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A major goal of patient advocacy groups is to address the unmet needs of patients with cancer or rare diseases by providing access to the most effective drugs. In recent years, patient advocacy groups have expanded their influence over the drug development continuum from discovery to approval to market entry. Many groups directly fund, help design, or recruit patients to participate in clinical trials.
This webinar reviews the history of patient advocacy groups in advancing clinical research and examines the evolution of their role in light of recent and pending legislative and regulatory changes in the United States and European Union. Included is a discussion of how patient advocacy groups and industry can join to respond most effectively to these anticipated changes. Presenters are Susan Stein, MPH, a member of the Board of Directors of worldwide patient advocate umbrella organization Global Genes, and Juliet Moritz, MPH, Executive Director of Strategic Drug Development for Rare Diseases at Premier Research.
Best Practices in Patient Advocacy Groups Collaboration and Relationship Mana...Best Practices
This document summarizes a study examining best practices for collaborating with patient advocacy groups. It provides an overview of the research methodology, participating companies, key findings and insights. Some of the main findings include: 1) there is no single best structure for patient advocacy groups, with companies taking decentralized, centralized and hybrid approaches; 2) social media and video platforms are increasingly important in patient education; and 3) transparency, aligning objectives, and trust are critical when working with advocacy groups on controversial therapies.
Top 25 IDNs by number of ACO affiliations: 49 hospitals in-network, $9.4 billion in net patient revenue
Types of ACOs: CMS ACO Models, Medicaid ACOs, Commercial ACO
Collection, Processing and Reporting of ICSRClinosolIndia
The collection, processing, and reporting of Individual Case Safety Reports (ICSRs) in pharmacovigilance involve several key steps and activities. Here's an overview of the process
This paper analyzes how American foreign policy regarding military intervention has changed over the past two centuries. It compares policies during the early republic period from 1788-1816, focusing on the Quasi-War, Barbary War, and War of 1812, to more recent policies from 1947-2012 involving the wars in Korea, Vietnam, Iraq, and Afghanistan. The analysis finds that early policies emphasized neutrality and limited intervention, while more recent policies reflect the growth of America as a global military power conducting numerous overseas interventions.
Signal Detection in Pharmacovigilance - Process proposed by CIOMS Working Gro...Perficient
This document outlines the process for signal detection, prioritization, and evaluation proposed by the Council for International Organizations of Medical Sciences (CIOMS) Working Group VIII. The process involves detecting potential safety signals from sources like clinical trials, literature reviews, and post-marketing surveillance reports. It then prioritizes these signals based on factors like biological plausibility. Signals are further evaluated through methods such as individual case reviews, aggregate analysis, and additional studies to determine if they require regulatory action.
Analysis of what patient services proposed by pharma companies should be. This document explains: 1. why patient centricity is essential? - 2. how to craft a patient-centric strategy? - 3. How to implement patient-centric initiatives?
Public Diplomacy: International Communication as StrategyJuan Manfredi
This document discusses public diplomacy as international communication strategy. It notes that sovereignty is no longer confined to states and that new actors like corporations, citizens, media and lobby groups influence international politics. It also notes the rise of new media like the internet. The document outlines that there are now around 200 countries and 100,000 multinational corporations and 50,000 NGOs. It defines traditional diplomacy versus public diplomacy and lists some preliminary findings. It identifies three main goals of public diplomacy: the international economy, identity projection, and influence. It discusses methods like strategic communication, relationship building, news management and positioning.
Best Practices in Patient Advocacy Groups Collaboration and Relationship Mana...Best Practices
This document summarizes a study examining best practices for collaborating with patient advocacy groups. It provides an overview of the research methodology, participating companies, key findings and insights. Some of the main findings include: 1) there is no single best structure for patient advocacy groups, with companies taking decentralized, centralized and hybrid approaches; 2) social media and video platforms are increasingly important in patient education; and 3) transparency, aligning objectives, and trust are critical when working with advocacy groups on controversial therapies.
