Development Group

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Development Group trends and new hot topics

Driven by the ever-increasing need to reduce product development lead times and the opportunities to exploit new technologies in development, BioPhorum Development Group (DG) has taken a detailed look at its portfolio of work and the work of its sponsors. This allowed it to reflect on where and how member companies are engaged. This was an important task and a very successful one and the Phorum is already seeing the impact in everything from...

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Key updates to Brazilian post-approval change requirements and use of Polysorbate 80 in China

The BioPhorum Post-Approval Strategy Team has been working hard in international regulatory environments over recent years and can now share intelligence on some significant breakthroughs in the key markets of Brazil and China. Brazil is planning to reduce its data requirements for post-approval change submissions, which will make it aligned with other ICH countries. While China has issued new monographs for Polysorbate 80, which means that the...

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MedTech considers drug device challenges

Following a positive response to BioPhorum’s proposal for a new collaboration in the combination products space, representatives from eight BioPhorum member companies gathered in early May to agree a plan for developing a MedTech Phorum program. Ten stakeholders joined the kick-off call and brought more than 125 years of combination product experience spanning functions across the full product lifecycle, including device design and engineering,...

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Expedited development: Leveraging prior knowledge (PK) for marketing approval filings in accelerated settings

This presentation details the benchmark survey conducted by the member companies of the CMC Considerations for Expedited Development Point Share .  The purpose of the survey was to help members understand how companies are defining and using Prior Knowledge (PK) to support marketing approval (eg BLA) filings in accelerated settings. The survey was completed by 16 companies and covers 11 key questions including, types of data considered as PK, how PK is obtained and used, the form of PK, and perceived and real benefits

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Microchip electrophoresis and novel excipients: learnings and opportunities

Development Group’s (DG) mission focuses on better and faster process development of biopharmaceutical medicines. Formed in 2011, DG now has more than 700+ subject matter experts collaborating in teleconferences every month across 13 collaboration workstream topics. There are also three face-to-face meetings (currently virtual) throughout the year with subject matter experts and key opinion leaders collaborating on the key hot topics and...

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Start your procurement journey with the right approach to knowledge management

Many IT systems allow information capture, storage and retrieval. And with the advent of advanced analytics and ‘big data’, more and more data can now be connected. However, the way data is transformed into information and then knowledge requires careful consideration. This is why the BioPhorum Knowledge Management Workstream has published a User Requirements Specification for a Knowledge Management System for Use in a Biopharmaceutical Setting...

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Knowledge mapping for the biopharmaceutical industry: A test case in CMC business processes from late-stage development to commercial manufacturing (paper and tool)

The management of knowledge in biopharmaceutical organizations has been recognized as an important challenge over recent years. Defining the pain points and designing successful knowledge management (KM) solutions have proven difficult. To address this challenge, BioPhorum Technology Roadmapping applied a KM best practice methodology to capture a process-based knowledge map for a major business process; this was performed by companies who develop and commercialize new therapies. The resulting assessment of knowledge flows revealed that there are significant challenges to both explicit and tacit knowledge flow across the control strategy and method development / technology transfer processes. Some generalized solutions have been proposed. As part of this work, a detailed spreadsheet tool was developed so that organizations can repeat this work on their business processes to understand their knowledge–flow issues and develop fit-for-purpose solutions.

The knowledge mapping tool is available here. Detailed instructions are available within the tool itself. The data in the sheet reflects that used in the illustrative example documented in the companion paper. The data is intended to be removed and replaced with end users data in support of their own KM efforts.

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New ideas on forced degradation studies

Forced degradation studies (FDS) are a crucial part of the drug lifecycle process because companies need to fully understand their molecule, including how it reacts to different stress conditions. However, there is a lack of clear regulatory guidance on how, when and why to undertake FDS—only that they should be performed to understand a product further. This means many companies commit a huge amount of time and money to these studies, and use...

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