IDSC is an interdisciplinary group of 40 ex-pharma leaders averaging 25-years of big-pharma, biotech, and academic experience. Our clients come to us for drug discovery and drug development interim leadership, consulting, fully integrated collaborations, due diligence, molecular modeling, and outsourcing management. Because we are a fully integrated drug discovery, preclinical development, and clinical development partner, we help our biotech, VC, academic, and pharma clients get from early discovery to IND filing and through phase I clinical trials in all major therapeutic areas and on to NDA in antibacterials, CNS, and oncology.
IDSC Expertise Capabilities Services Short 10 slides V5 Modified for PDF 2014...Mark Creswell
IDSC is an interdisciplinary group of over 55 former pharmaceutical leaders with expertise in drug discovery and development from small molecules and biologics to medical devices. They provide consulting, project management, and integrated collaboration services across therapeutic areas from hit identification to clinical trials. IDSC's clients include biotech, pharma, academia, and venture capital seeking expertise in discovery, preclinical and clinical development to advance their programs.
Idsc Expertise Capabilities Services Short 10 Slides 2013 10-09Mark Creswell
IDSC provides drug discovery,preclinical development, clinical development, and outsourcing expertise to assist clients in delivering innovative medicines to the clinic & market faster, while minimizing attrition. We are an interdisciplinary group of 40 ex-pharma leaders averaging 25 years of big pharma experience. Our clients come to us for six main reasons: Drug discovery and development Interim leadership, consulting, fully integrated collaborations, due diligence, molecular modeling, and outsourcing management. Because we are a fully integrated drug discovery, preclinical development, and clinical development partner, we help our biotech, VC, academic, and pharma clients get from early discovery to IND filing and through phase I clinical trials in all major therapeutic areas and on to NDA in antibacterials, CNS, and oncology.
Additive Manufacturing: Industry Addresses Standards, Quality, Evidence Build...April Bright
The SME Medical Additive Manufacturing/3D Printing Workgroup collaborates to identify challenges, develop resources and facilitate changes to support anyone using the technologies for medical/biomedical applications. Ms. McDaniel shares the group's progress and the headwinds that remain with non-technology barriers to adoption.
FDA's 510(k) Modernization: What if Anything has Changed? Is Changing? Will C...Greenlight Guru
FDA caused quite a stir when it announced transformative changes to modernize its 510(k) program to improve the safety and effectiveness of medical devices.
But as we all know, the more things change, the more they stay the same. If you dive deep into FDA’s statement, you’ll realize that there’s probably not a lot that’s different.
In this session, Michael Drues, Ph.D., President of Vascular Sciences, will share what FDA's 510(k) Modernization means, any evidence that changes are happening, and what medical device manufactures need to know about 510k modernization.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
MedWize Solutions provides services across the drug development process including clinical operations, data management, regulatory affairs, medical writing, and safety to reduce costs and accelerate drug development. They partner with biopharmaceutical companies using innovative technologies and a pay-as-you-go model to improve success rates. Their vision is to provide an industry-leading platform for clinical research and development through data analytics and new technologies.
Nanobiz assisted a Fortune 500 medical device company in identifying potential Indian partners to help validate or co-develop a new point-of-care device. Nanobiz systematically identified Indian companies and researchers developing relevant technologies, gathered detailed information on their technologies, commercialization status and openness to collaboration. This study enabled the client to target specific candidates for product validation in India and build a database of prospective partners.
This document discusses challenges for inventors and investors in raising capital for medical device development. It outlines four levels of innovation risk from lowest to highest - marginal, technological, therapeutic, and radical. Radical innovation involving new technology and new clinical uses poses the highest uncertainty. The document also compares perspectives of inventors, who focus on developing products, and investors, who seek returns. Their differing goals can cause challenges in collaborating on ventures. Additional hurdles include regulatory requirements and changing markets and technologies.
IDSC Expertise Capabilities Services Short 10 slides V5 Modified for PDF 2014...Mark Creswell
IDSC is an interdisciplinary group of over 55 former pharmaceutical leaders with expertise in drug discovery and development from small molecules and biologics to medical devices. They provide consulting, project management, and integrated collaboration services across therapeutic areas from hit identification to clinical trials. IDSC's clients include biotech, pharma, academia, and venture capital seeking expertise in discovery, preclinical and clinical development to advance their programs.
Idsc Expertise Capabilities Services Short 10 Slides 2013 10-09Mark Creswell
IDSC provides drug discovery,preclinical development, clinical development, and outsourcing expertise to assist clients in delivering innovative medicines to the clinic & market faster, while minimizing attrition. We are an interdisciplinary group of 40 ex-pharma leaders averaging 25 years of big pharma experience. Our clients come to us for six main reasons: Drug discovery and development Interim leadership, consulting, fully integrated collaborations, due diligence, molecular modeling, and outsourcing management. Because we are a fully integrated drug discovery, preclinical development, and clinical development partner, we help our biotech, VC, academic, and pharma clients get from early discovery to IND filing and through phase I clinical trials in all major therapeutic areas and on to NDA in antibacterials, CNS, and oncology.
