National OncoVenture (NOV) was launched as a now government R&D program for cancer drug development in 2011 to bridge the gap between discovery and development in drug development in Korea. NOV is carrying out high standard preclinical and early stage clinical trials of novel anti-cancer drug candidates from industry, academia and research institutes in Korea
The National Cancer Center Korea(NCC) launched a new government R&D program, called "National OncoVenture" for cancer drug development in 2011 to bridge the gap between discovery and development in drug development in Korea. The National OncoVenture, formerly known as the Bridging and Development ("B&D") Program for Cancer Therapeutics with System Integration, is to facilitate the drug development process by letting a group of drug development experts in and out of the NCC carry out preclinical, clinical trials of the new anti-cancer drug candidates they have licensed in from the original inventors in industry, academia and government-funded institutes. The National Oncoventure aims to develop 4 Global Drug Candidates that have completed phase 2a human clinical trials by 2016.
National OncoVenture (NOV) is a Korean government funded oncology drug development program. We are focusing on non-clinical and early stage clinical development of promising oncology drug candidates. These candidates are provided by researchers in academics, research institutes, biotech and pharmaceutical companies. We are co-developing the compounds with the originators through a virtual development model. The majority of the development activities are outsourced to domestic and global CRO/CMOs as well as specialized laboratories throughout the world. During the pre-clinical and clinical development, we aim to improve the value of our candidates by out-licensing our development programs to global pharmaceutical companies who can develop them further for the global market.
National OncoVenture, a system-integrated oncology drug development group, was established in June 2011. NOV is supported and located at the National Cancer Center of Ilsan. NOV is a national research and development project group of the Ministry of Health and Welfare.
Their purpose is to carry out the development of oncology drug candidates that were discovered by domestic pharmaceutical companies or academic institutes. NOV aims to develop the candidates into oncology drugs for the global market by providing significant drug development expertise.
National OncoVenture aspires to break through the bottleneck phenomenon in new drug development. Many academic research institutes and small biotechnology or pharmaceutical companies lack the resources to develop new drugs from the preclinical to clinical stage. We, as the non-originators, lead and support the development with experienced experts through an entire new drug development process.
NOV is the first governmental virtual drug development organization as an independent developer of new oncology drugs in South Korea. We select promising drug candidates from originators and lead joint-development projects of new drug candidates with originators utilized by outside networks. These external networks have the necessary know-how and experiences of new drug developments like CROs, CMOs, and consulting firms.
After completing the non-clinical and early clinical phase development, we license out the candidates or projects to domestic and overseas pharmaceutical companies. The profits are shared with the original candidate providers.
National OncoVenture provides consultations to the originators of drug candidates in need of knowledge, information, and experience for oncology market trends, drug candidates licensing, and various other processes.
This document provides an introduction to clinical research and good clinical practice (GCP). It discusses the types of scientific and clinical research, including observational and experimental study designs. The document outlines the phases of clinical trials from I to IV. It emphasizes the importance of ethics in research and describes GCP as international ethical and quality standards for clinical research. GCP aims to protect research participants and ensure valid, reliable results. The document lists the parties involved in clinical research, including investigators, sponsors, and ethics committees, and their roles and responsibilities.
Presentation working on clinical trialsSarah Henter
Working on Clinical Trials discusses the types of documents used in clinical trials and the skills needed by linguists working in this field. It outlines the different types of essential documents created before, during, and after clinical trials including protocols, consent forms, reports, and documentation of trial processes and product accountability. It also describes the various audiences that clinical trial documents target, such as healthcare providers, patients, and oversight committees. Linguists need knowledge of clinical trial procedures and terminology as well as the ability to adapt texts for different audiences. Resources provided include glossaries, templates, online courses, books and articles to help linguists acquire this expertise.
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
The National Cancer Center Korea(NCC) launched a new government R&D program, called "National OncoVenture" for cancer drug development in 2011 to bridge the gap between discovery and development in drug development in Korea. The National OncoVenture, formerly known as the Bridging and Development ("B&D") Program for Cancer Therapeutics with System Integration, is to facilitate the drug development process by letting a group of drug development experts in and out of the NCC carry out preclinical, clinical trials of the new anti-cancer drug candidates they have licensed in from the original inventors in industry, academia and government-funded institutes. The National Oncoventure aims to develop 4 Global Drug Candidates that have completed phase 2a human clinical trials by 2016.
National OncoVenture (NOV) is a Korean government funded oncology drug development program. We are focusing on non-clinical and early stage clinical development of promising oncology drug candidates. These candidates are provided by researchers in academics, research institutes, biotech and pharmaceutical companies. We are co-developing the compounds with the originators through a virtual development model. The majority of the development activities are outsourced to domestic and global CRO/CMOs as well as specialized laboratories throughout the world. During the pre-clinical and clinical development, we aim to improve the value of our candidates by out-licensing our development programs to global pharmaceutical companies who can develop them further for the global market.
National OncoVenture, a system-integrated oncology drug development group, was established in June 2011. NOV is supported and located at the National Cancer Center of Ilsan. NOV is a national research and development project group of the Ministry of Health and Welfare.
Their purpose is to carry out the development of oncology drug candidates that were discovered by domestic pharmaceutical companies or academic institutes. NOV aims to develop the candidates into oncology drugs for the global market by providing significant drug development expertise.
National OncoVenture aspires to break through the bottleneck phenomenon in new drug development. Many academic research institutes and small biotechnology or pharmaceutical companies lack the resources to develop new drugs from the preclinical to clinical stage. We, as the non-originators, lead and support the development with experienced experts through an entire new drug development process.
NOV is the first governmental virtual drug development organization as an independent developer of new oncology drugs in South Korea. We select promising drug candidates from originators and lead joint-development projects of new drug candidates with originators utilized by outside networks. These external networks have the necessary know-how and experiences of new drug developments like CROs, CMOs, and consulting firms.
