Code of Conduct – BioPhorum information sharing ( v5.1 )

Introduction

BioPhorum Operations Group (BioPhorum) is a cross industry collaboration with the aim of sharing best practice in the area of Operational Excellence. Participation in BioPhorum is restricted to authorized member company representatives as described in the Principles of Membership Agreement.

While sharing information is central to the process of this collaboration, it is important to understand what information is appropriate to share. Our companies have a great deal of confidential information and intellectual property that should not be shared within BioPhorum.

This document seeks to guide the reader so that the individuals and companies involved follow the correct code of conduct and problems are avoided. It is the clear and stated intention of BioPhorum that the Group and its activities are conducted at all times in full compliance with relevant competition/anti-trust rules.

Responsibilities

It is the responsibility of every person who participates in a BioPhorum event or sharing activity to make sure they are aware of what information is appropriate to share.

When sharing third party documents on The BioPhorum Hub (or other IT systems), participants should use links to documents to avoid breaching copyright requirements.

The BioPhorum facilitators are responsible for reminding all participants of their obligations with respect to information sharing and will ensure that the relevant watermark will be included on documents.

Participants should not share outside workstream/Phorum teams unpublished material including but not limited to:

  • Ask BioPhorum or survey responses including summary data
  • Meeting preparation material or minutes of BioPhorum meetings
  • Draft papers (including but not exclusively documents currently marked Membership draft)
  • Individual opinions of representatives or their companies spoken at BioPhorum meetings
  • Industry feedback captured using tools such as virtual whiteboards, polls or surveys.

Members can share BioPhorum confidential information (including documents marked Membership published) within their own organization, but the key contact (L2) for each member should ensure confidentiality and that IP issues are highlighted to their colleagues and all applicable company policies regarding external collaboration and public disclosure are adhered to.​ All participants  are responsible for vetting information to be shared via their company’s public disclosure review processes and that all information shared is free of any ‘Confidential’ label .​

Participants’ contact details

  • Every person who participates in the BioPhorum collaboration will have access to the business contact details of other participants. These details should only be used for making contact with other participants in matters that relate directly to their work in BioPhorum.
  • Use of these contact details by participants in the following circumstances is prohibited:
  • Compilation of mailing lists and advertising or marketing of any kind
  • Creating a database of contact details in any circumstances
  • Recruitment and job advertising
  • Participants who are unsure as to whether their use of contact information is acceptable or not should refer to their BioPhorum representative.

Sharing information

The following list is representative of the types of disclosures commonly allowed by corporate policies. BioPhorum participants should review their company policies to ensure they are in compliance prior to any disclosures. Information in the following areas is typically allowed:

  • Operational excellence best practice models
  • Management approaches and philosophies
  • Organizing and planning ways of working
  • Non-product or process specific generic operating procedures
  • Information in the public domain
  • Information provided by suppliers which would ordinarily be shared with customers
  • Non-product or process specific generic engineering or technical information relating to process equipment
  • General learning and ‘context’ conclusions from QA and Regulatory activity

Sharing information from the following areas is typically prohibited by corporate policies

  • Product related information
  • Product related process data which constitutes intellectual property
  • Specific audit or regulatory inspection findings or observations
  • Product specific analytical methods
  • Specific cost numbers where a market advantage may result or a supplier might be disadvantaged
  • Information that is marked as confidential by the member company or a supplier
  • Price information of any type
  • Proprietary information including intellectual property and patented processes and equipment.

BioPhorum event participants should direct all questions regarding information disclosure to their L2 BioPhorum representatives or corporate legal departments

Cell & Gene Therapy

Maximizing the impact of the many advanced therapies under development requires that the industry comes together to improve understanding of how to develop, control and manufacture these life changing therapies.

We connect strategic thinkers in drug development and contract manufacturing organizations with the aim of ensuring harmonization and alignment around issues such as potency assays, phase-appropriate guidance for critical quality attributes, operator safety, regulatory guidelines, and C&GT-specific validation issues, as well as working toward resolving the current challenges to commercializing C&GT products. Discover more and learn about the outputs here.

Development Group

The ever-increasing need to reduce product development lead times and the opportunities to exploit innovative technologies in development are two key industry themes that remain at the forefront of our work. The Phorum successfully connects process development organizations and provides a space where subject matter experts can work on issues such as quality by design and process characterization, cell line technologies, and molecule selection. Read some of the outputs and discover how you could benefit by getting involved.

Drug Substance

Accelerating improvement, exploiting opportunities offered by innovation, and identifying best practice approaches across all aspects of the manufacturing process – these are the essential objectives

Data and digital capabilities are at the core of many of these industry challenges. Work in BioPhorum Drug Substance is informed by BioPhorum Technology Strategy, which has summarized our industry’s market drivers and trends. Capacity, flexibility, sustainability and pace all feature as requirements to succeed in a rapidly changing environment.

Find out more about what our members are currently discussing and learn about some of the successful implementations of our output.

Fill Finish

Quality and demonstrating compliance are two priorities of BioPhorum Fill Finish. Representatives of the world’s top sterile filling operations come together to develop solutions to some of the most intractable technical and regulatory challenges.To address these challenges in drug product aseptic filling (‘fill’) and secondary packaging (‘finish’) operations, our community of industry experts is working relentlessly to continually improve the pharmaceutical quality system (PQS). Together they continue to strive towards developing and implementing safe, predictable, lean, and agile processes in drug product operations. Find out more about the Phorum output here. 

Information Technology

IT and digital advances are crucial in responding to the pharmaceutical industry’s challenges around speed, cost, quality, flexibility, and sustainability. Unlocking and realizing the value in the industry’s IT opportunities is the core mission of the IT Phorum. 