Additive Manufacturing: Industry Addresses Standards, Quality, Evidence Build...April Bright
The SME Medical Additive Manufacturing/3D Printing Workgroup collaborates to identify challenges, develop resources and facilitate changes to support anyone using the technologies for medical/biomedical applications. Ms. McDaniel shares the group's progress and the headwinds that remain with non-technology barriers to adoption.
FDA's 510(k) Modernization: What if Anything has Changed? Is Changing? Will C...Greenlight Guru
FDA caused quite a stir when it announced transformative changes to modernize its 510(k) program to improve the safety and effectiveness of medical devices.
But as we all know, the more things change, the more they stay the same. If you dive deep into FDA’s statement, you’ll realize that there’s probably not a lot that’s different.
In this session, Michael Drues, Ph.D., President of Vascular Sciences, will share what FDA's 510(k) Modernization means, any evidence that changes are happening, and what medical device manufactures need to know about 510k modernization.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
MedWize Solutions provides services across the drug development process including clinical operations, data management, regulatory affairs, medical writing, and safety to reduce costs and accelerate drug development. They partner with biopharmaceutical companies using innovative technologies and a pay-as-you-go model to improve success rates. Their vision is to provide an industry-leading platform for clinical research and development through data analytics and new technologies.
Nanobiz assisted a Fortune 500 medical device company in identifying potential Indian partners to help validate or co-develop a new point-of-care device. Nanobiz systematically identified Indian companies and researchers developing relevant technologies, gathered detailed information on their technologies, commercialization status and openness to collaboration. This study enabled the client to target specific candidates for product validation in India and build a database of prospective partners.
This document discusses challenges for inventors and investors in raising capital for medical device development. It outlines four levels of innovation risk from lowest to highest - marginal, technological, therapeutic, and radical. Radical innovation involving new technology and new clinical uses poses the highest uncertainty. The document also compares perspectives of inventors, who focus on developing products, and investors, who seek returns. Their differing goals can cause challenges in collaborating on ventures. Additional hurdles include regulatory requirements and changing markets and technologies.
The document provides an overview of the Avoca Quality Consortium, which was formed to develop best practices for proactive quality management of outsourced clinical trials. It discusses the state of the clinical trials industry that led to the Consortium's formation, including increased outsourcing and globalization. It then outlines the Consortium's approach, deliverables produced to date like Quality Agreements and metrics, and areas of ongoing focus such as guidelines for effective quality oversight and operationalizing proactive quality management. The overall goal is to improve quality and efficiency in clinical trials through collaboration and standardization.
http://MedicalDeviceEvents.com At the 10x Medical Device Conference in 2014, presenters Carrie Kuehn, Jorge Ochoa, and Robert Packard explained why, according to data from FDA, more than 58% of 510(k) submissions were refused under FDA’s Refuse to Accept (RTA) policy during its first year of implementation.
This presentation examined some of the reasons why industry got such a bad “grade.” We discussed the RTA requirements and some of the challenges from industry’s perspective on meeting the requirements of the RTA checklist and ended with recommendations on how industry can improve its odds of getting past the RTA hurdle on the first try.
This document provides an overview of the clinical trial services offered by inVentiv Health Clinical, including: Phase I-IIA services conducted in their dedicated clinical facility; Phase IIB-III services including biostatistics and project management; Late Stage services such as post-marketing studies and risk evaluation; strategic resourcing capabilities including functional service providers; bioanalytical laboratory services with over 1,000 validated assays; quality assurance auditing to ensure regulatory compliance; consulting expertise in areas such as regulatory services and clinical development; therapeutic expertise across key areas like oncology and neuroscience; and a global network of over 7,000 employees in 36 countries.
The document describes Aptuit INDiGO's accelerated drug development program. It offers integrated services to help clients advance molecules from candidate selection to clinical trials in as few as 52 weeks. This is significantly faster than the industry average of 122 weeks. Aptuit's program provides world-class expertise across preclinical and clinical development, API manufacturing, and regulatory submission preparation to streamline the process. It aims to reduce costs and development time while improving data quality for clients.
Avoca Group was founded in 1999 and has since established several programs and initiatives focused on improving relationships and quality in clinical outsourcing. Some key events include Avoca launching the first comprehensive Relationship Management Program for a CRO in 2004, developing a system for measuring key relationship indicators in 2000, and CEO Patricia Leuchten being named one of the most inspiring individuals in the life sciences industry in 2012.
Medvantage International has acquired rights to a new vascular coupling device called CUVASLAR that represents an alternative to manual suturing for connecting arteries and veins. The device is expected to reduce surgical time, minimize errors from suturing, and improve patient outcomes. Medvantage plans to submit the device for FDA approval over the next year and market it to the 340,000 microsurgery procedures performed annually in the US.