Top 25 IDNs by number of ACO affiliations: 49 hospitals in-network, $9.4 billion in net patient revenue
Types of ACOs: CMS ACO Models, Medicaid ACOs, Commercial ACO
Collection, Processing and Reporting of ICSRClinosolIndia
The collection, processing, and reporting of Individual Case Safety Reports (ICSRs) in pharmacovigilance involve several key steps and activities. Here's an overview of the process
This paper analyzes how American foreign policy regarding military intervention has changed over the past two centuries. It compares policies during the early republic period from 1788-1816, focusing on the Quasi-War, Barbary War, and War of 1812, to more recent policies from 1947-2012 involving the wars in Korea, Vietnam, Iraq, and Afghanistan. The analysis finds that early policies emphasized neutrality and limited intervention, while more recent policies reflect the growth of America as a global military power conducting numerous overseas interventions.
Signal Detection in Pharmacovigilance - Process proposed by CIOMS Working Gro...Perficient
This document outlines the process for signal detection, prioritization, and evaluation proposed by the Council for International Organizations of Medical Sciences (CIOMS) Working Group VIII. The process involves detecting potential safety signals from sources like clinical trials, literature reviews, and post-marketing surveillance reports. It then prioritizes these signals based on factors like biological plausibility. Signals are further evaluated through methods such as individual case reviews, aggregate analysis, and additional studies to determine if they require regulatory action.
Analysis of what patient services proposed by pharma companies should be. This document explains: 1. why patient centricity is essential? - 2. how to craft a patient-centric strategy? - 3. How to implement patient-centric initiatives?
Public Diplomacy: International Communication as StrategyJuan Manfredi
This document discusses public diplomacy as international communication strategy. It notes that sovereignty is no longer confined to states and that new actors like corporations, citizens, media and lobby groups influence international politics. It also notes the rise of new media like the internet. The document outlines that there are now around 200 countries and 100,000 multinational corporations and 50,000 NGOs. It defines traditional diplomacy versus public diplomacy and lists some preliminary findings. It identifies three main goals of public diplomacy: the international economy, identity projection, and influence. It discusses methods like strategic communication, relationship building, news management and positioning.
This document provides an overview of propaganda, including its definition, types, characteristics, and techniques. It defines propaganda as the planned use of communication to influence groups for a specific purpose. There are three main types: overt vs covert based on transparency, and white, grey, and black based on the perceived source. Key characteristics include the use of selective information, examination of intentions, and appeals to emotion over intellect. Common mediums are television, radio, print, and now the internet. Seven key techniques are also discussed: name-calling, glittering generalities, euphemisms, transfer, testimonials, plain folks appeal, and bandwagon effect.
This is a 20-minute lecture covering points to consider when building value proposition unique to medical technology. It begins with a brief review of issues related to market adoption for medical technology and the hurdles that a medical technology innovator may encounter when taking a product to market. You will learn about the 7 key factors that would boost market fit.
http://semoegy.com
This document discusses pharmacovigilance and the role of consumers in reporting adverse drug reactions (ADRs) in India. It outlines how India established a pharmacovigilance program to monitor ADRs. Underreporting of ADRs by healthcare professionals is a limitation, so consumer reporting can help detect more ADRs earlier, especially for over-the-counter drugs. India has launched forms and a mobile app to facilitate consumer ADR reporting to strengthen pharmacovigilance. While consumer reporting cannot replace healthcare professional reporting, it can complement it.
Making Key Decisions in New Product Planning When “Perfect” Information is No...Anthony Russell
Presentation given at New Product Planning Summit 2021.
Learning Objectives:
* Review the types of decisions typically made in New Product Planning
* Discuss the nature of information available to support decision-making in New Product Planning
* Review the impact and context of decision-making in New Product Planning
* Review potential approaches to assist in New Product Planning decision-making
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
The document outlines the roles and responsibilities of sponsors according to ICH-GCP guidelines. It discusses that sponsors are responsible for initiating, managing, financing, and monitoring clinical trials. They must ensure trials are conducted according to GCP standards, applicable regulations, and the approved protocol. Sponsors are also responsible for safety monitoring, reporting adverse events, quality assurance, selecting and compensating investigators, and maintaining required trial documentation.
This annotated compendium of evaluation planning guides can help you understand the basics of conducting an evaluation; learn how to create a logic model and indicators; understand evaluation terminology; develop performance management metrics; and evaluate your research, knowledge translation and commercialization activities, outputs and outcomes.
