Posted on: 20th December 2016
The Development group have had a busy few months preparing for 2017 and are happy to report that Pfizer will be joining them in the new year.
The phorum has finalized their forthcoming program of collaboration for 2017 that includes 2 new Point Shares – Outsourcing and IND Enabling Toxicology Material and they will also be continuing to link with Technology Roadmapping and BPOG Regulatory Interaction. The team also have white papers in various stages of production from the following teams: Host Cell Protein (HCP), Monoclonality, Qualification of Scale Down models, Forced Degradation and Formulation – the latter being at the most advanced stage. All white papers include an abundance of data that would have been difficult to generate individually but collectively will help support new claims and stimulate scientific discussions both within the industry and with regulators perhaps influencing the industry and regulators in some of these concepts.
It’s also been a busy year in terms of output for 2016, the BPDG collaboration saw the first position paper published by the Viral Clearance team in the PDA Journal and presented at several conferences in Europe and North America they also initiated two new point shares in 2016: BioAssay and CMC Considerations for Expedited Development. The Point Share on Evaluation and Implementation of new technologies reached its conclusion in August. To see the first set of deliverables on imeet click here. The BPDG collaboration continues to develop benchmarking data, best practices, and industry positions. These elements are the culmination of rich debate and combined learning. These deliverables are not the end game by any means; they are the stepping-stones of a multi-year journey towards the goals of each point share.