This document discusses a resource for students to investigate issues around drug development costs. The resource includes discussion cards with statements about drug development for students to agree or disagree with. It also includes information cards providing more details. Students are split into small groups and discuss the statements, placing the cards on a continuum between "agree" and "disagree". The goal is for the group to come to a consensus on where each card is placed through discussion. The resource is intended to promote discussion of ethical, legal and socioeconomic issues related to drug testing, marketing, investment and effects of globalization.
Government cost containment methods in Asia-Pacific markets are as diverse as the cultures represented in the region, so what lessons are the markets leveraging from cost containment experiences? And what, in the end, are pharmaceutical companies supposed to do about it?
A partnership model for the control of unethical marketing of medical drugs i...Alexander Decker
This document summarizes a research study on assessing the effects of enforcing anti-counterfeit drug laws and penalties on unethical drug marketing in Nigeria. The study found that enforcing existing penalties had a non-significant positive impact in reducing unethical marketing. To better control unethical marketing, the study designed a partnership model called the Regulatory Excellence Model to enhance enforcement efforts through cooperation between regulatory agencies and other stakeholders. Recommendations were made to address the ongoing issues of counterfeit drugs in Nigeria.
Corporate Strategy Assignment - The Global Pharmaceutical IndustryAmany Hamza
This report provides an analytical strategic review of the global pharmaceutical industry. In the first part, it covers the external environment of the global pharmaceutical industry using PESTEL analysis and outlines the Key drivers for change. It then uses the Five Forces analysis to demonstrate the industry attractiveness. Secondly, we illustrate the strategic capabilities of Novartis using the Value chain. Finally, we attempt to highlights its financial performance, position and culture.
False Advertising in the Drug and Food Industries JoshuaRiger
This document discusses the regulation of false advertising in the food and drug industries. It outlines that the FDA regulates prescription drug advertisements while the FTC oversees over-the-counter drug ads. Both agencies want to ensure ads are truthful and not misleading to consumers. Food and drug labels must include accurate ingredient and dosage information. Failure to do so or making unsupported health claims can result in products being deemed misbranded or legal action from the FTC and FDA.
Pharma Co's in Emerging Markets - Innovation & Technology are Key to GrowthAnup Soans
Emerging markets are predicted to account for a third of global pharmaceutical spend by the end of next year – and seen as critical for the sustained growth of leading pharma companies.
The report summarises the findings of a Cambridge Consultants workshop held in Mumbai, India, earlier this year. The product design and development firm brought together senior personnel from both Indian and multinational pharma companies to debate whether emerging markets can be an opportunity to drive sustainable growth.
The consensus was that the term ‘emerging markets’ covers nations in parts of Africa, the Middle East and South East Asia, as well as the more traditional countries of Brazil, Russia, India and China. But all the delegates said emerging markets cannot be grouped into a single cluster to chalk out common strategies. Clustering markets around parameters such as regulatory pathways or therapeutic applications was considered the best approach.
“Emerging markets are facing rapid growth of chronic ‘Western’ diseases like diabetes, hypertension, chronic respiratory problems, cancer, heart disease and neurological disorders,” said Ambuj Jain, India general manager at Cambridge Consultants. “In some cases, conditions like diabetes are turning into near-epidemic situations.
“In India, for example, the prevalence of diabetes and cancer is projected to rise by 25-40% over the next 10 years. This shift gives pharma companies an opportunity to market their global products in emerging markets, backed by tested ‘go-to-market’ strategies and operating models.”
The report says key barriers which need to be addressed in many emerging markets are the affordability and accessibility of medicines. Improvements in affordability will be driven by rising disposable incomes and increasing insurance coverage. Growth in accessibility will come from increases in government spending and medical infrastructure, and new business models for rural areas. The acceptability of medicines is also expected to rise, as a result of the growth in chronic conditions – and the resulting increase in the self-administration of drugs.
Workshop delegate Sanjay Bhanushali, a director of global pharma company Cipla, said: “Emerging markets are critical for the sustained growth of leading pharmaceutical organisations. They represent a significant proportion of the world’s population and many of their governments are increasingly focusing on improving healthcare. Innovation and technology – with the emphasis on patient and stakeholder needs – will be crucial to success in these markets.”
Diagnostics was seen by the workshop delegates as a key focus area where innovation can drive sustained growth.
This document provides an overview and summary of a conference on the perception and management of drug safety risks. It discusses the increasing public focus on drug risks over the past decades and the challenges around balancing risks and benefits. The conference brought together experts from academia, pharmaceutical companies, regulatory agencies, and consumer advocacy groups to have an open dialogue on improving understanding of risk perception, benefit-risk assessment, and risk communication regarding pharmaceutical products on an international level. It aimed to recognize the social dimensions of drug safety and risk management and identify opportunities for multidisciplinary collaboration to address existing issues.
Thomas Müller, MD & Pharmacist, Head of Pharmaceuticals Dept Federal Joint Committee.
Pharma Pricing & Market Access Congress 2017
22 February 2017
London
Government cost containment methods in Asia-Pacific markets are as diverse as the cultures represented in the region, so what lessons are the markets leveraging from cost containment experiences? And what, in the end, are pharmaceutical companies supposed to do about it?
A partnership model for the control of unethical marketing of medical drugs i...Alexander Decker
This document summarizes a research study on assessing the effects of enforcing anti-counterfeit drug laws and penalties on unethical drug marketing in Nigeria. The study found that enforcing existing penalties had a non-significant positive impact in reducing unethical marketing. To better control unethical marketing, the study designed a partnership model called the Regulatory Excellence Model to enhance enforcement efforts through cooperation between regulatory agencies and other stakeholders. Recommendations were made to address the ongoing issues of counterfeit drugs in Nigeria.
