Presented by James Rao at the Workshop on the Distribution, Delivery and Improvement of the
Infection and Treatment Method Vaccine for East Coast Fever, Nairobi, 19-20 August 2014
The document discusses trends in the pharmaceutical industry through 2020. It notes ongoing challenges like unmet medical needs, aging populations, and chronic diseases. Future drivers include these aging and underserved populations in developing countries and effects of global warming. The industry will see more integrated value chains between pharma, payers, and providers. Treatment costs are unsustainable so the focus will shift to prevention and pharma providing full healthcare packages with payment for outcomes not just treatment. Pharma business models will change significantly, moving from blockbuster drug sales to more services across the healthcare spectrum. Laboratories of the future will need to develop new capabilities and talent to achieve this changed vision.
Security Of The Pharmaceutical Supply Chain - Part 4b: The Pharmaceutical Ind...Stuart Silverman
Security Of The Pharmaceutical Supply Chain - Part 4b: The Pharmaceutical Industry Relies Heavily On Sourcing From India & China – India Segment
SPECIAL FOCUS - The environment as a risk to the supply chain.
This document discusses managed entry agreements and patient support programs (PSPs) for rare diseases. It defines a managed entry agreement as an arrangement between a manufacturer and payer/provider that enables coverage/reimbursement of a health technology subject to conditions. PSPs for rare diseases are product-focused and patient-centric, gathering real-world data useful to payers. The goal is to leverage PSPs to demonstrate a technology's real-world effectiveness and value in order to gain payer access.
The pharmaceutical value chain involves three main components: manufacturing the drug, distributing it, and dispensing it to patients. Manufacturing includes research and development, clinical trials, regulatory approval, and commercial production. It represents a significant cost, especially for innovative drugs that can take over a decade to develop. Generic manufacturers have lower costs. The value provided includes new medical treatments and wider health and economic benefits. Manufacturers' net prices are often lower than list prices due to discounts negotiated with buyers. The level of discount varies between generic and branded drugs and countries.
This document discusses pharmacovigilance risk management audits. It defines an audit and explains why pharmacovigilance system audits are performed. It describes different types of audits, including global pharmacovigilance system audits, company affiliate audits, and marketing partner audits. It also outlines audit scheduling, fundamentals, reporting, corrective actions, follow-up, metrics, and inspection readiness best practices. The overall purpose of pharmacovigilance audits is to ensure compliance and patient safety.
Corporate Research Project on Pharmaceutical Industry of SingaporeSanket Golechha
This document outlines a capstone research project on logistics and supply chains in the pharmaceutical industry. The project aims to study supply chain regulations and security in Singapore to eliminate counterfeit drugs. The research framework includes examining the pharmaceutical business environment, logistics environment, supply chain complexity, regulations, and counterfeiting risks. Primary research will involve interviews with industry and academic experts. Secondary research methods include reviewing literature, reports, and case studies. Key findings and recommendations will aim to suggest improvements to supply chain security for the pharmaceutical industry in Singapore.
The document discusses trends in the pharmaceutical industry through 2020. It notes ongoing challenges like unmet medical needs, aging populations, and chronic diseases. Future drivers include these aging and underserved populations in developing countries and effects of global warming. The industry will see more integrated value chains between pharma, payers, and providers. Treatment costs are unsustainable so the focus will shift to prevention and pharma providing full healthcare packages with payment for outcomes not just treatment. Pharma business models will change significantly, moving from blockbuster drug sales to more services across the healthcare spectrum. Laboratories of the future will need to develop new capabilities and talent to achieve this changed vision.
Security Of The Pharmaceutical Supply Chain - Part 4b: The Pharmaceutical Ind...Stuart Silverman
Security Of The Pharmaceutical Supply Chain - Part 4b: The Pharmaceutical Industry Relies Heavily On Sourcing From India & China – India Segment
SPECIAL FOCUS - The environment as a risk to the supply chain.
This document discusses managed entry agreements and patient support programs (PSPs) for rare diseases. It defines a managed entry agreement as an arrangement between a manufacturer and payer/provider that enables coverage/reimbursement of a health technology subject to conditions. PSPs for rare diseases are product-focused and patient-centric, gathering real-world data useful to payers. The goal is to leverage PSPs to demonstrate a technology's real-world effectiveness and value in order to gain payer access.
The pharmaceutical value chain involves three main components: manufacturing the drug, distributing it, and dispensing it to patients. Manufacturing includes research and development, clinical trials, regulatory approval, and commercial production. It represents a significant cost, especially for innovative drugs that can take over a decade to develop. Generic manufacturers have lower costs. The value provided includes new medical treatments and wider health and economic benefits. Manufacturers' net prices are often lower than list prices due to discounts negotiated with buyers. The level of discount varies between generic and branded drugs and countries.
This document discusses pharmacovigilance risk management audits. It defines an audit and explains why pharmacovigilance system audits are performed. It describes different types of audits, including global pharmacovigilance system audits, company affiliate audits, and marketing partner audits. It also outlines audit scheduling, fundamentals, reporting, corrective actions, follow-up, metrics, and inspection readiness best practices. The overall purpose of pharmacovigilance audits is to ensure compliance and patient safety.
