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By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinicaltrials holding great hope for the treatment of challenging and uncurable diseases.
There is no denying that trial complexity is continuing to increase. Several factors in recent years have contributed to this rise including more complex trial designs, the rapid adoption of decentralisation stemming from the pandemic, and larger global trials. Demand planning drives trial efficiency.
Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. While clinicalsupply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance.
As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinicaltrials.
Avoiding “Customs Chaos” in ClinicalTrials Means Working Closely with Your Importer of Record Many global clinicaltrial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinicaltrials.
Avoiding “Customs Chaos” in ClinicalTrials Means Working Closely with Your Importer of Record Many global clinicaltrial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinicaltrials.
In this episode, you’ll learn about the world of ClinicalTrial Site Networks. There are advantages and disadvantages when it comes to being a standalone clinicaltrial site. Standalone clinicaltrial sites enjoy the freedom of running their own operations. This is where site networks come in.
Planning on running clinicaltrials in Japan? How can you reliably supply these studies? Discover Catalent’s clinicalsupply packaging facility in Shiga, Japan.
Modern software development concepts from ecommerce applications are helping eClinical applications meet the precise needs of each clinicaltrial. IRT solutions help clinicaltrial sponsors meet the complexities of patient randomization and clinicalsupply management. until the database lock of the system.
In this episode, I’m excited for you to learn about Heart Failure ClinicalTrials for medical devices. Sonna and her team successfully completed enrollment in an FDA-approved feasibility trial and are now working towards the next phase of their medical product development lifecycle. Our guest today is Sonna Patel-Raman.
Randomization and TrialSupply Management (RTSM) play a pivotal role in the successful execution of clinicaltrials. As the complexity of clinicaltrials continues to increase, especially with the rise of multi-center, adaptive, and decentralized trials, the need for robust RTSM systems has become more critical than ever.
The global landscape of clinicaltrials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinicalsupply challenges, including patient demand and reducing delays.
Analyzing the benefits and challenges of implementing direct-to-patient services in the clinicalsupply chain to help meet patient requirements, improve supply chain efficiency and accelerate speed to market.
The benefits of developing a patient-centric clinicalsupply chain.
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Unlike commercial pharmaceutical packaging, the primary consideration in clinicaltrial packaging is protecting the product quality and reliability for research. Finding the best clinicaltrial packaging services providers. Clinicaltrial packaging and labelling solutions.
The Phase I clinicaltrial that is underway is assessing SY-5609 plus chemotherapy in subjects with pancreatic cancer whose disease has advanced after Folfirinox treatment. . Tolerability and safety, as well as efficacy parameters, such as disease control rate and progression-free survival, will be analysed in the trial. .
Overview: Clinical site monitoring metrics and Key Performance Indicators (KPIs) are fundamental tools in the realm of clinicaltrial management. They provide a way to quantify and evaluate critical aspects of a clinicaltrial’s performance at individual investigative sites.
The expansion forms part of Catalent’s ongoing global strategy to increase its ability to handle, store and manage advanced therapies for clinicalsupply, and follows investments at its facilities in Philadelphia, Singapore, and Shanghai, China, in specialized, ultra-low temperature storage capabilities. With sites in the U.S.,
NUCLIDIUM has signed a strategic collaboration deal with PharmaLogic for the manufacturing and clinicalsupply of copper-based theranostics ⁶¹Cu in the US. ⁶¹Cu It will also enable NUCLIDIUM to achieve a sustainable supply of ⁶¹Cu in the US for its proposed clinicaltrials and upcoming commercialised products.
Find out solutions to mitigate the impact from clinicalsupply chain risk and discover how to improve dynamic drug supply forecasting strategies. Join this webinar to learn how supply forecasting and interactive response technology can help biotech companies improve supply planning and distribution while reducing cost and risk.
Supply chain uncertainty is a challenge every clinicalsupply chain manager wrestles with – stemming from increasing product demand and quality, the growing complexity of clinicaltrial designs and a lack of visibility in the supply chain. Accelerating your clinicaltrialsupply through digitalization.
According to GlobalData’s clinicaltrials database, there are currently 1,231 planned and ongoing trials for gene therapies and gene-modified cell therapies alone. Cell and gene therapies are not your typical clinicalsupply chain.
Collaboration provides clinicaltrial sponsors with access to the world’s most efficient clinicalsupply processes using a single contract. As a result, global clinicalsupply and operations teams can now single source their commercial drug requirements by utilizing two best-in-class solution providers.
In the fast-paced world of clinical research, Randomization and TrialSupply Management (RTSM) systems play a pivotal role in ensuring the success of trials. Late integration of RTSM means it inherits decisions made upstream in the trial process.
In the fast-paced world of clinical research, Randomization and TrialSupply Management (RTSM) systems play a pivotal role in ensuring the success of trials. Late integration of RTSM means it inherits decisions made upstream in the trial process.
In the fast-paced world of clinical research, Randomization and TrialSupply Management (RTSM) systems play a pivotal role in ensuring the success of trials. Late integration of RTSM means it inherits decisions made upstream in the trial process.
In the fast-paced world of clinical research, Randomization and TrialSupply Management (RTSM) systems play a pivotal role in ensuring the success of trials. Late integration of RTSM means it inherits decisions made upstream in the trial process.
Do consider the impact of decisions A lot of decisions get made during the design of a clinicaltrial; be they decisions on data or packaging and distribution design. Aligning RTSM with the protocol is the easiest thing to do, not least because RTSM integrates with a lot of other systems within your trial landscape.
VTX-801 is a novel investigational gene therapy to be evaluated in a Phase 1/2 clinicaltrial to determine the safety, tolerability, and pharmacological activity of a single intravenous infusion in adult patients with Wilson Disease. Pfizer is collaborating with Vivet on the clinicalsupply of VTX-801 for the Phase 1/2 clinicaltrial.
The agreement also puts in place a three year clinicalsupply agreement for the two companies. Under the terms of the deal, Oxford Biomedica will receive an undisclosed upfront payment, with additional payment related to development and manufacturing of lentiviral vectors for use in clinicaltrials.
Do consider the impact of decisions A lot of decisions get made during the design of a clinicaltrial; be they decisions on data or packaging and distribution design. Aligning RTSM with the protocol is the easiest thing to do, not least because RTSM integrates with a lot of other systems within your trial landscape.
Do consider the impact of decisions A lot of decisions get made during the design of a clinicaltrial; be they decisions on data or packaging and distribution design. Aligning RTSM with the protocol is the easiest thing to do, not least because RTSM integrates with a lot of other systems within your trial landscape.
The trial, which will explore the pharmacokinetics and safety of ATX01 in healthy volunteers, is due to start in January 2021. AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinical development of ATX01.
. “In collaboration with our partner, Novartis, our team continues to move at extraordinary speed from idea to bench to clinicaltrials, driven by a common desire to help patients against this devastating disease and help bring the world back closer to normalcy.” million doses of MP0420, if it is approved in Switzerland.
MorphoSys Forward-Looking Statements
This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding Monjuvi’s ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab-cxix, including (..)
Do consider the impact of decisions A lot of decisions get made during the design of a clinicaltrial; be they decisions on data or packaging and distribution design. Aligning RTSM with the protocol is the easiest thing to do, not least because RTSM integrates with a lot of other systems within your trial landscape.
The results were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine. Concerns of Early Deaths The expanded approvals come after the FDA had flagged reports of early deaths in clinicaltrials evaluating the therapies in earlier treatment line settings.
Originally launched in 2019 for early-phase protein therapy development, OneBio Suite offers customers an integrated service to accelerate programs from development to manufacturing, including fill/finish and packaging, and support for clinicalsupply and commercial launch. At the BIO International Convention, Carey Connolly, Ph.D.,
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Approval of amendments to PARADIGME protocol is proceeding as planned and completed in the best-recruiting countries
Designed to enlarge the eligible patient population and increase the rate of enrolment into the trial.
59 patients enrolled as of 18 November 2020.
Financial Highlights.
Data is the single most important thing in a clinicaltrial. The data serves as the cornerstone for critical decisions determining the fate of therapies and the performance of trials. The data highlights fast or slow recruitment and how the drug supply is managed. Simply put, it’s the story of the trial.
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