Flow Cytometry 2012: Market Needs, Emerging Developments and Future UseReportsnReports
This document summarizes a study examining the current and future needs and uses of flow cytometry. Over 260 flow cytometry users in 53 countries were surveyed about their current and planned applications, purchases, and budgets for flow cytometry over the next three years. Key findings of the study include details on users' main flow cytometry applications and systems, budgets, and requirements for innovation in areas like new clinical applications and biomarkers. The report provides insights into developing trends in the flow cytometry market through 2015.
Generics: Challenges summary for a growing sector of pharmaceuticalsUSTC, Hefei, PRC
A short summary regarding core challenges faced by generic parmaceutical enterprises in competitive environments.
For further information, contact at: faisal786.btc@gmail.com
Presentation from the 3rd Joint Meeting of the Antimicrobial Resistance and Healthcare-Associated Infections (ARHAI) Networks, organised by the European Centre of Disease Prevention and Control - Stockholm, 11-13 February 2015
This document summarizes presentations and discussions from a working group meeting between the EU and US to propose standards for measuring antimicrobial use in hospitals. It was noted that while surveillance of hospital antimicrobial consumption is becoming more widespread, challenges remain in harmonizing measurement methods between regions. Key challenges include determining the best data sources, units of measurement, and ways to account for differences in patient case mix between hospitals. The group discussed various approaches used in the US and EU and potential standardized indicators, but recognized further work is still needed to develop truly comparable data across multiple healthcare settings and jurisdictions.
Presentation by Dennis Ross-Degnan on tools and approaches that can be used by countries involved in the Medicines Transparency Alliance (MeTA), at the London launch in May 2008
How to Make Your University the Technology Source of Choice for Innovation -...Fuentek, LLC
The document discusses a versatile microscale particle fabrication technique developed at the University of Illinois at Urbana-Champaign that has applications in drug delivery, industrial manufacturing, and more. Commercialization options were explored, including licensing to established companies or starting a startup. A two-path strategy was pursued, but delays and market shifts hindered licensing interest. However, one of the co-inventors later started a new company, Orbis Biosciences, to develop the technique, achieving commercial success. Lessons included being flexible and not waiting too long if the market is ready.
R&D Productivity and Costs in Today's Health Care Arena - Pat AudetTTC, llc
The document discusses challenges facing the pharmaceutical industry including increased healthcare costs, decreased R&D productivity, and more difficulty achieving blockbuster drugs. It also outlines strategies the industry is taking to address these challenges such as focusing on specialty and biologic drugs, reducing R&D costs through outsourcing and adaptive clinical trial designs, and pursuing mergers and acquisitions.
Flow Cytometry 2012: Market Needs, Emerging Developments and Future UseReportsnReports
This document summarizes a study examining the current and future needs and uses of flow cytometry. Over 260 flow cytometry users in 53 countries were surveyed about their current and planned applications, purchases, and budgets for flow cytometry over the next three years. Key findings of the study include details on users' main flow cytometry applications and systems, budgets, and requirements for innovation in areas like new clinical applications and biomarkers. The report provides insights into developing trends in the flow cytometry market through 2015.
Generics: Challenges summary for a growing sector of pharmaceuticalsUSTC, Hefei, PRC
A short summary regarding core challenges faced by generic parmaceutical enterprises in competitive environments.
For further information, contact at: faisal786.btc@gmail.com
Presentation from the 3rd Joint Meeting of the Antimicrobial Resistance and Healthcare-Associated Infections (ARHAI) Networks, organised by the European Centre of Disease Prevention and Control - Stockholm, 11-13 February 2015
This document summarizes presentations and discussions from a working group meeting between the EU and US to propose standards for measuring antimicrobial use in hospitals. It was noted that while surveillance of hospital antimicrobial consumption is becoming more widespread, challenges remain in harmonizing measurement methods between regions. Key challenges include determining the best data sources, units of measurement, and ways to account for differences in patient case mix between hospitals. The group discussed various approaches used in the US and EU and potential standardized indicators, but recognized further work is still needed to develop truly comparable data across multiple healthcare settings and jurisdictions.
Presentation by Dennis Ross-Degnan on tools and approaches that can be used by countries involved in the Medicines Transparency Alliance (MeTA), at the London launch in May 2008
How to Make Your University the Technology Source of Choice for Innovation -...Fuentek, LLC
The document discusses a versatile microscale particle fabrication technique developed at the University of Illinois at Urbana-Champaign that has applications in drug delivery, industrial manufacturing, and more. Commercialization options were explored, including licensing to established companies or starting a startup. A two-path strategy was pursued, but delays and market shifts hindered licensing interest. However, one of the co-inventors later started a new company, Orbis Biosciences, to develop the technique, achieving commercial success. Lessons included being flexible and not waiting too long if the market is ready.
