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The document discusses the challenges of drug development, including the long timelines and high costs. It notes that the average spending for drug development is $1.8 billion over 13 years. It then highlights different areas where smarter approaches in biology, chemistry, materials, and medicine could help streamline the drug development process and make information more actionable. The overall goal is to improve lives and save costs through more efficient discovery and development pathways.
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CHAPTER 5Epidemiologic Principles and MethodsCopyrig
CHAPTER 5
Epidemiologic Principles and Methods
Copyright © 2021 by Jones & Bartlett Learning, LLC an Ascend Learning Company. www.jblearning.com.
Copyright © 2021 by Jones & Bartlett Learning, LLC an Ascend Learning Company. www.jblearning.com
Definition of Epidemiology
Epidemiology is defined as “the study of the distribution and determinants of disease frequency in human populations.”
Copyright © 2021 by Jones & Bartlett Learning, LLC an Ascend Learning Company. www.jblearning.com
Step 1: Define the Disease
Death is easy to determine.
A death certificate states cause of death.
A blood test or stool culture is needed to verify a diagnosis of certain diseases.
Some diseases are hard to define.
EMS and SARS
Sometimes a definition changes as more is learned.
AIDS
Other health outcomes include injuries and risk factors.
Copyright © 2021 by Jones & Bartlett Learning, LLC an Ascend Learning Company. www.jblearning.com
Disease Frequency
Count the number of people with a disease and relate that to the population at risk (PAR).
PAR (denominator) may be the total population or exposed population, or one gender or age group.
PAR often comes from a census.
Two ways to measure frequency are:
Incidence, the number of new cases
Prevalence, the number of existing cases
Incidence is used for studying causes of disease.
Copyright © 2021 by Jones & Bartlett Learning, LLC an Ascend Learning Company. www.jblearning.com
Disease Frequency (cont.)
Prevalence depends on incidence and prognosis.
If causes or risk factors increase, incidence and prevalence increase.
If ability to diagnose increases, incidence and prevalence appear to increase.
Prevalence rates are most useful in assessing the societal impact of a disease and planning for healthcare services.
Mortality rates are used to measure frequency for diseases that are often fatal.
Copyright © 2021 by Jones & Bartlett Learning, LLC an Ascend Learning Company. www.jblearning.com
Distribution of Disease
Who:
Sex, age, occupation, race, and economic status
When:
Looks for disease frequency over time: Season, year (long-term trends), elapsed time since an exposure (epidemic curve)
Is crucial in tracking an outbreak of infectious diseases such as hepatitis and legionellosis
Where:
Neighborhood (e.g., clusters), latitude (climate), urban vs. rural, national variations
Looks at comparisons of disease frequency in different countries, states, counties, or other geographical divisions
Copyright © 2021 by Jones & Bartlett Learning, LLC an Ascend Learning Company. www.jblearning.com
Determinants of Disease
Why is distribution as it is?
We can make inferences from distribution.
Epidemiologists usually speak of risk factors not causes.
Copyright © 2021 by Jones & Bartlett Learning, LLC an Ascend Learning Company. www.jblearning.com
Human Population
Epidemiology studies human population, usually using observational rather than experimental methods.
Biomedical approach uses animal models to investiga ...
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The document provides an overview of life science trends in 2016, focusing on regenerative medicine. It includes interviews with thought leaders in regenerative medicine on the past, present and future of the field. The document also covers research and innovation in areas like cancer immunotherapy and personalized medicine. It discusses fundamental trends in the industry including biosimilars, biopharma blockbusters, gene editing treatments and digital medicine. The document summarizes investment and deal making activity as well as regulatory issues and developments in healthcare related to areas like antibiotics and whole genome sequencing.
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CHAPTER 5Epidemiologic Principles and MethodsCopyrig
CHAPTER 5
Epidemiologic Principles and Methods
Copyright © 2021 by Jones & Bartlett Learning, LLC an Ascend Learning Company. www.jblearning.com.
Copyright © 2021 by Jones & Bartlett Learning, LLC an Ascend Learning Company. www.jblearning.com
Definition of Epidemiology
Epidemiology is defined as “the study of the distribution and determinants of disease frequency in human populations.”
Copyright © 2021 by Jones & Bartlett Learning, LLC an Ascend Learning Company. www.jblearning.com
Step 1: Define the Disease
Death is easy to determine.
A death certificate states cause of death.
A blood test or stool culture is needed to verify a diagnosis of certain diseases.
Some diseases are hard to define.
EMS and SARS
Sometimes a definition changes as more is learned.
AIDS
Other health outcomes include injuries and risk factors.
