A Community Advisory Board (CAB) is a group of patients who offer their expertise to advise sponsors of clinical research. CABs can advise on overall program development, individual trials, and other aspects beyond research. The same CAB can advise multiple sponsors in the same disease area. This avoids patients being selected by any single sponsor. The CAB agenda and secretariat are driven by patients. CABs provide value by shortening development timelines, improving trial design, and increasing quality and transparency. They can advise on topics like informed consent documents, educational materials, and providing overall feedback on trial protocols. EURORDIS supports establishing CABs and can act as a backend office to help match patients and sponsors.
The document provides guidance and templates for joint working between the NHS and pharmaceutical companies, outlining best practices for developing agreements, projects, and measurements that benefit both parties through open collaboration while prioritizing patient outcomes. Key points include defining joint working and distinguishing it from other types of partnerships, emphasizing transparency and preventing inducement to prescribe certain drugs.
The issue of open-source models in the cost-effectiveness and disease-level (collaborative) models has been brewing for many years. There has been a marked growth in open science, and funding bodies and publishers increasingly require that research data be made available. As mentioned in our previous Issue Panel, “cost-effectiveness models synthesise a wide range of evidence to facilitate extrapolation over time and from intermediate to final decision endpoints. These models are often statistically sophisticated and require assumptions that are not directly testable. This can lead to decision-makers “discounting” the results of cost-effectiveness analyses, particularly if the developer is seen as partial.” Open-source models, then, would encourage greater transparency in pharmacoeconomic modeling and the reuse and updating of the best/most useful models; they are essential if cost-effectiveness analyses are to be widely accepted to reduce bias, increase transparency, improve model access, and allow for faster access to critical knowledge. The ISPOR-SMDM guidelines and the EUnetHTA joint action projects, are supportive of these views on collaboration, transparency, confidentiality, processes and consistency offered by the availability of open-source models to improve decision-making around health care and reimbursement. With openness and sharing, however, come issues of copyright and access and a need to define how model sharing can be achieved in a fair and equitable manner. There is, therefore, a need to develop an ongoing dialog on openness, especially where the research may be considered precompetitive and not worthy of IP investment. The pros and cons of open source models and the proposed mission of the Open Source Model SIG to curate an ongoing dialog regarding issues around creating, disseminating, sharing, evaluating, and updating open source cost-effectiveness and comparative effectiveness models will be debated amongst SIG members.
Author(s) and affiliation(s): Nancy Risebrough, Senior Principal, ICON plc, Toronto, Canada Jeroen P Jansen; Innovation & Value Initiative; Precision Medicine Group; and Stanford University Lotte Steuten, Vice President & Head of Consulting, Office of Health Economics, UK Renée JG Arnold, PharmD, RPh, ICON plc, New York, NY and Icahn School of Medicine at Mount Sinai, New York, NY, USA
Event: ISPOR 2019 Annual Meeting
Date: 20/05/2019
EUPATI guidances for interaction between Patient organisations and other stak...EUPATI
David Haerry
Increasing patient involvment
EUPATI guidances for interaction between Patient organisations and other stakeholders in medicines development
The document discusses a presentation on the Joint Clinical Assessment (JCA) process under the European HTA Regulation and how it may impact patient experience and involvement in HTA.
It begins with an introduction to the JCA process and an overview of a presentation by Sophie Werkö from the Swedish Agency for Health Technology Assessment on their experiences with JCA. It then discusses challenges and opportunities for patient involvement in JCA, including timely involvement, defining PICOs, and ensuring input from both European and national level patient groups.
Finally, it provides an overview of EUCAPA and HTA4Patients, two projects aimed at training and building capacity for patient representatives to participate in European HTA processes like JCA
Presentation by Rachel Holloway, Department for Business, Energy, & Industrial Strategy, United Kingdom, at the RIA workshop which took place in Lima on 22-24 May 2017. Further information is available at www.oecd.org/gov/regulatory-policy/.
The document summarizes an expert panel discussion on EFPIA transparency and physician consent management. The panel will discuss practical experiences implementing transparency solutions, legal risks in consent management, and the impact of transparency on stakeholders. They will also cover upcoming regulation changes and expected consent rates. The panel will address manufacturer reporting, consent collection, physician engagement, report production, and policies/procedures. They will discuss the impact on business practices, physician-manufacturer relationships, industry associations, and the public. The panel will provide recommendations to improve consent collection and address risks of paper-based processes and lack of revocation options.
Having a Prosperous New Year with Your CRO: The Gift of a Great Contract!mwright1
The document discusses key considerations for clinical trial contracts between sponsors and contract research organizations (CROs). It notes that:
1) The CRO industry is large and growing, taking on more of the research and development expenditures of pharmaceutical companies. Contracts must carefully define responsibilities to ensure expectations are met.
2) Data ownership, security, and management are important issues to address. Sponsors will want ownership and control over trial data specific to their drug or device.
3) Confidentiality is paramount, as intellectual property is highly valuable in the life sciences industry. Contracts must specify what information is confidential and how it will be protected.
A Community Advisory Board (CAB) is a group of patients who offer their expertise to advise sponsors of clinical research. CABs can advise on overall program development, individual trials, and other aspects beyond research. The same CAB can advise multiple sponsors in the same disease area. This avoids patients being selected by any single sponsor. The CAB agenda and secretariat are driven by patients. CABs provide value by shortening development timelines, improving trial design, and increasing quality and transparency. They can advise on topics like informed consent documents, educational materials, and providing overall feedback on trial protocols. EURORDIS supports establishing CABs and can act as a backend office to help match patients and sponsors.
