As compared to IV route, ODT can provide a convenient oral route of administration for proteins, peptides and vaccines. Join experts from Catalent for an overview of the challenges and opportunities in using ODT technology as a patient-centric drug delivery tool and get updates on the new developments in ODT technology including delivery of peptides and vaccines.
With transformational changes in biologics, there are increasingly newer formats of new biologic drugs including bispecific antibodies, antibody drug conjugates and antibody-peptide fusion proteins.
The complex structure of Biologics, the nature of the interactions with their partners, require accurate modelling method to predict their physicochemical properties.
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.
Explore how to leverage the major clinical supply centers of China, Singapore and Japan to support clinical trials within the Asia-Pacific region for both local and global study sponsors.
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.
Maintaining product integrity of supply can be especially challenging for biologic and biosimilar studies as the investigational and reference products will almost certainly require cold chain handling.
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