Q&A with Fredrik Sundberg, Global Director Strategic Customer Relations at Cytiva

Media 7 | September 17, 2021

Fredrik Sundberg, Global Director Strategic Customer Relations at Cytiva, is responsible for working with the pharmaceutical industry to improve current workflows with innovative bioanalytical solutions. He also advises on R&D projects and business development activities. Fredrik is the author of several publications on drug discovery and biosimilar strategies. He is also a member of an EMEA Pharmaceutical Industry Expert Panel, and he lectures and discusses regulatory issues with government officials and health authorities.

It is important to view drug discovery and development projects as long-term strategic activities. You could say, it is more like a marathon than a sprint.



MEDIA 7: Could you please take us through your professional journey?
FREDRIK SUNDBERG:
I am currently based at Cytiva HQ in Uppsala, Sweden, working as the Company’s subject matter expert in bioprocess market trends, analytics, and regulatory. As the Global Director of Strategic Customer Relations and Technology at Cytiva, I am responsible for working with the biopharmaceutical industry to improve current workflows with innovative methodologies and analytical solutions including validation strategies. Apart from that, I also advise on R&D projects and business development activities. Since joining the solution-provider business in 1998, I have had different roles within senior product management and strategic marketing as well as the executive commercial leadership team. For the past several years, I have been leading a Global Expert Team initiative focused on application support through strategic customer collaborations to deliver impactful outcomes with novel analytical solutions to improve drug discovery and bioprocessing operations.

Prior to Cytiva, I had various project management roles in Pfizer’s Process Development and Bio-analysis groups, where I gained extensive experience in commercial manufacturing, continuous improvement projects (Kaizen), clinical trials, and capital investment projects. Regulatory compliance has always been near and dear to my heart. I started working actively with health authorities globally already in 1995 and hold a track record including hundreds of successfully executed equipment qualification projects, plus dozens of health authority approved assays to support development programs including GMP manufacturing of commercial drugs.


M7: Cytiva recently opened a new experience and learning lab in Singapore. How will this new lab contribute to the country’s biopharma ecosystem?
FS: 
Our Cytiva Experience Learning Lab (CELL) in Singapore, established in April 2021, is an educational facility that provides access to application training in specialized bioprocessing techniques. We opened the lab in Singapore to strengthen the country’s local biopharma ecosystem and it will contribute to Singapore’s goal to be more innovative and competitive in the biopharmaceutical industry. It is also part of our expansion plans to meet the increasing demands in the region. The lab will be equipped with the latest process equipment, research tools, and digital technologies. It can provide hands-on training and know-how to both researchers and bio-manufacturers, supporting them, and bringing their innovation through development and to market more efficiently. In addition, the lab will serve as a platform for the exchange of important ideas and access to the latest technology. We will also support talent development as there is a shortage of well-trained staff in bioprocessing globally. In Singapore, we aim to be a key partner and enabler to support their ambition to be a leading economy of technology and innovation. Our expertise will make sure to facilitate the development of local R&D and digital manufacturing talent in Singapore.


In general, there are increasing demands to deliver drugs to the market faster.



M7: What are the top challenges that you see for the industry this year?
FS:
Major challenges are complex modalities, process economics, lack of trained staff, harmonization of regulatory requirements, and validation standardization. Biologics continue to go strong, but more complex modalities, such as ADCs, bi-specifics, fragments, viral vectors, etc. are increasing. New modalities require technology innovation for efficient manufacture as there are no platforms available and establishing well-characterized biological products is becoming increasingly difficult. Biosimilars are steadily increasing, here analytics really take center stage as it is very challenging to establish bio-similarity and navigate through the regulatory maze.

There is an increasingly competitive landscape with a focus on reducing COGS and accelerating time-to-market. It is challenging to optimize productivity without compromising on quality. In general, there are increasing demands to deliver drugs to the market faster. For example, COVID-19 vaccines and drugs dominated the industry in 2020. Here speedy delivery to market, security-of-supply, and innovation will continue to be critical. Manufacturing capacity is another bottleneck and there are issues around sustainability. The overall cost-pressure and need-for-speed will drive both process intensification and process analytical technology implementation, such as in-line or on-line biosensors. Digital solutions and automation are overall drivers for future efficiency, but cyber-security will continue to be a challenge together with associated complex validation issues for computerized systems.


M7: How do you maintain strong, mutual partnerships with academic and pharmaceutical customers?
FS:
By taking a true customer-and application-centric approach to address the current challenges in biopharma development and manufacturing. It is important to view drug discovery and development projects as long-term strategic activities. You could say, it is more like a marathon than a sprint. It is important to work as long-term partners and make sure to address the most pressing challenges in the best possible way. For example, when deciding upon analytical control strategy, always focus on the critical quality attributes of the customer’s drug molecule and then pick the best fit-for-purpose methods. Do not fall into the trap of “we’ll just keep on doing what we’ve always done”. It is very important to have an open mind and a thorough understanding of the client’s process and strategic objectives. This is where our decades of expertise play a key role together with our unique way of working as a true partner.


