Regulatory Governance and External Partners (RegX)
REGx has developed from BioPhorum’s regulatory team as a program of work to truly enable cross-phorum discussions through our core set up. It aims to connect internal technical and regulatory discussions that may not happen outside the BioPhorum collaboration, strengthening internal alignment in our member organizations.
Our aims include:
- To act as the one voice of the industry to enable delivery of the industry’s technical changes rapidly and effectively
- To lead innovation in regulatory science through a team of regulatory experts who has the capability and credibility to create consensus and ultimately drive real change that enables patient’s access to our most innovative medicines
- To collaborate with other industry groups, standard organizations and regulators to make the BioPhorum positions the new standard of industry
Why collaborate?
BioPhorum’s unique ability is to link technical and regulatory innovation though professional and dedicated facilitation to make the journey to innovation better and faster
A single organization cannot change the regulatory framework, our team can and has.
How do we work?
Facilitation of complex teams
We manage technical and regulatory experts to ensure delivery of a tangible industry consensus position, truly enabling cross-phorum discussions through our core set up. And we ensure regulatory aspects are considered in parallel with scientific interests.
Third party discussions
We have directly interacted with regulators, pharmacopoeias, standard organizations and other industry groups and, where relevant, we have set up of memorandums of understanding and non-disclosure agreements. We’ve facilitated the assessment of most relevant partners to move the BioPhorum positions to industry standards.
Member discussions
We have connected internal technical and regulatory discussions that may not happen outside the BioPhorum collaboration, strengthening internal alignment in our member organizations.
Communications
We have touchpoints with L1, L2 and L3 members across the different phorums (including business development, phorum directors and account managers) for a clear communication path for best regulatory alignment and support at all stages.
Regulatory at BioPhorum
In addition to the latest Phorum launch, regulatory issues are receiving a further deep dive within our new program of work Regulatory Governance and External Partnerships (REGx). And at Phorum-specific level, there are workstream teams you can join as an existing member.
New Phorum
Regulatory CMC
BioPhorum Regulatory CMC leads innovation and transformation in the regulatory ecosystem, driving the vision for ‘One product, one dossier, one submission, one review, one approval’. It provides a dedicated space for strategic leadership and a coordinated industry voice to move from divergence to convergence.
New program of work
REGx – Regulatory Governance and External Partnership
REGx has developed from BioPhorum’s regulatory team as a program of work to truly enable cross-phorum discussions through our core set up. It aims to connect internal technical and regulatory discussions that may not happen outside the BioPhorum collaboration, strengthening internal alignment in our member organizations.
Internal regulatory teams
Cell and Gene Therapy, Development Group and Drug Substance
These teams are Phorum-specific L2 and L3 technical workstream members, with a deep regulatory focus.
A typical collaboration
An example of how we work can be shown in this example collaboration with Technical Innovation and Supply Chain Continuity to solve lifecycle management issues.
Drug Substance L2s say:
- Registered single source supply of raw materials is not a sustainable option
- COVID has revealed that our raw materials can be made unavailable to us overnight
- We want to implement changes that will make our processes more efficient and more sustainable
10 BioPhorum member companies:
- Working collaboratively between technical and regulatory SMEs to design a solution and illustrate it with a real life example
- Biomanufacturers and raw material suppliers involved
- Published paper here https://www.biophorum.com/download/biophorum-approach-to-the-registration-of-innovative-raw-materials-using-quality-by-design-principles/
REGx solution:
- There are regulatory solutions to enable lifecycle management changes but our current submissions do not allow this
- We can define recommendations that will change our submissions to make our industry more flexible
- Collaboration for global acceptance and implementation
- Presentation to FDA and EMA and others in industry: small molecules, CGT
- Regulatory sandpit – direct regulatory feedback
“Establishing partnerships with complementary organizations is an important enabler to accelerate biomanufacturing advancement and industry adoption”
Regulatory agencies
education to accelerate global harmonization and adoption of new technologies and approaches
Standards organizations (SDOs)
to transition industry best practice into global standards
Trade/Advocacy bodies
leverage each others’ knowledge, capabilities; increase industry productivity
Conferences/publications
channels to educate agencies and harmonize with the wider industry
Hubs - Regional Development agencies/academia
to align research and global investments to big challenges
Industry
horizon scanning areas of global patient importance to support existing and new modalities of medicines.
