External engagement and influence

BioPhorum has a long-established record of providing a respected voice for the biopharmaceutical industry.

The collective strength of our membership expertise and our unique model (a highly representative, responsive and facilitated consensus group) enables us to engage with Regulatory Agencies, Standards Bodies, Pharmacopoeia, other Trade/Advocacy bodies, Innovation Hubs as well as other influential organizations. This engagement allows BioPhorum to:

  • Represent the views and concerns of our industry
  • Educate and raise awareness of our scientific and technical work and publications
  • Seek feedback to determine the regulatory acceptability of our work
  • Understand concerns and encourage industry input into on-going policy development, where appropriate
  • Identify opportunities for collaboration and partnering on behalf of our members and the industry

Membership of BioPhorum provides external engagement opportunities otherwise not available to our members as individual companies. Members are able to engage and lead discussions with Regulators to obtain direct feedback which they can feed back and apply in their own companies. Regulators welcome the opportunity to discuss with our subject matter experts; they value the technical quality and consensus basis of BioPhorum workstream outputs.

FDA meeting on EtO

January 2024

BioPhorum met with CDER and CBER to discuss outstanding questions following an earlier meeting with EPA on proposed
changes to the US Clean Air Act to cut Ethelyne Oxide (EtO) emissions

An opportunity for our member representatives to engage and present their work to the Regulator and to invite the
Regulator to become involved in our members’ work to develop an exemption process

Further meetings are likely to discuss outstanding details and potential scoping of an exemption process.

MHRA Regulatory Sandpit meeting

October 2023

Members engaged directly with the regulator to request scientific advice and actionable feedback

Authors of two BioPhorum papers attended and presented the papers, asked questions, and sought feedback

Having seen the quality of our work, the MHRA encouraged BioPhorum to feed into upcoming consultations on the development of new regulatory frameworks and signposted possible opportunities to use BioPhorum work as pilot studies for future work on ICH framework development.

EPA EtO response team delegation
meeting

October 2023

BioPhorum member companies met with the Office of Air and Radiation and the Office of Pesticides Programs to voice their concerns about draft proposals and to ask the EPA directly about the key issues

BioPhorum offered our subject matter expertise to help the EPA understand our concerns and why this is a critical issue for patient access to critical biotherapeutics and vaccines

PFAS European Commission delegation
meeting

July 2023

BioPhorum engaged with the European Commission to secure a meeting on behalf of our members. We accompanied representatives from seven member companies and met with the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs

We provided an educational presentation and explained why ECHA’s currently drafted proposals were not fit for our industry and threatened patient access to critical biotherapeutics and vaccines

BioPhorum proposed a complete exemption for direct fluoropolymers materials used in biopharma. We also proposed that the biopharmaceutical industry and the required supply chain should be considered a missing use category and be exempt from proposed restrictions where alternatives are not available.

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Join us at the forefront of this important global change.
Get in touch with our team to discuss how we can support your business to become more sustainable.

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.

Drug Substance

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.

Fill Finish

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.

Information Technology

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

Quality

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.

Regulatory-CMC

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.

Supply Chain to Patient

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.

Supply Resilience

Supply Resilience is a trusted advisory group and collaboration that is the engine for driving change across the global industry for all things relevant to the inbound supply chain. Addressing the challenges of complexity, resilience, cost, sustainability, and innovation.

Sustainability

Sustainability enables the industry’s transition to a low carbon, circular future – supporting members to improve patient health while respecting the planet. We activate multi-disciplinary teams drawn from our network to deliver environmental sustainability improvements across the value chain.

Technology Strategy

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.

DOWNLOAD
An industry perspective on understanding AAV capsid content variants
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EXTERNAL-RESOURCE
An intercompany perspective on practical experiences of predicting, optimizing and analyzing high concentration biologic therapeutic formulations
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The Drug Substance 2.0 Strategic Value Framework
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BioPhorum’s holistic approach to container closure integrity
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Digital Plant Maturity Model 3.0
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Inaugural BioPhorum Quality face to face – get involved
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The next step in building regulatory as a capability to enable strategic innovation across the BioPhorum community
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A launchpad for an improved CGT outbound supply chain
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A vision for the biopharmaceutical industry’s inbound supply chain
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Building a resilient business means adopting water stewardship
Technology Roadmap V 2.0
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BioPhorum Technology Roadmapping roadmap vision 2.0

Publications

Documents including best practices, vision statements and peer reviewed papers to help you take value back to your business.

Webinars

Discussing all aspects of the biopharmaceutical industry, from digitization and knowledge management to raw materials, supply chain, sustainability and more. Learn from the perspectives of those at the forefront of the industry.

Podcasts

BioPhorum Connect is our podcast series that keeps you up to date with the latest news and trends in the biopharmaceutical industry. From experienced professionals to thought leaders, these podcasts bring you the insights and perspectives of experts from around the world.

Tools

A variety of resources including design tools and user requirement specifications to help you improve and streamline your business processes.

Benchmarks and Surveys

Research conducted among the BioPhorum membership providing evidence to support change and identify best practice.

Browse all

Access a variety of free tools and papers and other resources designed to provide you with up-to-date information and insights to help you make informed decisions and maximize your success. Access our resources today and start making improving and streamlining your business processes.

WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
Magnifying glass over a tablet all coloured blue
DOWNLOAD
Digital Plant Maturity Model 3.0
WEBINAR
Bioreactivity testing in single-use system biomanufacturing