Temporal Concept
Pfizer Temporarily Suspends Dosing in Advanced Duchenne Muscular Dystrophy (DMD) Trial After Patient Fatality
Pfizer, Duchenne Muscular Dystrophy (DMD), clinical trial, dosing halt, patient death, late-stage study, temporary suspension, safety concerns, investigation.
Amgen Discontinues Obesity Program, Shifts Focus to MariTide after Phase 1 Results
Amgen, obesity asset, phase 1 results, MariTide, drug development, biotechnology, clinical trials
Moderna Maintains Long-Term Vision, Terminates Collaboration with Metagenomi
Moderna, first-quarter update, long-term strategy, Metagenomi, collaboration termination
Novartis to Revise CRO Partnerships Amidst US Senate Bill Scrutiny
Novartis, CRO relationships, US Senate bill, Chinese companies, pharmaceutical industry, regulatory changes, partnership revisions
FDA Approves Long-Established European UTI Antibiotic by Utility Therapeutics
Utility Therapeutics, FDA, UTI antibiotic, European market, 40-plus years.
Strategic Acquisition, Partnership, and Development of Innovative Assets in Biopharma
Biopharma, Innovative Assets, Acquisition, Partnership, Development, Strategic Decision-Making, Pharmaceutical Industry, Drug Development, Market Trends, Risk Management, Portfolio Diversification
FDA Issues Complete Response Letter to Abeona’s Cell Therapy for Rare Skin Disease
FDA, Complete Response Letter (CRL), Abeona, cell therapy, rare skin disease, Epidermolysis Bullosa (EB)
Roche’s Alecensa Gains FDA Approval for Postsurgical Early Lung Cancer Treatment
Roche, Alecensa, FDA approval, Postsurgical treatment, Early lung cancer
Cerevel Reports Phase 3 Parkinson’s Study Success Amidst AbbVie Acquisition
Cerevel Therapeutics, Phase 3 Parkinson’s disease trial, Tavapadon, AbbVie acquisition, Successful clinical trial results
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