In-Licensing in Pharma Essay Example for Free

In-Licensing in Pharma Essay INTRODUCTION The process of bringing a new drug to market is an extremely expensive one, often costing above $200 million. This enormous cost can be explained by the fact that a very small fraction of molecules in research and development ultimately become pharmaceutical products. However, the rewards of a successful new product can be tremendous generating, depending on the therapeutic areas in which the product will be used and the disease it will directed to, from millions to billions of dollars of sales annually worldwide. Many pharmaceutical companies are facing a pipeline gap because of the increasing economic burden and uncertainty associated with internal research and development programs designed to develop new pharmaceutical products. The need for large pharmaceutical companies to constantly replenish the supply of potential blockbusters requires a consistent and dedicated approach to drug RD. However no longer is inhouse research expertise sufficient. To fill this pipeline gap, pharmaceutical companies are increasingly relying on in-licensing opportunities. Business development and licensing department identifies new pharmaceuticals that satisfy unmet needs and are a good strategic fit for the company, completes valuation models and forecasts, evaluates the ability of the company to develop and launch products, and pursues in-licensing agreements for pharmaceuticals that cannot be developed internally on a timely basis. The in-licensing process provides a source of new drugs to a given company to supplement internal laboratory research, to reach the company’s goal in term of present and future portfolio. As competition in the pharmaceutical market continues to grow, effective business development strategies become critical to maintain momentum and improve global market share for the leading pharma companies. An increasing proportion of revenues are expected to be generated from licensed products and as a result licensing will become an ever more important component of the overall business development mix (source: Wood Mackenzie’s Licensing insight Multi-Client study, April 2003) The in-licensing process might imply enormous effort by the company. It can be compared to the proverbial search for a needle in the haystack. First, the haystacks are large and require a massive amount of searching. Second, no one knows how many needs are in the haystack. There might be none, or multiple. Third, the search is conducted in public and multiple companies compete for innovative therapies, and resource allocation and financial aspect play a role in such competition. The key to pursing in-licensing opportunities is rapidly to identify individuals and companies with the intellectual property sought by the company. New business development teams maintain a business development customer relationship management information system. The information stored in this system has been gathered from personal networking contacts, industry available organization directories, membership directories, commercially PubMed, and online databases. The system contains the contact information, therapeutic interest areas, development stage information for products in development, and other relevant information needed to identify potential in-licensing partners, such as key clinical researchers, biotechnology companies, and small specialty pharmaceutical companies. A search of this system provides a list of potential inlicensing partners. To supplement this list, the new business development team begins a systematic marketing campaign in select industry trade publications and Web sites to promote the company’s desire for an in-licensing partner. The campaign highlights the company’s strengths in clinical development, manufacturing, and sales and marketing. Information regarding the type of product desired (therapeutic class, clinical development stage, and so forth) and the type of licensing agreement being sought is specified. From the list of potential in-licensing partners, the new business development team selects the most appropriate candidates and begins to evaluate the feasibility of in-licensing each potential partner’s product. Despite there is no standard formal process in in-licensing of pharmaceutical products, it is quite standard to utilize a stepwise approach, composed of go/no go gates, that can be summarised in the following stages: 1. evaluation of potential in-licensing opportunities 2. first pass review 3. product evaluation 4. due diligence 5. in-licensing contractual negotiation and deal closing. This stages are ordered following a timeline perspective, so to have a subsequent flow of actions. The approach includes examining opportunities from other pharmaceutical companies and from academic centers involved in research. Once the opportunity has been identified, the first pass review consist generally in the evaluation of information provided by the potential licenser, the medical and scientific literature, and specialised consultant if there is a in-house gap in specific knowledge. This initial step has often been based on a ‘’gut feeling’’ and the company overall strategy in term of therapeutic area focus. For those opportunities not rejected in the first pass review, a more detailed evaluation of the scientific, commercial and financial issues, are undertaken. Additional people with various area of expertise participate in this secondary evaluation. Only if the entire evaluation is positive the opportunity is taken to senior management, that finally approves the in-licensing after due diligence and a full negotiation on terms of the agreement. One aspect that is often underestimated in in-licensing opportunity is the in depth commercial assessment of the putative candidate, leaving the go/no-go decision mainly at strategic fit in terms of therapeutic area focus or financial aspect taken from capital budgeting calculations. In this regards, sales forecast plays a critical role in assessing the net present value of the in-licensing opportunity, but they need to be supported by a complete, although preliminary, full product evaluation. This evaluation has to include external analysis in the context of the future scenario, internal analysis of the given putative candidate, and a preliminary but clear product strategy. The scope of the development of a qualitative model for a full product evaluation in the context of an putative in-licensing opportunity is to define the key relevant steps within the full product evaluation related to commercial aspect that are critical for the precise and coherent definition of the sales potential of the product, that will used in the Capital Budgeting (e.g. Net Present Value) models to assess the financial aspect of the opportunity and set the basis for the full negotiation. Common financial analysis measures for valuation of an in-licensing opportunity Pay Back Period (PBP) Length of time required to recover the cost of an investment Discounted Cash Flow (DCF) Analyzes future free cash flow projections and discounts them using the after tax weighted average cost of capital to arrive at a present value (value in local currency at the time of analysis); DCF analysis estimates the money a company would receive from an investment and adjusts for the time value of money.