SMi Group's Prefilled Syringes East Coast 2018 conferenceDale Butler
This document summarizes a two-day conference on pre-filled syringes taking place in Boston on April 10-11, 2018. The conference will include two pre-conference workshops on human factors for connected drug delivery systems and design considerations for drug delivery outside the clinic. The main conference will focus on challenges and solutions for PFS manufacturing and processes, integrating quality by design principles, and trends toward increasing biologics and their implications for PFS. It will feature speakers from major pharmaceutical companies and include panel discussions on challenges of biologics delivery and PFS development.
Andwin Scientific specializes in Clinical Supplies and Equipment product manufacturing, sourcing, procurement, storage and distribution as a supplier to global life science organizations and a distributor to direct end using companies (including sites). This makes Andwin Scientific the only company that offers true consolidation for clinical studies by facilitating the purchase of products from various suppliers in one transaction.
Design Considerations to Maximize Medical Device Cloud ConnectivityGreenlight Guru
Medical device manufacturers are faced with a myriad of design decisions during product development. Several key decisions affecting market readiness must be addressed between bench-top prototypes and initiation of clinical trials. Among the most important are cloud connectivity considerations surrounding firmware, hardware, and use cases. The earlier cloud connectivity factors are identified, considered, and integrated into the design process, the more successful the resulting commercial roll-out in terms of cost, certification, and market acceptance.
• Key design factors medical device manufacturers should consider
• Advantages of considering connectivity early in the design process
• Practical use-case examples highlight more cost-effective clinical trials, wider market acceptance, and reduction in operational costs
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
The document describes TSRL Inc.'s Technology Accelerator program, which aims to help move therapeutic assets past the "Valley of Death" by providing infrastructure, scientific and business resources, and funding to drive projects from pre-clinical development to an Investigational New Drug application. The accelerator selects potential drug candidates based on criteria to maximize commercialization potential and provides services like project management, drug development expertise, and access to networks to help obtain funding and partners. The goal is to generate necessary data packages and commercialization plans to support projects reaching their next development milestones.
Orbis Clinical is a specialized consulting firm that provides drug safety, risk management, regulatory, and quality assurance services to pharmaceutical and biotechnology companies. It has experienced consultants with decades of expertise in these areas. Orbis uses a flexible engagement model to quickly respond to clients' needs with individual specialists or broad-based teams.
As an expert provider of a wide spectrum of clinical development support services, KCR has developed
a supreme Data Management (DM) solution geared towards full data transparency as well as
delivering the highest level of quality within the defined timelines and in adherence to study budgets,
all the while ensuring the meeting of all Good Clinical Practice (GCP) and ICH requirements. Read our DM brochure and learn more about KCR DM capabilities.
Supplier Quality Management: Best Practices and Practical Insights in 2015 LI...Thomas LaPointe
Supplier Quality Management (SQM) is becoming an important business practice as more companies are out-sourcing manufacturing, distribution, shipping, and sales across the globe. Aside from the implications of failure to comply with a myriad of regulations, failure of SQM can lead to litigation, added costs, and harmed reputation among other problems such as product adulteration and mis-branding. However, there is a trade-off between managing supplier quality and costs. As such, SQ managers need to be aware of the risks and benefits of the relationship with suppliers as a whole.
Our panel of key thought leaders and practitioners assembled by The Knowledge Group will discuss Supplier Quality Management and provide Best Practices and Practical Insights.
Key topics include:
Supplier Quality Management – Overview
Supplier Selection, Evaluation, and Monitoring
Supplier Quality Agreements and Contracts
Cost of Poor Supplier Quality (COPQ)
Quality Management Systems
Cost Recovery and Supplier Audit
Closed Loop Corrective Actions
Suppliers Quality Metrics
Supply Chain Pressures
To view the webcast go to this link: http://youtu.be/FhW15o2pfCw
To learn more about the webcast please visit our website: http://theknowledgegroup.org
Avoca Quality Consortium Associate Membership OverviewThe Avoca Group
The document summarizes initiatives for the 2015 Avoca Quality Consortium (AQC). Key initiatives include developing an online community portal for members, continuing work to establish prequalification standards for service providers, conducting research on quality management systems and protocol quality, and hosting educational webinars and annual meetings. The AQC aims to collaborate across the pharmaceutical and biotech industries to optimize approaches to proactive quality management.
This document discusses the application of ICH Q8 and Q10 principles to pharmaceutical product development and manufacturing. It begins with an example of a dissolution failure incident to highlight the importance of understanding products and processes. It then outlines tools and approaches like knowledge management and quality risk management that can be used from development through commercial manufacturing following ICH Q8 and Q10 guidelines. Finally, it provides a case study example of how these principles were applied to the development of the drug Saxagliptin.
