PAREXEL Early Phase Clinical Research Services experts discuss developing trends in drug development including adaptive trials design, real-world data and biomarkers.
Innovative Pricing and Reimbursement Schemes - The Why, What, Which & HowPAREXEL International
Learn about the need for innovation in global reimbursement mechanisms, the potential risks and benefits of implementation, and real world examples in a presentation by PAREXEL Access Consulting Experts.
Leveraging Imaging and Wearable Technology For Agile Clinical TrialsPAREXEL International
Learn how to manage and overcome key challenges to deploying imaging and wearable technology effectively in clinical trials from PAREXEL Consulting experts.
Understanding Regulatory and Payer Requirements Throughout CommercializationPAREXEL International
Learn about regulator and payer evidence requirements as well as other key market access considerations in drug development. Read this presentation from PAREXEL Consulting experts.
The document discusses strategies for successful global drug development. It focuses on navigating FDA accelerated approval programs, new frontiers in personalized medicine, and evolving regulatory paradigms for digital health. The presentation provides an overview of key FDA expedited programs like fast track designation and breakthrough therapy designation. It also examines how regulators are adapting approaches to personalized medicine and digital health technologies.
Aligning on Patient Outcomes - How Market Dynamics Can Facilitate RWD SolutionsPAREXEL International
This document discusses how real-world data can be used to better understand patient outcomes. It notes that legislation, technology advances, and a shift toward valuing outcomes over volume are accelerating the focus on using real-world data to determine what treatment approaches improve patient outcomes. The document outlines challenges to using real-world data like data quality issues and privacy concerns, and proposes strategies like using hybrid study designs that combine electronic medical record data with traditional clinical trial data collection to help overcome these challenges. Finally, it emphasizes that solutions in this area will need to be developed incrementally while protecting patient privacy and gaining regulatory acceptance.
Innovative Pricing and Reimbursement Schemes - The Why, What, Which & HowPAREXEL International
Learn about the need for innovation in global reimbursement mechanisms, the potential risks and benefits of implementation, and real world examples in a presentation by PAREXEL Access Consulting Experts.
Leveraging Imaging and Wearable Technology For Agile Clinical TrialsPAREXEL International
Learn how to manage and overcome key challenges to deploying imaging and wearable technology effectively in clinical trials from PAREXEL Consulting experts.
Understanding Regulatory and Payer Requirements Throughout CommercializationPAREXEL International
Learn about regulator and payer evidence requirements as well as other key market access considerations in drug development. Read this presentation from PAREXEL Consulting experts.
The document discusses strategies for successful global drug development. It focuses on navigating FDA accelerated approval programs, new frontiers in personalized medicine, and evolving regulatory paradigms for digital health. The presentation provides an overview of key FDA expedited programs like fast track designation and breakthrough therapy designation. It also examines how regulators are adapting approaches to personalized medicine and digital health technologies.
Aligning on Patient Outcomes - How Market Dynamics Can Facilitate RWD SolutionsPAREXEL International
This document discusses how real-world data can be used to better understand patient outcomes. It notes that legislation, technology advances, and a shift toward valuing outcomes over volume are accelerating the focus on using real-world data to determine what treatment approaches improve patient outcomes. The document outlines challenges to using real-world data like data quality issues and privacy concerns, and proposes strategies like using hybrid study designs that combine electronic medical record data with traditional clinical trial data collection to help overcome these challenges. Finally, it emphasizes that solutions in this area will need to be developed incrementally while protecting patient privacy and gaining regulatory acceptance.
Improving Processes for Temperature Traceability from Packaging to PatientPAREXEL International
Check out this presentation from PAREXEL Randomization and Trial Supply Experts to learn about temperature monitoring practices throughout the clinical trial supply chain, including: traditional temperature monitoring methods, innovative methods and how to apply the best approach to individual studies.
Understanding Different Stakeholder Requirements Throughout CommercializationPAREXEL International
The document discusses the emerging gap between the evidence required by regulators for drug approval and payers for reimbursement. Regulators are approving new therapies like gene and CAR-T cell therapies based on early phase clinical trial data through expedited pathways. However, payers increasingly demand real-world evidence of comparative effectiveness and economic value. The use of real-world evidence is presented as a way to bridge this gap by providing additional evidence on benefits, safety, and cost-effectiveness to optimize market success and reimbursement.