R&D Productivity and Costs in Today's Health Care Arena - Pat AudetTTC, llc
The document discusses challenges facing the pharmaceutical industry including increased healthcare costs, decreased R&D productivity, and more difficulty achieving blockbuster drugs. It also outlines strategies the industry is taking to address these challenges such as focusing on specialty and biologic drugs, reducing R&D costs through outsourcing and adaptive clinical trial designs, and pursuing mergers and acquisitions.
The document summarizes baseline assessments that were conducted as part of the MeTA (Medicines Transparency Alliance) initiative in various countries including Jordan. Baseline assessments involved collecting data on the pharmaceutical sector through tools like a pharmaceutical sector scan, household and health facility surveys, and assessments of multi-stakeholder engagement. The assessments revealed gaps in Jordan's pharmaceutical system related to things like availability of medicines, treatment guidelines, and rational drug use. The baseline data provides evidence to help decision-makers reform policies and improve access to quality medicines.
This document discusses the biosimilar drug market and opportunities for biosimilar drug developers. It notes that as biologic drug patents expire, biosimilar drugs that are comparable in efficacy and safety to reference biologics at a lower cost represent a major market opportunity. However, biosimilar market uptake faces challenges from regulatory uncertainty, physician concerns about switching patients, and efforts by innovator companies to defend their biologic drugs. The document estimates that biosimilars may not achieve critical mass adoption until 2023-2025.
The document summarizes the work of the Access to Medicine Foundation, an independent non-profit organization that works to improve access to medicine globally. It discusses the Foundation's Antimicrobial Resistance Benchmark, which evaluates pharmaceutical companies' efforts to address antimicrobial resistance (AMR) in their R&D pipelines, manufacturing processes, and access and stewardship programs. The Benchmark covers 20 large research-based pharmaceutical companies and generic drug manufacturers. It finds that while some leading companies have strong environmental management and stewardship programs, overall pipeline development for novel antibiotics remains limited, and strategies to prevent AMR in manufacturing vary widely among companies.
This presentation covers the essential concept of ensuring all promotional communications are on label and the safe harbors established by FDA for disseminating off-label information compliantly.
This document discusses the fundamentals and purpose of primary competitive intelligence for biopharmaceutical companies. It describes how competitive intelligence can provide actionable insights throughout a drug's lifecycle from pre-clinical to post-marketing. Robust competitive intelligence is needed to understand competitor strategies, monitor the landscape, and position companies for strategic success against competitive forces in the industry.
Side event WFN_Antonio Carretero, AENOR, 14th January, 2015 UN Water Conferen...water-decade
This document summarizes ISO 14046:2014, which provides principles, requirements, and guidelines for assessing water footprints. It outlines the standard's scope, normative references, terms and definitions, principles, methodological framework, reporting requirements, and critical review process. The methodological framework follows a life cycle assessment approach and includes defining goals and scope, conducting a water footprint inventory analysis, performing a water footprint impact assessment, and interpreting results. Water footprint reporting must include the study goal, scope, inventory analysis, impact assessment, and interpretation. The standard can be applied to organizations and products to identify water use and impacts throughout their life cycles and supply chains.
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.
Presentation on approaches to measure medicine prices and price components, by Marg Ewen, Health Action International, at the launch of the Medicines Transparency Alliance, London 15 May 2008
Evolving Regulation of Biosimilars and Update on Generic Drug RegulationMichael Swit
Presentation to the Annual Educational Conference, jointly sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and FDA, in June 2009, with a focus on:
Biosimilars
Overview of Current Situation in Europe
Regulatory and Scientific Issues
Product Development Issues
U.S. Legislative Options
Waxman Bill
Eshoo
Generic Drugs – Update on U.S. Initiatives
Question Based Review (QBR)
User Fees
Patent Settlements
An analytical framework for consistent evaluation of pest and disease managem...EMPHASIS PROJECT
Presentation at the ICPP 2018.
• The Analytical Framework evaluates technologies against 27 indicators across 4 dimensions
• This allows to:
• Integrate a multi-actor approaching to technology development
• Identify the strengths and weaknesses of individual technologies
• Compare novel technologies with each other and conventional measures
• Identify market opportunities and support business plans
This powerpoint presentation was made by Jennifer McEntire, Ph.D, with the Institute of Food Technologists to the joint FDA/FSIS meetings held in Washington D.C. on December 9 & 10 regarding traceability for produce.
Biosimilars: Regulatory and Clinical ConsiderationsCovance
Other considerations for clinical studies are that the regulations are written with some flexibility, and although clinical studies have been required thus far, they are not mandated by the regulations. Perception from sponsors is that innovators make process changes all the time that impact structure and no clinical study is done because of good analytical characterization so why are biosimilars different? With solid analytical and functional data, we should continue to challenge regulators on the need for clinical studies.