Corporate Strategy Assignment - The Global Pharmaceutical IndustryAmany Hamza
This report provides an analytical strategic review of the global pharmaceutical industry. In the first part, it covers the external environment of the global pharmaceutical industry using PESTEL analysis and outlines the Key drivers for change. It then uses the Five Forces analysis to demonstrate the industry attractiveness. Secondly, we illustrate the strategic capabilities of Novartis using the Value chain. Finally, we attempt to highlights its financial performance, position and culture.
False Advertising in the Drug and Food Industries JoshuaRiger
This document discusses the regulation of false advertising in the food and drug industries. It outlines that the FDA regulates prescription drug advertisements while the FTC oversees over-the-counter drug ads. Both agencies want to ensure ads are truthful and not misleading to consumers. Food and drug labels must include accurate ingredient and dosage information. Failure to do so or making unsupported health claims can result in products being deemed misbranded or legal action from the FTC and FDA.
Pharma Co's in Emerging Markets - Innovation & Technology are Key to GrowthAnup Soans
Emerging markets are predicted to account for a third of global pharmaceutical spend by the end of next year – and seen as critical for the sustained growth of leading pharma companies.
The report summarises the findings of a Cambridge Consultants workshop held in Mumbai, India, earlier this year. The product design and development firm brought together senior personnel from both Indian and multinational pharma companies to debate whether emerging markets can be an opportunity to drive sustainable growth.
The consensus was that the term ‘emerging markets’ covers nations in parts of Africa, the Middle East and South East Asia, as well as the more traditional countries of Brazil, Russia, India and China. But all the delegates said emerging markets cannot be grouped into a single cluster to chalk out common strategies. Clustering markets around parameters such as regulatory pathways or therapeutic applications was considered the best approach.
“Emerging markets are facing rapid growth of chronic ‘Western’ diseases like diabetes, hypertension, chronic respiratory problems, cancer, heart disease and neurological disorders,” said Ambuj Jain, India general manager at Cambridge Consultants. “In some cases, conditions like diabetes are turning into near-epidemic situations.
“In India, for example, the prevalence of diabetes and cancer is projected to rise by 25-40% over the next 10 years. This shift gives pharma companies an opportunity to market their global products in emerging markets, backed by tested ‘go-to-market’ strategies and operating models.”
The report says key barriers which need to be addressed in many emerging markets are the affordability and accessibility of medicines. Improvements in affordability will be driven by rising disposable incomes and increasing insurance coverage. Growth in accessibility will come from increases in government spending and medical infrastructure, and new business models for rural areas. The acceptability of medicines is also expected to rise, as a result of the growth in chronic conditions – and the resulting increase in the self-administration of drugs.
Workshop delegate Sanjay Bhanushali, a director of global pharma company Cipla, said: “Emerging markets are critical for the sustained growth of leading pharmaceutical organisations. They represent a significant proportion of the world’s population and many of their governments are increasingly focusing on improving healthcare. Innovation and technology – with the emphasis on patient and stakeholder needs – will be crucial to success in these markets.”
Diagnostics was seen by the workshop delegates as a key focus area where innovation can drive sustained growth.
This document provides an overview and summary of a conference on the perception and management of drug safety risks. It discusses the increasing public focus on drug risks over the past decades and the challenges around balancing risks and benefits. The conference brought together experts from academia, pharmaceutical companies, regulatory agencies, and consumer advocacy groups to have an open dialogue on improving understanding of risk perception, benefit-risk assessment, and risk communication regarding pharmaceutical products on an international level. It aimed to recognize the social dimensions of drug safety and risk management and identify opportunities for multidisciplinary collaboration to address existing issues.
Thomas Müller, MD & Pharmacist, Head of Pharmaceuticals Dept Federal Joint Committee.
Pharma Pricing & Market Access Congress 2017
22 February 2017
London
This document discusses how the global healthcare profit pool will shift between 2010 and 2020. It predicts that the total profit pool will grow at 4% annually from $520 billion to $740 billion over this period. However, profitability will decline for most players as the sources of growth and margins change significantly between sectors and regions. Innovative pharmaceutical and medical technology companies will see much slower growth and declining margins. In contrast, providers of healthcare delivery and lower-margin sectors like generics will capture a larger share of profits. To remain competitive, companies will need to develop new business models focused on improving healthcare delivery and outcomes rather than just generating more products and procedures.
The Subversion of Medicine Through Treatment Guidelinesjerryleonard999
A detailed examination of how treatment guidelines ghost-written by "big pharma" are destroying medicine. Part II: Application of the basic model to show how manufactured pharma "thought leaders" created the Lyme disease epidemic to treat symptoms in perpetuity rather than address the underlying cause.
This document discusses direct-to-consumer (DTC) advertising of pharmaceutical products. It defines DTC advertising as marketing pharmaceutical products directly to consumers through various media like TV, print, radio, and social media. DTC advertising is meant to educate consumers about medical conditions and available treatments, and works in conjunction with doctors, not in isolation. The document also notes how new media and the internet have expanded consumers' access to health information and enabled the evolution of DTC advertising. Some examples of early DTC advertising campaigns for specific drugs are provided. The document concludes by discussing opportunities for the company Vasu to conduct DTC advertising through educational camps and seminars and targeted product leaflets.
This document provides a history of pharmaceutical advertising in the United States from the early 1900s to the 1960s. It discusses the emergence of direct-to-consumer advertising and the original debates around patent versus ethical drugs. As the pharmaceutical industry grew in the postwar period, advertising agencies applied more creative techniques to promote drugs. However, safety issues in the late 1950s and 1960s led to increased regulation, including the Kefauver hearings which expanded the FDA's authority over drug advertising.
Is European market access becoming an incubator for rare disease development?...KateBenson18
FIECON's white paper 'Is European market access becoming an incubator for rare disease development?' explores the hypothesis that successful commercialisation in Europe is the biggest commercial opportunity for orphan drug manufacturers right now.
