Essay On Case Study Summary

Essay on Case Study Summary
Avid Radiopharmaceuticals Case Study Summary
In November of 2008 Dan Skovronsky, founder and CEO of the biotech start–up Avid
Radiopharmaceuticals, had a very important decision to make regarding the future of his company.
One option was for Dan to run the trials for both AV–45 and AV–133, commit to the Easton real
estate space, take on $7.5 million venture debt, and start raising money. This option could
potentially allow for the company to experience rapid growth and capture a competitive advantage
in molecular imaging for Alzheimer's and Parkinson's. The other alternative for Dr. Skovronsky was
a "Hibernation" strategy where the company would take on no venture debt at all. Trials for AV–133
would pause; and only AV–45 would ... Show more content on Helpwriting.net ...
In late 2005, Avid received funding from pharmaceutical heavyweights Eli Lilly and Pfizer of $8.9
million in Series B financing. Also, in 2007 Avid received $26 million of Series C financing in early
2007.
By early 2008. Avid's A–45 was showing great progress in late trials and also were beginning Phase
I trials on a Parkinson's compound (AV–133). This would allow Avid to be more than just a one–
trick pony and be a viable candidate as a stand–alone company. Also, that summer investment banks
started visiting Avid's offices in Philadelphia hoping to lead the IPO, which was scheduled for late
2009, subject to market conditions. Bankers suggested that a $25 million D round in early 2009
might be priced at $200 million post–money, followed closely by an IPO. That, however, was before
the destruction of more than 25% of the world's wealth. With an aggressive growth plan in mind,
Avid's management team began to execute on its growth strategy in early 2008. Priorities were the
next round f clinical trials with AV–133 and Av–45. A venture debt loan could support the company
of necessary finances (Easton Technology Properties) as the company began fund–raising for a pre–
IPO round. Dr. Skrovonskey worried about the timing of the Venture debt loans. He stated that by
the time Avid actually needed the cash they would have already paid part of the loan back plus
interest. However, Avid investors looked at the Venture debt loans as a cushion that would allow
Avid time to
... Get more on HelpWriting.net ...

Most Important Drug Discoveries Ever Made
Antibiotics or antimicrobial agents are known to be one of the most important drug discoveries ever
made. It has transformed the expanding field of medicine in various ways. Be it as curative efforts
for diseases, empirical treatments for clinically diagnosed ailments or preoperative medications,
they have known to be miraculous drugs. Exceptional scientific histories of the development of
these medications are valuable in showing us the variety of its actions on the bacterial cell wall
biosynthesis and at the level of intracellular metabolism of bacteria.
Antimicrobial agents induce bacterial cell death by interactions between a drug fragment and
proteins on bacteria. It can act on very specific stages of bacteria (Briand, 1978). Widely speaking,
most antimicrobial agents can be classified in a variety of ways. It can be classified based on purely
the chemical structure such as polypeptides, acyclic or glycosides. Other than that, it can also be
divided based on its source: synthetic, semi–synthetic or natural forms. Another form of its division
is based on its spectrum of activity, making it broad or narrow spectrum or based on the type of
organism its effective against, such as gram positive, gram negative, aerobes or anaerobes species.
An essential classification is based on its function on bacterial cell replication and also based on its
type of actions, whether causing an effect on cell growth or directly cell demise. These two
imperative classifications will be

The Problem Of Development Of India
In the summer of 2012, a hope was in the air. Something that seemed impossible just a decade ago
was now within grasp. India had not seen a case of polio since January 2011.As our group of
volunteers worked in the immunization camp in the sweltering heat, with only iceboxes to keep the
vaccine fresh, the line of children seemed endless. At dusk, we set out on foot, going house to
house, counseling and cajoling the holdouts. It was well into the night before we started to drive
back on the dusty road. On that day in a monumental exercise, a hundred and seventy million
children were immunized in the country. The entire nation erupted in joy, when in early 2014, India
was declared polio–free. Even as the magnitude of the achievement slowly dawned on me, I knew I
had played my little part in the life of those children. It is this happiness and fulfillment that I come
across in the faces of children and their families that motivates me. Pediatrics my field of choice as
the opportunity to take care of children during their formative years of life is a gratifying experience
in total. From taking care of newborns immediately after delivery to counselling the teenagers
regarding safe health practices, from the ever smiling 4 year old who believes in me to the wary 16
year old whose trust I have to win over, the opportunities and at the same time the challenges of this
field are something that excites me and have played part in solidifying my interest in Pediatrics.
During my

Arguments Against Animal Testing
With the technology and social development, the animal testing is common and widely used in lots
of industry. The debate about whether animal testing is fair or not last for decades. My position is
that animal testing is fair. Animal testing could be used in psychology research. In most of the time,
animal has the similar thinking process as human, which could be applied to analysis human
behavior. Also in pharmaceutical industry, animal testing can reduce the death of human life in new
drug development. In law of nature, human is on the top of the food chain. Human consumes
animals for surviving reason. This is the fact that anyone could not reject or ignore. However, the
opposing voice comes from some organization likes the PETA (People for the Ethical Treatment of
Animals). They believe that animals have the same right as human in term of ethical treatment.
They did not encourage the animals testing in psychology research. They hold the position that
animal testing is unfair. For most general people, they think animals are so cute and should be our
friends. Thus they should not be used for testing reason. I will illustrate three points to support the
argument that the animal testing is fair.
First, animal testing could be used in psychology research to simulate human behavior. Psychology
is a new branch of nature science since early 20 century. Human are always curiosity about our own
behavior, feelings, emotion and the connection among them. It is impossible to use real

Biocon India Case Study
Biocon India
Introduction:
Strategic Choices prevails in many companies' setting to progress towards betterment. Somehow it
comes with benefits and opportunity costs as well. Based on the case study for this week, Biocon
India, a pharmaceutical company in India, is being faced with a strategic choice to proliferate but as
mentioned, it comes with costs. Today this essay will scrutinize this case in terms of the strategic
choices availability, the key groups involved and their relationship, the risks and rewards for
growing Biocon, the primary structure of Biocon, the threats for such a structure, and my
recommendation to the company.
What are the strategic choices available?
Biocon India is a pharmaceutical company that primarily ... Show more content on Helpwriting.net
...
Another group that will have to be considered are the future crew of Clinigene. Due to the expected
expansion of Clinigene, additional employees would be needed and based on Biocon structure, it
would be within Biocon. Another key group is the participants in the clinical trials. They will be the
reason to justify the success of Clinigene. Finally, there will be the buyers of the service that
Clinigene will provide. They will relate to the successful clinical trial of the organization.
What are the rewards available to expanding or growing Biocon India's business?
There are several rewards to consider with expansion of Biocon. Currently in India, there is a
growing market for contract research organization and the growth of Biocon falls right within this
opportunity. The growth is expected to last for more than few years with a rate that looks promising.
Clinigene is expected to reap revenues much higher than the current Biocon and Syngene combined
(Kalegaonkar A., Nov 4, 2008). It will take clinical studies to a higher level with better options in
terms of drug manufacturing. With other countries ready to outsource the service of clinical studies,
Clinigene's future looks bright.
What are the risks?
Somehow other countries outsourcing may be slow for in India because of the uncertainty and lack
of credibility that exists within the Indian market (Kalegaonkar A., Nov 4, 2008). This may be an
obstacle for Clinigene. Moreover, with