Global Reach, Local Touch outlines factors for drug developers to consider when choosing a functional service provider (FSP) partner, including global reach, expertise that can scale up or down on demand, technology platform flexibility, and staff continuity. The document discusses two FSP models - the Clinical FSP model which provides resource flexibility and operational efficiency, and the Clinical Analytics model which consists of services such as clinical data management and biostatistics. It emphasizes that differentiation can be found in a provider's ability to seamlessly adapt to sophisticated clinical trial technology, retain talent that flexibly fits trial needs, and design effective staff onboarding transitions.
Companies in multiple industries have found that lean and agile methods speed up their product development while simultaneously improving quality and cutting costs. In spite of these proven advantages, these methods have not been widely adopted in the highly regulated medical device industry. Regulations and standards do not prevent the adoption of lean and agile methods but many companies’ quality systems do. Understanding these barriers and how to modify quality system procedures is key to more efficient medical device development and improved compliance.
If you had time for an open discussion with our MyRBQM® Academy instructors, what would you ask Johann, Jo, Linda, or Artem? In our monthly Ask the Expert webinars, we give you that chance. These webinars will focus on trending topics in the area of risk-based quality management (RBQM) - like remote and adaptive monitoring, centralized statistical monitoring, change management, predictive analytics... and more.
Besides a 20-minute Q&A session, our industry experts Jo Burmester and Dr Johann Proeve will dive into:
- How things might change while going forward post-COVID-19
- Statistical guidance for trials impacted by COVID-19
Learn more about MyRBQM Academy here: https://cyntegrity.com/myrbqm-academy/
IDSC Expertise Capabilities Services Video 2013Mark Creswell
IDSC offers fully integrated drug discovery and development services to biotech, pharma, academic, and VC clients. They have expertise in discovery, preclinical development, clinical development, and project leadership. Their services include medicinal chemistry, pharmacology, ADME/toxicology, API management, clinical development, and regulatory compliance. IDSC has therapeutic area experience in CNS, cardiovascular, oncology, and more. They provide individual experts or fully integrated project teams along with outsourcing management to guide clients' programs from hit identification through clinical development.
Orbis Clinical is a staffing and consulting company that provides contract professionals focused on drug safety, risk management, clinical operations, medical affairs, regulatory affairs, and quality assurance. They deliver qualified professionals to help clients solve challenges. With offices in Boston, they have served clients nationwide since 2004. Orbis Clinical provides flexible solutions and maintains a bench of qualified resources. Their services include clinical operations support, regulatory submissions and operations assistance, medical affairs support, and quality assurance auditing. Orbis Clinical aims to listen to clients, consult on solutions, and partner with them.
The document provides an overview of the Avoca Quality Consortium, which was formed to develop best practices for proactive quality management of outsourced clinical trials. It discusses the state of the clinical trials industry that led to the Consortium's formation, including increased outsourcing and globalization. It then outlines the Consortium's approach, deliverables produced to date like Quality Agreements and metrics, and areas of ongoing focus such as guidelines for effective quality oversight and operationalizing proactive quality management. The overall goal is to improve quality and efficiency in clinical trials through collaboration and standardization.
http://MedicalDeviceEvents.com At the 10x Medical Device Conference in 2014, presenters Carrie Kuehn, Jorge Ochoa, and Robert Packard explained why, according to data from FDA, more than 58% of 510(k) submissions were refused under FDA’s Refuse to Accept (RTA) policy during its first year of implementation.
This presentation examined some of the reasons why industry got such a bad “grade.” We discussed the RTA requirements and some of the challenges from industry’s perspective on meeting the requirements of the RTA checklist and ended with recommendations on how industry can improve its odds of getting past the RTA hurdle on the first try.
This document provides an overview of the clinical trial services offered by inVentiv Health Clinical, including: Phase I-IIA services conducted in their dedicated clinical facility; Phase IIB-III services including biostatistics and project management; Late Stage services such as post-marketing studies and risk evaluation; strategic resourcing capabilities including functional service providers; bioanalytical laboratory services with over 1,000 validated assays; quality assurance auditing to ensure regulatory compliance; consulting expertise in areas such as regulatory services and clinical development; therapeutic expertise across key areas like oncology and neuroscience; and a global network of over 7,000 employees in 36 countries.
The document describes Aptuit INDiGO's accelerated drug development program. It offers integrated services to help clients advance molecules from candidate selection to clinical trials in as few as 52 weeks. This is significantly faster than the industry average of 122 weeks. Aptuit's program provides world-class expertise across preclinical and clinical development, API manufacturing, and regulatory submission preparation to streamline the process. It aims to reduce costs and development time while improving data quality for clients.
Avoca Group was founded in 1999 and has since established several programs and initiatives focused on improving relationships and quality in clinical outsourcing. Some key events include Avoca launching the first comprehensive Relationship Management Program for a CRO in 2004, developing a system for measuring key relationship indicators in 2000, and CEO Patricia Leuchten being named one of the most inspiring individuals in the life sciences industry in 2012.
