Name: FDA 허가 프로세스 505(b)(2) 경로, 이것은 무엇인가요? Pre-IND와 NDA제출(Submission)은 무엇을 의미하나요?
Start: 2021-08-26T07:00:00Z
End: 2021-08-26T07:00:34.000Z
Location: BrightTALK
Rating: 5

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.

Topic : The Art of Decentralizing Pediatric Rare Disease Studies: Clinical Trials Suited for Daily Life

Pediatric rare disease trials combine rarity of disease with a restricted and geographically-dispersed population of vulnerable subjects for research, creating unique challenges for study design and execution. Recruitment is challenging, as patients, parents and caregivers need to juggle school schedules, work responsibilities and family obligations to accommodate study participation.

Incorporating decentralized clinical trial (DCT) strategies can help sponsors attract patients and increase access, enrollment and retention by limiting site visits and facilitating participation for those who might not otherwise be able — or willing — to travel to distant sites or specialized centers.

Join this webinar to learn:

• Challenges of conducting clinical research in pediatric rare diseases
• Potential applications of DCT strategies in pediatric rare disease studies
• Risks to applying DCT strategies in these clinical trials
• Key considerations when operationalizing pediatric rare disease studies with decentralized elements
• Future trends in decentralization for pediatric rare disease studies

Please note: If we do not attend to your questions, we may follow up afterwards.
Questions? Contact info@premier-research.com

The Art of Decentralizing Pediatric Rare Disease Studies

Topic : [In Vitro Diagnostics for Early Cancer Detection: The Evolution and Promise of Liquid Biopsy Technology]

As liquid biopsies become more commonplace, gaining wider US Food and Drug Administration (FDA) acceptance and even becoming standard of care in some instances, the technology is giving rise to important new questions. In this webinar, the featured speakers will explore the technique’s growing importance in early cancer detection and address common questions about its use.

The webinar will provide insights into developing an in vitro diagnostics test for early cancer detection with clinical, analytical and performance validation considerations. Attendees will learn how to approach single indication vs. multi-cancer screen indications, the advantages and disadvantages of lab-developed tests vs. premarket approval and the regulatory landscape for in vitro diagnostics. In addition, discover strategies for operationalizing large-scale clinical validation studies.

Join this webinar on in vitro diagnostics for early cancer detection for a discussion on the evolution and promise of liquid biopsy technology.

Please note: If we do not attend to your questions, we may follow up afterwards.
Questions? Contact info@premier-research.com

In Vitro Diagnostics for Early Cancer Detection

505(b)(2) 경로에서 성공적인 신약 개발의 복잡성을 포괄적으로 살펴보게 될 웨비나에 참여해 보세요. 이 웨비나에서는 505(b)(2) 신약 개발을 학습하는데 필수적인 전략적 기본 원칙과 가교자료 준비시 고려사항도 모색합니다.

웨비나의 첫 파트에서는 성공의 전략적 기본 원칙에 집중합니다. 성공적인 개발 프로그램의 기초가 되는 5가지 핵심 기본 원칙(상업화, 과학, 규제, 의료, 법적 지적재산과 사업)을 살펴봅니다. Real-World 예시 및 관련 질문을 통해 상업적 타당성, 가치 제안, 과학적 가교, 규제기관 설득에 대해 살펴봅니다. 과학 및 규제 관련 기본 원칙을 통합함으로써, 제품에서부터 기존 데이터 또는 출판된 문헌에 이르기까지 강력한 과학적 가교를 설정하여 개발 비용을 낮추고 시판까지의 시간을 단축하는 방법에 대하여 논의합니다.