RxWiki is a digital medication encyclopedia created by pharmacists that aims to address limitations of Wikipedia's medication content such as lack of editor transparency, slow publishing of FDA updates, and information written at too high of a reading level. RxWiki utilizes a pharmacist-only crowdsourcing model where pharmacist editors must meet standards and all edits are published within minutes of FDA announcements. The encyclopedia is written at an 8th grade reading level to be easily understood by consumers.
Cook medical incorporated product pipeline analysisraja1233
Companyprofilesandconferences.com glad to promote a new report on "Cook Medical Incorporated - Product Pipeline Analysis" which is a source for data, analysis, and actionable intelligence on the company’s portfolio of pipeline products also provides key information about the company, its major products and brands.
The Other Agency: An introduction to Pharma MarketingDale Cooke
This presentation helps people understand FDA's regulation of the marketing and promotion of prescription products. Included are the most prominent regulations that promotion of prescription products must meet.
The document outlines the World Health Organization's first edition of the Model List of Essential In Vitro Diagnostics (EDL). The EDL provides guidance to countries on selecting important diagnostic tests to address disease priorities based on their health systems and needs. The EDL lists general diagnostic tests and disease-specific tests for primary healthcare facilities and facilities with clinical laboratories. It is intended to complement the WHO Model List of Essential Medicines and help improve access to quality diagnostics globally. Selection of tests was based on disease burden, unmet needs, and priorities. The EDL provides information on test purpose, format, specimens, recommended facility level, and links to WHO guidance and prequalified products. Countries should consider local factors in adapting
Post market surveillance (PMS) and post market clinical follow up (PMCF) reports play a vital role in determining the post-market clinical performance and safety of medical devices. PMS uses feedback, complaints, regulatory reports, literature reviews, failure analyses, and in-house testing to prepare an annual report on a device's long-term performance, complications, quality improvements, and risk analysis. PMCF monitors safety after market release through reporting databases, clinical studies, and conclusions relating to original objectives which are used to reassess devices and ensure compliance with essential requirements. Both PMS and PMCF reports can identify issues requiring corrective actions to submit to regulatory auditors.
Sharing my learning in dealing with complexity and uncertainty and shed some light on:
(a) Understanding the ‘biosimilar paradox’
(b) Accelerating our “QbD” Journey – focusing on ‘from Generics to Biosimilars’
(c) In preparing this talk, collect my thoughts to help NIPTE consider ways for developing its program on Biosimilars to help the Nation improve assurance of quality with confidence and lower costs
(D) Invite the audience to get to know NIPTE and provide us ways to collaborate with industry
This document provides an overview of post-marketing surveillance requirements for drug products. It discusses general reporting requirements including field alert reports, annual reports, labeling changes, and adverse event reporting. The key aspects of post-marketing surveillance are monitoring adverse drug reactions, ensuring compliance with manufacturing standards, and completing any agreed upon Phase IV clinical studies. Maintaining vigilance during post-marketing surveillance is important to discover new safety risks and provide additional information on a drug's benefits and risks.
The Drug Effectiveness Review Project (DERP) was established in 2003 to provide systematic reviews of drug classes to support evidence-based drug policy decisions. Over time, DERP expanded its membership from 3 states to 15 states and 2 other organizations. It developed formal processes for selecting review topics and updating existing reviews to efficiently manage its growing portfolio given limited resources. The topic selection process involves prioritizing potential review topics based on criteria like disease burden, alternatives, and evidence quality to select the most pressing issues for evaluation.
The document summarizes baseline assessments that were conducted as part of the MeTA (Medicines Transparency Alliance) initiative in various countries including Jordan. Baseline assessments involved collecting data on the pharmaceutical sector through tools like a pharmaceutical sector scan, household and health facility surveys, and assessments of multi-stakeholder engagement. The assessments revealed gaps in Jordan's pharmaceutical system related to things like availability of medicines, treatment guidelines, and rational drug use. The baseline data provides evidence to help decision-makers reform policies and improve access to quality medicines.
This document discusses the biosimilar drug market and opportunities for biosimilar drug developers. It notes that as biologic drug patents expire, biosimilar drugs that are comparable in efficacy and safety to reference biologics at a lower cost represent a major market opportunity. However, biosimilar market uptake faces challenges from regulatory uncertainty, physician concerns about switching patients, and efforts by innovator companies to defend their biologic drugs. The document estimates that biosimilars may not achieve critical mass adoption until 2023-2025.