Medvantage International has acquired rights to a new vascular coupling device called CUVASLAR that represents an alternative to manual suturing for connecting arteries and veins. The device is expected to reduce surgical time, minimize errors from suturing, and improve patient outcomes. Medvantage plans to submit the device for FDA approval over the next year and market it to the 340,000 microsurgery procedures performed annually in the US.
SMi Group's Prefilled Syringes East Coast 2018 conferenceDale Butler
This document summarizes a two-day conference on pre-filled syringes taking place in Boston on April 10-11, 2018. The conference will include two pre-conference workshops on human factors for connected drug delivery systems and design considerations for drug delivery outside the clinic. The main conference will focus on challenges and solutions for PFS manufacturing and processes, integrating quality by design principles, and trends toward increasing biologics and their implications for PFS. It will feature speakers from major pharmaceutical companies and include panel discussions on challenges of biologics delivery and PFS development.
Andwin Scientific specializes in Clinical Supplies and Equipment product manufacturing, sourcing, procurement, storage and distribution as a supplier to global life science organizations and a distributor to direct end using companies (including sites). This makes Andwin Scientific the only company that offers true consolidation for clinical studies by facilitating the purchase of products from various suppliers in one transaction.
Design Considerations to Maximize Medical Device Cloud ConnectivityGreenlight Guru
Medical device manufacturers are faced with a myriad of design decisions during product development. Several key decisions affecting market readiness must be addressed between bench-top prototypes and initiation of clinical trials. Among the most important are cloud connectivity considerations surrounding firmware, hardware, and use cases. The earlier cloud connectivity factors are identified, considered, and integrated into the design process, the more successful the resulting commercial roll-out in terms of cost, certification, and market acceptance.
• Key design factors medical device manufacturers should consider
• Advantages of considering connectivity early in the design process
• Practical use-case examples highlight more cost-effective clinical trials, wider market acceptance, and reduction in operational costs
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
The document describes TSRL Inc.'s Technology Accelerator program, which aims to help move therapeutic assets past the "Valley of Death" by providing infrastructure, scientific and business resources, and funding to drive projects from pre-clinical development to an Investigational New Drug application. The accelerator selects potential drug candidates based on criteria to maximize commercialization potential and provides services like project management, drug development expertise, and access to networks to help obtain funding and partners. The goal is to generate necessary data packages and commercialization plans to support projects reaching their next development milestones.
Orbis Clinical is a specialized consulting firm that provides drug safety, risk management, regulatory, and quality assurance services to pharmaceutical and biotechnology companies. It has experienced consultants with decades of expertise in these areas. Orbis uses a flexible engagement model to quickly respond to clients' needs with individual specialists or broad-based teams.
As an expert provider of a wide spectrum of clinical development support services, KCR has developed
a supreme Data Management (DM) solution geared towards full data transparency as well as
delivering the highest level of quality within the defined timelines and in adherence to study budgets,
all the while ensuring the meeting of all Good Clinical Practice (GCP) and ICH requirements. Read our DM brochure and learn more about KCR DM capabilities.
Supplier Quality Management: Best Practices and Practical Insights in 2015 LI...Thomas LaPointe
Supplier Quality Management (SQM) is becoming an important business practice as more companies are out-sourcing manufacturing, distribution, shipping, and sales across the globe. Aside from the implications of failure to comply with a myriad of regulations, failure of SQM can lead to litigation, added costs, and harmed reputation among other problems such as product adulteration and mis-branding. However, there is a trade-off between managing supplier quality and costs. As such, SQ managers need to be aware of the risks and benefits of the relationship with suppliers as a whole.
Our panel of key thought leaders and practitioners assembled by The Knowledge Group will discuss Supplier Quality Management and provide Best Practices and Practical Insights.
Key topics include:
Supplier Quality Management – Overview
Supplier Selection, Evaluation, and Monitoring
Supplier Quality Agreements and Contracts
Cost of Poor Supplier Quality (COPQ)
Quality Management Systems
Cost Recovery and Supplier Audit
Closed Loop Corrective Actions
Suppliers Quality Metrics
Supply Chain Pressures
To view the webcast go to this link: http://youtu.be/FhW15o2pfCw
To learn more about the webcast please visit our website: http://theknowledgegroup.org
Avoca Quality Consortium Associate Membership OverviewThe Avoca Group
The document summarizes initiatives for the 2015 Avoca Quality Consortium (AQC). Key initiatives include developing an online community portal for members, continuing work to establish prequalification standards for service providers, conducting research on quality management systems and protocol quality, and hosting educational webinars and annual meetings. The AQC aims to collaborate across the pharmaceutical and biotech industries to optimize approaches to proactive quality management.
This document discusses the application of ICH Q8 and Q10 principles to pharmaceutical product development and manufacturing. It begins with an example of a dissolution failure incident to highlight the importance of understanding products and processes. It then outlines tools and approaches like knowledge management and quality risk management that can be used from development through commercial manufacturing following ICH Q8 and Q10 guidelines. Finally, it provides a case study example of how these principles were applied to the development of the drug Saxagliptin.