전략적 기본 원칙을 바탕으로, 웨비나의 두 번째 파트에서는 가교자료 준비시 고려사항을 살펴봅니다. 가교는 신약 개발에서 핵심적인 역할을 담당하므로 가교를 적용할 수 있는 다양한 전략과 시나리오를 탐구합니다. 생물학적 동등성의 개념, 비교 생체이용률 그리고 생물학적동등성 시험에 관한 FDA의 가이드라인을 살펴봅니다. 추가로, 생리화학적 특성 또는 시험관실험-생체내실험 상관관계 (in vitro-in vivo correlations)를 바탕으로 생동성시험 면제와 같은 임상 데이터가 필요하지 않은 가교 전략을 논의합니다. 또한 제조법 변경, 국소 안전성, 그리고 제형 수정에도 불구하고 일관성 입증과 관련된 가교 고려사항도 탐구합니다.
전략적 기본 원칙 및 가교자료 준비시 고려사항을 활용하여 개발 프로그램을 최적화하고 규제 관련 승인을 확보하기 위한 505(b)(2) 신약 개발을 위한 논의를 들어보세요.

강의 내용 (Agenda):
Part  1 505(b)(2) 신약 개발 성공의 기본 원칙
- 성공의 기본 원칙 파악
- 기회와 도전과제 파악
- 505(b)(2) : 주요 주제 - 제품 관념화, 개발 전략
- 핵심 메시지
Part  2 가교자료 준비에 관한 전략적 고려사항
- "가교자료"란 무엇인가요? 
- 가교자료의 핵심 사유
- 가교자료 준비에 관한 방법 및 고려사항
- 결론

Contact info@premier-research.com

505(b)(2) 신약 개발 마스터 : 전략적 기본 원칙 및 가교자료 준비시 고려사항

Join us for a comprehensive webinar that delves into the intricacies of successful drug development under the 505(b)(2) pathway. In addition, this webinar will explore the strategic pillars and bridging considerations essential for mastering the art of 505(b)(2) drug development.

The first part of the webinar will focus on the strategic pillars of success. We will examine the five key pillars - commercial, science, regulatory, medical, and legal intellectual property and business - that form the foundation of a successful development program. Through real-world examples and relevant questions, we will delve into commercial viability, value proposition, scientific bridging, and persuading regulatory agencies. By integrating the scientific and regulatory pillars, we will discuss how to establish a strong scientific bridge from your product to existing data or published literature, resulting in reduced development costs and accelerated time to market.

Building upon the strategic pillars, the second part of the webinar will dive into bridging considerations. Bridging plays a critical role in drug development, and we will explore various strategies and scenarios where bridging can be applied. We will examine the concept of bioequivalence, comparative bioavailability, and the FDA's guidelines for bioequivalence studies. Additionally, we will discuss bridging strategies that do not require clinical data, such as bio waivers based on physiochemical properties or in vitro-in vivo correlations. Furthermore, we will explore bridging considerations related to manufacturing changes, local safety, and demonstrating consistency despite formulation modifications.

Join us and master the art of 505(b)(2) drug development by leveraging strategic pillars and bridging considerations to optimize your development program and achieve regulatory approval.

Please note: If we do not answer your questions during the webinar, we will follow up afterwards. 
Contact info@premier-research.com

Mastering 505(b)(2) Drug Development:Strategic Pillars & Bridging Considerations

CAR T-cell therapies have transformed the therapeutic landscape for hematologic malignancies, offering substantial benefit to patients with few alternative treatment options. While these innovative therapies represent a breakthrough in immuno-oncology, their impact thus far has been limited to a small subset of patients, and challenges to development and commercialization remain a hurdle. These challenges range from narrow patient eligibility criteria and complex administration processes to off-tumor toxicity, complicated manufacturing scale-up and high costs.

There is significant potential to expand the applications of — and broaden access to — CAR T-cell therapies to address unmet needs. Opportunities exist to not only optimize the safety, efficacy and clinical potency of these treatments, but also make them more widely available to larger, more diverse patient populations.

Join the featured speaker as they explore key strategies for broadening access to CAR T-cell therapies and discuss important considerations for sponsors focused on increasing patient-centricity and diversity in clinical trials involving these novel treatments.

