Veranova的动态

Asciminib (Scemblix?) faced major hurdles in dosing, drug interactions, and patient variability, which would have required over 10 clinical trials. PBPK modeling streamlined the process, enabling FDA approval with essential data only, cutting costs, and speeding up patient access. Key Benefits: - 10+ Clinical Trials Avoided - FDA Approval for 80 mg & 200 mg Dosing - Faster Development Timeline Discover how PBPK modeling transformed Asciminib’s development. https://lnkd.in/gKvbTmwU #PBPK #DrugDevelopment #Modeling #Simulation #ClinicalTrials

Time to register for this month's Unbridled Excellence webinar! (https://lnkd.in/gtQa5bNS) On Friday, July 19th (at 9 am Pacific), join hosts Wendy Liang and Sara Mills to learn "Practical Recommendations for Early Phase IND Authorship." While providing phase-appropriate considerations and recommendations for IND authorship, DHC’s experts will include a survey of the recommended general structure of a CGT IND, discuss defining and codifying drug substance and drug product, review best practices for streamlining authorship, and provide insight into what to expect after IND submission.

A few of the potential benefits of microneedle: -rapid uptake of drug into the body, faster than IM/sub-Q -no needle -at home administration -room temperature storage Kindeva has commercial manufacturing capabilities. This webinar is a good start to understanding the developments in MAP.

Across my time at the FDA and Industry, I have learned the importance of being an effective story teller and how this helps position a development program to receive useful insights from regulatory agencies. My collegues Matthew Hight, PhD, RAC , Joshua Taylor, PhD, RAC, and I have shared insights from our experiences engaging the FDA in formal meetings and approaches to leverage these insights while preparing for and attending Pre-NDA and Pre-BLA meetings. Please enjoy these insights as you read and share the blog post below here! #Allucent #BringNewTherapiesToLight #ClinicalTrials #DrugDiscovery #FDAApproval #RegulatorySubmissions

Your regulatory strategy relies in part on your ability to confidently predict transporter-mediated DDIs. In this webinar, Senior Scientist Revathi chapa and Scientist II Suvarchala kiranmai Avvari Avvari will explain how to characterize and validate the effect of transporters on drug absorption, systemic distribution, and systemic clearance. They’ll share real-life case studies, highlighting how GastroPlus DDI projections have been used in lieu of clinical studies. They’ll walk you through the data and reports that can be submitted to support regulatory decision-making, increasing the likelihood of your program approval and success. https://lnkd.in/gm-yjXRu

Interesting practical issue in relation to oral hearings before the UPC: in Sanofi v Amgen (UPC_CFI_1/2023 and UPC_CFI_14/2023, order of 27/02/2024), the Munich Local Division (JR Kupecz) informed the parties about the use of slides: 1. Slides (but not models) are permitted but they may not introduce new facts or substance tot the case. Parties have to include a table indicating the exact basis for the slides in pleadings and evidence in the record. 2. Both parties get to use the same amount of slides. 3. Slides have to be communicated about one month before the hearing. Clearly, the Court will not put up with last-minute surprises in visual aids. https://lnkd.in/e6JwrcDQ

Next week we will run our next webinar, this one on IND authorship practices. DHC has written many INDs in the CGT space, and regulatory supports clients with optimising their content or addressing key risks. Sign up for insight into how to efficiently manage your IND authorship process and optimise for regulatory success. Key speakers will be Wendy Liang and Sara Mills

?? Eularis is hosting a free Webinar event on the 17th April 2024 at 5pm UK/ 6pm EU/ Midday EST/ 9am PT. On this webinar, experienced AI in Pharma expert Dr. Andrée Bates ?? from Eularis will help you understand what AI is all about in pharma and how to get real impact from it for your business unit - including: ● 30% – 60% reduction in drug discovery, R&D and clinical trial time. ● 1,000% efficiency increase in regulatory and medical affairs. ● Faster and broader market access for higher profit ● Maximize launch success in year 1 ● Generate higher revenue and profit from in-market brands ● Rapid finding of rare disease patients ● Soften the impact of the patent cliff Registration link: https://lnkd.in/daNMa4GD

When a 500-Patient Study for $36M is a Bargain: True Cost of a Clinical Trial Clinical trials are the most expensive component of the overall cost of developing a new drug but there is little agreement on what a given trial should cost. Last month, Doctors Without Borders reported that it cost them $36 million to complete a 552-patient multinational trial indicating that the cost of the trials should be... Read More: https://lnkd.in/gwxJHPSM Author: Mukesh Kumar, PhD, RAC, | CEO, FDAMAP #fda #clinicaltrial #clinicalstudies #clinicaldevelopment #clinicalresearch #drugs #fdaapproveddrug #fdaregulations #fdacompliance

Interested in learning more about fragment-based drug design and innovative tools? Join our free webinar! Discover how to use fragment drug design to create novel compounds and how BMaps can simplify your design process. ?? Date: 10/17 ?? Time: 11:00 AM - 12:00 PM ET ?? Register here: https://lnkd.in/ei_Ck9TJ Don’t miss this chance to enhance your lab’s efficiency and productivity with BMaps!??? #DrugDiscovery #DrugDevelopment #FBLD #FBDD #ChemComp #MedChem #Webinar