The document provides guidance and templates for joint working between the NHS and pharmaceutical companies, outlining best practices for developing agreements, projects, and measurements that benefit both parties through open collaboration while prioritizing patient outcomes. Key points include defining joint working and distinguishing it from other types of partnerships, emphasizing transparency and preventing inducement to prescribe certain drugs.
The issue of open-source models in the cost-effectiveness and disease-level (collaborative) models has been brewing for many years. There has been a marked growth in open science, and funding bodies and publishers increasingly require that research data be made available. As mentioned in our previous Issue Panel, “cost-effectiveness models synthesise a wide range of evidence to facilitate extrapolation over time and from intermediate to final decision endpoints. These models are often statistically sophisticated and require assumptions that are not directly testable. This can lead to decision-makers “discounting” the results of cost-effectiveness analyses, particularly if the developer is seen as partial.” Open-source models, then, would encourage greater transparency in pharmacoeconomic modeling and the reuse and updating of the best/most useful models; they are essential if cost-effectiveness analyses are to be widely accepted to reduce bias, increase transparency, improve model access, and allow for faster access to critical knowledge. The ISPOR-SMDM guidelines and the EUnetHTA joint action projects, are supportive of these views on collaboration, transparency, confidentiality, processes and consistency offered by the availability of open-source models to improve decision-making around health care and reimbursement. With openness and sharing, however, come issues of copyright and access and a need to define how model sharing can be achieved in a fair and equitable manner. There is, therefore, a need to develop an ongoing dialog on openness, especially where the research may be considered precompetitive and not worthy of IP investment. The pros and cons of open source models and the proposed mission of the Open Source Model SIG to curate an ongoing dialog regarding issues around creating, disseminating, sharing, evaluating, and updating open source cost-effectiveness and comparative effectiveness models will be debated amongst SIG members.
Author(s) and affiliation(s): Nancy Risebrough, Senior Principal, ICON plc, Toronto, Canada Jeroen P Jansen; Innovation & Value Initiative; Precision Medicine Group; and Stanford University Lotte Steuten, Vice President & Head of Consulting, Office of Health Economics, UK Renée JG Arnold, PharmD, RPh, ICON plc, New York, NY and Icahn School of Medicine at Mount Sinai, New York, NY, USA
Event: ISPOR 2019 Annual Meeting
Date: 20/05/2019
EUPATI guidances for interaction between Patient organisations and other stak...EUPATI
David Haerry
Increasing patient involvment
EUPATI guidances for interaction between Patient organisations and other stakeholders in medicines development
The document discusses a presentation on the Joint Clinical Assessment (JCA) process under the European HTA Regulation and how it may impact patient experience and involvement in HTA.
It begins with an introduction to the JCA process and an overview of a presentation by Sophie Werkö from the Swedish Agency for Health Technology Assessment on their experiences with JCA. It then discusses challenges and opportunities for patient involvement in JCA, including timely involvement, defining PICOs, and ensuring input from both European and national level patient groups.
Finally, it provides an overview of EUCAPA and HTA4Patients, two projects aimed at training and building capacity for patient representatives to participate in European HTA processes like JCA
Presentation by Rachel Holloway, Department for Business, Energy, & Industrial Strategy, United Kingdom, at the RIA workshop which took place in Lima on 22-24 May 2017. Further information is available at www.oecd.org/gov/regulatory-policy/.
The document summarizes an expert panel discussion on EFPIA transparency and physician consent management. The panel will discuss practical experiences implementing transparency solutions, legal risks in consent management, and the impact of transparency on stakeholders. They will also cover upcoming regulation changes and expected consent rates. The panel will address manufacturer reporting, consent collection, physician engagement, report production, and policies/procedures. They will discuss the impact on business practices, physician-manufacturer relationships, industry associations, and the public. The panel will provide recommendations to improve consent collection and address risks of paper-based processes and lack of revocation options.
Having a Prosperous New Year with Your CRO: The Gift of a Great Contract!mwright1
The document discusses key considerations for clinical trial contracts between sponsors and contract research organizations (CROs). It notes that:
1) The CRO industry is large and growing, taking on more of the research and development expenditures of pharmaceutical companies. Contracts must carefully define responsibilities to ensure expectations are met.
2) Data ownership, security, and management are important issues to address. Sponsors will want ownership and control over trial data specific to their drug or device.
3) Confidentiality is paramount, as intellectual property is highly valuable in the life sciences industry. Contracts must specify what information is confidential and how it will be protected.
This document provides a summary of a 942-page report on dermatology partnering terms and agreements from 2007 to 2012. The report details trends in big pharmaceutical company dealmaking in dermatology, including deal structures, financial terms, and over 1,500 links to actual deals and contracts. It analyzes headline values, upfront payments, milestone payments, and royalty rates by development stage. The report is intended to help readers understand and access trends in dermatology partnering and dealmaking.
International regulatory cooperation: more important than everTGA Australia
The presentation was given by the TGA at the 2014 ARCS Scientific Congress, and covers the importance and future of international regulatory cooperation
FIDIC produces various documents, contract forms, guides and manuals to assist parties involved in infrastructure projects. These publications help establish standards for consulting engineers and their clients. The document proposes five 2-day workshops covering topics like applying FIDIC contracts, claims management, contract management, using dispute boards, and writing and responding to claims. Each workshop would provide an in-depth look at its topic.
Developing strategies for contract adherence in medical devices cro contractsErik Vollebregt
This presentation was delivered at the Outsourcing in Clinical Trials: Medical Devices Europe 2016 conference in München on 17 February 2016. It covers do's and don'ts for CRO contracts in the medical devices sector.