Please note: If we do not attend to your questions, we may follow up afterwards.
Questions? Contact info@premier-research.com

Extending Hope: Broadening Access to CAR T-Cell Therapies

Completing nonclinical studies to support FDA investigational new drug applications is an essential milestone for progressing a new drug into the clinic. Conducting studies according to relevant regulatory requirements, such as good laboratory practices, and guidelines from the FDA and the International Council for Harmonisation is essential for ensuring acceptance by the FDA and that IND-opening clinical trials can proceed without a clinical hold.

For outsourced animal studies, it is tempting to rely solely upon the nonclinical laboratory for study design, conduct, and reporting. However, these laboratories and their study directors have many competing pressures, and it’s important for sponsors to provide appropriate oversight of their studies to verify that they are receiving adequate attention.

Also, IND-enabling studies require significant input on design, conduct, and reporting from the sponsor. It is important to confirm that a lab has appropriate processes and controls in place to conduct studies that meet the applicable regulatory requirements or, if not, to provide even greater input and oversight than might otherwise be required. Although the scientific results are dependent upon the drug, this webinar will provide practical guidance for designing, contracting, monitoring, and reporting nonclinical/toxicology studies to ensure regulatory acceptance by the FDA.

Watch this webinar to find out how to best prepare for conducting and managing IND-enabling nonclinical studies and meeting FDA guidelines.

Topics will include:

Critical aspects of nonclinical laboratory qualification
Obtaining comparable laboratory quotes
Logistics of study startup through reporting
Monitoring best practices
Ensuring GLP compliance and regulatory acceptance by the FDA

Please note: If we do not attend to your questions, we may follow up afterwards.
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IND-Enabling Nonclinical Studies: Are You Prepared?

미국 식품의약국(FDA)의 임상시험계획 승인신청(IND)에 필요한 비임상 연구를 완료하는 것은 신약을 임상으로 진행하기 위한 중요한 단계입니다. 임상시험이 비임상시험 관리기준(GLP)과 같은 관련 규제 요건 및 FDA 및 국제의약품 규제조화 위원회의 지침에 따라 연구를 수행하고 있는지 확실히 하는 것은 FDA의 승인을 보장하고 임상시험 보류 없이 IND 개시 임상시험이 진행될 수 있도록 하는데 필수적입니다.

위탁된 동물 임상시험의 경우 임상시험 설계, 수행 및 보고를 비임상 실험실에만 의존하는 경향이 있습니다. 하지만, 이러한 실험실과 임상시험 책임자들은 많은 경쟁적인 압박을 받고 있으며, 의뢰자들은 임상시험이 적절한 주목을 받고 있는지 확인하기 위해 해당 임상시험에 대한 적절한 감독을 제공하는 것이 중요합니다.

또한 IND에 필요한 임상시험은 의뢰자로부터 설계, 수행 및 보고에 대한 상당한 인풋을 필요로 합니다. 해당 규제 요건을 충족하는 임상시험을 수행할 수 있는 적절한 프로세스와 통제력을 실험실에서 보유하고 있는지 확인하는 것이 중요합니다. 또는 그렇지 않은 경우, 실험실에서 필요한 사항보다 보다 많은 인풋과 관리를 제공할 수 있는 적절한 프로세스와 통제력을 갖추고 있는지 확인하는 것이 중요합니다. 과학적 결과는 약물에 의존하지만, 본 웨비나에서는 FDA의 규제 수용을 보장하기 위해 비임상/독성 연구를 설계, 계약, 모니터링 및 보고하기 위한 실질적인 지침을 제공할 것입니다. 

강의 내용 (Agenda):
• 비임상 실험실 자격에 대한 주요 측면
• 비교 가능한 실험실 견적 확보 후 계약
• 보고를 통한 임상시험 개시 세부 계획
• 모범 사례 모니터링
• GLP 준수 및 FDA의 규제 승인 보장

Questions? Contact info@premier-research.com

IND에 필요한 비임상 연구 준비

In clinical research and development, comparison to a control is highly recommended by regulatory agencies for the purpose of demonstrating evidence of clinical efficacy of a drug or device. The control could be a placebo, a known standard-of-care or an available market-approved drug or device. With some diseases or certain classes of devices, a viable control (prospective or retrospective) may not be feasible for ethical or pragmatic reasons. In addition, this problem is not uncommon in the biotech and medtech industries.

