Drug Development and Clinical Pharmacology Strategy

Strategic Drug Development Involves Thinking Without Borders™

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, will dramatically improve efficiency and reduce costs. Creating unquestionable value for our clients is our objective.

To achieve these objectives, Certara employs a strategic and programmatic approach that leverages its expertise in drug development, clinical pharmacology, model-informed drug development (MIDD), health economics/outcomes research (HEOR), real world evidence (RWE) services and regulatory science to optimize end-to-end decision-making. As an outsourced part of your R&D team, we support specific products, programs, or entire portfolios, advise on licensing and due diligence activities, work alongside a drug development team, or serve as a fully outsourced partner for products intended for regulatory approval or those going for proof-of-concept.

Sponsors benefit from Certara’s ability to align our broad end-to-end competencies, technological advances, and global experience to meet each situation. 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.

Engagement Strategies Tailored to Achieve Project Goals—from POC to Approval

Certara has helped sponsors bring hundreds of drugs to market over the past several years, working in partnership from early clinical development through proof-of-concept to regulatory approval and market access. Those drug programs, for companies both large pharma and emerging biotech, 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, co-morbidities, and global health challenges. They have been developed in accordance with the leading global regulatory agencies, such as FDA, EMA, MHRA, and PMDA. And they have been executed under unique regulatory programs for breakthrough drugs, orphan designation, and priority review.

We help to navigate the increasingly complex landscape of drug development to maximize probability of success by:

  • increasing confidence in proof-of-concept
  • increasing confidence in understanding of the compound and target
  • addressing the regulatory and commercial decision-making process for a new product

Clinical Pharmacology as a Strategic Lever

Clinical pharmacology is the science of the relationship between drugs and humans. It focuses on drug action and incorporates pharmacological principles and techniques into the clinical development cycle. It is increasingly leveraged at all phases of development with an eye toward delivering the right drug to the right patient with the right dose at the right time. Clinical pharmacology contributes to a range of clinical decisions and comprises more than 50 percent of a drug label.

Thus, this expertise is critical for optimizing safety and efficacy in drug development. From both industry-wide and regulatory perspectives, the levers of clinical pharmacology can address the huge challenges of late-stage attrition and increase the efficiency of drug development. We understand the impact of clinical pharmacology on a drug development program.

The Role of Clinical Pharmacology in the Drug Label

 

Contact us to learn how we can help you devise clinical pharmacology strategies that benefit your program.

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