Oncology Consulting Wolff LLC is an American small company solely owned by the founder and operated from the Seattle area in Washington State. We provide consulting services in oncology and hematology drug development.
Oncology Consulting Wolff LLC的外部链接
US，WA，PUYALLUP，98374
CMO Oncology Consulting | Clinical Development | Strategy |Medical Affairs | IND | NDA | CDP | Protocol design | Phase 1 | FIH | Phase 3 | Go/NoGo | GNG | | acquisitions | data review | teaching | mentoring
Kaplan Meier Curves: 90 minute of teaching. For all those that are coming into drug development, and have to wait for the next flight: enjoy. https://lnkd.in/gR_SDu2F
Very nice summary
Medical Affairs and Clinical Development Recruiter |90% CV to interview ratio| Biotech, Pharma, and CROs | USA & Canada
Science Explained ???? : Understand the FDA Designations Following the latest FDA grant for "breakthrough therapy designation" to one of?Novartis?NSCLC therapies, I realized I never fully understood what all these designations mean and how they differ. After a brief research, this is what I could put together. 1. Breakthrough Therapy Designation: Given to promising drugs that show early signs of being significantly better than existing treatments for serious conditions. It helps speed up the development and review process by enhancing communication between the FDA and drug developers. 2. Fast Track Designation: Speeds up the development and review of drugs for serious conditions with unmet needs. It includes more communication with the FDA and the potential for a quicker review. 3. Priority Review Designation: Granted to drugs that bring substantial improvements in safety or effectiveness for serious conditions. It shortens the FDA review time from 10 to 6 months. 4. Orphan Drug Designation: Given to drugs aimed at treating rare diseases, offering incentives to encourage their development for small patient populations. 5. Accelerated Approval: Allows for the early approval of drugs for serious conditions with unmet needs based on an endpoint likely to predict clinical benefit. 6. Regenerative Medicine Advanced Therapy (RMAT) Designation: For certain innovative therapies like cell or gene therapies that have the potential to treat serious or life-threatening conditions. 7. Qualified Infectious Disease Product (QIDP) Designation: Given to drugs for serious or life-threatening infections, offering incentives like priority review and extra market exclusivity. Let me know if you think this is accurate, I've tried my best! Did you know all the different designations? Drop me a comment if I have missed something! #clinicaldevelopment?#medicalaffairs?#regulatoryaffairs?#FDA?#clinicaltrials?#medicalcareers?#clinicalcareers
Enjoy the Quiz
CMO Oncology Consulting | Clinical Development | Strategy |Medical Affairs | IND | NDA | CDP | Protocol design | Phase 1 | FIH | Phase 3 | Go/NoGo | GNG | | acquisitions | data review | teaching | mentoring
Test You Knowledge about Kaplan Meier Curves in 8 minutes https://lnkd.in/gf9pe-Zw
CMO Oncology Consulting | Clinical Development | Strategy |Medical Affairs | IND | NDA | CDP | Protocol design | Phase 1 | FIH | Phase 3 | Go/NoGo | GNG | | acquisitions | data review | teaching | mentoring
Why does the PFS curve look like a step ladder ? You know, but : try to explain it - or else: forward this video and save your time. Enjoy - like - subscribe - forward https://lnkd.in/gBhd6pGz
Explaining Kaplan Meier Curves is difficult. Here is the pessimist/optimist approach. https://lnkd.in/gGCDXfyj ???? ?
CMO Oncology Consulting | Clinical Development | Strategy |Medical Affairs | IND | NDA | CDP | Protocol design | Phase 1 | FIH | Phase 3 | Go/NoGo | GNG | | acquisitions | data review | teaching | mentoring
Great News:?The great state of Washington granted us the business license. Oncology Consulting Wolff LLC is ready to do its part in curing cancer.? Let us know how we can help. ??????????????https://wolffoncology.com/ ?