Krzysztof Potempa’s Post

Remember to register for the In-Person (+Virtual) Drug-Device Combination Products: Updates and Challenges with Demonstrating Generic Substitutability workshop at The Universities at Shady Grove; Rockville, MD on March 14-15, 2024! Symposium III is an in-person-only event where each in-person attendee will participate in two working session sub-groups and help identify challenges, knowledge gaps, resource needs, and next steps with members of the FDA, Industry, and Academia. Topic co-facilitators will summarize outcomes on Day 2 of the workshop and document outcomes in a white paper for possible publication. Symposium outcomes will inform a “roadmap” for a CRCG working committee and ongoing work related to DDCP comparative user interface assessment. Register Now, https://lnkd.in/eiuZqkSc Katharine Feibus, MD, MaryBeth Privitera, PhD, FIDSA, Betsy Ballard, Lee Leichter, Irene Chan, Michelle Lin, Claire McDiarmid, Heidi M., Tim Briggs, Somesh Chattopadhyay, Jason Flint, Thomas Gwise, Satyashodhan Patil, Liang Zhao #generics #genericdrugs #drugdevelopment

As a drug developer in a complex industry, you need to remain at the forefront of scientific innovation while ensuring scientific integrity and responsibility. Join Laura Lotfi on July 18 for a live webinar, Unlock Hidden Insights: Virtual Control Groups as a Data-Driven Novel Method, where she will discuss the practical and regulatory steps for implementing VCGs into future nonclinical studies. https://okt.to/CpQHZm #drugdevelopment #virtualcontrolgroups

‼️💊‼️📢DONT FORGET TO JOIN THIS YEARS FDA/CRCG WORKSHOP IN ROCKVILLE, MD, THIS THURSDAY AND FRIDAY IN PERSON OR VIRTUALLY📢‼️💊‼️ I will be attending and co-facilitating at this year’s FDA and Center for Research on Complex Generics workshop titled: Drug-Device Combination Products:  Updates and Challenges with Demonstrating Generic Substitutability on March 14-15th, 2024 at the Universities of Shady Grove in Rockville, MD. The workshop will focus on comparative user interface assessments in generic drug-device combination product (DDCP) development, e.g., comparative use human factors studies, and the challenges thereof. I will be co-facilitating Topic 2 of the workshop, which will focus on “Other” design differences and examples thereof and aim to gather industry’s insights to inform and improve the science and methodologies of human factors comparative user interface assessments in DDCP with respect to such. Please come and join and share your insights, perspectives, experiences, and ideas for improvements. Whether you are in clinical, human factors, engineering, or regulatory, we promise it will be two days of insightful and thought provoking collaborative discussions. Frankly, I can’t hardly wait to see you all there and dive deep into comparative user interface assessments and as always geek out on all things human factors and how to improve the future of it! To learn more about the event and to register please follow the link below. #fda #drugdelivery #combinationproducts #comparativeuse #workshop #workshopfacilitation #generics #genericdrugs #drugdevelopment #drugproduct #science #humanfactors #humancentered #userresearch #userinterface #userinterfacedesign #humancentereddesign

Patel and the team have compiled various computational tools to aid drug design and discovery. This manuscript has been gaining wide attention worldwide since 2022. https://lnkd.in/dC9zF8MP #telemedicine #DHPSP #DigitalHealth #DHPSP2024 #Machinelearning #Artificialintelligence

Debunking 7 Common Myths About Data Quality in Clinical Trials | Fierce Biotech: This article – an abstract to our white paper (link) – aims to dispel common myths surrounding data quality in clinical trials and shed light on ...

RECORDING & SLIDES POSTED (for DIA members): June 26 #diarim #intelligentautomation meeting where Wim DHaeze, PhD, ELS from Sarepta Therapeutics facilitated a discussion of Adoption of AI-Driven Automation in #rim Systems. Lots of good nuggets and experiences in here about what's working, not working, challenges companies are facing after the proof-of-concept stage, etc. Let me know if you have any questions or would like to discuss further. Slides for DIA members only - https://lnkd.in/ecX6SJWq Recording for DIA members only - https://lnkd.in/eh7mXPtH #ai #automation #regulatory #regops #pharma

Are you ready for a paradigm shift in blood collection? Clinical Lab Chat talked with Bridget Bagnato, worldwide president, Specimen Management for BD, about the BD MiniDraw™ Capillary Blood Collection System, the future of blood collection and the potential for a major shift in the industry that would impact patients, clinicians and labs: https://lnkd.in/eTDi56Wj #BD #bloodcollection #ClinicalLabChat

Every clinical research project has a unique set of challenges. That’s why LabConnect offers a full suite of innovative Central Laboratory Services that are designed to meet the unique needs of your #clinicaltrial – of any size and complexity. With access to more global points of service than any other central lab, discover how LabConnect makes it easy to keep your research moving forward. => https://lnkd.in/dJe82SXN #CentralLab #DrugDevelopment #LabConnect

🌐 The Lynx.MD team is heading to San Diego for DIA 2024. Drug discovery is a complex, lengthy process. DIA brings together the life sciences community to discuss innovations accelerating advancements, bringing therapies to care faster. Reach out to the Lynx.MD team, including Collin Labar, on LinkedIn to learn more about how our partners are using Lynx.MD’s rich structured and unstructured data sets to find insights addressing medical affairs and market access. See you at #DIA2024! 🌟 #Data #Research

ICYMI - Aetion's Chief Science Officer Nicolle Gatto weighs in on the biggest clinical trial trends of 2024 in Pt. 5 of Scrips Asks. Follow the link to learn more about why Nicolle thinks #RWD and #RWE will be used more proactively and systematically in clinical development activities and integrated evidence planning to support regulatory approvals. https://hubs.li/Q02lZdn50