Modern, integrated drug development

Certara has demonstrated that a modern, state-of-the-art integrated drug development approach, using quantitative methods to inform, guide, and supplant traditional development methods, dramatically improves efficiency and reduces costs.

We work as an integrated part of your team, asking and answering questions, leveraging the most innovative modeling and simulation technologies, and providing deep scientific and regulatory acumen to impact the ROI of your R&D investment.

We have helped our partners successfully bring over 250 new drugs to market with an integrated approach including model-informed drug development, regulatory science, and market access solutions.

“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 FDA approval of moxidectin for river blindness (onchocerciasis).

Strategies Tailored to Achieve Your Goals

Our work on drug programs, for large pharma and emerging biotech companies, cover a range of therapeutic areas, including oncology, immunology, rare disease, CNS, metabolic, and infectious disease. They address the needs of special populations, such as pediatrics, geriatrics, and co-morbidities.

They have been developed in accordance with leading global regulatory agencies, such as FDA, EMA, MHRA, and PMDA. We have executed unique regulatory programs for breakthrough drugs, orphan designation, and priority review.

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Confident Decision-Making

Key decisions informed by our work include:

  • Making go/no go portfolio decisions
  • Pressure testing and optimizing development strategies
  • Selecting first-in-human, final dose, and dosing regimens
  • Comparing candidates for safety, efficacy, and commercial viability
  • Developing safer and more efficient trial designs
  • Identifying drug-drug interactions and optimizing labeling
  • Analyzing real world outcomes for value assessment
  • Demonstrating improved benefit/risk 

“We engaged with Certara to help us challenge conventional pediatric development paradigms for our RSV program.” – Dr. Sushmita Chanda, Vice President at Alios Biopharma

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Early integration of MIDD and regulatory strategy

Increase your product’s chance of expedited approval and greater patient access with global program guidance from seasoned regulatory strategy experts specializing in regulatory intelligence, policy, and strategy.  The integration of model-informed drug development and regulatory strategy early on in development is critical to your success plan:

  • Proof-of-concept
  • Accelerated approval pathways
  • In-and-out licensing
  • Global dossier development
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Darrell Nix, PhD Vice President, Integrated Drug Development

Darell has 30 years of experience in leadership positions at major pharmaceutical firms spanning oncology, CNS, inflammation, and cardiovascular. Areas of expertise include IND/NDA enabling GLP toxicology, nonclinical and clinical protocols, PK/PD modeling and simulation, pharmacology, ADME, and regulatory support. He was a distinguished member of the U.S. Army’s Medical Corp assigned to the US FDA, Div. of Clinical Pharmacology.

Terrance Ocheltree, PhD Vice President, Regulatory Strategy

Terry provides technical and strategic advice on CMC activities to support product development from pre-investigational new drug (IND) submission to commercialization.  Previously, he was at AbbVie as senior director in regulatory and the FDA in the Office of New Drug Quality Assessment as a reviewer and division director.

Elaine Taylor Vice President, Regulatory Strategy and Policy

Elaine has extensive regulatory experience and specializes in innovative and efficient regulatory strategies for drug development, including 505(b)(2) programs, regulatory agency meetings, responses to regulatory agencies, INDs, and NDAs/BLAs/MAAs.  Previously, she was at Syneos Health and Camargo Pharmaceutical Services.