Our holistic development strategy encompasses an exhaustive review of US and global regulatory status and pathways and identifies the product’s target market, clinical development pathway, and commercialization strategy. The strategic planning process should start with a clear understanding of who the patients are that may benefit and their unmet needs. Once the target market is understood, the clinical development pathway can be developed, including identifying the clinical trials needed to support regulatory approval. A well-researched and thought-out strategic plan, developed in consultation with subject matter and regulatory experts, will save time, resources, and costs.
We are keenly aware that the strategic planning process is iterative, requiring updates to reflect new information, and our experienced problem-solving team will be with you every step of the way to ensure your development program remains on-track amidst the changing regulatory landscape.
We have found that success is achieved by focusing on these 3 concepts:
Involve all stakeholders: The strategic planning process is best served when all stakeholders are involved, including scientists, clinicians, marketers, and regulatory affairs.
Be flexible: The strategic plan must be flexible enough to accommodate changes in the drug development process.
Elicit feedback: The strategic plan should be routinely reviewed by experts and stakeholders to assure each aspect is in line with current development plans.
Contact us for the strategic planning expertise your program needs.