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Homework answers / question archive / Project Plan This is the second component of your 18-Week Project
This is the second component of your 18-Week Project. Computerized solutions to business problems may take several forms: develop your own solution from scratch, customize an off-the-shelf solution, and outsource all or part of the project or a combination of any one or more of these approaches. Each of these alternatives has its own risks and rewards. Each is capable of assisting an organization maximize profits and revenues. Each might be capable of providing competitive advantage, if positioned properly. However, each alternative must be carefully researched, perhaps even prototyped, to assure proper alignment with the project’s goals.
Based on the opportunity you selected in Week Three (Link to an example of the project http://www.pharmamanufacturing.com/articles/2006/072.html), complete a 2,500-3,250-word R&D project plan with supporting charts that discusses the approach you will use in completing the project. In the paper, do the following:
Make sure that all charts and tables created from charting and spreadsheet programs are incorporated into a single Word document.
Pfizer – Opportunities Analysis
Executive Summary
Pharmaceutical industry is going through tough times and the big pharmaceutical manufacturers like Pfizer are passing through an era of extreme regulatory and compliance pressures from the regulatory authorities, pressure to reduce drug costs, threat from generic drug manufacturers due to patent expiry of blockbuster drugs and increasing demand and pressure from the consumers to come up with new and innovative drugs rapidly. The population today needs new exotic drugs. Counterfeiting and Piracy are rampant throughout global supply chains and it is very hard to "track back" and find out where they came from, or who made them. It costs an average of $800 million to bring a drug to market, and legislatures are considering reducing patent protection.
Pfizer’s situation is no different in these times. Some of the key issues faced by Pfizer today are:
In these tough times, Process Analytical Technique or PAT, which is an FDA initiative, is all set to change the picture of pharmaceutical organizations. Even though it may not resolve all the problems for companies like Pfizer, PAT can surely bring the much needed improvement in manufacturing efficiency, cycle times and relationship with regulatory authorities. Pfizer has been a pioneer and leader in terms of PAT implementation and is a step ahead in this regard as compared to its peers. However, there has been a continuous effort from Pfizer and other industry experts to develop Standard PAT software to enhance the benefits and performance of PAT software. The primary reason for the slow development of PAT is the lack of common standards and companies like Pfizer are trying to overcome this problem by working closely with industry experts, end users and software vendors.
The face of the customer is fundamentally changing for drug manufacturers like Pfizer. During an interview with Andrew Grenville, Andrew says, “The key trend we see developing is a better understanding of opportunities and limits of the role of patients as consumers in driving prescription drug use.” Some of the aspects that were brought up during this interview were the choice the consumer makes when making the purchase, the consumer making the choice to continue taking the drug and the last element is the limit of consumerism.
One of the major shortcomings for pharmaceutical companies is their high cost structure and the intense pressure to reduce the cost of drugs. This is an opportunity in disguise in the sense that is driving the pharmaceutical companies like Pfizer to radically transform and improve their manufacturing productivity and operations by implementing new technologies and tools such as Process Analytical Technique (PAT), which greatly enhances the manufacturing productivity and changes the whole structure of a pharmaceutical firm. Thus, this shortcoming becomes an asset as firms resort to better and improved technological innovations to sustain in the competitive marketplace.
In order to assess Pfizer’s readiness with respect to technology related changes, let us examine some of the salient features of its vision and values, as depicted on its corporate website:
“We are deeply committed to meeting the needs of our customers, and we constantly focus on customer satisfaction”
“Innovation is the key to improving health and sustaining Pfizer's growth and profitability. Innovation is the key to improving health and sustaining Pfizer's growth and profitability. The quest for innovative solutions should invigorate all of our core businesses and pervade the Pfizer community worldwide. In our drive to innovate, we support well-conceived risk-taking and understand that it will not always lead to success.”
“We know that to be a successful company we must work together, frequently transcending organizational and geographical boundaries to meet the changing needs of our customers”
These statements strongly reflect the focus of the company on attaining customer satisfaction and show its commitment with respect to make innovative changes in order to meeting changing customer needs and wants. Thus, it is sage presume that Pfizer’s corporate culture will be ready to adapt to technological changes, given that it leads to significant improvement in customer satisfaction and quality. Pfizer will not shy to experiment on new and improved technologies that can provide a huge impetus to its global R&D efforts for developing new and innovative products for improving the health of the people.