Propaganda is designed to influence and manipulate audiences through the selective presentation of information. It aims to change emotions, behaviors, and attitudes. While propaganda was negatively associated with wartime uses, it can also be employed in positive ways like promoting health and safety issues. Examples of propaganda techniques include name calling, testimonials from famous people, appealing to common values, encouraging bandwagon behavior, manipulating information, and transfers that help audiences envision themselves.
What is a patient registry?
In it’s simplest form, a registry is a list of all patients in a physician’s practice who share some characteristic, such as gender, age group, or disease state. By tracking like characteristics, physicians can better organize patient’s care.
Introduction to Argus Product Tab Screen in Pharmacovigilance or Drug Safety of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
This document discusses how the healthcare system is shifting from a claims-centric model to a more patient-centric one. It notes that the aging population and increasing diversity are driving changes in healthcare. Currently, healthcare is ineffective and inefficient at influencing consumer behavior. However, applying traditional marketing approaches focused on research can help employers, insurers, pharmacies, and providers be more successful. The system is becoming more complex and segmented, requiring different approaches for different groups. A successful transition depends on empowering consumers with information and tools to take control of their healthcare.
The document discusses key opinion leader (KOL) identification and selection for pharmaceutical companies. It outlines regulatory guidance requiring transparency in KOL relationships and selection criteria based on medical expertise. The document proposes that citation analysis is an effective method for determining a scientist's influence and peer esteem, as shown by Thomson Reuters' success in predicting Nobel Prize winners based primarily on citations. It provides methods for identifying KOLs based on a company's business needs, such as publication count for new markets or citation analysis for established markets. The document recommends aligning KOLs with development stages, using both established leaders and rising stars.
FDA Regulation of Advertising and Promotion -- the BasicsMichael Swit
Presentation to the November 9-10, 2017 Course sponsored by ComplianceOnline, in Boston, MA, focusing on the basics of FDA regulation of drug and device advertising.
Argus Screen Shots General Tab - Katalyst HLSKatalyst HLS
Introduction to Argus Screen Shots General Tab - Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
All about Clinical Trials_Katalyst HLSKatalyst HLS
Introduction to All about Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to ICSR Workflow and Management in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
UCSF Life Sciences: Week 7 Devices Resources, Activities and CostsStanford University
This document discusses critical resources, activities, and costs for medical device startups. It identifies physical, intangible, human, and financial resources needed. Key activities include generating data through clinical trials to demonstrate safety and efficacy, obtaining FDA regulatory approval, and achieving reimbursement. Costs include fixed costs like capital and overhead as well as variable costs during revenue generation. Unit economics and metrics like cash to milestones are important measures. Intellectual property is also a core asset that requires careful development and protection to support commercialization efforts.
TSDP emphasizes on understanding client’s requirements for drafting proposals for preparation of medico-marketing documents. To know more about medical writing training, visit: http://turacozskilldevelopment.org/
Spies during the Cold War tried to gain information through surveillance, recruiting foreign sources, and tapping communications. They would write reports on the information obtained and send it back to their headquarters to be analyzed. At the time, this information was beneficial for the United States because it helped the country understand and prepare for tensions with the Soviet Union without openly fighting. The information could inform military plans in the event of a war.
Decades ago, Peter Drucker was invited to address the senior management team at General Motors, he asked them a simple, but penetrating question: “Why should I buy a GM car?”
Many senior executives attempted to answer that simple question but, nobody was able to give a convincing answer! The senior managers at General Motors had unlearnt the art of winning customers by not being able to answer the simple question - “Why should I buy a GM car?” But they kept introducing more and more new models which less and less customers bought. And that was the prelude to GM’s decline and bankruptcy.
That question still resonates for every business including Indian Pharma. I wonder how many field sales people - Medical Reps and their managers can answer the question - Why Should the Doctor Rx Your Product? Having a clear answer to that question is the key to winning customers - be they doctors, chemists, distributors or hospitals.
As companies grow larger, hierarchies are created and sales processes like CRM/SFA evolve and become embedded. In the absence of a dynamic top leadership, hierarchy and processes become rigid and difficult to change even though rapidly changing market dynamics demand that they do. Bureaucracy slows down customer-centric decision making and inaction becomes part of the organisation's culture. The emphasis shifts from developing employees and winning customers to launching products and hitting numbers.
