Pharmaceutical Product Development

About: Pharmaceutical Product Development is a company organization based out in Wilmington, North Carolina, United States. It is known for research contribution in the topics: Immunotoxin & Fusion protein. The organization has 402 authors who have published 353 publications receiving 16396 citations.

Giving Voice to Clinical Study Participants: Development and Deployment of Sequential Patient Experience Surveys for Global Clinical Studies.

Abstract: Biopharmaceutical companies are piloting patient experience surveys (PES) to help enhance patient satisfaction with clinical studies. However, most PES have been conducted at study close-out, which can hinder recall and responsiveness, and at a limited number of sites, which restricts their applicability to global studies. Our aim was to investigate the feasibility of developing sequential PES, which would be deployed globally, and to provide practical recommendations based on our real-world experience. To develop sequential PES (introductory, interim, close-out), we customized a previously developed patient experience close-out survey. Extensive input was gained from multiple stakeholders (e.g., survey experts, patient advisors, psychometricians, clinical trialists, lawyers). To deploy the PES in global studies, we prepared PES-specific ethics committee submissions, training materials (e.g., slides, videos), and PES invitation aids (postcards, digital app reminders). Developing and deploying sequential PES in global clinical studies was feasible. The 3-part online PES (25 to 37 questions per survey) passed health literacy testing. To facilitate benchmarking, the PES included core questions (including a Net Promoter Score question). The PES gained ethics approval and was deployed globally in 2017–2018 in 12 phase 2 and 3 clinical studies in North America, Europe, and the Asia–Pacific. Based on the real-world insights gained and the challenges encountered, we have made recommendations for PES. Our practical recommendations on the development and deployment of sequential global PES may assist others to implement PES efficiently and effectively, allowing them to gain feedback from patients globally during clinical studies.

Synthesis of Palladium-Based Supported Catalysts by Colloidal Oxide Chemistry

Abstract: In the field of heterogeneous catalysis, the control of the characteristics of supported particles is one of the main objectives of all researchers who want to establish relationships between structure and reactivity. Catalysts with the same macroscopic composition may exhibit very different catalytic performances because of large variations of the active site properties at the nanometer scale. Because of the structure sensitive nature of most of the phenomena involved in heterogeneous catalysis, future improvements of heterogeneous catalysts, in terms of reaction rate, selectivity, stability in operation or sensitivity to poisons, will necessarily be obtained through the nanoscaled control of the physical and chemical characteristics of active sites. For this purpose, many sophisticated preparation methods have been explored including controlled surface reactions such as redox reactions, electrochemical methods, and surface grafting or physical techniques such as vapor deposition of metallic precursors. Chemical methods to prepare supported heterogeneous catalysts generally use the different possible

Groupwise Bayesian dimension reduction

Abstract: Nearly all existing estimations of the central subspace in regression take the frequentist approach. However, when the predictors fall naturally into a number of groups, these frequentist methods treat all predictors indiscriminately and can result in loss of the group-specific relation between the response and the predictors. In this article, we propose a Bayesian solution for dimension reduction which incorporates such group knowledge. We place a prior whose variance is constrained to the form of a direct sum on the central subspace and directly model the response density in terms of the sufficient predictors using a finite mixture model. This approach is computationally efficient and offers a unified framework to handle categorical predictors, missing predictors, and Bayesian variable selection. We illustrate the method using both a simulation study and an analysis of a temperature data set.

314 Cell therapy development in oncology requires a collaboration between sponsors and cell therapy experienced CROs

Abstract:

Background

From 2017 to 2022 the oncology community has seen a significant increase in the number of cell therapy clinical trials in both hematologic malignancies and solid tumors. With breakthrough designations, priority reviews and orphan drug status, cell therapy regulatory approvals in hematologic malignancies have also significantly increased during this time based on acceptable safety/tolerability and positive clinical efficacy data from single-arm studies with relatively small sample sizes. As a global CRO, PPD has gained a wealth of experience in the management of these complex cell therapy trials in hematologic malignancies and solid tumors. Project teams managing these complex trials are supported by our Immuno-Oncology Cell and Gene Therapy Center of Exellence which provides a platform for sharing of knowledge and best practices as well as comprehensive cell therapy training. Through these cross-functional monthly meetings we review safety/tolerability between the different genetically modified cell therapies as well as those that are not genetically modified. We can also identify gaps in the management of cell therapy trials that could impact study timelines and create enrollment challenges. We demonstrate our comprehensive analysis of factors that could impact enrollment into our cell therapy trials and describe proposed solutions.

Methods

We reviewed cell therapy approvals in relapsed/refractory DLBCL from 2017 to 2022 and the changing treatment options that could impact enrollment into current and future clinical trials using the IPSOS prescribing database. The Citeline-Trialtrove study database was then used to assess the number of studies competing for the same patient population.

Results

From this evaluation we identified multiple factors that could impact enrollment requiring mitigation strategies to be implemented to prevent delays to study timelines (figure 8,9).

Conclusions

By using a combination of experiential metrics and publicly available data, it is possible to identify remediable factors which could negatively impact enrollment. Rapid implementation of targeted measures can improve enrollment and keep study timelines on track (figure 9).