Johnson & Johnson's 2015 marketing plan analyzes the company's current strengths and weaknesses, as well as opportunities and threats. It identifies JNJ's dominance in the healthcare market as a strength but notes weaknesses like lawsuits over illegal promotion of Risperdal. The plan proposes three strategies: implementing a prescription savings program, engineering a drug to treat a disease caused by antipsychotics, and expanding into foreign markets through meetings with officials. The goal is to improve customer loyalty, gain market share internationally, and address issues like Risperdal to benefit JNJ's performance in 2017.
This document provides an overview of key trends in the generic pharmaceutical industry in South Africa, as reported by the National Association of Pharmaceutical Manufacturers. It discusses challenges facing generic medicine suppliers, including prescriber and consumer perceptions, intellectual property issues, regulatory delays, and pricing factors. It also summarizes the chairman's comments on recent generic market growth trends and provides details on guidelines proposed for biosimilar medicines.
Safe Prescribing Practices Conference for Medical Professionals, June 2013Heidi Denton
Participants will:
Report their intent to support and/or actively work towards incorporating best practices in responsible prescribing guidelines into their everyday practice of medicine.
Report an increased knowledge of the Michigan Automated Prescription System (MAPS) and the benefits of reporting regularly to MAPS.
Report intent to support and/or actively work towards incorporating consistent use of the MAPS into their everyday practice of prescribing controlled substances.
Report that at the training they received easy to use tools that can help them to better educate their patients on the importance of taking medications as prescribed.
Gain an increased knowledge of local, state, and national substance abuse and mental health treatment resources.
The global pharmaceutical market is growing due to an aging population, rising incomes in developing countries, and a shift towards chronic diseases globally. However, pharmaceutical companies face productivity challenges, as research and development spending has increased substantially while the number of new drugs approved has decreased. Emerging markets like the E7 countries (Brazil, China, India, Indonesia, Mexico, Russia and Turkey) are becoming more important as their economies and healthcare spending grow rapidly. Demographic and economic shifts are transforming disease burdens and creating new opportunities for pharmaceutical companies, but they will need to improve research productivity to capitalize on these changing global healthcare trends.
Case for emerging 9 sustaining oncology innovationyuvrajgill
The document discusses the challenges facing major oncology innovator companies as their traditional cash cow drugs lose market share to biosimilars. It argues that innovators need to look beyond traditional Western markets and consider partnering with emerging markets like India to strengthen their healthcare systems and generate sustainable revenues. This could help build new cash cows to fund future innovation while improving access in populations with high cancer rates. The document outlines how an integrated approach with partners across government, non-profits and hospitals could work to mutually benefit patients, innovators and healthcare systems in emerging markets.
The document discusses how new technologies are creating opportunities for over-the-counter (OTC) healthcare products. It notes that technologies allow remote monitoring of health, while budgets pressures are increasing switches from prescription to OTC drugs. Experts predict technologies will converge with personal health records and allow some consumers access to new OTC drugs with remote monitoring of their health status. This could expand the self-care market for conditions like hypertension and diabetes. Consumer companies are partnering with startups to develop new health-focused products and services using technologies. The future outlook for the global OTC market remains positive due to ongoing healthcare needs, though some political instability could disrupt supply chains.
Market Access, Pricing and Reimbursement streamlinedWang-yee Liu
This document provides an agenda for the "Market Access, Pricing and Reimbursement 2016 Europe" conference taking place on June 9-10, 2016 in London. The agenda includes presentations and speakers on topics related to market access strategies, challenges in pharmaceutical pricing and reimbursement, and maximizing access in emerging markets. Key industry experts scheduled to speak include leaders from pharmaceutical companies such as Celgene, Sanofi, Alcon, and Daiichi Sankyo. The conference aims to provide a platform for stakeholders to discuss macroeconomic factors, policies, and drivers influencing the pharmaceutical industry.
A presentation I did for my Leadership and Special Topics in Pharmaceutical Marketing and Management class on social media. I completed this project with Tae Lee.
Advanced Sales Force Remodeling Strategies in a Multi-Channel Environment Ind...Moch Kurniawan
The document discusses strategies for pharmaceutical companies in emerging markets like Indonesia. It notes that emerging markets have great potential but also diversity in healthcare infrastructure development. Within emerging markets, there are three clusters of markets with differing levels of readiness: BRICMT countries, second-tier countries like Indonesia, Vietnam and Thailand, and African countries. The global pharmaceutical market is expected to be worth $1.6 trillion by 2020, with emerging markets playing an important role in industry growth. Pharmaceutical companies must adapt to new realities in emerging markets like price pressures, demand for low-cost generics, and healthcare reforms.
WHAT IF: A health impact fund rewarded innovation and managed spending on new...CFHI-FCASS
The document proposes the Health Impact Fund (HIF) as a solution to weak market incentives for developing drugs for diseases that primarily affect the poor. The HIF would reward drug developers based on the assessed health impact of their drugs. Developers could optionally register drugs with the HIF, making them available globally at cost while receiving rewards from the HIF over 10 years for new drugs or 5 years for new uses. The rewards would be billions annually and scaled based on each drug's share of total health impact achieved by all registered drugs. This would incentivize development of drugs for important diseases of the poor by rewarding drugs with high health impact.
This document provides a business plan for a new pharmaceutical company called NEWTech Advant. The plan includes a situation analysis of the pharmaceutical market, noting trends like an aging population and increased regulation. It outlines NEWTech Advant's goals of improving existing drugs and discovering new ones. The marketing strategy discusses targeting physicians and patients aged 45+, and increasing market share through advertising. Financial objectives include achieving profitability in three years. The plan also analyzes strengths, weaknesses, opportunities and threats for the new company.