Peter Drucker rarely blamed individuals; he saw root causes in the design of organizations—in their structures, processes, norms, and routines. He would ask leaders a few provocative questions: “What is your mission? What should you stop doing? Where has the drive for short-term efficiencies undermined long-term effectiveness? What should be your objectives and guiding principles?”
Real-World Evidence: The Future of Data Generation and UsageApril Bright
As data is captured through electronic health records, registries and unique device identifiers, the generation of evidence based on this data is expected to play a crucial role in informing orthopedic manufacturers’ decisions before and after regulatory approval. While regulators, payors, hospitals and manufacturers support this shift, they acknowledge that gaps remain in its optimal execution. Priority considerations include how to generate evidence to expedite regulatory market decisions, device indication expansion, postmarket studies, postmarket surveillance and reimbursement decisions. The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), is leading the conversation with various stakeholders, including FDA and orthopedic device companies to support the sustainable generation of Real-World Evidence (RWE) using Real-World Data (RWD).
The document discusses collaboration between patient advocacy organizations for rare cancers in Canada. It summarizes discussions from a panel on empowering patients which included representatives from Myeloma Canada, GIST Sarcoma Life Raft Group Canada, and the Canadian Organization for Rare Disorders. The panel addressed issues for rare cancers around definitions, impact vs attention and research, screening, access to specialists, regulatory challenges, treatment pathways, and opportunities for the rare cancers community to work together.
Is there patient involvement in HTA? Can patients influence HTA decision making?Kathi Apostolidis
Is HTA purely technical?
drivers for patient involvement in HTA
patient participation or tokenism
medicines do not reach patients due to delays in HTA evaluation
need for harmonized HTA
This document provides an overview of propaganda, including its definition, types, characteristics, and techniques. It defines propaganda as the planned use of communication to influence groups for a specific purpose. There are three main types: overt vs covert based on transparency, and white, grey, and black based on the perceived source. Key characteristics include the use of selective information, examination of intentions, and appeals to emotion over intellect. Common mediums are television, radio, print, and now the internet. Seven key techniques are also discussed: name-calling, glittering generalities, euphemisms, transfer, testimonials, plain folks appeal, and bandwagon effect.
This is a 20-minute lecture covering points to consider when building value proposition unique to medical technology. It begins with a brief review of issues related to market adoption for medical technology and the hurdles that a medical technology innovator may encounter when taking a product to market. You will learn about the 7 key factors that would boost market fit.
http://semoegy.com
This document discusses pharmacovigilance and the role of consumers in reporting adverse drug reactions (ADRs) in India. It outlines how India established a pharmacovigilance program to monitor ADRs. Underreporting of ADRs by healthcare professionals is a limitation, so consumer reporting can help detect more ADRs earlier, especially for over-the-counter drugs. India has launched forms and a mobile app to facilitate consumer ADR reporting to strengthen pharmacovigilance. While consumer reporting cannot replace healthcare professional reporting, it can complement it.
Making Key Decisions in New Product Planning When “Perfect” Information is No...Anthony Russell
Presentation given at New Product Planning Summit 2021.
Learning Objectives:
* Review the types of decisions typically made in New Product Planning
* Discuss the nature of information available to support decision-making in New Product Planning
* Review the impact and context of decision-making in New Product Planning
* Review potential approaches to assist in New Product Planning decision-making
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
The document outlines the roles and responsibilities of sponsors according to ICH-GCP guidelines. It discusses that sponsors are responsible for initiating, managing, financing, and monitoring clinical trials. They must ensure trials are conducted according to GCP standards, applicable regulations, and the approved protocol. Sponsors are also responsible for safety monitoring, reporting adverse events, quality assurance, selecting and compensating investigators, and maintaining required trial documentation.
This annotated compendium of evaluation planning guides can help you understand the basics of conducting an evaluation; learn how to create a logic model and indicators; understand evaluation terminology; develop performance management metrics; and evaluate your research, knowledge translation and commercialization activities, outputs and outcomes.