You're Hot Then You're Cold - Temperature Management & RTSM IntegrationPAREXEL International
The document discusses innovative temperature monitoring solutions for clinical trial supply chains. It presents two approaches: near real-time temperature monitoring and in-pack Bluetooth enabled monitoring. The near real-time approach uses loggers in shipments that upload data to automatically analyze material status. The in-pack approach uses loggers placed in medication packs that remain with the pack and can be scanned via Bluetooth. Two case studies apply the solutions: near real-time is best for a personalized medicine study, while in-pack fits a 9-month vaccine study due to long battery life and final dispensation check. Innovative temperature monitoring can streamline processes while ensuring drug safety and quality.
PAREXEL Principal Consultant Angela McGillivary discusses commercial considerations, clinical development, regulatory requirements, submission and post approval strategies in emerging markets
Overcoming the Challenges of Benefit Risk Assessment for Established ProductsSGS
Conducting/Implementing a benefit/ risk assessment can be very challenging for “old” established products. Scientific assessment on benefit/ risk is conducted based on the best evidence available. The main objective of this presentation is to discuss how this approach can be applied for different type of regulatory documents that are to be prepared for established products.
Canadian Expert Patients in Health Technology Conference
Nov 7 – 8, 2016: Day 2 Appropriate Place in Therapy Allan Miranda (Janssen), John Snowden (Amgen), Dawn Richards (Canadian Arthritis Patient Alliance), Seema Nagpal (Canadian Diabetes Association),
Pharmacovigilance Training in Oracle Argus Safety DatabaseGratisol Labs
Pharmacovigilance training is essential for pharmaceutical and healthcare organizations to ensure your operations comply with the latest regulatory guidelines, laws and standards. At Gratisol Labs, we provide industry-leading pharmacovigilance training courses with hands on experience on safety databases & medical coding that cover the basics of Pharmacovigilance till advanced drug safety topics, the regulatory requirements of pharmacovigilance, signal detection, and pharmacovigilance audits are covered in the complete Gratisol Labs Pharmacovigilance Training Programme.
Drug manufacturers are looking to emerging markets like Latin America to fuel long-term success.
View this PAREXEL Consulting presentation to learn more.
Setting up of new pharmacovigilance centresPriti Gupta
Cure & Care Pharma proposes establishing a Pharmacovigilance Centre to monitor drug safety. The centre would be approved by regulatory authorities and function to collect, analyze and communicate information about adverse drug reactions and risks. The proposal outlines the need for pharmacovigilance due to increasing drug availability and irrational practices. It describes the centre's scope, reporting processes, infrastructure needs and budget to effectively oversee post-marketing drug safety.
Clinical development, contract & outsourcing in mena & asia pac webinar-l aju...Larry Ajuwon
This document provides a summary of a webinar on clinical development, contracting, and outsourcing in the MENA and Asia-Pacific regions. The webinar covered the clinical development process and landscape in these regions, opportunities and challenges, notable industry partnerships and transactions, and key growth areas. It found that clinical development accounts for a large share of pharmaceutical R&D spending. Both regions are growing markets and R&D is shifting there due to lower costs and other advantages. Outsourcing of clinical activities is increasing to access these markets and improve productivity. The CRO market in Asia-Pacific is more developed with strategic partnerships, while MENA's market is smaller and local.
Adverse drug reaction, pharmacovigilance, spontaneous ADR monitoring, Good Pharmacovigilance Practices, drug safety, patient safety, an overview of regulatory guidelines, medicine safety, medical regulations.
This document discusses pharmacovigilance in India, both past and present. It notes that India did not previously have a formal pharmacovigilance system, but initiated activities in 1986 and joined the WHO program in 1997. The National Pharmacovigilance Program was launched in 2004 and became operational in 2005. It has since expanded to include 90 monitoring centers across India. The program aims to ensure drug safety, identify new adverse drug reactions, and support regulatory decision making. Future prospects include expanding the program further and implementing hemovigilance and biovigilance initiatives to monitor blood and medical devices.
Pharmacovigilance is the science of monitoring approved drugs to detect adverse effects. It aims to identify new risks, assess known risks, and prevent harm. Pharmacovigilance relies on collecting data on adverse drug reactions (ADRs) through passive and active methods. Data is analyzed to detect safety signals and assess risks and benefits of medicines to optimize safe use. Regulatory authorities use pharmacovigilance data to take actions like updating product information or withdrawing approval if risks outweigh benefits.
