Enterprise Architecture and Its Implementation in Federal Domain

Enterprise Architecture and Its Implementation in Federal Domain Definition of Enterprise Architecture (EA) and Federal Enterprise Architecture According Michael Platt, â€Å"enterprise architecture (EA) is a conceptual blueprint that defines the structure and operation of an organization† (Platt 5). This definition takes into account how â€Å"an organization can effectively use EA to achieve both its current and future aims† (Platt 5).Advertising We will write a custom essay sample on Enterprise Architecture and Its Implementation in Federal Domain specifically for you for only $16.05 $11/page Learn More This means that an organization must define its business vision and strategies in terms of enterprise aspiration by determining, improving, and communicating main needs, rules and models which demonstrate the organizational future aspiration and create chances for its development. The EA scope must include people, information and technology, stages, existing relationships, and contacts with the external fa ctors. EA provides whole-system solutions that cater for business opportunities and challenges of the organization and offer solutions needed for the implementation of the EA system. EA offers advantages in terms of enhancing decision-making, adjusting according to the needs of the market, avoidance of redundancy and inefficiency, making maximum use of organizational resources, and reduce staff turnover. The Federal Enterprise Architecture (FEA) is an initiative by the Federal government to combine its agencies and their related functions under one and available-everywhere enterprise architecture. FEA initiative is still under development, and its main applications are not yet available. However, the program started long ago, and there has been failures, and improvement in its development. Studies view FEA has a system with only five performance models. These include service, data, business, technical and data models. However, under these models, FEA offers much more than what we ca n see. The five models entail ideas on how we should view EA under the segment models. There are also collections of reference models to demonstrate various aspects of the EA under the five models, and also stages of developing an EA platform. This model provides opportunities for movement from a pre-EA to post-EA model. EA also has a cataloging taxonomy for resources that are within its scope. In addition, it also has a measuring system that determines its success in enhancing business values. This analysis shows that EA has many components that the models highlight. It offers the necessary materials needed to create an EA for the most complex and elaborate organizations like the US government.Advertising Looking for essay on business economics? Let's see if we can help you! Get your first paper with 15% OFF Learn More The FEA-Program Management Office (FEAPMO) puts it in totality that FEA offers a common language and framework to describe and analyze IT in vestments, enhance collaboration and ultimately transform the Federal government into a citizen-centered, results-oriented, and market-based organization as set forth in the Presidents Management Agenda (The Chief Information Officers Council 25). Fig 1: Segment map of the federal government Enterprise Architecture Framework and Federal Agencies and their mission alignment The FEA offers a general approach for acquiring information technology (IT), using and discarding within the Federal government domain. In this respect, EA helps the Federal government aligns its resources so as to enhance business values and assist government agencies to perform their main missions. In addition, it offers a plan for transformation from the existing state to the preferred future state. Thus, FEA is an EA that will help the Federal government achieve its desired objectives. The US government based this platform on Clinger-Cohen Act and attempts to align it with the budget. The main aim of the FEA is to facilitate â€Å"sharing of information, enhance service provision for citizens, and reduce costs† (CIO Council 24). The FEA works on a common platform that allows for IT acquisition within the Federal government (CIO Council 24). FEA has offered E-governance, change management, program management and deployment system in the Federal government missions. It is the responsibility of the agency to control and manage the processes and applications of the EA in service provisions and policies implementation. Every agency is also responsible for sponsoring their EA at the executive level, allocation of resources, and appointing its Chief Architect. The agencys office carries out the maintenance, development and implementation of the EA. This implies that all agencies must have the capacity to manage any change in the system, artifacts, and EA documents. At the same time, every agency must be in a position of facilitating the deployment and accessibility of EA content to the ir intended recipients and user community.Advertising We will write a custom essay sample on Enterprise Architecture and Its Implementation in Federal Domain specifically for you for only $16.05 $11/page Learn More This should also include training, communication and repository deployment. Further, for accountability, every agency must be able to avail the artifact in every level of EA and offer justification in case of failure to provide artifacts. The rationale for using this approach is to ensure effective governance and management of policies according to the compliance and alignment with the EA procedures, and stages in order to offer