Corporate Research Project on Pharmaceutical Industry of SingaporeSanket Golechha
This document outlines a capstone research project on logistics and supply chains in the pharmaceutical industry. The project aims to study supply chain regulations and security in Singapore to eliminate counterfeit drugs. The research framework includes examining the pharmaceutical business environment, logistics environment, supply chain complexity, regulations, and counterfeiting risks. Primary research will involve interviews with industry and academic experts. Secondary research methods include reviewing literature, reports, and case studies. Key findings and recommendations will aim to suggest improvements to supply chain security for the pharmaceutical industry in Singapore.
This document discusses specialty drug management solutions from PwC. It notes that specialty drugs are the fastest growing component of pharmacy costs, accounting for 32% of costs while only representing 1% of prescriptions. There are concerns about the high and increasing costs of specialty drugs, variations in their management across pharmacy and medical benefits, and lack of transparency. PwC's approach involves diagnosing spending trends, formulating management strategies like innovative pricing and site of care optimization, and implementing programs to realize annual savings of 5-15% or $186,000-$558,000 for a typical employer.
Pfizer is the world's largest pharmaceutical company with revenues of $49.6 billion in 2014. It has over 78,000 employees worldwide and key products include Lipitor, Lyrica, Viagra, and Celebrex. In India, Pfizer has over 3,000 employees and a manufacturing facility in Thane, Maharashtra. Pfizer utilizes a complex global supply chain network involving over 300 suppliers to procure and deliver materials and finished products to customers in over 175 distribution centers worldwide while managing risks such as cargo theft and counterfeiting.
The New Pharma Ecosystem: 2014 Trends Reshaping the Pharmaceutical Supply ChainLaura Olson
The pharmaceutical industry is undergoing tremendous changes. Numerous forces are re-shaping the new pharmaceutical ecosystem. Technology, demographics, regulations and shifts in wealth are creating transformative change. Increasingly becoming a more patient-centric world, patients use Smart devices to monitor research and evaluate pharmaceutical products. Healthcare reform regulations, the devaluation of the existing pharma model and trend towards patient empowerment and access to information are shaping the changing pharma industry, much as the retail industry was shaped by the multichannel and omni channel retailing trends of recent years. Regulators have become increasingly more cautious when improving innovative medicines. As pharmaceuticals have become more successful in prolonging life and treating illness, many medical conditions are now chronic. Today healthcare providers have become increasingly interested in measuring the outcomes of pharma performance and basing pricing accordingly. There has been a dramatic increase in prescription volume and an increased production and use of generic drugs. Producing pharmaceuticals in other countries can be complicated. Customs, local regulations and other factors impact products and require brands to adapt. Generic pharmaceuticals are becoming the dominant category globally, especially in developing rather than just industrial countries. Adding to the complexity, a large number of pharmaceutical products are made by multiple countries. These factors and the move towards specialty pharmaceuticals and greater production of pharmaceutical products globally have resulted in more pressure on global supply chains. Because supply chains have moved from local to global in operation, even one significant event can interrupt the global supply chain. Events such as hurricanes and typhoons, earthquakes, political and economic upheaval can have serious impacts on global supply chains, adding unforeseen costs and delays. Health care reform magnifies the effect of longer supply chains and increases the intense cost pressure on drug manufacturers. In order to reduce costs, more production as well as research and development are being offshored and outsourced.
The document summarizes a report on the perspectives of pharmaceutical, healthcare, and medical device supply chain executives. It highlights their key supply chain priorities for the year and biggest upcoming challenges. The report profiles respondents from various industries and geographic regions. It also examines the respondents' biggest supply chain priorities and obstacles, as well as their use of contract manufacturing, technology, and third-party logistics partners.
Healthcare Supply Chain Management in the USLevi Shapiro
Healthcare Supply Chain Management in the US, presentation by Robert Burkholder, SVP Supply Chain, Jefferson Health System. Delivered on May 11, 2021 for mHealth Israel. Includes an overview of Jefferson, organization chart for Supply Chain Management department, overview of financing Healthcare in the US, discussion about M&A in the US healthcare providers sector, description of how Payers, Providers and Supliers are chasing scale, Jefferson's merger timeline, approach toward Integrating Legacy Supply Chain Departments, breakdown of the Fragile Global Supply Chain, efforts toward Supply Chain Resiliency, Value analysis in the healthcare supply chain, Enterprise Value Analysis, Strategic Sourcing and Purchasing, strategic sourcing model, Sourcing Prioritization Pipeline, Proposed prioritization map, Sourcing Prioritization Matrix, Advanced Analytics
The document summarizes a presentation on managed entry agreements for high-cost innovative pharmaceuticals. It discusses the issues of assessing value for money given uncertainty around health effects and budget impact. It defines managed entry agreements and performance-based risk-sharing agreements as formal arrangements to address these issues. While these schemes aim to improve access to innovative treatments, the evidence on their effectiveness is limited and implementation has proven difficult, particularly for outcomes-based arrangements. Overall, more structured evaluation is still needed but these schemes may help address challenges posed by high-priced drugs when traditional reimbursement is not suitable.
This document summarizes key information about the medical device industry in the US and challenges facing a company called MTC. It discusses proposals to address MTC's challenges, including implementing lean manufacturing, establishing strategic supplier relationships, rationalizing sales commissions, building hospital partnerships, and acquiring other companies to increase capacity and product variety. Risks of the proposals are also summarized along with mitigation strategies.
This presentation was hosted by Gerry Jeffcott from 3Sixty Public Affairs, who was joined by two pharmaceutical policy researchers who have conducted analyses of Canada’s access performance over time and in comparison with other countries.
The session began with an overview of each of the elements of the Canadian review and approval process by our moderator. After that, the session explored each agency’s performances in terms of supporting efficient access to needed new medicines. We will also compare Canada with other similar countries to determine how we fare internationally in terms of gaining access.
The presentation includes an interactive question and answer session.
The Veterinary Feed Directive: Past and PresentJohn Blue
The Veterinary Feed Directive: Past and Present - Dr. Heather Fowler, National Pork Board, from the 2019 Iowa Pork Congress, January 23 - 24, 2019, Des Moines, IA, USA.
More presentations at https://www.youtube.com/channel/UCEFNbfee_Rq3AfAFTRpuCrQ
MCDA can help address some challenges in health technology assessment by systematically considering multiple criteria, such as health impacts, costs, equity and other value dimensions. Some countries have piloted the use of MCDA in HTA processes, but there are still open questions around which criteria and weights to use, how to incorporate opportunity costs and deal with uncertainty. While MCDA shows promise for improving transparency and decision-making in HTA, further work is needed to balance its benefits and costs for different healthcare systems.
Brent Johnson, VP of Supply Chain at Intermountain Healthcare, gave a presentation on supply chain best practices in healthcare. He discussed Intermountain's supply chain transformation efforts that have saved over $130 million through strategic sourcing, centralization, and performance management. He outlined 12 fundamental best practices of supply chain management, including developing a strategy, strategic sourcing, managing total cost of ownership, and establishing key supplier alliances. The presentation provided examples of how these practices have been applied within Intermountain to improve outcomes and lower costs.
How should the effectiveness of additional risk minimisation activities be m...TGA Australia
The effectiveness of additional risk minimization activities should be measured using both process and outcome indicators. Process indicators relate to reaching the target population and assessing knowledge and actions, while outcome indicators relate to actual safety outcomes and adverse event rates. Regular evaluation is important to determine if risk minimization is successful and if corrective actions are needed. Guidance from the EU and TGA provides more details on developing evaluation plans and reporting effectiveness.
Clinical validation and regulation for AI medical devicesDr Hugh Harvey
This document discusses clinical validation and regulation of artificial intelligence in the EU. It covers why regulation is needed for safety, transparency and quality. Medical device software must meet regulatory requirements if used for clinical purposes. The risk class determines the regulatory route for CE marking. Common standards like ISO 13485 cover quality management systems, while clinical evaluation reports summarize relevant clinical data and conclusions. Academic institutions producing medical software may need to comply with quality standards to legally deploy or market their products. Both benefits and challenges of the current regulatory framework are discussed.
Wharton Undergraduate Healthcare Conference- Merck Revenue Growth PlanKazim Ali
As a team we worked to create a strategic plan to allow Merck to grow its revenue over time. We considered a number of strategic options and completed a situation analysis of the options available. We presented our findings to a panel of judges from Accenture & University of Pennsylvania. This project involved strategic planning, timeline development, financial analysis, and a competitive analysis.
Medical Devices Postmarket Surveillance in Europe updatedAnnet Visscher
Medical Device Postmarket Surveillance and Clinical Follow-up under the proposed European Medical Device Regulation updated according to the latest amendments.
The secret formula to getting health tech to marketDr Hugh Harvey
The UK Israel Tech Hub has partnered with some of the UK’s leading healthcare consultancies to bring you this carefully curated series to help demystify the UK and its wonderful National Health Service, focusing on getting back to business and not on COVID-19.
Medicines and Medical Devices Regulation – current developments and future op...TGA Australia
1. The document summarizes recent developments and future options in medicines and medical devices regulation in Australia, as presented by John Skerritt from the Department of Health.
2. Key updates included planned changes to medicines labeling, reviews of programs for orphan drugs and recalls, and a new online system for clinical trial notifications.
3. The presentation also discussed an expert panel review that recommended modernizing approval pathways for new drugs and generics, adopting risk-based approaches, and reforms to schemes for unapproved products.
The document summarizes the findings of a national supply chain baseline assessment conducted in Myanmar in 2014 by the Ministry of Health and partners. The assessment aimed to provide an evidence-based understanding of the supply chain to guide strengthening efforts. Data was collected from 285 facilities across all levels of the health system and analyzed. Overall, the findings showed that maturity and performance across functional areas of the supply chain were low, requiring strengthening in order to positively impact the supply chain. Specific key performance indicators such as stockout rates, stock accuracy, and order fill rates demonstrated needs for improvement.
The Vaccine Control System (VCS) is a software program that facilitates vaccine inventory management, ordering, administration, and reporting. It allows nurses to select vaccine lots for patients directly from the screen without writing anything down. The VCS monitors inventory levels and can project future needs to prevent stockouts. It integrates with electronic medical record and practice management systems to automatically record lot numbers and update patient records.
Dr Schucheng Zhang, Vice President, Sinovet (Beijing) Biotechnology Co LtdKisaco Research
Sinovet is a private research company focused on animal biological product development. It has sites in Beijing and Jiangsu Province. The company values innovation, quality, and service. It has over 200 employees and $30 million in investment capital. Sinovet's R&D center focuses on vaccines and diagnostics for swine, bovine, and small animals. It has multiple licensed vaccines and pipelines in development. Sinovet has GMP-certified production facilities and collaborates with universities, government agencies, and other animal health companies on research. The company aims to be a leader in animal health through continued innovation.
This document discusses specialty drug management solutions from PwC. It notes that specialty drugs are the fastest growing component of pharmacy costs, accounting for 32% of costs while only representing 1% of prescriptions. There are concerns about the high and increasing costs of specialty drugs, variations in their management across pharmacy and medical benefits, and lack of transparency. PwC's approach involves diagnosing spending trends, formulating management strategies like innovative pricing and site of care optimization, and implementing programs to realize annual savings of 5-15% or $186,000-$558,000 for a typical employer.
Pfizer is the world's largest pharmaceutical company with revenues of $49.6 billion in 2014. It has over 78,000 employees worldwide and key products include Lipitor, Lyrica, Viagra, and Celebrex. In India, Pfizer has over 3,000 employees and a manufacturing facility in Thane, Maharashtra. Pfizer utilizes a complex global supply chain network involving over 300 suppliers to procure and deliver materials and finished products to customers in over 175 distribution centers worldwide while managing risks such as cargo theft and counterfeiting.
The New Pharma Ecosystem: 2014 Trends Reshaping the Pharmaceutical Supply ChainLaura Olson
The pharmaceutical industry is undergoing tremendous changes. Numerous forces are re-shaping the new pharmaceutical ecosystem. Technology, demographics, regulations and shifts in wealth are creating transformative change. Increasingly becoming a more patient-centric world, patients use Smart devices to monitor research and evaluate pharmaceutical products. Healthcare reform regulations, the devaluation of the existing pharma model and trend towards patient empowerment and access to information are shaping the changing pharma industry, much as the retail industry was shaped by the multichannel and omni channel retailing trends of recent years. Regulators have become increasingly more cautious when improving innovative medicines. As pharmaceuticals have become more successful in prolonging life and treating illness, many medical conditions are now chronic. Today healthcare providers have become increasingly interested in measuring the outcomes of pharma performance and basing pricing accordingly. There has been a dramatic increase in prescription volume and an increased production and use of generic drugs. Producing pharmaceuticals in other countries can be complicated. Customs, local regulations and other factors impact products and require brands to adapt. Generic pharmaceuticals are becoming the dominant category globally, especially in developing rather than just industrial countries. Adding to the complexity, a large number of pharmaceutical products are made by multiple countries. These factors and the move towards specialty pharmaceuticals and greater production of pharmaceutical products globally have resulted in more pressure on global supply chains. Because supply chains have moved from local to global in operation, even one significant event can interrupt the global supply chain. Events such as hurricanes and typhoons, earthquakes, political and economic upheaval can have serious impacts on global supply chains, adding unforeseen costs and delays. Health care reform magnifies the effect of longer supply chains and increases the intense cost pressure on drug manufacturers. In order to reduce costs, more production as well as research and development are being offshored and outsourced.
The document summarizes a report on the perspectives of pharmaceutical, healthcare, and medical device supply chain executives. It highlights their key supply chain priorities for the year and biggest upcoming challenges. The report profiles respondents from various industries and geographic regions. It also examines the respondents' biggest supply chain priorities and obstacles, as well as their use of contract manufacturing, technology, and third-party logistics partners.
Healthcare Supply Chain Management in the USLevi Shapiro
Healthcare Supply Chain Management in the US, presentation by Robert Burkholder, SVP Supply Chain, Jefferson Health System. Delivered on May 11, 2021 for mHealth Israel. Includes an overview of Jefferson, organization chart for Supply Chain Management department, overview of financing Healthcare in the US, discussion about M&A in the US healthcare providers sector, description of how Payers, Providers and Supliers are chasing scale, Jefferson's merger timeline, approach toward Integrating Legacy Supply Chain Departments, breakdown of the Fragile Global Supply Chain, efforts toward Supply Chain Resiliency, Value analysis in the healthcare supply chain, Enterprise Value Analysis, Strategic Sourcing and Purchasing, strategic sourcing model, Sourcing Prioritization Pipeline, Proposed prioritization map, Sourcing Prioritization Matrix, Advanced Analytics
The document summarizes a presentation on managed entry agreements for high-cost innovative pharmaceuticals. It discusses the issues of assessing value for money given uncertainty around health effects and budget impact. It defines managed entry agreements and performance-based risk-sharing agreements as formal arrangements to address these issues. While these schemes aim to improve access to innovative treatments, the evidence on their effectiveness is limited and implementation has proven difficult, particularly for outcomes-based arrangements. Overall, more structured evaluation is still needed but these schemes may help address challenges posed by high-priced drugs when traditional reimbursement is not suitable.
This document summarizes key information about the medical device industry in the US and challenges facing a company called MTC. It discusses proposals to address MTC's challenges, including implementing lean manufacturing, establishing strategic supplier relationships, rationalizing sales commissions, building hospital partnerships, and acquiring other companies to increase capacity and product variety. Risks of the proposals are also summarized along with mitigation strategies.
