IDDI - Regulatory Statistics & Clinical Data Science Experts’ Post

Come join the #IDDI team for a complimentary Lunch & Learn to discover how to strategically navigate the FDA’s expectations for drug approval regarding the adaptive designs for dose optimization and accelerated approvals. Hope to see you there!

Our webinar during which we will demonstrate our Quantum-Aided Drug Design (QuADD) system is coming up next week, and we hope you are able to join the many researchers from across the the pharmaceutical, quantum, and chemistry sectors who have already signed up. We will demonstrate how #QuADD searches over a nonillion molecular options in a matter of minutes in a variety of modes including Best-In-Class and First-In-Class searches. Sign up today to fin out how you can integrate #quantumcomputing into your #drugdiscovery pipeline. https://lnkd.in/gdpihsGF

Our scientists are ready to listen, understand, and partner with you to overcome bioanalytical challenges. By working together, we can optimize accuracy, sensitivity, and regulatory compliance throughout your drug development journey. Contact us today to schedule a consultation with our knowledgeable scientists and learn vital advanced techniques to tackle nitrosamine impurities. 🚀 #CollaborativeScience, #BioanalyticalTesting, #DrugDevelopment

If you are interested in learning more about how we are empowering our clients and partners to use #quantumcomputing to accelerate their #drugdiscovery with our Quantum-Aided Drug Design platform, don't miss our webinar later this month. Our CTO, Bill Shipman will be discussing how employing #quantumutility currently available can represent a value add for #pharmaceutical research today, not years in the future. https://lnkd.in/grQn4PJR

Download Sannova's whitepaper and gain valuable insights from high-resolution biomarker analysis to evaluate drug safety and efficacy. #BiomarkerValidation #DrugDevelopment #Biomarker

From challenge to solution, Sannova offers innovative techniques for nitrosamine detection. Download our FREE whitepaper to: ✅ Discover expert strategies for tackling nitrosamine impurities. ✅ Gain critical knowledge on FDA guidelines and the regulatory landscape. ✅ Unlock valuable insights for proactive nitrosamine control. Proactive action is key! #nitrosamine #pharmaceutical #compliance #detection #analyticaltesting

As IPSE, we have an exciting opportunity for you to contribute your technical expertise to the upcoming draft ISPE Good Practice Guide: ATMPs – Equipment Design for Cell Therapies. Team leads for this project have requested assistance from subject matter experts participating in the following Communities of Practice groups in reviewing the draft ISPE Guidance Document: Advanced Therapy Medicinal Products (ATMPs) Biotechnology Commissioning and Qualification (C&Q) Disposables/Single-Use Technologies GAMP® Process Analytical Technology (PAT) and Lifecycle Control Strategy Process/Product Development Quality Control/Analytical Sterile Products Processing The deadline for volunteer participation is 1700 EST, Thursday, 27 June 2024.    Your participation is crucial if you possess expertise in these areas and are interested in reviewing the technical content of the draft ISPE Guidance Document. Participant Information: Any ISPE members with technical expertise in this area are welcome to participate, and we encourage global participation. Before expressing your interest, ensure familiarity with the ISPE Guidance Document's topic and a commitment to providing feedback on the technical content.   If you choose to volunteer, you will receive a link to view the draft in PDF format, an MS Excel comment form, and review instructions when the draft is ready.   Please note: Volunteers will have three weeks to review the draft and submit comments. A specific review deadline will be provided with the draft document and comment form.   If you have any questions or need clarification, please email Guides@ISPE.org. 

What are your plans for the day after tomorrow (Wed, May 15th) at 9 am Pacific Time? We hope you'll be at the Unbridled Excellence 7th expert webinar: "Navigating nonclinical development for CGT products: common challenges & lessons learned!" (Register here if you haven't already: https://bit.ly/UnBrEx7) You'll be treated to wisdom shared by Nathan Manley and Sean O'Farrell, gained from the decade of nonclinical strategy support DHC has amassed to date. This webinar explores the current state of nonclinical development for CGT products, focusing on big picture questions, such as selection of suitable model systems, dose determination, and design of GLP tox studies. Nate and Sean will discuss how developers are approaching these challenges for different types of CGT products, highlighting key considerations for both cell- and gene-based therapeutics and in the context of the evolving regulatory landscape. See you there!

Registration is filling up for our May 17 Webinar: "Quantum-Aided Drug Design: Find Your Start Molecule." Sign up today to reserve your spot and see our demonstration of how our #QuADD platform is able to use the increased #optimization power of #quantumcomputing to search a chemical space of up to 10^30 molecular options to find drug-like molecules in a matter of days rather than weeks or months. https://lnkd.in/gdpihsGF

GenoFAB is developing a new service to distribute standard and custom plasmids. The new service will improve the quality of the plasmid documentation, streamline the licensing process, clarify the intellectual property status of plasmids, and streamline the plasmid quality control process. We are interested in getting the perspective of potential users, including: - Biotechnology companies who need to access plasmids developed by third parties. - Academic and corporate developers of plasmids who want to license their plasmids to third parties for research purposes. - Biotech companies who need to control the distribution of their plasmids with business partners. Interested in getting early access to GenoFAB plasmid distribution service? Tell us how you purchase and distribute your plasmids by filling out this form: https://lnkd.in/gVqX4tEB #biotechnology #syntheticbiology #synbio #security #cyberbiosecurity #reproducibility #intellectualproperty #mta #plasmids #bioengineering #molecularbiology