Disha Vidhate’s Post

On the matter of development plans in the pharmaceutical and biotech industries: One common question that comes up is where the information belongs and who owns each document in the development process. The Product Development Plan (PDP) provides the foundational strategy for bringing a product to market, while the Clinical Development Plan (CDP) expands on that strategy to cover the specifics of clinical research. It adds critical insights but also stands alone as a document, much like a regulatory strategy or preclinical plan. Both are essential for guiding development, ensuring that all crucial aspects of research, regulatory requirements, and patient needs are thoroughly considered. Here's a quick visual reminder to help you navigate the big differences between the two documents.  How does your team handle the distinction between PDP and CDP? Share your thoughts or experiences in the comments.

𝐀𝐫𝐞 𝐲𝐨𝐮 𝐫𝐞𝐚𝐝𝐲 𝐭𝐨 𝐚𝐝𝐯𝐚𝐧𝐜𝐞 𝐲𝐨𝐮𝐫 𝐩𝐫𝐞𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐩𝐫𝐨𝐠𝐫𝐚𝐦 𝐢𝐧𝐭𝐨 𝐭𝐡𝐞 𝐧𝐞𝐱𝐭 𝐩𝐡𝐚𝐬𝐞 𝐨𝐟 𝐝𝐫𝐮𝐠 𝐝𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭? At 2 Bridge, we understand that translating your scientific discoveries into successful therapeutic products is a complex journey. That’s why our CMC services play a pivotal role in ensuring smooth progress from the 𝐩𝐫𝐞𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐩𝐡𝐚𝐬𝐞 𝐮𝐩 𝐭𝐨 𝐥𝐚𝐭𝐞-𝐬𝐭𝐚𝐠𝐞 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭, 𝐫𝐞𝐠𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐨𝐧, 𝐚𝐧𝐝 𝐩𝐨𝐬𝐭-𝐚𝐩𝐩𝐫𝐨𝐯𝐚𝐥 𝐥𝐢𝐟𝐞-𝐜𝐲𝐜𝐥𝐞 𝐦𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭. Ready to leverage our expertise for your project’s success? Contact us at [email protected] to discuss how we can support your development journey! #CMC #Pharmaceuticals #DrugDevelopment

Software in Clinical Research: A Key to Accelerating Drug Development and Approval Every new medicine released on the market undergoes an arduous journey from the lab to the pharmacy shelves. Traditional drug development often takes more than a decade and requires significant funding. https://lnkd.in/gmHF4PAS #clinicalresearch #drugdevelopment #pharmaceuticals #healthtech #healthcaretechnology #biomedicalengineering #medicalsoftware #DrugApproval #RegulatoryCompliance #researchquality #ClinicalTrials #drugdiscovery Frontiers Misty Robson Formedix Mark Wheeldon Clinical Research News

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🌟 Exciting Collaboration in Digital Medicine! 🌟 The Digital Medicine Society (DiMe) is partnering with major pharmaceutical companies on a groundbreaking new digital endpoints project! 🎉💡 This initiative aims to develop and validate digital endpoints, leveraging cutting-edge technology to enhance clinical trials and improve patient outcomes. 📊🩺 By collaborating with pharma giants, DiMe is at the forefront of integrating digital innovation into healthcare, paving the way for more efficient and precise medical research. 🌐🔬 Eager to see the transformative impact this project will have on the future of clinical trials and patient care! #DigitalMedicine #HealthcareInnovation #ClinicalTrials #DigitalEndpoints #DiMe #Pharmaceuticals #MedicalAdvancements #TechInHealthcare #InnovationInHealthcare #PatientOutcomes #DigitalHealth #Biotech

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Navigating the intricate world of 𝐝𝐫𝐮𝐠 𝐚𝐩𝐩𝐫𝐨𝐯𝐚𝐥 𝐢𝐧 𝐭𝐡𝐞 𝐔.𝐒. 𝐩𝐡𝐚𝐫𝐦𝐚 𝐥𝐚𝐧𝐝𝐬𝐜𝐚𝐩𝐞 can be a daunting task. From preclinical testing to clinical trials and post-approval monitoring, the process is designed to ensure the safety and efficacy of new medications. Join us as we explore the complexities of this journey and uncover the critical steps that bring lifesaving #drugs to market. 𝐋𝐞𝐚𝐫𝐧 𝐌𝐨𝐫𝐞: https://lnkd.in/gmSmiRAd 𝐕𝐢𝐬𝐢𝐭 𝐏𝐡𝐚𝐫𝐦𝐚 𝐅𝐨𝐜𝐮𝐬 𝐀𝐦𝐞𝐫𝐢𝐜𝐚:  https://lnkd.in/gEBJvXVx #drugapproval #uspharmaceuticals #clinicaltrials #fdaregulation #medicalresearch #pharmaceuticaldevelopment #patientsafety #drugdiscovery #therapeuticbenefits #medicationapproval #innovativedrugs #drugsafety #pharmaceuticalindustry #medicalinnovation #healthcareadvances

Setting R&D Strategy requires an appreciation of innovations in the pharma and biotech sector, the evolving regulatory landscape, and the perspectives around decision-making. RECON 2025 is bringing together professionals from the pharmaceutical industry, academia, and the regulatory bodies to discuss and develop strategies on contemporary topics such as Biomarker-to-Endpoint Translation, Diversity in Clinical Trials, Project Optimus, and Global Regulatory Harmonization.

Our Innovation Ecosystem unites academia’s deep understanding of disease biology with the pharmaceutical industry’s expertise in drug development. This model has led to the initiation of seven clinical trials for ALS with unprecedented speed over the last decade, propelling research from the bench to the bedside. #ALSResearch #ALS #EveryoneLives #ALSClinicalTrials