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From the Laboratory to Bedside: Expediting Development of Novel Cancer Treatment

Study of rare cancers poses special challenges for drug developers, who often must draw on their experience in both oncology and rare disease. Current strategies and processes for general oncology drug development don’t always apply to rare oncology, a field that today accounts for up to 20 percent of new cancer diagnoses.

To optimize drug development, study designs should maximize the percentage of patients on effective treatment and minimize overall sample size to limit patient exposure to drugs or doses that have no effect. This can be achieved through use of adaptive design techniques and more rigorous oversight of patient eligibility to define the optimal trial population.

Researchers should consider alternative statistical principles — for example, estimating survival when further lines of therapy are anticipated — along with interim analyses and proper futility management.

Biomarkers and surrogate endpoints of efficacy, such as response duration and progression-free survival, also need special consideration and may be required as part of the regulatory review process. Collecting information beyond survival is becoming more important, with payers increasingly requiring quality survival be demonstrated. Development plans should encompass expanded access to bridge the gap between clinical trials and market approval.
Recorded Apr 22 2020 70 mins
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Presented by
Collin Hayward and Peter Larson
Presentation preview: From the Laboratory to Bedside: Expediting Development of Novel Cancer Treatment

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  • Considerations for Practical Execution of a Risk-Based Monitoring Strategy Mar 25 2021 3:00 pm UTC 60 mins
    Crystal Stone, Director, Customer Engagement and Amanda Coogan, Product Specialist
    Today, risk-based monitoring (RBM) of your clinical trial is simple thanks to both integrated and standalone technology solutions. Such technologies can provide seamless, in-depth, real-time insights into every aspect of your trial, simplifying overall trial management and informing decisions that both limit risks and save time and money.
    Yet, many people find the prospect of implementation daunting. Others plunge ahead without proper preparation, neglecting to establish internal processes or success metrics or to identify key stakeholders and decision-makers. As a result, they face huge roadblocks that may even derail the entire process.
    It doesn’t have to be that way.
    Join Remarque Systems specialists Crystal Stone and Amanda Coogan for a first-hand look at best practices in implementing RBM technology and successfully utilizing the resultant output.
  • 임상규정 업무(RA) U.S. FDA's Pharmaceutical Regulatory Affairs Recorded: Feb 25 2021 20 mins
    발표자인 Kirsti Miller는 Premier Research 의 RA 전문 자회사인 RPI 그룹에서 Head of RA 로 근무중이신 임상규정업무의 전문가 입니다.
    국내 스폰서 분들의 FDA IND 제출 시 주요 고려 사항

    *웨비나: 인터넷상의 세미나

    국내 스폰서분들이 미국 FDA 임상계획승인(IND)진행 시 FDA기준에 부합하도록 지원하는 자사의 임상규정 서비스에 대해서 발표 예정입니다.
    - 미국 FDA 임상시험계획승인 제출
    - IND에 대한 CMC 및 GMP 요구 사항
    - FDA IND 신청을 위한 외국 데이터 사용
    - IND 개발을 위한 타임 라인 예시
    - 약물 개발 및 희귀질환 치료제 지정을 위한 신속한 절차

    또한 IND 제출시 CMC와 의약품제조품질관리기준(GMP)에 대한 내용, 미국 외 국가에서 진행된 연구 데이터의 FDA에서 사용시의 유의사항 과 다양한 IND 제출 경로의 예시 및 Timeline 등 을 발표할 예정입니다.
  • 全面解读:如何高效实施儿科临床研究 Recorded: Jan 27 2021 46 mins
    Jonathan Kornstein, 普米尔医药罕见病与儿科治疗和设备项目管理部项目战略执行董事 和 Ming Pei 负责中国区团队的组建,管理及亚太业务拓展
    跟随专家深究儿童临床研究实践中面临的挑战及应对策略

    由于儿童群体的特殊性,开展儿科临床试验时,往往存在许多有异于成人临床试验的难题。挑战可能来自伦理、生理、药理学和经济学等各层面,例如儿童对许多药物的代谢、排泄和耐受性较差,临床试验儿童招募困难,受试儿童依从性较差,家长无法理解知情同意书,儿科研究资源匮乏等问题。药物临床试验是新药上市前的必经环节,临床试验的每一步都关系到试验结果,任何一个小错误都可能导致整个试验以失败告终。

    1月27日(周三),来自普米尔医药的罕见病和儿科领域专家Jonathan Kornstein将在“全面解读:如何高效实施儿科临床研究”网络研讨会中,带大家探讨在开展儿科研究时,应该注意哪些可能出现的关键问题,以及如何制定能够高效执行的创造性解决方案。同时,还将由特邀嘉宾普米尔医药大中华区商务发展负责人裴明和大家现场问答,深入交流互动。