Association consulting business outlineTAKESHI HONDA
This document introduces an association consulting business that supports business alliance activities between companies. The principal consultant has experience in business development and legal compliance at large pharmaceutical companies. Consulting services include building business schemes for alliances, financial analysis and contract valuation, preparing legal documents like NDAs and term sheets, developing negotiation strategies, and joining negotiations. The consulting process supports all stages from planning through contract execution. Trends show alliances shifting from capital-based models like M&A to non-capital models like licensing and joint research. Example cases presented are a pharmaceutical licensing alliance and joint R&D alliance between a research institute and pharmaceutical company. In summary, the association offers full-service support for clients' business alliance processes and negotiations.
Association consulting business outlineTAKESHI HONDA
This document introduces an association consulting business that supports business alliance activities between companies. The principal consultant has experience in business development and legal compliance at large pharmaceutical companies. Consulting services include building business schemes for alliances, financial analysis and contract valuation, preparing legal documents like NDAs and term sheets, developing negotiation tactics and strategies, and joining negotiations with business partners. The consulting process supports all stages from initial planning through contract execution. Major business alliances are shifting from capital-based models like M&A and JVs to non-capital models like licensing, OEM agreements, and joint research. Example cases discussed are a licensing alliance in pharmaceuticals and a joint R&D alliance between a research institute and pharmaceutical company.
The document discusses the growing importance of demonstrating value through evidence for biotech companies when engaging with payers. It outlines how health technology assessments and real-world evidence are being used by payers globally to determine coverage, reimbursement, and contracting. Additionally, it explores emerging innovative contracting models between payers and manufacturers that are shifting focus to outcomes over utilization and sharing risk.
The document discusses the growing importance of demonstrating value through evidence for biotech companies when engaging with payers. It outlines how health technology assessments and real-world evidence are being used by payers globally to determine coverage, reimbursement, and contracting. Additionally, it explores emerging innovative contracting models between payers and manufacturers that are shifting focus to outcomes over utilization and sharing risk.
This document provides a summary of a report on cross-sector partnerships in healthcare. It finds that partnerships have great potential to drive innovation and improve quality and productivity compared to traditional contracts. However, the recent UK procurement review focused mainly on goods procurement rather than service partnerships. It provides tips for successful partnerships, including having a shared long-term vision, taking time for early discussions, understanding each partner's culture, openly addressing risks and rewards, and ensuring commercial skills at the board and management levels.
A very important result from the EUPATI project was the development, broad consultation and final release of guidances on the best approach to interaction of patients with pharmaceutical industry-led medicines R&D, regulatory authorities, ethics committees and HTA agencies. This webinar focuses on the Patient Involvement in Industry-led R&D guidance document
In December 2014 the Higher Education Funding Council for England (HEFCE) published, ‘Sustainable development in higher education - HEFCE’s role to date and a framework for its future actions’, outlining some of the ways higher education can contribute to sustainable development. The document included a framework for HEFCE’s support for the sector, whilst encompassing their earlier policy statements on sustainable development and carbon reduction. This will also have a bearing on future funding.
Key points from the document:
Protecting and enhancing quality of life for current and future generations is central to sustainable development. There are social, environmental and economic dimensions to this, and the benefits and the challenges are considerable.
Higher education is working to address these challenges from a unique position in society. Its institutions can play a substantial role through teaching and research, through influence on staff and students, through business operations, and through the sustainability of their campuses. We want sustainable development to be central to higher education.
In 2010, HEFCE, Universities UK and GuildHE demonstrated co-leadership by publishing carbon reduction targets for higher education in England. These targets were based on extensive research and wide consultation. The overall sector target is reduction of Scope 1 and 2 carbon emissions by 34 per cent by 2020 and 80 per cent by 2050, against a 1990 baseline.
The higher education sector has demonstrated strong commitment to these targets, with each higher education institution producing a carbon management plans which move the sector substantially towards the afore mentioned targets. Research published by HEFCE in 2010 showed that for the 45 universities with data for both years, emissions per full-time equivalent student were on average 39 per cent lower in 2005 than in 1990.
Institutions have risen to the challenge of reducing environmental impacts by setting themselves stretching targets for carbon reduction. They have made significant investments and altered their ways of working, monitoring their progress with increasingly sophisticated systems whilst disseminating good practice and helping institutions learn from each other.
Although these achievements are creditable, more needs to be done if the sector’s contribution to internationally agreed target carbon reductions is to be achieved.
Sustainable Education provided the platform for discussion and dissemination of good practice whilst also highlighting the tools and systems in place to ensure your institution adheres to carbon reduction targets and becomes economically and environmentally sustainable.
A life sciences consulting firm based in Chicago, Aagami Inc., offers strategic consulting, technology licensing, and business/market research services to support global biotech, pharmaceutical, medical device, and consumer health companies in their initiatives with India and Asia. The document provides details on Aagami's services, approach, clients, leadership team, and case studies highlighting strategic partnerships and licensing deals facilitated by Aagami that helped clients establish partnerships and reduce costs in emerging markets.
Common Protocol Template (CPT) Initiative - Implementation Toolkit Executive ...TransCelerate
The document provides an executive summary of the Common Protocol Template (CPT) developed by TransCelerate BioPharma Inc. The CPT aims to streamline clinical trial protocols by standardizing format, content and terminology. This is intended to improve quality, reduce costs and complexity for sponsors, investigators, regulators and patients. The summary outlines the vision/mission of TransCelerate, the rationale for developing a common template, its near term and potential future benefits for stakeholders, guidance principles, and alignment of the CPT with the NIH-FDA clinical trial protocol template.
Collaborative medicinal chemistry research between AstraZeneca and external partners aims to build more open innovation organizations. AstraZeneca shares examples of compound collection collaborations and a case study of collaborating in real time on a design-make-test-analyze project. Challenges include defining roles and managing processes, but tools like ChemTraX help enable real-time collaboration. AstraZeneca's open innovation platform provides opportunities for target innovation and new molecule profiling to further external partnerships.
