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FDA新药注册审批全解读

新药研发一直是生物医药界最引人关注的领域。随着法规环境日趋完善,中国医药产业逐渐与全球体系接轨,医药研发市场愈发火热,生物医疗企业的国际化之路越走越宽。普米尔医药大中华区商务发展负责人裴明将为大家深度解读有关FDA新药注册审批的相关法规事务,包括FDA新药临床试验如何申报、申报资料及药品生产质量管理规范详解、如何采用境外数据进行FDA的新药临床试验申请等。
Recorded Nov 4 2020 19 mins
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Presented by
作者 - Kristi Miller博士,普米尔医药法规事务部全球负责人 主讲人 - 裴明,普米尔医药大中华区商务发展负责人
Presentation preview: FDA新药注册审批全解读

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  • Considerations in Conducting Pediatric Clinical Trials Dec 17 2020 4:00 pm UTC 56 mins
    Jonathan Kornstein and Heather McKenney
    There are many challenges inherent in pediatric clinical studies, where the traditional paradigms for evaluating pharmaceutical agents in adults often do not apply. These occur on ethical, physiological, pharmacometrics and economic grounds, among many others. It’s important to recognize that while these efforts are challenging, they are not impossible — and they may be better suited to creative solutions that center on documenting outcomes within these patient populations.

    In this webinar, the featured speakers will discuss challenges in implementing clinical studies in children and creative solutions to effectively implement them.

    • Clinical trial design
    • Regulatory considerations
    • Pre-study considerations
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    Brian Marks and Ashley Jones
    For many years, the primary forms of cancer treatment have been chemotherapy, radiation and surgery, but the toughest forms of cancer demand breakthrough therapies. Advances in immuno-oncology have led to the advent of Chimeric Antigen Receptor T (CAR T) cell therapy, which combines a patient’s own T cells with engineered T cell receptors known as “CARs”. The CAR enables the final product to produce chemicals in the hopes that the “enhanced” product or cells will bind to the cancer cells and kill them.

    The industry has seen successes in using CAR T therapy in several blood cancers, including acute myeloid leukemia, acute lymphoblastic leukemia and lymphoma. Some of these unique therapies have already been cleared by the US Food and Drug Administration (FDA), but the pathway to the clinic comes with several challenges.

    In this free webinar, learn about the principles of CAR T cell therapy and the ways these technologies can reach patients.
  • Asia-Pacific – Taking Device Clinical Development to the US & Europe Dec 3 2020 12:00 am UTC 61 mins
    Nach Dave, RPh. MSc, Vice President, Development Strategy and Marlis Sarkany, MD Senior Medical Director
    Medical devices play an increasingly critical role in the health and quality of life for millions of people worldwide. While clinical trials for medical devices have many similarities to those for pharmaceuticals, the regulatory evaluation of devices is distinct from that of drugs – and there are critical differences in the way the device trials are designed and executed.
    In this webinar, the presenters draw on their extensive experience in both medical device and clinical product development to share what manufacturers need to know. The pair will explore the latest US and European medical device regulatory pathways, agency expectations, and other critical best practices.
    To reflect the substantial technological and scientific advances made by the medical device sector and to respond to the need for regulations that would significantly tighten the controls around medical devices, the European Commission published the EU Medical Devices Regulation (MDR) on May 5, 2017.
    These new regulations seek to set the standard for medical device regulation globally and impact the entire product development cycle, from concept to clinical trial conduct and post-marketing surveillance. Manufacturers will need to conduct more rigorous clinical investigations than ever on both safety and effectiveness to support their claims both in Europe and in the USA. By understanding this evolving regulatory landscape, device manufacturers across the globe can better position their products to adapt to these changes in support of their device development programs.
    What You Will Learn
    • An Overview of the EU MDR/IVDR Regulations for Device Development
    • Ways to accelerate and optimize device development by partnering with the US FDA
    • Factors for clinical development success of combination products in therapeutic and aesthetic dermatology, including a selection of relevant evaluation scales, training of investigators, and quality of study monitoring
  • FDA新药注册审批全解读 Recorded: Nov 4 2020 19 mins
    作者 - Kristi Miller博士,普米尔医药法规事务部全球负责人 主讲人 - 裴明,普米尔医药大中华区商务发展负责人
    新药研发一直是生物医药界最引人关注的领域。随着法规环境日趋完善,中国医药产业逐渐与全球体系接轨,医药研发市场愈发火热,生物医疗企业的国际化之路越走越宽。普米尔医药大中华区商务发展负责人裴明将为大家深度解读有关FDA新药注册审批的相关法规事务,包括FDA新药临床试验如何申报、申报资料及药品生产质量管理规范详解、如何采用境外数据进行FDA的新药临床试验申请等。
  • Essential Strategies in Dermatology Clinical Trials Recorded: Oct 14 2020 62 mins
    Jasmina Jankicevic, MD, Vice President, Medical Affairs & Asya Tsaneva-Maksimova, Director Study Start-up
    Essential Strategies in Dermatology Clinical Trials: The Convergence of Patients, Regulations, and Study Design