This creates the need for alternative approaches for carrying out comparative evaluation. Computational Modeling and Simulation (CM&S) has been identified by the US Food and Drug Administration (FDA) as a necessary component for developing in silico trial designs, in which the comparator arm is generated using CM&S techniques. The FDA encourages the use of in silico clinical trials in which a drug or device is tested against a cohort of virtual patients, therefore providing an empirical basis for appropriate comparative assessment.

Understanding clinical outcomes, safety, effectiveness and developmental challenges early can impact the investment sponsors put forth towards a new compound or device. Innovative trial designs are needed to maximize existing outcomes data and to leverage advanced computational techniques for making increasingly better decisions, accelerate product development and decision making, while reducing overall R&D costs.

Join Premier Research and InSilicoTrials Technologies for this joint webinar and explore the potential for including in silico modeling & simulation as an integral part of the product development plan.

Please note: If we do not attend to your questions, we may follow up afterwards.
Questions? Contact info@premier-research.com

Accelerate Product Approval Using In Silico Modeling & Simulation

방사성의약품 요법은 여러 유형의 암 치료에 대한 안전하고 효과적인 표적 접근법으로 새롭게 부상하고 있습니다. 이러한 요법에 대한 임상시험들은 의미 있고 결정적인 결과를 도출하기 위해 다학제간 접근법과 신중한 협력을 요하기 때문에 복합적인 과정입니다.

본 웨비나에서는 방사성의약품의 과거 이력과 미래 전망에 대해 살펴본 후, 이러한 요법의 잠재적 이점과 요법 개발에 관한 특정한 어려움이 무엇인지 설명 드리고자 하며, 아울러 임상시험에서 규제 요구사항을 충족하는 것부터 환자를 모집하는 것까지 주요 고려사항이 무엇인지 알아보겠습니다. 주제는 다음과 같습니다.

강의 내용 (Agenda):
• Alexander Graham Bell이 라듐 함유 선원을 종양 내부 또는 근처에 배치하는 아이디어를 처음 제안한 1903년 이후 방사성의약품의 진화 과정
• 앞으로의 과제: 새 동위원소의 생산 및 가용성, 새 영상 기술, 새 표적의 발견 등에 대한 발전
• 지리적 위치에 따라 크게 상이한 규제 요구사항들
결론과 질문

Questions? Contact info@premier-research.com

종양학에서의 방사선치료요법

Every drug development program must begin with an understanding of how the relevant key stakeholders factor into the development process. It’s not just a matter of courtesy; a comprehensive examination of the roles played by all participants has the potential to produce faster and more concrete results, leading to improved patient outcomes.

Watch this webinar to learn about these and other vital product development considerations, such as:

- Developing a framework for handling multiple endpoints for the drug’s go-to-market label
- Determining the potential of adaptive design for optimizing the trial and evaluating the applicability of various adaptive design approaches
- Key interactions and questions to ask when seeking regulatory input of pivotal study designs

Please note: If we do not attend to your questions, we may follow up afterwards.
Questions? Contact info@premier-research.com

Considerations to Improve Patient Outcomes in Early Drug Development

여러 지역에 제품을 판매하려는 의뢰자는 의약품 개발 중에 발생할 수 있는 현재의 표준과  프로세스를 이해해야 합니다.
즉, 전 세계의 두  주요 규제 기관인 미국 식품의약국(FDA)과 유럽 의약품 기구(EMA)의 서로 다른 요구 사항을 인식해야 한다는 의미입니다.
이 웨비나는 승인 과정, 기관 미팅의 유형(및 비용), 신속허가 프로그램, 소아과 질환 계획 등을 비교할 것입니다.