Karen Livingstone - ECO 17: Transforming care through digital healthInnovation Agency
The document discusses the Innovation Exchange and SBRI Healthcare programs which aim to accelerate the development and adoption of innovative healthcare solutions in England. It provides background on Karen Livingstone, the director of the programs. It then outlines key forces shaping global healthcare and describes the 15 Academic Health Science Networks that work locally and nationally to drive innovation adoption across England. The rest of the document details how the Innovation Exchange identifies healthcare needs and supports companies through funding competitions, needs assessments, and providing support to help ready solutions for adoption across the NHS. It provides examples of companies it has supported in areas like patient engagement, chronic condition management, and early disease detection.
The document provides an overview of innovation management and collaboration strategies. It discusses the advantages and disadvantages of collaborating versus going solo. Different forms of collaboration are examined, including strategic alliances, joint ventures, licensing, outsourcing, and collective research organizations. Choosing and monitoring partners is also addressed, highlighting the importance of partner selection, contracts, and governance to collaboration success. Key factors for collaborative failure are outlined.
This document provides an overview of medical writing, including:
- Defining medical writing as applying clinical research principles to develop documents that clearly describe research results and medical information.
- Outlining the different types of medical writing such as regulatory, educational, and publication/presentation.
- Explaining that medical writing emerged in the pharmaceutical industry to produce well-structured documents that present complex clinical trial information clearly.
- Detailing the skills required for medical writing like domain knowledge, statistics, writing ability, and understanding guidelines.
All patients are different, and data collected during product development or Randomised Clinical Trials (RCT) does not always paint the full picture of everyday patients. RWE insights complement the manufacturing process and RCT findings, adding more value and providing real-world impact. While together data from the manufacturing process and RWD paint a fuller picture.
Due to the limitations of the study design, data from the manufacturing process and RCTs are inadequate for demonstrating an intervention’s long-term safety and effectiveness. Moreover, it is possible to compare multiple product or interventions in RWE.
The document discusses innovation with commercial electronic health records (EHRs) at Partners HealthCare. It describes Partners HealthCare's structure and approach to innovation, which includes advancing core work and creating new solutions. The clinician team focuses on areas like clinical process redesign, clinical informatics, and knowledge management. Guiding principles for fostering innovation emphasize supporting innovators, prioritizing innovations aligned with Partners' strategy, and disseminating innovations across Partners HealthCare. A prioritization framework is being created to evaluate innovative projects according to standard criteria.
Les Schumers Presentation Pcehr Nsw Health Update 23 June 2011nstanzer
The document discusses the consultation process for the Personally Controlled Electronic Health Record (PCEHR) system in Australia. It outlines the various working groups providing input, including consumer and clinical reference forums. It then summarizes some of the key design elements that have been informed by this input, such as voluntary participation, consumer control of provider access, and health information only containing copies not originals.
Don't just talk about patient centricity - put meaningful patient engagement ...jangeissler
"Don't just talk about patient centricity - put meaningful patient engagement into the design of your cancer research", presented by Jan Geissler at Meet2Win on 7/5/2021
More Related Content
Similar to Reasonable Legal Agreements between Patient Advocates and Pharma Companies
This document provides a summary of a 942-page report on dermatology partnering terms and agreements from 2007 to 2012. The report details trends in big pharmaceutical company dealmaking in dermatology, including deal structures, financial terms, and over 1,500 links to actual deals and contracts. It analyzes headline values, upfront payments, milestone payments, and royalty rates by development stage. The report is intended to help readers understand and access trends in dermatology partnering and dealmaking.
International regulatory cooperation: more important than everTGA Australia
The presentation was given by the TGA at the 2014 ARCS Scientific Congress, and covers the importance and future of international regulatory cooperation
FIDIC produces various documents, contract forms, guides and manuals to assist parties involved in infrastructure projects. These publications help establish standards for consulting engineers and their clients. The document proposes five 2-day workshops covering topics like applying FIDIC contracts, claims management, contract management, using dispute boards, and writing and responding to claims. Each workshop would provide an in-depth look at its topic.
Developing strategies for contract adherence in medical devices cro contractsErik Vollebregt
This presentation was delivered at the Outsourcing in Clinical Trials: Medical Devices Europe 2016 conference in München on 17 February 2016. It covers do's and don'ts for CRO contracts in the medical devices sector.
Association consulting business outlineTAKESHI HONDA
This document introduces an association consulting business that supports business alliance activities between companies. The principal consultant has experience in business development and legal compliance at large pharmaceutical companies. Consulting services include building business schemes for alliances, financial analysis and contract valuation, preparing legal documents like NDAs and term sheets, developing negotiation strategies, and joining negotiations. The consulting process supports all stages from planning through contract execution. Trends show alliances shifting from capital-based models like M&A to non-capital models like licensing and joint research. Example cases presented are a pharmaceutical licensing alliance and joint R&D alliance between a research institute and pharmaceutical company. In summary, the association offers full-service support for clients' business alliance processes and negotiations.
Association consulting business outlineTAKESHI HONDA
This document introduces an association consulting business that supports business alliance activities between companies. The principal consultant has experience in business development and legal compliance at large pharmaceutical companies. Consulting services include building business schemes for alliances, financial analysis and contract valuation, preparing legal documents like NDAs and term sheets, developing negotiation tactics and strategies, and joining negotiations with business partners. The consulting process supports all stages from initial planning through contract execution. Major business alliances are shifting from capital-based models like M&A and JVs to non-capital models like licensing, OEM agreements, and joint research. Example cases discussed are a licensing alliance in pharmaceuticals and a joint R&D alliance between a research institute and pharmaceutical company.