Introduction to MedDRA Coding in Drug Safety & Pharmacovigilance Process for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
The document discusses pharmacovigilance, which involves monitoring the safety of medical products. It outlines various methods for collecting and analyzing adverse event reports, including spontaneous reports from healthcare professionals and patients, literature reviews, and solicited reports from clinical trials. It also discusses prioritizing cases, signal detection methods, and actions that may be taken in response to potential safety issues. The main objectives are to minimize risks for patients and the company while meeting regulatory requirements.
Pharmacovigilance is the science of monitoring approved drugs to detect adverse effects. It aims to improve patient safety by understanding drug risks. Clinical trials cannot detect all risks due to limited size and duration. Spontaneous reporting allows healthcare providers to report suspected adverse drug reactions. Limitations of clinical data and withdrawals like thalidomide led to pharmacovigilance programs worldwide including the WHO program and national programs in India, UK, and US. Pharmacovigilance involves collecting, analyzing, and communicating safety information to improve patient therapy and public health.
This document discusses the rise of personalized medicines and their impact on drug development. It notes that nearly 1 in 4 new drugs approved in recent years were precision medicines, and the proportion of personalized medicines in clinical development is expected to increase to 70% over the next five years. The use of genomics is also increasing in clinical trials, with over half of phase 1 trials and nearly two-thirds of phase 2 trials including some aspect of genomic medicine. The role of biomarkers, pharmacogenomics, and other approaches are enabling more targeted patient selection and dosing in clinical development. While promising, precision medicines also present challenges including complex trial designs, regulatory hurdles, data management needs, and the integration of multiple types of genomic and clinical
A biomarker strategy aims to answer key clinical questions to support drug development through identifying and testing biomarkers. Developing a robust biomarker strategy can mitigate risks and inform clinical study design by generating testable hypotheses to bridge pre-clinical and clinical research. Effective biomarker strategies consider assay suitability, study design, and sample availability to reliably detect biomarkers and provide statistically meaningful results. Emerging technologies allow deeper interrogation of drugs and disease through multiplexed readouts to enhance biomarker discovery and clinical development.
Improving Processes for Temperature Traceability from Packaging to PatientPAREXEL International
Check out this presentation from PAREXEL Randomization and Trial Supply Experts to learn about temperature monitoring practices throughout the clinical trial supply chain, including: traditional temperature monitoring methods, innovative methods and how to apply the best approach to individual studies.
Understanding Different Stakeholder Requirements Throughout CommercializationPAREXEL International
The document discusses the emerging gap between the evidence required by regulators for drug approval and payers for reimbursement. Regulators are approving new therapies like gene and CAR-T cell therapies based on early phase clinical trial data through expedited pathways. However, payers increasingly demand real-world evidence of comparative effectiveness and economic value. The use of real-world evidence is presented as a way to bridge this gap by providing additional evidence on benefits, safety, and cost-effectiveness to optimize market success and reimbursement.
You're Hot Then You're Cold - Temperature Management & RTSM IntegrationPAREXEL International
The document discusses innovative temperature monitoring solutions for clinical trial supply chains. It presents two approaches: near real-time temperature monitoring and in-pack Bluetooth enabled monitoring. The near real-time approach uses loggers in shipments that upload data to automatically analyze material status. The in-pack approach uses loggers placed in medication packs that remain with the pack and can be scanned via Bluetooth. Two case studies apply the solutions: near real-time is best for a personalized medicine study, while in-pack fits a 9-month vaccine study due to long battery life and final dispensation check. Innovative temperature monitoring can streamline processes while ensuring drug safety and quality.
PAREXEL Principal Consultant Angela McGillivary discusses commercial considerations, clinical development, regulatory requirements, submission and post approval strategies in emerging markets
Overcoming the Challenges of Benefit Risk Assessment for Established ProductsSGS
Conducting/Implementing a benefit/ risk assessment can be very challenging for “old” established products. Scientific assessment on benefit/ risk is conducted based on the best evidence available. The main objective of this presentation is to discuss how this approach can be applied for different type of regulatory documents that are to be prepared for established products.