Propaganda is designed to influence and manipulate audiences through the selective presentation of information. It aims to change emotions, behaviors, and attitudes. While propaganda was negatively associated with wartime uses, it can also be employed in positive ways like promoting health and safety issues. Examples of propaganda techniques include name calling, testimonials from famous people, appealing to common values, encouraging bandwagon behavior, manipulating information, and transfers that help audiences envision themselves.
What is a patient registry?
In it’s simplest form, a registry is a list of all patients in a physician’s practice who share some characteristic, such as gender, age group, or disease state. By tracking like characteristics, physicians can better organize patient’s care.
Introduction to Argus Product Tab Screen in Pharmacovigilance or Drug Safety of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
This document discusses how the healthcare system is shifting from a claims-centric model to a more patient-centric one. It notes that the aging population and increasing diversity are driving changes in healthcare. Currently, healthcare is ineffective and inefficient at influencing consumer behavior. However, applying traditional marketing approaches focused on research can help employers, insurers, pharmacies, and providers be more successful. The system is becoming more complex and segmented, requiring different approaches for different groups. A successful transition depends on empowering consumers with information and tools to take control of their healthcare.
The document discusses key opinion leader (KOL) identification and selection for pharmaceutical companies. It outlines regulatory guidance requiring transparency in KOL relationships and selection criteria based on medical expertise. The document proposes that citation analysis is an effective method for determining a scientist's influence and peer esteem, as shown by Thomson Reuters' success in predicting Nobel Prize winners based primarily on citations. It provides methods for identifying KOLs based on a company's business needs, such as publication count for new markets or citation analysis for established markets. The document recommends aligning KOLs with development stages, using both established leaders and rising stars.
FDA Regulation of Advertising and Promotion -- the BasicsMichael Swit
Presentation to the November 9-10, 2017 Course sponsored by ComplianceOnline, in Boston, MA, focusing on the basics of FDA regulation of drug and device advertising.
Argus Screen Shots General Tab - Katalyst HLSKatalyst HLS
Introduction to Argus Screen Shots General Tab - Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
All about Clinical Trials_Katalyst HLSKatalyst HLS
Introduction to All about Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to ICSR Workflow and Management in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
UCSF Life Sciences: Week 7 Devices Resources, Activities and CostsStanford University
This document discusses critical resources, activities, and costs for medical device startups. It identifies physical, intangible, human, and financial resources needed. Key activities include generating data through clinical trials to demonstrate safety and efficacy, obtaining FDA regulatory approval, and achieving reimbursement. Costs include fixed costs like capital and overhead as well as variable costs during revenue generation. Unit economics and metrics like cash to milestones are important measures. Intellectual property is also a core asset that requires careful development and protection to support commercialization efforts.
TSDP emphasizes on understanding client’s requirements for drafting proposals for preparation of medico-marketing documents. To know more about medical writing training, visit: http://turacozskilldevelopment.org/
Spies during the Cold War tried to gain information through surveillance, recruiting foreign sources, and tapping communications. They would write reports on the information obtained and send it back to their headquarters to be analyzed. At the time, this information was beneficial for the United States because it helped the country understand and prepare for tensions with the Soviet Union without openly fighting. The information could inform military plans in the event of a war.
Decades ago, Peter Drucker was invited to address the senior management team at General Motors, he asked them a simple, but penetrating question: “Why should I buy a GM car?”
Many senior executives attempted to answer that simple question but, nobody was able to give a convincing answer! The senior managers at General Motors had unlearnt the art of winning customers by not being able to answer the simple question - “Why should I buy a GM car?” But they kept introducing more and more new models which less and less customers bought. And that was the prelude to GM’s decline and bankruptcy.
That question still resonates for every business including Indian Pharma. I wonder how many field sales people - Medical Reps and their managers can answer the question - Why Should the Doctor Rx Your Product? Having a clear answer to that question is the key to winning customers - be they doctors, chemists, distributors or hospitals.
As companies grow larger, hierarchies are created and sales processes like CRM/SFA evolve and become embedded. In the absence of a dynamic top leadership, hierarchy and processes become rigid and difficult to change even though rapidly changing market dynamics demand that they do. Bureaucracy slows down customer-centric decision making and inaction becomes part of the organisation's culture. The emphasis shifts from developing employees and winning customers to launching products and hitting numbers.