Drug Discovery And Development Of New Medicine
Describe and discuss recent developments in drug discovery. As our society is evolving so is
diseases many drugs that were previously effective to cure certain diseases are simply not as
effective any more or on the other hand there isn't sufficient medicine to battle the current new
health problems that are arising with our evolving society for example obesity and a range of
cardiovascular diseases. In addition many of the medicine available today either only treats the
symptom or cures the disease with the addition of unwanted side effects. Hence, this is why drug
discovery and development is vital. It is through drug discovery and development that new medicine
is found.
Currently a lot of effort is going into Binuclear metallohydrolases as a target in drug development.
This is due to the fact this enzyme group has the potential to find solutions to health problems such
as erectile dysfunctions, osteoporosis, cardiovascular dieses and also even become the seed in
possible eradication of some antibiotic resistance.
The main enzymes in the binuclear metallohydrolases group that are most vital us are purple acid
phosphatases, metallo–β–lactamases and arginases. The homologous feature in all these enzymes is
the existence of two very nearly touching metal ions that hold the ability to attract water molecules
that will then act as a nucleophile in a very particular hydrolytic reaction the importance of this is
that it means that binuclear acids will have a powerful ionic

The Pros And Cons Of The Pharmaceutical Industry
Nowadays it seems like legal drugs are more expensive than illegal ones. This dilemma occurs
because the pharmaceutical industry affects the economy significantly. Although the United States is
a mixed market economy, there are instances where the economy seems like a free market economy.
A free market economy allows companies to determine the prices of goods free from government
intervention. The pharmaceutical industry, despite several regulations set by the Food and Drug
Administration (FDA), is a free market economy. Meaning, the pharmaceutical sector lacks
government regulation and has control over the prices of specialty drugs desperately needed by the
public. Therefore, the pharmaceutical industry being a free market negatively affects ... Show more
content on Helpwriting.net ...
According to Paul Antony, DTCA aids consumers because it helps them recognize symptoms and
their increases communication between doctors and patients. He states that consumers that
advertisements empower them to seek out their doctor (para 3,10). However, advertisements are
often emotional and misleading. This type of advertisements causes patients to urge their doctors to
prescribe them a specialty drug because they notice they have a symptom. Doctors then would have
to comply which can end up being more harmful to the patient. Another argument is that
pharmaceuticals make little profit because new drugs cost so much to develop. Derek Lowe, a
chemist, states that "Expenses [are] doing nothing but rising, and the success rate for drug discovery
[is] going in the other direction" (para 5). By his quote, Lowe means that the development of a drug
outweighs the cost of the drug, resulting in little profit. However, this case is on drugs that failed in
the market. Drugs that are long past development have the prices gouged for more profit. Therefore
the government should regulate the pharmaceutical industry because the industry is harmful towards
the economy and patients. The government can achieve this by enabling a cap on prices of specialty
drugs and ensuring DCTA is not

Big Pharma Business Analysis
Industry: Big Pharma
The pharmaceutical industry is considered to be on of the fastest growing sectors in America. The
IMS Institute for Healthcare Informatics reported revenues of $424.8 billion in 2015, a 12.2 percent
increase from last year (pharma commerce). Furthermore, the U.S. pharmaceutical industry is
considered to be a worldwide leader with sales accounting for approximately 44.5 percent of global
sales (Whiteside, 2016). The driving force of these revenue figures is Big Pharma –the largest
pharmaceutical companies in the United States. In fact, Pfizer, Merck & Co., and Johnson and
Johnson [J&J] are three American companies ranked at the top of the global pharmaceutical market
(Dezzanni, 2016).
In recent years, American media outlets ... Show more content on Helpwriting.net ...
Big Pharma companies have the necessary distribution networks and infrastructure needed to mass
produce drugs at low costs. Since small lack the expensive infrastructure needed to mass produce
drugs, it is often in their best interest to be acquired by Big Pharma companies. The following
economic analysis will show how larger firms have greater economies of scale when compared to
smaller firms.
First, lets assume that the bigger firm has a cost function of C(q) = 115 + 2q2, a marginal cost
function of MC = 4q, and an average cost function of AC =. Average cost divided by Marginal cost
results in a value of S. After setting up this equation , and simplifying, we get . Next we set S equal
to 1 and solve for q. In this case q=7.58.
Assume the smaller firm has a cost function of C(q) = 75 + 6q2 , a marginal cost function of MC =
12q, and an average cost function of AC =. Logically, the smaller firm's fixed costs are lower by 40
in this example. After setting up this equation , and simplifying, we get . Next we set S equal to 1
and solve for q. In this case

Symptoms And Treatment Of Gi Cancer Resistance Networks
Abstract:
Gastrointestinal (GI) cancers, such as colon and pancreas are highly resistant to both standard and
targeted therapeutics. Therapy–resistant and heterogeneous GI cancers harbor highly complex
signaling networks (Resistome) that resist apoptotic programming. Commonly used Gemcitabine
(GEM) or platinum–based regimens fails to induce perturbations in the resistome, resulting in high
rate of treatment failure. GI cancer resistance networks are in part due to interactions between
parallel signaling and aberrantly expressed microRNAs (miRNAs) that collectively promote the
development and survival of drug–resistant cancer stem cells (CSCs) with epithelial–to–
mesenchymal transition (EMT) characteristics. The lack of understanding of ... Show more content
on Helpwriting.net ...
This short editorial article provides an overview on the different challenges in understanding of GI
resistome and how novel computational biology can help in the design of effective therapies to
overcome resistance.
Running title: Overcoming drug resistance
Defined Key Terms: Gastrointestinal Cancer, Pancreatic Cancer (PC), Colon Cancer (CC), Network
Pharmacology, Network Medicine, Systems Biology, Systems Pharmacology, Pleiotropic Agents,
Drug Repurposing, PPI Networks, Network Targeted Drugs, Neutraceuticals
Introduction:
GI (PC and CC) cancer accounts for approximately 30% of the total cancer patient population in the
U.S [1;2]. Gemcitabine (Gem), the standard drug for PC, does not improve on the dismal survival
rate (median survival increased by only a few weeks) [3], and FUOX (5–FU+Oxaliplatin) for CC
has shown limited clinical utility [4] especially because of high rate of tumor recurrence. Alternative
platinum–based regimens incorporating OX have demonstrated only marginal benefits in PC and
CC patients [5]. Emerging evidence suggests that the poor response to the current treatment
modalities in GI cancer is linked to aberrations in multiple signaling pathways together with the
presence of a small subpopulation of drug–resistant CSCs/CSLCs that have the propensity to
promote tumor recurrence, invasion and metastasis [6]. Although genotoxic chemotherapies target
the majority of tumor cells, CSCs/CSLCs in the

The Potential Growth Of Companies
Our purpose is to find the potential growth of companies in both the large cap and small–mid cap
category of biotechnology industry.
Therefore, we selected two mature companies and two companies that are in development stage.
Our choices mainly base on the companies' pipeline because biotechnology companies lives or dies
depending on their pipeline, level of expertise and network of partners/distributors they have. For
mature companies, we looked at their financial strength, the source of financing they have to fund
their research and development, as well as their products' breadth in the pipeline. We prefer mature
companies with dominating market shares and are focusing on common diseases, cancer or heart
diseases. For that reason, we ... Show more content on Helpwriting.net ...
These diseases, though chronic and progressive with high mortality rates, affect small numbers of
patients as less than 20 per million patients are affected by an ultra–rare disorder. There are limited
number of physicians that are familiar with diagnosing and treating such diseases. Alexion's first
marketed product, Soliris, is also the world's first and only approved drug used to treat two ultra–
rare genetic disorders, PNH and aHUS. Quarterly sales of Soliris reaches $400 million in mid–2013.
In 2012, Alexion acquired asfotase alfa, a targeted enzyme replacement therapy that is the first
potential treatment of HPP – an ultra–rare metabolic disease, through the acquisition of Montreal
based Enobia Pharma Corp. Today, its global operations platform serves patients in nearly 50
countries.
Direction of Company:
Alexion is investigating Soliris in other severe and rare complement–mediated disorders, including
antibody–mediated rejection (AMR) and delayed graft function (DGF) both related to transplanted
organs' dysfunction. It is also conducting registration studies in its lead neurology program with
Soliris in ultra–rare neurological disorder neuromyelitis optica (NMO) and myasthenia gravis (MG).
Besides, asfotase alfa is in preparation to be launched as Alexion's next product. Other breakthrough
potential programs being developed consisting of

