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 fantastic levels of engagement to holding on-trend conferences.
Successes include the planned sunsetting of the Knowledge Management Workstream to make room for new missions, and some workstreams – such as Host Cell Proteins – with more than 40 team members attending virtual meetings. This is a level of engagement only previously seen at face-to-face events.
The DG’s industry knowledge and close relationships with sponsors mean we will always ensure that the work program reflects industry trends and priorities.
One emerging topic creating lots of member interest is In-silico Modeling. This creates computer tools that can be used to run experiments virtually (using machine learning, AI, etc.) and help scientists to design more efficient studies for understanding the biological effect of molecules in the body. This promises the exciting prospect of performing fewer physical experiments and saving money while increasing the speed of development.
To meet members’ growing interest in this area, the DG recently held a virtual conference called In-Silico Modelling, Digital Strategies & Data Management that looked at this type of modeling and the importance of digital strategies and data management. It was an excellent opportunity to share ideas on different strategies and understand how to use models to improve predictions in process development work.
It was also a superb forum for companies to see what others are doing to reduce wet laboratory work and what organizations are beginning to do in terms of solving the problem of handling and storing incredible amounts of data. Attendees also benefited from discussing the connection between data structures, machine learning and data clean-up.
The conference was a terrific occasion for the DG to take the ‘regulatory pulse’ through the informal sharing of regulatory feedback and experience, and gather information through an in-depth benchmarking survey.
Another area gaining a lot of traction is Applied Automation. Development laboratories are increasingly using sophisticated equipment, such as robotics, to drive efficiencies – but some find there are many opportunities to maximize efficiencies when implementing these new technologies to realize their full benefits. In response, the DG has started work in this area and is looking at how equipment can be optimized to deliver these opportunities.
Industry’s focus on technology was a reason why the Phorum ran a virtual spring conference called applied process intensification and economic considerations.
Applied process intensification is a ‘golden halo’ for the industry because of the clear benefits of using technology to obtain far greater yields from a much smaller footprint than typical batch manufacturing. This is why conference attendees benefited from a wide-ranging agenda discussing the gaps, barriers and potential solutions for applied process intensification.
The meeting focused on organizations that are ‘pushing the envelope’ in applied process intensification, and what is on the technological horizon for clinical or commercial production. It also looked at justifying the applied process intensification business case and the ever-present need to consider regulatory requirements.
An innovation at the event was using the Ask BioPhorum system as a chat function to pull in the many discussion threads and facilitate a discussion beyond the life of the meeting itself. A follow-up call later in the year will highlight companies that are going beyond the laboratory-scale and moving towards pilot, clinical and commercial settings.
Process-related Impurities is another area of enormous interest to sponsors and we have been seeing how this could fit into existing workstreams. Host Cell Proteins is a strong candidate and we are exploring how this workstream can be expanded and managed without disrupting its current plans.
The DG is now starting to plan for a BPDG30 meeting on October 13–15 on Drug Product Development. The initial agenda outline is starting to shape up really well and members have already started to book their places.
The industry faces many challenges, such as trying to accelerate development timelines and do more in less time. To address this, it is looking at the principles applied to ‘accelerated development’ products’ that increasingly seem to merge with regular development pathways.
This type of challenge on accelerated timelines is why the Phorum welcomes the deeper involvement of sponsors in sanity-checking its priorities and the clarity of the program.
We are planning to increase sponsor engagement at a technical level in the CMC Considerations for Expedited Development programs to fertilize thinking. Another option is to create an aligned package of work across some of the technical and tactical workstreams, such as Viral Clearance and Process-related Impurities (to be part of the Host Cell Proteins Workstream).
These steps could lead to more sponsors and more strategic work packages linked to other workstreams from the CMC Considerations for Expedited Development programs – the teams are assessing how this could work. However, this will not detract from the sponsors’ current role in overseeing the program as a whole.
The DG has always managed the program in a practical and considered way, ensuring that engagement remains robust. Yet the latest review is bringing forward even more fascinating new missions and a spectacular increase in member engagement and the quality of our work. Watch this space.