    通过本次研讨会,您将了解到:在儿科研究前期需要面对哪些挑战,儿童作为受试群体存在哪些特殊性,法规策略如何推动临床试验设计,以及开展儿科研究的各类创造性方法。

    会议议程
    • 儿科研究有哪些重点考虑因素?
    • 儿科临床试验设计时需要注意的问题
    • 进行全球法规注册时,对儿科研究的具体规定
    • 儿科研究前期的须知要点
    • 儿科研究中面临的挑战,以及如何应对?
    • 观众问答环节
  • 종합 분석 : 소아임상연구 진행 시 고려 사항 Recorded: Jan 26 2021 33 mins
    Jonathan Kornstein, 희귀 질환 및 소아임상 프로그램 전략 전무이사
    소아임상연구 진행 시 주요과제와 대응 방안을 모색하기 위한 전문가 의견

    *웨비나: 인터넷상의 세미나

    소아의 특수성 때문에 소아 임상시험은 성인 임상시험과 다른 많은 문제점이 있습니다. 과제는 윤리, 생리학, 약리학, 경제학 및 소아의 낮은 신진대사, 많은 약물에 대한 구토와 내성, 임상시험에 대한 소아모집의 어려움, 소아의 낮은 규정준수율, 부모의 피험자동의 거부, 소아연구 자원 부족 등과 같은 여러 다른 측면에서 발생할 수 있습니다. 약물 임상 시험은 신약이 시장에 판매되기 전에 필요한 단계입니다. 임상 시험의 모든 단계는 시험 결과와 관련이 있습니다. 어떤 작은 실수라도 있으면 모든 임상시험이 실패할 수 있습니다.

    1월 26일, Premier Research 의 희귀 질환 및 소아임상 분야의 전문가인 조나단 콘스테인(Jonathan Kornstein) 전무님이 "소아임상연구 진행 시 고려사항" 웨비나에서 소아임상연구 진행 과제를 이해하고, 효율적으로 진행할 수 있는, 창의적인 해결책을 개발하는 방법에 대한 토론을 통해 스폰서님들에게 도움을 줄 것입니다. 한편 한국에서 직접Premier Research 비즈니스 개발을 담당하고 있는 송윤석(Julian Song) 이사님이 해당 강의 이후 참석자분들의 여러가지 추가 질문과 요청사항에 대해 팔로우업 드릴 예정입니다.

    이 웨비나를 통해 PPT 마지막 페이지에 언급된 핵심 사항인 " 환자를 잘 알아야 합니다. 어린이는 성인과 다릅니다 " 와 임상디자인을 촉진하는 임상규정 접근법, 임상연구 운영에 대한 다양한 접근법을 배울 수 있습니다.
    웨비나 일정
    소아임상연구를 시행하는 데 있어서의 어려움과 이를 효과적으로 시행하기위한 창의적인 솔루션. 주제는 다음과 같습니다.
    • 소아임상연구의 일반적인 고려사항
    • 임상디자인
    • 임상규정 고려사항
    • 사전연구 고려사항
    • 시행과 운영시의 어려움
    • 질의응답시간
  • Considerations in Conducting Pediatric Clinical Trials Recorded: Dec 17 2020 56 mins
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    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
    • Implementation and operational challenges
  • Principles Of CAR T-Cell Therapy And The Pathway To Regulatory Approval Recorded: Dec 9 2020 36 mins
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    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 Recorded: Dec 3 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.
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    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
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    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:
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    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:
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    Speakers:
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    Peter Larson, M.D.
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    - Working with sponsors and investigators as well as patients, their caregivers, and local physicians to populate trials
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  • Setting a Real-World Strategy in an Evolving Clinical Research Environment Recorded: Jul 29 2020 59 mins
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    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
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    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
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    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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    Dr. Krista Armstrong, Vice President, Neuro Business Unit and Strategic Development, discusses best practices for forging strategic Sponsor-CRO partnerships. As recorded at OCT New England.
  • The Potential For Disease-Modifying Therapies In Parkinson’s Disease Recorded: Apr 23 2020 62 mins
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    Parkinson’s disease is a progressive neurodegenerative disease that strikes its victims in the prime of their lives. Most available treatments have remained largely unchanged for years, with Levodopa the “gold standard” for treating Parkinson’s disease for nearly 50 years, with only marginal advances in improving the drug’s efficacy. It also only targets the symptoms, not the underlying cause of the disease.

    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.
  • Driving Product Development and Finding the Fast Track in Early-Phase Oncology Recorded: Apr 23 2020 63 mins
    Luke Gill, Peter Larson, and George Hemsworth
    Your company has received funding for a first-in-man trial of a novel oncology compound. The circumstances are typical: limited budget, uncomfortable timeline, a scarcity of skilled clinical trial professionals, and limited knowledge of regulatory hurdles to form a robust clinical strategy. And you recognize that the success of the drug — and possibly the company — depends on the outcome of this trial.

    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.
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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: From the Laboratory to Bedside: Expediting Development of Novel Cancer Treatment
  • Live at: Apr 22 2020 9:35 pm
  • Presented by: Collin Hayward and Peter Larson
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