The document discusses the growing importance of demonstrating value through evidence for biotech companies when engaging with payers. It outlines how health technology assessments and real-world evidence are being used by payers globally to determine coverage, reimbursement, and contracting. Additionally, it explores emerging innovative contracting models between payers and manufacturers that are shifting focus to outcomes over utilization and sharing risk.
The document discusses the growing importance of demonstrating value through evidence for biotech companies when engaging with payers. It outlines how health technology assessments and real-world evidence are being used by payers globally to determine coverage, reimbursement, and contracting. Additionally, it explores emerging innovative contracting models between payers and manufacturers that are shifting focus to outcomes over utilization and sharing risk.
This document provides a summary of a report on cross-sector partnerships in healthcare. It finds that partnerships have great potential to drive innovation and improve quality and productivity compared to traditional contracts. However, the recent UK procurement review focused mainly on goods procurement rather than service partnerships. It provides tips for successful partnerships, including having a shared long-term vision, taking time for early discussions, understanding each partner's culture, openly addressing risks and rewards, and ensuring commercial skills at the board and management levels.
A very important result from the EUPATI project was the development, broad consultation and final release of guidances on the best approach to interaction of patients with pharmaceutical industry-led medicines R&D, regulatory authorities, ethics committees and HTA agencies. This webinar focuses on the Patient Involvement in Industry-led R&D guidance document
In December 2014 the Higher Education Funding Council for England (HEFCE) published, ‘Sustainable development in higher education - HEFCE’s role to date and a framework for its future actions’, outlining some of the ways higher education can contribute to sustainable development. The document included a framework for HEFCE’s support for the sector, whilst encompassing their earlier policy statements on sustainable development and carbon reduction. This will also have a bearing on future funding.
Key points from the document:
Protecting and enhancing quality of life for current and future generations is central to sustainable development. There are social, environmental and economic dimensions to this, and the benefits and the challenges are considerable.
Higher education is working to address these challenges from a unique position in society. Its institutions can play a substantial role through teaching and research, through influence on staff and students, through business operations, and through the sustainability of their campuses. We want sustainable development to be central to higher education.
In 2010, HEFCE, Universities UK and GuildHE demonstrated co-leadership by publishing carbon reduction targets for higher education in England. These targets were based on extensive research and wide consultation. The overall sector target is reduction of Scope 1 and 2 carbon emissions by 34 per cent by 2020 and 80 per cent by 2050, against a 1990 baseline.
The higher education sector has demonstrated strong commitment to these targets, with each higher education institution producing a carbon management plans which move the sector substantially towards the afore mentioned targets. Research published by HEFCE in 2010 showed that for the 45 universities with data for both years, emissions per full-time equivalent student were on average 39 per cent lower in 2005 than in 1990.
Institutions have risen to the challenge of reducing environmental impacts by setting themselves stretching targets for carbon reduction. They have made significant investments and altered their ways of working, monitoring their progress with increasingly sophisticated systems whilst disseminating good practice and helping institutions learn from each other.
Although these achievements are creditable, more needs to be done if the sector’s contribution to internationally agreed target carbon reductions is to be achieved.
Sustainable Education provided the platform for discussion and dissemination of good practice whilst also highlighting the tools and systems in place to ensure your institution adheres to carbon reduction targets and becomes economically and environmentally sustainable.
A life sciences consulting firm based in Chicago, Aagami Inc., offers strategic consulting, technology licensing, and business/market research services to support global biotech, pharmaceutical, medical device, and consumer health companies in their initiatives with India and Asia. The document provides details on Aagami's services, approach, clients, leadership team, and case studies highlighting strategic partnerships and licensing deals facilitated by Aagami that helped clients establish partnerships and reduce costs in emerging markets.
Common Protocol Template (CPT) Initiative - Implementation Toolkit Executive ...TransCelerate
The document provides an executive summary of the Common Protocol Template (CPT) developed by TransCelerate BioPharma Inc. The CPT aims to streamline clinical trial protocols by standardizing format, content and terminology. This is intended to improve quality, reduce costs and complexity for sponsors, investigators, regulators and patients. The summary outlines the vision/mission of TransCelerate, the rationale for developing a common template, its near term and potential future benefits for stakeholders, guidance principles, and alignment of the CPT with the NIH-FDA clinical trial protocol template.
Collaborative medicinal chemistry research between AstraZeneca and external partners aims to build more open innovation organizations. AstraZeneca shares examples of compound collection collaborations and a case study of collaborating in real time on a design-make-test-analyze project. Challenges include defining roles and managing processes, but tools like ChemTraX help enable real-time collaboration. AstraZeneca's open innovation platform provides opportunities for target innovation and new molecule profiling to further external partnerships.
Karen Livingstone - ECO 17: Transforming care through digital healthInnovation Agency
The document discusses the Innovation Exchange and SBRI Healthcare programs which aim to accelerate the development and adoption of innovative healthcare solutions in England. It provides background on Karen Livingstone, the director of the programs. It then outlines key forces shaping global healthcare and describes the 15 Academic Health Science Networks that work locally and nationally to drive innovation adoption across England. The rest of the document details how the Innovation Exchange identifies healthcare needs and supports companies through funding competitions, needs assessments, and providing support to help ready solutions for adoption across the NHS. It provides examples of companies it has supported in areas like patient engagement, chronic condition management, and early disease detection.
The document provides an overview of innovation management and collaboration strategies. It discusses the advantages and disadvantages of collaborating versus going solo. Different forms of collaboration are examined, including strategic alliances, joint ventures, licensing, outsourcing, and collective research organizations. Choosing and monitoring partners is also addressed, highlighting the importance of partner selection, contracts, and governance to collaboration success. Key factors for collaborative failure are outlined.