After completing the non-clinical and early clinical phase development, we license out the candidates or projects to domestic and overseas pharmaceutical companies. The profits are shared with the original candidate providers.
National OncoVenture provides consultations to the originators of drug candidates in need of knowledge, information, and experience for oncology market trends, drug candidates licensing, and various other processes.
This document provides an introduction to clinical research and good clinical practice (GCP). It discusses the types of scientific and clinical research, including observational and experimental study designs. The document outlines the phases of clinical trials from I to IV. It emphasizes the importance of ethics in research and describes GCP as international ethical and quality standards for clinical research. GCP aims to protect research participants and ensure valid, reliable results. The document lists the parties involved in clinical research, including investigators, sponsors, and ethics committees, and their roles and responsibilities.
Presentation working on clinical trialsSarah Henter
Working on Clinical Trials discusses the types of documents used in clinical trials and the skills needed by linguists working in this field. It outlines the different types of essential documents created before, during, and after clinical trials including protocols, consent forms, reports, and documentation of trial processes and product accountability. It also describes the various audiences that clinical trial documents target, such as healthcare providers, patients, and oversight committees. Linguists need knowledge of clinical trial procedures and terminology as well as the ability to adapt texts for different audiences. Resources provided include glossaries, templates, online courses, books and articles to help linguists acquire this expertise.
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
Suzanne Pozsonyi MedicReS World Congress 2013MedicReS
1. The document outlines the key study preparation and start up activities that are typically the responsibility of sponsors and CROs.
2. It discusses feasibility studies, site selection, pre-study visits, contracting, submitting documents to ethics committees, training, and initiation visits.
3. The purpose of these activities is to ensure clinical sites and investigators are properly qualified and prepared to conduct the study according to regulatory standards and the study protocol.
Well-trained clinical research professionals are in high demand. The tremendous increase in medical technology and information in the last decade has resulted in an explosion of potential new drugs, devices and biologics that must be tested before being released for use by the public. The profession is constantly challenged to improve and streamline the clinical research programs in order to shorten the development timelines and control the cost for new product development
Clinical research involves systematic studies on humans to test new drugs, devices, or procedures for safety and effectiveness. The document outlines the various phases of clinical research and drug development process. It describes the roles and responsibilities of key players on a research team including the principal investigator, clinical research coordinator, clinical research associate, and others. It also discusses ethical principles in clinical research and important considerations like informed consent and safety monitoring.
Clinical research involves conducting research studies in human volunteers to answer health questions and find new treatments. It typically involves several phases from preclinical testing in animals to clinical trials in human subjects. India is emerging as a global hub for clinical research due to its large patient pools, low costs, and trained professionals. However, there is a large gap between the growing demand for trained clinical research professionals and current supply. Cliniminds aims to address this need by providing a wide range of clinical research training programs and courses.
This document discusses clinical trials and their various components. It begins with an introduction to clinical trials, their purpose and importance. It then describes the key elements of a clinical trial protocol including the trial design, eligibility criteria, safety measures, statistical analysis plan and informed consent process. It also discusses the role and composition of the Institutional Review Board/Independent Ethics Committee which reviews and approves clinical trial protocols and procedures. Finally, it provides an overview of the four phases of clinical trials and concludes with references.
This document provides an overview of clinical research and the clinical trial process. It discusses the various phases of clinical trials from phase 1 to phase 4. Phase 1 trials assess safety in a small group of participants, while phase 2 trials provide preliminary efficacy and safety data in patients. Phase 3 trials further evaluate efficacy and monitor safety in a larger group of patients. Phase 4 trials collect additional safety and efficacy data after marketing approval. The document outlines the objectives and requirements of each phase of clinical trials and the overall goal of generating evidence about new treatments to improve human health.
This document discusses ICH-GCP and compares it to Indian GCP guidelines. It begins by explaining that ICH is an international body that establishes quality standards for clinical trials called Good Clinical Practice (GCP). GCP guidelines ensure clinical trials are scientifically valid and investigational products are properly documented. The document then outlines some key differences between ICH-GCP and Indian GCP guidelines, such as investigator qualifications, informed consent procedures, and the roles of investigators, monitors and ethics committees.
The document provides information about an upcoming presentation on Good Clinical Practice (GCP). It includes:
1) Details about the presenter including his background and experience in clinical research.
2) The learning objectives of the presentation which are to define GCP, differentiate GCP requirements from recommendations, and identify circumstances where industry best practices go beyond FDA requirements.
3) An introduction stating the presentation was developed to correct common myths and errors heard about GCP throughout the presenter's career.
This document discusses the process of informed consent for clinical research studies. It defines informed consent as a voluntary confirmation by a research subject of their willingness to participate after being informed of all relevant study details. The goal is to provide sufficient information for subjects to make an informed choice about participation. Key aspects of the informed consent process include guidelines from regulatory bodies, ensuring subjects' comprehension and voluntariness, obtaining consent at the right time and place, addressing any questions, and documenting consent with a signed form. The form should include essential elements like the study purpose, risks, benefits, and subjects' rights, as well as additional details like withdrawal criteria and contact information.
- The document compares the FDA regulations for clinical trials to the International Conference on Harmonization's (ICH) Good Clinical Practice (GCP) guidelines.
- There are some differences between the two, such as ICH requiring more documentation of trial procedures and delegation of duties, while FDA regulations are less specific.
- Overall ICH GCP guidelines facilitate international harmonization and acceptance of clinical trial data between the US, EU, and Japan. Compliance with ICH GCP helps assure rights and safety of trial subjects.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive function. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
The document provides information about opportunities in the clinical research industry. It discusses what clinical research is and the drug development process. It outlines the growing industry opportunity, with increasing demand for clinical research professionals and rapid investment growth in the field. Various career opportunities and paths in clinical research are also presented, along with salary ranges and eligibility requirements to work in clinical research.