Canadian Expert Patients in Health Technology Conference
Nov 7 – 8, 2016: Day 2 Appropriate Place in Therapy Allan Miranda (Janssen), John Snowden (Amgen), Dawn Richards (Canadian Arthritis Patient Alliance), Seema Nagpal (Canadian Diabetes Association),
Pharmacovigilance Training in Oracle Argus Safety DatabaseGratisol Labs
Pharmacovigilance training is essential for pharmaceutical and healthcare organizations to ensure your operations comply with the latest regulatory guidelines, laws and standards. At Gratisol Labs, we provide industry-leading pharmacovigilance training courses with hands on experience on safety databases & medical coding that cover the basics of Pharmacovigilance till advanced drug safety topics, the regulatory requirements of pharmacovigilance, signal detection, and pharmacovigilance audits are covered in the complete Gratisol Labs Pharmacovigilance Training Programme.
Drug manufacturers are looking to emerging markets like Latin America to fuel long-term success.
View this PAREXEL Consulting presentation to learn more.
Setting up of new pharmacovigilance centresPriti Gupta
Cure & Care Pharma proposes establishing a Pharmacovigilance Centre to monitor drug safety. The centre would be approved by regulatory authorities and function to collect, analyze and communicate information about adverse drug reactions and risks. The proposal outlines the need for pharmacovigilance due to increasing drug availability and irrational practices. It describes the centre's scope, reporting processes, infrastructure needs and budget to effectively oversee post-marketing drug safety.
Clinical development, contract & outsourcing in mena & asia pac webinar-l aju...Larry Ajuwon
This document provides a summary of a webinar on clinical development, contracting, and outsourcing in the MENA and Asia-Pacific regions. The webinar covered the clinical development process and landscape in these regions, opportunities and challenges, notable industry partnerships and transactions, and key growth areas. It found that clinical development accounts for a large share of pharmaceutical R&D spending. Both regions are growing markets and R&D is shifting there due to lower costs and other advantages. Outsourcing of clinical activities is increasing to access these markets and improve productivity. The CRO market in Asia-Pacific is more developed with strategic partnerships, while MENA's market is smaller and local.
Adverse drug reaction, pharmacovigilance, spontaneous ADR monitoring, Good Pharmacovigilance Practices, drug safety, patient safety, an overview of regulatory guidelines, medicine safety, medical regulations.
This document discusses pharmacovigilance in India, both past and present. It notes that India did not previously have a formal pharmacovigilance system, but initiated activities in 1986 and joined the WHO program in 1997. The National Pharmacovigilance Program was launched in 2004 and became operational in 2005. It has since expanded to include 90 monitoring centers across India. The program aims to ensure drug safety, identify new adverse drug reactions, and support regulatory decision making. Future prospects include expanding the program further and implementing hemovigilance and biovigilance initiatives to monitor blood and medical devices.
Pharmacovigilance is the science of monitoring approved drugs to detect adverse effects. It aims to identify new risks, assess known risks, and prevent harm. Pharmacovigilance relies on collecting data on adverse drug reactions (ADRs) through passive and active methods. Data is analyzed to detect safety signals and assess risks and benefits of medicines to optimize safe use. Regulatory authorities use pharmacovigilance data to take actions like updating product information or withdrawing approval if risks outweigh benefits.
Introduction to MedDRA Coding in Drug Safety & Pharmacovigilance Process for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
The document discusses pharmacovigilance, which involves monitoring the safety of medical products. It outlines various methods for collecting and analyzing adverse event reports, including spontaneous reports from healthcare professionals and patients, literature reviews, and solicited reports from clinical trials. It also discusses prioritizing cases, signal detection methods, and actions that may be taken in response to potential safety issues. The main objectives are to minimize risks for patients and the company while meeting regulatory requirements.
Pharmacovigilance is the science of monitoring approved drugs to detect adverse effects. It aims to improve patient safety by understanding drug risks. Clinical trials cannot detect all risks due to limited size and duration. Spontaneous reporting allows healthcare providers to report suspected adverse drug reactions. Limitations of clinical data and withdrawals like thalidomide led to pharmacovigilance programs worldwide including the WHO program and national programs in India, UK, and US. Pharmacovigilance involves collecting, analyzing, and communicating safety information to improve patient therapy and public health.