the call of the wild Essay -- essays research papers

The Call of the Wild, on the surface, is a story about Buck, a four- year old dog that is part Shepherd and part St. Bernard. More importantly, it is a naturalistic tale about the survival of the fittest in nature. Throughout the novel, Buck proves that he is fit and can endure the law of the club, the law of the fang, and the laws of nature. Buck had been raised in California, on the ranch of Judge Miller. There he had the run of the place and was loved and pampered by all. Unfortunately, one of the judge's workers had a gambling problem and stole Buck to sell him for fifty dollars. Buck fights being tied, caged, and beaten, but his efforts only frustrate him. He is put on a train and a boat, being shipped to Alaska to be used as a sled dog. Although he is miserable on the journey, Buck learns an important lesson - the law of the club. If he does not obey, he will be beaten. In Alaska, Buck is sold to become a sled dog. Intelligent and hard working, he quickly learns to adapt to his new life. He becomes a good sled dog, working as part of the team; he also learns how to protect himself from the miserable cold, burrowing under the snow, and how to find food, stealing if necessary. He also learns he must always be alert, for there are dangers everywhere. Additionally, Buck learns the law of the whip, for if he does not obey the driver or do his fair share of pulling, he will be popped. Buck also learns the law of the fang. Unlike the domesticated dogs at Judge Miller's ...

