KinderPharm

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CRISPR Babies

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 […]

FDA Unveils Guidances on Innovative Trial Design

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 […]

Synteract Acquires Pediatric CRO KinderPharm to Further Strengthen its Pediatric Center of Development

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 […]

Assessing Drug Safety in Children — The Role of Real-World Data

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 […]

AAPS Conference Highlights Modeling & Simulation

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 […]

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  • Pediatric Regulatory
    • Protocol Development
    • Waivers and Deferrals
    • PIP and PSP Submission
  • Age Appropriate Formulation
    • Pediatric Formulation Development
  • Juvenile Toxicology
    • Juvenile Toxicology Study Design & Conduct
  • Pharmacometrics
    • PK Data Analysis
    • Modeling & Simulation
      • Physiologically Based Pharmacokinetic (PBPK)
      • Pediatric Extrapolation
      • Population PK (POP PK) & Sparse Sampling
  • Clinical Trials

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  • New York Venture Summit - great place to meet new companies and investors. https://t.co/BpvYTwjklH July 19, 2017 11:32 pm
  • Thank you #LifeSciencesPA for hosting the #PAPavilion Looking forward to #BIO2018 in Boston. https://t.co/DMmvmSYItT June 27, 2017 12:35 am
  • Bringing Better Medicines to Children through collaborations at #BIO2017 KinderPharm CEO Dr Graham and American M… https://t.co/YLxQwVZGKw June 22, 2017 12:02 am
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We have a single mission, simply “Bringing Better Medicines to Children” – but as everybody involved in pediatric drug development knows, this is not simple.

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US Location
100 Arrandale Blvd. (Suite 101)
Exton, PA 19341 USA

UK Location
40 Bank Street Level 18 Canary Wharf,
London E14 5NR UK

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