The document summarizes the work of the Access to Medicine Foundation, an independent non-profit organization that works to improve access to medicine globally. It discusses the Foundation's Antimicrobial Resistance Benchmark, which evaluates pharmaceutical companies' efforts to address antimicrobial resistance (AMR) in their R&D pipelines, manufacturing processes, and access and stewardship programs. The Benchmark covers 20 large research-based pharmaceutical companies and generic drug manufacturers. It finds that while some leading companies have strong environmental management and stewardship programs, overall pipeline development for novel antibiotics remains limited, and strategies to prevent AMR in manufacturing vary widely among companies.
This presentation covers the essential concept of ensuring all promotional communications are on label and the safe harbors established by FDA for disseminating off-label information compliantly.
This document discusses the fundamentals and purpose of primary competitive intelligence for biopharmaceutical companies. It describes how competitive intelligence can provide actionable insights throughout a drug's lifecycle from pre-clinical to post-marketing. Robust competitive intelligence is needed to understand competitor strategies, monitor the landscape, and position companies for strategic success against competitive forces in the industry.
Side event WFN_Antonio Carretero, AENOR, 14th January, 2015 UN Water Conferen...water-decade
This document summarizes ISO 14046:2014, which provides principles, requirements, and guidelines for assessing water footprints. It outlines the standard's scope, normative references, terms and definitions, principles, methodological framework, reporting requirements, and critical review process. The methodological framework follows a life cycle assessment approach and includes defining goals and scope, conducting a water footprint inventory analysis, performing a water footprint impact assessment, and interpreting results. Water footprint reporting must include the study goal, scope, inventory analysis, impact assessment, and interpretation. The standard can be applied to organizations and products to identify water use and impacts throughout their life cycles and supply chains.
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.
Presentation on approaches to measure medicine prices and price components, by Marg Ewen, Health Action International, at the launch of the Medicines Transparency Alliance, London 15 May 2008
Evolving Regulation of Biosimilars and Update on Generic Drug RegulationMichael Swit
Presentation to the Annual Educational Conference, jointly sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and FDA, in June 2009, with a focus on:
Biosimilars
Overview of Current Situation in Europe
Regulatory and Scientific Issues
Product Development Issues
U.S. Legislative Options
Waxman Bill
Eshoo
Generic Drugs – Update on U.S. Initiatives
Question Based Review (QBR)
User Fees
Patent Settlements
An analytical framework for consistent evaluation of pest and disease managem...EMPHASIS PROJECT
Presentation at the ICPP 2018.
• The Analytical Framework evaluates technologies against 27 indicators across 4 dimensions
• This allows to:
• Integrate a multi-actor approaching to technology development
• Identify the strengths and weaknesses of individual technologies
• Compare novel technologies with each other and conventional measures
• Identify market opportunities and support business plans
This powerpoint presentation was made by Jennifer McEntire, Ph.D, with the Institute of Food Technologists to the joint FDA/FSIS meetings held in Washington D.C. on December 9 & 10 regarding traceability for produce.
Biosimilars: Regulatory and Clinical ConsiderationsCovance
Other considerations for clinical studies are that the regulations are written with some flexibility, and although clinical studies have been required thus far, they are not mandated by the regulations. Perception from sponsors is that innovators make process changes all the time that impact structure and no clinical study is done because of good analytical characterization so why are biosimilars different? With solid analytical and functional data, we should continue to challenge regulators on the need for clinical studies.
RxWiki is a digital medication encyclopedia created by pharmacists that aims to address limitations of Wikipedia's medication content such as lack of editor transparency, slow publishing of FDA updates, and information written at too high of a reading level. RxWiki utilizes a pharmacist-only crowdsourcing model where pharmacist editors must meet standards and all edits are published within minutes of FDA announcements. The encyclopedia is written at an 8th grade reading level to be easily understood by consumers.
Cook medical incorporated product pipeline analysisraja1233
Companyprofilesandconferences.com glad to promote a new report on "Cook Medical Incorporated - Product Pipeline Analysis" which is a source for data, analysis, and actionable intelligence on the company’s portfolio of pipeline products also provides key information about the company, its major products and brands.
The Other Agency: An introduction to Pharma MarketingDale Cooke
This presentation helps people understand FDA's regulation of the marketing and promotion of prescription products. Included are the most prominent regulations that promotion of prescription products must meet.
The document outlines the World Health Organization's first edition of the Model List of Essential In Vitro Diagnostics (EDL). The EDL provides guidance to countries on selecting important diagnostic tests to address disease priorities based on their health systems and needs. The EDL lists general diagnostic tests and disease-specific tests for primary healthcare facilities and facilities with clinical laboratories. It is intended to complement the WHO Model List of Essential Medicines and help improve access to quality diagnostics globally. Selection of tests was based on disease burden, unmet needs, and priorities. The EDL provides information on test purpose, format, specimens, recommended facility level, and links to WHO guidance and prequalified products. Countries should consider local factors in adapting
Post market surveillance (PMS) and post market clinical follow up (PMCF) reports play a vital role in determining the post-market clinical performance and safety of medical devices. PMS uses feedback, complaints, regulatory reports, literature reviews, failure analyses, and in-house testing to prepare an annual report on a device's long-term performance, complications, quality improvements, and risk analysis. PMCF monitors safety after market release through reporting databases, clinical studies, and conclusions relating to original objectives which are used to reassess devices and ensure compliance with essential requirements. Both PMS and PMCF reports can identify issues requiring corrective actions to submit to regulatory auditors.