the executive the needed support. Change and system setups are essential parts of managing the EA system. This is necessary so as to keep EA processes and outcomes current for factual information due to its role in IT investing and agencies strategic planning. All the stakeholders of the EA must be able to understand its processes and outcomes. Overview of the Federal Enterprise Architecture The FEA functions as a business-based framework for the Federal government and its agencies. It helps in developing IT investment portfolios according to different Federal agencies processes and functions, in addition to providing cross-agency requirements. The FEA has many artifacts under its various models to support the agencies functions and processes. The FEA framework works under five models in order to provide benchmark terms and scopes of EA; thus, it facilitates â€Å"collaboration and sharing of information among the federal government agencies† (Bernus and Nemes 179). Business Reference Model The Business Reference Model (BRM) provides the business side of the different roles of the Federal government. For instance, under natural resources, BRM may provide a benchmark business function as water resource management. We may take this as a line of business function for citizens’ business ar ea. The BRM is mainly framework that relies on function capabilities so as to describe functions of the business Federal government, irrespective of the Federal agencies that carry out such duties. The BRM gives step-by-step and organized patterns for describing the daily business activities of the Federal government through a performance-based approach. The BRM is the top layer of FEA, and it serves the main purpose in â€Å"data analysis, technology, and service components viewpoint† (CIO Council 24). It has four domains. Services For Citizens Mode of Delivery Support Delivery of Services Management of Government Resources The BRM framework is rather functional than organizational in relations to the Federal government. The BRM overrides the functions of agencies in describing duties such as internal operations and services accorded to the citizens independent of the performing office, bureaus, or agency.Advertising Looking for essay on business economics? Let's see if we can help you! Get your first paper with 15% OFF Learn More It describes the Federal government based on general business areas instead of each agency. This approach enhances collaboration among various agencies and makes the BRM serves the main purpose of the E-government strategy and the foundation of FEA. The BRM offers an improved approach to the Federal government operations. However, we must note that it is only a model which we can only realize its effectiveness when used well. It core approach can facilitate low collaboration and description in Federal government. In addition, it can achieve little in accomplishing the aim of â€Å"the E-government if policymakers do not incorporate it into EA and as part of management platform of all Federal branches† (CIO Council 24). Components Reference Model (CRM) The Component Reference Model provides a performance-driven and business view of the platforms, which can offer support to the business functions of the agencies. It may also classify service components along the line of the sup port they provide or performance objective they fulfill. The main purpose of the CRM is to support the discovery of the Federal government business and use of service components in the investments of IT and resources. The CRM relies on both vertical and horizontal scopes, which are independent of the function of the business. It can offer a leverage foundation that can â€Å"support parts, business services, application functionalities, and the reuse applications† (CIO Council 24). The CRM domain consists of the following components â€Å"Customer Services, Process Automation Services, Business Management Services, Digital Asset Services, Business Analytical Services, Back Office Services, and Support Services† (CIO Council 24). These domains have their Service Types. For instance, under Customer Service Domain, we may find â€Å"other three sub-domains, namely, Customer Relationship Management, Customer Initiated Assistance, and Customer Preferences† (CIO Counc il 24). Technical Reference Model (TRM) The TRM provides definitions of â€Å"benchmarks and different technologies that architects can use in creating IT platforms† (USA Government 1). For instance, TRM may create a â€Å"definition of HTTP under a subset of the transport system† (Bernus and Nemes 179). TRM has parts and technical framework that differentiate information technologies and service standards so as to allow delivery and access of Service Components and functionalities. TRM also functions as a unifying platform of E-government and existing agencies by offering a basis that enhances the reuse and adaptability of Service Components, and IT from a wide view of Federal government. The basic parts of TRM are mainly the following. TRM has Service Areas. These mainly represent complex layers that support a secure creation, swap, access and delivery of Service Components. Every Service Area sums up technologies and standard into functional areas of low-level tiers . This place also has several categories and standards of Service Components. This step-by-step arrangement of layers offers the framework to technologies that ultimately provide support for the Service Areas. TRM also has Service Categories. These sections group the low-level technologies according to their functions and business utilities they fulfill. As a result, a Service Category will