Patient safety has always been the industry’s focus during clinical trials. However, a recent spate of well-publicized patient safety issues have increased public scrutiny and the biotechnology, pharmaceutical and CRO industries' desire to improve study quality, resulting in larger, longer, more expensive trials. In this Q&A, James T. Gourzis, M.D., Ph.D., discusses issues affecting patient safety, including factors that have launched safety to the forefront; what to look for in evaluating CRO excellence; unique oncology considerations and the ramifications of the rare toxicity; optimizing the Data Monitoring Committee; budget decisions that affect patient safety and the evolution/future of FDA requirements.
Guideline on patient safety and well being in clinical trialsTrialJoin
Patient safety is and should be the number one priority in clinical research. Human participants in a clinical trial are necessary in order to improve and develop new therapies for certain conditions and advance the understanding of how a condition can be treated. Such medical advancements wouldn’t be possible without human subjects as participants. However, even though we all know the importance of clinical trials in the advancement of medicine, most people still have some misconceptions regarding this topic.
The feeling of being treated as a ‘’guinea pig’’ and fear of potential risks and side effects are still common among patients who suffer from a certain condition. Such misinformation and misconceptions regarding clinical trials can unnecessarily prevent patients from finding a potential cure or relief, and can also decrease the number of enrolled patients in studies.
In order to clarify these misunderstandings, we’ve decided to tell you everything there is to know about patient safety in clinical trials. We hope that with this information we can help you to better understand patient safety in clinical trials so that you gain more insight and start considering clinical trials as valid options that can help you improve any condition.
Clinical trial protocol, ammendments, Protocol deviations and violationsAmol Patil
This document provides guidelines for developing a clinical trial protocol including general information, background, aims and objectives, inclusion/exclusion criteria, study design, methodology, statistics, ethics, quality control, and protocol amendments. Key elements that must be addressed in the protocol are enumerated such as the research question, treatment characteristics, data collection and analysis, and legal responsibilities. Protocol deviations and violations that occur during the study are also discussed along with examples and regulatory requirements for reporting them. Adherence to good clinical practice and obtaining necessary approvals are emphasized.
clinical trial Management with ethics committeeSrinivasanBB
The document discusses key aspects of clinical trial management including experimental units, treatment and evaluation, approaches to clinical trials, the roles of various organizations, and essential documents. It provides definitions for experimental units and outlines how treatments and evaluations are conducted in clinical trials. It describes the trial approach process including principal investigators, feasibility questionnaires, ethics committee approval, and registration. It also outlines the roles of site management organizations, ethics committees in reviewing protocols and risks/benefits, and regulatory requirements in India including the Drug and Cosmetic Act, regulatory bodies, and the application process. Finally, it discusses important documents for conducting and reporting clinical trials.
The document provides an overview of clinical trials, including:
1) Clinical trials involve studying new drugs, procedures, or therapies on human subjects to test safety and efficacy.
2) Trials are organized into phases from 0 to IV, with Phase 0 involving microdosing and Phase I-III testing in larger groups.
3) Phase IV trials monitor safety after approval and can find rare side effects.
4) Trials must follow ethics guidelines to protect participants and receive oversight from institutional review boards.
Research Ethics Committees (RECs- IRBs)Tamer Hifnawy
This document discusses the roles and functions of research ethics committees (RECs) and institutional review boards (IRBs). It provides an overview of when REC/IRB approval is required, the review process, and composition of RECs/IRBs. It also discusses interactions between IRBs in different countries and the roles of data safety monitoring boards. The document is authored by Dr. Tamer Hifnawy, an associate professor of public health in Egypt and Saudi Arabia who trains others in international research ethics.
Clinical research involves investigating medical treatments and devices with human subjects to determine safety and effectiveness, and can include clinical trials, mechanisms of disease, and outcomes research. A sponsor initiates and finances clinical trials and is responsible for selecting qualified investigators, while investigators ensure ethical conduct of the trial and respect for subjects. Clinical research associates support investigators and sponsors in carrying out clinical trials.
Threechada Boonchan is a Thai clinical researcher currently working as a quality assurance specialist in Thailand. She has a Master's degree in Pharmacy and is pursuing a PhD. Her CV details her experience monitoring over 30 clinical trials across various therapeutic areas, including vaccines, tuberculosis, and cardiovascular disease. She has monitored trials in multiple countries and taken on roles such as monitor, clinical research associate, and internal auditor.
The document discusses the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guideline.
ICH-GCP is an international ethical and scientific quality standard for clinical trials involving human subjects. It aims to ensure trials are scientifically sound and respect the rights, safety and well-being of participants. The guideline was developed in response to medical tragedies and the need for harmonized standards across regions to facilitate global drug development. It outlines principles for conducting clinical trials, including obtaining informed consent and ensuring confidentiality. Adherence to ICH-GCP provides assurance that clinical trial data are credible and that participants are adequately protected.
The document summarizes a webinar presented by the Patient-Centered Outcomes Research Institute (PCORI) Methodology Committee regarding their draft report on setting standards for patient-centeredness and research prioritization. The webinar covered PCORI's focus on patient engagement, the Methodology Committee's mission and draft report, standards for patient-centeredness and engagement, and a framework for research prioritization. Attendees were invited to submit questions and comments on the draft report.
Suzanne Pozsonyi MedicReS World Congress 2013MedicReS
1. The document outlines the key study preparation and start up activities that are typically the responsibility of sponsors and CROs.
2. It discusses feasibility studies, site selection, pre-study visits, contracting, submitting documents to ethics committees, training, and initiation visits.
3. The purpose of these activities is to ensure clinical sites and investigators are properly qualified and prepared to conduct the study according to regulatory standards and the study protocol.
Well-trained clinical research professionals are in high demand. The tremendous increase in medical technology and information in the last decade has resulted in an explosion of potential new drugs, devices and biologics that must be tested before being released for use by the public. The profession is constantly challenged to improve and streamline the clinical research programs in order to shorten the development timelines and control the cost for new product development
Clinical research involves systematic studies on humans to test new drugs, devices, or procedures for safety and effectiveness. The document outlines the various phases of clinical research and drug development process. It describes the roles and responsibilities of key players on a research team including the principal investigator, clinical research coordinator, clinical research associate, and others. It also discusses ethical principles in clinical research and important considerations like informed consent and safety monitoring.
