Market Research Ongoing Market analyses Competition Target audience

Planning Needs x 3 : Full Portfolio & All Products & All Projects ►

Fig. 2.1. Phases (6) - Content - Processes in R&D

[Investigational New Drug application] or CTA [Clinical Trials Application] for Europe), (4) clinical research program,

(5) regulatory review of the NDA (New Drug Application), BLA (Biologics License Application), IDE (Investigational Device Exemption), or CTD (Clinical Trials Document), and

(6) postapproval phase. Within each phase many activities are included, some of which are listed here as examples, but each phase will be discussed at length later in subsequent chapters. The regulatory authority (e.g., FDA) and company interactions are now several-fold throughout the product development timeline, intended to be an iterative, supportive, and collaborative process, while regulatory compliance and public protection remain as paramount functions of government. Four other activities that occur throughout the drug development process are presented. Planning for the products, overall portfolio, and individual projects is an overarching process. Government regulatory inspections of research, manufacturing, or clinical operations can occur at any time. Manufacturing is refined repeatedly to provide the best quality product, improve the output, and reduce costs, lowering the cost of goods. Quality assurance (QA) is performed continuously to assess and assure attainment of quality goals. Marketing obtains information repeatedly about the unmet need, diseases, therapies, the ideal product, marketplace, competition, thought leaders, providers, payers, patients, and sales opportunities, in order to fine tune the strategies, targets, research plans, and the marketing and sales plans [23].

Planning and governance in R&D requires corporate plans (both strategic and operational) that must be global, comprehensive, and focused on critical pathways in the product research and approval process. A representative global plan involves, for example, seven possible overarching programs or functions of the company that comprise such critical pathways for product development: global project teams, clinical (and marketing) strategy, market development, clinical operations plan (studies), regulatory milestones, safety updates, and manufacturing updates (Fig. 2.2). Their integration, the tracking of progress, and the decisions (go-no go) are the responsibility of senior management, through optimal leadership, organizational effectiveness, and portfolio product planning. The global product plan also will include three other elements, as shown in the diagram, to plan for and help assess progress on product advancement from the lab toward approval in the seven critical pathways: (1) decision points at key milestones to anchor and guide senior management and the company, (2) a timeline that integrates the critical pathways and for gauging progress, and (3) a planned evolution in the nature of the team as the product status matures. Within each of these critical pathways, major milestones are established that must be achieved and then reviewed and approved by senior management for a product to advance. Costs and budget projections must be identified annually as well.

The global project team creates the global plans for product advancement incorporating the major work outcomes or milestones from the other pathways, for example, target indications, desirable product profile, studies to be done, safety reports, manufacturing needs, budget needs, and sales forecasts. Membership on the team evolves over time as the product matures and the focus of work changes from a purely research focus to market launch mode; however, always a dual science and marketing approach needs to exist. The clinical

7 Plan AreasiT

Decision Points: 0

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