Sharing my learning in dealing with complexity and uncertainty and shed some light on:
(a) Understanding the ‘biosimilar paradox’
(b) Accelerating our “QbD” Journey – focusing on ‘from Generics to Biosimilars’
(c) In preparing this talk, collect my thoughts to help NIPTE consider ways for developing its program on Biosimilars to help the Nation improve assurance of quality with confidence and lower costs
(D) Invite the audience to get to know NIPTE and provide us ways to collaborate with industry
This document provides an overview of post-marketing surveillance requirements for drug products. It discusses general reporting requirements including field alert reports, annual reports, labeling changes, and adverse event reporting. The key aspects of post-marketing surveillance are monitoring adverse drug reactions, ensuring compliance with manufacturing standards, and completing any agreed upon Phase IV clinical studies. Maintaining vigilance during post-marketing surveillance is important to discover new safety risks and provide additional information on a drug's benefits and risks.
The Drug Effectiveness Review Project (DERP) was established in 2003 to provide systematic reviews of drug classes to support evidence-based drug policy decisions. Over time, DERP expanded its membership from 3 states to 15 states and 2 other organizations. It developed formal processes for selecting review topics and updating existing reviews to efficiently manage its growing portfolio given limited resources. The topic selection process involves prioritizing potential review topics based on criteria like disease burden, alternatives, and evidence quality to select the most pressing issues for evaluation.
Nathalie Boeglin, Alice Rolland, Frederic Pailloux and David Uguen provide an overview of the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation.
Post Market Clinical Surveillance, Experience of the Industry by S. Menzl - ...qserveconference2013
Stefan Menzl, Director of International Regulatory Affairs at Abbott Medical Optics, discusses post-market clinical surveillance and follow-up. He outlines the requirements for post-market surveillance under the current Medical Device Directive and proposed new Medical Device Regulation. Key elements of a post-market surveillance plan include vigilance reporting, literature review, registries, and clinical studies. Challenges to meeting requirements include non-harmonized regulations worldwide and ensuring safety data is consistently updated from various sources.
Comparative assessment of stakeholder feedback capt-poster presentation-2019Naghmeh Foroutan
The present study was designed for obtaining Canadian pricing and reimbursement stakeholders’ opinion on a list of proposed recommendations for updating the 2007 Patented Medicine Prices Review Board (PMPRB) Budget Impact Analysis guidelines. Methods: Stakeholders from different perspectives including policymakers (public and private payers) and industry experts/consultants were invited to participate in the study (private payer and industry perspectives were not included in the PMPRB 2007 BIA guidelines). Using a mixed methods approach, an interview guide and a written survey were developed based on discordance between the PMPRB 2007 BIA guidelines recommendations and Canadian provincial, and other national or transnational BIA guidelines. A thematic content analysis was applied for the qualitative data analysis. Results: We conducted nine interviews with policymakers and twenty-seven surveys with industry experts/consultants. Most interviewees were positive about the usefulness of BIA in disinvestment decisions and believed that reviewing cost-effectiveness analysis (CEA) and BIA together, at the same time, could be particularly informative for setting value-based prices. Fifty-six percent of the proposed recommendations were approved (e.g., the use of post-market real-world data for assessing the reliability of BIAs first-year forecasts), whereas, 30% were not supported by stakeholders (e.g., indirect costs). Some recommendations will need further input from public and private payers before being included in a revised version of the PMPRB BIA guidelines (e.g., inclusion of cost offsets). Conclusions: In the present study, Canadian payers and manufacturers’ views on the BIA recommendations, obtained through qualitative and quantitative methods, provide additional insight to help define BIA guidelines from a Canadian perspective. This information may also be of value for updating or creating BIA guidelines worldwide.
How can HTA’s in Asia respond to Increased Clinical Uncertainty: the potentia...Office of Health Economics
This document summarizes a panel discussion on how health technology assessments (HTAs) in Asia can respond to increased clinical uncertainty through the potential use of outcomes-based risk sharing agreements (PBRSAs). The panel focused on implementing risk sharing in the region, examining case studies from other areas, and identifying barriers and opportunities. It provided an overview of PBRSAs in the US and Europe, discussed feasibility challenges, and outlined alternatives to outcomes-based risk sharing that payers could consider at drug launch.