Clinical research involves conducting research studies in human volunteers to answer health questions and find new treatments. It typically involves several phases from preclinical testing in animals to clinical trials in human subjects. India is emerging as a global hub for clinical research due to its large patient pools, low costs, and trained professionals. However, there is a large gap between the growing demand for trained clinical research professionals and current supply. Cliniminds aims to address this need by providing a wide range of clinical research training programs and courses.
This document discusses clinical trials and their various components. It begins with an introduction to clinical trials, their purpose and importance. It then describes the key elements of a clinical trial protocol including the trial design, eligibility criteria, safety measures, statistical analysis plan and informed consent process. It also discusses the role and composition of the Institutional Review Board/Independent Ethics Committee which reviews and approves clinical trial protocols and procedures. Finally, it provides an overview of the four phases of clinical trials and concludes with references.
This document provides an overview of clinical research and the clinical trial process. It discusses the various phases of clinical trials from phase 1 to phase 4. Phase 1 trials assess safety in a small group of participants, while phase 2 trials provide preliminary efficacy and safety data in patients. Phase 3 trials further evaluate efficacy and monitor safety in a larger group of patients. Phase 4 trials collect additional safety and efficacy data after marketing approval. The document outlines the objectives and requirements of each phase of clinical trials and the overall goal of generating evidence about new treatments to improve human health.
This document discusses ICH-GCP and compares it to Indian GCP guidelines. It begins by explaining that ICH is an international body that establishes quality standards for clinical trials called Good Clinical Practice (GCP). GCP guidelines ensure clinical trials are scientifically valid and investigational products are properly documented. The document then outlines some key differences between ICH-GCP and Indian GCP guidelines, such as investigator qualifications, informed consent procedures, and the roles of investigators, monitors and ethics committees.
The document provides information about an upcoming presentation on Good Clinical Practice (GCP). It includes:
1) Details about the presenter including his background and experience in clinical research.
2) The learning objectives of the presentation which are to define GCP, differentiate GCP requirements from recommendations, and identify circumstances where industry best practices go beyond FDA requirements.
3) An introduction stating the presentation was developed to correct common myths and errors heard about GCP throughout the presenter's career.
This document discusses the process of informed consent for clinical research studies. It defines informed consent as a voluntary confirmation by a research subject of their willingness to participate after being informed of all relevant study details. The goal is to provide sufficient information for subjects to make an informed choice about participation. Key aspects of the informed consent process include guidelines from regulatory bodies, ensuring subjects' comprehension and voluntariness, obtaining consent at the right time and place, addressing any questions, and documenting consent with a signed form. The form should include essential elements like the study purpose, risks, benefits, and subjects' rights, as well as additional details like withdrawal criteria and contact information.
- The document compares the FDA regulations for clinical trials to the International Conference on Harmonization's (ICH) Good Clinical Practice (GCP) guidelines.
- There are some differences between the two, such as ICH requiring more documentation of trial procedures and delegation of duties, while FDA regulations are less specific.
- Overall ICH GCP guidelines facilitate international harmonization and acceptance of clinical trial data between the US, EU, and Japan. Compliance with ICH GCP helps assure rights and safety of trial subjects.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive function. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
The document provides information about opportunities in the clinical research industry. It discusses what clinical research is and the drug development process. It outlines the growing industry opportunity, with increasing demand for clinical research professionals and rapid investment growth in the field. Various career opportunities and paths in clinical research are also presented, along with salary ranges and eligibility requirements to work in clinical research.
Patient safety has always been the industry’s focus during clinical trials. However, a recent spate of well-publicized patient safety issues have increased public scrutiny and the biotechnology, pharmaceutical and CRO industries' desire to improve study quality, resulting in larger, longer, more expensive trials. In this Q&A, James T. Gourzis, M.D., Ph.D., discusses issues affecting patient safety, including factors that have launched safety to the forefront; what to look for in evaluating CRO excellence; unique oncology considerations and the ramifications of the rare toxicity; optimizing the Data Monitoring Committee; budget decisions that affect patient safety and the evolution/future of FDA requirements.
Guideline on patient safety and well being in clinical trialsTrialJoin
Patient safety is and should be the number one priority in clinical research. Human participants in a clinical trial are necessary in order to improve and develop new therapies for certain conditions and advance the understanding of how a condition can be treated. Such medical advancements wouldn’t be possible without human subjects as participants. However, even though we all know the importance of clinical trials in the advancement of medicine, most people still have some misconceptions regarding this topic.
The feeling of being treated as a ‘’guinea pig’’ and fear of potential risks and side effects are still common among patients who suffer from a certain condition. Such misinformation and misconceptions regarding clinical trials can unnecessarily prevent patients from finding a potential cure or relief, and can also decrease the number of enrolled patients in studies.
In order to clarify these misunderstandings, we’ve decided to tell you everything there is to know about patient safety in clinical trials. We hope that with this information we can help you to better understand patient safety in clinical trials so that you gain more insight and start considering clinical trials as valid options that can help you improve any condition.
Clinical trial protocol, ammendments, Protocol deviations and violationsAmol Patil
This document provides guidelines for developing a clinical trial protocol including general information, background, aims and objectives, inclusion/exclusion criteria, study design, methodology, statistics, ethics, quality control, and protocol amendments. Key elements that must be addressed in the protocol are enumerated such as the research question, treatment characteristics, data collection and analysis, and legal responsibilities. Protocol deviations and violations that occur during the study are also discussed along with examples and regulatory requirements for reporting them. Adherence to good clinical practice and obtaining necessary approvals are emphasized.
clinical trial Management with ethics committeeSrinivasanBB
The document discusses key aspects of clinical trial management including experimental units, treatment and evaluation, approaches to clinical trials, the roles of various organizations, and essential documents. It provides definitions for experimental units and outlines how treatments and evaluations are conducted in clinical trials. It describes the trial approach process including principal investigators, feasibility questionnaires, ethics committee approval, and registration. It also outlines the roles of site management organizations, ethics committees in reviewing protocols and risks/benefits, and regulatory requirements in India including the Drug and Cosmetic Act, regulatory bodies, and the application process. Finally, it discusses important documents for conducting and reporting clinical trials.