Copyright © 2021 by Jones & Bartlett Learning, LLC an Ascend Learning Company. www.jblearning.com
Disease Frequency
Count the number of people with a disease and relate that to the population at risk (PAR).
PAR (denominator) may be the total population or exposed population, or one gender or age group.
PAR often comes from a census.
Two ways to measure frequency are:
Incidence, the number of new cases
Prevalence, the number of existing cases
Incidence is used for studying causes of disease.
Copyright © 2021 by Jones & Bartlett Learning, LLC an Ascend Learning Company. www.jblearning.com
Disease Frequency (cont.)
Prevalence depends on incidence and prognosis.
If causes or risk factors increase, incidence and prevalence increase.
If ability to diagnose increases, incidence and prevalence appear to increase.
Prevalence rates are most useful in assessing the societal impact of a disease and planning for healthcare services.
Mortality rates are used to measure frequency for diseases that are often fatal.
Copyright © 2021 by Jones & Bartlett Learning, LLC an Ascend Learning Company. www.jblearning.com
Distribution of Disease
Who:
Sex, age, occupation, race, and economic status
When:
Looks for disease frequency over time: Season, year (long-term trends), elapsed time since an exposure (epidemic curve)
Is crucial in tracking an outbreak of infectious diseases such as hepatitis and legionellosis
Where:
Neighborhood (e.g., clusters), latitude (climate), urban vs. rural, national variations
Looks at comparisons of disease frequency in different countries, states, counties, or other geographical divisions
Copyright © 2021 by Jones & Bartlett Learning, LLC an Ascend Learning Company. www.jblearning.com
Determinants of Disease
Why is distribution as it is?
We can make inferences from distribution.
Epidemiologists usually speak of risk factors not causes.
Copyright © 2021 by Jones & Bartlett Learning, LLC an Ascend Learning Company. www.jblearning.com
Human Population
Epidemiology studies human population, usually using observational rather than experimental methods.
Biomedical approach uses animal models to investiga ...
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Chemical influence
Some chemicals can cause harm to human health. Toxic chemicals include carcinogens that cause cancer, mutagens that cause genetic mutations, and teratogens that cause birth defects. Many chemicals also affect the immune, nervous, and endocrine systems. The toxicity of a chemical depends on factors like dose, route of exposure, and individual susceptibility. Scientists use animal testing and epidemiological studies to estimate toxicity, but these have limitations. More research is needed to understand the health impacts of many chemicals, especially at low exposure levels. Efforts to reduce chemical pollution and require safety testing aim to apply the precautionary principle.
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- Pepper's platform incorporates multi-omics data across genomics, transcriptomics, proteomics, and phosphoproteomics to capture a more functional and global understanding of disease biology.
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Week 5 Instructions Please use the materials attache.docx
Week 5
Instructions: Please use the materials attached on the following assignment. Minimum of 800
words total and up to 3 scholarly references. Use the online eBook as one of the references.
Must address new section properly. Narratives should be written in APA style, with in-text
citations and separate reference listing as needed. Be complete but concise. Must provide
100% original work. No free of grammatical, spelling, syntax, and punctuation errors.
Absolutely no plagiarism.
Assignment – minimum of 800 words total
1. You are opening a new pharmacy in your healthcare organization. How do you get
the internal stakeholders (e.g. clinical and non-clinical staff) to buy in to this change?
Who would serve in the role of the biggest advocate?
REQUIREMENTS:
Correct spelling, grammar, and formatting in APA.
No plagiarism! Must provide 100% original work.
Use only on-line eBook to assist with assignment.
eBook Reference:
Williams, S.J. & Torrens, P.R., (2008). Introduction to Health Services. 7th Ed. Thomson Delmar
Learning.
Research
o You may use any other database/source, but make sure the articles you cite are
scholarly.
o Wikipedia, Wiki Answers, About.com, Ask.com, Yahoo Answers, eHow, Personal
blogs, and other sources of that ilk are not credible for academic work. Quoting
such sources as credible is strictly forbidden.
245
P A R T
F O U R
Nonfinancial Resources
for Health Care
12890_11_ch11_p245-265.qxd 8/16/07 10:41 AM Page 245
Copyright 2008 Cengage Learning, Inc. All Rights Reserved. May not be copied, scanned, or duplicated, in whole or in part.
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CHAPTER TOPICS
Regulatory and Legal Issues
From Idea to Treatment: The Long,
Uncertain Research and Development
Process
Access, Pricing, and Patent Issues
The Value of Medicines
LEARNING OBJECTIVES
Upon completing this chapter, the reader
should be able to
1. Understand the nature of the pharmaceuti-
cal industry.
2. Understand the drug discovery process.
3. Appreciate the role of pharmaceuticals in
promoting health.