The document summarizes the International Federation of Pharmaceutical Manufacturers & Associations' (IFPMA) Code of Practice. The key points are:
1. The IFPMA Code is a model for self-regulation of the pharmaceutical industry's promotion, communication, and interactions with stakeholders like healthcare professionals. Compliance is required for IFPMA membership.
2. The Code aims to ensure promotion is responsible, ethical, and based on scientific evidence. It regulates standards for promotional materials but not pricing or public communication.
3. The 2012 revision strengthened provisions on clinical trials disclosure and interactions with healthcare professionals, among other changes. Global implementation began in September 2012.
This document discusses how the global healthcare profit pool will shift between 2010 and 2020. It predicts that the total profit pool will grow at 4% annually from $520 billion to $740 billion over this period. However, profitability will decline for most players as the sources of growth and margins change significantly between sectors and regions. Innovative pharmaceutical and medical technology companies will see much slower growth and declining margins. In contrast, providers of healthcare delivery and lower-margin sectors like generics will capture a larger share of profits. To remain competitive, companies will need to develop new business models focused on improving healthcare delivery and outcomes rather than just generating more products and procedures.
The Subversion of Medicine Through Treatment Guidelinesjerryleonard999
A detailed examination of how treatment guidelines ghost-written by "big pharma" are destroying medicine. Part II: Application of the basic model to show how manufactured pharma "thought leaders" created the Lyme disease epidemic to treat symptoms in perpetuity rather than address the underlying cause.
This document discusses direct-to-consumer (DTC) advertising of pharmaceutical products. It defines DTC advertising as marketing pharmaceutical products directly to consumers through various media like TV, print, radio, and social media. DTC advertising is meant to educate consumers about medical conditions and available treatments, and works in conjunction with doctors, not in isolation. The document also notes how new media and the internet have expanded consumers' access to health information and enabled the evolution of DTC advertising. Some examples of early DTC advertising campaigns for specific drugs are provided. The document concludes by discussing opportunities for the company Vasu to conduct DTC advertising through educational camps and seminars and targeted product leaflets.
This document provides a history of pharmaceutical advertising in the United States from the early 1900s to the 1960s. It discusses the emergence of direct-to-consumer advertising and the original debates around patent versus ethical drugs. As the pharmaceutical industry grew in the postwar period, advertising agencies applied more creative techniques to promote drugs. However, safety issues in the late 1950s and 1960s led to increased regulation, including the Kefauver hearings which expanded the FDA's authority over drug advertising.
Is European market access becoming an incubator for rare disease development?...KateBenson18
FIECON's white paper 'Is European market access becoming an incubator for rare disease development?' explores the hypothesis that successful commercialisation in Europe is the biggest commercial opportunity for orphan drug manufacturers right now.
Johnson & Johnson's 2015 marketing plan analyzes the company's current strengths and weaknesses, as well as opportunities and threats. It identifies JNJ's dominance in the healthcare market as a strength but notes weaknesses like lawsuits over illegal promotion of Risperdal. The plan proposes three strategies: implementing a prescription savings program, engineering a drug to treat a disease caused by antipsychotics, and expanding into foreign markets through meetings with officials. The goal is to improve customer loyalty, gain market share internationally, and address issues like Risperdal to benefit JNJ's performance in 2017.
This document provides an overview of key trends in the generic pharmaceutical industry in South Africa, as reported by the National Association of Pharmaceutical Manufacturers. It discusses challenges facing generic medicine suppliers, including prescriber and consumer perceptions, intellectual property issues, regulatory delays, and pricing factors. It also summarizes the chairman's comments on recent generic market growth trends and provides details on guidelines proposed for biosimilar medicines.
Safe Prescribing Practices Conference for Medical Professionals, June 2013Heidi Denton
Participants will:
Report their intent to support and/or actively work towards incorporating best practices in responsible prescribing guidelines into their everyday practice of medicine.
Report an increased knowledge of the Michigan Automated Prescription System (MAPS) and the benefits of reporting regularly to MAPS.
Report intent to support and/or actively work towards incorporating consistent use of the MAPS into their everyday practice of prescribing controlled substances.
Report that at the training they received easy to use tools that can help them to better educate their patients on the importance of taking medications as prescribed.
Gain an increased knowledge of local, state, and national substance abuse and mental health treatment resources.
The global pharmaceutical market is growing due to an aging population, rising incomes in developing countries, and a shift towards chronic diseases globally. However, pharmaceutical companies face productivity challenges, as research and development spending has increased substantially while the number of new drugs approved has decreased. Emerging markets like the E7 countries (Brazil, China, India, Indonesia, Mexico, Russia and Turkey) are becoming more important as their economies and healthcare spending grow rapidly. Demographic and economic shifts are transforming disease burdens and creating new opportunities for pharmaceutical companies, but they will need to improve research productivity to capitalize on these changing global healthcare trends.
Case for emerging 9 sustaining oncology innovationyuvrajgill
The document discusses the challenges facing major oncology innovator companies as their traditional cash cow drugs lose market share to biosimilars. It argues that innovators need to look beyond traditional Western markets and consider partnering with emerging markets like India to strengthen their healthcare systems and generate sustainable revenues. This could help build new cash cows to fund future innovation while improving access in populations with high cancer rates. The document outlines how an integrated approach with partners across government, non-profits and hospitals could work to mutually benefit patients, innovators and healthcare systems in emerging markets.
The document discusses how new technologies are creating opportunities for over-the-counter (OTC) healthcare products. It notes that technologies allow remote monitoring of health, while budgets pressures are increasing switches from prescription to OTC drugs. Experts predict technologies will converge with personal health records and allow some consumers access to new OTC drugs with remote monitoring of their health status. This could expand the self-care market for conditions like hypertension and diabetes. Consumer companies are partnering with startups to develop new health-focused products and services using technologies. The future outlook for the global OTC market remains positive due to ongoing healthcare needs, though some political instability could disrupt supply chains.
