Accelerating the Biopharma Supply Chain

I recently attended the BIO International Convention 2024 in San Diego, CA from June 3-6, the foremost gathering for the biopharma industry. With over 20,000 industry leaders in attendance, the event offered a platform for sharing the latest advancements, covering topics such as AI and digital health, next-generation biotherapeutics, oncology, and gene therapy.

At Vector, we're dedicated to spotlighting the talent that drives innovation in the life science industry and acknowledge its pivotal role in positively impacting the health and well-being of people globally. We took our research and podcast (Talent Talkbox) on the road for this trip, speaking to and engaging several business leaders. Recognising the complexities of bringing molecules to market and the reliance on a robust supply chain, my goal was to investigate the factors influencing success and how to optimise the supply chain at every stage. I was delighted to speak with leaders from academia, innovators, CDMOs, and Big Pharma, including Pfizer, Bora Pharmaceuticals , MilliporeSigma, KBI Biopharma, FUJIFILM Diosynth Biotechnologies, PBOA - Pharma & Biopharma Outsourcing Association and Rentschler Biopharma. In addition, I met with academic institutes and Innovators who remain anonymous. This article shares the key themes from interviews, and I would like to thank all those who took part and shared their valuable insights.

United by a common goal

It was very clear that everyone I spoke to and discussed in every session at the event consistently shared one common goal: how to get molecules to market faster and safely. However, to achieve that goal, significant challenges must be addressed, whether that’s finding the right investment partner, how to blend outsourced and in-house activities, lack of workforce and talent planning, navigating upcoming legislation, or a dearth of leadership/commercial challenges skills. All of this means there isn’t a clear pathway to get groundbreaking treatments to market fast enough.

“The industry is looking to move fast and constantly thinking about how to get the molecules to market faster.” J.D. Mowery, CEO, KBI Biopharma.

Finding the Right Growth Partners

During my discussions with industry leaders, I found a strong desire to forge effective partnerships with investors and outsourcing partners, although the intention did not always seem to translate into actions. The challenge seems to lie partly between the different approaches innovators and outsourcing companies take, as they seek to collaborate effectively but often struggle to align their perspectives. This disconnect is particularly evident between younger generations who drive innovation, such as Millennials, Gen Z and Gen Y, and the outsourcing firms. Innovators may lack the knowledge and skills to pose the right questions or effectively select an outsourcing partner from the vast pool of 5000 firms.

This is a challenge recognised by Pfizer:

There is no linear pathway to approvals; we (Pfizer) understand well the role we can play with virtual biotechs early in their maturity.” GM VP Pfizer, Contract Manufacturing Business Leader

Cultural elements are also becoming important with outsourcing companies. How does the outsourcer show up and behave with the innovators? Often, the language that is being used is no longer corporate; in fact, it is far from it. This presents a significant obstacle in accessing the expertise and fit required for scaling up, navigating regulatory processes, and making informed decisions about outsourcing partnerships. As a result, valuable lessons can be learned from a business and talent standpoint to bridge this gap and optimise collaboration.

People and talent

Biopharma companies focus heavily on bringing their molecules to market, often prioritising scientific research over operational and commercial expertise. They encounter difficulties scaling up production, navigating regulatory pathways, and identifying suitable outsourcing partners. With limited resources and expertise, there’s a danger they enter into partnerships with a great commercial deal but with no people plan to scale and succeed. As the industry evolves at pace, thinking critically about the breadth and depth of skills required both now and in the future - commercial, leadership, data and technology, and relationship building – will build a competitive advantage.

Data and AI

The dialogue about the potential of AI is ongoing in our industry, as service providers seek to understand its potential at every stage of the supply chain. From my conversations with industry leaders, it was evident that they see the potential to transform the industry in different ways:

• Accelerate the pace of innovation and time to market.
• Enhance the predictiveness of molecule success through simulations, expediting early-phase development.
• Capability to process and analyse vast amounts of data, with a commitment to prioritising patient safety.
• Prioritising fact-based decision-making augmented by technology and processes.

Service providers are proactively embracing AI's potential to drive transformative improvements while prioritising ethical and safe practices.

‍

Upcoming Legislation: BIOSECURE ACT

The BIOSECURE Act is a pivotal piece of US federal legislation designed to thwart the access of "foreign adversary biotech companies" access to US federal funding. If approved by Congress, this Act aims to restrict firms receiving federal funds from engaging with specified Chinese service providers, including genomics companies such as BGI, MGI, and Complete Genomics, as well as CDMO manufacturer WuXi App Tec and WuXi Biologics. If passed, this means US and other drugmakers would need to cut ties with the Chinese contractors by 2032 to retain their spots on Medicare and Medicaid. Biotech companies are therefore urged to proactively develop contingency plans, meticulously assess their supply chain's resilience, and carefully deliberate on their choice of CDMO partners.

The impact of the BIOSECURE Act has not been fully realised, as Gil Roth, President and Founder of PBOA - Pharma & Biopharma Outsourcing Association commented earlier this year, "It is a very fast moving and fluid situation. Any company could end up on this list." Gil comments about the Act's potential impact, "There seems to be a potential for other markets to grow up around some of the areas WuXi currently operates in." The fluidity and pace of the market continue with the latest news release by Fierce Pharma citing the uncertainties of the legislative path of the BIOSECURE Act, resulting in WuXi Biologic's stock jumping.

Commenting on the current political climate at the Financial Times Pharma and Biotech Summit in New York in May, Biogen, Inc. CEO Christopher Viehbacher said,

“I don’t think it’s going to matter which administration wins in November on this subject; I think we’re seeing an increasing East-West divide, and we have to be careful because regardless of what you might think a Chinese company does with data, the fact is that we could have barriers to access people and equipment. As an industry, we don’t want to get in the way of national security,” he said. “What we have tried to do is negotiate transition arrangements because you can’t just stop clinical trials, or if you have supply, you can’t just switch a source of supply.”

In my interview, Jean-Baptiste Agnus, Chief Commercial Officer, KBI Biopharma, echoed this sentiment: “The continues to be a hot topic for our industry and customers. We will continue to see an impact on commercial discussions.”

Summary

In summary, as confidence returns to the industry, academia, innovators, investors, CDMOs, and big pharma companies must move quickly and safely to get molecules to market. Finding the right growth partner, having the right skills in the organisation, navigating the supply chain, leveraging new technology, and being agile amid a dynamic regulatory environment are all challenges that must be overcome. How to solve those issues can no longer be done in silo and require a collective effort across the supply chain.

Vector’s vision is to make assessing and engaging with a CDMO much easier. Think about the process and personas of those involved in these discussions. Do not assume the people on the other side of the table understand what and how to ask the right questions. Revisiting your playbook to engage an innovator would be a strong outcome of this research.

We are proud to play our part in building the teams that change the world. for more information about Vector, get in touch.

‍