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Provider Acceptance

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Fig. 2.7. Profits in the Paradigm (P 8th Power)

Fig. 2.7. Profits in the Paradigm (P 8th Power)

of documents filed by the company with the regulatory authorities intended to achieve product approval.

The next parameter of the product development paradigm involves the eight Ps for the profits necessary to fund all the work (Fig. 2.7). Profitability will only occur with the development of both medically and then financially successful products. A blockbuster describes such a product that achieves a sales level of $1 billion per year. Profitability of a product and the company is predicated on eight parameters to be attained; meeting an unmet patient medical need; good provider acceptance for an innovative product based on its safety, efficacy, and convenience (sound scientific information); purchaser (hospitals and physician offices) acceptance to minimize barriers to access to products; payer acceptance with willingness to pay for products based on clinical utility and value to health care system; a competitive price premium that can be charged for an innovative product; patent protection offering opportunity for sustained sales over several years without generic competition; aggressive promotion to achieve the sales level (e.g., $50 million-$100 million for launch phase of marketing); high prescription volume from the providers; and low production costs in the manufacturing and distribution of the product (reasonable cost of goods [COGS], that is, less than 25% with a target of 10% of the sales price.

The company leadership, the senior management team, needs to exemplify and foster certain principles or behaviors that will stimulate creativity, productivity, and success in their staffs. Yet again, this area of the paradigm involves eight Ps or eight principles (Fig. 2.8). Purpose is needed to generate motivation and offer overall direction for the organization, which often is captured in a corporate vision and in mission statements that must be reality and not a set of words. Strategic planning frames the vision and mission with strong disease, product, and market opportunities, appropriate resources, and measurable targeted goals, all integrated across the organization. Principles about how the company operates day-to-day for patients, employees and stockholders serve powerfully to motivate, encourage, and guide the organization. A sense of satisfaction from the contribution to better

Fig. 2.8. Principles in the Paradigm (P 8th Power)

Patients

Payers

Politicians

People/Players

^ Providers/Practitioners

Public

Professionals - Company

Principal-Investigators

Fig. 2.9. People in the Paradigm (P 8th Power)

quality health care for their fellow man often is a an important principle and motivational driver at companies. Preparation of the senior team means each part of their organization is ready to optimally perform their share of the product development process with an experienced and trained staff, efficient systems, sufficient budget, and informed and organized management. The executive team needs a dual perspective, that is, to both realize and create the best science (R&D) and also the best sales opportunity (S&M) for the product portfolio. A pioneering spirit is needed to foster smart and innovative risk taking in the organization that can create and sustain scientific advances with market potential. Patience is also a proverbial golden rule for research success, given the time it takes for R&D (5-10 years per product) and the risk spends to be made. However, time is money in business and product development with limited patent lives of products, such that operational efficiency and optimal research planning and execution must be demanded. Finally, the corporate leadership must embrace and consistently support portfolio management, which takes the resources of specialized people with budget authority, includes both support and oversight over departments and their management (coordination and leadership rather than actual supervision and decision-making authority), and fosters the communication and collaboration in goals, work items, and outcomes that result in successful product development.

The people that influence the R&D of a product in our paradigm of Ps include eight groups of internal and many external players (Fig. 2.9). For the company players, we have discussed previously in this chapter the operating divisions and the roles of the professionals in general and R&D in particular. The patients are the study subjects participating in the clinical trials to establish safety and efficacy of the products. Principal investigators are the research experts in health care settings, most often at universities, that provide input on study design and perform the clinical trials. Providers and practitioners, especially physicians, pharmacists, and nurses, help identify the optimal product profile by providing market

P'coeconomics _P'cotherapy .Pharmacokinetics .Pharmacovigilance .Pharmacogenomics .Pharmacology .Pharmaceutics (Dose Forms)

.Platforms in Discovery Sciences Pipeline = 8 Pharmaceutical Disciplines = Products

Fig. 2.10. Pipeline in the Paradigm (P 8th Power)

research information, as well as also providing a source of patients for clinical trials and ultimately write the prescriptions. Politicians and policymakers in government create and execute the regulations and laws that govern research requirements, product applications, approval of the products, and marketing practices. Public creates health care demands, and also influences health care systems, providers, and government by prioritizing disease care needs and choices available, as well as impacting policies and practices. Payers, private and government, help set health care treatment goals, product access, and product choices through payment policies. The press serves as a forum for the public, providers, politicians, and payers to communicate and discuss health priorities, express health care or drug needs or problems, and offer some level of education of the public and others about product development challenges, success and failures.

Pipeline component of the R&D paradigm is comprised of eight scientific disciplines, all of which comprise the work of basic research and clinical development and create the information that supports the approval and use of the product (Fig. 2.10). Ultimately, the pipeline also is commonly considered the portfolio of products, in either basic research or clinical ress development stages that the company is studying. These terms for the disciplines are defined in the glossary of terms appendix.

The first five Ps, parameters, in the R&D paradigm (processes, people, profits, pipeline, and principles) need to be executed, coordinated, and integrated. The sixth P in the product development paradigm is performance of the overall company organization and all the personnel, that is, in the departments, the consultants and service vendors, and the investigators at the universities and health care institutions (Fig. 2.11). Eight distinct and complementary practices are expressed as adjectives focused on individual performance. As a composite, they can be characterized as doing more, better, smarter, faster, now and over time. The eight practices although being distinct personal actions need all to be utilized at the appropriate times, in the appropriate setting, and

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