Market Access, Pricing and Reimbursement streamlinedWang-yee Liu
This document provides an agenda for the "Market Access, Pricing and Reimbursement 2016 Europe" conference taking place on June 9-10, 2016 in London. The agenda includes presentations and speakers on topics related to market access strategies, challenges in pharmaceutical pricing and reimbursement, and maximizing access in emerging markets. Key industry experts scheduled to speak include leaders from pharmaceutical companies such as Celgene, Sanofi, Alcon, and Daiichi Sankyo. The conference aims to provide a platform for stakeholders to discuss macroeconomic factors, policies, and drivers influencing the pharmaceutical industry.
A presentation I did for my Leadership and Special Topics in Pharmaceutical Marketing and Management class on social media. I completed this project with Tae Lee.
Advanced Sales Force Remodeling Strategies in a Multi-Channel Environment Ind...Moch Kurniawan
The document discusses strategies for pharmaceutical companies in emerging markets like Indonesia. It notes that emerging markets have great potential but also diversity in healthcare infrastructure development. Within emerging markets, there are three clusters of markets with differing levels of readiness: BRICMT countries, second-tier countries like Indonesia, Vietnam and Thailand, and African countries. The global pharmaceutical market is expected to be worth $1.6 trillion by 2020, with emerging markets playing an important role in industry growth. Pharmaceutical companies must adapt to new realities in emerging markets like price pressures, demand for low-cost generics, and healthcare reforms.
WHAT IF: A health impact fund rewarded innovation and managed spending on new...CFHI-FCASS
The document proposes the Health Impact Fund (HIF) as a solution to weak market incentives for developing drugs for diseases that primarily affect the poor. The HIF would reward drug developers based on the assessed health impact of their drugs. Developers could optionally register drugs with the HIF, making them available globally at cost while receiving rewards from the HIF over 10 years for new drugs or 5 years for new uses. The rewards would be billions annually and scaled based on each drug's share of total health impact achieved by all registered drugs. This would incentivize development of drugs for important diseases of the poor by rewarding drugs with high health impact.
This document provides a business plan for a new pharmaceutical company called NEWTech Advant. The plan includes a situation analysis of the pharmaceutical market, noting trends like an aging population and increased regulation. It outlines NEWTech Advant's goals of improving existing drugs and discovering new ones. The marketing strategy discusses targeting physicians and patients aged 45+, and increasing market share through advertising. Financial objectives include achieving profitability in three years. The plan also analyzes strengths, weaknesses, opportunities and threats for the new company.
The document summarizes the International Federation of Pharmaceutical Manufacturers & Associations' (IFPMA) Code of Practice. The key points are:
1. The IFPMA Code is a model for self-regulation of the pharmaceutical industry's promotion, communication, and interactions with stakeholders like healthcare professionals. Compliance is required for IFPMA membership.
2. The Code aims to ensure promotion is responsible, ethical, and based on scientific evidence. It regulates standards for promotional materials but not pricing or public communication.
3. The 2012 revision strengthened provisions on clinical trials disclosure and interactions with healthcare professionals, among other changes. Global implementation began in September 2012.
Creative Technosoft Systems (CTS) is an Indian offshore software development company established in 2007 that provides customized product and application development services globally, mainly for Middle Eastern clients. CTS leverages its software engineering expertise to deliver cost-effective and innovative solutions such as web and mobile applications, as well as product development from conceptualization through implementation and support. CTS has developed several products including systems for online clinics, travel management, feedback management, document management, facilities information, hospitals, campuses, homes, enterprises, and hotels.
The film tells the story of con artists Irving Rosenfeld and Sydney Prosser who are forced to work with an unpredictable FBI agent Richie DiMaso. Starring Jennifer Lawrence and Jeremy Renner, the 138-minute film was financially successful with a worldwide box office total of $248.9 million, though it received an age rating of 15 for violence and language.
Rachel Hynes' senior project involved retraining a racehorse to be a well-rounded riding horse that is safe, versatile, and reliable. Through the process, Rachel learned patience, dedication, and had to overcome financial demands, time constraints, training obstacles, and challenges requiring selflessness. The project resulted in an overall healthier horse suitable for multiple riding disciplines.
This document provides an agenda for the "Wind Power HR & Talent Management" conference taking place on October 9-10, 2012 in Hamburg, Germany. The conference will feature 15 expert speakers discussing topics such as effective recruitment channels, improving employee retention, training programs, and bridging skills gaps in the wind industry. Speakers will share case studies and lessons learned from companies such as ENERCON Services UK Ltd, Centrica Energy, EDP Renewables, and KENERSYS GmbH. Participants can learn recruitment strategies for international roles and using company reputation to attract senior candidates.
Csr training: Seven strategies to make it work for participantsWayne Dunn
Making CSR training work. Training should produce meaningful value for participants, and those who pay for their participation.
Executive training programs can be boring, dull and virtually useless. Or they can be dynamic, career altering, fun and productive.
Here are some thoughts on how we can make CSR Training work better for participants.
To keep updated on postings and events go to www.csrtraininginstitute.com and sign up for the newsletter. If interested the CSR Knowledge Centre http://bit.ly/CSRknowledge contains a series of short, pragmatic articles on CSR Strategy, Management and related areas.
The document discusses the economic environment and its impact on businesses. It defines economic environment as the economic factors that affect business operations, including the system, policies, nature of the economy, trade cycles, resources, income levels, and more.
The key elements of economic environment are: 1) economic conditions like income, demand, business cycles 2) the economic system like capitalism, socialism, mixed 3) economic policies set by government 4) the international economic situation and 5) economic legislation. It also discusses factors that influence economic conditions like GDP, inflation, and industry growth.