    Competition for patients among sponsors in the field of dermatology drug development has never been as intense as it is now — so much so that it’s becoming difficult to meet project timelines, attract and retain patients, and achieve comprehensive study results.

    Patients are in high demand, and making studies appealing to them — convenient, safe, and offering good prospects for success — is essential. Prospective enrollees need to be involved early in the trial development process to ensure that their interests and the sponsors’ needs align. Even regulators call for more robust patient engagement through techniques such as e-consent, which helps patients make informed decisions using interactive multimedia tools.

    What’s more, sponsors and CROs need to develop and apply innovative approaches to determining what countries offer the greatest chance of success, and to getting studies up and running quickly.

    This webinar will cover essential topics for driving competitive advantage, including:
    • How to start the study in the shortest time possible, beginning with an assessment of what country or countries can offer the fastest start-up
    • Strategies for engaging patients, making your study more appealing, safe, and rewarding than competing trials
    • Accelerating the timeline from country selection to the first patient screened
    • Evaluating protocol considerations to increase the overall feasibility of the study and optimize regulatory start-up timelines
  • Initiation & Execution of Early Oncology Clinical Trials in the Time of COVID-19 Recorded: Oct 6 2020 46 mins
    Luke Gill, B.Sc. (Hon), M.Sc., MBA and Peter Larson, M.D.
    Initiation and Execution of Early Oncology Clinical Trials in the Time of COVID-19
    Early-phase oncology, emerging from the crisis, and research and innovation for the future

    As the world emerges from the pandemic of novel coronavirus disease (COVID-19), the treatment need for cancer patients is greater than ever. Join Premier Research’s upcoming webinar to learn how to manage ongoing cell and gene therapy (CAGT) trials.

    We will share Premier’s real-time clinical insights into conducting early-phase oncology and CAGT trials during the COVID-19 crisis to help you plan for future success. We will explore how CAGT is being applied to treating tumors and discuss key study design and operational considerations for new early-phase oncology trials. Finally, we will review the impact of COVID-19 on the CAGT clinical trial environment and share lessons learned in this new emerging reality.

    Key takeaways:
    • Gain an understanding of the science and pathophysiology associated with CAGT
    • Review key trial design considerations for CAGT in solid and liquid tumors and potential telemedicine options
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    Speakers:
    Luke Gill, B.Sc. (Hon), M.Sc., MBA
    Vice President and Head of Oncology
    Clinical Development Service

    Peter Larson, M.D.
    Executive Medical Director
  • Asia-Pacific – Taking Device Clinical Development to the US & Europe Recorded: Oct 1 2020 61 mins
    Nach Dave, RPh. MSc, Vice President, Development Strategy and Marlis Sarkany, MD Senior Medical Director
    Medical devices play an increasingly critical role in the health and quality of life for millions of people worldwide. While clinical trials for medical devices have many similarities to those for pharmaceuticals, the regulatory evaluation of devices is distinct from that of drugs – and there are critical differences in the way the device trials are designed and executed.
    In this webinar, the presenters draw on their extensive experience in both medical device and clinical product development to share what manufacturers need to know. The pair will explore the latest US and European medical device regulatory pathways, agency expectations, and other critical best practices.
    To reflect the substantial technological and scientific advances made by the medical device sector and to respond to the need for regulations that would significantly tighten the controls around medical devices, the European Commission published the EU Medical Devices Regulation (MDR) on May 5, 2017.
    These new regulations seek to set the standard for medical device regulation globally and impact the entire product development cycle, from concept to clinical trial conduct and post-marketing surveillance. Manufacturers will need to conduct more rigorous clinical investigations than ever on both safety and effectiveness to support their claims both in Europe and in the USA. By understanding this evolving regulatory landscape, device manufacturers across the globe can better position their products to adapt to these changes in support of their device development programs.
    What You Will Learn
    • An Overview of the EU MDR/IVDR Regulations for Device Development
    • Ways to accelerate and optimize device development by partnering with the US FDA
    • Factors for clinical development success of combination products in therapeutic and aesthetic dermatology, including a selection of relevant evaluation scales, training of investigators, and quality of study monitoring
  • Novel Trial Approaches for Rare Cancer Patients Recorded: Sep 28 2020 58 mins
    Rupa Doshi, PhD, Executive Director – Program Strategy, Oncology and Sameena Sharif, PhD, Senior Vice President, Product Stra
    Best practices for managing ongoing cell and gene therapy trials
    Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

