In the bustling halls of CPHI Barcelona, BioPharma BoardRoom had the privilege to sit down with Lars Petersen, the President and CEO of FUJIFILM Diosynth Biotechnologies. we delved into the strategic vision and the pivotal role of Maja Pedersen, who recently assumed the position of Chief Quality Officer at the biopharmaceutical giant. Petersen provided insights into the organization's ambitious goals, emphasizing the importance of quality and reliability in their journey towards unprecedented customer delivery and the remarkable milestone of generating $1.4 billion in annual sales by the fiscal year ending March 2025.

The interview shed light on Maja Pedersen's return to FUJIFILM Diosynth Biotechnologies from Biogen and her unique contributions to the company's growth and success. Furthermore, Petersen detailed the critical role that Maja will play in fostering a "quality culture" within the organization and the significance of aligning quality principles with the broader mission of the company. Finally, he revealed how Maja's appointment as a member of the executive leadership team will influence decision-making and the overall direction of the company, addressing the challenges and opportunities in the dynamic field of biopharma. As the conversation unfolded, it became evident that Maja Pedersen's expertise and commitment to quality will be instrumental in the ongoing success of FUJIFILM Diosynth Biotechnologies as they strive to meet the evolving demands of the biopharmaceutical industry.

Can you provide some insights into the strategic importance of appointing Maja Pedersen as the Chief Quality Officer for FUJIFILM Diosynth Biotechnologies at this particular juncture

As we look to grow FUJIFILM Diosynth Biotechnologies over the next 5+ years, unprecedented delivery to our customers is one of our core objectives. Supporting these growth plans, we have set a goal of generating $1.4 billion in annual sales by our FY ending March 2025, and we are targeting a 20% annual growth rate beyond FY2026 through the introduction of new process capabilities, adding in-house capacity and supporting customers with mammalian production capacity.

Maja’s appointment is a key step to delivering on these goals. She brings deep expertise and a proven track record across all areas of compliance, as well as a complete understanding of GMP manufacturing. Maja understands that a proven regulatory track record is a key differentiator for us, and critical to our business. As well as her technical ability, Maja’s ability to foster and nurture cross-functional relationships built on trust makes her an asset to FUJIFILM Diosynth Biotechnologies and will support us through this tremendous growth phase.

What specific responsibilities and expectations do you have for Maja Pedersen in her role as Chief Quality Officer?

In order for us to deliver to our customers, it is essential that we embed a united quality-culture across our entire organization - spanning all functional areas and sites. Using her broad knowledge of regulatory affairs and compliance, alongside her Qualified Person designation, Maja will be responsible for the improvement and harmonization of quality processes across our global organization. 

How does Maja Pedersen's extensive experience in quality assurance and control, regulatory affairs, and external manufacturing uniquely position her to contribute to the growth and success of FUJIFILM Diosynth Biotechnologies?

As previously mentioned, unprecedented delivery to our customers is one of our key strategic initiatives as we look to achieve our growth projections. Maja has a strong understanding that reliable quality is critical along the entire project lifecycle, and that excellence and reliability are non-negotiable factors that will underpin the delivery of our goals.

It is important for us to have someone who is fully versed in pharmaceutical regulations, from a number of the major regulatory authorities. Maja’s experience in this field will ensure that we continue to offer consistent systems and process optimization across all our operations.

Could you elaborate on the significance of her return to FUJIFILM Diosynth Biotechnologies from Biogen and the key achievements she has had in her prior roles within the company?

It is no secret that I am very happy to welcome Maja back to our team at FUJIFILM Diosynth Biotechnologies. Maja brings a lot of history, alongside a wealth of experience from her time at Biogen. These attributes, combined with her mindset for quality, make her a perfect fit that we as a PDMO (Partnership Development and Manufacturing Organization) want to emphasize even further as prerequisite for our ambition to become the preferred partner providing unprecedented delivery.

Similarly to Maja, I have a been on the innovator side of the business for the majority of my career. My time in this industry has shown me that an innovator-like mindset – that is the way we understand, think and act like our innovator partners – is a critical part of who FUJIFILM Diosynth Biotechnologies is as a PDMO. In her role as Chief Quality Officer, Maja will be critical in ensuring this innovator mindset is translated across all our sites, as well as our large- and small-scale networks globally.

In what ways do you anticipate Maja Pedersen will drive a "quality culture" within the organization, and how will this culture benefit patients and customers?

A strong quality mindset anchored in a robust quality management system is key to ensuring successful delivery to all our customers. Maja embodies these qualities, and I expect her to take quality at all our sites to another level in pursuit of the highest common denominator. This is critical part of KojoX – providing an agile supply chain to our partners - and will enable us to deliver in full, on time, every time!

Maja’s role as Chief Quality Officer will support the Company by building on and strengthening our quality and regulatory track record. These factors are critical to ensure our reputation within the market and for our growth plans, which are ultimately key to our ambition to be the preferred PDMO by delivering trust, reliability, and flexibility to our partners. Commercial production – which is highly regulated - is a critical part of our offering across scales, and also why we want to ascertain smooth and fast interaction with regulatory authorities with low/no risk or uncertainties – both for FUJIFILM Diosynth Biotechnologies and the partners who trust us in manufacturing their life saving medications to millions of patients in need.

Quality and reliability are emphasized as strategic principles for the company. Can you explain how these principles align with the broader goals and mission of FUJIFILM Diosynth Biotechnologies?

We view ourselves as Partners for Life with a purpose of advancing tomorrow’s medicines. The life-impacting medicines we produce today are greatly advanced over those just a few years ago, and innovations continue to occur. In order to be able to meet the advanced demands of novel therapeutics, we need to be able to deliver right-first-time for our customers.

We understand the financial pressures of our small-scale and large-scale clients, and Maja will lead the development of harmonized, second-to-none quality systems that will withstand the due diligence of any customer.

As Maja Pedersen becomes a member of the executive leadership team, how will her role impact decision-making and the overall direction of the company?

We have built a very strong leadership team. Final pieces are coming together very nicely. As a member of the Executive Leadership team, I expect that Maja – as all other members of the Executive team – will be involved in and have a huge impact on both decisions and the direction we are setting with the Corporate Strategy for FUJIFILM Diosynth Biotechnologies. Quality is at the heart of our company and will continue to be at the center of our strategy.

What challenges or opportunities do you foresee in the field of biopharma that make having a Chief Quality Officer of Maja Pedersen's caliber essential?

Quality, regulatory compliance and reliability are three must-have deliverables that encompass all customer segments for CDMOs. To achieve this, we need to ensure thorough quality systems are established and that we have a workforce fully committed to compliance with our quality systems and standards. We also need to be able to demonstrate our regulatory experience and history, both of which are foundational for Maja to build upon and deliver to our clients across the entire product lifecycle.

Could you shed some light on any specific initiatives or projects that Maja Pedersen will lead to ensure unprecedented customer delivery and enhance the patient experience?

Following her appointment, Maja has already started making a significant impact across our sites. In particular, she has put forward an innovative OneFDB vision, of which the backbone is a best-in-class enterprise system hosting all Quality processes, and she is rolling out an all commercial excellence program across the organization with the ambition to allow approval of new molecules, faster. As you can see, she has already provided huge benefits to our customers and to the patients that they serve.

 ( editor@biopharmaboardroom.com )