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Where Expertise Meets Nuance: Conducting PTSD Clinical Trials

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.
Recorded Apr 23 2020 58 mins
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Presented by
Krista Armstrong
Presentation preview: Where Expertise Meets Nuance: Conducting PTSD Clinical Trials

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    • 질의응답시간
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    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
    • Get an overview of new CAGT products in development and their impact on clinics during and post-COVID-19
    • Discuss regulatory agency guidance, operational issues, and strategies to streamline procedures

    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
    - Understanding the regulatory landscape for cross-border enrollment including submission requirements and informed consent as well as the requirements for visa and insurance
    - 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.
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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: Where Expertise Meets Nuance: Conducting PTSD Clinical Trials
  • Live at: Apr 23 2020 2:55 am
  • Presented by: Krista Armstrong
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