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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Zynx Health Introduces Complimentary Monkeypox Order Set and Care Plan Bundle

Zynx Health | September 20, 2022

Zynx Health announced that it has published new order set and care plan guidelines to aid clinicians in the treatment of patients diagnosed with monkeypox. Created by the Zynx Clinical Team and based on recommendations from World Health Organization and the Centers for Disease Control and Prevention, the content is available as a single, downloadable PDF on the Zynx Health website. Given the public health emergency, this content is being made available at no cost. “As monkeypox cases continue to rise, and with hospitals still facing shortfalls in the wake of the COVID-19 pandemic, our Zynx clinicians have developed and deployed this comprehensive order set and care plan bundle to alleviate the burden of researching the underlying evidence and then building the associated clinical decision support from scratch,” said Chuck Tuchinda, MD, president of Zynx Health. “The monkeypox content on the Zynx site is comprehensive, evidence-based, and ready for use.” The Zynx Clinical Team will continue to update its monkeypox care guidance as new evidence emerges and best-practice recommendations evolve. About Zynx Health Zynx Health, a market leader in providing evidence- and experience-based clinical improvement solutions since 1996 and part of the Hearst Health network, provides healthcare professionals with vital information and processes that guide care decisions and reduce complexity across the entire patient journey in a way that leads to healthier lives for all. Named the “Best in KLAS” Category Leader for Clinical Decision Support – Care Plans and Order Sets in 2021 and 2022, Zynx is a pioneer and market leader in evidence- and experience-based clinical solutions that help health systems improve patient outcomes, financial outcomes, clinical engagement, and technology performance. With Zynx Health, healthcare organizations exceed industry demands for delivering high-quality care at lower costs under value-based reimbursement models. About Hearst Health The mission of Hearst Health is to help guide the most important care moments by delivering vital information into the hands of everyone who touches a person’s health journey. Each year in the U.S., care guidance from Hearst Health reaches 85% of discharged patients, 205 million insured individuals, 103 million home health visits, and 3.2 billion dispensed prescriptions. The Hearst Health network includes FDB Zynx Health, MCG, Homecare Homebase, and MHK. Hearst also holds a minority interest in the precision medicine and oncology analytics company M2Gen.

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HEALTH TECHNOLOGY

Veranex Expands European MedTech Capabilities With Acquisition of Medidee

Veranex and Medidee Services | September 21, 2022

Veranex, the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry, announced that it has acquired Medidee, a top MedTech consultancy company headquartered in Lausanne, Switzerland. As a trusted European regulatory and quality service consultancy joining Veranex, Medidee expands and strengthens regulatory affairs, clinical development, and quality assurance services and capabilities for MedTech companies across Europe and the world. This improved ability to navigate the European Union’s Medical Device and In Vitro Diagnostic Device Regulations challenges supports truly full-service MedTech product development and commercialization. “Our acquisition of Medidee significantly expands our European footprint while also materially expanding the scale and scope of the clinical studies we can manage. The combined organization offers offices and expertise across Europe, the U.S., and Asia, augmenting our ability to help MedTech innovators achieve FDA and CE Mark approvals and uninterrupted market access for new as well as proven medical technologies that advance patient care.” Veranex CEO David Dockhorn With Medidee’s 11 locations across Europe, India, and Asia-Pacific, and Veranex’s 13 locations across the U.S., Europe, and China, the company now has unprecedented reach to serve clients with a full spectrum of integrated concept-to-commercialization services — design, engineering, regulatory, quality, preclinical research, clinical development, clinical operations, commercial strategy, and market access services — all under one umbrella. Medidee is one of the Top 3 medical device consultancy service providers in Europe uniquely positioned as a leader in future key areas such as digital health, machine learning, and cybersecurity. The company also brings expertise in clinical research exclusively focused on medical devices and in vitro diagnostics. “Medidee has a proven track record serving regulatory, clinical, and quality needs for companies of all sizes, with consulting expertise and clinical trial support in increasingly diverse therapeutic areas and technology categories across multiple geographies,” shared Medidee co-founders Kim Rochat, Philippe Etter, and Michael Maier. “With these services, coupled with the global infrastructure of Veranex, we expand expertise and resources for the benefit of our clients as well as for all EU innovative manufacturers wishing to access rapidly and efficiently the U.S. market and beyond. We look forward to providing these additional strengths and capabilities,” added the co-founders who take on new roles in the combined organization. About Veranex Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept to commercialization and across the development continuum, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex customers realize efficiencies in cost and time, while its comprehensive solutions unify and streamline the entire development process. Veranex is backed by Summit Partners, Accelmed, and Lauxera Capital Partners. About Medidee Services With sites in Switzerland, Germany, Denmark, Belgium, Spain, USA, and APAC, Medidee is a global services supplier serving companies ranging from academic startups to majors. Medidee was established by three partners, all experts in the field of medical devices. With 50 experts in all fields necessary to ensure compliance with the most stringent requirements, Medidee provides the necessary competencies to ensure and demonstrate compliance with all key medical device regulations. Medidee expends regularly to provide the best resources and competencies and supports more than 350 manufactures all over the world.