Global Reach, Local Touch outlines factors for drug developers to consider when choosing a functional service provider (FSP) partner, including global reach, expertise that can scale up or down on demand, technology platform flexibility, and staff continuity. The document discusses two FSP models - the Clinical FSP model which provides resource flexibility and operational efficiency, and the Clinical Analytics model which consists of services such as clinical data management and biostatistics. It emphasizes that differentiation can be found in a provider's ability to seamlessly adapt to sophisticated clinical trial technology, retain talent that flexibly fits trial needs, and design effective staff onboarding transitions.
Companies in multiple industries have found that lean and agile methods speed up their product development while simultaneously improving quality and cutting costs. In spite of these proven advantages, these methods have not been widely adopted in the highly regulated medical device industry. Regulations and standards do not prevent the adoption of lean and agile methods but many companies’ quality systems do. Understanding these barriers and how to modify quality system procedures is key to more efficient medical device development and improved compliance.
If you had time for an open discussion with our MyRBQM® Academy instructors, what would you ask Johann, Jo, Linda, or Artem? In our monthly Ask the Expert webinars, we give you that chance. These webinars will focus on trending topics in the area of risk-based quality management (RBQM) - like remote and adaptive monitoring, centralized statistical monitoring, change management, predictive analytics... and more.
Besides a 20-minute Q&A session, our industry experts Jo Burmester and Dr Johann Proeve will dive into:
- How things might change while going forward post-COVID-19
- Statistical guidance for trials impacted by COVID-19
Learn more about MyRBQM Academy here: https://cyntegrity.com/myrbqm-academy/
IDSC Expertise Capabilities Services Video 2013Mark Creswell
IDSC offers fully integrated drug discovery and development services to biotech, pharma, academic, and VC clients. They have expertise in discovery, preclinical development, clinical development, and project leadership. Their services include medicinal chemistry, pharmacology, ADME/toxicology, API management, clinical development, and regulatory compliance. IDSC has therapeutic area experience in CNS, cardiovascular, oncology, and more. They provide individual experts or fully integrated project teams along with outsourcing management to guide clients' programs from hit identification through clinical development.
Orbis Clinical is a staffing and consulting company that provides contract professionals focused on drug safety, risk management, clinical operations, medical affairs, regulatory affairs, and quality assurance. They deliver qualified professionals to help clients solve challenges. With offices in Boston, they have served clients nationwide since 2004. Orbis Clinical provides flexible solutions and maintains a bench of qualified resources. Their services include clinical operations support, regulatory submissions and operations assistance, medical affairs support, and quality assurance auditing. Orbis Clinical aims to listen to clients, consult on solutions, and partner with them.
Medical Device and Diagnostics Solutions for Every Stage of Your Product's De...Covance
Getting a medical device to the patient takes more than good technology in today's environment. Compelling evidence and convincing value proposition matter. Competing priorities and differing stakeholder definitions of value are driving the need for creative, connected strategies to get the most from each step in the development process. And - as evidence is gathered - it should be used to inform and iterate regulatory, reimbursement and clinical post-market strategies.
Clinical Research Organization Services | Contract Research Company - PepgraPEPGRA Healthcare
Pepgra is a global contract research organization and drug development services company. It provides various phases of clinical research trials services to pharmaceutical and biotechnology companies to help reduce the time and costs associated with drug development.
Contact Us:
Website : https://bit.ly/33Fwsye
Email us: sales.cro@pepgra.com
India: +91 9884350006
United Kingdom: +44- 74248 10299
This document provides information about the "Biosimilars & Biobetters" conference being held on October 1-2, 2013 in London. The conference will discuss guidelines for biosimilars and biobetters from regulatory bodies, market access pathways, intellectual property, clinical development processes, and case studies on successful products. It will also feature two half-day workshops on developing marketing plans and the commercial realities of biosimilars. The conference is aimed at professionals in areas like regulatory affairs, clinical development, marketing, and intellectual property for pharmaceutical and biotechnology companies.
Orbis Clinical is a consulting firm focused on providing regulatory affairs, quality assurance, drug safety, and risk management expertise to biopharmaceutical clients. It has over 70 employees and has experienced strong revenue growth. Orbis Clinical delivers flexible, client-driven solutions through engaged consultants and a large virtual bench of additional experts.
Kelly Services provides project services including scalable project development and deployment, customized PMO integration solutions, global talent delivery, industry-specific expertise, and project innovation. They have expertise across industries like engineering, science, IT, oil and energy, mining, and environmental management. Kelly Services uses best-in-class project management methodologies to provide a complete continuum of services including project scoping, feasibility studies, PMO integration, and knowledge transfer to help clients meet objectives and budgets.
