BioPhorum Regulatory CMC

As regulatory professionals navigate a complex tapestry of evolving requirements on a global scale, our goal is to harmonize approvals, envisioning a future of “one product, one dossier, one submission, one review, one approval.”

The regulatory ecosystem, transitioning from static, paper-based processes, is at an inflection point as it adapts to the digital age. Regulatory bodies are shifting towards a data-driven approach, compelling life sciences organizations to swiftly adapt and devise their own digitalization strategies, led by the collective expertise of you, the industry experts our esteemed members.

Become a member and experience a collaborative platform where members, under the guidance and leadership of industry experts, actively shape and drive change. Our Phorum supports industry leaders in crafting innovation strategies, fostering a unified industry voice, and aligning towards a harmonized future. Our collaborative ambition is to reduce approval timelines, enhance interactions with health authorities, and advance towards more inclusive representation of the biomanufacturing ecosystem for the benefit of all patients.

Are you ready to become a member? Make an enquiry today.

Challenges

The biopharmaceutical industry is working at the forefront of novel treatments and therapies but with the dominance of small molecules, ensuring that their voice is heard and considered when regulations are updated and adapted remains a challenge. Moreover, the regulatory approval process itself is outdated, cumbersome and sorely in need of change to embrace the digital revolution.

To address these challenges, our Phorum members have identified three key strategic objectives that guide our work:

Harmonization: one product, one standard, one submission, one review

Globally harmonized approvals process and standards offers the biggest impact in reducing time to market and getting essential medicines to patients as quickly as possible. Patients should be able to obtain access to life saving medicines quickly and safely no matter where they reside in the world. The COVID-19 pandemic illustrated this is an achievable goal to strive for. Our members collaborate with a variety of different stakeholders to advance work in harmonization efforts.

Interacting and engaging with health authorities

Health authorities, standards bodies and local agencies are all key stakeholders in the regulatory approvals process. With so many new innovations and modalities on the horizon, it is clear they need to update their approaches to further patient access, unlocking the expert knowledge inherent in the biopharmaceutical sector for the mutual benefit to all. Establishing effective ways of collaborating with health authorities whilst respecting their autonomy and critical role in patient safety is a key challenge our members are coming together on.

Transformation and digitization

Data-driven ways of working are permeating the biopharmaceutical manufacturing industry at pace. Yet regulators are only beginning to embrace this, leading to different rates of maturity, understanding and adoption worldwide. Moreover, a digital and data-driven regulatory dossier would do much to support the one dossier approach so key to harmonization efforts. The landscape is at present confusing and chaotic, our members are striving to use their collective knowledge to establish a roadmap for the future.

BioPhorum delivers very commendable and important work in the field of regulatory, with many more deliverables than other regulatory groups.
BioPhorum member

Contact BioPhorum Regulatory CMC

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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 Partner

Supply Partner 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
DOWNLOAD
The Drug Substance 2.0 Strategic Value Framework
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DOWNLOAD
BioPhorum’s holistic approach to container closure integrity
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DOWNLOAD
Digital Plant Maturity Model 3.0
NEWS
Inaugural BioPhorum Quality face to face – get involved
PODCAST
The next step in building regulatory as a capability to enable strategic innovation across the BioPhorum community
PODCAST
Delivering a Cell and Gene Therapy Outbound Supply Chain Pathway for the Industry
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DOWNLOAD
A vision for the biopharmaceutical industry’s inbound supply chain
NEWS
A major milestone – a harmonized approach to product carbon footprint data
Technology Roadmap V 2.0
DOWNLOAD
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