also contain its components of Service Standards. There are also Service Standards in TRM. Service Standards mainly depict the technologies and standards that provide support for a Service Category. Most Service Standards use â€Å"illustrations and specifications of plain text as indicators so as to support mapping of the agency into TRM† (Bernus and Nemes 179). TRM uses a general, â€Å"collaboration, standard vocabulary, interagency discovery, and interoperability to align Federal capital investments† (Bernus and Nemes 179). This approach offers the Federal government and its age ncies opportunities for taking advantage of economies of scale through â€Å"identifying and reusing the best technological solutions for enhancing missions, and business applications in the model architecture† (Bernus and Nemes 179). The hierarchy of TRM defines the technologies and standards that function in support of the FEA and create secure channels of delivery, swap, and building of business and functional Service Components. These applications work in a service-oriented or component-based architecture. Data Reference Model (DRM) The DRM defines the â€Å"total level, information, and data that offer solutions to government program and operations lines of business† (Bernus and Nemes 179). DRM provides opportunities for different agencies to define the â€Å"types of involvements and interactions that happen between the citizens and Federal government† (Bernus and Nemes 179). DRM offers a thorough creation of the government information into a high degree o f details. DRM also provides a chance for grouping Federal data and notice any duplicates regarding data constructs. Performance Reference Model (PRM) The PRM focuses on providing standard methods of stating the value that the EA delivers. According to PRM, quality may be a technological gauge area that defines how technology can fulfill functionality and requirements in its role. Thus, PRM assists in generating improved information content for enhancing day-to-day decision-making and strategic options. PRM also enhances alignment of inputs and outputs in order to distinguish the outcomes of the desired results. In addition, it also enables policymakers identify areas of improvement across the organization. The PRM relies on many ways of carrying out functional measurement. These methods include the Balance Scorecard, the Theory of Constraints, Methodology for value measuring, Baldrige Criteria, Value chain, and Program logic. Further, the PRM uses methods within the agencies for me asuring, such as â€Å"GPRA, EA, PART assessments, Investment Control and Capital planning† (CIO Council 24). The PRM has four areas of measuring functionalities in the EA. Mission and Business Results Customer Results Processes and Activities Technology FEA and Managerial Flexibility The FEA initiative provides strategic options that may allow the system to change scale, defer, explore, grow or combine sequential together. These adaptabilities allow the FEA to use the options for analysis of further details through breaking down and relating each area in building decision trees for benefits of making optimal decisions. Thus, managerial flexibility in the system provides opportunities for the investment to conduct any analysis in case of availability of new information. However, the presence of flexibility in the system changes characteristics of the FEA risk initiative. Consequently, this changes the cost of capital (Brach 370). In this context, risk management forms the b asis of incorporating flexibility in the system. Analysis of Real Options The second to last step under-investment plan relies on analyzing the benefits in the decision tree by applying risk-neutral or repeating portfolio methods. The calculation takes into account many investment portfolios depending on various perceptions of risks and related trade exchanges. According to Benaroch, there are several configurations that we cannot exhaust; thus, he suggests â€Å"three rules of excluding implausible configurations† (Benaroch 45). First, â€Å"consistency between sequences of options in an investment configuration with the sequence in which options materialize in the investment lifecycle, second, ability of options to coexist in an investment configuration, and finally, consideration for configurations involving maximal subsets of viable options† (Benaroch 45). The concept of Reuse and Cost Saving in Enterprise Architecture best practices Reuse shows agency achievement in moving towards their target functionality and sharing of services content, and building an environment of service within the agency. Gauging the agency achievements in terms of sharing information usually focuses on reuse. The system uses varieties of arrangements and other similar patterns to measure agency results and combine all requirements in the process of procurement. It can also measure the agency achievements in terms of building a positive service environment so as to enable both the consumption and production of general data, services and component services. At the same time, it will also measure investment accuracy and its mapping categories together with consistency of the Service Reference Model service parts, and TRM service mappings (Groth 51). For an EA to be effective, it must identify chances of consolidating, reuse, sharing, and standardizing. This enhances effectiveness in mission and financial performance among the agencies. This is the only way an agency ca n justify its massive spending in advanced IT systems i.e. by achieving superior outcomes of mission performance (The Chief Information Officers Council 2). Likewise, every