C4 Therapeutics, Inc.’s Post

Check out the newest Aleon Regulatory Insights: FDA Accelerated Approval Strategy for Oncology Drug Development (https://bit.ly/3VtN5sZ) where our team outlines the current key considerations from FDA pertaining to accelerated approval, expectations for the oncology pivotal trial supporting accelerated approval, recent accelerated approvals, and confirmatory trials following accelerated approval. #RAPS #TOPRA #FDA #regulatoryaffairs #acceleratedapproval

What is Joint Clinical Assessment (JCA) process and how will it impact your product launch? Amanda Hansson Hedblom, FIECON's JCA expert, provides an in-depth overview of the forthcoming mandatory evaluations commencing January 2025. These evaluations are set to standardise drug assessments across EU member states, covering a range of medicines from oncology to orphan drugs. Amanda details the chronological steps of this streamlined assessment process, highlighting how it will influence future healthcare decisions. Discover the key insights from the full interview article here: https://lnkd.in/eVtp7cbU and stay tuned for the upcoming JCA updates on our website. #JCA #Pharma #EURegulations #HEOR #MedicalAccess

Thought I would share a “win” (case study) for those who want to quickly get a #licensing deal for their drug. How we Sosna + Co secured a licensing partnership for an oncology asset (while retaining U.S. rights) in 6 months: https://buff.ly/3Wx3zSn #druglicensing #licensing #pharma #biopharma #biotech #partnerships #lifesciences #businessdevelopment

What does diversity mean in practice for FDA? In 2022 we saw some new text added to a FDA stock response template, which let each and every sponsor know that diversity plans would be needed as they proceeded through development—and even encouraged sponsors to look at patient focus drug development, and diversity early on in their clinical trials. Now, as we move into 2024, FTA is firming up the diversity plan process. Moreover, there’s plans for FDA to look across diversity, plans for trends, and to better understand how we can bring diversity in the clinical trials in the future. To me, this is particularly significant. Clinical trials tend to represent the majority populations, and historically women and minorities — groups, who may be more prone to hypersensitivity or adverse drug reactions— have not been adequately, represented in clinical trials. For example, for the long marketed drug warfarin (apprived by FDA in 1954) Asians, Latinos, and African Americans have higher risks of warfarin-related potentially deadly intracranial hemorrhage than individuals with European ancestry. Yet, it took decades before this was known. Understanding gender, ethnic, and other population differences in drug response is a critical next step in drug development and healthcare #nursesonlinkedin #healthcare #drugdevelopment #biotech #dei #diversity #pharma #fda #regulatory

New Case Study 📣 Learn how we used our business development process to successfully secure a licensing partnership for an oncology asset (while retaining U.S. rights) within 6 months. #licensing #pharma #biopharma #partnering #strategicpartner #druglicensing #pharmalicensing Get the case study: https://buff.ly/3JUupfI

By engaging in voluntary licensing, #pharma companies can improve availability and affordability of innovative #CancerMeds in low- and middle-income countries #LMICs. The 2022 #AccesstoMedicine Index found that Novartis signed the first non-exclusive voluntary licensing agreement for a #cancer drug with Medicines Patent Pool, the first such agreement for a non-communicable disease. We must keep this momentum on access to new therapies, with more non-voluntary licence agreements, especially for #NCDs. Read the key finding here ➡️ https://lnkd.in/eUqZ3xxG #WorldCancerDay #ClosetheCareGap #CancerCare #AccesstoMedicine #EquitableAccess #AccesstoHealthcare #GlobalHealth

Interesting read.

Look at this panel discussion webinar coming up. With experts from the likes of 4c LifeSciences, Kyowa Kirin, ADC Therapeutics, Dragonfly Therapeutics (and of course our very own Anca Copaescu). You will learn about - Importance of category management - Key criteria for vendor onboarding - Vendor evaluation workflows - Risk Management - Latest trends and innovation

🤝 This year, World Science Day for Peace and Development highlights the importance of building trust in science. 🔬At Servier, we are committed to therapeutic progress, with the objective of serving patient needs. To achieve this goal, it is crucial for us to include patients at every stage of the development of a new drug. In 2022, we were ranked No. 2 out of 23 companies by patient organizations who work with pharmaceutical groups in oncology (+5 places) #PatientView. 🧫 To conclude, trust means nothing to patients without innovation. That’s why we opened our R&D institute in Paris-Saclay at the beginning of 2023. It complements our other 3 R&D centers in Denmark, Budapest, and Boston. Learn more about our commitments for patients at 👉 https://swll.to/8phqHti #ScienceDay #BuildingTrustInScience #patient #WeAreServier #MovedByYou