The document provides an overview of clinical trials, including:
1) Clinical trials involve studying new drugs, procedures, or therapies on human subjects to test safety and efficacy.
2) Trials are organized into phases from 0 to IV, with Phase 0 involving microdosing and Phase I-III testing in larger groups.
3) Phase IV trials monitor safety after approval and can find rare side effects.
4) Trials must follow ethics guidelines to protect participants and receive oversight from institutional review boards.
Research Ethics Committees (RECs- IRBs)Tamer Hifnawy
This document discusses the roles and functions of research ethics committees (RECs) and institutional review boards (IRBs). It provides an overview of when REC/IRB approval is required, the review process, and composition of RECs/IRBs. It also discusses interactions between IRBs in different countries and the roles of data safety monitoring boards. The document is authored by Dr. Tamer Hifnawy, an associate professor of public health in Egypt and Saudi Arabia who trains others in international research ethics.
Clinical research involves investigating medical treatments and devices with human subjects to determine safety and effectiveness, and can include clinical trials, mechanisms of disease, and outcomes research. A sponsor initiates and finances clinical trials and is responsible for selecting qualified investigators, while investigators ensure ethical conduct of the trial and respect for subjects. Clinical research associates support investigators and sponsors in carrying out clinical trials.
Threechada Boonchan is a Thai clinical researcher currently working as a quality assurance specialist in Thailand. She has a Master's degree in Pharmacy and is pursuing a PhD. Her CV details her experience monitoring over 30 clinical trials across various therapeutic areas, including vaccines, tuberculosis, and cardiovascular disease. She has monitored trials in multiple countries and taken on roles such as monitor, clinical research associate, and internal auditor.
The document discusses the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guideline.
ICH-GCP is an international ethical and scientific quality standard for clinical trials involving human subjects. It aims to ensure trials are scientifically sound and respect the rights, safety and well-being of participants. The guideline was developed in response to medical tragedies and the need for harmonized standards across regions to facilitate global drug development. It outlines principles for conducting clinical trials, including obtaining informed consent and ensuring confidentiality. Adherence to ICH-GCP provides assurance that clinical trial data are credible and that participants are adequately protected.
The document summarizes a webinar presented by the Patient-Centered Outcomes Research Institute (PCORI) Methodology Committee regarding their draft report on setting standards for patient-centeredness and research prioritization. The webinar covered PCORI's focus on patient engagement, the Methodology Committee's mission and draft report, standards for patient-centeredness and engagement, and a framework for research prioritization. Attendees were invited to submit questions and comments on the draft report.
This document provides an overview of clinical research and career opportunities in the field. It defines clinical research as organized studies conducted on humans to evaluate the safety and efficacy of drugs, medical devices, and other therapies. Various types of clinical research are described. The document outlines the clinical research process and regulations, and notes the growth of the industry in India. Career opportunities are discussed for various roles in clinical research organizations, pharmaceutical companies, and other settings. Requirements and top cities for clinical research in India are also summarized.
The Business of Genomic Testing by James CrawfordKnome_Inc
This document summarizes the key findings from a survey of 13 early adopter institutions that have implemented next-generation genomic sequencing (NGS) technologies. The survey identified common drivers for adoption including demands from clinical colleagues, anticipated efficiency gains, and acquiring institutional expertise. It also explored barriers such as lack of informatics expertise and high costs. Respondents provided lessons learned such as NGS being more complicated than expected and the importance of multidisciplinary teams. Common measures of successful outcomes included growth in test volumes and expansion of testing menus. The document concludes with recommendations for professional organizations like the College of American Pathologists, including providing educational programs and testing standards.
Did you know 40-65% of all clinical trials involving FDA-regulated products are being conducted overseas? Time, reduced costs, and easier subject recruitment are the factors that make life science companies to conduct clinical trials overseas.
The new role of R&D and process for new products in pharmaceutical industry has been established
Productivity increase of Orion R&D within 6 years by :
-Classification of partners
-Partnering and outsourcing models in use
Need of reliable key metrics to value R&D investment and boost the future growth of the company
This document provides an overview of plain language summaries (PLS) and a company's PLS program. It defines a PLS as a scientifically accurate, non-promotional translation of clinical trial results into easy-to-understand language. The document discusses the importance of sharing results with trial participants and investigators based on feedback from studies. It also reviews regulatory requirements for posting PLS, such as the EU Clinical Trials Regulation requiring posting within 1 year of study completion. Finally, it states that the company's PLS program information will be inserted to describe how it will implement PLS within timelines and any pilot studies.
Webinar: Oncology Trial Recruitment: Challenging Indications and Challenging ...Medpace
Medpace experts discuss how to overcome oncology recruitment challenges for clinical trials for specific populations, indications, and challenging studies.
The document summarizes a webinar presented by the Patient-Centered Outcomes Research Institute's (PCORI) Methodology Committee on their report setting standards for patient-centeredness and research prioritization. The webinar agenda included introductions, a focus on patient engagement, an overview of the Methodology Committee's mission and report, and a discussion of patient-centeredness and research prioritization. The report proposed standards in key domains to guide high-quality, patient-centered outcomes research.
ExL Pharma Clinical Trials Phase I and Phase IIa Conference Brochure: Phase 1...bryonmain
There is a pill or treatment for almost everything, or at least, that is how it seems. However, the amount of effort that goes into a pill or treatment before it is launched is extensive, expensive and often inefficient.