4. Appreciate the complex legal and regulatory
issues facing the industry.
5. Understand the role of government and pub-
lic policy with regard to pharmaceuticals.
246
CHAPTER 11
The Pharmaceutical Industry*
*This chapter is adapted from Pharmaceutical Industry Profile 2007, Pharmaceutical Research and Manufacturers of America (PhRMA),
2007, Washington, DC: PhRMA. Copyright © 2007 by the Pharmaceutical Research and Manufacturers of America.
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Breakthrough medicines and vaccines have
played a central role in this century’s unprecedented
progress in the treatment of fatal diseases. New
m.
Anny Serafina Love - Letter of Recommendation by Kellen Harkins, MS.
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IN THIS SUMMARY
The United States Food and Drug Administration (FDA) has significant reach in the American economy, ranging from medicines and medical devices to items on the grocery store shelves. Since its inception in 1906, the agency has faced a variety of technical and political challenges. Looking ahead, the FDA faces many new demands that could enlarge the agency’s already expansive mandate. New responsibilities may include the cost of medicine, consumers’ pursuit of perfection through drugs, consumer lifestyles, tobacco, and counterterrorism. As the nature of public health changes over time, it is inevitable that the FDA’s scope and responsibilities will change as well. In Inside the FDA, Fran Hawthorne explains the history of the FDA, how its processes work, and what the future may hold for this government agency.
SUBSCRIBE TODAY
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Research careers in drug discovery & development
This document provides an overview of careers in drug discovery and development. It discusses the multi-stage process of discovering new drugs, from identifying drug targets through clinical trials and regulatory approval. The document notes that drug development is a highly time-intensive and costly process involving many disciplines. It also aims to dispel common myths about careers in the pharmaceutical industry, emphasizing that industry scientists have opportunities for publication, innovation, and interesting work.
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This document discusses the limitations of current approaches to drug discovery and development and introduces Pepper's transomics platform as a solution. Specifically:
- Traditional drug R&D focuses on static, limited, and unlinked data that misses causal relationships and the full complexity of biology.
- Pepper's platform incorporates multi-omics data across genomics, transcriptomics, proteomics, and phosphoproteomics to capture a more functional and global understanding of disease biology.
- This transomics approach exceeds other methods in target identification and aims to address key questions in drug development around identifying the right target and developing the right drug for patients.
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Introduction to Regulatory Affairs - Pauwels Consulting Academy
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Fiorenzo and Nick talked about RA and their projects, each from their unique angle. They delivered their presentations for ## attendees at our Brussels office at the Lambroekstraat 5a in Diegem.
Biomonitoring: Its Expanding Role in Public Health Evaluations and Litigation
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Personalized medicine involves the prescription of specific therapeutics best suited for an individual based on their genetic or proteomic profile. This talk discusses current approaches in drug discovery/development, the role of genetics in drug metabolism, and lawful/ethical issues surrounding the deployment of new health technology.
The Translational Medicine Ontology: Driving personalized medicine by br...
The Translational Medicine Ontology provides terminology that bridges diverse areas of translational medicine including hypothesis management, discovery research, drug development and formulation, clinical research, and clinical practice. Designed primarily from use cases, the ontology consists of essential terms that are mapped to other ontologies. It serves as a global schema for data integration while simultaneously facilitating the formulation of complex queries across heterogeneous sources. We demonstrate the utility of the ontology through question answering over a prototype knowledge base composed of sample patient data integrated with linked open data. This work forms a basis for the development of a computational platform for managing information relevant to personalized medicine.
Keep Pharmaceuticals out of our water
Drugs are in our water, mostly from human excrement. Only a small category of Medicines are are given to patients at the levels found in the environment, mostly Chemotherapy drugs. this presentation to the EPA was given on Jan 15, 2009.
Week 5 Instructions Please use the materials attache.docx
Week 5
Instructions: Please use the materials attached on the following assignment. Minimum of 800
words total and up to 3 scholarly references. Use the online eBook as one of the references.
Must address new section properly. Narratives should be written in APA style, with in-text
citations and separate reference listing as needed. Be complete but concise. Must provide
100% original work. No free of grammatical, spelling, syntax, and punctuation errors.
Absolutely no plagiarism.
Assignment – minimum of 800 words total
1. You are opening a new pharmacy in your healthcare organization. How do you get
the internal stakeholders (e.g. clinical and non-clinical staff) to buy in to this change?
Who would serve in the role of the biggest advocate?
REQUIREMENTS:
Correct spelling, grammar, and formatting in APA.
No plagiarism! Must provide 100% original work.
