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

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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Rudolf Riester GmbH Announces Global Market Launch of Telemedicine Solution, Showcases ri-sonic® E-Stethoscope + eMurmur® AI Integration

Rudolf Riester GmbH | January 29, 2024

Rudolf Riester GmbH, a global leader in medical technology, proudly announces the full market launch of its comprehensive Telemedicine offering. Already in active use across Europe, the Middle East, and Africa, the solution from the trusted Riester brand delivers industry-leading quality and versatility through integration of a broad range of medical devices to meet the needs of diverse user scenarios. "Since its founding 75 years ago, Riester has been a pioneer in providing accurate and efficient diagnostic devices for front-line healthcare. We have brought this passion and expertise to the creation of our telemedicine solution," said Dr. Georgiana Gasquères, Global Business Unit Director, Telemedicine at Riester. "Now we empower healthcare providers worldwide with the tools they need to deliver accurate diagnosis and exceptional care to every patient, everywhere, and to do it more sustainably." Riester is demonstrating its Telemedicine Case and Cart offerings at the Arab Health show in Dubai, 29 January – 1 February 2024, at booth SA.E30. Traveling nurses with South African healthcare innovator EQiGate are already evaluating dozens of patients every week with the Riester Telemedicine Case. "EQiGate selected the Riester Telemedicine solution for its high quality, comprehensiveness, and versatile, Windows-based compatibility with our portfolio of operating applications," stated Braam Kruger, CEO at EQiGate. "The Riester solution integrates seamlessly with our Hospital at Home concept, enabling us to bring the hospital to the patient, a healthcare paradigm shift that yields significant cost and time savings for both the healthcare system and the patient." At Arab Health, Riester is showcasing the integration of their industry-leading ri-sonic® E-stethoscope with the eMurmur® AI platform. Digital auscultation with ri-sonic and eMurmur AI enables the early detection and analysis of heart murmurs, informing better, more timely decisions about treatment pathways. To demonstrate their commitment to raising heart health awareness and improving quality of life through accurate and efficient diagnosis, Riester is offering complimentary advisory heart checks to all exhibition attendees at their booth at Arab Health, conducted by a professional cardiologist. "Our participation at Arab Health reaches beyond showcasing our technological advancements; it is about educating and engaging with the public – including Arab Health attendees – and healthcare professionals," said Irina Zhdanova, CEO of Riester. "By providing free advisory heart checks, we emphasise the significance of regular cardiac health assessments and demonstrate how innovative technology can be a pivotal tool in advancing diagnostic cardiac care to improve health outcomes. This is a perfect way to honor Riester’s 75-year heritage and act on our vision and mission." About Rudolf Riester GmbH Since its founding in Germany in 1948, Rudolf Riester GmbH has been a pioneering force in improving quality of life through accurate and efficient diagnosis on the front-line of healthcare. By developing and manufacturing high-quality, market-leading medical diagnostic products, Riester has earned a global reputation for quality, reliability, and innovation in the healthcare sector, with a presence in over 150 countries. Specializing in diagnostic devices, Riester's product portfolio includes telemedicine solutions as well as stethoscopes, blood pressure monitors, otoscopes, ophthalmoscopes, and other medical equipment. Riester is part of the Halma plc group of companies.