Efficiency and innovation go hand-in-hand with R&D and the development of clinical trials, however, FDA regulations and clinical trial standardization end up stifling these two key factors. This leads to drawn out processes that cost companies hundreds of millions of dollars before the drugs hit the market. Efforts have been made to increase efficiency in phase I/IIA with some companies changing their clinical trial manifestos to suit the available patient population at clinical sites, but more emphasis should be placed on creating more efficient processes for first in human studies by optimizing pharmacokinetics/pharmacodynamics, dosage selection, technological advancements to improve efficacy and structured patient mapping to increase successful trial and patient recruitment opportunities.
This program will give delegates the opportunity to share proven strategies between companies to help increase efficiency in this space and streamline processes to cut down costs. This event will bring together large and small companies and experts in this space to share best practices to decrease the financial drain theses phases have on the overall clinical trial budget. Life science corporations need the most up-to-date tools and practices to increase success by streamlining processes, sharing successful biomarker strategies, anticipating dosing quantities, and optimizing healthy or specialty patient recruitment and retention. Current strategies include patient mapping before organizing and setting up a clinical space, tailoring early phase clinical trials to patient populations, purchasing biological samples from collection companies, and trying to accelerate the process by submitting for breakthrough therapy designation.
Top Reasons To Attend
Identify Compound Development Strategies to Optimize Success in Clinical Trials
Learn Best Practices for Early Decision-Making Through Analysis of Biomarker Utility in Drug Development
Utilize Analytical Technology to Evaluate Multiple Configurations of a Small Molecule to Increase the Feasibility of Drug in Clinical Trials
Implement Adaptive Design in Proof of Concept Studies to Increase Efficiency, Decrease Time and Decrease Overall Cost
Explore the Seamless Development of Phase I to Phase II in Clinical Trials
NINE Case Studies and a Panel Session on Early Phase Clinical Trial Strategies
The document discusses various ways that nonprofit organizations partner with patients and the medical research community to advance research and drug development. It provides examples of how organizations fund research, develop tools and resources, facilitate clinical trials, advocate for policy changes, and build communities to accelerate the development of new treatments. Specific organizations highlighted include the Alzheimer's Drug Discovery Foundation, Juvenile Diabetes Research Foundation, Multiple Myeloma Research Foundation, ALS Therapy Development Institute, and Genetic Alliance.
The document discusses various ways that nonprofit organizations partner with patients and the medical research community to advance research and drug development. It provides examples of how organizations fund research, develop tools and resources, facilitate clinical trials, advocate for policy changes, and build communities to accelerate the development of new treatments. Specific organizations highlighted include the Alzheimer's Drug Discovery Foundation, Juvenile Diabetes Research Foundation, Multiple Myeloma Research Foundation, ALS Therapy Development Institute, and Genetic Alliance.
2nd Annual Oncology Asia
Date: 7 – 9 September 2015 | Sheraton Miyako, Tokyo, Japan
www.oncologyasia.com
The 2nd Annual Oncology Asia zeroes in on the latest cutting edge developments in oncology drug discovery and late phase strategies to get oncology drugs to market faster! Under the Drug Discovery track, this conference will discuss latest immune checkpoint inhibitor combinations, preclinical development trends, novel biomarkers and oncology drug development case studies in Asia. Under the late phase track, it will discuss pricing for success, global and regional commercialization case studies, healthcare policy updates and pricing for success.
Find out about the latest drug discovery trends along with latest strategies for global and regional commercialization at the ONLY senior industry gathering focused on advancing cutting edge oncology R&D and commercialization strategies for Asia in Tokyo, Japan!
1) Traditional early oncology development has high costs and long timelines due to the size and scope of clinical trials, resulting in few drugs progressing to approval.
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3) Advances in targeted therapies and molecular profiling provide hope for more efficient development, but biomarkers still need to be better utilized in early trials to facilitate go/no-go decisions.
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The 10 best medical & clinical laboratories to watch for 2019insightscare
SCL Healthcare Central Laboratory (SHC C-LAB) is the largest clinical laboratory and reference lab in Korea, founded in 2006 with a vision of promoting healthcare. The lab focuses on clinical trials, research, and new drug development. SHC C-LAB prides itself on maintaining high quality standards through validated testing methods and specialized data management. The lab utilizes advanced equipment and takes safety seriously. CEO Kyoung Ryul Lee emphasizes meeting client needs through collaboration and communication. SHC C-LAB aims to become a global leader and continue innovating healthcare.
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2. 2
Table of Contents
1. Program summary
2. Organization
3. Operation Model & Procedure
4. Selection Process
5. Distinctive Features
6. Pipelines
7. NOV Performance
8. Alliance Models
3. 1. Program Summary
Mission: Support Korean global anti-cancer drug development & Korean
pharmaceutical industry
Program Period : 2011~2016 (1st stage) + 5 yrs (2nd stage)
Budget : Ministry of Health & Welfare + Matching fund from originator
Model:
Select pre-clinical anti-cancer drug candidates from various sources
(Universities, National labs., Biotech & Pharmaceutical companies, etc.)
Develop through clinical stages (PIIa)
Project managed by joint development committee between National
OncoVenture and drug candidate provider
Eventually, license out to domestic/global pharmaceutical companies
Share profit with candidate provider and collaborators
Operation methods:
Directed by new (anti-cancer) drug development experts
Virtual drug development operation utilized by CROs, CMOs, consulting
network, etc.
3
4. 2. Organization
President
General management
Business Development
- R&D&B trend analysis
- Identify drug candidates
- L/I, L/O, contract
- Patent/Legal management
Steering Committee
- Overall strategic decision
- Decision sub-committee
recommendations
Advisory
Committee
Advisory
recommendation
Drug Development
- Project management for
drug candidates through
preclinical & clinical stages
- Manage outsourcing studies
- Study result analysis
NCC Research Institute
- Pilot preclinical studies
- Clinical study plan
Administrative Office
- Business planning
- Personnel, Budget
- Public Relation
Network Group
- Collaborative studies: University, Nat’l Lab, Biotech/Pharma
- Outsourcing studies: CRO, CMOs
- Advisory consulting: KFDA, Global network
Scientific/Oncology
Advisory Committee
- Provide expert opinions &
recommendations throughout
drug development stages
NOV-KFDA Committee
-Provide expert opinion on regulatory strategy
-Guide requirements for efficient approval
process
4
5. Head & SVP
Young-
Whan
Park
Ph.D. Rutgers University
Project Leader at Merck USA
ID research center
Head of Research Institute
at Daewoong Pharm. Co.ltd.