This document provides an overview of medical writing, including:
- Defining medical writing as applying clinical research principles to develop documents that clearly describe research results and medical information.
- Outlining the different types of medical writing such as regulatory, educational, and publication/presentation.
- Explaining that medical writing emerged in the pharmaceutical industry to produce well-structured documents that present complex clinical trial information clearly.
- Detailing the skills required for medical writing like domain knowledge, statistics, writing ability, and understanding guidelines.
All patients are different, and data collected during product development or Randomised Clinical Trials (RCT) does not always paint the full picture of everyday patients. RWE insights complement the manufacturing process and RCT findings, adding more value and providing real-world impact. While together data from the manufacturing process and RWD paint a fuller picture.
Due to the limitations of the study design, data from the manufacturing process and RCTs are inadequate for demonstrating an intervention’s long-term safety and effectiveness. Moreover, it is possible to compare multiple product or interventions in RWE.
The document discusses innovation with commercial electronic health records (EHRs) at Partners HealthCare. It describes Partners HealthCare's structure and approach to innovation, which includes advancing core work and creating new solutions. The clinician team focuses on areas like clinical process redesign, clinical informatics, and knowledge management. Guiding principles for fostering innovation emphasize supporting innovators, prioritizing innovations aligned with Partners' strategy, and disseminating innovations across Partners HealthCare. A prioritization framework is being created to evaluate innovative projects according to standard criteria.
Les Schumers Presentation Pcehr Nsw Health Update 23 June 2011nstanzer
The document discusses the consultation process for the Personally Controlled Electronic Health Record (PCEHR) system in Australia. It outlines the various working groups providing input, including consumer and clinical reference forums. It then summarizes some of the key design elements that have been informed by this input, such as voluntary participation, consumer control of provider access, and health information only containing copies not originals.
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Here are some key objectives of communication with children:
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Enable children to articulate their thoughts, feelings, and experiences.
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Help children identify and understand their own emotions and the emotions of others.
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Develop children’s ability to listen attentively and respond appropriately.
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Acknowledge and encourage positive actions and behaviors.
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Reasonable Legal Agreements between Patient Advocates and Pharma Companies
1. Corporate Compliance & Transparency in the Pharmaceutical Industry
Zurich, 21 Feb 2019
Jan Geissler, WECAN
Workshop on reasonable legal
agreements between patient
advocates and pharmaceutical
companies
2. Objectives of this session
• Provide patient perspective on the challenges of
legal agreements between patient advocates and
pharmaceutical companies
• Give an update on WECAN‘s „Reasonable Legal
Agreements“ collaboration project
• Give an introduction to our Guiding Principles
• Introduce the concept of template contracts
• Making you work!
3. What patient advocates do
Support patients
Inform, support, provide navigation to patients
Run services and meetings, provide tools and apps
Patient-centric policy
Influence health policy and healthcare provisioning
Provide input to regulators and institutions
Research reflecting patients's needs
Provide patients needs to academic and industry
research
Participate in publicly funded projects
4. Why the reasonable legal agreements
project?
• Collaboration between pharma and patient advocates
requires them to sign contracts, e.g. speaker agreements,
advisory agreements, consultancy or collaboration contracts
• The contracts are often too long and difficult to understand,
unilateral, disproportionate, and contain ambiguous clauses or
terms that are in conflict with the nature of patient advocacy.
They may even put the patient advocate at legal risk
• WECAN, the Workgroup of 22 pan-European Cancer Patient
Advocacy Networks wanted to change this and initiated this
project in 2016, based on data from a survey
5. Main issues identified in major survey
to over 80 patient advocates in 2016
• The contracts provided to patient advocates are often too long and are
difficult to understand
• 81% said all contracts are unreasonably extensive in length (6 pages or
more, 19% even said they usually get contracts with more than 10
pages)
• Patient advocates invest on average 295 minutes (almost 5 hours) into
reading negotiating and processing each contract
How much
time (in
minutes) do
you usually
invest for
each
agreement?
36 7 10 15 220
0 50 100 150 200 250 300
Minutes
Reading Printing Scanning Sending Negotiating
Source: WECAN survey “Reasonable agreements between patient advocacy and the pharmaceutical industry”, WECAN (2016)
6. 54% of patient advocates only understand
some, few or none of the contracts they
receive
Almost all of then
Some
Few
None
Always
Sometimes
Rarely
Never
11,11%
36,51%
34.92%
17,46%
If you tried to change unreasonable
clauses, did the companies agree to
change these clauses to your satisfaction?
~20% rarely or never read all legal
agreements in detail before signing
because:
● no legal support,
● no time to check contracts,
● trusting pharmaceutical companies,
● other reasons such as the length of
the contract, or the confusing terms
used
Source: WECAN survey “Reasonable agreements between patient advocacy and the pharmaceutical industry”, WECAN (2016)
Main issues identified in major survey
to over 80 patient advocates in 2016
7. The contracts provided to patient advocates contain ambiguous clauses or
terms that are in conflict with the very nature of patient advocacy.