This document provides an introduction to pharmacoeconomics including:
- Pharmacoeconomics compares the costs and benefits of pharmaceutical products and services to help optimize the allocation of healthcare resources.
- It evaluates the costs of drug therapy from different perspectives (e.g. patient, provider, payer) and uses various analytical techniques (e.g. cost-minimization analysis, cost-effectiveness analysis, cost-benefit analysis).
- Pharmacoeconomic evaluations are important for clinical and policy decision making to improve health outcomes given limited healthcare budgets.
This document provides an introduction to pharmacoeconomics. It defines pharmacoeconomics as a branch of health economics concerned with the costs and benefits of pharmaceutical products and services. The document outlines the need for pharmacoeconomics to optimize resource allocation and make efficient choices when resources are limited. It also describes different types of economic evaluations used in pharmacoeconomics like cost-minimization analysis, cost-effectiveness analysis, cost-benefit analysis, and cost-utility analysis.
Epithelial ovarian cancer – pipeline review, h2 2012Rose088
The document summarizes a market research report from Global Markets Direct titled "Epithelial Ovarian Cancer – Pipeline Review, H2 2012". The report provides an overview of the current therapeutic pipeline for epithelial ovarian cancer, including information on late stage projects, companies involved in development, and assessment of products by factors such as molecule type and administration route. It also lists key report sections such as executive summary, pipeline analysis, company profiles, and individual drug profiles.
This report provides comprehensive information on the therapeutic development for Seborrhea, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Seborrhea and special features on late-stage and discontinued projects.
http://www.researchmoz.us/seborrhea-pipeline-review-h1-2015-report.html
The document discusses the Medicare Part D Overutilization Monitoring System (OMS) which was developed by CMS to monitor effectiveness of Part D sponsors' interventions for opioid and acetaminophen overutilization. The OMS identifies outliers based on Prescription Drug Event data and issues quarterly reports to sponsors. Key changes discussed include lowering the opioid criteria threshold in 2015, encouraging but not requiring hard acetaminophen edits in 2016, and potential future adoption of opioid overutilization measures under development. The importance of sponsors' role in monitoring medication therapy and identifying unsafe practices is also emphasized.
The document discusses improving health outcomes and reducing costs through better use of molecular diagnostics. It notes that health care expenditures have significantly increased worldwide over recent decades and are predicted to continue rising. The current model of developing new diagnostics provides inadequate incentives and validation may not reflect real-world use. The Partnership for Precision Medicine (PPM) introduces a new, collaborative model of diagnostic development that engages health systems and payers. PPM aims to identify high-impact diagnostic opportunities, validate promising candidates within healthcare settings, and assess real-world impact on patient management and costs.
The document provides an overview of the global liquid biopsy market forecast from 2020 to 2025. It discusses key aspects of the market such as application, end user, clinical application, product/service, circulating biomarker, technology, and region. It also profiles major companies in the market and their recent developments. The global liquid biopsy market is expected to grow significantly due to the rising adoption of non-invasive cancer screening and monitoring techniques. However, lack of standardization and low reimbursement rates may hinder the market growth.
Market Research Reports, Inc. has announced the addition of “Vulvar Cancer - Pipeline Insight, 2018” research report to their offering. See more at - http://mrr.cm/UBP
The partial pharmacoeconomic evaluations are cost analysis, cost-effectiveness analysis and cost-utility analysis. A comparison of costs and consequences of two alternatives is an example of a full pharmacoeconomic evaluation known as cost-benefit analysis. Therefore, the answer is not a.
b) A cost analysis of a single intervention
c) A comparison of costs per life-year gained for two interventions
d) An estimation of the total costs of a disease to the society
12/10/2018
DEPARTMENT OF PHARMACOLOGY
KMCH COLLEGE OF PHARMACY
42
Which one of the following is an example of a partial
pharmaco-economic evaluation
This document discusses the field of pharmacoeconomics. It begins by defining pharmacoeconomics as the scientific discipline concerned with comparing the costs and benefits of drug therapies. It describes how pharmacoeconomics helps optimize health care resource allocation by comparing drug costs and outcomes. The document then outlines several key aspects of pharmacoeconomics including its need, challenges, evaluation methods, and applications. In conclusion, it states that pharmacoeconomics provides a means to quantify pharmaceutical value by balancing costs and outcomes to help inform better healthcare decisions.
USA Commercial Strategy, Medical Devices, National Technology Transfer Confer...Debra A. Chanda
This document discusses financing trends in the medical device industry and strategies for US commercialization of medical devices. It notes that venture capital funding and deal activity declined in recent quarters, forcing companies to seek alternative financing from angels, crowdfunding, and strategic partners. The document provides examples of recent funding rounds for medical device companies and outlines strategies for developing regulatory and commercialization plans that address clinical needs and reimbursement pathways. It emphasizes the importance of strong operational management to execute business plans and stresses that investors fund management teams rather than just technologies.