Biology Lab. Introduction to Science Essay

You should submit your document in a Word (.doc or .docx) or Rich Text Format (.rtf) for best compatibility. Exercise 1: Data Interpretation Table 1: Water Quality vs. Fish Population Dissolved Oxygen |0 |2 |4 |6 |8 |10 |12 |14 |16 |18 | |Number of Fish Observed |0 |1 |3 |10 |12 |13 |15 |10 |12 |13 | | 1. What patterns do you observe based on the information in Table 1? The patterns that I observe based on the information in Table 1 are: †¢ The level of ‘Dissolved Oxygen’ consistently increases by an increment of 2 with each subsequent data point †¢ The ‘Number of Fish Observed’ seems to fluctuate with no real consistency (with the exception that after the peak # of 15 fish was observed, the next 3 data points reflect â€Å"10, 12, 13† which was the same # of fish that were observed in the exact order prior to reaching the peak 15. (In short, the pattern 10, 12, 13 seems to have repeated itself.) †¢ The level of ‘Dissolved Oxygen’ does not seem to decrease when the ‘Number of Fish Observed’ decreases 2. Develop a hypothesis relating to the amount of dissolved oxygen measured in the water sample and the number of fish observed in the body of water. Based on the information provided in the table, I would hypothesize that the number of fish observed has no bearing on the level of oxygen dissolved. This hypothesis would be based on the fact that the dissolved oxygen steadily and consistently increased by an increment of 2 with each progressive data point. When the number of fish observed was significantly increased from 3 to 10, the dissolved oxygen level only increased by 2. Conversely, when the number of fish observed significantly decreased from 15 to 10, the dissolved oxygen still maintained that consistent increase of 2. 3. What would your experimental approach be to test this hypothesis? The experimental approach that I would use to test this hypothesis would be to obtain a 2 freshwater fish tanks, fresh water, fish, an aquarium water level meter and a dissolved oxygen meter. In one tank, I would ensure that the aquarium was filled with a specifically determined level of water and measure the level of dissolved oxygen present with no fish. Then I would gradually begin adding fish daily, starting with one fish. Each day I would ensure that the water level remained the same as it was prior to adding the first fish and I would continue increasing/decreasing the total number of fish daily. I would also consistently measure the dissolved oxygen levels as I introduced or removed fish to observe the levels. In the 2nd fish tank, I would ensure that the level of freshwater and dissolved oxygen matched the levels of the first fish tank prior to adding  any fish. Then, I would add the maximum number of fish that I intended to observe in the 1st tank and observe the oxygen level. For the duration of the experiment, I would not ensure that the water level remains the same but I would not modify the total fish in this tank. I would also observe the oxygen levels in the 2nd tank throughout the experiment. 4. What are the independent and dependent variables? The independent variable in this experiment would be the total number of fish being observed, and the dependent variable would be the dissolved oxygen. 5. What would be your control? My control in this experiment would be the 2nd fish tank, which I would not fluctuate the total number of observed fish. 6. What type of graph would be appropriate for this data set? Why? The most appropriate type of graph to utilize, which would best illustrate the data being compared in this example, would be a line graph. I would use a line graph because it most clearly and effectively demonstrates how the two independent data sets are related, as well as how their independent fluctuations in volume affect one another. 7. Graph the data from Table 1: Water Quality vs. Fish Population (found at the beginning of this exercise). You may use Excel, then â€Å"Insert† the graph, or use another drawing program. You may also draw it neatly by hand and scan your drawing. If you choose this option, you must insert the scanned jpg image here. [pic] 8. Interpret the data from the graph made in Question 7. The data from the graph supports my hypothesis that the total number of fish observed does not have any bearing on the level of dissolved oxygen, which steadily increases by a level of two with each data point. Exercise 2: Testable Observations Determine which of the following observations (A-J) could lead to a testable hypothesis. For those which are testable: Write a hypothesis and null hypothesis What would be your experimental approach? What are the dependent and independent variables? What is your control? How will you collect your data? How will you present your data (charts, graphs, types)? How will you analyze your data? 1. When a plant is placed on a window sill, it grows three inches faster per day than when it is placed on a coffee table in the middle of the living room. – TESTABLE †¢ Hypothesis – The plant will grow at a faster rate per day when it is placed on a window sill as opposed to being placed on a coffee table in the middle of a living room. †¢ Null Hypothesis – The location of the plant has no bearing on the growth rate per day. †¢ Experimental Approach – I would gather four identical plants, two of which I would I would rotate between the living room and window sill daily, and the other two would remain static in their locations for the entire duration of the experiment. I would treat and care for all plants in an identical manner, ensure that their respective locations remained precisely the same, as well as measure and record the growth of each plant daily. After a sufficient period of time had elapsed, I would record the final relevant data in Excel, and insert a line graph with all four plants incorporated into a single chart, which would also demonstrate the growth rate over time. Subsequently, based on the information contained within the data points, and the line graph comparison, I would draw a final conclusion and present my data to interested parties in the form of a brief Microsoft PowerPoint presentation. I would include a brief summary of the intent of the experiment, a detailed explanation of the tools and exact process in which I used to conduct my tests, and all of the raw data statistics relative to the daily growth rate of all four plants. †¢ Dependent Variable – The location of the plants. †¢ Independent Variable – The growth rate of the plants. †¢ Control – The 2 static plants. 2. The teller at the bank with brown hair and brown eyes and is taller than the other tellers. – NOT TESTABLE 3. When Sally eats healthy foods and exercises regularly, her blood pressure is 10 points lower than when she does not exercise and eats unhealthy foods. – TESTABLE †¢ Hypothesis – Sally’s blood pressure will be lower when she eats healthy foods and exercises regularly. †¢ Null Hypothesis – The fact that Sally eats healthy foods and excercises regularly will have no effect on Sally’s blood pressure. †¢ Experimental Approach – I would first observe and record, for a sufficient period of time, Sally’s eating habits, exercise regimen, and blood pressure, when she is not eating as healthy or exercising as regularly to accurately gauge a reliable average of the range of her blood pressure in this phase of the experiment. Then, I would ensure that Sally was placed on a healthy eating plan, approved by a nutritionist, and prescribe an exercise routine. Sally’s eating habits and exercise regimen would again be recorded daily, along with her blood pressure statistics and other relevant information. I would track and record the daily relevant statistics in Excel, and I would also use a line graph to illustrate the comparison of her blood pressure over time under the two different scenarios. Subsequently, based on the information contained within the data points, and the line graph comparison, I would draw final conclusion and present my data to interested parties in the form of a brief Microsoft PowerPoint presentation. I would include a brief summary of the intent of the experiment, a detailed explanation of the tools and exact process in which I used to conduct my tests, and all of the raw data statistics relative to the changes in Sally’s blood pressure as well as her diet and exercise habits throughout the experiment process. †¢ Dependent Variable – Sally’s eating and exercise plan. †¢ Independent Variable – Sally’s blood pressure reduction. †¢ Control – the phase of the experiment when Sally’s blood pressure is observed and recorded when she is not eating healthy or exercising regularly. 4. The Italian restaurant across the street closes at 9 pm but the one two blocks away closes at 10 pm. – NOT TESTABLE 5. For the past two days the clouds have come out at 3 pm and it has started raining at 3:15 pm. – NOT TESTABLE 6. George did not sleep at all the night following the start of daylight savings. – NOT TESTABLE Exercise 3: Conversion For each of the following, convert each value into the designated units. 1. 46,756,790 mg = _46.7568 kg 2. 5.6 hours = _20160 seconds 3. 13.5 cm = _5.31496_ inches 4. 47  °C = 116.6  °F Exercise 4: Accuracy and Precision During gym class, four students decided to see if they could beat the norm of 45 sit-ups in a minute. The first student did 64 sit-ups, the second did 69, the third did 65, and the fourth did 67. 2. The average score for the 5th grade math test is 89.5. The top 4th graders took the test and scored 89, 93, 91 and 87. – Both Yesterday the temperature was 89  °F, tomorrow it’s supposed to be 88 °F and the next day it’s supposed to be 90 °F, even though the average for September is only 75 °F degrees! – Precision Four friends decided to go out and play horseshoes. They took a picture of their results shown to the right: – Neither A local grocery store was holding a contest to see who could most closely guess the number of pennies that they had inside a large jar. The first six people guessed the numbers 735, 209, 390, 300, 1005 and 689. The grocery clerk said the jar actually contains 568 pennies. – Neither Exercise 5: Significant Digits and Scientific Notation Part 1: Determine the number of significant digits in each number and write out the specific significant digits. 405000 – 3 (405) 0.0098 – 2 (98) 39.999999 – 8 (39999999) 13.00 – 4 (1300) 80,000,089 – 8 (80000089) 55,430.00 – 7 (5543000) 0.000033 – 2 (33) 620.03080 – 8 (62003080) Part 2: Write the numbers below in scientific notation, incorporating what you know about significant digits. 70,000,000,000 = 7 X 1010 0.000000048 = 4.8 X 10-8 67,890,000 = 6.789 X 107 70,500 = 7.05 X 104 450,900,800 = 4.509008 X 108 0.009045 = 9.045 X 10-3 0.023 = 2.3 X 10-2 ———————– TYPE YOUR FULL NAME:

