?? ?????? ?????? ???????????? ???? ???? ????????, ??????'?? ???????????? ???? ???????????????? ?????? ?????? ???????????????? ?????????????????????? ??????????????: ?????????????? ???????????????????????? & ???????????? ???? ???????? ?????? ???????? ?????????????? The?Institute for Advanced Clinical Trials for Children?is excited to invite you to a free virtual webinar on Cell and Gene Therapy, part 2 of our series! Join us on December 10, 2024, at 12 pm ET/9 am PT for an enriching discussion on the science, trial designs, and ethical considerations in this revolutionary field. Our expert speakers,?Daniel Eisenman PhD, CBSP,?and? Luke Gelinas, will discuss the latest insights and challenges. Don’t miss this opportunity to enhance your understanding! Register now and let's explore the future of pediatric drug development together. Looking forward to seeing you there! ???????????????? ?????? https://lnkd.in/ewJrhJFx #CGT #innovation #researcheducation #ethics Be sure to follow us on LinkedIn and visit our website, iactc.org, to stay current on educational offerings, industry updates, and trends in pediatric drug development.
关于我们
We are an independent non-profit organization and believe that children of all ages deserve innovative medical therapies that are developed with the same level of urgency and commitment afforded to adults. The Institute works to assure that studies are designed to generate sufficient data to allow safe and effective use of new medications and devices in pediatric populations. A key factor in making this a reality is to optimize and accelerate biomedical innovation using child-centered clinical trial networks and collaboration with like-minded institutions, trial sponsors and other stakeholders.
- 网站
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https://www.iactc.org
Institute for Advanced Clinical Trials for Children的外部链接
- 所属行业
- 研究服务
- 规模
- 11-50 人
- 总部
- Rockville，MD
- 类型
- 非营利机构
- 创立
- 2016
- 领域
- Non-Profit、Clinical Trials For Children、Pediatric Research和Pediatric Drug Development
地点
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主要
获取路线
9200 Corporate Blvd
Suite 350
US，MD，Rockville，20850
Institute for Advanced Clinical Trials for Children员工
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Jeff Barrett
Chief Science Officer, Aridhia Digital Research Environment
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Albert John "A.J." Allen
Advocate for Pediatric Patients and Specialist in Pediatric Drug Development, Pediatric Drug Safety, and Pediatric Bioethics (Retired Senior Medical…
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Kim Doolan-Jennings
Senior Project Manager
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Kristen Swingle
COO | CBO | President | Nonprofit Leadership | Laboratory & Manufacturing Operations | Biotech | Cell Therapy | Biobank | Women’s Health | Private…
动态
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?? ???????????????? ???????? ?????????? ?? A word from our CMO,?Albert John "A.J." Allen,?on the importance of vaccines. In the late 1800s and early 1900s, families in the US often had 10 or more children, with many of them dying of diphtheria, whooping cough, measles, mumps, rubella ("German" measles) and more. The proof is in many cemeteries where rows of tiny headstones can be seen in older sections. My parents' generation was the first where smaller families in the US became more common - each of them came from a family with only two children. The difference was the increase in the use of vaccines, which protected millions of children who would have otherwise died. In the 1950s polio paralyzed 15,000 or more young people per year in the US until new vaccines brought it under control and sent iron lungs to museums. One of the most powerful ways of increasing the average life span in a country is to eliminate many often-deadly infectious diseases of childhood via vaccines. The lives saved and other serious effects of diseases prevented are benefits to individuals and society that far outweigh the common, but generally mild risks to individuals. It is rare for moderate or severe side effects to occur, and even then, the risk of contracting infectious diseases of childhood with their high risk or dying or disability is much higher when not vaccinated. Bottomline, the science (and this historical record) is very clear. The benefits of vaccines to individuals and society far outweigh the limited risks. Vaccines save lives. #Vaccines #protectourchildren
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? ??????'?? ???????? ?????? ???????????????? ?????????????????????? ?????????????? ???? ???????????????????? ?????? ???????????? ???? ???????????????? ????????????. Join an expert panel from diverse backgrounds as they explore the challenges and opportunities in platform trials, focusing on regulatory requirements and data analysis techniques Ultimately, the successful implementation of platform trials will help us bring new medicines to market more quickly and efficiently, advancing medical research and giving hope to patients in need of new treatments. #platformtrials #innovation #trialdesigns