This document outlines plans for developing a destination co-working property called Kudavi Forest on 10,000 acres of land. Phase 1 involves building a founding team and community of creatives and remote workers. An operating company will manage and market the property, while a property company owns the land and infrastructure. Phase 2 envisions Kudavi Forest becoming a hub for remote work as autonomous vehicles and VR technology change the nature of work by enabling more remote opportunities. The long-term plan is to identify 100 sites for new satellite cities optimized for remote work that will thrive as transportation and work become more virtual.
Creative Technosoft Systems (CTS) is an Indian software development company that provides customized product and application development services and solutions to global businesses. CTS aims to exceed expectations with quality service, an inspiring workplace, and business excellence. The company offers solutions in web development, mobility, digital marketing, and more through technologies and innovation.
8/12 MediaKey /// "Tunnel Studios un laboratorio di idee"Tunnel Studios
1) Tunnel Studios is an Italian communication agency that focuses on creativity, experimentation, and online projects. Over the past 10 years they have built a reputation working with major companies, institutions, and media.
2) Today they have a staff of 20 people across creative and technical roles. They take a custom approach to each project grounded in a deep understanding of technique and a focus on quality.
3) Looking ahead, Tunnel Studios aims to stay adaptive to market needs and technological changes, and continue their partnership approach with clients through transparent dialogue.
1) The document discusses key concepts in bioenergetics including the first and second laws of thermodynamics, enthalpy, entropy, free energy, coupled reactions, and how these concepts relate to biochemical processes.
2) Thermodynamics is essential for understanding metabolic pathways, why molecules cross membranes, and how muscles generate force. The first law states that energy is conserved while the second law states that spontaneous processes increase disorder.
3) Free energy is used to determine reaction spontaneity and how coupled reactions allow endergonic reactions to be driven by exergonic ones, providing a thermodynamic basis for metabolic pathways.
This document provides strategies for incorporating rigor into a mathematics classroom using Bloom's Taxonomy. It discusses understanding the curriculum and standards, using questioning techniques to check for understanding at higher levels of thinking, allowing mistakes to promote learning, and pacing instruction to ensure deep conceptual understanding of mathematical concepts. The goal is to challenge students with authentic problem-solving that requires critical thinking, collaboration, and applying knowledge in new situations.
This document provides an overview of topics related to tourism in Taiwan including gender equality, common souvenirs to buy in different locations, a vocabulary review, and questions to ask a partner about travel experiences. Gender equality is high in Taiwan, which ranks first in Asia and near the top globally. Souvenirs vary by location, such as Sun Moon Lake, Taichung, and Penghu. A vocabulary review covers words like beige, toiletries, and skyrocket. Sample questions ask about reasons for travel, travel benefits and destinations, best and worst travel experiences, and travel preferences.
This document provides an overview of research methods and processes. It begins with a welcome to class and then discusses various types of research such as descriptive research and predictive research. It also distinguishes between basic research and applied research. Several examples of potential research questions are provided for business research. The document concludes with a diagram illustrating the overall research process and notes that students will learn how to conduct their own research projects over multiple courses.
Ethical Implications of Orphan Drug Research IncentivesKuldeep Badoniya
1. This presentation will go over the implications of research incentives limited to orphan drugs.
2. It will demonstrate the case and summarize the key points from a high level. Furthermore, this will provide a basis on how to address the the dilemmas.
NOTE - This presentation was made as part of an assignment for a Course PME 542 (Regulation and Compliance in the Pharmaceutical Industry) at Stevens Institute of Technology, Hoboken, New Jersey
Prepared By - Jing Mi, Ali Raza and Kuldeep Badoniya
The document proposes a new model called the Health Impact Fund (HIF) to stimulate research and development of life-saving pharmaceuticals. The HIF would reward drug developers based on the actual health impact of their products, as measured by quality-adjusted life years (QALYs). Developers could opt into the HIF and sell their drugs at low prices in exchange for reward payments over 10 years. The HIF aims to address current inefficiencies in drug development and access by incentivizing research for neglected diseases and making drugs affordable for more people. A pilot program is suggested to test the HIF model.
This document summarizes a study conducted by the U.S. Department of Commerce on pharmaceutical price controls in OECD countries and their implications. The key findings are:
1) All 11 OECD countries studied rely on some form of price controls to limit drug spending, resulting in patented drug prices below U.S. levels.
2) Intellectual property rights are adequately enforced in these countries, but price controls still reduce revenues that could support more research and development.
3) Estimates suggest price controls reduce annual global pharmaceutical R&D by $5-8 billion and new drug development by 3-4 drugs per year.
4) Eliminating price controls could provide U.S. consumers $5-
Pharmaceutical Fraud: Health 2.0 Conference Highlights Scams Health 2Conf
This presentation by Health 2.0 Conference talks about pharmaceutical fraud and what are some of the most common spam perpetrated by scammers. This presentation also highlights how AI can help mitigate the effects of fraud better than any traditional method.
The document summarizes the Orphan Drug Act of 1983 and its impact. It provides incentives like 7 years of marketing exclusivity and tax credits to stimulate development of drugs for rare diseases defined as affecting fewer than 200,000 people. Since 1983, over 1000 designations and 200 product approvals have occurred. While the Act has met its objectives, concerns around the high costs of orphan drugs and determining appropriate access and reimbursement are discussed.
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Chapter wise All Notes of First year Basic Civil Engineering
Syllabus
Chapter-1
Introduction to objective, scope and outcome the subject
Chapter 2
Introduction: Scope and Specialization of Civil Engineering, Role of civil Engineer in Society, Impact of infrastructural development on economy of country.
Chapter 3
Surveying: Object Principles & Types of Surveying; Site Plans, Plans & Maps; Scales & Unit of different Measurements.
