a. Accelerating preclinical development to clinical proof of concept
During the exploratory phase of medicine development it is critical that development candidates that do not have the capacity to become a medicine are identified efficiently, and no-go decisions made swiftly and definitively. Stopping non-viable candidates frees up resources to be re-deployed on the next promising potential medicine.
d3 utilizes modern techniques to maximise the efficiency of early phase development, with the goal of delivering rapid and efficient Proof-of-Concept. Our translational medicine and Phase I approach begins with a focus on directing a preclinical program that will meet the objectives of a customized clinical development program. The integration of biomarkers including consideration of personalized medicine opportunities, quantitative and translational pharmacology , use of appropriate patient population(s) and/or volunteers, and adaptive study designs both maximizes the quality and enhances efficiency. The result is the highest quality data available for decision-making.
b. Accelerating Clinical Development and Launch
Especially important during the later phase of medicine development it is critical that development programs are enabled to withstand scrutiny of both regulators and payers.
d3’s experience and expertise extends across the range of activities required to design and successfully implement global clinical development programs for regulatory approval and product differentiation. Thought leader and regulatory interactions, development of late stage and post-approval clinical protocols, medical monitoring, strategic planning and execution of a label-enabling clinical pharmacology plans, preparation of study reports, representation at health authority meetings, and writing of NDAs help to ensure a successful outcome to maximize the impact of a new therapeutic entity.
c. Application of quantitative methods to strengthen decision making
Quantitative pharmacology and pharmacometrics are core competencies for modern drug development. d3 has significant experience in defining customised pharmacometric strategies, and directly deploying quantitative approaches that have demonstrated a real impact on both internal decision-making and key interactions with health authorities.
We have extensive experience in applying new disease models to predict clinical outcomes, preclinical estimation of the human efficacious dose, real-time simulation of pharmacokinetics/pharmacodynamics to inform ongoing studies, and population pharmacokinetic/pharmacodynamic analyses for regulatory submission. We are continuously exploring ways to enhance the impact quantitative methods on decision making including integration of quantitative pharmacology with epidemiology and health economic disciplines.
d. Support interactions with Health Authorities on innovative development programs
Development teams need to be prepared for high stakes strategic and tactical interactions with many counterparties as a new medicine progresses towards and beyond its initial approval.
d3 has extensive global experience in the requirements for, and achievement of, successful regulatory submissions and approvals. This experience includes first in human trial applications, pediatric filings as well as NDA and supplemental NDA approvals. d3 experts have been involved and presented to major regulatory authorities (including MHLW, EMA, CHMP) and successfully at numerous FDA Advisory Committee Panels, and has growing first-hand experience in the successful bridging of NMEs to facilitate development in Asia-Pacific markets, including China. d3 has extensive experience of working both in the developed world and in emerging markets.