강의 내용 (Agenda):
• FDA와 EMA가 신약 신청 프로세스에 접근하는 방법 및 의뢰자와 만나는 방법
• Breakthrough (US) 및 PRIME(EU) 지정을 통한 신속 의약품 개발 기회
• 소아용 의약품 평가를 위한 기관 요구 사항의 중요한 차이점
결론과 질문


Questions? Contact info@premier-research.com

FDA vs EMA 협력 시 규제 고려사항

Radiopharmaceutical therapy is emerging as a safe and effective targeted approach to treating many types of cancer. Clinical trials for these therapies are complex requiring a multi-disciplinary approach and careful coordination to produce meaningful and conclusive results.

In this webinar, we will look at the history and future trajectory of radiopharmaceuticals, describe their potential advantages, examine challenges specific to the development of these therapies, and identify key considerations for clinical trials, from meeting regulatory demands to recruiting patients. Topics will include:

• How radiopharmaceuticals have evolved since 1903, when Alexander Graham Bell introduced the idea of placing radium-containing sources in or near tumors

• What’s ahead: advances in production and availability of new isotopes, new imaging technologies, discovery of new targets, and more

• Regulatory requirements, which differ considerably depending on geography

Patient recruitment: overcoming misconceptions about exposure to radioactivity and management of travel for site visits and study assessments.

Key Learning Objectives:
• How radiopharmaceuticals have evolved
• Advances in radiopharmaceuticals
• Regulatory requirements
• Patient Recruitment

Questions? Contact info@premier-research.com

Tuning Into Radiotherapeutics: Considerations for Oncology Trials

Moving an investigational new drug through FDA approval can seem like a monumental task. It’s a complex and demanding journey, but understanding the steps — and how the agency works — can alleviate the stress and get your product on the path to approval. This webinar examines some key questions and issues to put you on sound footing as you begin the process.

Electronic submission of IND applications: Sponsors must submit IND applications electronically through the FDA gateway. Understand and follow the formatting rules to avoid potentially costly delays. 

Adherence to GMPs: Sponsors must demonstrate that their drug product and substance are manufactured according to good manufacturing processes, starting with Phase 1 CMC data that ensures patient safety.

Use of foreign-generated data: Study data generated outside the U.S. can support US INDs or Marketing Applications, provided those studies follow good clinical practices and meet other conditions.

Expedited pathways and orphan designations: The FDA offers several avenues to accelerate approval of new drugs: orphan designation, fast-track approval, breakthrough therapy designation, accelerated approval, and priority review. Which might apply to your product?

The regulatory timeline: We’ll walk through what our clients can expect from the kickoff meeting through critical development milestones.


Please note: If we do not attend to your questions, we may follow up afterwards.
Questions? Contact info@premier-research.com

New-Drug Development: Succeeding With the FDA

This webinar will compare approval processes, types (and costs) of agency meetings, expedited programs, pediatric plans, and more. We will discuss:

– How the FDA and EMA approach the new drug application process and meet with sponsors
– Opportunities for expedited drug development through the breakthrough (U.S.) and PRIME (European) designations
– Significant differences in agency requirements for evaluating pediatric drugs

Please note: If we do not attend to your questions, we may follow up afterwards.
Questions? Contact info@premier-research.com

Regulatory Considerations for Working with the FDA vs. the EMA

- 505(b)(2) 제품 식별
- pre-IND 및 NDA 준비 및 제출을 포함한 505(b)(2) 제품에 대한 임상 규정 마일스톤 탐색
- 505(b)(2)와 관련된 자주 묻는 질문(FAQ)과 일반적인 오해 해결

FDA 허가 프로세스 505(b)(2) 경로, 이것은 무엇인가요? Pre-IND와 NDA제출(Submission)은 무엇을 의미하나요?

505(b)(2)

pre-IND and NDA

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FDA 허가 프로세스 505(b)(2) 경로, 이것은 무엇인가요? Pre-IND와 NDA제출(Submission)은 무엇을 의미하나요?

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