Accelerating medicines to patients who need them the most

Certara Global Health (CGH) brings together talent, technology, software, systems and processes to accelerate the development of medicines for those that need them most.

Working closely with the global health sector, CGH focuses on creating novel and impactful drug development, regulatory science and patient access approaches that delivers effective and affordable therapies to populations in need around the world.

We accelerate the drug development process and access to critical therapies by:

  • Applying modeling and simulation in an integrated drug development environment to propel drug discovery and lead optimization. For example, using QSP alongside modern screening approaches to improve hit-to-lead, lead candidate selection, and first-in-human dosing strategy
  • Supporting due diligence of assets, stage-gate decisions and portfolio management to identify and triage optimal drugs for select populations
  • Developing technologies, software and processes across all areas to codify and scale best practices, increase quality and support/enable best outcomes

“It takes a broad community to develop a new medicine, and the FDA approval represents decades of work by thousands of scientists, disease control specialists, expert advisors, community health workers, funders and study participants. The Certara team were (and remain) tremendous collaborators and were very much part of our team.”  – Mark Sullivan, founder and managing director of Medicines Development for Global Health (MDGH) on the approval of moxidectin for river blindness (onchocerciasis).

Sandbox of innovation

CGH leverages Certara’s cross-functional, interdisciplinary global scientific staff to create a ‘sandbox of innovation,’ employing:

  • New quantitative drug development methodologies, such as model-informed translational medicine, innovative clinical trial designs, human infection models, quantitative systems pharmacology
  • Novel regulatory science approaches to expedite regulatory review
  • Expertise in Chemistry, Manufacturing and Control to tackle the toughest CMC challenges in delivering quality medicine to low- and middle-income countries
  • Epidemiological models, real-world evidence, pharmacology-to-payer prototyping, early deployment approaches, and tools to support product distribution and access.
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