Drug pipelines are now more diverse than ever, which will require new technology and more flexibility.



M7: How are biopharma companies’ needs and values changing? How will these changes affect the decision-making process?
FS:
The industry is undergoing unprecedented change with biologics going off-patent and new treatments emerging. Drug pipelines are now more diverse than ever, which will require new technology and more flexibility. There is also a shift to local manufacturing, fueled by COVID-19 developments, which have set new standards for collaborations between academic power centers, global biopharma outfits, vendor companies, and regulators to accelerate speed to market. This puts pressure on the supply chain and security of supply. We are now expected to move faster but still meet compliance expectations. What do these changes really mean for the biopharma industry? Well, companies need to be able to develop new drugs at lower costs through process intensification and innovation, have more flexibility and adapt quickly to market changes, and be able to move from idea-to-product with entirely new levels of speed and efficiency. We’re now not only talking time-to-result but really time-to-decision. Solution-providers will need to adapt and make sure to evolve along with these market trends, customer needs, and new expectations.


M7:  If we were talking a year from now celebrating what a great 12 months it’s been for you in this role, what would you have achieved?
FS:
 My mission is to advance therapeutics and vaccines development. From that perspective, I wish to keep on channeling my 25+ years of experience towards strategic partnerships with customers to focus on innovative bioprocessing solutions and enable better characterization of complex biologics to support their development efforts of novel drugs for indications with unmet needs. Additionally, together with other key opinion leaders and health authorities, implement a globally recognized validation pathway for assays to accelerate comparability assessment and release testing.

ABOUT CYTIVA

Cytiva is a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings speed, efficiency, and capacity to research and manufacturing workflows, enabling the development, manufacture, and delivery of transformative medicines to patients. We are 7000+ associates with operations in 40 countries. Our customers are working with fundamental biological research to life-saving vaccines, biological drugs, and novel cell and gene therapies.

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AnMed Chooses XSOLIS' AI for Utilization Management in Its Hospital System

XSOLIS | February 01, 2023

On January 31, 2023, AnMed has chosen XSOLIS, the artificial intelligence company supporting healthcare systems, to remodel its utilization management across its health systems. The XSOLIS' CORTEX platform will share real-time clinical data across its connected network of providers and players. Due to the shortage of nursing staff and increased number of patients, a technology solution would provide accurate patient status from the beginning to minimize rejections and associated interactions with payers. XSOLIS will centralize AnMed's operations, track work over its three hospitals, and connect its Physician Advisor and Utilization Management teams. In addition, CORTEX's advanced case management analytics and reporting efficiencies with AnMed's electronic medical record system will enhance the leverage time of the hospital systems. Associate Vice President of Population Health at AnMed, Suzanne Wilson, said, "When evaluating next-generation utilization management platforms, XSOLIS was in a league of its own. The healthcare industry has reached a tipping point, where improved provider-payer relations are imperative to reduce administrative waste and unnecessary friction. XSOLIS will help us achieve just that through its innovative technology." (Source – Cision PR Newswire) Chief Financial Officer at AnMed, Christine Pearson, said, "This is a challenging time for provider organizations across the U.S. By providing an automated, objective view of medical necessity, XSOLIS will help increase the efficiency of our existing staff so that we can better serve our patients." (Source – Cision PR Newswire) CEO and Co-Founder at XSOLIS, Joan Butters, said, "There is a growing need for transformative solutions as providers continue to contend with a shortage of healthcare professionals and friction across the healthcare system. We're looking forward to helping AnMed transform their operations to work more efficiently internally, as well as with payer organizations." (Source – Cision PR Newswire) About XSOLIS XSOLIS, the technology solutions and data science platform, serves hospitals and payer organizations nationwide for effective healthcare systemization, enhancing data-driven decision-making and collaboration with providers and payers. Its CORTEX, an AI platform, uses real-time predictive analytics to continuously objectify medical needs and care with appropriate settings. In addition, it offers patient status evaluation through health systems, reduces the administrative burden of hospitals, and increases automation between payers, health plans, and providers-sponsored health plans (PSHPs), inpatient as well as observation status. About AnMed AnMed, a non-profitable health system upstate in northeast Georgia and South Carolina, includes four hospital systems: AnMed Cannon in Pickens, AnMed Women's and Children's Hospital, and AnMed Rehabilitation Hospital with around 3,700 employees and 400 physicians. It provides routine care, urgent care as the requirement, life-saving emergency treatment, specialized care, home health visits, and virtual visits, as well as options to schedule an appointment, pay bills, volunteer, access medical records, donate, and find a job in its hospital systems.

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