Source: WECAN survey “Reasonable agreements between patient advocacy and the pharmaceutical industry”, WECAN (2016)
Main issues identified in major survey
to over 80 patient advocates in 2016
• Litigation will ruin the organization or
individual if ever executed
• Losing the rights on your own ideas and
contributions
• Time invested in work not fairly reflected
• Confidentiality of non-sensitive work blocks
important patient advocacy work
• Unfair travel conditions for busy patient
advocates and for frail individuals
• Unlimited use of photos, quotes and
recordings put credibility at risk
8. Overall objectives and goals
of the project
• Improve balance between parties by establishing contracts
• Allowing patient organisations to operate in their role and purpose
while protecting the pharmaceutical companies from reasonable risk
• Incorporate patient organisation’s capacity, legal expertise and
experience on potential consequences in legal contracts
• Better reflect the diversity of relationships in consultancy, advisory,
speaker and collaborative roles, which are usually totally different to
classical consultancy
• Provide guiding principles for reasonable legal agreements
• Provide template contracts with simplified terms and language
• Prevent from unnecessary clauses (that create unnecessary
uncertainty)
Objective
Our goal
9. Who is involved?
Drafting group
Multi-stakeholder Alignment Workgroup (MSAW)
Legal experts 3 pharmaceutical companies’
representatives
Ananda Plate (MPE,
project lead)
Ana Vallejo (MPE)
Šarunas Narbutas (POLA)
Gordon Oliver (IBTA)
Jan Geissler (CMLAN)
Kathy Oliver (IBTA)
• Nicholas Brooke (PFMD) • Jean-Francois Germain
(Fieldfisher)
• Imma Barral (University of
Barcelona)
Andrea Herrmann
(Takeda)
Jordane Fura Cosse
(Novartis) – now replaced
by Gregor von Arx
Virginie Vassart (Merck
MSD)
10. Guiding Principles
• After several rounds of multi-stakeholder consultation, the
“Guiding Principles on reasonable agreements between patient
advocates and pharma companies” are finalised, based on
feedback from advocates and company representatives.
• Contract types: Covered topics:
• Consultancy agreement
• Collaboration agreement
• Advisory Board agreement
• Speaker agreement
• Confidentiality
• Intellectual property
• Recordings of meetings
• Data protection and use of personal
data
• Indemnification, remedies and conflict
resolution
• Financial Compensation and
reimbursements of expenses
• Adverse event reporting
• Independence and conflict of interest
• Glossary
11. Structure and sections of
Guiding Principles
All sections have 3 parts:
1. Rationale
2. Examples
3. Guiding principles
Guiding Principles document finalized on
16 Oct 2018, ratified by WECAN on 21 Oct
2018 and PFMD on 25 Oct 2018
For download at
http://www.wecanadvocate.eu/rapp
For download: www.wecanadvocates.eu/rapp
12. Templates for
- Advisory Agreement
- Consultancy Agreement
- Speaker Agreement
- Collaboration Agreement
currently under development
Soon for download at
http://www.wecanadvocate.eu/ra
pp
13. Status and next steps
2017-
2018:
Drafting
work
15 Oct
2018:
End of
multi-
stakeholder
consultatio
n
21 Oct
2018:
WECAN
meeting:
approval of
guiding
principles,
advocacy
strategy
25 Oct
2018:
PFMD
Board
Meeting
5 Nov 2018:
Publication of
guiding
principles,
communicati
on
29 Oct-9
Nov:
Collection
of “best
contracts”
from
workgroup
members
10 Nov
2018:
Start of
template
and
toolbox
develop
ment
January
2019:
First
contract
template
finalised
June
2019:
toolbox
finalised
Advocacy for & adoption of guiding
principles
14. Group exercise
• Make sure you have the following documents:
• Copy of the legal agreement for a speaker at a
meeting organized by a pharma company
• Copy of the emails sent between the company
and the advocate
• Guiding Principles on Legal Agreements
between industry and advocates
• Choose a clause from the speaker agreement on
which you will work (clauses 2-9). There needs to be
at least one person allocated per clause!
Exercise:
1. Each table builds a team and chooses a rapporteur (1 minute)
2. Choose one clause from the speaker agreement on which you will work (5 minutes)
3. Look for “your clause” in the Guiding Principles document and read the rationale,
examples and principles (5 minutes)
4. Make notes of the changes you would request if you were a patient advocate and the
reason why you would want those changes (10 minutes)
5. Make notes of the changes you would accept if you were industry (5 minutes)
6. Make notes of the changes you would not accept and the reason why you wouldn’t (5 min)
7. Each table to report back & discuss (20 min)
17. Confidentiality
Rationale Examples Guiding Principles
• Protect sensitive information of
both contractual parties
Take into account that
• company representatives may
forget to label confidential
• patient advocates’ core task is
spreading information and
knowledge
• Commercially sensitive
information about products or
services
• Strategic plans, project plans,
concepts or processes
• Unpublished scientific data of
either contractual party
• Planned campaigns or policy
actions
• Personal data, patient data
• Provide definition of confidential
information
• Have consent on disclosure of
confidential information
• Provide justification for
requesting confidentiality
• Ensure labelling of
confidentiality level of information,
define status of unlabeled
information
• Agree that public information is
no longer confidential
• Ensure deletion of confidential
information
• Acknowledge that legal
requirements and disclosure
obligations may override
confidentiality
18. Intellectual property (IP)
Rationale Examples Guiding Principles
• IP protects creations of the
mind, which have both a moral
and a commercial value
• IP gives both parties the
opportunity to further develop
ideas and concepts brought in
and generated in such meetings,
either jointly or separately, and
also with competing
organisations
• IP allows to exploit the results
of work in products, initiatives
and services
• IP rules ensure information,
projects and work owned by a
party prior to the collaboration
remains their property
• Most content or results of a
meeting are not commercially
sensitive
• Consultancy work: Advice
provided on company documents,
strategic initiatives and other
commercially sensitive projects.
• Collaborative work: Jointly
developed concepts and servies,
e.g. reports, advice, workshop
agendas, patient information
materials
• Presentations, projects,
concepts, documents presented
at a meeting
• Third-party material: Illustrations
or slides of third parties in the
meeting
• Logos of organisations or
companies.
