NDA Partners Introduces Quantitative Drug Development Strategies Practice

Our new QDDS Practice will enable rapid development and approval of drugs to meet unmet medical needs via FDA’s expedited approval programs, 505(b)(2) drug applications, as well as to satisfy requirement for pediatric labeling under PREA.

NDA Partners Chairman Carl Peck, MD, announced today the formation of a specialized practice area in quantitative drug development strategies (QDDS) to address the needs of its clients. Utilizing state-of-the art quantitative methodologies and data-driven approaches, including quantitative clinical pharmacology, PKPD and PBPK modeling, clinical trial simulation, and adaptive trial designs, the new QDDS Practice is intended to helps clients address important issues such as predicting optimal dose and clinical outcomes more accurately, optimizing information value and efficiency of clinical trial designs, identifying patients who would benefit most from therapy, and producing compelling evidence of effectiveness. By focusing on the most clinically relevant development questions, NDA Partners will support the design and execution of clinical trials that can accelerate development programs and that produce high-quality regulatory packages containing the data needed to secure regulatory approval without delays.

The new QDDS Practice is led by Roger Williams, MD, a Partner in the firm. Before joining NDA Partners, Dr. Williams was Chief Executive Officer and Chair of the Council of Experts at the US Pharmacopeial Convention; Director of the Office of Generic Drugs at the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER); and Deputy Center Director and Director, FDA Office of Pharmaceutical Sciences (CDER). He is an expert in clinical pharmacology, has been board…

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