    This shifting paradigm may well underestimate the incidence of rare cancers, and further underscores the need for innovative approaches in developing new therapies. Challenges include patient access, biomarker testing requirements, selecting the right endpoints, developing alternative study designs that minimize sample size and improve data outcomes, and an ever-changing regulatory landscape.

    This webinar will explore the promise and challenges associated with the planning and execution of rare cancer trials.
  • Operational & Regulatory Factors in Cross-Border Enrollment in Rare Disorders Recorded: Aug 11 2020 19 mins
    Hanna Wide Director, Program Delivery Rare Diseases & Pediatrics at Premier Research
    Researchers are more focused than ever on finding treatments and cures for rare diseases, encouraged by a regulatory environment that is increasingly welcoming to innovation and collaboration. But even under these favorable conditions, the potential success of orphan drug development hinges on finding patients and getting them to trial sites.

    Patients for rare disease trials can be exceedingly hard to find, and because of variations in regulations, hospital capabilities, standard of care, and/or financial reasons, it’s often not practical to have trial sites in each of the countries where patients live. This webinar will examine challenges and solutions in cross-border trial enrollment, including:

    - Working with sponsors and investigators as well as patients, their caregivers, and local physicians to populate trials
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    - Ensuring anonymity of patient records, either by working with local healthcare providers or relying on information provided by the patient or caregiver
    - Paving the way for uneventful patient and caregiver travel by minimizing out-of-pocket costs and providing support for visa interviews, travel booking, local accommodations, and more
    - Carefully attending to the details of living in another country to maximize patient retention

    Premier Research’s rare disease experience spans more than 190 rare disease trials over the past five years. Our connections with patient advocates help us locate hard-to-find patients, even among extremely small populations. Register to get access to insights you can leverage in your rare disease drug development program.
  • Setting a Real-World Strategy in an Evolving Clinical Research Environment Recorded: Jul 29 2020 59 mins
    Stacy Weil - Senior Vice President of Clinical Informatics & Nach Dave, RPh. MSc, Vice President, Development Strategy
    Since early this year, many standard clinical trial processes have been significantly disrupted. Patients have been prevented from attending regular physician visits. Clinical research associates who traveled regularly to study sites to review and verify processes and data were unable to do so. Supply-chain upheaval has forced schedule modifications and substitutions for products in short supply. Committees and boards accustomed to meeting in person were relegated to virtual gatherings, and clinical trial logistics had to be re-evaluated for time, cost, and quality expectations.

    We need to change the way patients participate in trials and how we collect and monitor data. Adopting processes that are more flexible and agile while maintaining data integrity and quality has emerged as a primary focus for everyone involved in conducting clinical trials.

    This webinar will focus on these process steps:

    • Quality data capture. What types of technology can be used to evolve processes that require a renewed focus on remote data capture? Where will the data come from and where will it live?
    • Data access. Who will handle the data? How it will it be transmitted and processed?
    • Information review. Once data becomes information, how will it be reviewed? What initiatives are driving collaborative, data-driven decision-making?