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HEALTH TECHNOLOGY

Johnson & Johnson Opens State-of-the-Art Science and Technology Campus in San Francisco Bay Area

Johnson & Johnson | September 21, 2022

Johnson & Johnson opened its San Francisco Bay Campus, a state-of-the-art Research & Development facility in the Bay Area, one of the world’s most established global hubs for innovation and entrepreneurship. The nearly 200,000 square-foot facility will house up to 400 employees, more than doubling the R&D presence of Johnson & Johnson in the Bay Area. The campus bridges key scientific and technological capabilities by co-locating Janssen R&D, Johnson & Johnson Innovation and Johnson & Johnson Technology. It will further integrate the Company into the Bay Area innovation ecosystem to strengthen and increase collaborations with innovators to accelerate growth. “Johnson & Johnson’s expanded presence in the Bay Area affirms our commitment to combining science and technology to deliver transformative healthcare solutions. On this campus, our talented teams will use their diverse experience and expertise to tackle society’s greatest health challenges to create a better future for patients.” Joaquin Duato, Chief Executive Officer, Johnson & Johnson The R&D focus at the new site spans Janssen’s therapeutic areas and key functions, including emerging science and technologies for gene and RNA therapies, novel treatments and approaches for retinal and infectious diseases, and advanced data science, including artificial intelligence and machine learning. Co-locating expertise at the site will enable the expansion of the Company’s world-class discovery engine and industry-leading pipeline. “Our new state-of-the-art science facility in the Bay Area will further strengthen our R&D capabilities and transform how we discover, develop and deliver innovative medicines faster and more efficiently. By integrating drug discovery, data science and digital health, we aim to accelerate the growth of our best-in-class portfolio and deliver better health outcomes for people worldwide,” said James Merson, Ph.D., Site Head, San Francisco Bay Campus and Global Therapeutic Area Head, Infectious Diseases, Janssen Research & Development, LLC. The Johnson & Johnson Innovation Center in California has facilitated investments and collaborations to accelerate early-stage healthcare innovation with academic and industry partners in the Bay Area and greater California ecosystem since 2014. The San Francisco Bay Campus, along with the Company’s JLABS @ South San Francisco, will continue to enable the Company to build strong relationships with entrepreneurs, scientists and investors to support and invest in highly differentiated innovations that extend and improve lives everywhere. Additionally, given the convergence of healthcare and technology in the region, the Company will increase its focus on the Johnson & Johnson Technology organization to enhance its ability to create innovative digital solutions to advance human health. Building on Johnson & Johnson’s long-standing commitment to use its expertise and resources to reduce the environmental footprint of its operations, the Bay Area hub is designed as a high-performance green campus, reinforcing the Company’s pledge to be responsible stewards in creating a healthy, more sustainable future. The aim is for the new site to receive Silver Leadership in Energy & Environmental Design (LEED) certification, the most widely used green building rating system in the world. About Johnson & Johnson At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 135 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension. Learn more at www.janssen.com. Follow us at @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. About Johnson & Johnson Innovation Johnson & Johnson Innovation LLC works across the pharmaceutical, medical device and consumer health sectors to accelerate early-stage, transformational solutions by catalyzing the best ideas, wherever they are in the world. We do this by harnessing our deep scientific capabilities coupled with a wide range of tools, including customized deal structures, company creation, incubation and startup services, capital investments and other innovative business models that aim to meet the diverse needs of entrepreneurs, scientists, and emerging companies. Our goal is to help life science and health technology innovations thrive through collaboration and partnership with the global ecosystem, so that together we can change the trajectory of human health. About Johnson & Johnson Technology Johnson & Johnson Technology solves big problems in healthcare through technology and digital innovation. Just as doctors use scalpels, we use data science, algorithms, artificial intelligence, robotics, and other digital solutions to transform patients’ lives. From guiding patients through treatment to accelerating vaccine development to enabling employees to work seamlessly from any location, our digital tools infuse our products with novelty, dexterity, and ease.

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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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