This document discusses the rise of personalized medicines and their impact on drug development. It notes that nearly 1 in 4 new drugs approved in recent years were precision medicines, and the proportion of personalized medicines in clinical development is expected to increase to 70% over the next five years. The use of genomics is also increasing in clinical trials, with over half of phase 1 trials and nearly two-thirds of phase 2 trials including some aspect of genomic medicine. The role of biomarkers, pharmacogenomics, and other approaches are enabling more targeted patient selection and dosing in clinical development. While promising, precision medicines also present challenges including complex trial designs, regulatory hurdles, data management needs, and the integration of multiple types of genomic and clinical
A biomarker strategy aims to answer key clinical questions to support drug development through identifying and testing biomarkers. Developing a robust biomarker strategy can mitigate risks and inform clinical study design by generating testable hypotheses to bridge pre-clinical and clinical research. Effective biomarker strategies consider assay suitability, study design, and sample availability to reliably detect biomarkers and provide statistically meaningful results. Emerging technologies allow deeper interrogation of drugs and disease through multiplexed readouts to enhance biomarker discovery and clinical development.
We can aid decision making from the pre-clinical to the clinical setting, supporting line of sight to the clinic, by identifying and translating crucial biomarker approaches into the real world.
UPDATED-Early Phase Drug Developmetn and Population PK and Its' ValueE. Dennis Bashaw
Presentation Given at Regional AAPS DDDI Meeting in Baltimore. Similar to previous talks BUT updated to include a discussion of BIA 10-2474 and extended discussion of risk
Health Canada's Clinical Evaluation Division chief Jian Wang presented on clinical data requirements and key issues for market authorization of biotherapeutics. Wang discussed Health Canada's international collaborations and highlighted regulatory authorities' decision-making based on efficacy and safety. He outlined submission data requirements including quality, non-clinical, clinical, and risk management data. Wang also reviewed key clinical trial design considerations and common efficacy and safety issues with biologics. He emphasized that benefit-risk assessments are context-specific and can lead different regulatory decisions in different jurisdictions based on the same data.
This document provides an overview of a proposed new drug called Regenozene to treat multiple sclerosis (MS) by inhibiting Death Receptor 6 (DR-6). The drug aims to promote remyelination of neurons in MS patients. If successful, Regenozene could potentially stop relapses and reverse disability from MS, addressing major unmet needs. The document outlines the pathogenesis of MS, Regenozene's proposed mechanism of action, target product profile, development plan through clinical trials and regulatory approval, manufacturing and intellectual property considerations, market analysis and financial projections. The virtual business model aims to minimize risk through partnerships while maintaining control over development.
Pharmacometrics is the science of using mathematical and statistical methods to characterize and predict the pharmacokinetic and pharmacodynamic behavior of drugs. It aims to improve decision making in drug development and pharmacotherapy. Pharmacometric models integrate pharmacokinetic and pharmacodynamic models to describe the relationship between drug concentration, effect, and patient characteristics. Population pharmacometric modeling is useful for characterizing variability in these parameters between individuals.
Pharmacometrics is the science of using mathematical and statistical methods to characterize and predict the pharmacokinetic and pharmacodynamic behavior of drugs. It aims to quantify uncertainty in drug behavior to aid decision making in drug development and pharmacotherapy. Pharmacometric models integrate pharmacokinetic and pharmacodynamic models to describe the relationship between drug concentration, effect, and patient characteristics. Population pharmacometric modeling is useful for characterizing variability in these parameters.
Discovery of Drug and Introduction to Clinical Trial_Katalyst HLSKatalyst HLS
Introduction to Discovery of Drug and Introduction to Clinical Trials in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Implementation of Pharmacogenomics in community pharmacies in Alberta:Percept...Dalia A. Hamdy
- Pharmacogenomics (PGx) utilizes DNA data to predict drug response and avoid side effects, leading to personalized therapy. Mutations in drug-metabolizing enzymes can impact drug metabolism and therapeutic outcomes.
- Benefits of PGx include increased medication effectiveness and reduced costs. However, barriers to implementation include lack of healthcare provider and patient education, insurance coverage, and legislation.
- A survey of 70 pharmacists, 105 pharmacy students, and 112 patients in Alberta found that while knowledge of PGx is limited, most agree it can improve care. Pharmacists and students want more education on using PGx for patient care.
Transalational Sciences and Clinical Pharmacology in Orphan Drug DevelopmentE. Dennis Bashaw
This document discusses challenges and solutions for developing orphan drugs and implementing precision medicine programs. It notes that orphan drug development faces resource constraints as trials require more patients than rare diseases have. However, using clinical pharmacology tools allows learning from small populations by incorporating biomarkers, modeling, and innovative designs. The future of drug development lies in going beyond traditional trials to involve patients more and continually learn from individual experiences. Quantitative tools during all stages of development can extract maximum knowledge from minimal data to improve understanding, approval chances, and labeling.
