Management of ODS Regulatory Referenced Deliverables ·      Integrated Clinical Study Data Reviewer’s Guide (icSDRG) ·      Best Practices in Data Standards Implementation Governance – What’s Next? ·      New Project Discussion Real World Evidence: ·      Requirements for Usability and Quality of Real-World Data ·      Estimands in RWD/RWE  ·      AI to Detect Data Quality Issues Risk Based Quality Management: ·      OpenRBQM Project – Working Session  ·      RBQM Education ·      RBQM Working Group – Open Door Safety Analytics: ·      Safety Analytics Working Group Overview ·      Clinical Visual Analytics for Review and Submission (CVARS) Update (in collaboration with Data Visualisation & Open Source Technology) ·      Safety Analytics Initiatives at the FDA  ·      Interactive Analyses & Displays for Laboratory Data ·      Analyses & Displays for Hepatotoxicity ·      Adverse Event Collection and Treatment Emergent Definitions ·      Vision of Interactive Safety Analyses and Displays  ·      Adverse Event Groupings in Safety ·      Safety Analytics Education  ·      Safety Analytics – Potential Future Projects/Wrap-Up View All Working Group Breakout Sessions: https://lnkd.in/eN9Jc4vK Find details on the other Working Groups in our post earlier this week: https://lnkd.in/e4DEaH3r #PHUSE