agency must demonstrate its reuse of Service Reference Model components, information, infrastructure, and other services and increased levels of services sharing among agencies. Further, agencies must demonstrate an application of a combined purchasing power by reuse of contract and procurement methods for getting needed services. The definitions of segments in a global context enable their reuse across several agencies. For instance, we can map out an application of a given segment, and then apply the same map in other areas of the aim of EA reuse. This indicates that all segments, whether vertical or horizontal, are suitable for facilitating the concept of sharing among the agencies (Sauer and Willcocks 497). Therefore, the initiative of FEA will ensure that the Federal government rectifies the existing lack of integration, immediate response to changes, and alignment. If the agencies can restore the anomalies, then services provisions to the public will be efficient and at low cost through enhanced government processes of services delivery. FEA has enormous potential for cost reduction and cost avoidance. FEA can make the Federal government realize costs reductions and avoidance through helping Federal agencies depend on a single EA platform, instead of developing and redeveloping several business support systems (Mun 46). Therefore, we can look at costs reduction in terms of economies of scale. This is whereby the FEA locates a common function among the agencies and then shows possible areas of cost-cutting through reuse of systems, models, and the entire processes by collaboration. Cost-saving can also occur through sharing of resources. The FEA identifies possible opportunities of sharing resources, such as support services, IT application and other solutions. Finally, the Federal gov ernment may realize cost saving in terms of conducting market research. The FEA depends on constant study of emerging technologies and their applications across the entire organization. The Federal government can share the research results across its multiple agencies, depending on their shared business functions. This will reduce extra costs and time used in conducting single studies (USA Government 1). There are indicators to show how agencies are using FEA and other IT platforms to control their costs. Cost savings and cost avoidance are long-term initiatives of the Federal government, which improve as the system becomes familiar with users. We can locate indicators of cost avoidance and cost savings from the analyses of financial records of the agencies. Every agency must produce its reports on cost savings and avoidance (Perks and Tony 13). Agencies must demonstrate their declining costs in given percentages over the years in IT spending. This may be in relations to the Federal government budget or other agencies. However, the system also allows for readjustment due to factors of inflation or changes in new IT applications at their initial stages. The agencies can decide to redeploy their savings according to their budgets and processes of executions. We can also estimate costs and perform a valuation of benefits. This stage in the process of investment and subsequent control entails establishing the increase in cash flows due to achievement of the desired EA capabilities. The system uses a basis of discounted cash flow (DCF) in its analysis (Benaroch 43). This base acts as the standard for analyses of the project cost savings and cash flows. The system uses the old methods based on forecasting of revenues and costs so as to determine the net present value (NVP). It also takes into account discounts associated with the costs and revenues and their risks at a given rate. Historical data enables the system to perform an analysis based on time-series forecas ting. In case the data is not available, then â€Å"analysts have to rely on assumptions of the management† (Taudes 165). We must also note that most analyses assume no flexibility in pricing (Taudes 165). Benaroch, Michel. Managing Information Technology Investment Risk: A Real Options Perspective. Journal of Management Information Systems 19.2 (2000): 43–84. Print. Bernus, Peter and Laszlo Nemes. A Framework to Define a Generic Enterprise Reference Architecture and Methodology. Computer Integrated Manufacturing Systems 9.3 (1996): 179–191. Print. Brach, Marion. Real Options in Practice. Hoboken, NJ: John Wiley Sons, 2003.Print. CIO Council. A Practical Guide to Federal Enterprise Architecture. Washington, DC: CIO Council, 2001. Print. Groth, Lars. Future Organizational Design: The Scope of the IT Based Enterprise. Chicester: Wiley, 1999. Print. Mun, Johnathan. Real Options Analysis: Tools and Techniques for Valuing Strategic Investments and Decisions. Hoboke n, NJ: John Wiley Sons, 2002. Print. Perks, Col and Tony Beveridge. Guide to Enterprise IT Architecture. New York, NY: Springer-Verlag, 2003. Print. Platt, Michael. Architect, Developer and Platform Evangelism Group. Microsoft Journal 4 (2005): 1-5. Print. Sauer, Chris and Leslie Willcocks. Establishing the Business of the Future: The Role of Organizational Architecture and Information Technologies. European Management Journal 21.4 (2003): 497–508. Print. Taudes, Alfred. Software growth options. Journal of Management Information Systems 15.1 (1998): 165–185. Print. The Chief Information Officers Council. Federal Enterprise Architecture Framework, v 1.1. Washington, DC: CIO Council, 1999. Print. USA Government. Improving Agency Performance Using Information and Information Technology: (Enterprise Architecture Assessment Framework v3.1). Washington, DC: The US Government, 2009. Print.

Presenting Rory Sutherland as a Hero of Advertising Essay Example

Presenting Rory Sutherland as a Hero of Advertising Essay Example Presenting Rory Sutherland as a Hero of Advertising Essay Presenting Rory Sutherland as a Hero of Advertising Essay Presenting Rory Sutherland as a Hero of Advertising BY Jaymes2510 James Essex Presenting Rory Sutherland as a Hero of Advertising Word Count: 1133 Words Born in 1965 in a small town called Usk, Monmouthshire, Rory Sutherland has rose through the ranks in the advertising industry to become one of the most influential fgures in advertising (The Marketing Society, 2013). Rory began his studies at his local school Haberdashers, and then on to further his studies at Christs College, Cambridge. During school, Rory was a mischievous child. His brother recalling a ituation in which, in Rorys Latin class the teacher wondered whether he had time for a new exercise. *dow much time have I got? the master muttered to himself as he looked at his watch. Not long unless you give up smoking, Sir, was Rorys response. (The Wiki Man, 2011) This sense of foolishness and carefree attitude seems to have followed Rory into his later life, work and has possibly made him the influential fgure he is today. Rory seemed to be following in the footsteps of Sir Martin Sorrell from an early age, however it seems that the rebellious attitude seemed to diminish the similarities egan teaching at a grammar school in Aylesbury. This would not last long however. The contents of the staff room proved too depressing to bear (Ogilvy, 2013). After applying to numerous advertising and marketing Jobs, Rory finally landed a position at Ogilvy Mather Direct where things did not improve, Paul ODonnell, chairman of Ogilvy Mather saying he was without a doubt the worst graduate trainee we ever hired (The Wiki Man, 2011). Rory had many Jobs at Ogilvy and it seemed like he was terrible at all of them. Rory always had a keen eye for seeking out new developments in technology and making se of them. Rory Joined the agency at the brink of a technological boom, when computers and the Internet were starting to advance rapidly. When Ogilvy got a new information machine called MAID, (a piece of equipment that would give answers to questions being typed into it), they had no choice but to let Rory use it, as he was the only one that knew how. Paul ODonnell (2011) stated that this was the worst thing they could have let Rory do. Instead of actually planning, he would sit in front of the machine typing in question after question, looking at the answers and saying fascinating, fascinating. After being moved from account management to planning, and then being fired from that, it seemed like there was no hope for Rory. That was until an outcry across the office forced them to give Rory one more chance. He was moved to the creative department and flourished. Within five years Rory was made Executive Creative Director. Rory has become an expert on behavioural economics and believes advertising and marketing must be seen as a science. In a TED Talk filmed in Athens, Rory talks about how Perspective is everything and how much too time is spent looking for technical engineering solutions and not enough time ooking for psychological solutions. Using the following example where he talks about the Eurostar Journey times, he sums his statement up perfectly: Six million pounds spent to reduce the Journey time between Paris and London by about forty minutes. For maybe ten percent of the money you could have paid all of the worlds top male and female supermodels to walk up and down the train, handing out free Chateau Petrus to all passengers. Youd still have five [million] pounds in change and people would ask for the trains to be slowed down. (TED Talks, 2012) This is a brilliant example of the creative and knowledgeable way Rory looks at the dvertising industry and using this insight, he has launched a new initiative called #ogilvychange. Founded by Rory himself and Director of Strategy Integration Jez Groom, #ogilvychange uses leading research in cognitive psychology and the communication expertise of Ogilvy to create a new way of advertising, to change the minds and behavior of the consumers in a way that makes advertising much more effective. Rorys view of looking at advertising and marketing as purely a science rather than an art form is not brand new however. In 1923, Claude C. Hopkins published his book advertising and the need to target the man rather than the masses. In other words, advertising that targets a large quantity of people is going to be less effective than advertising that focuses on targeting an individual, finding out the way they think and targeting a more psychological advertising campaign towards them using a scientific approach. In his book, Claude Hopkins says: Dont think of people in the mass. That gives you a blurred view. Think ofa typical individual, man or woman, who is likely to want what you sell. Dont try to be amusing. Money spending is a serious matter (Scientific Advertising, 1923) Rory seems to be carrying on this scientific approach to advertising, working with big lients such as British Airways, British Gas, IBM and many more to change the way people think and behave. Rory has championed the behavioural economics agenda at Ogilvy Mather and working with a team of experts, he will oversee the future of Looking at Rory Sutherland, as a hero of advertising at the present moment may be slightly difficult to comprehend, after all, Claude Hopkins pioneered the idea of scientific advertising and as such, shaped the way advertisers target their consumers. As a personal opinion, I would argue that Claude Hopkins has made much more of a contribution to advertising in the behavioural economics and sychological advertising segment and is therefore more worthy of the title Hero of Advertising. However if we look at the work Rory Sutherland is currently undertaking at Ogilvy Mather, the use of his understanding of behavioural economics and psychological advertising to create a whole new agenda for the company, #ogilvychange, I can not say that he has had no contribution to the advertising industry. His skills speak for himself; his bubbly and rebellious attitude from a young age has made him a charismatic person and as such, he has managed to rise through the ranks at Ogilvy Mather at a substantial rate. Perhaps this is why he has such an understanding of behavioural economics and consumer psychology, because he can relate to the consumer on a human level. As such, although Rory Sutherland may not be worthy of the title Hero of Advertising at the present moment in comparison to such pioneers as Claude Hopkins, I can see the use of his understanding of consumer psychology and his founding and running of #ogilvychange putting him in a prime place to soon become a Hero of Advertising. Hopkins, C. , 1923. Scientific Advertising [online] Available from: http:// www. scientificadvertising. com/ScientificAdvertising. f [Accessed October 2013] The Marketing Society, 2013. Ogilvy and Pimp My Cause partnership [online] The Library. Available from: https://www. marketingsociety. co. uk/the-library/ogilvy-and- pimp-my-cause-partnership [Accessed October 2013] #ogilvychange, 2013. Little Ideas From Big Thinkers [online] #ogilvychange. Available from: ogilvychange. com/ [Accessed October 2013] Og ilvy Mather. 2013. Rory Sutherland. [online] Available from: http:// www. ogilvy. co. uk/our-people/rory-sutherland/. [Accessed October 2013] Ogilvy Mather. 2012. Ogilvy Mather UK Launches new Behavioural Sciences Practice [online] Available from: ogilvy. co. uk/blog/ogilvy-mather-uk- launches-new-behavioural-sciences-practice/ [Accessed October 2013] Ogilvy Change, 2013. An Introduction to #ogilvychange [video, online] Available from: youtube. com/watch? v=PYoD1 IWEYpg [Accessed October 2013] Sutherland, R. , 2011. The Wiki Man [online] London: Its Nice That and Ogilvy Group Ted Talks, 2012. Rory Sutherland: Perspective is Everything [video, online] Available from: ted. com/talks/rory_sutherland_perspective_is_everything. html [Accessed October 2013]

What determines the research and development costs for innovative new PowerPoint Presentation

What determines the research and development costs for innovative new prescription drugs, how might legal and ethical considerations affect the cost of developing a new prescription drug - PowerPoint Presentation Example As a function of describing and critiquing each of these constraints, this author will analyze each of these factors and attempt to draw a clear level of discussion as a means of identifying the core components and key considerations that must be engaged with as a function of the developmental cycle for new/prospective pharmaceuticals. As a guiding entity of the process, the legal departments of the requisite entities must be continually engaged and aware of the process. This represents an added cost and necessity that each and every pharmaceutical firm engaged in research and development must necessarily incorporate a team of legal experts and lawyers to guide them through each and every process of clinical trials, reporting requirements, paperwork, and associated compliance issues. Ultimately, economic theory dictates that that price discrimination corresponds to the following three market conditions: the power of market sellers, the segmentation and overall price responsiveness of the market, and the direct and indirect potential that exists for arbitrage. With respect to market power, this is a concept which can simply be understood as a function of the ability of the seller to raise its prices as compared to the other sellers that exist within the market. Obviously, in the case of a brand name drug that has r ecently been cleared by clinical trials and is available to the marketplace, the ability of the seller to raise his/her prices above that of the competition is very high due to the fact that no perfect substitute exists and there is a near perfect monopoly engaged by the given pharmaceutical manufacturer; albeit for a limited amount of time (Gupta et al 2011, p. 15). As a way of understanding such a construct to a more full and complete level, the researcher and/or reader must consider the total cost that is necessitated in bringing a drug to market in the first