Linear Measurements: Instruments used. Linear Measurement by Tape, Ranging out Survey Lines and overcoming Obstructions; Measurements on sloping ground; Tape corrections, conventional symbols. Angular Measurements: Instruments used; Introduction to Compass Surveying, Bearings and Longitude & Latitude of a Line, Introduction to total station.
Levelling: Instrument used Object of levelling, Methods of levelling in brief, and Contour maps.
Chapter 4
Buildings: Selection of site for Buildings, Layout of Building Plan, Types of buildings, Plinth area, carpet area, floor space index, Introduction to building byelaws, concept of sun light & ventilation. Components of Buildings & their functions, Basic concept of R.C.C., Introduction to types of foundation
Chapter 5
Transportation: Introduction to Transportation Engineering; Traffic and Road Safety: Types and Characteristics of Various Modes of Transportation; Various Road Traffic Signs, Causes of Accidents and Road Safety Measures.
Chapter 6
Environmental Engineering: Environmental Pollution, Environmental Acts and Regulations, Functional Concepts of Ecology, Basics of Species, Biodiversity, Ecosystem, Hydrological Cycle; Chemical Cycles: Carbon, Nitrogen & Phosphorus; Energy Flow in Ecosystems.
Water Pollution: Water Quality standards, Introduction to Treatment & Disposal of Waste Water. Reuse and Saving of Water, Rain Water Harvesting. Solid Waste Management: Classification of Solid Waste, Collection, Transportation and Disposal of Solid. Recycling of Solid Waste: Energy Recovery, Sanitary Landfill, On-Site Sanitation. Air & Noise Pollution: Primary and Secondary air pollutants, Harmful effects of Air Pollution, Control of Air Pollution. . Noise Pollution Harmful Effects of noise pollution, control of noise pollution, Global warming & Climate Change, Ozone depletion, Greenhouse effect
Text Books:
1. Palancharmy, Basic Civil Engineering, McGraw Hill publishers.
2. Satheesh Gopi, Basic Civil Engineering, Pearson Publishers.
3. Ketki Rangwala Dalal, Essentials of Civil Engineering, Charotar Publishing House.
4. BCP, Surveying volume 1
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Discussion continuum - Who pays for drug development?
1.
Discussion Continuum 1:
Who pays to develop
drugs?
Introduction:
The process from the research into a new drug and its arrival onto the shelves of
pharmacists is long and complex, and involves significant investment. This resource
gives young people the opportunity to investigate ethical, legal and socioeconomic
issues around the drug discovery and development process, such as drug testing,
marketing investment, and the effects of globalisation, and asks them to consider a
number of statements and situations surrounding the costs of drug development, and
the investment on rare diseases.
Groups of 811 people discuss the issues raised by each statement and agree where
each card should go between ‘agree’ and ‘disagree’. Larger groups could use the
resource to have a free discussion of the topic or you could use formats that require the
students to work more formally or in smaller groups.
Contents:
The resource consists of:
• An AGREE and a DISAGREE card
• 11 Discussion Cards, which include a statement on some aspect of drug development
and if appropriate some further information
2.
• 5 Info Cards, containing more detailed information on elements referred to by the
discussion cards
Gameplay:
1. Players form small groups, up to 11 per group. Each group is given an AGREE
and DISAGREE card and 11 discussion cards.
2. Within each group, the AGREE card and DISAGREE card are placed on the
floor/table about one metre apart, to represent the two extremes of the
continuum. The space in between is where the discussion cards will be placed.
3. The first player reads the first discussion card to the rest of the group. The player
should check everyone understands the card, and use Info Cards where
necessary to ensure the group understands the statement.
4. The first player then decides to what extent s/he agrees with the first card. S/he
places the card face up, anywhere on the discussion continuum, closer to
AGREE or DISAGREE as s/he chooses. This is entirely the choice of the
individual player, and is not discussed by the group. The player can give a
reason, if s/he wishes.
5. Each player in turn then reads a card, checks that everyone understands, and
chooses individually where to place it on the continuum in a similar way.
6. When all the cards have been read, understood and placed on the continuum,
the discussion begins. The aim is to place the cards between AGREE and
DISAGREE in an order that most of the players agree on. Players should pick a
card for discussion, and debate whether to move it.
7. At the end of the discussion, each group should have a continuum which they
mostly agree with.
8. If several groups are playing at the same time, the facilitator may wish to bring
the different groups’ results together. Are they similar? Can someone from each
group explain their choices on particular cards?
Discussion continuum developed by Ecsite, in collaboration with Barcelona Science Park, in the context of
the Xplore Health project.
Thanks to AtBristol for the development of the discussion continuum format: www.atbristol.org.uk
5. Discussion cards
Text in bold is the “statement” which the player can agree or disagree with. Text in italics is additional
information. For even more additional information, players can refer to Info cards.
“The government has a limited budget for research and
development of new drugs. For rare diseases, the
government should spend less money for the research of
new drugs.”
The drug discovery and development process takes an average of 1015 years
from idea to drug in the market, and costs around 600 800 million euros. For more
information, see Info Card A.
“Adverts and marketing for pharmaceutical drugs should
be banned, as they make drugs expensive. Information
about medicines available should come from the
government via doctors, not from private companies.”
Pharmaceutical companies who want to promote the use of their approved new
products usually approach medical doctors to highlight the benefits to patients of
the use of their pharmaceutical drugs. For more information, see Info Card B.
“Doctors should be encouraged to prescribe brandname
drugs, rather than generic drugs, in order to ensure
pharmaceutical companies can make enough money to
keep costs low.”
Generic drugs contain the same active ingredient as brandname drugs but at a
much lower sales price. For more information, see Info Card B.
6. “Pharmaceutical companies should be forced to declare
all the costs related with developing a new drug –
research, testing, registration, approval and marketing.
