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SESSION 1 PHARMACEUTICAL PROJECT STRATEGY

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SESSION 1 PHARMACEUTICAL PROJECT STRATEGY


As you read the following think about how you would go about implementing a pharmaceutical project. If you may have already had some experience in project management in other sectors some of what follows will seem familiar- and it is. The underlying tenets of project management are common to all projects, no matter what the sector is. Much time and effort has been devoted to the study of projects and project management. There are now academic post-graduate studies being offered at some universities and organizations such as the Project Management Institute (http://www.pmi.org/). Project Management finds its roots in military engineering where project management principles were applied to construction projects and then later in Henry Fords automobile assembly lines. In both cases, the purpose was to reduce costs and maximize output. Essentially, project management is about efficiency and effectiveness. While this is a noble goal most project strategies, when implemented, fail to recognize the most variable factor in the project management equation- the human factor. This often has disastrous consequences up to, and including, failure of the project. So as you assimilate the following and think of implementation, think always in terms of how you will motivate and relate to the people you come into contact with while carrying out project tasks. Dealing with people is always the most difficult aspect in managing any project. The impact of the human factor and remedies for situations that arise are not often written about in practical terms- mainly because every decision and situation that calls for interacting with other people are as interesting and unique as the person making them. For most of us, these are learned skills that require a certain amount of self discipline and patience. Often, we are not even aware what our moods may be doing to those reporting to us. For example, have you ever stopped to think what your stress does to innocent bystanders? When you are stressed you wear that fact in your body languagefile:///C|/MMPS/SESSION 1 .htm (1 of 8) [06\26\2004 8:52:08 AM]

SESSION 1 PHARMACEUTICAL PROJECT STRATEGY

from the screwed up face that looks like you just had a cold drink on hot day to that ramrod-straight march that says you have no time for anything. Stress and negativity are highly infectious and you will soon find that there is an air of stress throughout the team as they notice your stress and begin to wonder if all is not well in Managerland. This is made worse by the fact that they will always assume the worse, i.e. their jobs are on the line. You must learn to deal with stress in your own way- through exercise, hobbies or whatever works for you. If you do not, you will not enjoy your job and this only worsens the stress. By confronting your stress and dealing with it on a regular basis you will be happier and this will also be reflected in your body language. Always going into work with a positive attitude and a sense of humor will have a profound affect on your team. Smiling and treating your staff as professionals, not dwelling on mistakes but learning from them and moving on and helping them in their career development are probably some of the most motivational and achievable habits that will boost your productivity. Remember: Happy Campers = Productive Campers

Clinical Development A pharmaceutical company is only as strong as its pipeline. Can you, as a future pharmaceutical project manager, propel growth in the years to come? To be truly effective, a clinical development organization or pharmaceutical company must: q Align its strategy with the corporate strategy q Build the organizational structure, tools, and procedures to make superior performance routine q Efficiently manage its development efforts With those keys to success in mind, you, as a future pharmaceutical project manager, should address critical strategic and operational issues: q Based on the corporate strategy, what will be required of the clinical pharmaceutical project? Is it equipped to satisfy those requirements? q What is the optimal organizational structure to fulfill these requirements and how do we build it? q How can we outsource more strategically to make development more efficient? q How can we identify and correct operational problems that are undermining our efficiency? r Clinical project management r CRO management r Patient recruitment r Investigator recruitment r Clinical data collection and management r Query resolution

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SESSION 1 PHARMACEUTICAL PROJECT STRATEGY

Research & Development Strategy q Determine how the R&D function will contribute to achieving the companys overall strategic vision q Determine how to most effectively manage the pipeline on a global basis q Perform a gap analysis, comparing the needs of the R&D function with its current capabilities q Develop a prioritized, change plan to show how organizational changes relate to each other and the company q Provide strategic perspectives on the macro pharma/biotech environment and identify their implications for R&D efforts Outsourcing Strategy When the company decides that it would be more efficient to appoint additional organization to conduct some parts of pharmaceutical project , it is called "outsourcing" q Determine the need for outsourcing activities, given the expected pipeline r Identify gaps in skills of the existing organization and determine whether outsourcing is an appropriate approach to resolving these gaps r Identify capacity constraints of the existing organization and determine whether the constraints should be solved with outsourcing q Develop an outsourcing strategy that ensures: r Knowledge and skills are transferred to internal staff r Compatible outsourcing resources are identified and leveraged proactively Organizational Structure and Staffing Strategy q Determine the optimal organizational structure required to successfully execute the R&D strategy q Determine the personnel and other resources required to meet R&D objectives r Perform a gap analysis comparing the current staffing levels and skill sets of the organization with the required staffing levels and skill sets r Determine how the organization needs to change to support the future environment q Develop an implementation plan to prepare for the changes that will occur Operations Improvement q Improve the overall Data Management environment by: r Improving quality through effective SOPs (Standard Operation Procedures - set of rules and instructions specific for each and every company). r Selecting appropriate data management tools q Create a stakeholder communication process to make communicating with marketing, sales, finance, and other key stakeholders consistent and more simple q Improve the current project management approach, especially if changes were made to the outsourcing strategy

