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How do FDA and biopharmaceutical companies bridge the gap from regulatory science innovation to routine practice? Hear more from Donna Boyce, Pfizer’s head of Global Regulatory Sciences, and other FDA and industry leaders on the panel "This is Your Pilot Speaking" at 3:15 PDT in Room 6F of the San Diego Convention Center. Join the conversation on best practices for piloting new regulatory approaches - such as real-world evidence, model-informed drug development, and innovative clinical trial designs - and discuss what we can learn together. #DIA2024. 

In this video, Maureen Makes, Director of Engineering at Recursion, discusses the impact that automation can have on clinical trials, particularly in the context of IND (Investigational New Drug) filings. Data lineage and traceability are paramount in the pharmaceutical industry. Maureen explains how automation can help standardise and streamline the processes involved in clinical trials. Watch the rest of the panel discussion here 👉 bit.ly/3KYKSjn

Did you know that Global Clinical Supplies Group is a not-for-profit organization that provides companies and individuals working in the biopharmaceutical industry clinical supply chain a platform to share knowledge, collaborate and enhance best practices?   If you haven’t joined us at a GCSG event before, our amazing format enables in-depth conversations on a wide range of topics allowing you to create the agenda that fits your needs, giving you the most from your attendance. Curious about what makes GCSG unique? Discover more: https://lnkd.in/eDFW4QnS

How do PAGs power rare disease research? For pharmaceutical companies navigating the complexities of rare disease drug development, PAGs have emerged as indispensable partners. Collaborating with them enables life-sciences companies to connect with patient communities, overcome translational challenges, and accelerate clinical and commercial success. Read more on our latest blog: https://bit.ly/41n6Tlp

What an informative read on the impact that site selection and support can have on radiopharmaceutical trials! Check out Sue Batchelor's BioPharma Dive article today, or stop by Booth 411 at #ESMO24 to speak with her about her insights: https://bit.ly/4eLSouP

Join us at PS30 at RISW on Friday morning 8:30am and get a free copy of ASA Biopharmaceutical report!! This special session is organized by ASA Biopharmaceutical report, and we’ll be distributing 100 free printed copies of the report (50 spring issues + 50 summer issues) at the session! It features with an 1-1 interview with regulator, following by a panel discussion with KOLs.  Different format and more interesting and interactive discussion on the topic of influencing regulatory guidance/policy to drive statistical innovation! Hope at the end of this session, participants will ·  Gain a better understanding of the process behind the regulatory guidance/policy; ·  Identify challenges in implementing the regulatory guidance and potential solution to overcome the challenges; ·  Learn how to collaborate effectively to drive statistical innovation in this process. Don’t miss this insightful discussion and get a free copy of the report! Ivan Chan, Margaret Gamalo, PhD, FASA,Gregory Levin, William Wang, Yabing Mai, Ling Wang,Meijing Wu Poster credit: Meijing Wu

Our selected services include expertise with Biomarkers & Surrogate Endpoints, Regulatory Affairs FDA & EMA, Medical Affairs & Clinical Research, Due Diligence, and Trial Management & Trial Rescue. BBCR’s Strategic Clinical Innovation OrganizationSM (SCIO) method is explicitly designed to help pharmaceutical innovators address their concerns and maneuver around evolving challenges. SCIOSM identifies time and cost […]

QREC Team (India-UAE) wishes everyone International Clinical Trial Day [ICTD] which is celebrated globally on May 20th. Thanks to Healthcare Industry including pharmaceuticals, lifesciences, biotech, medical device etc. and all the stakeholders involved in the conduct and participants in clinical trials. #pharmaceuticals #clinicalresearch #clinicaldatamanagment #statisticalanalysis #medicalwriting #ICTD2024 #ISCR #medicaldevice #biotech

What an informative read on the impact that site selection and support can have on radiopharmaceutical trials! Check out Sue Batchelor's BioPharma Dive article today, or stop by Booth 411 at #ESMO24 to speak with her about her insights: https://bit.ly/3zhWThM

In the ever-evolving landscape of pharmaceutical research and development, a groundbreaking approach is taking center stage: the feedback loop. This innovative concept is transforming the way pharmaceutical companies interact with patients, healthcare providers, and regulatory bodies, creating a more efficient and effective drug development process. As we delve into this exciting new frontier, we’ll explore how the pharma feedback loop is reshaping the industry and paving the way for more personalized, patient-centric healthcare solutions. https://lnkd.in/exR7brXA