Drug Discovery And Clinical Research
ntroduction
Drug research is connected to a range of academic studies such as biology, pharmacology, medicinal
chemistry and toxicology. Pharmaceutical researchers can design novel therapeutic drugs based on
these studies above. The invention of new drug can be divided by function into two stages: drug
discovery and drug development. Drug discovery is the process by which a new drug candidate is
found and identified. Distinctively, bringing a new drug candidate to the market through clinical
trials is called drug development. The first part of this essay provides an overview of drug discovery
and pre–clinical research and development
An Overview of Drug Discovery and Pre–clinical Research and Development
At pre–discovery stage, it will ... Show more content on Helpwriting.net ...
The various lead compounds can be initially tested and virtual screened by high–throughput
screenings (HTS) to evaluate their properties in biochemical reactions, and then the lead compounds
will be optimized through altering their molecular structure. Several physicochemical properties and
pharmacokinetics properties of the lead compounds will be established, such as lipophilicity,
solubility, ionization, molecular size and H–bonding. The process of lead optimization can not only
improves lead compounds' physicochemical properties, but also makes them more effective and
safer. Simultaneously, medicinal chemists begin to consider about chemical manufacture and control
(CMC), such as synthesis, formulation, delivery mechanism and large–scale manufacturing. The
optimized lead compound could ultimately evolve into a new drug candidate. The function of pre–
clinical research is to assess all of the physicochemical and pharmacokinetics parameters prior to
clinical trials. Or, to put it another way, whether the lead compound is safe enough to move on to
clinical trials depends on pre–clinical research. For example, pharmaceutical researchers carry out
pharmacokinetics (PK) testing which involves absorption, distribution, metabolism, excretion
(ADME), and toxicology to estimate the safety starting dose through in vitro and in vivo testing.
After these complicated and rigorous pre–clinical trials, scientists have

Ethics of Offshoring: Novo Nordisk and Clinical Trials in...
Ethics of Offshoring: Novo Nordisk and Clinical Trials In Emerging Economies
Offshoring is a highly debatable topic throughout the country and the world. Many people base their
opinions on different aspects of offshoring. Some people are against offshoring because they feel as
if the working conditions in other countries aren't up to par and are unethical. Some people are
against offshoring because they feel it is taking jobs away from people within their own country.
Some people are for offshoring because they feel there is greater profit involved or that they can get
harder workers in other countries. No matter what side of the debate, everyone can agree on a few
things like there needs to be better standards for working conditions, ... Show more content on
Helpwriting.net ...
Another question that needs to be addressed is if trials are conducted in an emerging economy, how
should they be managed and which standards should apply? I think medical ethics is a big issue
when it comes to trials being conducted in an emerging economy. One famous incident of this was
the Tuskegee syphilis study. This study left 400 African Americans untreated in order to research
how they obtained the disease. The cure for syphilis, penicillin, had already been found in the
1940s. To prevent this from happening again, professional medical organizations developed
guidelines and principles of ethics to guide their research, notably the Helsinki Declaration. I
believe Novo Nordisk does a great job of adhering to these guidelines by putting safety measures in
place. Emerging economies like India and China are attractive places to have clinical trials because
of how much cheaper it is, the willingness to try new things as an emerging economy, and because a
possible lack of standards. Novo Nordisk only conduct trials in countries where they have affiliates
with necessary competence to arrange and monitor the trials. Also, they conduct clinical trials
globally to test the safety and efficacy of new drug candidates in order to obtain global marketing
authorization. These trials always have the same standards at all trial sites. The standards in

Imatinib Marketed By Novartis And Onyx Pharmaceutical
As technology advances, advances in the pharmaceutical industry increase as well. While most
companies use the mentality of screening drugs that show the most binding affinity or particularity
of drug applicants to a single defined target, this is not always the best way of doing things. Many
off target activities or multi–targeted particularities have been successful in targeted therapeutics.
For example, Imatinib marketed by Novartis and Sorafenib co–developed and co–marketed by
Bayer and Onyx Pharmaceuticals and Nexavar have shown that looking at the broader spectrum of
biological context of how a specific agent works is very important. Increasing importance of
translational and clinical research in the early stages of drug development can help connect the
drug's activity to biological impact and clinical significance. Improvement in early stage R&D
productivity can be increased greatly by looking more at the scientific disease state being treated
rather than just looking at the target. Evolving clinical and commercial requirements of the scientific
data from the disease state will rapidly advance the early stage patients being tested to clinical trials.
A biomarker is a measured indicator of a targeted disease. It can be used in drug development and
contributes to increased probability for phase transitioning specifically in phases II & III, the longest
phases. A recent study in oncology drug development displayed "908 oncology drug candidates
Phase I, II, and III

CNS Drug Discovery
CNS Drug discovery for the transport of Blood Brain Barrier:
By CNS drug discovery we produce new CNS pharmaceutics which have the dual activity i.e.
solubility of lipids and molecular size and have the capability to cross blood–brain barrier by the
diffusion into endothelial plasma membranes.
In CNS drug development, transport through the brain capillaries is the rate–limiting step. Unlike
other organs, blood is protected by BBB (Blood–Brain Barrier) in vertebra's brain and spinal cord.
Vertebrate brain capillaries are Highly–resistant, tight junction of Epithelial–like structure and
permeability barrier is present in endothelium, and due to these features drugs cannot cross the
BBB.
Pathways for solving the problem of Brain Drug Discovery: ... Show more content on
Helpwriting.net ...
For example for the detection of endocrine tumors we use PET imaging.
For the treatment of CNS diseases Neurotrophins are used as these are transportable through the
BBB. Such as erythropoietin is a neurotherapeutic agent, produced from kidney and binds to the
surface receptors of cells and play hormonal role as it signals the Bone marrow to produce the
increased no. of red blood cells.
Erythropoietin is very effective as it reduce the inflammation and do healing process in brain and
repairs the injuries of spinal cord i.e. it is best for neurologic diseases. As when it passes through the
BBB it exhibit effective biodistribution of drug in brain.
Role of Chimaric peptides in BBB: For the peptide–based drugs it is a rate–limiting step to cross the
BBB. Chimaric peptides contain the drug in brain but are unable to cross the BBB so; we conjugate
the drug with targeting vector. Now, these Chimaric proteins can easily pass through the BBB and
can be detected by fluorescent markers in the