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SESSION 1 PHARMACEUTICAL PROJECT STRATEGY

Drug development is not a simple process. Drug development is more comprehensible if the team member has the good fortune to join a project team at its inception rather than, as is often the case, as a replacement team member. It is at the initial team meetings that the core early development strategy is decided. Successful drug development depends on the quality of the development strategy. Ultimately, successful drug development is about translating science into an optimal investment proposal that provides value to a variety of stakeholders and customers. This can be achieved only be establishing a strategy which recognizes who the customers for new medicines are and addresses their needs. This will mean moving increasingly from designing for to designing "with" the customer. Health care provided in most countries has experienced significant change in recent years. Probably the greatest change to be faced in the future will be the expectation that new medicines will be not only safe and effective but also cost effective in the overall context of disease management. Drug development strategy is concerned with establishing clearly set objectives for the development and life cycle management of an asset, recognizing critical hurdles to success, and structuring plans to achieve the best reward/risk for the investment. It requires a range of skill sets which include strong technical knowledge of drug development and understanding of development risk management. Project attrition rates are high, and it is important to understand why and when these can occur. Most of pharmaceutical projects fail. A primary objective in drug development, therefore, is to eliminate from development, at the earliest time, projects that offer poor prospects for commercial return. Termination decisions are rarely made with certain knowledge which is why they are so often painful for teams and companies to take. It requires understanding of the importance of the target product profile as a strategic tool and the need for its continuous review throughout development. The TARGET PRODUCT PROFILE definition is critical to the design of clinical development strategy. It depends on good understanding of planning skills to ensure that alternative development scenarios are recognized and their impacts are fully explored. It also requires business skills to evaluate the investment opportunity integrating the key parameters of risk, time, cost, and return. At the core of all of this is knowledge of the disease area which enables the impact of a new medicine in the total scheme of intervening in the disease state to be assessed. If this analysis is at fault, all else is of little value. In an increasingly cost-constrained environment, where cost effectiveness is a passport of access to patient groups, pharmacoeconomics will be a key strategic driver in formulating development plans. It also requires an understanding of life cycle management. The commercial value of a product will be realized only by ensuring that the product benefits are fully exploited. New medicines will need to "earn their keep" by justifying price at time of market entry and by sustaining their competitive value during their life cycle. An investment in health economics studies will be needed to underpin this case. Opportunities may exist for developing better dosage forms and dose regimens and may also exist for switching Rx medicines to OTC (Over The Counter - drugs that are sold without Rx from the doctor). Finally it is essential to establish a clear post-patent strategy in good time. The U.S. and Canadian systems of new drug approvals are perhaps the most rigorous in the world. On average, it costs a company $359 million to get one new medicine from the laboratory to the pharmacist's shelf, according to a February 1993 report by the Congressional Office of Technology Assessment. It takes 12 years on average for an experimental drug to travel from lab to medicine chest. Only five in
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5,000 compounds that enter preclinical testing make it to human testing. One of these five tested in people is approved. New medicines are developed as follows: Synthesis and Extraction The process of identifying new molecules with the potential to produce a desired change in a biological system (e.g., to inhibit or stimulate an important enzyme, to alter a metabolic pathway,or to change cellular structure). The process may require: 1) research on the fundamental mechanisms of disease or biological processes; 2) research on the action of known therapeutic agents; or 3) random selection and broad biological screening. New molecules can be produced through artificial synthesis or extracted from natural sources (plant, mineral, or animal). The number of compounds that can be produced based on the same general chemical structure runs into the hundreds of millions. Look at these charts:

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New Drug Discovery and approval can take up to 20 years

