regulatory
Innovent to Submit IL-23 Psoriasis Drug to Chinese Regulators Following Phase 3 Success
Innovent, IL-23, psoriasis, picankibart, phase 3, China, regulatory submission, plaque psoriasis, CLEAR-1 study
Novartis Achieves Success in Two Phase III Trials for Rare Kidney Diseases, Eyes Regulatory Submissions
Novartis, Phase III trials, Rare kidney diseases, IgA nephropathy, C3 glomerulopathy, Regulatory submissions
FDA Revokes Accelerated Approval of Helsinn’s Cancer Drug at Company’s Request
FDA, Helsinn, accelerated approval, cancer drug, company request, drug withdrawal, regulatory decision, clinical trials, patient safety.
Revolutionizing Healthcare: Streamlining Cell and Gene Therapy Manufacturing (Part 1)
Cell therapy, gene therapy, manufacturing, biotechnology, healthcare innovation, personalized medicine, production challenges, regulatory compliance, scalability, cost-effectiveness.
Revolutionizing Medicine: The Evolution and Future of Cell and Gene Therapy Manufacturing
Cell therapy manufacturing, gene therapy manufacturing, biomanufacturing, advanced therapies, CAR-T cell therapy, stem cell therapy, viral vectors, bioreactors, automation, scale-up, regulatory compliance, personalized medicine.
Revival of Gene Editing Clinical Trials in China Post CRISPR Baby Scandal
CRISPR baby scandal, China, gene editing, clinical trials, restart, regulations, ethics, CRISPR-Cas9, genetic diseases, biotechnology.
Novartis to Revise CRO Partnerships Amidst US Senate Bill Scrutiny
Novartis, CRO relationships, US Senate bill, Chinese companies, pharmaceutical industry, regulatory changes, partnership revisions
Director/Vice President of Translational Research: Leading the Bridge from Discovery to Clinical Development
Translational Research, Biomarker Discovery, Preclinical Development, Early Clinical Development, Drug Molecule Development, Translational Science Leadership, Biomarker Development, Target Engagement Strategies, Assay Development (PK/ PD/ Immunogenicity), Clinical Trial Design, Endpoint and Biomarker Strategy, Team Building and Leadership, Cross-Functional Collaboration, Regulatory Approvals