Advantages and Disadvantages Giving Aid - 1521 Words

Our world now is divided into develop and develop and developing countries. The one who achieved the process countries are those which are in the process of development. (Ashwath Komath, April 19, 2010). According to (Andrew Page, 2005) Foreign Aid or Official Development Assistance (ODA) is a transfer of resources on concessional terms which are undertaken by official agencies. Mostly, the countries that receive foreign aid are usually developing countries. Poverty is the main focus of giving the foreign aid. This situation always happened to many countries due to the conditions where the people live and from that it will show the quality of living is poor among the people. Foreign aid is given to poor countries that having a limited†¦show more content†¦It is also provide to solve problems such as refugees, terrorism, rehabilitation and many other problems. Meanwhile, giving international aid to poor countries is an internationally common practice. Its main motive is based on moral obligations which stipulate that all fellow humankind should help each other, according to their respective abilities. This practice also has its own disadvantages. Some of them are international aid is found to be often misused. By giving the aid, the donors sometimes require the recipients to do something the benefit of which is disproportionately more favourable to the former than to the latter. Many recipient countries have often complained that donor countries are often found to take advantage of them by means of international aid. Sometimes, the aid is given in such a way that makes the recipients ever dependent on their donors. Every county has responsibility to guarantee prosperity of its citizens. Unfortunately, many countries are unable to do that because of several reasons such as limited financial condition, instability economic and political condition, and so on. 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