    There is growing consensus that researchers and regulators must adopt a holistic product development approach versus the limited approach of years past. Developers will need to build development plans that include traditional clinical trials and then some. Areas that will complement the traditional randomized clinical trial data will include use of real-world data and evidence to support future clinical trial submissions, building economic strategies in support of product development, and understanding how traditional and non-traditional data points will contribute to an overall data strategy for a product or a portfolio of products.
  • Strengthening Neuroscience Clinical Research Through Innovation Recorded: Apr 23 2020 63 mins
    Juliet Moritz and Barry Dussault
    There’s a lot of discussions these days about innovative ideas to make clinical research more patient-focused. The concept goes hand-in-hand with the development of technology that permits researchers to design and execute trials that can significantly reduce the burden of participation.

    Development of neuroscience drugs is benefiting from these advances in patient-focused research, as new technologies and approaches are challenging traditional research models. This webinar will explore innovative technology being used to collect data in neuroscience trials, including wearables, remote medication compliance monitoring, data analytics and even virtual study visits to enhance compliance, data quality and patient-centricity.

    In this free webinar, the featured speakers will discuss:

    • How new technologies can make neuroscience trials more productive, efficient and the endpoints more objective
    • How these technologies can improve patient engagement and reduce patient burden, while raising new regulatory/operational concerns
    • How new technologies such as wearable devices, remote monitoring, and virtual patient visits have the potential to make trials more patient-friendly, whilst improving the speed and reliability of the studies
    •How social media provides many opportunities to increase patient engagement
  • Planning for Quality in Medical Device Trials Recorded: Apr 23 2020 58 mins
    Kristen Welz and Vicki Gashwiler
    The concept of risk-based monitoring (RBM) has been discussed, implemented and refined in the pharmaceutical and medical device worlds for more than a decade. Most large sponsor companies in the medical device industry have adopted RBM in their clinical trials. Meanwhile, smaller medical device companies, seem to be slower to embrace the concept. Despite years of conversation and availability of regulatory guidance from the Food and Drug Administration (FDA), European Medicines Agency (EMA), and ICH-GCP E6R2, these smaller organizations continue to be hesitant about adopting this tried-and-tested monitoring method.

    In this webinar, the featured speakers discuss RBM — also referred to as quality-managed monitoring — and explore how to effectively implement this monitoring process into their medical device trials in a methodical and compliant way. They show how this model can reduce costs and give a few examples of reporting and tracking tools that allow for better management of RBM.

    Attendees will gain insight on:

    How to build quality into clinical trials, from planning to reporting
    Site management concepts — out of site does not mean out of mind
    Specific monitoring procedures including:
    Centralized monitoring
    Targeted source data verification
    Reduced monitoring
    Remote monitoring
    Key performance indicators in quality-management monitoring such as escalation triggers and documentation of quality actions
  • Developing Best Practices for Forging Strategic Sponsor-CRO Partnerships Recorded: Apr 23 2020 30 mins
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    Andreas Schreiner and Barry Dussault
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    This webcast will explore the definition of disease modification and what it means in Parkinson’s disease and to patients with Parkinson’s, why previous attempts at disease modification have failed, some of the targets for renewed attempts at disease-modifying treatments, and the challenges (and benefits) of conducting clinical trials that target disease modification.
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    Luke Gill, Peter Larson, and George Hemsworth
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    To complicate matters, your target is a newly validated mutated receptor present in a limited number of cancer patients, with no diagnostic test yet approved. You’re also using an antibody-like molecule that inhibits the receptor’s activity, but also stimulates a potent immune response. Neither the class of drug nor the target has ever been tested in a clinical trial, and much of the preclinical data suggests it will synergize with unapproved newer molecules that are now in later-stage trials.

    Companies like yours, at the forefront of personalized medicine, are co-developing — at a very early stage — biomarkers and diagnostic kits to define those patients who will best respond to the therapy. These biomarkers and diagnostics also can yield noninvasive information about whether patients are getting the desired pharmacodynamic effect from the drug.

    That’s a lot to consider, but you’re not alone. There are many highly skilled people and organizations to help plan and execute such studies. Some contract research organizations specialize in exactly this type of situation and can help you meet your goals, ideally getting involved immediately after (if not before) you meet critical funding milestones. You want to adopt a one-team approach and an agreed-on definition of attainable objectives, combined with a clinical development plan of engaging the agencies and execution of a high-quality, timely trial at a reasonable cost. This will improve the likelihood of meeting study objectives and establish continuity that aids in development of more advanced trials.
  • Where Expertise Meets Nuance: Conducting PTSD Clinical Trials Recorded: Apr 23 2020 58 mins
    Krista Armstrong
    The invisible wounds caused by post-traumatic stress disorder can dramatically affect mental health and diminish quality of life. According to the Sidran Institute, a nonprofit organization serving people who have experienced or witnessed traumatic events, PTSD is associated with an extremely high rate of medical and mental health service use. Patients may incur the highest per-capita cost of any psychological condition.