Head & VP
Drug Dev.
Sung-
Sook
Lee
Ph.D., Ohio State University
Committee of KDDF
Head of Research Institute
at Chonkundang Pharm. Co.ltd.
Senior Researcher at Cerep Inc.
Head & VP
Clinical Dev.
Jung-
Yong
Kim
MD. Seoul National Univ.
Roswell Park Cancer Inst./ SUNY
at Buffalo
Practicing at Prostate Cancer
center (National Cancer Center)
President & CEO
In-Chull Kim
Ph.D. University of Illinois
CEO at LG Life Science
Head Researcher at Glaxo US
Responsible Developer of Factiv”
Business Development Drug Development
2. Organization
Management Team of OncoVenture
5
6. Advisory Board
2. Organization
Jungshin Lee
Prof.
Division of Medical Oncology
Seoul ASAN Medical Center
President(ex),
Seoul ASAN Medical Center
Prof.(ex), Fox Chase Cancer Center
YungJue Bang
Prof.
Dept. of Internal Medicine
Seoul Nat’l Univ.
College of Medicine
Scientific Council Member ,
WHO /IARC
Jaekyung Rho
Prof. (ex)
Dept. of Internal Medicine
Yonsei Univ. College of
Medicine
Fellow (ex),
Medical Oncology, Vincent Lombardi Cancer
Research Center
Jinsoo Lee
President (ex)
National Cancer
Center of Korea
Prof, (ex),
MD Anderson Cancer Center
Hoogeun Chun
Director,
Catholic Comprehensive
Cancer Inst. at Seoul St.
Mary's Hospital,
Catholic Univ. of Korea
President,
Korean Assoc. for Clinical Oncology
6
Paul A. Bunn
Prof & Head, Division of
Medical Oncology , State
Univ. of Colorado
President of ASCO, IASLC,
and AACI (ex)
Chairman of the FDA
Oncology Drug Advisory
Committee (ex)
Eric K. Rowinsky
CMO & EVP Stemline
Therapeutics
Boards of directors of
Biogen Idec, Inc.
Founder/CEO,Primrose
Therapeutics (ex)
CMO & EVP ImClone
System Inc. (ex)
Associate Professor Johns
Hopkins University School
of Medicine (ex)
7. New Paradigm: A Gov-funded Virtual Drug Development
Joint
Development
Committee
OncoVenture +
Candidate Provider
Global
Anti-Cancer
Drug
Candidate
National
OncoVenture
Candidate
Provider
Knowhow
Facility
Consulting
L/O Dev
Global
Anti-
Cancer
Drug
Joint
Development
Agreement
Supporting Networks
Nat’l Cancer Center/KFDA/
Academia/Nat’l Lab
Advisory board
CMO/CRO
3. Operation Model & Procedure
7
Knowhow/Fund
Anti-Cancer
Drug
Candidate
Expertise
Fund
8. Business Operation Procedure
Step 1. Candidate Selection Procedure
: Accepting application all year around, Evaluation 2-3 times/year
Step 2. Development of Candidate
: Drug development by Joint Development Committee
Pre-evaluation procedure required for premature candidates
Step 3. License Out & Further Development
: License out for global development during or upon completion of human
clinical phase2a
2 page simple
application
Evaluation by new
drug R&D experts
Document
Evaluation
Oral Presentation
Evaluation by
clinical oncologist
Clinical
Evaluation
Confirm integrity
of data &
development
capability
Due Diligence
Rapid agreement
contract within 2
months
Joint
Development
Agreement
3. Operation Model & Procedure
8
9. 4. Project Selection Process
Pre-Evaluation
(Written document)
Development track
Application
Bridging track
Peer Review
(Oral presentation)
CDA/
Due Diligence
MTA/
Substance Evaluation
Peer Review
(Oral presentation)
Joint
Development
Agreement
9
Term
Negotiation
11. 4. Project Selection Statistics
11
Evaluation/Selection
Document
Evaluation
Oral
Presentation
& clinical
evaluation
Due
Diligence
Selection
142 72 23 14
Development
6 programs
On going
7 programs
Stopped
1 programs
On negotiation
12. 5. Distinctive features
12
•Target, Hit, Lead,
Lead optimization
Discovery
•Preclinical, P1 & P2
•Translational
Research
Bridging &
Development
•P3, Approval &
•Commercialization
Development
Develop selected pre-clinical anti-cancer drug candidates through P2 stage
Academic candidates: 100% government fund through preclinical stage
Commercial candidates: 50-75% financial support through clinical stage
Supported by
Ministry of Education, Science &
Technology
National OncoVenture
Supported by
Ministry of Health &
Welfare
Preclinical: 100% support
Clinical: 50-75% support
Pharmaceutical companies
(Domestic & Global)
13. Dept. of
Clinical
development
Candidate
Provider
Advisory:
NCC & Clinical
Oncology
committee
CRO
Central Lab
Genetic Analysis
Lab
Tumor
Assessment
PK
Analysis Lab
Other
Advisor group
Clinical
Sites
Medical
Writing
Statistics
Design
Concept
Genotyping
plan
DMPK plan Production &
Packaging
Vendor selection,
Delivery & Insurance
eCRF
Safety/
DSMB
Site due
diligence
Site contract
IRB
Clinical
Study!