This way it is clear whether or not they are making their
prices too high.”
For more information, see Info Card C.
“When a drug is under development and being tested, the
researchers who perform the tests should be funded by
the same pharmaceutical company which will sell the
drug.”
For more information, see Info Cards A and B.
“When a drug is being tested, the company developing
the drug should be obliged to report the results of all
tests, not just the ones where the result showed the drug
is effective.”
For more information, see Info Card B.
7.
“If you want to know what the side effects of a medicine
are, you usually have to read a lot of small print. Drug
manufacturers should be obliged to print the commonest
side effects clearly on the front of the packet.”
“Governments should reward pharmaceutical companies
with tax reductions if they develop drugs against rare
diseases, as these drugs are expensive to produce and
will not be bought by many.”
A rare disease is a disease which affects less than one person in every 2,000
people. Treatments for rare diseases are known as orphan drugs – see Info Card
D for more information.
“The government of each country should focus the health
budget on developing drugs for the diseases which are
most common in that country.”
See Info Card E for more information.
8.
“If a new treatment is found for malaria, the governments
of developing countries should respect international
patenting laws, and should not be allowed to develop a
generic drug until the patent has expired.”
When a new drug is developed, it gets a patent to prevent generic alternatives
entering the market until the patent expires, and thus maintains high prices for
medication. For more information, see Info Card E.
“Pharmaceutical companies in Western countries should
not be allowed to test drugs on volunteers from
developing countries, where people are more likely to
accept tests because they can’t find any other treatment
for their disease.”
See Info Card E for more information.
11. Info Card C:
Marketing new drugs
When a new drug has been developed and tested, a dossier is submitted for approval to
regulatory agencies in each country or geographical area (the European Medical Evaluation
Agency, EMEA, or the Food and Drug Administration Agency, FDA, for example).
These agencies analyse the documentation and either approve the new drug to enter the
market, or request additional tests, or deny approval of the drug, because of lack of efficacy or
because of possible sideeffects associated with drugs administered to humans.
Finally, if they are approved, the price of pharmaceutical products is usually regulated in each
country by the government. Governments can attempt to keep prices low either by enforcing low
prices, or by loosening regulations in an attempt to encourage competition.
Patents and generic drugs
When a pharmaceutical company first markets a drug, it is usually under a patent that allows
only the pharmaceutical company that developed the drug to sell it. Once the patents protecting
a pharmaceutical drug expire (which is usually around 20 years after the patent was filed), the
pharmaceutical drugs become generic products, which may be manufactured and sold (usually
at lower prices than the original product) by any approved company.
How drugs are marketed
Pharmaceutical and biotechnological companies who want to promote the use of their approved
new products usually approach medical doctors to highlight the benefits to patients of the use of
their pharmaceutical drugs. In addition, under certain regulations, pharmaceutical drugs are
directly advertised to customers through many different marketing channels, a practice that has
been controversial, since administration of new pharmaceutical drugs to patients should only be
approved by medical doctors.
Some pharmaceutical drugs may be directly distributed to pharmacies by the companies
producing them. However, for some products, distribution has to be carried out by hospitals
only, because of the need of specialised equipment to administer these drugs.
Source: How are drugs developed? Ethical, legal and social aspects. Dr. Albert Royes,
Dr. Jordi Quintana www.xplorehealth.eu
12. Info Card D:
Orphan drugs
In the European Union, around 30 million people suffer from rare diseases. The EU defines a
rare disease as a disease which affects less than one person in every 2,000 people. Because
expected sales for drugs to treat rare diseases are small, there is little incentive for drug
companies to develop new therapies to diagnose and treat such disorders.
Incentives for orphan drug development
In 1999 the EU unanimously passed the Orphan Medicinal Products Regulation, to encourage
industry to develop therapies for rare conditions by giving financial incentives. Orphan drugs are
drugs developed for diagnosing and treating rare diseases. In the current system, drug
candidates are designated as “orphan” and market authorised through a centralised European
procedure. Availability and reimbursement remain a national responsibility.
Although orphan drugs can improve health for millions of people, their high development costs,
a small market and marketing exclusivity mean that they tend to be very expensive for the
patients and health care systems.
Source: Orphan Drugs Decide game, www.playdecide.eu
13. Info Card E:
Effects of globalisation
Developing countries often have less means to develop and manufacture drugs, and so buy
them from other countries at the regular market price. Public health in developing countries is
often of a lower standard than more developed countries, and citizens tend to have a lower life
expectancy.
Patents and developing countries
For some time now, some developing countries, including Brazil, India and South Africa, have
decided to bypass the rules of international trade with regard to drug patenting, and have
started to produce cheaper generic drugs for serious diseases that are widespread in these
populations.
Clinical trials in developing countries
Furthermore, more and more drug manufacturing companies use volunteers from developing
countries to conduct their clinical trials. The International Bioethics Committee of UNESCO has
warned that this practice is extending because even if these volunteers are financially rewarded,
their compensation is very small in comparison to what is considered acceptable in richer parts
of the world.
In trials with people who are already suffering from illness, participating in clinical trials is often
the only way people in developing countries can get treatment for their disease.
Research into diseases affecting developing countries
A 2001 report from Médecins Sans Frontières found that 10% of the world´s research on health
care is dedicated to diseases that affect 90% of the world’s population. The report showed there
were no effective therapeutic options or ongoing research for many of the diseases that affect
particularly poor countries and their citizens, probably because the investment needed would
not be sufficiently profitable for the large companies that develop and market these drugs.
These diseases include malaria, the Human African trypanosomiasis also known as sleeping
sickness, Dengue fever, Chagas disease, leprosy, and others that mostly affect developing
countries.
Source: How are drugs developed? Ethical, legal and social aspects. Dr. Albert Royes, Dr. Jordi
Quintana