by Biotech Primer Earlier this week, a research team at the Southern University of Science and Technologyin Shenzhen, China, announced the birth of twin girls whose genomes had been edited using CRISPR/Cas9. The work was done at an in vitro fertilization clinic prior to implantation of days-old embryos. The targeted gene, CCR5, produces a protein that the HIV […]

by Bill Myers, CenterWatch The FDA late last week issued two new draft guidances — one on adaptive clinical trials and the other on master protocol designs — that it hopes will help sponsors innovate and get treatments to market more swiftly and efficiently. “The standard approaptive clinical trials can give sponsors the flexibility to […]

Research Triangle park, NC – Nov. 15, 2018 – Synteract, an innovative CRO partnering with biotech and pharma companies to bring new medicines to market, has acquired KinderPharm, a specialty pediatric CRO, focused on advancing pediatric drug development across all phases of clinical research. Like Synteract, KinderPharm has extensive experience in helping clients efficiently navigate […]

Ann W. McMahon, M.D. and Gerald Dalpan, M.D., M.H.S. Office of Pediatric Therapeutics (A.W.M.), and the Office of Surveillance and Epidemiology (G.D.P.), Food and Drug Administration, Silver Spring, MD Over the past 20 years, several legislative initiatives in the United States have resulted in hundreds of clinical trials assessing the treatment effects of various drugs […]

The AAPS Conference: PharmSci360 Held November 4th – November 7th Highlights the importance of Modeling and Simulation in Clinical Drug Development.  KinderPharm’s Pharmacokinetic Scientist were there to share our expertise in PBPK Modeling and Population PK approaches. PBPK Modeling and Clinical Pharmacology in Regulatory Applications & Decision Making The ability to accurately predict drug absorption […]