Peter Drucker rarely blamed individuals; he saw root causes in the design of organizations—in their structures, processes, norms, and routines. He would ask leaders a few provocative questions: “What is your mission? What should you stop doing? Where has the drive for short-term efficiencies undermined long-term effectiveness? What should be your objectives and guiding principles?”
Real-World Evidence: The Future of Data Generation and UsageApril Bright
As data is captured through electronic health records, registries and unique device identifiers, the generation of evidence based on this data is expected to play a crucial role in informing orthopedic manufacturers’ decisions before and after regulatory approval. While regulators, payors, hospitals and manufacturers support this shift, they acknowledge that gaps remain in its optimal execution. Priority considerations include how to generate evidence to expedite regulatory market decisions, device indication expansion, postmarket studies, postmarket surveillance and reimbursement decisions. The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), is leading the conversation with various stakeholders, including FDA and orthopedic device companies to support the sustainable generation of Real-World Evidence (RWE) using Real-World Data (RWD).
The document discusses collaboration between patient advocacy organizations for rare cancers in Canada. It summarizes discussions from a panel on empowering patients which included representatives from Myeloma Canada, GIST Sarcoma Life Raft Group Canada, and the Canadian Organization for Rare Disorders. The panel addressed issues for rare cancers around definitions, impact vs attention and research, screening, access to specialists, regulatory challenges, treatment pathways, and opportunities for the rare cancers community to work together.
Is there patient involvement in HTA? Can patients influence HTA decision making?Kathi Apostolidis
Is HTA purely technical?
drivers for patient involvement in HTA
patient participation or tokenism
medicines do not reach patients due to delays in HTA evaluation
need for harmonized HTA
The Patient Values Project aims to better define, measure, and incorporate patient preferences into the cancer drug approval process in Canada. It involves a 3-phase approach: 1) Developing and administering a patient preferences survey; 2) Identifying metrics to measure values from survey data; 3) Generating a quantitative weight for patient values to be included in submissions to pCODR expert committees. The project seeks to empower patient groups to provide more objective, research-based input and allow for a more balanced assessment of new cancer drugs. It could ultimately help improve reimbursement decisions and be applied to other disease sites.
This document provides an agenda for the 5th Annual Advocacy conference on July 14-15, 2016 in Baltimore, MD. The conference will focus on strengthening relationships between patient advocacy organizations and the pharmaceutical industry through effective communication and collaboration. Distinguished speakers from various pharmaceutical companies and patient advocacy groups will discuss topics such as measuring the success of advocacy relationships, engaging patients beyond treatment, and ensuring compliant collaborations. The agenda includes keynote speeches, case studies, panels, workshops, and networking activities designed to advance patient advocacy and define patient-centric approaches.
The document discusses the evolving role of patient advocacy groups in orphan drug development. It notes that historical barriers to orphan drug research included limited funding, lack of researcher interest, and few patient groups. The 1983 Orphan Drug Act and similar European regulations aimed to incentivize orphan drug development by providing tax credits, reduced fees, and extended market exclusivity for sponsors. Both the FDA and EMA have increasingly engaged with patient groups over the past few decades. Industry and patient groups both seek collaboration to advance research, though their needs differ. Frameworks like the EFPIA and CTTI guidelines provide recommendations for transparent and ethical partnerships between stakeholders.
> Patient engagement
> Patient advocacy groups
> Patient focused drug development
> Patient reported outcomes
> Patient centric clinical trials
> Patient preference studies
> Make patients as partners in research
> Institutionalised involvement - NICE, EMA, US-FDA
> Indian perspective
> Drivers for involving patients
The document discusses patient involvement in pharmaceutical research and development. It describes the European Patients' Academy project, which aims to build patient and public competencies and facilitate their involvement in research. The findings of a qualitative study on pharmaceutical industry professionals' beliefs are presented. While most believed patients should be involved, there were few concrete plans and uncertainty around how to operationalize involvement. Challenges included patients' research knowledge and distrust of industry. Facilitators included increased transparency and revised codes of practice. The discussion focuses on lessons to be learned across public and private research and recommendations for meaningful patient involvement.