Clinical trials are scientific studies that test new drugs in human subjects. This document discusses the multi-phase clinical trial process, from pre-clinical animal studies through post-approval monitoring. It notes that trials progress from small Phase I safety studies in healthy volunteers to large Phase III efficacy trials in patients. The goal is to demonstrate a drug's benefits outweigh its risks before regulatory approval and marketing.
This document discusses clinical trials and the drug development process. It begins with an overview of the stages of clinical trials from Phase 0 to Phase IV. It then covers topics like trial design, endpoints, biases, sample sizes, regulatory authorities, and cost-effectiveness. The failures and successes of translating pre-clinical findings to human studies are analyzed. Repurposing existing drugs and the challenges academic researchers face are also addressed.
The document discusses the increasing need for companion diagnostics to accompany targeted cancer therapies. It outlines three categories of diagnostic development: 1) Co-development of the drug and diagnostic from an early stage; 2) Development of a diagnostic after a drug is approved to identify patients who will benefit; and 3) Development of a diagnostic for one indication that is later repurposed for another. It also discusses the regulatory environment, noting that regulatory agencies like the FDA are increasingly requiring companion diagnostics and biomarkers to guide patient selection and drug approval. Developing diagnostics poses challenges for drug companies who must partner with diagnostic firms and navigate regulatory requirements.
How to Submit Non-Clinical Data to CBER Using SEND : Understanding New FDA Re...MMS Holdings
What You Will Learn
The FDA’s CBER will begin requiring electronic submissions of nonclinical data to be submitted using the 3.1 and 3.1.1 versions of CDISC SENDIG on March 15th, 2023. With these requirements taking effect soon, Sponsors need to understand how to meet the new rules and regulations provided by SEND, as failing to meet them could result in FDA refusal.
In this webinar, a cross-functional team of statistical programmers and regulatory experts will share actionable insights to help study teams prepare for the new requirements.
Attendees will learn how to:
Understand nonclinical study data submissions to CDER and CBER
Differentiate biologics from drug submission in non-clinical studies
Prepare for this change to ensure a successful submission.
Solve the challenges of a SEND package
Ensure compliance with both SEND 3.1 and 3.1.1 for submission of nonclinical data to CDER and CBERHo
Separate SEND IG DART 1.1 from SEND IG
Manage legacy studies and studies that already meet requirements
Differentiate between submission packages
Use the FDA’s data standard catalog, technical conformance guide and controlled terminology
Who Will Benefit from Attending?
Regulatory Affairs and Submissions Professionals
Pharmaceutical Data and Programming Professionals
Nonclinical/Preclinical Development Professionals
The dream of any physician and consequently every patient is to receive the right treatment in the right time with cost effectiveness. To achieve this goal, the 3 pillars: evidence based medicine, clinical research innovation & resources utilization should be integrated efficiently.
In this presentation, I'll try to comprehensively review the following:
1- How are we used to perform clinical trials in Oncology?
2- Does it fits in today’s needs?
3- Integration of biology knowledge in shaping drug development
4- New Clinical trial designs “Can they offer solution for accelerating drug development?”
5- The supporting infrastructure role in clinical trial execution
This document provides an overview of drug utilization research (DUR). It defines DUR as the marketing, distribution, prescription, and use of drugs in a society and its resulting medical, social and economic consequences. The document outlines the history, levels, aspects, study designs, and guidelines for DUR based on WHO standards. It describes quantitative and qualitative DUR approaches and explains indicators like the Anatomical Therapeutic Chemical classification system and Defined Daily Dose concept for standardized DUR analysis. The goal of DUR is to promote rational and appropriate drug use.
Drug Discovery path
Pharma R & D –overview
Discovery & Development
Preclinical research
Clinical Trial
NDA and FDA Approval
Post marketing data
References
Check out this presentation from PAREXEL Consulting experts to learn about key regulatory processes affecting biosimilars development including an an overview of the 351(k) Pathway, FDA approvals and managing post-approval challenges.
This document discusses the synergies between regulatory information management (RIM) and identification of medicinal products (IDMP). It argues that RIM and IDMP should be considered together, not separately, as IDMP expands on product data beyond what was traditionally included in RIM. The implementation of IDMP standards will converge various regulatory data initiatives and shape future regulatory submissions that will utilize structured IDMP data instead of documents. RIM systems will benefit from using the IDMP data model to standardize product information captured across systems and sources.