History Of The Company1 : Johnson And Johnson
1.0 History of the company1:
Johnson and Johnson is the largest pharmaceutical company in the United States. The World Head
Quarter of the company is located at one Johnson and Johnson Plaza in New Brunswick, New
Jersey, USA. The company was founded in 1886 by three Johnson bothers; Robert Wood Johnson I,
James Wood Johnson, And Edward Mead Johnson. The initial business of the company was to
produce antiseptic surgical dressing1. Since then the company has been pioneer in many great
pharmaceutical inversions; such as: first aid kit (1888), baby powder (1896), sanitary napkin (1896),
dental floss (1898), rH factor (1944) and many more. During 1800's the company also contributed in
natural disasters in Galveston, TX and San Francisco, CA. The legacies of helping community still a
big part of the company1. In 1944 the company becomes public and enters the NYSE (New York
Stock Exchange). Robert Wood Johnson I, was the first president of the company who served from
1887 to 1910. After that the second Johnson brother, James Wood Johnson took over the presidency
of the company and served until 19321. In 1932, Robert Wood Johnson II, the son of Robert Wood
Johnson I became the president and served until 1962. Robert Wood Johnson was probably the most
futuristic president of the company who was responsible for establishing "The Credo" of the
company in 1943 which is still followed by the company very effectively. He also initiated the
decentralization of the company as well1. "The

Solubility Lab Report
Pharmaceutical scientists have to account for multiple properties when developing new drugs, and
they need to understand what could affect different patients when developing these drugs. Solubility
is one of these properties, and it is the ability of a solid, liquid, or gaseous substance to dissolve in a
solid, liquid or gaseous solvent, and it is critical to absorption into the body. In drug discovery over
the years, the number of insoluble drug candidates has increased recently, with almost 70% of new
drug candidates showing poor water solubility.
The solubility of a substance fundamentally depends on the solvent used, as well as on temperature
and pressure. Forms of dosages, like tablets, capsules, and solutions, consisting of the drug plus ...
Show more content on Helpwriting.net ...
The USP/NF generally expresses the solubility in terms of the volume of solvent required to
dissolve 1 gram of the drug at a specified temperature. There is also the Biopharmaceuticals
Classification System (BCS), which is a scientific classification of a drug substance based on its
aqueous solubility and intestinal permeability that correlates in vitro dissolution and in vivo
bioavailability of drug products. BCS takes into account two major factors: solubility and
permeability, which control the rate and extent of drug absorption from solid dosage forms, and its
bioavailability. A drug is considered highly soluble when the highest strength is soluble in 250 ml
(this volume is typical study protocols) or less of aqueous media over the pH range of 1.0–7.5;
otherwise the drug substance is considered poorly

The Inter-Relationship between Pathways to Drug Discovery,...
The Inter–relationship between pathways to drug discovery, drug development and drug
manufacturing
When it comes to small–molecule drugs specifically, the journey to eventually becoming an
approved and marketed drug ready for the public is an exhausting and comprehensive odyssey
which involves the following components: basic research, finding the medicine, initial testing,
complex clinical trials involving human beings and then eventually hard–sought after approval by
the Food and Drug Administration (FDA) (Corr & Williams, 2009). On average, the process
generally takes a decade to a decade and a half, millions upon millions of dollars and the most ideal
circumstances before the drug is approved this overall reason attributes to why drug discovery and
development is one of the "drug discovery and development is widely recognized as one of the most
financially risky endeavors in all of science and a major challenge for the biomedical industry.
Much of this cost comes from failures, which account for 75 percent of the total research and
development costs" (Corr & Williams, 2009). Corr and Williams are wise to point out that despite
the fact that these failures are expensive and can chip away at morale, they still add to a collective
body of knowledge on the process of disease: this knowledge is gained from carrying out research
and clinical trials, even ones that fail (2009). One could even argue that the path to approval for
biologics is even more arduous because they

GSK What is your assessment of Yamada’s proposal for the...
Chandler – GlaxoSmithKline
What is your assessment of Yamada's proposal for the centers of excellence in drug discovery
(CEDD)? What are its strengths and weaknesses relative to other potential organizational structures
for R&D?
Overview:
Yamada reorganization of drug discovery at GlaxoSmithKline (GSK) following a merger to combat
bureaucracy in decision making, approval, and authorization. This reorganization was necessary for
the continued success of the company. Often the process for drug discovery and market is a slow
and tedious process which can cost a company a lot in resources and financially. The smaller biotech
companies are able to move quicker and push new drugs to market faster. The shift, Yamada thinks,
... Show more content on Helpwriting.net ...
There were areas of artificial barriers in the old system of product development and research. What
Yamada is trying to attempt is to focus the groups into one area, create accountability, and speed up
the process similar to what happens in the small biotech firms. Where Yamada had difficulties was
the performance of the CEDD in the first 18 months, and possibly the buy in from the CEDD
leadership. While some of this is because of bad legacy products from the heritage organizations
some was also to the CEDD leadership leaving the organization. This is not unlike the case study of
Kodak and the leadership backing at new product development. Leadership accountability comes
with buy in to the development process. Lack of defining structure in genetic research and discovery
research in this case.
Strengths:
Harness Talent – Allows the research scientist to be vested in the development of new drugs and
compounds. Finical rewards for product success and creation.
Focus development – The products are developed by the CEDD and the artificial barriers of product
development lessen or eliminated. Increase the speed at development of compounds and products.
Cost effectiveness – Set Budgets for CEDD to operate within and creates incentive to operate
efficiently.
Create accountability – Brings more marketable

Non Clinical Studies : The Discovery Of A New Drug Without...
Non clinical Studies for Biologic
The discovery of a new drug without involving human subjects is called as non clinical studies.
Goals of non–clinical testing of Biologics are: characterization of probable undesirable drug effects,
identifying toxicities on organs, identifying convertibility of toxicity , characterization of
pharmacokinetic report, characterization of favorable pharmacodynamic effects –proof of standard,
guideline for safe application in human clinical studied, determination of a safe and practical
starting dose, and offer monitoring strategy for the clinical study, offer adequate clinical data to
conclude ... Show more content on Helpwriting.net ...
Discovery of New Biologics
1. Traditional Drug–Discovery Methods used trial and error approach where substances introduced
to animals or in vitro on the target without any prior knowledge of what would be the result. The
effects observed in these cases are examined the treatments for the disease. If a drug gives an effect
to a pancreas cells, it can test for insulin related disease like diabetes.
2. Rational Drug Discovery approach starts with a hypothesis, typically the modification of a
present known molecule giving a therapeutic effect. After selection of biologic, the next process is
screening, this involves the screening of many variants of the prospective therapy. It is a common
practice to use:
High–Throughput Screening –Once a target has been chosen, it is generally cloned and expressed to
produce thousands or millions of same copies which are then incubated separately known as screens
and can be tested on the target (Rollins et al,. 2014). A positive reaction is called hits and further
screened to determine if it acts on particular target or other targets too."Hit" more targets produce a
toxic effect in following trials in animals and humans. The best "hits" labeled as a lead compound,
and can go for further testing and the others are labeled as backups.
Other method uses –extracts from a natural product like plant–derived molecules, antimicrobials
from microorganisms, active compounds.
What to test in animal –in vivo testing – four commonly used species:

