Speed to market

Every month that a treatment with potential $billion-plus of annual revenues is delayed getting to market represents 1000s to potentially tens of thousands of patients whose potential to benefit is delayed, or for life threatening conditions, is lost forever. And with the average cost of bringing a new drug to market estimated at $1.3 billion (Wouters et al JAMA. 2020;323(9):844–853), for the manufacturer each month delay can be $100m+ of lost revenues that would enable a return on those investments.

Improving speed to market, and speed across the manufacturing process, has always been a major priority for drug developers and manufacturers. The Covid-19 pandemic experience delivering new vaccines in record time to patients showed how coordinated industry, regulatory and governmental focus could achieve what was previously thought unachievable. But how to bring some of that pace safely into the day-to-day post-pandemic operations for member companies across a broad range of therapies?

BioPhorum members are focussed on collaborating to establish step-by-step speed improvements in processes, supply chains, and plant build cycles among other areas. Often this involves leveraging the benefits of digital transformation, supporting regulatory alignment, and in embedding a culture of quality and compliance to minimize risk of delays.

Many of our Phorums have extensive records of outputs that have directly impacted on the acceleration of bringing products to market. Our members work together to support improvements that ultimately mean more patients can receive benefits earlier, and the industry can maximize its ability to invest in more therapies.

BioPhorum success stories

By using a modular approach to facilities builds, members can reduce completion time by around 25%.

Accelerating multi-product biopharmaceutical manufacturing facility project lifecycle through modular design
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Establishing a standard approach could cut product submission timelines and diminish the risk of a regulatory finding.
Potential to deliver an annual saving of between $0.5m and $1m per shipping solution, as well as a 50% reduction in resource requirements.

Best practice on transport qualification
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The team shared experiences of ATMP APS processes and generated recommendations for APS processes customized to ATMPs – estimating these suggestions could reduce the APS time and cost by half.

Cell and gene therapy aseptic process simulation reflections
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Get in touch

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.

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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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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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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
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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
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DOWNLOAD
Digital Plant Maturity Model 3.0
WEBINAR
Bioreactivity testing in single-use system biomanufacturing