This document provides tips for productive FDA meetings. It advises understanding FDA's perspectives and being flexible in discussions. While FDA aims to innovate, sponsors need to show how their approaches address current needs. Agreement is not always the goal; it is better sometimes to get FDA to tolerate an approach. Meeting minutes may lack clarity, so sponsors should summarize discussion points. Experts and patients at meetings can provide value if well-prepared.
Janice Haigh, PAREXEL's Worldwide Head of Pricing & Market Access, on how clinical research organizations simplify the journey from strategy to results.
PAREXEL's Matt Neal joins experts from Microsoft and Allergan to discuss how innovations in technology can help patients by reducing the time and expense of bringing life-saving treatments to market.
The Evolution of Drug Development and Market Access via Connected Data-Driven...PAREXEL International
The document discusses Parexel's Connected Journey approach to drug development and market access using connected data-driven solutions. It provides several case studies as examples, including accelerating a drug's journey while decreasing costs through an innovative modular study design, implementing advanced technology to streamline a large observational study, utilizing protocol optimization to identify cost and time savings, transforming real-world evidence through hybrid data collection, and achieving perfect customer satisfaction in a fast-track oncology trial. The Connected Journey aims to expedite the entire drug development process from design through commercialization by connecting technologies, processes, and expertise to provide data-driven insights.
The presentation discusses the use of wearable devices and sensors for collecting data in clinical trials. While consumer wearables are becoming more common, their data may not be suitable for labeling claims with regulatory agencies without proper validation and approval. Major pharmaceutical companies are exploring how mobile health technologies can supplement traditional trial data collection methods to make trials less costly and more convenient. However, simply having FDA approval as a medical device does not guarantee its data can be used to support drug approval. Proper infrastructure, analytics, and clinical expertise is needed to incorporate sensor data into clinical trials in a way that is robust, secure, and produces scientific results.
This document summarizes different adaptive designs that can be used in early phase oncology trials. It discusses modifications that can be made to dose levels, tumor types considered, and early termination of selected arms. Specific adaptive designs covered include model-based dose escalation methods like the N-CRM and mTPI, zone-based designs for combination treatments, methods for stopping early in single-arm trials, basket and umbrella trial designs, and an example of the Keytruda first-time-in-human study. The goal of adaptive designs is to incorporate interim data to modify trial aspects and make trials more efficient.
This document summarizes a presentation on imaging endpoints for biosimilar development. It discusses clinical trial design considerations for biosimilars including choice of primary endpoint, equivalence vs. non-inferiority designs, and margins. It also covers risks of using response rate as the primary endpoint, such as smaller sample sizes, lack of measurable disease, and quality of radiology reads. Case studies demonstrate the impact radiology read quality and lack of measurable lesions can have on response rates. Overall it addresses balancing risk and benefit in biosimilar trial design.
The document discusses effective pathways for late-stage biosimilar clinical trials. It outlines strategies for optimizing patient recruitment and retention, leveraging data-driven monitoring, and enhancing operational efficiencies. Specific considerations include understanding regulatory environments, selecting appropriate reference products and clinical endpoints, identifying qualified investigator sites, and employing risk-based monitoring approaches using data surveillance technologies. The presentation emphasizes that innovative trial designs and leveraging data-driven approaches will be important to efficiently reach biosimilar approval in the intensifying race to launch new products.
This document discusses the regulatory complexities of developing biosimilar drugs. It summarizes key differences between the US and EU pathways for biosimilar approval and lessons learned from early biosimilar approvals. The document also outlines considerations for evaluating analytical, preclinical, and clinical data to demonstrate biosimilarity, including which quality attributes are most critical. Finally, it discusses future challenges for next-generation biosimilars, including those with engineered properties or novel conjugate formats.
The APCO Geopolitical Radar - Q3 2024 The Global Operating Environment for Bu...APCO
The Radar reflects input from APCO’s teams located around the world. It distils a host of interconnected events and trends into insights to inform operational and strategic decisions. Issues covered in this edition include:
HOW TO START UP A COMPANY A STEP-BY-STEP GUIDE.pdf46adnanshahzad
How to Start Up a Company: A Step-by-Step Guide Starting a company is an exciting adventure that combines creativity, strategy, and hard work. It can seem overwhelming at first, but with the right guidance, anyone can transform a great idea into a successful business. Let's dive into how to start up a company, from the initial spark of an idea to securing funding and launching your startup.
