LONG READHarmonizing the industry and improving confidence through risk-based microbial testingThe integrity of...
How do I join?
BioPhorum is a company-to-company collaboration for the industry. If your company is a member of one of our Phorums speak to your company’s BioPhorum Lead to agree how to get involved. If you do not know who your company lead is contact us. Individuals can not take out membership of BioPhorum.
If your company is not a member of any part of BioPhorum or not in the Phorum you are interested in then use the form at the bottom to contact us,and read on to learn a little more.
Is your company a member of any Phorum?
How does BioPhorum work?
BioPhorum consists on a number of distinct Phorums, each focused on a different therapy or stage in its lifecycle, or its supply chain. This creates focused communities and enables close collaboration. Companies become BioPhorum members by joining the Phorums that best match their strategic needs. Then as members, they target the workstreams in a Phorum’s portfolio that best mirror their operational priorities and engage by missioning their most suitable subject matter experts (SMEs) to act on their behalf as company representatives. These SMEs network, benchmark and contribute to a team’s collaboration, learning from each other as they go and taking better ways of working back into their company.
What benefits do companies take?
Companies commit to the collaboration because they want to be involved with the ‘in the moment’ discussions on regulatory, operational and technology challenges, find solutions to seemingly intractable problems and be part of the industry voice and be at the forefront of change. Member companies recognize the benefits they can gain from this collaboration can far exceed the cost of their membership in time and money.
The knowledge gained addressing common industry opportunities, enables SMEs to make smarter and faster decisions in their companies avoiding risks, improving business continuity, making operational savings across their networks, improving compliance and delivering therapies to market faster than would have been possible working in isolation.
While companies do not often publicly communicate the benefits taken, private conversations and a 97% membership renewal rate confirm BioPhorum is a good investment. And when they do pause to calculate returns from individual cases, it is obvious why BioPhorum has become the collaboration of choice for so many.
Some example company and industry results
- One company re-entered the Brazilian market because ANVISA simplifying their post approval changes process, as a result of BioPhorum’s work
- One company saved $1.5m in one year at one site implementing harmonized cleaning efficacy studies by following BioPhorums guidance, many others are doing the same
- The amount of stability testing in development has reduced across the industry as a result of BioPhorum benchmarking
- The number of companies adopting rapid sterility technology doubled between 2017 and 2019 due to BioPhorum collaboration
- A new buffer stock blending system was informing facility designs before it was published and is predicted to reduce capital requirements by up to $100m per new factory build
- Between $500k-$1m can be saved annually, and validation timelines improved by 6-12 months, by adopting the BioPhorum optimized shipping validation best practices for cold storage
- BioPhorum member companies have been reducing development lead-times and saving costs through better small scale model qualifications, well in advance any publication of learning
- Substantial costs of multiple engineering runs avoided thanks to the use of a validated computer model of the lyo freeze dry cycle at commercial scale
- 12,000 hours released, improved investigations and CAPA effectiveness raised through the implementation of a risk-based deviation management system
- Months of ‘zero microbial excursions’ experienced by multiple operations based on the sharing of practices in the microbial control team
- 50% reduction in repeat deviations (90% in one CMO) through the thorough adoption of human performance
How does membership work?
Being part of BioPhorum is a strategic decision. All member companies have a sponsor, a senior executive, who authorizes engagement, sets out the companies’ goals from the collaboration, confirms continuation and the payment of membership fees each year.
The sponsor will nominate a leader, typically a director with relevant network-wide responsibilities, to manage the company’s engagement. The leader is responsible for missioning SMEs to be representatives of the company in each workstream, collaborate and bring benefit back to the business.
BioPhorum appoints account managers to liaise monthly with each leader, help them navigate through the opportunities membership offers, and provide activity updates, helping them ensure value realization.
Collectively, the leaders from the members’ companies, facilitated by Phorum Leads, come together in two to three meetings each year as well as regular telecoms to discuss emerging topics, agree new missions and provide governance for the Phorum.
To bring the workstreams to life, the SME representatives attend bi-weekly or monthly workstream telecoms and, as needed, an annual face-to-face meeting. Ongoing project work may include survey design and analytics, case-study preparation, the development of best practices and mutual assistance with adoption. All workstreams are managed by experienced and impartial BioPhorum facilitators to ensure deliverables progress in a timely fashion, and to create a positive and creative environment for the team.
How much time is needed?
Each representative should typically plan for two to four hours per month of team activities, that might include shared learning, interpreting regulatory expectations and developing harmonized approaches. As SMEs are embedded in teams of peers answering shared questions, the team becomes an extended resource for them. In effect, the time invested by a company’s SMEs replaces the effort and uncertainty of solving the same problems in isolation, with the confidence they are getting aligned tested industry approaches in return.
Who can join?
Membership is only available to companies.
Membership of BioPhorum is available to licence holders, manufacturers and suppliers of materials or services in the biopharmaceutical, vaccines, cell and gene therapy, and medical device industries. In addition to paying the annual fees, companies must agree to follow and abide by the rules of the community and make an equitable contribution to the collaboration. This may include sharing benchmarking data, case studies on current practice and the development and adoption of best industry practice.
Fees are based on the realizable value each Phorum delivers to its member companies. This will be a function of the maturity of the community, its productivity, the number of active workstreams and ambition level of their missions. As such, each Phorum carries its own membership fee which is reassessed annually. Membership is valid for 12 months from time of invoice.
To learn more about membership and understand the relevant investment costs please contact us using the form below: