Actym Therapeutics, Inc.的动态

Assessing the likelihood of the success of a new pharmaceutical treatment requires context. Learn more about one way to look at that contextual information at the link below.

Free virtual FDA workshop 25APR2024, 9 AM - 1 PM ET. "This virtual workshop will be hosted by the newly established FDA Center for Drug Evaluation and Research (CDER) Quantitative Medicine Center of Excellence (QM CoE). The purpose of this workshop is to introduce the CDER QM CoE, providing an overview of the scope, goals, and current state, while gaining feedback from the public on needs and opportunities in education, outreach, and policy." #FDA #CDER #DrugDevelopment

#CGIC24, FDA Commissioner Dr. Robert Califf reflected on the early days of Critical Path Institute, nearly 20 years ago, "There's a whole list of achievements from this public-private partnership...part of the Critical Path Initiative and the Critical Path Institute has been the development of the methods and the playbook," he said. C-Path’s CEO Klaus Romero, was also joined by FDA members Peter Stein, and Celia Witten, plus European Medicines Agency member Spiros Vamvakes (virtually) to discuss the impact of global public-private collaborations on drug development. Public-private partnerships are critical to modern drug development because of: 1. Neutrality to focus on addressing unmet needs in the process.? 2. Scientific and clinical trust in the tools generated.? 3. Global collaboration that can de-risk the process overall. #CPath #CGIC24 #FDA #DrugDevelopment #neutral #datasharing #globalhealth #collaboration #regulatoryscience

Let's talk about scientific advice (SA) procedure - focusing EMA ? Why do sponsors need SA? Developing a drug is complex, especially if it is an innovative medicine, a rare disease and/or a disease with high unmet need. Available guidance may not sufficiently respond the questions of the sponsors regarding dose, study design, patient population, quality, strategy or any other aspect of drug development. Asking for scientific advice, therefore can make companies gain time and effort while developing drugs. ? How to get prepared for a SA? Sponsors have to prepare a briefing book with an EMA template available in their website. Questions should be carefully discussed with the team and the company position should be included in the briefing book. ? When can sponsors ask for a SA? ? EMA SA is given by Scientific Advice Working Party (SAWP) which is a multidisciplinary group providing SA, established by CHMP. SAWP has meeting dates and submission deadlines pre-determined yearly. Sponsors have to take these dates into consideration when preparing the SA dossier. ? Is the SA binding? No, the advice provided is not binding and it is limited to the documents that are submitted at that time. With the scientific progress, novel findings and changing circumstances, the SA may no longer reflect Agency's perspective over time. Should this be the case, a follow-up SA may be requested. #regulatoryaffairs #scientificadvice #emascientificadvice #drugdevelopment #drugregulatoryaffairs #ema

CDER's New Drugs Regulatory Program modernization is driving efficiency and effectiveness in drug development! Learn about the initiative's accomplishments and its impact on public health. Read more on the strategic objectives that are shaping the future of medicine. #gmdpacademy #medicalaffairs #medicinesdevelopment #CDER #FDA

Last month's "Advancing Psychedelic Clinical Study Design" workshop, co-hosted by the FDA and the Reagan-Udall Foundation for the FDA, marked a pivotal moment for psychedelic drug research. ?? Aimed at tackling the unique challenges in this field, the workshop offered valuable insights, especially around the FDA's June 2023 guidance on psychedelic clinical investigations, highlighting key aspects like #RBQM and #patientmonitoring. Missed it? Watch the sessions on-demand: https://lnkd.in/gihSE2xr For more updates like this, subscribe to TRI's monthly RBQM newsletter, “The Quality Issue”. Find the link in the post comments ?? #psychedelics #psychedelictherapy #psychedelicresearch #psychedelicmedicine #psychedelic #clinicaltrials #clinicalresearch

In response to a rapid increase in the complexity of drug development and volume in the past two decades, and the anticipation that this will only continue to grow, CDER began the modernization of the New Drugs Regulatory Program (NDRP) in 2017. Since then, this initiative has seen significant achievements and impacts on public health. In this CDER conversation, Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs (OND), talks in detail about what those have been, as well as the future of the initiative. #medicalaffairs #medicinesdevelopment #gmdpacademy #CDER #NDRP #OND #FDA

?? A Leap Forward in Clinical Trials: FDA’s New Innovation Center ?? As I delve deeper into my Master’s studies in Clinical Trials Monitoring, I’m continually amazed by the groundbreaking advancements in drug development. Today, I’m excited to share one such development with you all! The FDA’s Center for Drug Evaluation and Research (CDER) has launched the CDER Center for Clinical Trial Innovation (C3TI) ??. This center is set to revolutionize clinical trials, improving their efficiency and effectiveness ??. C3TI will be a central hub within CDER, supporting innovative approaches to clinical trials, and facilitating the sharing of lessons learned across CDER’s existing clinical trial innovation initiatives. This is a huge step towards accelerating the development of safe and effective new drugs ??. Let’s celebrate this milestone in drug development and look forward to its positive impact on our industry and, most importantly, on patients’ lives ???. For more details, check out the link below ?? ??https://lnkd.in/dWp8Pxr9 #FDA #ClinicalTrials #Innovation #Healthcare

Across my time at the FDA and Industry, I have learned the importance of being an effective story teller and how this helps position a development program to receive useful insights from regulatory agencies. My collegues Matthew Hight, PhD, RAC , Joshua Taylor, PhD, RAC, and I have shared insights from our experiences engaging the FDA in formal meetings and approaches to leverage these insights while preparing for and attending Pre-NDA and Pre-BLA meetings. Please enjoy these insights as you read and share the blog post below here! #Allucent #BringNewTherapiesToLight #ClinicalTrials #DrugDiscovery #FDAApproval #RegulatorySubmissions

The FDA announced the establishment of a new Center for Clinical Trial Innovation (C3TI) within the Center for Drug Evaluation and Research (CDER). The C3TI will enable: ? Easier access to information on clinical trials for internal/external parties ? Engagement for collaborations ? Identifying resources to further support the use of innovative modalities ? Finding development programs for concerted clinical trial approaches ? Managing a Demonstration Program in 3 areas ?? Sponsors may apply to the Demonstration Program for which up to 9 proposals will be accepted on a rolling basis within a 12-month period. https://bit.ly/3Jqs8Za #Innovation #clinicalresearch #clinicaltrials