    It’s clear that more research must be conducted, and treatments developed, to address this unmet medical need.

    While there are currently more than 350 ongoing clinical research studies in PTSD, most are in the academic arena. Consequently, there is limited knowledge within industry on conducting these clinical trials. Having worked in PTSD research for several years, Premier Research understands the combination of expertise and nuance to achieve a successful clinical trial.

    Topics Covered
    • Study design considerations, including assessment frequency and target population (military versus civilian).
    • An overview of the CAPS-5 assessment, including the importance of the structured interview and alignment of the scoring rules.
    • Recruitment strategies and site dynamics unique to this indication.
  • Immuno-Gene Therapeutics in Hematological Cancers: How Science Drives Study Stra Recorded: Apr 23 2020 62 mins
    Colin Hayward and Luke Gill
    This webcast will review the current state of technology in gene therapeutics and examine trends in immuno-oncology and gene therapy for hematological malignancies. Topics will include:

    - Ingredients for successful study planning and delivery
    - Operationalizing studies to achieve conclusive data outcomes
    - Data-driven approach to choosing the right sites in the right countries
    - Key drivers to retaining patients and meeting study end points
    - Exploring future trajectories in outsourcing models for innovative biotech companies
  • Improving Regulatory and Operational Performance in Orphan Drug Development Recorded: Apr 23 2020 57 mins
    Nach Davé and Kimberly Glen
    Today more than ever, regulatory bodies are providing a progressive platform for rare disease drug development. Extensions to existing regulations and incentives and attempts to reduce orphan drug designation applications provide a collaborative environment for companies developing orphan drugs.

    Understanding the regulatory landscape in orphan drug development — specifically the various pathways, incentives, and engagement opportunities — with regulators can help optimize the process and bring therapies to market faster. The U.S. Food and Drug Administration is introducing new review cycles and initiatives to aid researchers, and regulators in other countries will likely follow with similar measures to promote orphan drug development.

    Sponsors stand to gain by seeking FDA engagement early and often, performing relevant studies in rare populations and using federal grants and other available programs. All of these measures can increase the value of their companies and contribute to a growing database within the rare disease space.

    People attending this webinar will better understand:

    - The regulatory and operational nuances of orphan drug development
    - The benefits of early planning and engagement
    - How to operationalize their regulatory strategy
    We will examine strategic considerations in the regulatory and operational nuances of rare disease drug development, including:

    - Changes in the regulatory landscape that provide a favorable environment for development of orphan drugs
    - The need for early regulatory engagement when developing and operationalizing plans for drug development
    - Operationalizing clinical trials within rare disease to support orphan drug designation, including:
    Patient identification, engagement, and retention
    Investigative site selection and site team engagement
    - Involving patient groups, obtaining increased funding, and taking advantage of significant government reforms that are focusing much-needed attention on treating rare diseases
  • A Vast Unmet Need: Challenges in Alzheimer’s Clinical Trials Recorded: Apr 23 2020 62 mins
    Sebastian Turek
    This webinar will review the current global pipeline of Alzheimer’s trials and their geographic locations, describe innovations in trial design, and promote consideration of optimal clinical trial processes, including preclinical patient populations, clinical assessments sensitive to the earliest disease-related changes, and biomarkers as outcomes of clinical trials.
  • Operationalizing Fibromyalgia Trials Recorded: Apr 23 2020 27 mins
    Scott Millard
    Scott Millard of Premier Research reviews how to best operationalize fibromyalgia clinical trials in a 2017 APS Town Hall Talk in Pittsburgh, PA.
Built for Biotech℠
Premier Research is a clinical research company, dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments. As a global company, Premier specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors. Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions.

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  • Title: FDA新药注册审批全解读
  • Live at: Nov 4 2020 8:00 am
  • Presented by: 作者 - Kristi Miller博士,普米尔医药法规事务部全球负责人 主讲人 - 裴明,普米尔医药大中华区商务发展负责人
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