Patient-centered pharmacovigilance represents a pivotal shift in the landscape of healthcare, emphasizing the active involvement of patients in the monitoring and reporting of adverse drug reactions. Unlike traditional pharmacovigilance, which primarily relies on healthcare professionals to identify and document adverse events, this approach recognizes patients as critical stakeholders in ensuring medication safety. By empowering patients to share their experiences, concerns, and observations regarding medication effects, whether positive or negative, healthcare systems can gain a comprehensive understanding of drug safety and efficacy in real-world settings. Patient-centered pharmacovigilance fosters a collaborative partnership between patients, healthcare providers, and regulatory agencies, promoting transparency, accountability, and ultimately, better patient outcomes. Through increased patient engagement and the utilization of patient-reported data, this approach enables healthcare systems to identify potential safety issues earlier, tailor treatment strategies to individual needs, and enhance overall drug safety surveillance efforts.
Pharmaceutical marketing aims to educate consumers and healthcare professionals about new treatments. While some question the value of marketing, it plays an important role in disseminating medical information. Recent changes include voluntary principles for direct-to-consumer ads and a strengthened industry code of ethics. Studies show marketing helps address underdiagnosis and undertreatment by raising disease awareness and prompting patients to see doctors. However, most physicians say clinical knowledge and patient needs strongly influence prescribing over marketing.
Pharmaceutical marketing to healthcare providers provides information on new treatment options, but it is only one of many factors that influence prescribing decisions. Surveys find clinical knowledge, patient factors, and insurance policies have greater impacts. Approximately 67% of US prescriptions are for generic drugs, much higher than other countries. While representatives provide information, prescribing is shaped more by clinical guidelines, peers, formularies, and insurers' prior authorization requirements than representative interactions.
Measuring the Relationship between Innovative Drugs and AE_2015Jonathan Bryan
This study used logistic regression to analyze the relationship between drug innovation classes and reported adverse events. It utilized a previous study's classification of 645 drugs from 1987-2011 into first-in-class, advanced-in-class, or addition-to-class based on FDA review designations. Adverse event data was obtained from FAERS reports from 2004-2014. The results found that total adverse events per drug followed a power law distribution, with most drugs having few events but some outliers with many. Logistic regression found a weak relationship between adverse events and innovation classes, except for more advanced-in-class drugs having higher lifetime adverse event totals. This highlights the need for more systematic drug outcome data to develop better models of drug
What’s Next in US Payor Communications: The Impact of FDA's Proposed Guidance...Nathan White, CPC
The recent enactment of the 21st Century Cures Act has profound immediate and long-term implications for development and communication of HEOR/RWE in the US, particularly in relation to communications with payors about healthcare economic information (HCEI). In January, the FDA released draft guidance for public comment to outline its thinking around communication to payors of HCEI, but there are still unanswered questions to be addressed in the final guidance. Industry will need to quickly establish new policies and procedures to maintain compliance with the new regulations, especially in relation to OPDP submission requirements – a steep transition from a space that has largely been unregulated.
Drug information centre resources@clinical pharmacy 4th pharm DDrpradeepthi
This document discusses drug information centers (DICs), including their establishment, personnel requirements, activities, challenges, and strategies to overcome challenges. It also discusses the role of pharmacists in DICs. DICs provide drug information to healthcare professionals and the public to promote safe and rational drug use. They require trained staff, resources, and standard operating procedures. Establishing DICs in hospitals can improve patient outcomes. Challenges include lack of awareness, funding, and trained professionals. Collaboration between healthcare groups can help address challenges and expand DIC services.
dic resources.pptx in pharmacoepidemiologyDrpradeepthi
This document discusses drug information centers (DICs), including their establishment, personnel requirements, activities, challenges, and strategies to overcome challenges. It also discusses the role of pharmacists in DICs. DICs provide drug information to healthcare professionals and the public to promote safe and rational drug use. They require trained staff, resources, and standard operating procedures. Establishing DICs in hospitals can improve patient outcomes. Challenges include lack of awareness, funding, and trained professionals. Collaboration between healthcare groups can help address challenges and expand DIC services.
Direct To Consumer Advertising Of Prescription Drugs Pharmaceutical Industryjinender16
The pharmaceutical industry views direct-to-consumer (DTC) drug advertising positively as it can educate patients, foster competition, and increase communication between patients and doctors. However, critics argue that DTC advertising leads to overuse of prescription drugs, increased drug prices, and can interfere with the physician-patient relationship. The Pharmaceutical Research and Manufacturers of America (PhRMA) works to advocate for policies supported by their industry and has established guiding principles for responsible DTC advertising.