• Applicable law may prescribe
definition of IP terms
• IP on consultancy or collaborative
work on specific company
products should belong to the
company
• IP resulting from collaborative
work unrelated to a specific
product of the company should
be agreed on a case-by-case
basis
• Authorship rules apply for
publications
• Background IP remains with the
owner
• Rights of third-party material
need to be clear and cannot be
transferred
• Use of logos requires written
consent
19. Recordings of meetings
Rationale Examples Guiding Principles
• Recordings of the meeting and of
individual participants are made
for the purposes of compiling
minutes or a report of the meeting
• These may be produced for
• internal use
• external use
• Minutes, documents, quotes,
photos or audio-visual
recordings in joint meetings
• Summary of meeting outcomes
and concepts
• Presentations held by
participants of the meeting
• Agree about use of recordings
prior to meeting.
• Without agreement, internal use
of recordings only is a given.
• Any external use requires prior
consent.
20. Data protection and use of personal data
Rationale Examples Guiding Principles
• Personal data of patients or
patient advocates needs to be
protected in order to avoid any
misuse of the information
• Protecting patients’ medical
condition from becoming known
in the public domain
• Protecting the credibility of a
patient advocate in the public
• Ensuring all external data are
used for limited, specifically
stated purposes, and in a way
that is adequate, relevant and not
excessive
• Ensures data are kept for no
longer than is absolutely
necessary
• Personal data: information
related with an identifiable person
(e.g. name, age, position,
address, affiliation with
organisations, medical condition,
or other personal details)
• Third parties data: data acquired
from another source, confidential
or public
• Use in quotes, internal or external
reports, websites, campaigns,
social medica channels, offline
media
• Personal data is confidential by
default
• Agree on good reasons for data
disclosure
• Allow sharing of data with
affiliates and involved service
providers
• Respect right to withdraw
consent
• Data protection rules should
comply with applicable privacy
laws
• Ensure data protection also in
countries with lower privacy
standards
21. Indemnification, remedies, conflict resolution
Rationale Examples Guiding Principles
• Indemnification clauses seek the
financial responsibility for
specific types of damages,
claims or losses
• Remedies or liability clauses
should take into account that their
execution in a dispute would
certainly ruin a patient advocate
or organisation
• It is very unlikely that any
pharma company will ever
make use of such an
indemnification or liability clause
• Patient advocates usually don't
have sufficient resources and
capabilities to have an
international liability insurance
• Misconduct or violation of any
clause, which can include
disclosure of confidential
information
• Failure to deliver on the contract
• Misuse of the information
received, or any other kind of
conduct that is considered as a
major breach of contract
• No case is yet known where
liability cases were ever filed by a
pharmaceutical company against
a patient organisation on the
basis of a collaboration
agreement between such parties.
• Limit liability to a reasonable
level
• Do not require liability
insurance
• Define terms for mediation
• Applicable law of defendant
should apply
22. Financial compensation and
reimbursement of expenses
Rationale Examples Guiding Principles
• Patient advocates deserve a
reasonable financial
compensation for their time
and contribution when acting
in advisory roles, consultancy,
speaking roles or other
collaborative work
• Financial compensation is
offered in exchange for
contributing with time, ideas
or other means by patient
advocates
• Financial contribution is
based on a company and
expertise-related “fair market
value” and subject to local
laws and regulations
• Contribution to a meeting,
conference, advisory board or
committee organised by the
company itself or by a third
party.
• Reviewing materials, leaflets,
protocols, guides, recordings,
concepts, etc. and providing
feedback on those.
• Consultancy work on
products or services of the
company.
• Develop materials together
with pharmaceutical
companies e.g. patient
information.
• Compensate according to fair market
value, taking into account e.g.
individual expertise and training, total
amount of time invested, complexity of
tasks, country of origin, similar to other
highly trained professionals
• Reflect total time invested, incl.
physical presence and preparatory time.
Consider also part of travel time.
• Respect the right to refuse
compensation
• Cover reasonable travel expenses
• Long-distance flights justify higher flight
class
• Reasonable 3-way travel costs on
advocacy duty should be covered
• Multi-day stopover on advocacy duty
should be permitted
• Pay within 30 days
23. Adverse event reporting
Rationale Examples Guiding Principles
• Regulatory provisions require
pharmaceutical companies and its
employees and contractors to
report adverse events through
its pharmacovigilance
department to regulators
• Legal agreements from
pharmaceutical companies often
require consultants to notify the
company in writing of any
adverse event occurring
relating to company’s products
• Due to the nature of an
independent advisory/speaker/
consultancy role and the
organisational structure of POs,
these obligations are
impossible for patient
advocates to fulfil
• "The Consultant will inform the
company within twenty-four (24)
hours of becoming aware of any
adverse event".
• "The Consultant will cooperate
with the company to enable the
company to comply with
applicable laws and regulations."
• Company remains responsible
for adverse event reporting
• An agreement between
pharmaceutical companies and
patient advocates should not
require the patient advocates to
do adverse event reporting, or it
should be limited strictly to the
adverse events detected within
the collaborative work
24. Independence and Conflict of Interest
Rationale Examples Guiding Principles
• Patient advocates promote the
interest of their constituencies,
usually patients and carers, and
the broader patient community.
• Patient advocates and
pharmaceutical companies may
have similar interests regarding
topics that can affect patients'
lives in areas such as research,
treatment, care and access.
• Interactions between patient
advocates and pharmaceutical
companies shall be done in a way
that ensures that the decision -
making of the patient advocate
side is respected and not
influenced by the
pharmaceutical company.
• Any incentive or reward of any
type that would influence the
decision making, the opinion or
statements a patient advocate
could do about any drug or
diagnostic tool, among others.
• Respect the independence and
autonomy of patient advocate
• Safeguard the independence of
patient advocates by avoiding
conflicts of interests and
declaring potential conflicts of
interest
• Avoid exclusivity clauses
• Refer to applicable Codes and
Guidelines