In this webinar Joaquina Mascarenhas, Ph.D. of Milliporesigma will discuss the following...
In this webinar Celia Landers from Milliporesigma discusses finding the optimal path to balance single-use lead times with design flexibility and supply predictability.
This webinar discusses aseptic process sampling with a focus on the regulatory aspects.
Antibody-drug conjugates (ADCs) have become de rigueur for pharmaceutical oncology drug development pipelines. There are more than 40 ADCs undergoing clinical trials and many more in preclinical development. Get the latest on novel protein modification platform and its application to generate ADCs, including new conjugation chemistries and linkers.
With the increasing complexity of biologics and growing competition, a comprehensive approach involving advanced drug delivery and development technologies, as well as cutting-edge analytical techniques is needed to support development goals. Learn about the strategies to drive biologics and biosimilar development programs and meet aggressive development timelines.
Clinical supply models need to provide for an adequate supply of patient kits that allow for variations in patient recruitment levels and clinical site activity. Traditional, or supply-led models, address this challenge by creating large quantities of finished patient kits upfront in order to create a cushion of static inventory to manage uneven demand. However, this cushion comes at a cost including lingering potential for stock-outs at high recruiting or new clinical sites, 30-200% drug waste and weeks or even months of lead time for packaging.
Widespread and diverse, the Asia-Pacific (APAC) region spans over two dozen countries where a population of over two billion and growing conduct business in more than a dozen major languages including Mandarin Chinese, English, French, Dutch, Korean, Japanese, Filipino, Vietnamese, Thai, Malay, and Khmer.
Explore how to drive excellence within the forecasting process and how to utilize forecasting throughout the study to plan for study clinical supply budgets and identify potential supply-related issues before they negatively impact your study.
As certain regions of the world are added to a clinical study, the logistical and regulatory challenges associated with clinical trial supply distribution can rise exponentially. Underestimating the often complex distribution logistics necessitated by the sensitive and highly regulated nature of clinical supplies can potentially put a study’s budget and timeline—and more importantly, patients— at risk. Standards and accepted practices in one part of the world may be unacceptable in another.
Specialized expertise in cold chain shipping and logistics are critical to avoid costly delays and potential for patient harm resulting from an interruption or delay in necessary clinical supply. Maintaining product integrity and reliability of supply can be especially challenging for biologic and biosimilar studies as the investigational and reference products will almost certainly require cold chain handling and may be high value, very limited in supply or require long lead times for new batches.
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