Obamacare : Promise For Antibiotics And Therapeutics For...
Healthcare Legislation Project: S.185: Promise for Antibiotics and Therapeutics for Health Act or
the PATH Act Introduction: The Promise for Antibiotics and Therapeutics for Health Act or the
PATH Act was introduced to the 114th Congress (2015 – 2016) by sponsor Senator Orrin Hatch, R–
Utah with the support of Senator(s) Michael Bennett (D–Colorado), Kelly Ayottee (R–New
Hampshire), John Isakson (R–Georgia), Mark Kirk (R–Illinois), Tom Carper (D–Delaware), and
Richard Blumenthal (D–Connecticut) on January 16th, 2015. This legislation is currently being
reviewed by the Senate Committee on Health, Education, Labor and Pension. After which, it will be
come up for vote in both the Senate and House, before being presented to the President for approval
into law. Section 3 of the Promise for Antibiotics and Therapeutics for Health Act or the PATH Act,
which call for current PATH Act legislation to be modified so that it "will allow health experts to
more easily develop new treatments for antibiotic resistant bacteria, and make real progress in
presenting a great number of illnesses and deaths in the United States"1. In addition, this new
legislation will impact Section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 356) by
introducing into its current language a new subsection (g) "Limited Population Pathway for
Antibacterial Drugs". Thus creating new avenues for the introduction of alternative treatments for
limited populations based on the recommendation of Secretary

Orphan Drug Market Development And Manufacturing Of Products
Sanofi Genzyme is a branch of the Sanofi Corporation that specializes in the development and
manufacturing of products to treat a variety of rare diseases. The Allston Landing Facility (ALF)
currently produces a single enzyme replacement therapy which treats patients with Type 1 Gaucher
disease. This treatment falls within the classification of an Orphan drug which is a drug or biologic
that treats a patient population of less than 200,000 within the United States. There is an entire
segment of the pharmaceutical industry comprised of companies that develop and manufacture
treatments for rare diseases. The Orphan Drug market has a projected Worldwide 2020 sales
forecast $178bn with a compound annual growth rate (CAGR) of 11.7% per ... Show more content
In addition, once a patient begins a treatment that improves their condition there is a low likelihood
that the patient will stop that treatment. Also, the low success rate of drugs from development
through FDA approval decreases the chance that a competitor will develop an alternative treatment.
The bargaining power of the customers within the Orphan Drug patient population is classified as
medium/low. While patients are price sensitive; the cost of treatment for most is subsidized by either
health insurance or government funding and therefore the price of these treatments are typically
very high. The average per patient on an orphan drug in the year of 2014 was calculated to be over
$110,0001. While the average cost is currently high, this has become and increased area of scrutiny
worldwide and many governments are enacting price control within the industry, eating away at
potential profits.
Once a company has successfully developed an orphan drug and gained FDA approval, the process
to build and operate a manufacturing facility can be extremely costly. This is driven by the fact that
the bargaining power of the supplies is medium/high. This classification is because of the extreme
regulations that exist for not only the equipment, but also the raw materials used within the drug
manufacturing process. The environment causes companies to create stringent supplier

Merc & Vioxx Case
Merck and the Recall of Vioxx Florence N. Wandera MGT 600 – Corporate Responsibility & Bus
Law Merck and the Recall of Vioxx Case Summary Merck & Co. Inc. is a global research–driven
pharmaceutical company that develops, manufactures and markets a broad range of human health
products. One such product is Vioxx, developed in 1994 and approved on May 21, 1999 by the
United States Food and Drug Administration (FDA) for the treatment of pain, inflammation, and
stiffness caused by arthritis. The drug was also later approved for use in the treatment of rheumatoid
arthritis in both children and adults. The product was promoted aggressively by Merck and had
emerged as one of the best selling drugs for the company within a year of ... Show more content on
Helpwriting.net ...
Another very disturbing factor was the company's "Dodge Ball Vioxx" training document.
According to the case, the results of the Vioxx–naproxen study alerted doctors and patients, and in
order to help sales personnel deal with questions that both doctors and patients raised, the company
developed a sales aid called "Dodge Ball Vioxx," basically a document intended to help sales
representatives get away with questions regarding concerns that customers and doctors had about
the drug. Who does that? I was seriously shocked that the company would go to such extremes to
avoid taking responsibility, especially when thousands of people's lives depended on it. Clearly
Merck was determined to fight anyone who was skeptical about Vioxx's safety. This was shown
through its actions to shut down academic researchers who tried questioning the drug's safety by
withdrawing its funding to these institutions or lectures that it sponsored at the various schools.
Merck even ignored the Kaiser Permanente study, which was sponsored by the FDA. The results of
the study showed that patients taking the highest recommended dosage of Vioxx had nearly 2.7
times the risk of heart attack and sudden cardiac death as patients taking Celebrex. Again Merck
dismissed these FDA conclusions about Vioxx. All this

Case Report: Glaxosmithkline Reorganizing Drug Discovery (a)
This case describes the reorganization of drug discovery at GlaxoSmithKline (GSK) following the
formation of GSK from the merger of Glaxo Wellcome and SmithKline Beecham. This
reorganization placed nearly 2,000 research scientists into six centers of excellence in drug
discovery (CEDD). Each CEDD focused on a small set of therapeutic areas and possessed decision
rights over the progression of pharmaceutical compounds through the early stages of development.
It addresses issues about the benefits of focus vs. diversification in R&D, the role of decentralized
vs. coordinated decision making, and the importance of alignment between the structural and
infrastructural (e.g., performance incentives) aspects of an operating model.
4. Economies ... Show more content on Helpwriting.net ...
In the case of GSK we see the "Efficiency effect". The monopolist firms that want anticipate the
entrant. GSK get the opportunity to innovate, promising to improve the research productivity by
leveraging the benefit of scale in certain areas and focus in other. Sunk cost, replacement and
efficiency effects all work simultaneously to determine if the incumbent will innovate or not. Large
firms are as rationale in their innovation choices as new entrants
GSK incentive to innovate was to increase the number of "locks" and to found their respective
"keys" faster than competitors. Yamada identified several weaknesses in the old R&D process in
GSK, like excessive bureaucracy, poor communication across functional areas and lack of
entrepreneurial spirit. His strategies focused on resources and motivate them not only on finding
new targets but on producing new medicines.
Yamada understood that large pharmaceutical firms were very good at the front–end of drug
discovery and at the later stages of drug development. They needed to improve the "middle ground"
of the R&D process, where flexibility and responsiveness of small firms is essential.
Biotech firms had the capabilities to alter the structures adopted by large firms. Bayern acquired
those skills while GSK chased the challenge, creating the beneficial characteristics of small biotech
by reviewing the existing capabilities of

The Challenges Of Bacterial Resistance And Natural...
Discuss how recent advances in medicinal chemistry have addressed the challenges of bacterial
resistance to natural antibiotics ABSTRACT Since the discovery of penicillin in 1928 many
discipline's, including medicinal chemistry, have worked on natural antibiotics and the rise of
bacterial resistance to them. In the last 15 years medicinal chemistry has worked to combat the
challenges of bacterial resistance that has emerged in the form of efflux pumps, degradation
enzymes and/or modification of targets. Advancements in structure determination has given a larger
number of high resolution structures for bacterial proteins that can be run in structure–based drug
design programs. High–throughput screening (HTS) has advanced so that hit to lead compounds
also have cellular activity, although this is predominantly giving output for Gram–positive bacterial
targets. Difficulties lie in fully understanding the mechanism of action and permeation of new drugs.
However, new understanding of translocation proteins, such as porins, has meant that new drugs
have been designed for homologous uptake channels or modified to be recognised by different
bacterial uptake pathways. Recent research has also worked to alter the mechanism of action of
older antibiotics by administering them with non–antimicrobial drugs that have synergistic or
additive effects, which may be a longer term solution that limits the emergence of resistance to new
drugs and extend the effective lifetime of antibacterials