This presentation was hosted by Gerry Jeffcott from 3Sixty Public Affairs, who was joined by two pharmaceutical policy researchers who have conducted analyses of Canada’s access performance over time and in comparison with other countries.
The session began with an overview of each of the elements of the Canadian review and approval process by our moderator. After that, the session explored each agency’s performances in terms of supporting efficient access to needed new medicines. We will also compare Canada with other similar countries to determine how we fare internationally in terms of gaining access.
The presentation includes an interactive question and answer session.
The Veterinary Feed Directive: Past and PresentJohn Blue
The Veterinary Feed Directive: Past and Present - Dr. Heather Fowler, National Pork Board, from the 2019 Iowa Pork Congress, January 23 - 24, 2019, Des Moines, IA, USA.
More presentations at https://www.youtube.com/channel/UCEFNbfee_Rq3AfAFTRpuCrQ
MCDA can help address some challenges in health technology assessment by systematically considering multiple criteria, such as health impacts, costs, equity and other value dimensions. Some countries have piloted the use of MCDA in HTA processes, but there are still open questions around which criteria and weights to use, how to incorporate opportunity costs and deal with uncertainty. While MCDA shows promise for improving transparency and decision-making in HTA, further work is needed to balance its benefits and costs for different healthcare systems.
Brent Johnson, VP of Supply Chain at Intermountain Healthcare, gave a presentation on supply chain best practices in healthcare. He discussed Intermountain's supply chain transformation efforts that have saved over $130 million through strategic sourcing, centralization, and performance management. He outlined 12 fundamental best practices of supply chain management, including developing a strategy, strategic sourcing, managing total cost of ownership, and establishing key supplier alliances. The presentation provided examples of how these practices have been applied within Intermountain to improve outcomes and lower costs.
How should the effectiveness of additional risk minimisation activities be m...TGA Australia
The effectiveness of additional risk minimization activities should be measured using both process and outcome indicators. Process indicators relate to reaching the target population and assessing knowledge and actions, while outcome indicators relate to actual safety outcomes and adverse event rates. Regular evaluation is important to determine if risk minimization is successful and if corrective actions are needed. Guidance from the EU and TGA provides more details on developing evaluation plans and reporting effectiveness.
Clinical validation and regulation for AI medical devicesDr Hugh Harvey
This document discusses clinical validation and regulation of artificial intelligence in the EU. It covers why regulation is needed for safety, transparency and quality. Medical device software must meet regulatory requirements if used for clinical purposes. The risk class determines the regulatory route for CE marking. Common standards like ISO 13485 cover quality management systems, while clinical evaluation reports summarize relevant clinical data and conclusions. Academic institutions producing medical software may need to comply with quality standards to legally deploy or market their products. Both benefits and challenges of the current regulatory framework are discussed.
Wharton Undergraduate Healthcare Conference- Merck Revenue Growth PlanKazim Ali
As a team we worked to create a strategic plan to allow Merck to grow its revenue over time. We considered a number of strategic options and completed a situation analysis of the options available. We presented our findings to a panel of judges from Accenture & University of Pennsylvania. This project involved strategic planning, timeline development, financial analysis, and a competitive analysis.
Medical Devices Postmarket Surveillance in Europe updatedAnnet Visscher
Medical Device Postmarket Surveillance and Clinical Follow-up under the proposed European Medical Device Regulation updated according to the latest amendments.
The secret formula to getting health tech to marketDr Hugh Harvey
The UK Israel Tech Hub has partnered with some of the UK’s leading healthcare consultancies to bring you this carefully curated series to help demystify the UK and its wonderful National Health Service, focusing on getting back to business and not on COVID-19.
Medicines and Medical Devices Regulation – current developments and future op...TGA Australia
1. The document summarizes recent developments and future options in medicines and medical devices regulation in Australia, as presented by John Skerritt from the Department of Health.
2. Key updates included planned changes to medicines labeling, reviews of programs for orphan drugs and recalls, and a new online system for clinical trial notifications.
3. The presentation also discussed an expert panel review that recommended modernizing approval pathways for new drugs and generics, adopting risk-based approaches, and reforms to schemes for unapproved products.
The document summarizes the findings of a national supply chain baseline assessment conducted in Myanmar in 2014 by the Ministry of Health and partners. The assessment aimed to provide an evidence-based understanding of the supply chain to guide strengthening efforts. Data was collected from 285 facilities across all levels of the health system and analyzed. Overall, the findings showed that maturity and performance across functional areas of the supply chain were low, requiring strengthening in order to positively impact the supply chain. Specific key performance indicators such as stockout rates, stock accuracy, and order fill rates demonstrated needs for improvement.
The Vaccine Control System (VCS) is a software program that facilitates vaccine inventory management, ordering, administration, and reporting. It allows nurses to select vaccine lots for patients directly from the screen without writing anything down. The VCS monitors inventory levels and can project future needs to prevent stockouts. It integrates with electronic medical record and practice management systems to automatically record lot numbers and update patient records.
Dr Schucheng Zhang, Vice President, Sinovet (Beijing) Biotechnology Co LtdKisaco Research
Sinovet is a private research company focused on animal biological product development. It has sites in Beijing and Jiangsu Province. The company values innovation, quality, and service. It has over 200 employees and $30 million in investment capital. Sinovet's R&D center focuses on vaccines and diagnostics for swine, bovine, and small animals. It has multiple licensed vaccines and pipelines in development. Sinovet has GMP-certified production facilities and collaborates with universities, government agencies, and other animal health companies on research. The company aims to be a leader in animal health through continued innovation.
