A comprehensive global drug development lifecycle management strategy is critical to drive maximum product value. At Parexel we are uniquely able to support this due to our broad range of (1000+) regulatory experts (including approximately 100 former regulators, in 110 countries, including the increasingly important Asia markets), together with our strategic commercial consulting division Health Advances.
Example: Oncology Lifecycle Management (LCM) Strategy: The team was engaged by a multinational life sciences company to prioritize the most attractive follow-on opportunities for their lead oncology compound. Using a comprehensive framework, Parexel evaluated the technical feasibility, development, and commercial attractiveness to build alignment on priority opportunities and recommend development strategies that would optimize the value of the program. We ultimately delivered a strategic roadmap for the most attractive near and long-term LCM initiatives for the lead compound and an evaluation framework for the management team to use for ongoing LCM decision-making.
Furthermore Parexel provides a variety of other services to support necessary initiatives related product strategies and packaging. With vast experience advising clients on such strategies, Parexel can customise solutions to your needs. Any developed solution will span the full lifecycle of product development and strategy. Additionally, with our focus on successful strategy development and outcome, the Parexel team will leverage its internal network of Subject Matter Experts (SME’s) who have extensive experience in relevant projects. Furthermore, our custom tailored, a-la-carte approach will allow your company to effectively plan and manage the overall process, control project costs and integrate any advisory support seamlessly within your ongoing organizational efforts. The attached chart provides further visibility into how we approach this.
Our advisory support services will focus on the following key tenants to support your internal company process and team:
- Advisory support for new product development strategies including product packaging
- Optimizing NPD processes to boost portfolio complexity management and improve efficiency within the R&D organization
- Insights on new innovations for combination products
- Identify and evaluate unmet market needs and opportunities for access
- Gather appropriate evidence to demonstrate safety, value and efficacy
- Prepare for submission and approval and product commercialization
- Drive market penetration and manage product lifecycle
- Identify relevant partnership opportunities, including M&A, licensing, KOL engagement and other potential market enhancements
- Develop a strategy to engage high-volume prescribers and practices to establish market positioning
These outlined services are a core competency of Parexel. We frequently conduct market assessment, indication prioritization for assets, portfolios or new formulations, evaluate whether to conduct trials in additional countries, and provide commercial input into development strategy.
Furthermore, our research and analytics team can provide additional, valuable insights related to specific regions or markets to help with forecasting and adoption acceleration in the marketplace. This global capability allows J&J a strategic, forward looking point of view as the product continues to grow and expand in the marketplace. By identifying potential future markets and opportunities in advance, J&J can position the product for growth prior to the initial market launch.