Biological Screening and Pharmacological Testing Studies to explore the pharmacological activity and therapeutic potential of compounds. These tests involve the use of animals, isolated cell cultures and tissues, enzymes and cloned receptor sites as well as computer models. If the results of the tests suggest potential beneficial activity, related compounds, each a unique structural modification of the original compound are tested to see which version of the molecule produces the highest level of pharmacological activity and demonstrates the most therapeutic promise, with the smallest number of potentially harmful biological properties. Pharmaceutical Dosage Formulation and Stability Testing The process of turning an active compound into a form and strength suitable for human use . A pharmaceutical product can take any one of a number of dosage forms (e.g., liquid, tablets, capsules, ointments, sprays, patches) and dosage strengths (e.g., 50. 100, 250, 500 mg.) The final formulation will include substances other than the active ingredient, called excipients. Excipients are added to improve the taste of an oral product, to allow the active ingredient to be compounded into stable tablets, to delay the drug's absorption into the body, or to prevent bacterial growth in liquid or cream preparations. The impact of each on the human body must be tested. Toxicology and Safety Testing Tests to determine the potential risk a compound poses to man and the
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SESSION 1 PHARMACEUTICAL PROJECT STRATEGY

environment. These studies involve the use of animals, tissue cultures, and other test systems to examine the relationship between factors such as dose level, frequency of administration, and duration of exposure to both the short- and long-term survival of living organisms. Tests provide information on the dose-response pattern of the compound and its toxic effects. Most toxicology and safety testing is conducted on new molecular entities prior to their human introduction, but companies can choose to delay long-term toxicity testing until after the therapeutic potential of the product is established Regulatory Review: Investigational New Drug (IND) Application An application filed with the U.S. FDA prior to human testing. The IND application is a compilation of all known information about the compound. It also includes a description of the clinical research plan for the product and the specific protocol for phase I study. Unless the FDA says no, the IND is automatically approved after 30 days and clinical tests can begin. Phase I Clinical Evaluation The first testing of a new compound in human subjects, for the purpose of establishing the tolerance of healthy human subjects at different doses, defining its pharmacologic effects at anticipated therapeutic levels, and studying its absorption, distribution, metabolism, and excretion patterns in humans. Phase II Clinical Evaluation Controlled clinical trials of a compound's potential usefulness and short term risks. A relatively small number of patients, usually no more than several hundred subjects, enrolled in phase II studies. Phase III Clinical Evaluation Controlled and uncontrolled clinical trials of a drug's safety and effectiveness in hospital and outpatient settings. Phase III studies gather precise information on the drug's effectiveness for specific indications, determine whether the drug produces a broader range of adverse effects than those exhibited in the small study populations of phase I and II studies, and identify the best way of administering and using the drug for the purpose intended. If the drug is approved, this information forms the basis for deciding the content of the product label. Phase III studies can involve several hundred to several thousand subjects. Process Development for Manufacturing and Quality Control Engineering and manufacturing design activities to establish a company's capacity to produce a product in large volume and development of procedures to ensure chemical stability, batch-to-batch uniformity, and overall product quality. Bioavailability Studies The use of healthy volunteers to document the rate of absorption and excretion from the body of a compound's active ingredients. Companies conduct bioavailability studies both at the beginning of human testing and just prior to marketing to show that the formulation used to demonstrate safety and efficacy in clinical trials is equivalent to the product that will be distributed for sale. Companies also conduct bioavailability studies on marketed products whenever they change the method used to administer the drug (e.g., from injection or oral dose form), the composition of the drug, the concentration of the active ingredient, or the manufacturing process used to produce the drug.

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Regulatory Review: New Drug Application (NDA) An application to the FDA for approval to market a new drug. All information about the drug gathered during the drug discovery and development process is assembled in the NDA. During the review period, the FDA may ask the company for additional information about the product or seek clarification of the data contained in the application. Postapproval Research Experimental studies and surveillance activities undertaken after a drug is approved for marketing. Clinical trials conducted after a drug is marketed (referred to as phase IV studies in the United States) are an important source of information on as yet undetected adverse outcomes, especially in populations that may not have been involved the premarketing trials (e.g., children, the elderly, pregnant women) and the drug's long-term morbidity and mortality profile. Regulatory authorities can require companies to conduct Phase IV studies as a condition of market approval. Companies often conduct post-marketing studies in the absence of a regulatory mandate. In summary many skills are needed to create a strong development strategy. Generally a well-structured project team has these skills. The experienced project manager should have a broad awareness of many of these skill requirements. However, generally, his or her greatest contribution will be in harnessing the skills within the project team to build a good project strategy.

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