Breakthrough Therapy For Patients With Chronic Lymphocytic...
Introduction
Breakthrough Therapy Designation is introduced as a new designation with the passage of the FDA
Safety and Innovation Act of 2012 (FDASIA) [1]. According to section 902 of the FDASIA, the
general criteria according to which this new designation can be applied are (1) serious or life–
threatening disease or condition and (2) the drug also demonstrates substantial improvement over
existing therapies on one or more clinically significant endpoints. Once a drug is designated as a
Breakthrough Therapy, the FDA and the drug sponsor work closely to determine the most efficient
pathway for generating additional evidence about safety and efficacy. As of March 31, 2015, a total
of 293 requests for Breakthrough Therapy designation have been submitted, out of which 82
requests are granted [2].
This document outlines the application process for Breakthrough Therapy designation for novel
drugs. It then proceeds with outlining the supporting data needed to apply for a Breakthrough
Therapy designation for a novel anti–cancer molecule that has evidence of efficacy to treat patients
with Chronic Lymphocytic Leukemia.
When to apply for designation request
The Breakthrough Therapy designation is granted on the basis of evaluating preliminary clinical
evidence obtained from clinical trial data in humans. The data from animal studies or studies
conducted in vitro are insufficient to defend this Breakthrough Therapy designation [1] . Therefore,
a sponsor usually submits a Breakthrough

Merck : An Ethical And Socially Responsible Drug Manufacturer
Question 1 Merck was known as an ethical and socially responsible drug manufacturer. Back in
1950, George W. Merck, CEO, said, "We try never to forget that medicine is for the people. It is not
for the profits" (Lawrence & Weber, 2014). Merck was also known for research and innovation in
developing new drugs as well as their philanthropic efforts. This was a company that had built its
success on a solid reputation of being an ethical and socially responsible organization. The Vioxx
case is evidence that somewhere along the way, the company lost sight of their "...medicine is for
the people...not for the profits" reputation (Lawrence & Weber, 2014). Spending $3 billion a year on
research, Merck enjoyed a decade long span of unveiling new drugs on a regular basis (Lawrence &
Weber, 2014). This was a major contributing factor to Merck's ranking as the third largest
pharmaceutical company in the world (Lawrence & Weber, 2014). In the 1980's, 80% of the drug
companies' growth was attributed to drugs that addressed chronic, nonfatal conditions that affected a
large population (Lawrence & Weber, 2014). These drugs, often referred to as blockbuster drugs,
were usually taken by patients with health insurance which insured healthy sales and profits for the
drug companies (Lawrence & Weber, 2014). Merck was in stiff competition with other drug
manufacturers to create the next big blockbuster drug that would drive up profits. Coupled with that
pressure was the amount of time involved in

A Diverse And Sustainable Compound Library For Aid Drug...
A diverse and sustainable compound library to aid drug development and sales.
________________________________________
Public Profile
The consumer–facing side of your profile is written so anybody can easily understand your product
or service. Information about the investment opportunity is detailed on the "Business Plan" side of
the profile to maintain compliance with SEC 'general solicitation' regulation.
Carmolex Inc.
3–5 sentence "quick pitch" outlining key takeaways that will be explored in more depth within the
body of the profile.
Pharmaceutical companies need robust and high quality compound libraries to develop and market
new prescription drugs. To help these companies develop top–tier compound libraries, Carmolex
Inc. has ... Show more content on Helpwriting.net ...
The founders of Carmolex believe that it is time to give the pharmaceutical industry a more
effective compound library to aid in the development or marketing of new prescription drugs.
Redefining Drug Discovery
Carmolex is a toolbox for drug discovery. There are 150+ million molecules in our library that drug
developers while synthesizing drugs to assess the viability of a specific receptor and molecule.
Carmolex is the world's largest molecular library.
The Carmolex library is virtual drug discovery. Instead of needing large quantities of molecules for
drug testing, drug developers can virtually test billions of potential molecules to see if they work
with receptors, before even synthesizing the drug. The Carmolex compound library streamlines the
drug development process.
Not only does Carmolex streamline the drug development process, it also expands it. Most drug
discovery efforts only sample a tiny portion of chemical space. Our software and databases make it
possible to virtually design and screen a much larger and more diverse chemical space.
By expanding the chemical space and overcoming the traditional multi–step chemical synthesis
process, our disruptive solutions increase the likelihood of successfully delivering molecules for
testing by 80%. Carmolex's fast and inexpensive approach overcomes the limitations of today's
inadequate molecule libraries and High

The Discovery Of New Drug Without Involving Human Subjects
Non clinical Studies
The discovery of new drug without involving human subjects is called as non clinical studies. Goals
of non–clinical testing of Biologics are: characterization of potential adverse drug effects, identify
end organ toxicities, identify reversibility of toxicity , characterization of pharmacokinetic profile,
characterization of beneficial pharmacodynamic effects –proof of principle , guideline for safe use
in human clinical studied determination of a safe and reasonable starting dose and provide
monitoring guidelines for the clinical study, provide sufficient clinical data to conclude that there no
... Show more content on Helpwriting.net ...
Traditional Drug–Discovery Methods used trial and error approach substances were introduce to
animals or in vitro on the target without any prior knowledge of what would be the result. The
effects observed in these cases are examined the treatments for the disease. For example, if a drug
gives an effect to a pancreas cells, it can tested for insulin related disease like diabetes.
2. Rational Drug Discovery approach starts with a hypothesis, typically the modification of a
present known molecule giving a therapeutic effect. After selection of biologic, the next process is
screening, this involves the screening of many variants of the prospective therapy. It is a common
practice to use:
High–Throughput Screening –Once a target has been selected, it is usually cloned and expressed to
generate thousands or millions of exact copies which are then incubated separately known as
screens and can be test on the target (Rollins et al,. 2014) A positive reaction are called hits and
further screened to determine if it act on particular target or other targets too."Hit" more targets
produce a toxic effect in following trials in animals and humans. The best "hits" labeled as a lead
compound, and can go for further testing and the others are labeled as backups.
Other method uses –extracts from a natural product like plant–derived molecules, antimicrobials
from microorganisms, active compounds.
What to test in animal –in vivo testing – four commonly used species:

Purinex, Inc.
I. CASE FACTS Purinex was a drug–discovery and –development company based in Syracuse,
New York, that sought to commercialize therapeutic compounds based on its purine drug–
development platform. Purine was a naturally occurring molecule that played an important role in
numerous biochemical processes. Purinex had developed a process for creating small molecules that
acted as selected agonists (activators) or antagonists (blockers) for specific purine receptors in the
cell membrane. Purinex's goal was to develop products that evoked a receptor–specific
pharmacodynamic effect without producing undesirable outcomes that could result from interactions
with other receptors. The company had 14 employees and maintained a chemistry laboratory a ...
2. The proposed deal for the treatment of sepsis and the deal for diabetes. The company planned to
take its new receptor–selective drugs into clinical trials to address a broad range of potential
indications. In June 2004, the most promising indications for its compounds were for the treatment
of diabetes and sepsis. Because of this, the company planned to take a proposed deal, each has an
estimated combination of up–front fees, milestone payments, and royalties that are to be evaluated
in order to gather a significant impact for the company which might be possible for six months. 3.
Lack of capital. The firm had experienced no sales and no earnings. It is the very concerned of the
firm because it had only $700,000 cash on hand which is good only for 11 months. Monthly burden
is $60,000 a month, which offset about $100,000 of the company's $160,000 in monthly expenses.
4. The funding through seed money from individual angel investors and venture–capital. The
company has the option to choose which from the two investors can provide additional capital that
has only lower risks and can give the company the higher value. These two investors have different
risks it provide for the company and it must be evaluated first in order to identify which of these
investors best suit the company's need. V. ALTERNATIVE COURSES OF ACTION 1. Evaluate the
financing options and determine which one from the three options