The document provides an overview of regulations for medicinal products in Germany. Medicinal products are regulated by laws addressing manufacturing, marketing, distribution, and pharmacovigilance. Medicinal products for human use require a marketing authorization from either the Federal Institute for Drugs and Medical Devices or the Federal Agency for Sera and Vaccines. The document then discusses specific regulations regarding pricing and state funding, manufacturing, clinical trials, marketing, advertising, packaging and labeling, traditional herbal medicines, patents, trademarks, and regulatory authorities.
The document discusses regulatory requirements and procedures for approval of new vaccines in India. It provides definitions of key terms like drugs, new drugs and vaccines. It describes the information and data required to be submitted for approval, including safety and efficacy data from clinical trials. It also discusses post-marketing surveillance requirements and procedures for investigating and reporting adverse events following immunization.
This document discusses the concept of developing "interpandemic vaccines" to provide protection against potential future disease threats, such as pandemic influenza strains or engineered bioweapons, as an alternative to the current approach of developing vaccines only for currently circulating pathogens. It argues that this approach could help constrain the evolution of existing pathogens and mitigate risks from engineered threats. However, it notes there are technical, regulatory, and commercial feasibility challenges to the development and licensure of interpandemic vaccines that would need to be addressed. Support from governmental and public health stakeholders would also be required to pursue this strategy.
This National Vaccine Policy document aims to strengthen India's Universal Immunization Programme by addressing issues related to vaccine research, regulation, introduction of new vaccines, operational efficiency, and monitoring. It provides a framework for decision making regarding current vaccines, new and underutilized vaccines, and potential future vaccines. The policy seeks to improve vaccine coverage, surveillance systems, forecasting, and human resources to optimize the vaccine enterprise in India and ensure a long-term affordable vaccine supply.
The development of an HIV vaccine faces significant challenges including viral diversity, establishment of viral reservoirs, and immune evasion. Current vaccine strategies aim to elicit broadly neutralizing antibodies or enhance cellular immunity through various approaches including recombinant proteins, viral vectors, and DNA vaccines. While two vaccine concepts have undergone efficacy trials, neither provided protective effects. Ongoing research continues through clinical trials evaluating prime-boost regimens combining DNA vaccines and viral vectors.
Process development considerations for quality and safety of vaccinesDr. Priyabrata Pattnaik
The document discusses several factors that can impact vaccine quality and safety during development, including:
1) Bioburden control is important to control contamination during manufacturing and avoid issues in later stages. Key areas are raw materials, equipment cleaning, and open processing steps.
2) Operating conditions for tangential flow filtration, such as pressure and flow rates, can cause product aggregation or degradation if not optimized.
3) Residual DNA from cell substrates must be removed through processes like nuclease treatment to very low levels due to potential safety concerns.
4) Excipient quality can impact drug product safety, so their selection and control is a critical quality attribute during development.
Clinical trials in Latin America face regulatory frameworks that vary by country. While countries like Argentina, Brazil, and Mexico have adopted international good clinical practice guidelines, regulatory approval processes can be lengthy, requiring documents translated to the local language and approvals from both local and national ethics boards. Common challenges include economic instability, intellectual property protection, and health care access and costs. Strategies for successful clinical trials in the region include early planning, partnering with experienced local clinical research organizations, and consulting regulatory experts from within each country.
Preparation and quality control of immunological productsMayur D. Chauhan
The following presentation is only for quick reference. I would advise you to read the theoretical aspects of the respective topic and then use this presentation for your last minute revision. I hope it helps you..!!
Mayur D. Chauhan
1) Development of dengue vaccines requires addressing regulatory issues like evaluating efficacy against the four virus serotypes and safety regarding antibody-dependent enhancement.
2) Clinical trials are most likely to occur first in developing countries with dengue, where discussions among regulators can define the approval pathway with WHO's guidance.
3) It is important to standardize diagnostic tests and identify a correlate of protection to help evaluate vaccines.
The document discusses the benefits of exercise for both physical and mental health. It notes that regular exercise can reduce the risk of diseases like heart disease and diabetes, improve mood, and reduce feelings of stress and anxiety. The document recommends that adults get at least 150 minutes of moderate exercise or 75 minutes of vigorous exercise per week to gain these benefits.
Dr. Scott Stehlik - What does Guidance 213 and the Veterinary Feed Directive ...John Blue
What does Guidance 213 and the Veterinary Feed Directive (VFD) Rule mean on the farm? - Dr. Scott Stehlik, D.V.M., director, technical operations, The Maschhoffs, from the 2015 World Pork Expo, June 3 - 5, 2015, Des Moines, IA, USA.
More presentations at http://www.swinecast.com/2015-world-pork-expo
This document discusses potential approaches universities can take to promote access to medicines in developing countries. It describes how lack of competition leads to high drug prices in developing markets. The document proposes a model called an Equitable Access License (EAL) that universities could use when licensing their patents. An EAL would allow generic producers to make and sell copies of the drugs in low-and middle-income countries, promoting competition and lower prices. Potential objections to this approach from universities and pharmaceutical companies are also outlined.