Global Patient Support Programs (PSP) Market Report 2022 to 2030Insights10
The Global patient support program market size was valued at $xx Bn in 2022 and is estimated to expand at a compound annual growth rate (CAGR) of xx% from 2022 to 2030 and will reach $xx Bn in 2030. Factors driving this market include an aging population, the increasing prevalence of chronic diseases, and the rising cost of healthcare. The market is segmented by delivery type, component type, and therapeutic area, application type, end-user type. Some of the key players in the global patient support program market include Pfizer, Novartis, Roche, and Merck.
Market Research Reports, Inc. has announced the addition of “Acute Lung Injury - Pipeline Insight, 2018” research report to their offering. See more at - http://mrr.cm/Unn
Similar to 2012 flow cytometry market needs, emerging developments and future use (20)
Threats to mobile devices are more prevalent and increasing in scope and complexity. Users of mobile devices desire to take full advantage of the features
available on those devices, but many of the features provide convenience and capability but sacrifice security. This best practices guide outlines steps the users can take to better protect personal devices and information.
Removing Uninteresting Bytes in Software FuzzingAftab Hussain
Imagine a world where software fuzzing, the process of mutating bytes in test seeds to uncover hidden and erroneous program behaviors, becomes faster and more effective. A lot depends on the initial seeds, which can significantly dictate the trajectory of a fuzzing campaign, particularly in terms of how long it takes to uncover interesting behaviour in your code. We introduce DIAR, a technique designed to speedup fuzzing campaigns by pinpointing and eliminating those uninteresting bytes in the seeds. Picture this: instead of wasting valuable resources on meaningless mutations in large, bloated seeds, DIAR removes the unnecessary bytes, streamlining the entire process.
In this work, we equipped AFL, a popular fuzzer, with DIAR and examined two critical Linux libraries -- Libxml's xmllint, a tool for parsing xml documents, and Binutil's readelf, an essential debugging and security analysis command-line tool used to display detailed information about ELF (Executable and Linkable Format). Our preliminary results show that AFL+DIAR does not only discover new paths more quickly but also achieves higher coverage overall. This work thus showcases how starting with lean and optimized seeds can lead to faster, more comprehensive fuzzing campaigns -- and DIAR helps you find such seeds.
- These are slides of the talk given at IEEE International Conference on Software Testing Verification and Validation Workshop, ICSTW 2022.
Maruthi Prithivirajan, Head of ASEAN & IN Solution Architecture, Neo4j
Get an inside look at the latest Neo4j innovations that enable relationship-driven intelligence at scale. Learn more about the newest cloud integrations and product enhancements that make Neo4j an essential choice for developers building apps with interconnected data and generative AI.
GraphSummit Singapore | The Future of Agility: Supercharging Digital Transfor...Neo4j
Leonard Jayamohan, Partner & Generative AI Lead, Deloitte
This keynote will reveal how Deloitte leverages Neo4j’s graph power for groundbreaking digital twin solutions, achieving a staggering 100x performance boost. Discover the essential role knowledge graphs play in successful generative AI implementations. Plus, get an exclusive look at an innovative Neo4j + Generative AI solution Deloitte is developing in-house.
UiPath Test Automation using UiPath Test Suite series, part 6DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 6. In this session, we will cover Test Automation with generative AI and Open AI.
UiPath Test Automation with generative AI and Open AI webinar offers an in-depth exploration of leveraging cutting-edge technologies for test automation within the UiPath platform. Attendees will delve into the integration of generative AI, a test automation solution, with Open AI advanced natural language processing capabilities.
Throughout the session, participants will discover how this synergy empowers testers to automate repetitive tasks, enhance testing accuracy, and expedite the software testing life cycle. Topics covered include the seamless integration process, practical use cases, and the benefits of harnessing AI-driven automation for UiPath testing initiatives. By attending this webinar, testers, and automation professionals can gain valuable insights into harnessing the power of AI to optimize their test automation workflows within the UiPath ecosystem, ultimately driving efficiency and quality in software development processes.
What will you get from this session?
1. Insights into integrating generative AI.
2. Understanding how this integration enhances test automation within the UiPath platform
3. Practical demonstrations
4. Exploration of real-world use cases illustrating the benefits of AI-driven test automation for UiPath
Topics covered:
What is generative AI
Test Automation with generative AI and Open AI.
UiPath integration with generative AI
Speaker:
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
Dr. Sean Tan, Head of Data Science, Changi Airport Group
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- Improved developer experience and productivity through actionable findings and reduction of false positives
- Maintenance of superior security standards and inherent policy enforcement with Authorization to Operate (ATO)
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We will cover:
- How to remove silos in DevSecOps
- How to build efficient development pipeline roles and component templates
- How to deliver security artifacts that matter for ATO’s (SBOMs, vulnerability reports, and policy evidence)
- How to streamline operations with automated policy checks on container images
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Neha Bajwa, Vice President of Product Marketing, Neo4j
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Introducing Milvus Lite: Easy-to-Install, Easy-to-Use vector database for you...