Nucleon
1/ What are your recommendations regarding the manufacturing of CRP–1 for Phase I and Phase II
clinical trials? Nucleon is about to launch Phases I and II clinical trials for their first product CRP–1
(cell regulating protein–1) targeted at treating burns and kidney failure. Both clinical trials would be
carried out on a small sample of volunteers lasting 6–12 months for Phase I and 1–2 years for Phase
II and Nucleon has to decide how to proceed regarding the production of necessary CRP–1 as they
do not have manufacturing facilities to supply it themselves. They could either build a small pilot
plant for Phases I&II CRP–1 which requires time and capital investment of 3,2 million USD or
consider two other options such as ... Show more content on Helpwriting.net ...
Once the Phases I&II are finished, raising the required capital for own manufacturing plant
should not be a problem. For marketing and distribution Nucleon would do better to find a
marketing partner. Licensing manufacturing and marketing rights at Phase III stage would also be an
option, though only receiving 10% partner's gross sales, so own in–house manufacturing would
bring in more revenues as well as having more control over product quality. 2/ How would you
justify your recommendations to would–be investors in the company? Nucleon has a strong patent
for a niche area of cell regulating proteins and its therapeutic properties. It requires venture capital
to bring drugs to clinics fast and before the competition gets there first. The company needs the
venture capital to finance the pilot manufacturing facility for Phases I & II trials but also to
establish process and manufacturing processes for scaling up production from a laboratory
environment to a commercial plant. The drug would be clinically tested for treatment of burns and
kidney failure, but CRP–1 has the potential for many other therapeutic uses . 3/ What is your
recommendation regarding Nucleon's long–term manufacturing strategy? What should this company
look like in 10 years (e.g. an R&D boutique, an R&D boutique with pilot scale
manufacturing capabilities, or an integrated manufacturing enterprise)? In–house manufacturing
brings in considerably higher revenues

Ethical Issues Of Drug Companies
"It is immoral for the drug companies to charge large sums for drugs that are cheap to manufacture."
Discuss Some of the leading pharmaceutical companies such as Novartis, AstraZeneca and
GlaxoSmithKline make a large sum of profit from drugs that are cheap to manufacture, many see
this as immoral and argue that these drug companies are making money at the expense of other
peoples illnesses and are exploiting the most vulnerable in society, but some argue that its
"business" and is ethical despite huge profits made by these drug companies. In this essay I will
discuss if it is morally wrong for drug companies to charge large sums for drugs that are cheap to
produce. In 2011 it was estimated that global spending on prescription drugs was around the region
of $954 billion with the United States accounting for more than a third of the market. Many of these
drugs companies have entered the market with the intention of making large amounts of profit rather
than treating people. In 2012 the Food and Drug Administration which is a federal agency of the
United States Department of Health and Human Services approved 12 cancer drugs, 11 out of the 12
were priced above an astonishing $100,000 per a year, according to Macmillan there is an estimated
2.5 million people in the UK today who have had a cancer diagnosis, this is an increase of almost
half a million in the previous five years. Which coincides with the price of cancer drug prices which
have virtually doubled from a decade ago,

Gyroscope: Heart Rate
Literature Review According to Gyroscope "Heart rate is a strong indicator of emotional state.
Whether it's watching a movie, playing poker, being interviewed, speaking in public, or breaking up
with someone, your heart rate might betray your emotions more than your facial expressions." and
In 2013 the multimillion dollar making film franchise Insidious proved this by previewing the
movie Insidious: Chapter 2. The movie trailer displays the audience's average heart rate and the
audience's heart rate during climactic scenes. The next year the franchise released an almost
identical advertisement for the next film in 2015 Insidious: Chapter 3. According to
http://www.neurosciencemarketing.com "Neuromarketing is a new field of marketing which ...
Made in 1888 the Roundhay Garden Scene was filmed in the Whitley's family house by Louise Le
Prince. The film showed four actors walking in a circle laughing. The film ran for only 2.11
seconds. After premiering the film in Leeds, United Kingdom making the film the first to ever be a
motion picture exhibition Le Prince intended to patent his camera. On September 16 Louise Le
Prince was scheduled to take a train to Paris. However Le Prince never showed up, and after that
was never seen again. Leaving his camera unpatented. After this different genres began to establish.
One of the most shocking and taboo of its time was horror. Horrors origin was in so called "Spirit
Pictures" which were really just simple photos of people in costume. Nevertheless audiences were
infatuated with the images and film producers took notice. One of the first of its genre The Cabinet
Of Dr Caligari otherwise known as "The Granddaddy of Horror films" was made in 1921. After
Caligaris debut in Los Angeles the theatre pulled the movie because of protesters and dissidents.
However critics from America to Germany were ecstatic about the film. After this films such as The
Golem and Nosferatu began to release with much higher

Molecular Visualization With High Throughput Screening (...
The in–silico discovery of drugs saves millions of lives each year. As such, there is extensive
research into drug discovery. Molecular visualization is one of the most important parts of structural
biology and the drug discovery process. Molecular visualization with high–throughput screening
(HTS) has been successful in the discovery of new drugs. Though HTS has been effective it is
expensive and covers a limited space. For these reasons, the high–level visualization of molecules
provides help to cut the work performed in HTS. Together, they offer one of the most effective
methods in structure–based drug discovery. On the whole, my aim is to simulate molecules to find
hidden protein ligand binding sites for the discovery of new drugs. I ... Show more content on
Helpwriting.net ...
This analysis follows a shift in genomics from identifying molecules to analyzing interactions in the
molecular network [12]. The effectiveness of each application is found by comparing several
features offered. Features compared include cost, availability, extensibility, difficulty, command line
access, scripting, selection and documentation [14], [15]. By comparing these categories, I decide
the most effective tool to use in structure–based drug discovery. In a classic approach to drug,
discovery testing would begin in–vivo. This would need the analysis of millions of molecules. The
molecular visualization of protein–ligand interaction analysis tools can cut the number of molecules
that need screening by calculating their potential docking scores. I can narrow the scope down to
only those that are most likely to show strong performance. The first tool I look at is Cytoscape [7].
A standalone application that has historically been successful in drug discovery. In addition, I
discuss molecular pathway techniques, proteome scale maps and, chemogenomics which have all
shown potential for drug discovery in the future.
Cytoscape is a popular tool used in molecular visualization. There are hundreds of plugins that can
enhance its functionality. In the analysis I use UCSF Chimera (Chimera), StructureViz2 and
RiNalyzer to uncover the protein–ligand binding pockets contained in

Two-Sample T-Test
A two–sample t–test is a hypothesis test that is used to compare if there is a difference between two
groups. One of the first steps in a two–sample t–test is to establish a hypothesis. The two–sample
test helps to answer hypotheses that question how the results of one group that may already be in
place compare to the results of another group that is new. The two–sample hypothesis test is a
common hypothesis test used in many industries.
One why that my organization uses a two–sample hypothesis test is for some studies when we are
testing a drug, there are two groups in which a newly developed drug is given to one group and the
other group will remain on the current drug. In other studies one group is given the study drug and
another group is ... Show more content on Helpwriting.net ...
In most cases the hypothesis is the newly developed drug treats the disease and has less adverse side
effects than the current drug. In the case where one group is given a placebo the hypothesis is the
newly developed drug has some

