Global Pharma Tek’s Post

Our biostatistics experts have put together a case study to show you how drug and health tech developers can assess long-term treatment effects of a drug or medical device by using shorter term clinical-study data to create pooled database analyses. Learn more. https://ow.ly/2T8S50QhQen #drugdevelopment #pharmaresearch #medtech #biostatistics #pooledanalysis

Personalized Medicine: Challenges, Milestones, and Possibilities Galyna Cordero, QPPV, Head of pharmacovigilance department, clinical expert JSC”Farmak’’ Abstract Personalized medicine represents a paradigm shift in healthcare, offering tailored medical treatment based on individual genetic, environmental, and lifestyle factors. This analytical article explores the challenges, milestones, and future possibilities of personalized medicine. Key challenges include the integration of complex genetic data, ethical concerns, regulatory hurdles, and the need for robust healthcare infrastructure. Significant milestones, such as the completion of the Human Genome Project and advances in genomic technologies, have paved the way for personalized medicine. The future holds promising possibilities, including more precise drug therapies, improved disease prevention strategies, and enhanced patient outcomes. However, realizing the full potential of personalized medicine requires addressing existing challenges through interdisciplinary collaboration and innovative solutions. If you'd like to get more actual knowledge, please follow me and subscribe to my YouTube channel: Drug safety from Galyna Cordero https://lnkd.in/dFbjtrf3 #personalized_medicine #pharmacovigilance # AI #pharmacogenomic #drugsafety #drug_safety #patientsafety #Farmak

DIA Biostatistics Industry and Regulator Forum Call for Topics is Now Open! Submit your idea by January 30th By brainstorming together, we aim to gain a better understanding of your professional needs and the type of content we should focus on for the Biostatistics Industry and Regulator Forum agenda. Please note - submission of a topic suggestion is not related to chairing a session or speaking at the forum. Participate in the DIA Biostatistics Industry and Regulator Forum Call for Topics - https://lnkd.in/egyZdVTW #Statistics #clinicaltrial #callfortopics #FDA #regulators #pharma #research Yun Wang Li Wang May Mo Renee Iacona Michelle Detry Zhenzhen Xu Joo Yeon Lee Bryant Chen Qianyu Dang Yuan-li Shen Yunfan Deng Pritibha Singh Satrajit Roychoudhury Lisa Rodriguez, Ph.D. Munish Mehra

Avoiding Biostatistical misinterpretation for Adverse events in Clinical trials is one of the top priorities in Clinical Research. Today ill discuss the topic - TEAE vs TRAE. TEAE - Treatment Emergent Adverse Events are any adverse events which occurred after the administration of the first treatment. (any TEAE might be actually causally related to the treatment but does not have to be, it could be related non causally and even non related to treatments but still documented) TRAE - Treatment Related Adverse Event is the adverse event which is also emergent after the administration of the first intervention and on, but it is confirmed to be associated with the treatment (note keep in mind that such confirmation is not easy, more strict approach is needed however in safety studies). Biostatistically speaking, not finding causal association or any other association between TEAE and Treatments does not mean the association is not there in reality. Further studies may sometimes show the causality not previously established. This is especially important to understand in Phase I and Phase II Clinical trials and collecting data for all relevant AE should be within documented within the TEAE . Also, Biostatistically speaking - a TEAE not having any direct causal association might acrually be a TRAE (Treatment related adverse event) trough other mechanisms, increasing the risk or having a specific interaction without a direct effect. Its important to document any TEAE after the first treatment and continuously reassess them and have safety first approach in Clinical Trials. Have a great Wednesday! #biostatistics #datascience #clinicaltrial #biomedical #research #pharma #analysis #adverseevents #rct

