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Expedited development: An overview and discussion of how accelerated scenarios impact CMC workflows and strategies

28 March 2018
Development Group
Expedited development: An overview and discussion of how accelerated scenarios impact CMC workflows and strategies
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The Development Group’s CMC Considerations for Expedited Development Point Share  presented a poster at the CASSS WCBP (2018) meeting

The poster summarizes this industry group’s collective thoughts on opportunities and challenges of CMC development under accelerated registration pathways – with a focus on breakthrough therapy designation.

The poster  and  the clear approach of the combined knowledge of 15 companies was very well received. Encouraged by the feedback received which included comments from the audience: “great to have the information in one place,” “do we have case studies, the strategies are very ‘do-able?” and “could we produce a white paper which could be used as an industry reference?”

Those presenting said that it attracted many inquires for the topic but also interest in BioPhorum,  there was a tremendous interest in both the poster and for the white paper.

The team is now gathering further information from member companies on the regulatory feedback and scientific justification and rationale used to justify risks taken and is considering preparing a white paper.

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Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

Development Group

Development Group accelerates and improves the development process of biopharmaceutical medicines for the benefit of the patient. Replacing isolation with collaboration by providing a “safe” space where subject matter experts can work on sharing solutions and best practice on emerging industry trends, implementation of new technologies and common issues whilst ensuring their intellectual property and confidentiality is protected.

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Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

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Fill Finish accelerates development and acceptance of sustainable world-class filling and packaging operations for drug product which meets the future needs of patients. Through innovative solutions resulting from the sharing of expertise, we can overcome common performance challenges and deliver on quality and regulatory compliance.

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Information Technology accelerates digital maturity across the ​global pharmaceutical manufacturing industry.

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BioPhorum Quality provides a dedicated, safe space for quality professionals from biomanufacturers and contract organizations to coalesce and enhance effective collaboration to address shared industry challenges.

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Regulatory CMC brings leaders together who have a common goal – to improve access to medicines through innovation in the Regulatory ecosystem. It provides a dedicated space for strategic leadership and a coordinated industry voice, to move from divergence to convergence.

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Supply Chain to Patient transforms the performance of global pharmaceutical clinical and commercial outbound supply chains through industry collaboration by creating transparent patient-centric, resilient and agile E2E supply chains, that consistently deliver high-quality medicines ensuring an uninterrupted supply to patients.

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Technology Strategy acts as one voice of the industry to define strategy, accelerate technology transformation and support technology translation and adoption. With a purpose of enabling the future state of flexible, resilient, sustainable end-to-end biomanufacturing.

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