The digital manufacturing facility of the future needs to consider technology advances alongside organizational perspectives while maintaining foundational security requirements. All elements must be considered in the long term to deliver systemic change toward the digital factory vision. Our members collaborate in a format that stimulates and supports industry innovation and implementation. 

Regulatory-CMC

BioPhorum Regulatory CMC is affording professionals the opportunity to shape their own collaboration program focused on challenges and opportunities across strategy, science, operations, submissions and compliance. Following a discovery program of work with Heads of Regulatory CMC, in which we identified some key topics of collaboration, we are giving you the opportunity to participate and help us to shape the final collaboration program. This will focus on, filing and review, interactions with Health Authorities, and harmonization. Our mission is not just to discuss, but to deliver applicable outputs and publications that will have an impact – learn more about how you can get involved.

Supply Chain to Patient

The pharmaceutical outbound supply chain was built on a blockbuster model and doesn’t fit the needs of the changing pipeline and new modalities currently being developed. The geopolitical challenges of recent years have shown that the outbound supply chain needs to evolve to become more agile, and resilient, and address a more expectant end-user bying on patient-centricity. Industry collaboration can accelerate improvements and transform performance in a way not possible when working independently. This Phorum is founded on the belief that learning from each other and challenging current thinking to re-imagine the supply chain can reduce costs and increase efficiency.

Supply Partner

BioPhorum SP members want the inbound supply chain for the biomanufacturing industry to be recognized as one of the best-understood and managed global supply chains. They intend to be not only a trusted advisory group but also the engine that drives change for the industry. Working together, we aim to achieve supply chain transformation that provides:

  • an enhanced robustness and resilience
  • accelerated capability and capacity to effect technology adoption
  • reduced cost of quality, and
  • industry-wide alignment on operational implementation

There’s an extensive list of Phorum successes and tangible benefits that have been delivered to define industry best practise.

Sustainability

The BioPhorum Sustainability program is jointly designed, governed, and delivered by a membership drawn from licence holders, contract manufacturers, major suppliers and niche suppliers. This dynamic partnership means that we can quickly focus on the areas that have the greatest industry impact, and we can leverage learning from each other and other sectors – the chemical industry and the built environment for example.

BioPhorum’s unique ability to build a strong coalition for change for an entire industry is now being applied to the greatest challenge of our generation. Driven by evident industry needs, Phorum members are working to develop agreed industry benchmarks, establish the ROI of sustainability investments and to increase the efficacy of implementation of members’ sustainability strategies.

Technology Strategy

With a mission to define strategies to accelerate technology transformation and support the adoption of innovative technologies, BioPhorum Technology Strategy evolved from BioPhorum Technology Roadmapping, strives to realize the technology roadmap vision 2.0.

This is being achieved through a multi-stakeholder team of member companies with collective capability and influence who are committed to driving forth industry goals associated with: Speed to market, Quality, Value, Agility and On-Demand Supply and Sustainability.

Building on industry feedback to standardize plasmid release specifications

Plasmids release specifications are critical to the manufacture of many cell and gene therapy (CGT) products, but current regulatory... read more

How to predict, optimize and analyze high-concentration biologic therapeutic formulations

Developing high-dose biologic drugs for subcutaneous injection often requires high-concentration formulations. It also needs to optimize... read more

A media fingerprinting toolbox that comes with a host of benefits

Cell culture media raw materials can contain many chemical substances, each with its own properties. While simple substances can be... read more

Why 100% visual inspection does not mean 100% defect detection

There is a common misunderstanding that 100% visual inspection (VI) of biopharmaceutical products should mean 100% detection of defects.... read more

How to bridge the data integration gap between sponsors and contract organizations

Bringing BioPhorum’s unique perspective to continuous manufacturing in biologics

Continuous manufacturing (CM) has been a goal for the pharmaceutical industry for several years. While small molecule drug substances and... read more

Supply Chain to Patient has launched!

Have your outbound supply chain costs increased? Do you want to leverage data and digital technologies more effectively to reduce... read more

Electronic data exchange – the foundation for an efficient, resilient inbound supply chain

The COVID-19 pandemic, geopolitical unrest, and military action across the world have fundamentally disrupted the assumption and practice... read more

How are you improving your environmental sustainability performance?

Climate change and global warming resulting from greenhouse gas emissions are widely recognized as the biggest threats to global health.... read more

Adding value for analytical instrument partners

Analytical instrument vendors have been integral to developing and publishing our technology roadmaps and developing product... read more

Introducing MediPhorum

The medical technology (MedTech) industry is a critical and complex sector. As highlighted during the Covid-19 pandemic, the MedTech industry provides a wide array of products and technologies that are vital to the safe and effective provision of care to many. Also, as seen over recent years, there is often the requirement for flexibility in supply, rapid development, and the introduction of new products to keep pace with global public health demands.

Advanced Wound Care and Wound Management

Advanced wound care (AWC) is the medical treatment for wounds that have not healed properly using conventional wound care products such as gauze, bandages, plasters, and wadding.

AWC involves treating chronic or complex wounds using products that are not as easily obtained over the counter. AWC can be divided into three main categories: wound healing, infection prevention, and restoration.

Drug Delivery

Drug delivery products are therapeutic and diagnostic products combining drugs, devices, and/or biological products, which enable safer and more efficient treatment due to careful and precise drug targeting, local administration, and tailored treatment.

Introducing the new MediPhorum

MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

Introducing the new MediPhorum

MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

Introducing the new MediPhorum

MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more
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