Pfizer’s investments in R&D are fairly large as compared to other players in the pharmaceutical industry, which provides another strong support to the fact that Pfizer is not afraid of innovation and risk.
The biggest opportunity is to meet the unmet needs of the consumers in terms of coming out with new and exotic drugs. Therefore, drug companies can sustain long-term revenues and profitability by focusing on research and development and coming up with new and innovative drugs on a continuous basis. The primary aim of any pharmaceutical company like Pfizer is to provide world-class drugs at affordable prices for improving the health of the target consumers or population, and the realization of this opportunity goes with this strategy and goal. By doing this if Pfizer can become automated in it’s manufacturing and packaging departments it would help with the reduction of workforce and the bottom line. The second important is provided by improved technological tools like PAT, which significantly improves the company’s manufacturing efficiency and productivity and results in speeding time to market for new products. The realization of this opportunity also aligns with the overall strategy to achieve cost effectiveness, efficiency and productivity, which in turn, provides significant boost to the company’s top line and bottom line revenues and profitability.
Process Analytical Technology (PAT) is a recent phenomenon in the pharmaceutical industry. Though it has been in other process industries for years, it now bringing similar improvements and benefits to many pharmaceutical applications.
PAT is defined by the FDA as “A system for designing, analyzing, and controlling manufacturing through timely measurements (i.e. during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.”
At present, the pharmaceutical industry is plagued with sparse pipelines, corporate mergers, less time before commercial drugs go off patent, market dropouts from pivotal blockbuster drugs, and pressure from consumers and politicians to produce high-quality drugs quickly. PAT cannot fix all of these problems, but it might affect the business picture of a pharmaceutical manufacturer.
Basically, PAT provides a number of benefits to pharmaceutical companies improved manufacturing increased production uptime, reduced production cycle times, efficiency, and reduced rejects. PAT can also speed time to market for new products, improve operator safety, and improve relationships with regulatory agencies.
To improve productivity, there is growing enthusiasm in pharmaceuticals for PAT, an FDA initiative to improve manufacturing efficiency and product quality, while also harmonizing regulatory expectations. The FDA expects pharmaceutical manufacturers to implement continuous improvement through the PAT framework.
PAT will help pharmaceutical manufacturers design, monitor, control, and predict process performance. Many of these functions are now implemented separately, but PAT promotes an integrated environment that combines modeling tools for design/analysis, process analyzers, and process control/optimization. Knowledge of all these functions is required to efficiently apply these technological innovations to pharmaceutical manufacturing.
One of the major problems and limitation with PAT today in organizations like Pfizer is the lack of communication between machines into one software program to collect data. Each piece of equipment that collects data has its own proprietary software and none of then communicates to each other which mean each and every one has its own PAT. In the early stages of PAT this was the norm, but as we have noticed in today’s advanced technology each and every one of these pieces of equipment must communicate with one another to acquire and process the data. This must be performed in real-time, to the second, so that data can be processed immediately to manage and optimize your control processes.
For example, at Pfizer, the company needs to deal with diverse global supply chains, new measurement methods, and provide more information, both role based and event based, about the process. A lot of the information is more valuable and longer lasting than the batch of product itself. Thus, Scalability is going to be critical for PAT processes in the future at Pfizer. Further, there is the typical gulf between process and IT at Pfizer. Pfizer has islands of automation, and many automation systems have been installed as the result of platform-based initiatives. Point application planning usually drives infrastructure planning. There are the typical domain silos, and the solutions are almost always tactical, not strategic, in nature.
Given this need for an integrated environment, there have been efforts, especially by Pfizer to develop a universal PAT software program, based on industry standards and government regulations. As the FDA explains, “In the PAT framework, these tools can be categorized as multivariate data acquisition and analysis tools, modern process analyzers or process analytical chemistry tools, process and endpoint monitoring and control tools and continuous improvement and knowledge management tools.”
Availability of a PAT software standard could help end-users develop and deploy new measurements by:
The reason for selecting this project as the most critical one among all the alternative projects was based on the strategic advantages and benefits due to standardized PAT software, which will not only result in driving PAT in the pharmaceutical industry but will also, improve the way in which pharmaceutical manufacturers control the processes and predict its performance.
In today’s competitive scenario in the pharmaceutical industry, where the patents on most of the blockbuster drugs are expiring and there is increasing pressure on the companies to come up with new and innovative drugs rapidly, PAT will be a plus for Pfizer in terms of reducing production cycle times and speed time to market for new products. Further, the increasing cost related to PAT would also reduce pressures due to tremendous improvement in processes. The increasing spending on Research and Marketing will fail if manufacturing productivity will not be enhanced. Thus, PAT can significantly improve the manufacturing capabilities of big Pharma companies like Pfizer.
PAT will significantly benefit Pfizer in terms of reducing regulatory pressure, cost related pressures and will complement its huge spending on R&D by enhancing its manufacturing process productivity. Thus, it scores over all other alternative technological projects. PAT has already been an integral part of Pfizer’s strategy and it has been a pioneer in promoting PAT. Thus, it become extremely important for Pfizer to capitalize on its first mover advantage in PAT by removing all the drawbacks and limitations by working in the direction of upgrading the software and IT with respect to PAT with the help of numerous other companies and software vendors.
In order to develop and implement standardize PAT software at Pfizer, the company and the vendors should work together. The collaboration of the end users and the vendors or software companies is crucial because it is essential for the software vendors to understand the real needs and problems of the users and will require their input and assistance with respect to standardizing data and other complex measurements.
A very basic technology roadmap for developing standardized PAT software will be:
Standardize current Measurements
Standardize data
Identify process owners and users for the data
Compile a Master Plan, with key impact assessments on applications, architecture and infrastructure
Leverage current infrastructure and slipstream new capabilities
Let us discuss these elements in detail:
The first step is to standardize complex measurements. Spectroscopy methods are routinely adapted for PAT. Examples are near infra-red (NIR), Raman, UV-visible, fluorescence, and acoustic. Measurement technologies suitable for pharmaceutical needs must be identified. This will help suppliers meet implementation challenges and simplify deployment.
Presently, we spend a lot of time specifying a measurement for a process application. We would like to see standards created that will reduce required time, and make time commitments more predictable.
In the most advanced implementations, PAT systems are used for monitoring, control, and prediction. In these cases, data needs to be exchanged with systems that perform analysis, control, decision making, and reporting. A good first step for data exchange in advanced implementations is to create standard ways of trading data across existing systems.
The master planning effort must align strategies and derive specific objectives for infrastructure, applications, integration, and PAT systems. To do this effectively, all functions must be mapped to domains. New functions, such as process optimization and process improvement, should be considered.
For each of these functions, impacts on level and approach to automation must be considered. This master planning exercise will help end users understand their business’ readiness to embrace continuous improvement outlined in the PAT framework.
We all have to deal with existing systems and infrastructure, even when creating PAT software standards. We’ll have to exchange data with existing systems for process control, enterprise resource planning, laboratory information management, and manufacturing execution. A unified schema is critical to facilitate data exchange among these platforms.
The above-mentioned roadmap to achieve standardization of PAT software can be divided into individual project, wherein each project corresponds to a step in achieving the standardized PAT software. The separate projects will be prioritized as per the steps or the roadmap outlined in the previous section, as it is not possible to skip steps or individual projects or rearrange them in a different manner.
The first step or project of standardizing the measurement and data can be considered the “platform” for the other steps or projects as it will provide a firm basis for the developers and vendors to come up with standardized PAT solutions.
The development of master plan by understanding and assessing the key impact on infrastructure, applications and architecture and by leveraging the current infrastructure will be the major “breakthrough” in this situation as it will take us closer to our ultimate objective.
After development of the plan, the final step of development of the software by the vendors will be a “partnered project”, wherein the vendors will work closely with the end-users to develop the platform as per the master plan and the needs of the end users.
In the analysis of our project, Brainstorming will indeed play a very important role in bringing together news ideas, solutions and proposals for developing standardized PAT software. End users and vendors can brainstorm together in the initial stages to generate various alternative solutions to the problem.
The 5Ws and H technique will be useful in understanding all the aspects of standardizing the PAT software, along with its implications on current infrastructure, applications and processes and other important factors that might be affected due to migration to a common PAT software. Basically, it will allow the project team to take a macro view of the problem and will assist in the development of the master plan, which will take care of all the aspects of the problem.
The force field technique can be useful in the initial stages when standardization of measurements and data will be completed as it will allow the project team to identify all the bottlenecks and problems that can hinder the standardization process and hamper the development of common platform.
References
Burgelman et al, (2004). Strategic Management of Technology and Innovation. New
York: The McGraw-Hill Companies.
Carroll, J. E. (2006). Investing Time to Make Money: A PAT Implementation Perspective. Retrieved October 20, 2006, from Pharmaceutical Technology Web site: http://electronic.pharmtech.com/061005/Page_2.asp
Pillai , V. A. (2006). PAT slaps pharmas with control system aftershave. Retrieved October 20, 2006, from Control Global Web site: http://www.controlglobal.com/articles/2005/536.html
Process Analytical Technology. Retrieved October 20, 2006, from CDER Web site: http://www.fda.gov/cder/OPS/PAT.htm
The convergence of information technology and biotechnology. Retrieved October 20, 2006, from About/Information Technology Web site: http://biotech.about.com/od/informationtechnology/
Thomas, P. (2006). 2006 TOTY Finalist Profiles: Pfizer Common PAT Software Team. Retrieved October 20, 2006, from Pharma Manufacturing Web site: http://www.pharmamanufacturing.com/articles/2006/072.html
(2006). Working for a Healthier World. Retrieved October 20, 2006, from Working for Pfizer: Vision & Values Web site: http://www.lunella.it/pfizer/are/careers/mn_working_vision.jsp
a. Identify the human resources required by your project, including management and end-users, if applicable. Define titles and the skill-sets required for each title. Discuss whether these resources are available or might have to be hired. Estimate the cost of each resource. Human resources costs are available on job sites such as monster.com or available through your Human Resources department. Document the source of your costs. Discuss how you intend to retain selected human resources via compensation and/or reward systems.
Specifics covered by me in the solution:
? Include human, technological, logistical or other resource needs; or tie the involvement of management and end-users to the resource requirements. Discuss required skill-sets and costs. Discuss how human resources will be retained via use of various reward or compensation systems. Provide a listing and discussion of human, technological, logistical and other resources needed for the project and how those resources can be deployed to meet a specific project completion date. Specify tie between resource needs and management and end-user roles for the project. Discuss costs of each resource. Discuss method of retaining selected human resources via compensation and reward systems. Assess the feasibility of other approaches to filling resource needs other than the one(s) chosen. Examples might include outsourcing, contracting, purchased off the shelf resources or other approach.
Solution:
Human Resources: Companies implementing PAT like Pfizer need to make it sure that they have a sufficient staffing commitment to support the deployment of a PAT system. This includes having people qualified to transfer that knowledge to the manufacturing staff. There's a very long learning curve for PAT applications, and firms need to commit to thorough training programs for personnel.
source: http://www.pharmamanufacturing.com/articles/2005/203.html
From the outset, clear and appropriate leadership needs to be established for the migration to PAT. We are currently witnessing a variety of approaches by pharmaceutical companies to project leadership. Some companies have appointed a vice president to co-ordinate the PAT initiative, in other companies it is the production/engineering or quality manager that takes the
initiative and is trying to convince and 'educate' top management. The vital thing is that companies need to be sure that their project leadership is empowered to make all the changes across the company that will be integral to project success.
source: PAT: Evolution or Revolution? by Dr Beatrijs Van Liedekerke, Senior Manager, Enterprise Advisory Department at PricewaterhouseCoopers
A PAT team needs a dedicated core, a cadre of senior-level professionals that will shepherd the program to completion. They can't split their time or orientation while doing so. And they can't do it by themselves. So, a successful PAT management group will use its core personnel for outreach to all affected operations within the company. Historically, PAT team leaders have come from the analytical ranks. They need expertise in production, engineering, finance and regulatory affairs.
source: http://www.pharmamanufacturing.com/articles/2006/042.html
Pfizer already has a dedicated team of 5 experts for the PAT initiative. This 5 member team includes team leader, PAT and IT experts, procurement expert, quality expert and a technical project manager.
Apart from this specialized team, the end users of the PAt software, ie, numerous employees at various levels and departments within Pfizer will also be actively involved in the implementation process as they will define their real needs and preferences and will assist in the smooth implementation of the technique.
The chosen vendor for the development of the software will send in a team of experts for the implementation and development of the PAT software. This team will work closely with the PAt project team within the company.
The future employees at companies like Pfizer after PAT implementation will be "process engineers," who understand processes and how plants work in general. They will be experts in getting a process to work inside a specific plant, based on a firm understanding of material properties and processing.
They will also need to have a broad understanding, and a wide spectrum of ideas of how things are manufactured, because some of the products in the future are going to be quite different from the conventional pharmaceuticals that we see today.
The quality professional working with PAT will require a broad understanding of how process technology works ? not heavy engineering and mechanical processes, but small-scale continuous processing such as the food or plastics industries would use. The quality control person of the future will actually be more like an auditor, assessing the manufacturing area where analyzers are installed, who checks that people are trained in how to use the system, that they're working correctly, that the data are being used properly. So they will be very focused on the "assurance" function and are likely to need some process engineering training.
source: http://www.pharmamanufacturing.com/articles/2005/370.html
Implementation of PAT will significantly increase the requirement of employees due to the following reasons:
The process work will need to continue (for the foreseeable future) as it is now, demanding the same number of analytical tests be run. But, the newly installed monitoring equipment will need technical help: installation, engineering, maintenance, and so forth. The current workers will not be trained (immediately), so more bodies will need to be added to specify, buy, install, and run the hardware.
The new technologies will need to be calibrated (both daily and for new methodologies). Since newer technologies (to Pharma, anything except pH and HPLC are "new") such as NIR, Thermal Effusivity, Acoustics, and LIF need "wet chemical" calibrations, many, many more assays will be performed in QC in order to calibrate them.
For instance, if a tablet analysis is desired and it will be performed (say, by NIR) on thousands of tablets per run, a robust calibration must be made. To do this, thousands of tablets (to assure variability in chemical and physical differences) will have to be run both by NIR and HPLC. Since the current release methods and stability samples will need to be run simultaneously, there will be an influx of QC chemists to accommodate all these additional assays. (And they won't go away as long as PAT methods are being investigated for each additional product.)
All the PAT data will need to be gathered, collated, store, retrieved and made available for reports. This will increase the number (and educational level) of IT personnel, often by a large amount. The integration of the various technologies will be a full-time job for more than one person. The mountain of data generated by PAT will need to be well-handled for the process to have any meaningful impact on product improvement.
source: http://www.pharmamanufacturing.com/articles/2006/015.html
Apart from human resources, several other technological resources will be required for the implementation of the PAT. Technological resources will include various PAT instruments, such as NIR instrument for the blender, data storage capabilities and resources to store all the data at one place and to avoid island of information, upgradation of existing IT and other technological infrastructure, and finally, the PAT software itself developed in association with the vendor.
Apart from the technological resources, various other resources should be available such as proper logistics, means of communication and other infrastructure for the implementation team to enable them to operate smoothly, travel across different locations and to assist them in communication with other people.
Kindly check the attached document to ascertain the technological requirements.
Costs: The implementation phase for PAt can be quite long and complex. Even development of an online blender system can take up to 117 weeks, as per a report by Pfizer.
Student: Not much information is available on the true costs of implementing PAT. However, I am presenting some of the cost related material found after extensive research on the web. I guess emailing vendors like Symbion (www.gosymbion.com) will solve the problem of ascertaining cost of software, if exact costs of implementing software is required.
Most of the facilities for implementing PAT might be in place in companies, but changes might be required:
1) Sensor and on-line technology can be adapted, if not installed
2) Data acquisition systems may be in-place
3) SCADA, BMS, and Computerized manufacturing systems may be in-place
4) SOPs will have to be changed
source: http://www.ispe.org/galleries/midwest-files/2005EducationDayPATPresentation.pdf.