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Healthcare Analytics

SHL Medical partners with SteriPack Group to set up final assembly service

SHL Medical | January 24, 2024

SHL Medical, a world-leading solutions provider of advanced drug delivery systems and SteriPack Group, renowned global supplier of secondary packing and final assembly services to the pharmaceutical industry, enter a non-exclusive strategic partnership. Together, they aim to establish a pre-validated final assembly service at the SteriPack facility in Poland, enhancing the overall flexibility of supply chain strategies for their customers. In addition to SHL Medical's existing final assembly, labeling, and packaging­ services in the United States, this collaboration extends high-quality CMO options to Europe. Markus Puusepp, SHL Medical's Chief Growth Officer, expressed enthusiasm about the partnership, stating "This partnership is a significant addition to the Molly® platform value proposition. We share common values with SteriPack, from focus on the customer to a commitment to quality, making the decision to collaborate straightforward." Recognizing the importance of flexibility and time-to-market, especially in clinical production, the partnership with SteriPack will offer SHL Medical's customers highly flexible and personalized final assembly and packaging solutions. This is particularly beneficial for small batch handling in clinical supply and niche markets like rare diseases. Emphasizing the comprehensive capabilities of the Molly platform, SHL Medical aims to deliver right-sized solutions that ensure improved service, faster timelines, and a more streamlined supply chain for its diverse customer base. John Ward, SteriPack Group's VP Pharmaceutical Solutions commented "SteriPack Group looks forward to supporting SHL Medical and their customers in providing quality and flexible solutions to a fast- moving market. With an emphasis on creating service solutions designed around specific customer requirements, this partnership will make the process of working with the Molly® platform an easy decision." About SHL Medical As a world-leading solutions provider of advanced drug delivery systems, SHL Medical is the partner of choice for many leading pharma and biotech companies. Driven by its company purpose – Enabling Patients' Independence – SHL Medical offers patient-centric solutions for the design, development, and manufacturing of autoinjectors, pen injectors, as well as innovative specialty delivery systems for large-volume and high-viscosity formulations. It also offers final assembly, labeling, and packaging solutions for its drug delivery systems. In response to the rising trend in home therapy, SHL Medical has increased its developmental work in the digital healthcare sector to help improve the drug delivery ecosystem. Located across Switzerland, Taiwan, Sweden, and the US, SHL Medical's global team of experts collaborate seamlessly as one team in utilizing its comprehensive in-house manufacturing capabilities. Its solutions offer customization and optimization for each project while proactively weaving sustainability-driven measures into its designs and processes to contribute to a cleaner earth. About SteriPack Group SteriPack Group is a globally renowned contract packing and manufacturing organisation serving the pharmaceutical and medical device sectors respectively. With a strong emphasis on innovation, quality and compliance, SteriPack's services to the pharmaceutical industry include device design and development, final assembly, labelling, secondary packing, serialisation and aggregation of injectable formats including vials, pre-filled syringes, and autoinjectors. SteriPack's tailored customer-focused solutions make it an ideally suited supplier for small to medium-sized batch volumes required for a growing market of targeted therapies as well as clinical trials. Its proven capabilities in cleanroom assembly and labelling as well as secondary packing services for drug delivery systems and medical devices, combined with significant investment into growing cold chain storage capacity, have helped to make it a trusted partner to top global pharmaceutical companies.

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Health Technology

Axxess Launches New Axxess Connect Solution to Accelerate Health Information Exchange

Axxess | January 23, 2024

Axxess, the leading global technology innovator for healthcare at home, launched a new product called Axxess Connect, a groundbreaking interoperability solution. This new product will revolutionize the way Axxess users connect and share data with healthcare providers and specialists, further enhancing care coordination, improving patient outcomes and driving the future by enabling new care models and value-based care. "Axxess Connect is a new benchmark for interoperability in healthcare," says Tim Ingram, Executive Vice President of Interoperability at Axxess. "By working with our partner Kno2 we can now connect our solutions to help accelerate the exchange of health information securely across any network. This means our clients will have easier access to a broader range of providers and specialists, making data sharing and referrals more efficient." By being Kno2 Connected™, Axxess Connect, enables the secure, effortless, and maximized exchange of patient information across patients, providers, payers and HIT vendors. ­­­­The solution meets data security and compliance requirements in accordance with HITRUST and HIPAA regulation for privacy, data sharing and healthcare communication standards supported by national and regional frameworks including Direct Trust, Carequality and most recently, TEFCA. This ensures that patient data is interoperable, secured and protected when shared across systems. "Our collaboration with Kno2 not only improves the overall experience for our users, but it also reduces the administrative load on healthcare providers," said Ingram. "By minimizing time spent on administrative tasks, our clients can focus more on providing quality patient care." Added Theresa Bell, Co-founder, President and Chief Technology Officer of Kno2: "By seamlessly connecting Axxess users with healthcare providers and specialists, we are breaking down barriers and revolutionizing the way data is shared in every care setting. Axxess Connect represents the power of the partnership and the value of being Kno2 Connected. Together, we are revolutionizing care delivery and thoughtfully solving healthcare's biggest problems." Axxess Connect will first be available to Axxess Palliative Care clients before eventually being rolled out to the entire Axxess suite of solutions for home health, hospice and home care. About Axxess Axxess is the leading global technology innovator for healthcare at home, focused on solving the most complex industry challenges. Trusted by more than 9,000 organizations that serve more than 5 million patients worldwide, Axxess offers a complete suite of easy-to-use software solutions that empower home health, home care, hospice, and palliative providers to make healthcare in the home human again. Multiple independent certifications have confirmed that Axxess has the most secure and industry-compliant software available for providers. The company's collaborative culture focused on innovation and excellence is recognized nationally as a "Best Place to Work."

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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 d...

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