Nutcracker Therapeutics’ Post

[Webinar] 📢 It's still time to register for SEQENS webinar to discover how to control the solid form of your API for higher bioavailability and easier drug development!   📅  Join us on April 𝟰 𝗮𝘁 𝟱𝗣𝗠 𝗖𝗘𝗧 (𝟭𝟭𝗔𝗠 𝗘𝗧)!  Gautier Decock, Julien LEROUDIER and Hong Shen will share how to benefit from early solid form screening and related activities.                                                                 During this webinar you will learn:                                    ✔️Insights from industrial practitioners on API solid form development  ✔️Why form screening at early stage is critical to avoid issues at later phases of development                                                  ✔️Key considerations in determining best solid form moving forward  ✔️How to efficiently expedite your solid state development activity   Register here ➡️ https://lnkd.in/e-8u7jsu 

The FDA Global Summit on Regulatory Science 2024 https://lnkd.in/etBBfF89 is just around the corner, starting on September 17 in Little Rock, AR. This year's focus is on Digital Transformation in Regulatory Science and Evidence-Based Toxicology Collaboration is hosting a pre-conference workshop on #FAIR data principles, highlighting the importance of data sharing across academia, the pharmaceutical industry, and regulatory agencies in advancing cures for devastating diseases. It's time for a paradigm shift in drug discovery and development, where patients are truly at the center. Pioneering physician-scientists like Istvan Petak, MD, PhD, founder of Genomate Health and David Fajgenbaum, MD, MBA, MSc, founder of non-profir Every Cure, Christopher Gregg and Jeff Barson, co-founders of Storyline Health are leading the way in breaking down silos and leveraging scientific tools, including recent #AI breakthroughs, to bring them into clinical practice and save lives. I echo Dr. David Fajgenbaum, MD, MBA, MSc call to the #raredisease community to support non-proprietary patient registries, data standardization, global #regulatory #harmonization, and #collaborative #research efforts as outlined in their publication: https://lnkd.in/eyRPZfRv I would argue that this model should extend to all diseases, addressing the communication gaps between clinicians, lack of treatment information, and prioritizing patient benefits over institutional policies, liability fears and personal egos. I hope the Summit will facilitate some impactful discussions between key stakeholders and accelerate the movement towards #openscience and truly #patientcentric #healthcare. Thomas Hartung Paul Whaley Alexander Tropsha Didier Verloo Tong Weida, Ákos Bernard Jóźwiak John R. "Jack" Fowle III Sebastian Hoffmann Emily Senerth, MS, MPH Maurice Whelan Mass General Brigham Mass General Brigham Innovation Foundation Medicine Beth Israel Deaconess Medical Center Penn State Health Johns Hopkins Bloomberg School of Public Health Darwin Health Group Andrew Lassman Evan Noch Michael Castro, M.D. Dawn Lemanne, MD, MPH Create Cures Foundation Kathy Archibald Jeno Gyuris Tom Needham David Donabedian #FDA #RegulatoryScience #DigitalTransformation #DataSharing #ResearchCollaboration #FAIRdata Cancer Patient Lab Brad Power

My article today should be insightful. It is a practical analysis of how the four stakeholders should fulfill three responsibilities each. US Congress: There should be no interchangeability, no patent dance, and no PBMs. The FDA should declare all first filings interchangeable and remove efficacy testing. The USP should be able to make monographs with validated methods to get rid of side-by-side testing. Developers should bring molecules that are not available yet, challenge the FDA, get approval with the fewest CRLs through CDMOs, and then do Q5E using small-scale lots. Read all the details here. FDASarah Yimjanet woodcockBiosimilars CouncilDamian NowakUS PharmacopeiaAfshin SafaviNicole F. RobertsIan HenshawSushil SuriKushal SuriCraig BurtonHillel CohenMartin Schiestl, Pierre BourdageDaniella KranjacDaniela Lifschitz TabakShahid Siddiqui, Ph.D.Jesse McCoolMourad Farouk REZK MD MBATony DemirjianAntoine Pompe van MeerdervoortDana AcetoGillian WoollettAndrea Kottke, PhDAlex MonnardSoenke Steinert

Beyond the Code: Exclusive Webinar Series Launching Next Week 🚀 Following the overwhelming success of our "Cracking the EMA Code" series, Partner Rare's team of seasoned industry veterans is thrilled to announce an exclusive webinar series designed to empower your Rare Disease strategy in Europe. The 'Beyond the Code' interactive series will delve into critical topics like market entry, #regulatory, #compliance, #clinicaltrials, #marketaccess, and more. 💚 6 Webinars > August to September > 55 Minutes Each > 30 Min Presentation > 25 Min Q&A. 💚 No More Endless Research – Gain direct insights from those who have successfully navigated the European landscape multiple times. 💚Ideal for busy senior leaders developing Rare Disease therapies and seeking to understand how to expand into Europe. 💛 Stay tuned for registration details on 09/07! Catch up on our bite size articles series 'Cracking the EMA Code' here: https://lnkd.in/e2PZnDJ9 #RareDiseases #Biotech #Pharma #Europe #Webinar

The content from the 2023 Digital CMC Summit is here! Grab some egg nog, put on some comfortable clothes, turn off your phone, and learn how your colleagues are advancing digitization and digitalization for CMC workstreams. #digitalcmc #knowledgemanagement #lifecyclemanagement

Understanding ICH Guidelines Q4B: Achieving Pharmacopoeial Harmonisation - https://lnkd.in/eYj7A7Rt

A day trip to Amsterdam to take part in the European Medicines Agency's (EMA) insightful workshop on leveraging Real-World Evidence (RWE) for Regulatory decision-making. A truly collaborative event that brought together experts across Regulatory, Patient Representatives, Industry, and Academia to discuss EMA’s recent white paper on Non-Interventional Studies and explore the latest advancements and challenges in harnessing real-world data. The workshop underscored the shared commitment across stakeholders to enhance confidence in RWE as a new source of evidence to support patient access to safe, effective medicines and drive regulatory excellence to improve outcomes. Another step in the right direction…

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

It's Microphysiological Systems Monday! Do you have questions about the FDA Modernization Act 2.0 and how it might impact the use of microphysiological systems in research? In 2022, Congress passed the Food & Drug Omnibus Reform Act (FDORA), commonly known as the “FDA Modernization Act 2.0,"" and this past February the “FDA Modernization Act 3.0” was introduced. Our Microphysiological Systems initiative has created a fact sheet about the FDA Modernization Act 2.0 to help clarify the potential impact of the proposed bill. Visit our page about microphysiological systems and the FDA Modernization Acts here: https://lnkd.in/eXMH4YDX

Exciting Update! Delve into the world of drug trials with our expert, Eric Tousset from AARDEX Group. His latest blog, "Reassessing Attitudes and Approaches to Medication Adherence in Drug Trials," offers ground-breaking insights on how electronic monitoring is revolutionizing trial accuracy and data integrity. 🔗 Ready for a deeper dive? https://lnkd.in/dKwFaapR   #MedicationAdherence #ClinicalTrials