The pharmaceutical supply chain is complex and highly regulated. It involves multiple players from drug discovery and development to manufacturing and distribution. Ensuring patient safety is the top priority and challenge, as the supply chain is vulnerable to counterfeiting and issues regarding product quality. Emerging technologies around tracking and authentication aim to address these problems. Regulation and compliance add further complexity, as the industry works to balance costs and efficiencies with ethical and safety requirements.
This document discusses assessing the value of new antibiotics through health technology assessment (HTA). It identifies four benefits typically included in HTA evaluations and six additional benefits not traditionally considered but relevant for antibiotics. These additional benefits include insurance value, diversity value, diagnostic value, uniqueness, enablement value, and spectrum value. The document notes that HTA methods may not fully capture the value of antibiotics in addressing antimicrobial resistance and that new payment mechanisms are needed given antibiotics must have limited use to delay resistance development.
Presented by Theo Knight-Jones and Lucy Robinson at the open session of the standing technical and research committees of the European Commission for the control of foot and mouth disease, Cavtat, Croatia, 29-31 October 2014.
The document discusses portfolio management techniques in the pharmaceutical industry. It covers 3 main topics:
1. The changing performance and drivers of the pharmaceutical industry that necessitate sophisticated portfolio management approaches.
2. How companies can shape their portfolio of candidates through comprehensive analysis of opportunities and strategic options to focus on areas of unmet need and core competencies.
3. The basics of marketing company portfolio management, including tools to identify, prioritize, and understand pipeline projects and marketed products to optimally allocate resources.
Dr. Larry Granger - USDA Antimicrobial Resistance Strategy - Farm Foundation ...John Blue
USDA Antimicrobial Resistance Strategy - Farm Foundation Results - Dr. Larry Granger, Antimicrobial Resistance Program; Animal and Plant Health Inspection Service, Veterinary Services; U.S. Department of Agriculture (USDA), from the 2015 NIAA Antibiotic Symposium - Stewardship: From Metrics to Management, November 3-5, 2015, Atlanta, Georgia, USA.
More presentations at http://swinecast.com/2015-niaa-symposium-antibiotics-stewardship-from-metrics-to-management
What strategies should be employed to win in Biosimilars?Santhosh R
What are the key strategies to win in biosimilars market? What should be your plan for payers, physicians, and launch? What should be the focus for pharmaceutical / biosimilar companies?
Key Takeaways -
- There is a need for a holistic approach to succeed in this market environment
- Many biologics are administered by physicians; therefore, more emphasis will have to be directed at the physicians than was the case with small-molecule generics
- Carefully constructed incentive from public and private payers / PBMs could boost biosimilar utilization significantly
- Companies need to instill confidence & awareness in patients just like they do with other stakeholders
- Launch biosimilars in emerging markets before developed markets to develop strong post-marketing data
- Manufacturing biosimilars requires scientific expertise and experience
- Success Checklist
Vertical market expansion hc gleikin2013q4campaignGary Leikin
This document provides an overview of vertical market expansion and opportunities in the healthcare technology market. It discusses why companies pursue vertical market expansion, best practices for evaluating opportunities, and risks to avoid. The document analyzes the healthcare industry and trends driving changes, such as a shift to value-based care and managing chronic diseases. It also examines economic factors like the importance of outcomes and return on investment for new technologies. Finally, the document discusses enabling technologies from other industries that could drive advances in medical technology if applied to healthcare challenges.
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Vaccine development is just the first step in eradicating the pandemic, the real challenge lies in managing and handling its supply chain. An ERP built specifically for Vaccines can be the way out in efficiently fighting these challenges. Go through the presentation to know how exactly an ERP for vaccines helps.
This document summarizes key information about a medical device company called MTC and proposes recommendations to address its challenges. It discusses that MTC operates in the large and growing US medical device industry. Key challenges for MTC include costs from the medical device tax, technological assistance, and managing distribution channels. The recommendations propose reducing inventory, establishing strategic partnerships with hospitals, rationalizing sales commissions, conducting R&D with hospitals, and pursuing mergers and acquisitions. The document outlines resources, risks, and mitigation strategies required to implement the recommendations.
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Towards increased uptake and impact assessment of ITM vaccine: A research agenda
1. Towards increased uptake and impact assessment of ITM vaccine
A research agenda
James Rao
Workshop on the distribution, delivery and improvement of the
Infection and Treatment Method vaccine for East Coast fever
Nairobi, 19-20 August 2014
2. Outline
1.Introduction
2.Reliable and consistent supply of vaccine
3.Demand Issues
4.Quality control and assurance
5.Favourable policy environment
6.Monitoring impacts
3. Introduction
What are the key incentives for increased uptake of ITM
•From a farmer perspective
•From a business perspective
•From a policy maker perspective
What are the disincentives impeding uptake of ITM?
What institutional innovations would improve uptake?
What are the full range of impacts of ITM vaccine – beyond what we know?
4. Reliable and Consistent Supply of Vaccine
Towards efficient production of vaccine – which way?
Public sector based production; but ……..
•Public sector incapable of responding efficiently and sustainably to demand
•Public sector also lack incentives (and probably capacity) to ensure quality control
Private sector based production
•Theoretically … private sector is more efficient … but only
–In the absence of externalities
–In the absence of informational failures
–When the good/product is not a public good
5. Reliable and Consistent Supply of Vaccine
Moreover, private sector may be discouraged by:
•High cost in establishing an efficient vaccine value chain
–Acquiring production technology
–Developing production capacity
–Establishing & maintaining a reliable distribution infrastructure
•Unpredictable & irregular demand projections - disincentive for private producers
•If production require specialized facilities, what happens to established facilities when demand declines?
Research questions
Is a pure private venture a feasible production alternative?
What preconditions would such a venture require?
How can these pre-conditions be realized?
6. Reliable and Consistent Supply of Vaccine
Towards efficient vaccine distribution: preferred distributor or open access?
•Preferred distributors
–Due to the irregular nature of the market
–Distributors may need protection guarantee to recoup investment
–However, ills of a preferential treatment are a concern
»Non responsive to client demand; inefficient pricing; market segmentation and a segment preference leading to exclusion of some users
•Open access market
–Competition: - price wars, low margins; incentives for quality compromises
Research questions
Which approach can ensure efficient and wider coverage/reach?
What institutional innovations if any, are needed to achieve the efficient outcome?
7. Demand issues
Fears of irregular demand pattern
•Initial mass immunization (large markets)
•But protection lasts at least 3 years – only calves and new cattle stock may require immunization on a regular basis
•Hence fear of a shrinking market and potential for increasing idle capacity
•Making the product unattractive for private sector players
Demand may be limited by current high prices of vaccine per dose
Limited access to the technology especially in marginal areas that are fraught with limited penetration of commercial delivery systems
8. Demand issues
Misperception/misinformation about the vaccine driven by interest groups benefiting from status quo
•Less use of acaricides and ECF clinical drugs – a threat to pharmaceuticals
•Reduced/elimination of clinical treatment of ECF – a threat to business for those engaged in clinical treatment (veterinarians/AHAs)
Research questions
Can we project long term demand – given possible changes in herd structure?
What is the optimum/efficient price of the vaccine per dose?
How does this vary by: country and/or system of production?
From equity perspective – is the current price increasing inter-household disparity
Are subsidised vaccine delivery to farmers sustainable; if so how best can we target subsidy?
Will vaccination crowd in/crowd out veterinary services to the benefit/detriment of the animal health service providers?
9. Quality control and assurance
Quality control at various levels of the cold chain is a concern
•Unreliable state of cold chains
•At the point of administration
–Poor handling techniques by personnel
–Intentional tampering with vaccines
Public agencies expected to enforce standards but they lack incentives to ensure adequate quality control
Research questions
Is there a possibility for self-regulation?
Can the fear (risk) of loosing reputation and hence business losses enhance compliance?
Can the drive towards compliance lead to investment by actors (vaccine producers and distributors) in quality control at all levels of the vaccine chain)?
If so, what form would this investment take – training of own AHAs and para-vets etc.?
10. Favourable policy environment
Country-specific versus regional policies
•Country-specific policies
–May fragment the market - different products needed in different sub-regions
–Requires multiple licensing and product registration procedures
•Regional policies
–Larger market – attractive for private players
–However,
»May require regional policies and oversight agencies
»Larger parasite stock on which to establish a vaccine
»Different sets of vaccines – an impediment to harmonization
»Inconsistent or lack of appropriate veterinary policies to enhance widespread uptake and use of the vaccine
Research Question
What are the trade offs between regional and country-specific approach to policy issues?
11. Monitoring impacts
Inadequate capacity (facilities, tools and personnel) to:
•Monitor impacts
•Monitor Vaccine failures/parasite breakthroughs
•Respond accordingly
Insufficient knowledge of full range of impacts
•Effects on full range of productivity
•Effects on herd structure
•Effects on the life of current crop of OTCs
13. Monitoring impacts
Possible impacts on productivity
•Most studies evaluate impacts under pastoral systems
•Clear impacts on mortality and morbidity
•Reduced losses in milk (due to morbidity and possible mortality)
•Downward shift in marginal cost of production
•Changes in herd structure
•Higher calf survival;
–incentive to keep fewer breeding stock; for shorter period resulting into smaller and probably younger breeding stock
•Reduced fear of keeping exotic/cross bred cattle leading to increased stocking of cross/exotic breeds in non-traditional dairy areas
•What could this imply for
–Demand for animal healthcare services
–Cattle population
–Further demand (for ITM vaccines) projections
14. Monitoring impacts
Are there changes in tick control regimes (less spraying/dipping)
•Do farmers really change their tick control regimes?
•Does this affect prevalence of other tick borne diseases?
•What complementary interventions are needed to realize the full benefits of ITM?
What other constraints limit adoptability of ITM?
15. Conclusion
Resolving outstanding technical issues could accelerate uptake of ITM
Further uptake can be sustained via suitable institutional innovations/business models that:
Are more adapted to peculiarities of the ITM vaccine and its final users (farmers)
Have an efficient pricing mechanism
Encourage efficient self-regulatory & monitoring mechanism
Need for comprehensive impact assessment to generate evidence that can justify public sector funding
16. The presentation has a Creative Commons licence. You are free to re-use or distribute this work, provided credit is given to ILRI.
better lives through livestock
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