Advantages And Disadvantages Of Cassette Dosing
Lead structures should have significant desired effect, specific binding to a corresponding receptor
to reduce the risk of unwanted side–effects, chemical synthesis and derivatization is possible, and
the absorption, distribution, metabolism, and excretion properties should not be prohibitive to
develop drugs with appropriate pharmacokinetic profiles. Historically, the main source of chemical
variety for screening has been obtained from natural products. Modern advances in organic
synthesis, and combinatorial chemical synthesis in particular, provided large libraries of small
synthetic compounds. The structural derivatization of these small synthetic molecules offers the
possibility of fast expansion of the chemical space around active compounds. ... Show more content
HTS is simple, rapid, high efficiency, less expensive and valuable in discover ligand for enzymes,
receptors (GPCR, ion–channels). High throughput technology has emerged over the last few years
as an important tool for drug discovery and lead optimization. HTS comprises the screening of large
chemical libraries for pharmacological activity against biological targets via the use of robotics,
miniaturized assays and large–scale data analysis. The purpose of HTS is to identify the hits, active
on the target and that can then be further converted by chemical optimization to a genuine lead
which emerges as candidate for clinical development. HTS is defined by the number of compounds
tested to be in the range of 10 000–100 000 per day, uHTS is defined by screening numbers in
excess of 100 000 data points generated per day. (Lorenz M Mayr and Dejan Bojanic, 2009).Various
technologies for assay miniaturization, lab automation and robotics enable testing of chemical
compounds in biological systems by means of high–throughput screening (HTS) and ultra–
highthroughput screening (uHTS). HTS assays are performed in "automation–friendly" micro–titer
plates with a 96, 384 or 1536 well format. Assays today are commonly run in 1536–well plate
format with low μL to high nL volumes per well. To increase speed and efficiency, ultra high–
throughput screening (uHTS) utilizing

Eli Lilly : The War On Patents And The Golden Pipeline
Introduction: Navigating through the strategic planning process with Eli Lilly, there are strategic
issues that they will encounter. They do fall within two different categories: strategic and
operational. Operational: There are two main operational strategic issues that Eli Lilly will face: the
war on patents and the golden pipeline. These operational issues go hand in hand with each other.
Taking a look at the golden pipeline, this an area that can either kill or bring a pharmaceutical
company to stardom. There is a choice that pharmaceutical companies need to make: either create a
different drug that is more effective for something that is already produced or create something new
that has not been on the market before. Eli Lilly needs to strategically think of where they want to
be and how their pipeline will align with their vision: "We will make a significant contribution to
humanity by improving global health in the 21st century" (Eli Lilly About). Eli Lilly is very open to
what drugs are being produced in their pipeline. The interactive chart lets anyone see what phase it
is along with stage it is in during that phase. They do note drugs that are lost during testing. Right
now there are four in Phase II that were lost due to attrition. There are numerous reasons why drugs
are pulled from the pipeline. The main reasons are the drugs cannot pass the safety testing or they
are costing too much with little chance for return. Pharmaceutical companies need to stay on

Arguments Against Animal Testing : Unethical And Unethable
Animal Testing; Unethical and Unreliable Ninety five percent of the animals experimented on in
America are not protected under the Animal Welfare Act. (Hoffman 1). This leaves the majority of
animal's rights unprotected and vulnerable. The animals may be subjected to things such as: "testing
drugs , infecting with diseases, poisoning, burning skin, causing brain damage, implanting
electrodes into the brain, maiming and blinding, long–term social isolation, electric shocks, and the
withholding of food and water" (Animals in Science/Research 1). The experimentation of animals
should be banned because it is unethical, unreliable, and has an extremely low ratio of the number
of experiments to amount of success they lead to.
Other species of animals are very different genetically from humans. Experimenting on another
species is not going to produce accurate or reliable results for humans. This even includes monkeys,
monkeys share over ninety percent of the same deoxyribonucleic acid as humans yet have proved to
be just as useless in experiments. Cruelty Free International gives two examples of this in their
article Arguments Against Animal Testing, one of which with the drug Vioxx. An arthritis
medication named Vioxx was deemed safe for human use when tested in 6 animal species, including
monkeys. But this drug "has been estimated to have caused around 320,000 heart attacks and strokes
and 140,000 deaths worldwide." Another example of this was the disaster when testing a

Design Company Novartis Hellas Pharmaceuticals Firms
SUBJECT: DESIGN COMPANY NOVARTIS HELLAS pharmaceuticals firms
PEST ANALYSIS
To understand the impact of the environment in any industry, it is imperative to consider four main
factors that influence this particular political, economic, social and technological factors. It is a fact
that in Greece factors are rather disproportionate influence on the functioning of a healthy market
competition.
The business environment is regulated by opaque procedures, middlemen, bureaucrats, businessmen
and politicians. Difficulty is something that encourages free enterprise for disposal.
Political Factors
1. Today there is an intense political uncertainty due to the economic crisis in the country but also
globally. The combination of different ... Show more content on Helpwriting.net ...
5. Persistence of pharmaceutical companies to make ' ' gifts ' ' to doctors for prescribing their
products.
Technological factors
The pharmaceutical industry is demonstrably intensive Research & Development.
1. All new medicines that are the result of precise, durable and high business risk research
(expensive clinical trials often years and many resources available necessarily) to get approval for
marketing. Risking failure in the companies themselves.
2. The only case of a company to meet its requirements and to fund R & D can have on various
markets new drugs but can more often.
3. The patents to occupy as much as possible in the hands of wins to them.
MODEL OF FIVE FORCES OF PORTER
(STRUCTURAL ANALYSIS OF INDUSTRY)
According to the theory of Porter, five are the main forces of the microeconomic environment that
determine the intensity and nature of competition within an industry, and strategies that can be
followed by businesses.
Here we will deal with these forces, each separately and in relation to the pharmaceutical industry.
The threat of new firms entering the industry
The advantages of existing firms in an industry against new entrants or for those who want to enter
him, called entry barriers. Of course, this meant that existing businesses prevent the entry of new

Case Study: Evolutec Plc.
The given case study was, The case is a young UK based biotechnology company. Evolutec was
founded in 1998 to commercialise the research from the Natural Environment Research Council's
(NERC) Centre for Ecology and Hydrology (CEH) (formerly Institute of Virology and
Environmental Microbiology) at Oxford. Weston–Davies, then development director, spearheaded
the formation of Evolutec with Professor Patricia Nuttall, as the principal inventor of Evolutec's
intellectual property (IP). A Virologist and an international authority on tick–borne diseases, she
proposed the opportunity of a new approach to therapeutics based upon isolating some proteins from
the saliva of ticks. This approach had no precedent and resulted in market scepticism that initially
adversely impacted the young company's fund raising ability. To get around these problems,
Evolutec was able to implement a streamlined outsourced business model that allowed it to survive
and develop its compounds from discovery research level to clinical development stage. Evolutec
successfully managed to turn around investor scepticism in stages to the ... Show more content on
Helpwriting.net ...
Thus the young company Evolutec has applied a new way for the theraputetic. The new way that the
company has approached was animal based vaccine. But is causes scepticism in the Evolutec market
because of its awkward results. Then the Evolutec found a new way in 2001by introducing a
recombinant based products in the market. Then the recombinant form of product rEV131was
analysed preclinical and applied along the side of animal based product. Thus the rEV131 became
the lead product to the young

Essay On Case Study Summary

Recommended

Recommended

More Related Content

More from Rebecca Diamond

More from Rebecca Diamond (20)

Recently uploaded

Recently uploaded (20)

Essay On Case Study Summary