The requirement of PAT tools can be categorized under following headings:
Multivariate data acquisition and analysis tools
Modern process analyzers or process analytical chemistry tools
Process and endpoint monitoring and control tools
Continuous improvement and knowledge management tools
source: http://www.fda.gov/Cder/guidance/5815dft.htm
Some of the other costs associated with PAT Are: An analytical instrument that costs $100,000 will typically mean a $325,000 installation?with $50,000 going to internal configuration costs, $100,000 for qualification and validation and $75,000 in engineering costs.
source: http://pharmamanufacturing.wordpress.com/2006/03/05/notes-from-ifpac-06-after-the-fact/
Discuss how you intend to retain selected human resources via compensation and/or reward systems.
In order to retain selected human resources, first of all a suitable salary, incentive and reward system will be designed to motivate the personnel for this complex and long implementation process and to secure and retain their loyatly towards the organization. The worst thing that could happen during the implementation phase will be the fact that a member of the project implementation team will leave the company. Thus, to avoid this risk, one needs to suitably reward the project team members by developing a series of incentives and rewards directly based on the successful implementation of the program. For example, rewards and incentives can be tied to criterias such as timelines in terms of completing implementation phases, reduction in inefficiency and wastages, savings in terms of cost of implementation,etc. All these benchmarks will act as a key motivator for the implementation team.
Further, many employees who are the end users of the project will also be part of the implementation project. Such employees also need to be motivated and a change in their outlook need to be made in order to achieve successful implementation. Thus, training program, incentives and rewards for employees will be announced for preparing them to adopt such new processes. For these people, company-wide training meetings, including an update conference for everyone who's working on PAT will be organized. These will be devoted to update presentations, and to a series of training modules on the techniques, equipment and approaches for doing PAT measurement.
Specify tie between resource needs and management and end-user roles for the project:
Kindly check the attached document for a well defined diagram on the tie between resource needs, managers and end-suer roles.
Assess the feasibility of other approaches to filling resource needs other than the one(s) chosen. Examples might include outsourcing, contracting, purchased off the shelf resources or other approach.
One of the approach to fill resource needs is outsourcing. Let us see if it is really feasible.
Outsourcing has become the new paradigm in pharmaceuticals. I'm not talking about moving production ? lock, stock and barrel ? to nations where labor costs are lower, although we all know that's happening, but outsourcing processes that are too expensive to "own," whether a specialty packaging line, a novel process for producing dosage forms, or analytical instrumentation expertise for pharmaceutical process analytical technology (PAT) program development.
Outsourcing NIR and pharmaceutical PAT projects involving NIR brings in technical expertise that's in short supply today. It also brings in a fresh, unbiased point of view, and can cut through the politics and turf battles that have stymied PAT projects at all too many pharmaceutical companies.
I have seen any number of pharmaceutical companies' PAT committees fail because they couldn't organize, or develop a coherent strategy for implementing PAT. Simply placing 12 or 14 people who don't have experience with NIR or PAT into a room will not spontaneously generate expertise.
Pharmaceutical managers generally like the concept of outsourcing. It's easy on the budget, and for esoteric, once-in-a-lifetime projects, why buy the truck when you can rent it? For esoteric projects like software validation or LIMS implementation, consultants are only a phone call away.
source: http://www.pharmamanufacturing.com/articles/2005/395.html
Another option is to purchase an off the shelf software from leading vendors such as Symbion, who offer standardized PAT software. However, the advantage is tremendous savings in terms of cost and time, but on the other hand, such off the shelf software will not be able to serve the purpose of the organization and need to be customized for effective implementation.
I am also providing information on supporting documents for this answer.
One of these documents can be viewed in the following link:
http://www.pharmamanufacturing.com/articles/2005/415.html
Another one is attached. (PDF File)
b. Develop a risk mitigation and monitoring plan by first listing all risks (i.e. technical, people, business, cultural, etc.), defining the likelihood of the risk occurring (e.g. 3 on a scale of 1 through 5 with 5 being highly likely it will occur), defining the severity of each risk listed (high, medium, low) and providing a mitigation or contingency strategy for each risk. Use a tabular format.
Specifics: Establish a risk mitigation and monitoring plan showing all risks, their likelihood of occurrence, and contingency plan for each risk. Establish a detailed risk mitigation and monitoring plan showing risks, contingency plan, as well as likelihood of occurrence. Include a discussion on technical, business, people, and cultural risks. Suggest alternative contingency plans for each risk.
kindly check the attached excel sheet for the solution.
