strategy even at an early stage incorporates the target indications, ideal product profile, key disease features, key data on the company's product as it exists at that time, marketplace factors (target prescribers, competition, health care system, market size, and payer issues with the value proposition for the product), manufacturing and cost of goods issues, patent status, and any known regulatory hurdles. The clinical strategy must be adjusted over time based on new data becoming available on the science, regulatory requirements, and market from the other pathways. This strategy guides all the other pathways.
Market development pathway includes internal and external roles. Internal company awareness of the drug and health care issues is developed by the team, the planning process, and senior management, including for example likely target audiences, optimal product profile (especially efficacy needed, safety, dosing, and formulation), competitive products, health care environment for the product, reimbursement issues, market size and segmentation, and sales forecasts. A primary question to answer is whether the projected revenue is worth the development costs for a product, which is asked throughout development as more product and related market data become available. This question can be answered "no" even at the end of phase 3 trials. The hurdle is defined differently depending on the size, structure, research interests, budgets, and philosophy of the company. For an Amgen example, they were developing a product for prostate cancer with another small company. The clinical data did not achieve the level of acceptance (efficacy and safety advantages compared with the proposed product profile and competitive products in their opinion) compared with the future research and market costs to Amgen, especially with all its other priorities. Amgen discontinued the license and gave the product back to the originator company, who subsequently continued the work and have received approval, but the drug was taken off the market for past sales. Externally, a novel product, or really any product, presents to marketing the exciting challenge of preparing the marketplace. For example, activities include educating the medical community about the new scientific advances, working with and seeking input of thought leaders for the target disease, creating public awareness, preparing the distribution channels, setting up reimbursement systems, preparing the sales force (their education of disease, product, health systems, providers, and marketplace), and creating the promotional materials.
The clinical operations (studies plan) includes all the different studies from across the company and around the world to be done to create the product profile, the data for product approval, and the data for product acceptance by providers, payers, and health systems in all countries. Certain countries may have specific data needs for approval and special studies to be done. The potential indication is the primary target for the studies' plan, along with the ideal package insert (PI). The proposed PI can guide the studies plan to fill in all the necessary elements (e.g., mechanism of action [MOA], efficacy, dosing, formulation, and stability). Regulatory milestones in the planning are probably the most significant landmarks for a product's advancement, where regulatory authorities have established requirements in content, formats, and timing of applications and reports that must be met, along with formal submissions to or meetings with them (e.g., IND, end of phase 2, NDA).
Safety of a product in the studies plan is such a major clinical question in product development plans that it usually is set apart from the rest of clinical work as a separate critical pathway. It needs special attention to ensure patient safety in the thousands of patients who will use the product after marketing. In the role of protecting the public, safety is the most significant focus for regulatory authorities, as well as the company. Safety has huge marketing implications as well in limiting the utility of the product in the mind of the provider and limiting the market. The worst case scenario needs to be anticipated as best as possible and avoided; that is, removal of a product from marketing after its approval because of serious and unexpected adverse experiences. Certain types of adverse reactions may require special attention in product development and added study and resolution, especially the ones that have led to such withdrawals (e.g., hepatotoxicity and cardiovascular events). Over the past 20 years, 21 drug products have been withdrawn from the market because of adverse events; the two aforementioned problems led to 12 of the 21 withdrawals. We need to realize that the majority of clinical studies are designed to evaluate efficacy as the primary end points with safety information always collected but derived from signals that appear during the course of studies. These signals may lead to the need for studies designed to adequately capture the safety profile of the product. Manufacturing issues are another critical pathway and have substantial impacts on clinical development and marketing. Can the formulation perform in the marketplace? Can it be manufactured in sufficient quantity, scale-up, for clinical trials and then meet marketing demand? Is the formulation for dose-response trials and phase 3 trials identical to the intended marketed product, as required? When does the new physical plant need to be built (a risk spend, capital outlay, initiated often 5 years before approval)?
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