KFDA
IND
An Example of Virtual Development: Clinical Development Division Interface
5. Distinctive features
Virtual oncology drug development w/ government support
Go/No-go milestone evaluation by global drug development experts
Early involvement of clinical oncologist Optimized clinical trial
“Quick Win, Fast Fail” model Low cost / High efficiency paradigm
13
14. Dong Wook
Kim
Division of Hematology
Seoul St. Mary’s Hospital
The Catholic University of Korea
Specialized in :Leukemia
2005- Tasigna P1/2, Sprycel P2
2007- Bosutinib P2, Tasigna P3
2008- Sprycel P3, Bosutinib P3
2008- Supect P1/2
Sun Young
Rha
Dept. of Medical Oncology
Severance Hospital
Yonsei Univ. College of Medicine
Specialized in : Stomach cancer ,
Renal cancer, Sarcoma
2004~ RPR109881 P2
Epothilone P3
2008~ Sutent GIST P3
2010~ Votrient vs. Sutent
Do-Hyun
Nam
Dept. of Neurosurgery
Samsung Seoul Medical Center
Sungkyunkwan Univ. School of
Medicine
Specialized in : Glioma, Cancer
/Neuro stem cell
2006~Temodal P2
2009~Cilengitide P3
2009~INNOCELL Immuncell-LC P3
2010~GBM-BO21990 P3
Oncology Advisory Committee
Center for Lung Cancer;
National Cancer Center, Korea
Specialized in: Lung cancer,
Esophagus cancer
2006~ Alimta P3
2007~ Aflibercept P3
2008~ TS-1 (TSIP) P1/2
2010~ Avastin P3 ,Belotecan P2b
Jungsil
Ro
Center for Clinical Trials
Center for Breast Cancer
National Cancer Center, Korea
Specialized in: Breast cancer
2002~ Herceptin P3
2006~ Tykerb P3
2008~ Tykerb P1b
2009~ Afnitor P3
Sung-Soo
Yoon
Dept of Internal Medicine,
Hematology/Oncology
Seoul Nat’l University Hospital
Specialized in : Blood Cancer ,
Multiple myeloma
2008~Velcade P3
2008~Vorinostat P2
2010~ GSK 220183 P1
2010- Panobinostat P3
Yoon-Koo
Kang
Dept of Oncology
ASAN medical Center
Univ.of Ulsan College of
Medicine
Specialized in: Stomach cancer,
hepatoma, GIST
2007~ Avastin P3
2008~ Sutent P3
2009~Tasigna P3
2010~ Regorafenib P3
Heung Tae
Kim
5. Distinctive features
Yeul-Hong
Kim
Dept of Internal Medicine,
Hematology/Oncology
Korea University Anam Hospital
Cancer Center
Specialized in : Stomach cancer ,
Gastrointestinal cancer
2008~ KT&G-MB40 P1
2008~ Nimotuzumab P2
2009~ RAD001 P3
14
Soonmyung
Paik
Director, Division of Pathology,
NSABP
1995 ~ : NSABP breast B27-51:
tratuzumab, lapatinib, pertuzumab,
bevacizumab, TDM1, etc. : P3
1995 ~: NSABP colon C06-11: UFT,
oxaliplatin, bevacizumab: P3
1995~ : NSABP rectal R04:
capecitabine, bevacizumab: P3
2004: OncotypeDx breast cancer
2010: OncotypeDx colon cancer
15. Scientific Advisory Committee
5. Distinctive features
Pre/Formulation
DMPK
Regulatory AffairsIP/Legal Affairs
ChemistryBiology
Project
Management
Manufacturing
Process
Development
Clinical Design &
Development
Marketing
Consists of ~100 nationally & globally well-known cancer drug R&D experts
Provide expert opinions & recommendations throughout drug development
process
15
Toxicology
/Pathology
16. 6. Pipeline (As of March 2016)
16
Project ID Description MOA Indication Project non-GLP GLP Ph 1 Ph 2
NOV1402
PARP/Tankyrase
Inhibitor
ADP ribose
polymerase &
Tankyrase dual
inhibitor
Solid tumors
NOV1401 PARP 1 Inhibitor
ADP ribose
polymerase 1
inhibitor
Metastatic
tumors
NOV1105
Anti-HGF
antibody
Neutralizing
HGF
GBM,
Sarcoma,
HCC
NOV1301 TGF-b inhibitor
Immune
modulator,
Inhibition of
EMT/metastasis
Metastatic
tumors
NOV1204
Vascular
Disrupting Agent
Tubulin
polymerization
inhibitor
Solid tumors
Oral
IV
NOV1201
Next Gen Pan-
Her inhibitor
Inhibition of
Her1,2&4
Breast
cancer
Salvage
NSCLC
1st line
2nd line
KFDA
KFDA
US-FDA
KFDA
KFDA
KFDA
LO
KFDA
17. 7. NOV performance
ROI (3.5 years): Estimated value based on data for Feb. 2015
Investor
Candidate
Provider
Investor
Candidate
Provider
NOV
Return
17
Input:
~ 3 B won
Milestone payments & royalty:
~ 300 B won
Bridge &
Development
~100x
18. Collaboration between
NOV & Global/Domestic Pharmaceutical Company
Company can join the NOV’s oncology project as a co-development partner or
matching fund provider, or can license in the project
Domestic company can join the NOV’s project◈
NOV can join domestic company to develop in-licensing oncology project from global
bio/pharmaceutical companies as a co-development partner.
NOV can join domestic company to develop in-licensing oversea project◈
8. Flexible Alliance Model
18
NOV develops/co-develops the company’s in-house project (pre-clinical or clinical) with
the research infra (NCC), extensive networks, expert’s know-how as well as development
fund
NOV co-develops the domestic company’s in-house project◈
19. Thank You!
National OncoVenture contact:
Business Development at
BD.NOV@ncc.re.kr
Lee, Mina
Sr.Director, minalee@ncc.re.kr
82-31-920-2772 (O)
Park, Young-Whan
SVP, parkyo@ncc.re.kr
82-31-920-2780 (O)
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