2012 flow cytometry market needs, emerging developments and future use
1. 2012 Flow Cytometry Market Needs,
Emerging Developments and Future Use
Report Details:
Published: September 2012
Price: Single User License: US$2355 Corporate User License: US$4710
Biopharm Reports has carried out a study of market needs in the flow cytometry field. This study
examined current techniques and applications, end-users’ plans for using flow cytometry over the next
three years, as well as preferred products, purchasing and new developments. The findings of this study
provide valuable support to developers and vendors operating in this field.
This study involved the participation of 260 experienced flow cytometry users and decision-makers in 53
countries. It investigated current and future applications, current and future purchasing plans, research
vs. clinical use across the study, new and emerging applications, end-users’ principal flow cytometers and
their strengths and weaknesses, current annual and future budgets, budget breakdown, main
consumables, challenges, innovation, use of analysis (offline) software, quality control guidelines, sample
preparation, and other areas. As part of this study, end-users provided details of their anticipated
purchases from suppliers in this field, over the period 2012 – 2015.
http://www.reportsnreports.com/reports/191887-
Buy your copy of this report @
flow-cytometry-2012-market-needs-emerging-developments-and-future-
use.html
Key Findings
Routine use: Use of flow cytometry (FC) by end-users for routine (developed and validated) FC
tests, the development or validation of FC tests and for qualitative discovery using FC methods.
Companies: End-users' purchases/use of FC systems from more than 25 companies and their
anticipated use of these systems over the next three years, each ranked according to their
competitive position
General and clinical: FC use (defined in this study description) by research scientists/research
managers and clinicians/physicians
FC methods: Current use of more than 25 FC general applications and 15 clinical applications by
end-users and the anticipated use of these applications over the next three years, each ranked
according to their competitive position.
2. Main applications: End-users’ two main applications of FC, each ranked according to their
competitive position.
New applications: New FC applications used by end-users in the last three years, each ranked
according to their competitive position.
Emerging applications: Emerging applications of FC, indicated by end-users.
Main flow cytometer: End-users’ main flow cytometer, each ranked according to their competitive
position.
Strengths: End-users’ disclosures of the strengths of their main flow cytometer, each ranked
according to their competitive position.
Weaknesses: End-users’ disclosures of the weaknesses of their main flow cytometer, each
ranked according to their competitive position.
Current financial budgets: End-users’ annual financial budgets for FC studies.
Current budget breakdown: The breakdown of end-users’ FC financial budgets in nine key areas,
relating to their current expenditure on FC products and activities.
Future financial budgets: End-users’ anticipated financial budget changes (percentage increases
or decrease, a measure of the financial growth of this field) over the next three years, relating to
their FC activities.
Consumables: End-users’ top consumables, associated with their FC activities.
Quality control guidelines: End-users’ adherence to quality control guidelines or procedures,
relating to the conduct of FC studies.
Cost per sample: End-users’ disclosures on the costs per sample analysed, using FC.
Current challenges: End-users’ disclosures on the parameters or measurements that present the
greatest technical challenges to FC analysis, together with the associated sample types
(matrices), associated FC methods and underlying reasons.
Innovation: End-users’ disclosures relating to 11 key areas of required innovation in the FC field,
each ranked (on a scale of 1 to 10) according to their importance.
Biomarkers: End-users’ application of FC methods for the study of disease biomarkers, namely
molecular types and their clinical utilities.
Organisations: End-users organisations include clinics or hospitals, government bodies, large
international companies, research institutes, small and medium sized companies, universities and
veterinary centres.
Fields: End-users professional fields include biotechnology, chemicals, clinical or hospital,
defence, energy, environmental, food and drink, forensics, geology, government, healthcare,
natural products, pharmaceuticals, research institutes, security and universities.
Therapeutic areas: End-users’ FC activities in terms of their general therapeutic area (20 different
areas covered), including the main diseases to which their work in this field relates.
3. Software: End-users’ disclosures on their preferred analysis (off-line) software, associated with
FC studies.
Purpose: End-users’ underlying reasons for using FC analysis across 17 major fields
(biotechnology, chemicals, clinical or hospital, defence, diagnostics (medical), energy,
environmental, food and drink, forensics, geology, government, healthcare, natural products,
pharmaceuticals, research institutes, security, university), each ranked according to their relative
importance.
Study samples: Study sample types analysed by end-users using FC methods, each ranked
according to their relative importance.
Sample preparation: The use of sample preparation methods by end-users for FC studies, each
ranked according to their importance.
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