Changing the game in drug development

As clinical pharmacology comprises more than 50% of a drug label, the need to understand how to optimize safety and efficacy in drug development is critical to your program.

We understand the impact of clinical pharmacology on a drug development program and devise strategies to harness that knowledge toward a more successful program in consideration of:

  • The rigors and latest thinking on the part of regulators
  • Speed, efficiency, and optimization of the drug development process
  • The competitive landscape and a ‘pharmacology-to-payer’ perspective

Clinical pharmacology can address the huge challenges of late-stage attrition and increase the efficiency of drug development.

We partner closely with our clients, forming one cohesive and integrated team. What our clients say:

“What I love most about working with Certara is their experience and expertise as well as their collegiality.”  – Executive Director of Clinical Pharmacology at a Japanese public pharmaceutical company

“Certara’s team thinks outside of the box.  They also move quickly.”  – Director at German-based large pharmaceutical company

Early engagement saves time and money

Early engagement assures that you are designing studies, collecting data, and anticipating the needs of regulators.

Starting now will enable go/no-go decisions, ramp up the drug development cycle, and potentially minimize or even eliminate some clinical studies.

The concrete benefits of our programmatic approach and quantitative methodology can be achieved throughout the development cycle. 

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Develop a clinical pharmacology roadmap

We typically begin with an assessment, diagnosis, and gap analysis. Next, we develop and implement a clinical pharmacology roadmap that translates model-informed drug development (MIDD) into the decision-making process and leverages all data to align with that optimized clinical strategy.

Having sat on both sides of the table at critical regulatory meetings, we are confident in our recommendations and know how to best leverage clinical pharmacology and MIDD throughout your program.

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Questions to ask in a clinical pharmacology gap analysis

• Will the completed or planned studies be adequate to support the OCP question-based review and labeling?
• Are the data collected sufficient to support planned analyses?
• Does the quality of existing data, analyses, study designs, and overall clinical approach support the desired regulatory strategy?
• Are we leveraging the ‘best’ science and technology available?
• Does the data support the goals of the TPP?
• Is more evidence needed? And if so, is the best way to obtain this evidence through standalone studies or through quantitative analyses?

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Julie Bullock, PharmD Vice President, Global Head of Clinical Pharmacology & Translational Medicine

Julie has over 10 years of drug development experience within the FDA and contributed to over 14 new molecular entity approvals. She has unique insights into pediatric development, PK/PD analysis and approaches for biologics, oncology dosing strategy, and development of breakthrough therapies and accelerated approvals.

Rajesh Krishna, PhD Sr. Director, Clinical Pharmacology Consulting

Rajesh has more than 20 years of drug development experience with past leadership roles in product value enhancement and quantitative clinical pharmacology at Merck, Aventis, and Bristol-Myers Squibb.  He holds an adjunct assistant professorship in therapeutics at Thomas Jefferson University.

Nolan Wood, PhD Sr. Director, Clinical Pharmacology Consulting

Nolan has more than 25 years of global drug development experience, specifically extensive clinical pharmacology experience of drug development programs at all stages of development, from first-in-human studies through to regulatory submissions.

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