Use only on-line eBook to assist with assignment.
eBook Reference:
Williams, S.J. & Torrens, P.R., (2008). Introduction to Health Services. 7th Ed. Thomson Delmar
Learning.
Research
o You may use any other database/source, but make sure the articles you cite are
scholarly.
o Wikipedia, Wiki Answers, About.com, Ask.com, Yahoo Answers, eHow, Personal
blogs, and other sources of that ilk are not credible for academic work. Quoting
such sources as credible is strictly forbidden.
245
P A R T
F O U R
Nonfinancial Resources
for Health Care
12890_11_ch11_p245-265.qxd 8/16/07 10:41 AM Page 245
Copyright 2008 Cengage Learning, Inc. All Rights Reserved. May not be copied, scanned, or duplicated, in whole or in part.
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CHAPTER TOPICS
Regulatory and Legal Issues
From Idea to Treatment: The Long,
Uncertain Research and Development
Process
Access, Pricing, and Patent Issues
The Value of Medicines
LEARNING OBJECTIVES
Upon completing this chapter, the reader
should be able to
1. Understand the nature of the pharmaceuti-
cal industry.
2. Understand the drug discovery process.
3. Appreciate the role of pharmaceuticals in
promoting health.
4. Appreciate the complex legal and regulatory
issues facing the industry.
5. Understand the role of government and pub-
lic policy with regard to pharmaceuticals.
246
CHAPTER 11
The Pharmaceutical Industry*
*This chapter is adapted from Pharmaceutical Industry Profile 2007, Pharmaceutical Research and Manufacturers of America (PhRMA),
2007, Washington, DC: PhRMA. Copyright © 2007 by the Pharmaceutical Research and Manufacturers of America.
12890_11_ch11_p245-265.qxd 8/14/07 12:15 PM Page 246
Copyright 2008 Cengage Learning, Inc. All Rights Reserved. May not be copied, scanned, or duplicated, in whole or in part.
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Breakthrough medicines and vaccines have
played a central role in this century’s unprecedented
progress in the treatment of fatal diseases. New
m.
Similar to Alexander's power point presentation SKO 2015 (20)
Epistemic lenses and virtues, beyond evidence-based medicine
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The Translational Medicine Ontology: Driving personalized medicine by br...
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Week 5 Instructions Please use the materials attache.docx
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一模一样【微信：A575476】【新西兰奥塔哥大学毕业证（otago毕业证）成绩单Offer】【微信：A575476】（留信学历认证永久存档查询）采用学校原版纸张、特殊工艺完全按照原版一比一制作（包括：隐形水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠，文字图案浮雕，激光镭射，紫外荧光，温感，复印防伪）行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备，十五年致力于帮助留学生解决难题，业务范围有加拿大、英国、澳洲、韩国、美国、新加坡，新西兰等学历材料，包您满意。
【业务选择办理准则】
一、工作未确定，回国需先给父母、亲戚朋友看下文凭的情况，办理一份就读学校的毕业证【微信：A575476】文凭即可
二、回国进私企、外企、自己做生意的情况，这些单位是不查询毕业证真伪的，而且国内没有渠道去查询国外文凭的真假，也不需要提供真实教育部认证。鉴于此，办理一份毕业证【微信：A575476】即可
三、进国企，银行，事业单位，考公务员等等，这些单位是必需要提供真实教育部认证的，办理教育部认证所需资料众多且烦琐，所有材料您都必须提供原件，我们凭借丰富的经验，快捷的绿色通道帮您快速整合材料，让您少走弯路。
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
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对于老客户或者被老客户介绍过来的朋友，我们都会适当给一些优惠。
选择实体注册公司办理，更放心，更安全！我们的承诺：可来公司面谈，可签订合同，会陪同客户一起到教育部认证窗口递交认证材料，客户在教育部官方认证查询网站查询到认证通过结果后付款，不成功不收费！
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Alexander's power point presentation SKO 2015
- 2. Alexander van Boetzelaer Managing Director Corporate R&D
- 3. Dr. Philip Lorenzi MD Anderson Cancer Center Dr. Carlos Faerman Vertex Pharmaceuticals Brady Godbey Fluor
- 16. 3 TO 5 YEAR LIFE EXPECTANCY POST DIAGNOSES
- 17. $1.8 BILLION spent on averageover 13 YEARS for drug development
- 23. SURVIVAL RATE
- 24. Smarter Biology Smarter Chemistry Smarter Medicine Smarter Materials Improving millions of lives Saving billions of dollars
- 26. But how do we make all this information actionable?
- 28. Then real discovery can begin
- 29. Top 50 Pharma Companies
- 30. Top 50 Chemical companies
- 31. Top 50 Oil & Gas Companies
- 33. You are leading the way in advancing science, technology and health.