The power of collaboration in uncertain times

BioPhorum’s unique partnership with the biopharmaceutical industry provides our members with a safe space in which to collaborate and drive positive change. With the threat of tariffs and a national security investigation looming, how will the industry react and how can BioPhorum help members deal with the fallout? Deborah Kobewka, BioPhorum CEO, shares her view.

Developing and manufacturing biopharmaceuticals and vaccines is inherently challenging – ensuring patient safety, whilst operating in a highly regulated environment and managing billions of dollars’ investment in facilities and technology. BioPhorum’s unique and respected collaboration partnership supports the biopharmaceutical industry across the breadth of these challenges, acting as a strategic mechanism for change. In April of this year, the Trump Administration announced its intention of imposing a 25% tariff on all imported pharmaceuticals—a move designed to curb imports and encourage pharma companies to switch manufacturing to the USA. It sent shockwaves across the industry, potentially upending the long-held World Trade Organization (WTO) Pharma Agreement that had ensured zero tariffs on drugs and some products used to manufacture them. The announcement was swiftly followed by a 90-day reprieve, which sowed further uncertainty. And in a further recent turn the US Federal Court has now deemed the tariffs illegal. Parallel to all this, the US Department of Commerce Bureau of Industry and Security announced a Section 232 national security investigation into the effect of pharmaceutical imports, to determine whether they threaten US national security. They will issue their findings at a time to be determined later this year. 

The result? A high degree of anxiety and increased uncertainty across the global biopharma sector. A US withdrawal from the WTOP agreement would create significant challenges. To minimize potential impact, companies have already begun to ship finished products and raw materials as fast as possible to beat any potential tariffs. Total pharma imports to the USA exceeded $50 billion in March according to the US Commerce Dept. Such a significant increase in imports could create a false demand pull and drive unnecessary production. Indeed, impact across the supply chain could be widespread: decisions on investments, new manufacturing facilities, new drug launches, and clinical trials could all be put on hold, with a likely  knock-on effect for CDMOs too. Ultimately, patients are likely to suffer, and lives could be at risk as costs increase and supplies are disrupted. 

A collaborative united front

From a positive standpoint, our industry has seen upheaval before – from regional conflicts to global pandemics – and we’ve learned some vital lessons along the way, becoming ever more resilient and increasingly prepared. One thing is for sure; experience has also taught us that challenges are better met when we work together more closely – harnessing the power of collaboration to achieve positive outcomes.  

Perhaps most salient is how the industry dealt with the challenges of COVID-19, with BioPhorum’s support.  

Early in the pandemic, the FDA challenged biopharma to show it was able to continue manufacturing during the ongoing period of uncertainty. BioPhorum were quickly able to create a united front by pulling together 100 industry experts from multiple functional areas across biomanufacturing and conduct a risk assessment using the FDA’s own template—successfully answering the challenge.  

Across our Phorums, we were also able to help members come to a collective understanding of the key issues and priorities in such a highly stressful environment. We supported them by repositioning our ‘Ask BioPhorum’ tool as the Materials Availability Request Process, to provide an invaluable platform to connect those with critical shortage of a certain material – whether for manufacturing or a clinical trial – with those who could provide it. With little or no competitive considerations involved. We were also able to make Supply Change Notifications simpler and quicker – by streamlining the data packages used for the impact assessment process. 

Further support came though sharing information and best practice and, essentially in those early days of the pandemic, by providing a safe space for members to share their thoughts, insights, ideas and concerns. That learning has been collated, and feeds into new work on resilience in times of change and uncertainty.

A proactive approach

Whereas during the pandemic the industry had a very distinct end-goal, the current situation is less defined and will continue that way until the issue of tariffs is resolved, and the findings of the Section 232 investigation are released.  

During this time of uncertainty, BioPhorum have been continuously supporting the industry by providing guidance on building more resilience across the supply chain. This has included the publication of best practice guidance documents and tools, all of which are available for our members – and in some instances the wider biopharmaceutical industry – to download and share across their organizations. Our regular connectivity calls have provided a platform for members to share insights, and we have held discussions, roundtables and task teams in areas from tariffs to crisis response management. 

I’m particularly excited by the response to our ‘Safe Space’ Meeting held on 15 May which was attended by over 150 senior leaders – a huge response that reflects the degree of concern across our industry and highlights our members’ appetite to unite over this issue. This is supported by feedback from our members telling us that almost all of them have created top level task forces to assess the operational impact of current uncertainty. The meeting was a valuable opportunity for subject matter experts to come together and share insights anonymously into their concerns, preparations and plans. 

We also have several new discussion groups that will address specific issues at the business unit level, enabling BioPhorum members to support each other and ultimately drive efficiency and impact. Our CDMO Relationship Management team is looking at the close relationship between contract partners and the market authorization license holders, for example. We also have a new project that will address the key issues around sourcing strategies.

Experience and expertise

Fundamental to our work across BioPhorum and our member communities is our ability to offer a safe space for collaboration, skilfully curated by expert facilitators who – with extensive industry experience – create environments that help drive positive outcomes—they enable the development of real solutions that drive change from the industry for the industry.  

None of this happens overnight. Such effective collaboration only comes with trust, something we’ve worked tirelessly to build over the past 15 years – time that has also shown us what effective collaboration looks and feels like. A multitude of great minds, thinking in different ways but focused on shared issues. It’s this access to top-level thinking that BioPhorum membership brings, with valuable information and outcomes, and critical learnings shared across our community.

One voice of the industry

The BioPhorum community is valued as a trusted source because of our independence and collaborative expertise. We’re not tied to a nation state, we don’t have a sovereign responsibility to anybody, and we’re not set up like a trade association. All this means we are unique, and able to approach issues from a neutral perspective.  

This has proved advantageous in the past when dealing with organizations such as the FDA, European Commission and European Chemicals Agency, and will continue to be a significant strength in the future. Particularly during periods of uncertainty and upheaval. We are seeking to provide information to the 232 investigation on behalf of our members, for example, and we may approach the US Trade Regulator to share valuable first-hand insight into the real impact of tariffs – both on the industry and, ultimately, on patients, with expert views sourced direct from our member companies. 

In the immediate future, we will continue to provide an environment in which our members can work together to solve any operational challenges that arise from the current period of uncertainty, ultimately making sure that the critical products they make as an industry are available to as many people, in as many parts of the world as possible. And it’s only through collaboration that they can achieve that. So, we are proud to play our part in creating and providing the safe space where collaboration can take place, for the benefit of all.