Dear Fellow Statisticians, We are pleased to announce an exciting upcoming roundtable discussion as part of the ISBS Webinar Series on clinical trial innovation. The seminar, titled "Platform Trials, Shaping the Regulatory Guidance for Future Innovation," will be held on December 6th, 10-12pm EST, moderated by Peter Mesenbrink from Novartis Pharmaceuticals Corporation. The roundtable include a distinguished panel of thought leaders around complex innovative designs and platform trials which includes: 1. Bob Beckman, Professor Oncology, Biostatistics, Bioinformatics and Biomathematics Scientific Advisor to Senior VP Research Georgetown University 2. Olivier Collignon, Statistics Director, GSK 3. Franz Koenig, Associate Professor, Medical University of Vienna 4. Robert (Skip) Nelson, Executive Director, Pediatric Development, Johnson & Johnson 5. Karen Lynn Price, Vice President, Eli Lilly and Company 6. Alex Sverdlov, Senior Director, Statistical Scientist, Novartis Biomedical Research 7. Kert Viele, Director of Research, Berry Consultants Abstract: In the evolving landscape of clinical trials, the use of master protocols, especially platform trials, has increased dynamically and their use has expanded beyond a tool for evaluating multiple investigational treatments in monotherapy and/or combination therapy in oncology. The COVID-19 pandemic brought an increased need to improve the efficiency of clinical trials through platform trials. However, for many there are many unknowns and fears of the complexity methodologically and operationally that has introduced with the design and execution of platform trials (e.g. multiplicity issues, sharing of control group information concurrently and non-concurrently, handling of changes to randomization ratio mid-study to name a few issues). The FDA issued a draft guidance for industry on platform trials in December 2023 which was received considered excitement and hope for guidance on how best to address some of the common issues faced during the design, execution, analysis of data from platform trials. This distinguished panel of experts from across industry and academia will have an open discussion on many of the topics and where the guidance for industry needs to land to have the best value to Sponsors of platform trials so that we are able to bring new medicines to patients with high needed efficiently and over the shortest duration. Registration Details: Please register by December 6 using the following link : https://lnkd.in/ebw2UxSj We look forward to your participation in this thought-provoking roundtable discussion! We look forward to your participation on December 6!
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Excited to share the collaboration between the Institute for Advanced Clinical Trials for Children in the US and European Pediatric Clinical Trial Networks! This partnership is a significant step forward in facilitating pediatric clinical trials and paving the way for global drug approval. Together, we're making a difference in children’s health. Check out the full article to learn more about this collaboration and the work being done to expedite pediatric drug development. https://lnkd.in/e5Acfb3M Eva Degraeuwe, Collin Hovinga, De Maré, A., Ricardo Fernandes, Heaton, C., Nuytinck, Persijn, L., Raes, A., Vande Walle, J., & Mark Turner.(2024). Partnership of I-ACT for children (US) and European pediatric clinical trial networks to facilitate pediatric clinical trials. Frontiers in Pediatrics, 12, 1388170. https://lnkd.in/ennagghZ #PediatricResearch #Collaboration #HealthcareInnovation
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Institute for Advanced Clinical Trials for Children转发了
?? Exciting news! Our newly revised website at the Institute for Advanced Clinical Trials for Children is live! Discover a wealth of resources, including educational webinars that offer valuable insights into pediatric drug development. We’re dedicated to keeping you informed on the latest industry updates and trends. Whether you’re a healthcare professional, researcher, or industry stakeholder, we’re here to support you in advancing pediatric drug development and improving healthcare outcomes for children. Visit us today and take advantage of the resources available: www.iactc.org #pediatricresearch #iactc #education
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?? Exciting news! Our newly revised website at the Institute for Advanced Clinical Trials for Children is live! Discover a wealth of resources, including educational webinars that offer valuable insights into pediatric drug development. We’re dedicated to keeping you informed on the latest industry updates and trends. Whether you’re a healthcare professional, researcher, or industry stakeholder, we’re here to support you in advancing pediatric drug development and improving healthcare outcomes for children. Visit us today and take advantage of the resources available: www.iactc.org #pediatricresearch #iactc #education
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Proud to witness the incredible dedication of Children's Hospital Colorado to pediatric research! A huge shoutout to the amazing team of clinical trial professionals who work tirelessly every day for the well-being of our children. Your hard work and innovation set the gold standard in healthcare! Keep it up, Colorado! #innovation #goldstandard #pediatricresearch
For eight decades, Children's Colorado team members have pushed the boundaries, revolutionizing pediatric research. We've never stopped innovating, and we're always making the world a healthier place for kids. With the University of Colorado Anschutz Medical Campus, we're shaping the future of pediatric medicine: https://bit.ly/3Yn2I5P
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?? Join the Institute for Advanced Clinical Trials for Children for an insightful, free virtual webinar on Cell and Gene Therapy, part 2 of our series! Delve into the science, trial designs, unique risks, and ethical considerations surrounding this groundbreaking field. Don't miss the chance to enhance your knowledge on December 10, 2024, at 12 pm ET/9 am PT. ???????????????? ?? Daniel Eisenman PhD, CBSP Executive Director, Biosafety Services, Advarra ?? Luke Gelinas Sr. IRB Chair Director Advarra Looking forward to seeing you there! ???????????????? ?????? https://lnkd.in/ewJrhJFx Be sure to follow us on LinkedIn and visit our website, iactc.org, to stay current on educational offerings, industry updates, and trends in pediatric drug development. #CGT #innovation #researcheducation #ethics
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?????????????????? ???????? ????????????-???? Long-term follow-up in pediatric investigational products is crucial, yet it has significant challenges. Sponsors need to recognize the importance of investing in this aspect to ensure the well-being of young patients. Adequate resources and support for sites are essential to effectively track and follow up with these children as they grow. #neotates #fdaguidance #safety
?????? ???????????? ?????????? ???????????????? ???? ????????-???????? ???????????????????????????????????? ???????????? ?????????????? ???? ?????????????? ???????????????? ?????? ???????????????? This final guidance is the culmination of a long process at the FDA to develop recommendations for researchers and industry on when and how to study the long-term neurodevelopmental safety of medical products (drugs, biologics, and devices) used to treat neonates and infants, a population that is at particular risk.?The FDA has been working on this project since at least April 2015, when it held the "Pediatric Neurocognitive Workshop; Advancing the Development of Pediatric Therapeutics Public Workshop." An example where it might be helpful, and which was discussed extensively at the 2015 workshop, is with gaseous anesthetics that are often used during the neonatal period during surgeries to correct various congenital anomalies.?Gaseous anesthetics used in this way have been linked to later neurodevelopmental delays. This guidance addresses three main topics: ? Determining the Need for Long-term Neurodevelopmental Safety Evaluations, ? Factors to Consider When Developing a Plan to Evaluate Long-term Neurodevelopmental Safety ? What to Measure, When and For How Long? What impact do you think this guidance will have? https://lnkd.in/dskGehM5 Follow I-ACT to stay current with pediatric drug development topics and educational opportunities. #FDAguidance #pediatric #neonates
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?????? ???????????? ?????????? ???????????????? ???? ????????-???????? ???????????????????????????????????? ???????????? ?????????????? ???? ?????????????? ???????????????? ?????? ???????????????? This final guidance is the culmination of a long process at the FDA to develop recommendations for researchers and industry on when and how to study the long-term neurodevelopmental safety of medical products (drugs, biologics, and devices) used to treat neonates and infants, a population that is at particular risk.?The FDA has been working on this project since at least April 2015, when it held the "Pediatric Neurocognitive Workshop; Advancing the Development of Pediatric Therapeutics Public Workshop." An example where it might be helpful, and which was discussed extensively at the 2015 workshop, is with gaseous anesthetics that are often used during the neonatal period during surgeries to correct various congenital anomalies.?Gaseous anesthetics used in this way have been linked to later neurodevelopmental delays. This guidance addresses three main topics: ? Determining the Need for Long-term Neurodevelopmental Safety Evaluations, ? Factors to Consider When Developing a Plan to Evaluate Long-term Neurodevelopmental Safety ? What to Measure, When and For How Long? What impact do you think this guidance will have? https://lnkd.in/dskGehM5 Follow I-ACT to stay current with pediatric drug development topics and educational opportunities. #FDAguidance #pediatric #neonates
Considerations for Long-Term Clinical Neurodevelopmental Safety
fda.gov