The document summarizes feedback from experts on the Canadian government's discussion guide for a national strategy on drugs for rare diseases.
Key critiques included that the proposed vision and principles were vague and meaningless, and that the four strategic pillars lacked specificity and commitment to concrete actions and goals. Experts argued the strategy needs bolder commitments to rapid access to the best treatments comparable to other countries. They also said data collection efforts should build on existing systems rather than propose new ones, and that assessing "value for money" could undermine the goal of optimal patient outcomes if not grounded in patient-centered principles.
This document discusses the Orphan Drug Act and rare disease policies. It provides background on the US Orphan Drug Act of 1983, which aims to facilitate rare disease drug development by providing incentives. Key points include that the Act defines rare diseases as affecting fewer than 200,000 people, and has led to over 450 approved orphan drugs. However, the document notes that rare disease policies and the Orphan Drug Act are not the same. It advocates for India to enact its own rare disease policies and definitions to improve diagnosis, treatment and research. The Organization for Rare Diseases India is working towards this goal.
Polypharmacy resource_JAN 15_NINA BARNETTZeshan Ahmed
This document provides resources to support the management of polypharmacy and deprescribing. It begins with an overview of key terms such as polypharmacy, oligopharmacy, and deprescribing. It then discusses the increase in polypharmacy among older adults and some of the risks associated with inappropriate polypharmacy. The document is structured to provide background information on polypharmacy, tools and initiatives to support practice, and references. It aims to assist healthcare professionals with medication reviews and decisions around deprescribing for patients taking multiple medications.
This document summarizes a presentation given by David Lin from Novartis Oncology on drug purchasing and pricing from the pharmaceutical industry perspective. The presentation covers:
- The growing demand for healthcare and new treatments putting pressure on pricing and access
- Malaysia's national medicine policy and efforts to improve access to medicines through affordability
- Factors considered in pharmaceutical pricing like production costs, reference pricing to other countries, and balancing access and sustainability
- Efforts by industry like access programs to help patients gain early access to innovative treatments
- The changing treatment landscape with new cellular and personalized therapies requiring new frameworks for evaluation and pricing assessment.
Patients’ priorities in assessing organisational aspects of a general dental ...Axex Dental
This study aimed to identify the organizational aspects of dental practices that are most important to patients in the Netherlands. Researchers developed a questionnaire with 41 organizational aspects and distributed it to 5,000 dental patients. The response rate was 63%. Six aspects were identified as most important by at least 50% of respondents: accessibility by telephone, continuing education for dentists, Dutch-speaking dentists, in-office waiting times, information about treatments offered, and waiting lists. Patients' preferences for some of these aspects varied based on their age and education level. The findings can help dental practices provide information focused on the aspects patients value most when choosing a provider.
This document provides an overview of key trends in the generic pharmaceutical industry in South Africa, as reported by the National Association of Pharmaceutical Manufacturers. It discusses challenges facing generic medicine suppliers, including prescriber and consumer perceptions, intellectual property issues, regulatory delays, and pricing factors. It also summarizes the chairman's comments on recent generic market growth trends and provides details on guidelines proposed for biosimilar medicines.
Consumer health: time for a regulatory re-think? is a report by RB in association with PAGB, written by the Economist Intelligence Unit. It looks at the changing healthcare environment and the role self-care plays and efforts at regulatory harmonisation, the barriers they have encountered, and prospects for the future.
This document analyzes reporting of adverse drug reactions (ADRs) by pharmacists in the Pharmacovigilance Programme of India (PvPI) between July 2011 and December 2014. It finds that of 110,000 reports in the database, 16,646 (15%) were reported by pharmacists. Of these, 3,782 (22.7%) were serious reactions while 9,601 (57.7%) were non-serious. Reporting by pharmacists has increased over time. The document concludes that pharmacists can play an important role in pharmacovigilance by detecting, reporting, and assessing ADRs.
Similar to The Powerful and Evolving Role ofPatient Advocacy Groups in Orphan Drug Development (20)
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.