Service Overview
Site management services to CRO and SITE:
A) Pre initiation
Identification of Potential Sites
Faster Feasibility
Site set up, supplies and other infrastructure needs
Regulatory and IEC/ IRB communications
Rapid negotiation of CTA
Setting up Standard Operating Procedures (SOPs)
B) During Study Duration
Provide dedicated trained and experienced CRCs (Clinical research coordinators)
Patient recruitment & retention Support
Maintenance of essential documents
Source documentation as per ALCOA standards (Attributable, Legible, Contemporaneous, Original & Accurate
Regular IP (Investigational Product) accountability and storage
Completion of CRF’s within timelines
Faster query resolution
Reporting of AE, SAEs within timelines
Support Monitoring visits and Quality Assurance audit action items.
Patient visit Follow Up and compliance assistance
Preparation of site for monitoring and audits/ inspections
C) Post Close out
· Archiving of site results and documents
Site Identification
Faster Feasibility
Ready Sites
TransCelerate Overview - Quality Management System Initiave TransCelerate
TransCelerate BioPharma is a non-profit organization whose mission is to collaborate across the biopharmaceutical industry to identify and implement solutions to improve the delivery of new medicines. The Quality Management System initiative aims to advance quality management across the industry by developing a conceptual framework for clinical quality management systems. The initiative has published several papers outlining its frameworks and tools. Its upcoming milestones include releasing additional tools and publishing additional framework papers on risk management and processes.
This document provides information about an upcoming conference on managing partnerships with contract research organizations (CROs). The conference will take place on October 3-4, 2012 in London and will include presentations from pharmaceutical companies and CROs on trends in clinical development outsourcing, developing effective CRO partnerships, and managing regulatory inspections of CRO activities. Pre-conference workshops on October 2 will focus on defining the scope of CRO relationships and ensuring quality in CRO engagements. Key speakers are listed from pharmaceutical companies like Pfizer, Eli Lilly and AstraZeneca and CROs like Quintiles. The document outlines the conference agenda and encourages those in clinical development, outsourcing, and related areas to attend.
We are a Life Science staffing firm focused in the areas of Scientific, Clinical Research & Engineering for the US Biotech, Pharmaceutical, Medical Device and Diagnostic markets.
Outsourcing is a Cost-effective strategy when used properly and at present is gaining more and more importance. Here's a short presentation about the importance of outsourcing in Clinical research.
PSTRIDE Solutions LLP is your premier business partner for Life Science, Pharma, Biotech & Healthcare. We closely track vendors performance, new product feature, How they are implementing automation in their existing and new products and services through AI, Robotics, ML, NLP, RPA & Blockchain enabled services
PSTRIDE Solutions LLP is your premier business partner for Life Science, Pharma, Biotech & Healthcare. We closely track vendors performance, new product feature, How they are implementing automation in their existing and new products and services through AI, Robotics, ML, NLP, RPA & Blockchain enabled services
Best Practices and Points to Consider for Small-Medium Bio-Pharma CompaniesCovance
Small to medium sized companies face a host of unique challenges in the management of drug safety as they prepare to launch and sustain their products. Lack of clinical, safety and regulatory resources and expertise, along with inadequate technology infrastructure can create significant challenges and risks when advancing products through the life cycle. Find out how you can help your organizations overcome some common obstacles, learn from best practices and efficiently comply with global pharmacovigilance requirements.
The document describes pharmacovigilance and drug safety services provided by Ashfield Pharmacovigilance including signal detection, literature review, medical case management, global regulatory reporting, risk management, quality assurance, and IT services to support pharmacovigilance programs. Key services include signal detection and analysis, case processing, medical review, literature searching, global regulatory reporting, risk management plan development, and audit preparation. Ashfield has experience working with pharmaceutical companies to establish compliant and effective pharmacovigilance systems and processes.
2016 Thermo Fisher Scientific Company OverviewJosie Zheng
Thermo Fisher Scientific is the world leader in serving science, with 50,000 employees in 50 countries and $17 billion in annual revenues. It invests heavily in R&D and provides resources and opportunities for its employees to make significant contributions. The company has a balanced portfolio across consumables, instruments, services, and end markets. It aims to meet customer needs through innovative technologies and a global presence.
Development and Co-Commercialization for Emerging Biotech organizationsIndegene
This document provides an overview of Indegene's capabilities to support emerging biotech organizations across the product lifecycle from pre-launch to post-launch. It outlines Indegene's expertise in areas such as clinical development, regulatory affairs, medical affairs, safety, pricing and market access, marketing, and patient engagement. For each area, it summarizes the challenges faced by emerging biotechs, Indegene's relevant expertise and solutions, including proprietary technologies and platforms. The document emphasizes Indegene's flexible engagement models and ability to scale its capabilities as needed to meet commercialization outcomes for emerging biotech clients.
This document provides an overview of clinical research and related career opportunities. It discusses the objectives of clinical research such as evaluating drug effectiveness and safety. Key areas covered include clinical trials process and phases, roles of various professionals like clinical research associates and project managers, domains like operations and data management. It also highlights India's potential as a hub for clinical research due to its skilled workforce and cost competitiveness. Salary ranges for different roles are provided.
