As regulatory complexity and scrutiny continue to grow, collaborative industry bodies are, without doubt, the most effective way for industry to determine how to meet regulatory guidance through ‘strength in numbers’ using a ‘common voice’. This is at the core of BioPhorum’s approach.
While direct interaction is one route to engage with agencies, a few conferences have audiences with large numbers of agency representatives who want to learn from industry and understand the latest trends in CMC initiatives, novel platforms, new technologies, product submissions, etc. One of these is the CASSS WCBP annual conference, which attracts many leaders and topic specialists from global agencies, especially the FDA.
The WCBP conference has become an established vehicle for BioPhorum teams to share the outputs of their work and link them to regulatory conversations – all to accelerate biomanufacturing advancement and the implementation of progress and change. BioPhorum has partnered with CASSS since 2015 and is part of the organizing committee. Our sessions have the common thread of providing industry positions on important challenges and we supply expert speakers as session chairs, presenters and panel members.
The CASSS WCBP conference takes place every year in Washington DC at the end of January. This year, BioPhorum had seven topics on the agenda and all were successful in engaging agencies and global networks of regulatory stakeholders. Sessions included:
In-Line Monitoring and Real-Time Release
A plenary workshop on the collaborative transformation of the biopharmaceutical industry introduced BioPhorum’s In-Line Monitoring and Real-Time Release initiative. RTR has been attempted in small molecule, but with limited success. However, it has potential game-changing opportunities for large molecules and is a crucial component of BioPhorum’s Biomanufacturing Technology Roadmap.
The session allowed agencies to do some ‘horizon scouting’ on ILM/RTR developments, which was very well received. Audience feedback highlighted how technology, IT experts and suppliers – whether of raw materials or the technologies – will need to collaborate to provide a single, joined-up approach to this complicated but essential innovation.
The session was well received and saluted by several agency representatives, acknowledging how difficult ILM/RTR is but noting that BioPhorum’s project scope and collaborative approach is very well placed to make it a reality.
Challenges in China
A workshop on the compliance challenges in China included discussions on the recent BioPhorum concept paper. Although improving, China continues to be a complex and fluid regulatory landscape for biomanufacturers, which the BioPhorum team is continually working to improve.
While others may speak about the problems surrounding China’s regulations on the registration of excipients and packaging materials, the BioPhorum team has been designing the solutions. It had strong support from the audience to engage the supply base and join with industry to form a single and common voice to help align China’s raw material requirements to global ICH guidelines.
Charlene Craig, Director, CMC-Global Regulatory & Safety Sciences at Bristol-Myers Squibb, facilitated the ‘Linking CMC to Clinical’ round table session and said the topic and proposed questions attracted a lot of people. “We had to divide into two tables and request another lead and scribe for our session. The session shared experiences in setting patient-centric specifications and continued the industry dialogue originally initiated by another of our Development Group experts – Taro Fujimori at the 2019 CMC Strategy Forum.” The Development Group CMC Regulatory Team will be considering how best to follow this up, possibly via direct engagement with regulators.
‘Prior knowledge’ was a theme throughout much of the meeting as it is being used in many ways to advance drug development. Athena Nagi, Director of Global Technical Operations – Biologics at Merck, said the WCBP conference was an excellent opportunity to represent the BioPhorum Development Group especially in the plenary session on ‘Putting prior knowledge to immediate use’.
“The session included a summary of Biophorum’s Prior Knowledge survey,” said Nagi. “Feedback from attendees underscored the consensus from the survey’s participants: that companies are in different stages of a ‘journey’ to incorporate and leverage prior knowledge to accelerate development. They were excited to see BioPhorum’s concrete examples of how this can be accomplished. Attendees were happy to see a broad swathe of industry representation and participation from BioPhorum.”
When other presentations in the session on Prior Knowledge had shared aspirational views, BioPhorum shared the ‘current state’ and demonstrated that there are pockets of industry already putting the concept into practice, while acknowledging that there is still a lot of work needed to close this gap. Several people commended Nagi’s presentation, including non-members interested in joining the team or those wanting to keep in touch about further developments.
As well as the success of the formal sessions, BioPhorum speakers and facilitators enjoyed informal 1:1 conversations with agencies from the Americas, Europe and Africa; these contacts continue to successfully build BioPhorum’s reputation as an industry voice that can accelerate biomanufacturing advancement. We look forward to commencing the planning for next year’s event in the coming months.