Did you miss Novotech’s informative webinar on Biostatistics in the Development and Evaluation of Advanced Therapies in China? It’s not too late! The recording of this highly insightful event is now available on demand for you to watch at your convenience. Join Dr. David Ng (VP. Biometrics & Data Management) and Dr. Yafei Zhang (Director Biostatistics), with special guest Dr. Shan Xiao (Assoc. Director Biostatistics) from Takeda as they discuss: 🔹 Overview of Statistical Methods in Innovative Drug Development. 🔹 Statistical Analysis of Advanced Therapies for Rare Diseases and Case Studies. 🔹 Considerations of Innovative Statistical Methods in FDA Review. Like to know more? Access the recording directly: https://lnkd.in/gS_tg8PG #ClinicalTrials #BioStatistics #Novotech

#Biostatistics services help #ClinicalTrials ensure the scientific validity, reliability and accurate interpretation of data. However, a sponsor or contract research organization (#CRO) may need to outsource these services on a project or study basis. Here are four reasons third-party biostatistics services are a good idea. ➡️ https://bit.ly/3TAcDDE

Awesome news regarding The Effective Statistician Conference #3 happening in November 2024! Beyond Prof. Sebastian Schneeweiss, who is best known for his outstanding work around RWE, target trials, and replicating trial results in real world data sets, we announce today a second keynote speaker: Prof. Tim Friede. Tim leads the biostatistics department at the University clinic in Göttingen (I studied there as well, which makes me really proud 🙂). He has significantly shaped our academic field and will talk about the combination of real-world and clinical trial data. The applications in this area are huge yet the challenges are not small either. You don’t want to miss out on this presentation either. And I have more news: the first panel discussion! Mouna Akacha (methods lead at Novartis), Kaspar Rufibach (method statisticians at Roche), and Nelson Kinnersley (Founder at Octo Consulting) will speak with me about how statistics can add value across the development phases. These 3 will share their outstanding state of the art overview of the industry across all phases and for both pharma and biotech. This panel discussion will surely be thought-provoking and provide you with clarity about your contribution to getting drugs to patients. You’ll get new ideas of how you can shape your environment and how to create value beyond the usual deliverables we work on. Now you have 4 options to join the conference: 1. You register for free to get access to a selected number of presentations and the networking space. 2. You get your poster, presentation or session approved and get the complete conference for free (you can submit at any time and get approved really fast now). 3. You register for the whole package (price increases on June 1st). 4. You convince your organization to sponsor the conference including a large number of free slots. Click here to learn more about the conference and all these options! https://lnkd.in/e-cWiv89 Special thanks to our Machine Learning Tier Sponsor Chrestos Concept GmbH & Co. KG!

Today Prasad Chalasani came out with a wonderful paper and code on Drug interactions. Now this is an important problem as doctors sometime miss out on possible distant side effects. In older and terminally ill patients these interactions can be detrimental and sometimes fatal. To help people understand the codebase better and possibly contribute, I have created a notion page to help understand the architecture of the code base. This document including the digging into the codebase took me about 30 mins with the help of #GenAI, #codeLLMs. This process would have taken atleast 2-3 days for any good engineer. If you need an explanation of the prompts, tools I used to come up with the anatomy of the code, update in comment and I will post a code walk through. https://lnkd.in/gDnvSKbX

Join Novotech’s Dr. David Ng (VP. Biometrics & Data Management) and Dr. Yafei Zhang (Director Biostatistics), with special guest Dr. Shan Xiao (Assoc. Director Biostatistics) from Takeda for an informative webinar on Biostatistics in the Development and Evaluation of Advanced Therapies in China. This expert panel will discuss: 🔹 Overview of Statistical Methods in Innovative Drug Development. 🔹 Statistical Analysis of Advanced Therapies for Rare Diseases and Case Studies. 🔹 Considerations of Innovative Statistical Methods in FDA Review. Like to know more? Register now: https://lnkd.in/gS_tg8PG #ClinicalTrials #BioStatistics #Novotech

NEW BLOG POST: PK/PD Basics pt 2: Compartmental Modelling Read now: https://hubs.la/Q02m_W2F0 We examine the importance of compartmental models and their applications in drug development, as well as tackling some of the key mathematical ideas behind their use to determine key PK charceteristics of new drug products. #biostatistics #statistics #blog #PK #PD #pharmacokinetics #drugdevelopment