Introduction
Have you ever dreamed of turning your innovative idea into a thriving business? Starting a company involves numerous steps and decisions, but don't worry—we're here to help. Whether you're exploring how to start a startup company or wondering how to start up a small business, this guide will walk you through the process, step by step.
IMPACT Silver is a pure silver zinc producer with over $260 million in revenue since 2008 and a large 100% owned 210km Mexico land package - 2024 catalysts includes new 14% grade zinc Plomosas mine and 20,000m of fully funded exploration drilling.
Digital Marketing with a Focus on Sustainabilitysssourabhsharma
Digital Marketing best practices including influencer marketing, content creators, and omnichannel marketing for Sustainable Brands at the Sustainable Cosmetics Summit 2024 in New York
Storytelling is an incredibly valuable tool to share data and information. To get the most impact from stories there are a number of key ingredients. These are based on science and human nature. Using these elements in a story you can deliver information impactfully, ensure action and drive change.
Zodiac Signs and Food Preferences_ What Your Sign Says About Your Tastemy Pandit
Know what your zodiac sign says about your taste in food! Explore how the 12 zodiac signs influence your culinary preferences with insights from MyPandit. Dive into astrology and flavors!
Building Your Employer Brand with Social MediaLuanWise
Presented at The Global HR Summit, 6th June 2024
In this keynote, Luan Wise will provide invaluable insights to elevate your employer brand on social media platforms including LinkedIn, Facebook, Instagram, X (formerly Twitter) and TikTok. You'll learn how compelling content can authentically showcase your company culture, values, and employee experiences to support your talent acquisition and retention objectives. Additionally, you'll understand the power of employee advocacy to amplify reach and engagement – helping to position your organization as an employer of choice in today's competitive talent landscape.
3 Simple Steps To Buy Verified Payoneer Account In 2024SEOSMMEARTH
Buy Verified Payoneer Account: Quick and Secure Way to Receive Payments
Buy Verified Payoneer Account With 100% secure documents, [ USA, UK, CA ]. Are you looking for a reliable and safe way to receive payments online? Then you need buy verified Payoneer account ! Payoneer is a global payment platform that allows businesses and individuals to send and receive money in over 200 countries.
If You Want To More Information just Contact Now:
Skype: SEOSMMEARTH
Telegram: @seosmmearth
Gmail: seosmmearth@gmail.com
Industrial Tech SW: Category Renewal and CreationChristian Dahlen
Every industrial revolution has created a new set of categories and a new set of players.
Multiple new technologies have emerged, but Samsara and C3.ai are only two companies which have gone public so far.
Manufacturing startups constitute the largest pipeline share of unicorns and IPO candidates in the SF Bay Area, and software startups dominate in Germany.
Unveiling the Dynamic Personalities, Key Dates, and Horoscope Insights: Gemin...my Pandit
Explore the fascinating world of the Gemini Zodiac Sign. Discover the unique personality traits, key dates, and horoscope insights of Gemini individuals. Learn how their sociable, communicative nature and boundless curiosity make them the dynamic explorers of the zodiac. Dive into the duality of the Gemini sign and understand their intellectual and adventurous spirit.
SATTA MATKA SATTA FAST RESULT KALYAN TOP MATKA RESULT KALYAN SATTA MATKA FAST RESULT MILAN RATAN RAJDHANI MAIN BAZAR MATKA FAST TIPS RESULT MATKA CHART JODI CHART PANEL CHART FREE FIX GAME SATTAMATKA ! MATKA MOBI SATTA 143 spboss.in TOP NO1 RESULT FULL RATE MATKA ONLINE GAME PLAY BY APP SPBOSS
Event Report - SAP Sapphire 2024 Orlando - lots of innovation and old challengesHolger Mueller
Holger Mueller of Constellation Research shares his key takeaways from SAP's Sapphire confernece, held in Orlando, June 3rd till 5th 2024, in the Orange Convention Center.
How MJ Global Leads the Packaging Industry.pdfMJ Global
MJ Global's success in staying ahead of the curve in the packaging industry is a testament to its dedication to innovation, sustainability, and customer-centricity. By embracing technological advancements, leading in eco-friendly solutions, collaborating with industry leaders, and adapting to evolving consumer preferences, MJ Global continues to set new standards in the packaging sector.