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Breast cancer: Post menopausal endocrine therapyDr. Sumit KUMAR
Breast cancer in postmenopausal women with hormone receptor-positive (HR+) status is a common and complex condition that necessitates a multifaceted approach to management. HR+ breast cancer means that the cancer cells grow in response to hormones such as estrogen and progesterone. This subtype is prevalent among postmenopausal women and typically exhibits a more indolent course compared to other forms of breast cancer, which allows for a variety of treatment options.
Diagnosis and Staging
The diagnosis of HR+ breast cancer begins with clinical evaluation, imaging, and biopsy. Imaging modalities such as mammography, ultrasound, and MRI help in assessing the extent of the disease. Histopathological examination and immunohistochemical staining of the biopsy sample confirm the diagnosis and hormone receptor status by identifying the presence of estrogen receptors (ER) and progesterone receptors (PR) on the tumor cells.
Staging involves determining the size of the tumor (T), the involvement of regional lymph nodes (N), and the presence of distant metastasis (M). The American Joint Committee on Cancer (AJCC) staging system is commonly used. Accurate staging is critical as it guides treatment decisions.
Treatment Options
Endocrine Therapy
Endocrine therapy is the cornerstone of treatment for HR+ breast cancer in postmenopausal women. The primary goal is to reduce the levels of estrogen or block its effects on cancer cells. Commonly used agents include:
Selective Estrogen Receptor Modulators (SERMs): Tamoxifen is a SERM that binds to estrogen receptors, blocking estrogen from stimulating breast cancer cells. It is effective but may have side effects such as increased risk of endometrial cancer and thromboembolic events.
Aromatase Inhibitors (AIs): These drugs, including anastrozole, letrozole, and exemestane, lower estrogen levels by inhibiting the aromatase enzyme, which converts androgens to estrogen in peripheral tissues. AIs are generally preferred in postmenopausal women due to their efficacy and safety profile compared to tamoxifen.
Selective Estrogen Receptor Downregulators (SERDs): Fulvestrant is a SERD that degrades estrogen receptors and is used in cases where resistance to other endocrine therapies develops.
Combination Therapies
Combining endocrine therapy with other treatments enhances efficacy. Examples include:
Endocrine Therapy with CDK4/6 Inhibitors: Palbociclib, ribociclib, and abemaciclib are CDK4/6 inhibitors that, when combined with endocrine therapy, significantly improve progression-free survival in advanced HR+ breast cancer.
Endocrine Therapy with mTOR Inhibitors: Everolimus, an mTOR inhibitor, can be added to endocrine therapy for patients who have developed resistance to aromatase inhibitors.
Chemotherapy
Chemotherapy is generally reserved for patients with high-risk features, such as large tumor size, high-grade histology, or extensive lymph node involvement. Regimens often include anthracyclines and taxanes.
The skin is the largest organ and its health plays a vital role among the other sense organs. The skin concerns like acne breakout, psoriasis, or anything similar along the lines, finding a qualified and experienced dermatologist becomes paramount.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
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.
Lecture 6 -- Memory 2015.pptlearning occurs when a stimulus (unconditioned st...AyushGadhvi1
learning occurs when a stimulus (unconditioned stimulus) eliciting a response (unconditioned response) • is paired with another stimulus (conditioned stimulus)
Travel Clinic Cardiff: Health Advice for International TravelersNX Healthcare
Travel Clinic Cardiff offers comprehensive travel health services, including vaccinations, travel advice, and preventive care for international travelers. Our expert team ensures you are well-prepared and protected for your journey, providing personalized consultations tailored to your destination. Conveniently located in Cardiff, we help you travel with confidence and peace of mind. Visit us: www.nxhealthcare.co.uk
Are you looking for a long-lasting solution to your missing tooth?
Dental implants are the most common type of method for replacing the missing tooth. Unlike dentures or bridges, implants are surgically placed in the jawbone. In layman’s terms, a dental implant is similar to the natural root of the tooth. It offers a stable foundation for the artificial tooth giving it the look, feel, and function similar to the natural tooth.
Nano-gold for Cancer Therapy chemistry investigatory projectSIVAVINAYAKPK
chemistry investigatory project
The development of nanogold-based cancer therapy could revolutionize oncology by providing a more targeted, less invasive treatment option. This project contributes to the growing body of research aimed at harnessing nanotechnology for medical applications, paving the way for future clinical trials and potential commercial applications.
Cancer remains one of the leading causes of death worldwide, prompting the need for innovative treatment methods. Nanotechnology offers promising new approaches, including the use of gold nanoparticles (nanogold) for targeted cancer therapy. Nanogold particles possess unique physical and chemical properties that make them suitable for drug delivery, imaging, and photothermal therapy.
Summer is a time for fun in the sun, but the heat and humidity can also wreak havoc on your skin. From itchy rashes to unwanted pigmentation, several skin conditions become more prevalent during these warmer months.
These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition