With sales to 86 countries, 450 employees from more than 30 nationalities, and production of vital vaccines against diseases such as diphtheria, tetanus, whooping cough, tuberculosis, and bladder cancer, AJ Vaccines is a significant player in global vaccine preparedness.

Since the Statens Serum Institut (SSI) sold its vaccine production in 2017 and it was taken over by AJ Vaccines, the organization has transitioned from a public entity to a private pharmaceutical company based in Copenhagen.

From legacy to cloud and compliance

After the divestment from SSI, AJ Vaccines inherited an 麻豆原创 system from the late 1990s, which was designed more for a public health organization than a pharmaceutical company.

鈥淲e were left with an outdated system that didn鈥檛 really fit our needs as a private player in a global market,鈥� Michael Kvistholm, head of IT at AJ Vaccines, said. 鈥淭hat鈥檚 why we decided to go all-in on a cloud solution with 麻豆原创 S/4HANA Cloud. We carried out a pure standard implementation from scratch (greenfield) in a RISE with 麻豆原创 setup and now have a modern, flexible, and scalable cloud ERP platform that supports our entire business.鈥�

The decision was made to ensure a platform that matches the company鈥檚 needs and future growth.

鈥淲e have reduced our technological debt and consolidated our systems, gaining a more intuitive and user-friendly platform so we can work more efficiently and securely鈥攚hile also meeting the high standards for quality, traceability, and documentation required in our industry,鈥� he explained.

Everyday examples: efficiency and user-friendliness

Since implementing in October 2025, AJ Vaccines has gained a unified platform that creates new opportunities to optimize and integrate processes across the company. The solution provides a solid foundation for better data quality and workflows, enabling improved management, increased transparency, and more effective decision-making.

The IT department has gained an overview and reduced complexity with 麻豆原创 LeanIX, a tool for mapping and managing the company鈥檚 entire application landscape and ensuring governance across both 麻豆原创 and non-麻豆原创 solutions. 麻豆原创 Cloud ALM is used for project management and lifecycle management, so releases, testing, and documentation are handled efficiently, and compliance is always top-notch.

During the implementation, AJ Vaccines used 麻豆原创 Signavio and based its approach on 麻豆原创 standard processes, which brought several advantages.

鈥淲e鈥檝e saved a lot of hours by using standard test cases from 麻豆原创 Signavio, which is our platform for process mapping, modelling, and optimization,鈥� said Kvistholm. “We鈥檒l also use these tools for other projects across the company.”

At the same time, 麻豆原创 Enable Now鈥攆or change management and end-user training鈥攈as made learning for existing staff and onboarding new employees easier.

鈥淲e鈥檝e created over 100 training videos so all employees can quickly find answers and learn new workflows鈥攊t鈥檚 been a huge success,鈥� Kvistholm confirmed.

Kvistholm also looks forward to early 2026, when the recruitment process will be digitized with 麻豆原创 SuccessFactors. Finally, he and his team will carefully consider the new opportunities created by 麻豆原创 Business Technology Platform. The platform enables rapid development and integration of new solutions and apps, allowing IT to support business needs flexibly, and, among other things, consolidate other platforms: 鈥淭here鈥檚 really no reason to pay double,鈥� as Kvistholm put it.

Change management and the foundation for the future

AJ Vaccines is focused on formalizing its superuser organization and strengthening governance around master data.

鈥淲e need to clean everything up and keep things in order,鈥� Kvistholm said. 鈥溌槎乖� has become the foundation for our continued digitalization. From now on, it鈥檚 about seeing how we can get 麻豆原创 spread even more out throughout the company.鈥�

Advice for other companies

Kvistholm emphasized the importance of management support and a narrow scope: 鈥淚t鈥檚 about staying focused and achieving a fundamental implementation鈥攁nd then continuously carrying out smaller improvement projects. That is and will be the key to our success.鈥�

Ellen Vig Nelausen is an integrated communications expert for 麻豆原创 Regional Communications.

What is true for its products also holds true for Mizuho OSI鈥檚 internal processes. Striving for operational efficiency, Mizuho OSI sought to modernize its processes. To leverage 麻豆原创鈥檚 low-code capabilities, the company worked with 麻豆原创 AppHaus in 2024. Together, they began exploring automation opportunities using 麻豆原创 Build Process Automation and 麻豆原创 Build Work Zone. During an initial 麻豆原创 Business Technology Platform (麻豆原创 BTP) , Mizuho OSI鈥檚 IT and business teams took a closer look at the manual fixed asset creation process.

Use case: Approving and creating new fixed assets

The workshop uncovered key inefficiencies in the manual purchase acquisition process, particularly its e-mail-driven workflow involving requesters, approvers, and finance accountants. This approach not only introduced a high risk of errors but also slowed down the process significantly. For high-value fixed asset purchases, the need for additional approvers and supporting details further extended the procurement cycle, highlighting the necessity for a more streamlined and automated solution.

With guidance from 麻豆原创 experts, the joint project team designed a streamlined, automated process for fixed asset approval and creation. Leveraging and , Mizuho OSI鈥檚 in-house IT team successfully developed and deployed a solution using a low-code application framework, accelerating implementation while reducing complexity.

鈥淎s we grow from a mid-sized to a large enterprise, tools like 麻豆原创 Build Process Automation are essential鈥攏ot only for driving process efficiency but also for extending the reach of our lean IT team,鈥� Lindsay Neill, director of Enterprise Application at Mizuho OSI, said. 鈥淲e鈥檙e grateful to 麻豆原创 AppHaus and the 麻豆原创 product team for their guidance throughout the journey鈥攆rom identifying the right use case to providing the technical support needed to bring this proof of concept into production. The new automated process is a major improvement over our previous manual approach. I couldn鈥檛 be happier with the results!鈥�

Measured results

After testing and implementing this new solution, both end users and the project team could measure a reduction in manual effort and observe improved process efficiencies, such as:

• 40% increase in process efficiency from days of pending response to automatic processing
• 65% reduction in approval time since asset costs below a certain threshold can be automatically processed
• 70% decrease in manual efforts, with fewer errors and faster decision-making since human intervention is now only required for exceptions

“It鈥檚 been a true pleasure collaborating with the team at Mizuho OSI. Their forward-thinking mindset and readiness to challenge the status quo made this collaboration exceptional,鈥� Tina Tuan, senior director at 麻豆原创 AppHaus Palo Alto, said. 鈥淚’m proud of what we achieved together using 麻豆原创 BTP and 麻豆原创 Build solutions and even more excited to see how this success inspires and empowers them to take on future projects with confidence and momentum.”

Through close collaboration between 麻豆原创 and Mizuho OSI, this project has proven that roadblocks can be overcome with the right partnership. The team successfully implemented an innovative solution for fixed asset approvals, laying a strong foundation for future initiatives leveraging 麻豆原创 Build solutions and . On the horizon is a promising next milestone, somewhat broader in scope, such as material master automation.

One thing is certain, the Mizuho OSI project team is driven by the company鈥檚 powerful mindset: Dare to go further. Care to do more.

Imke Vierjahn is communications lead for 麻豆原创 AppHaus.

The biopharma industry faces substantial challenges in managing temperature-controlled logistics, leading to an estimated $35 billion in annual losses due to cold chain failures. , 50% of vaccines are rendered ineffective upon arrival due to uncontrolled temperature fluctuations. This not only poses risks to patient health, but also results in significant environmental and resource wastage. Every damaged vaccine represents a loss of raw materials, energy, and resources invested in production, transportation, and storage — ultimately contributing to environmental strain through increased waste.

Cold chain management is crucial for preserving the efficacy of temperature-sensitive products like vaccines and biologics. In the U.S., FDA regulations, including the CGMP and USP <1079> Good Storage and Distribution Practices for Drug Products, mandate temperature control to help ensure drug stability throughout the supply chain. Similarly, the EU Good Distribution Practice guidelines require strict temperature monitoring to maintain pharmaceutical quality, setting high standards for handling temperature-sensitive products.

To address these challenges, companies in the life sciences industry are leveraging advanced technologies with 麻豆原创 Business Technology Platform (麻豆原创 BTP) to proactively manage temperature fluctuations.

麻豆原创 BTP enables seamless integration and data sharing across systems, providing critical insights for rapid, data-driven decisions that help maintain temperature stability. This strengthens supply chain resilience, minimizes product loss, and reduces environmental impact, helping ensure the safe and effective delivery of temperature-sensitive products.

Fusion鈥檚 Cold Chain Management Solution

In this context, Fusion Consulting has developed Cold Chain Management Solution (CCMS), a standard solution built on 麻豆原创 BTP in close collaboration with the 麻豆原创 product team for Life Sciences. The solution supports the integrity of temperature-sensitive products, including medicines, vaccines, and other perishables across the end-to-end supply chain. Any failure can result in temperature excursions and deviations, which threaten product efficacy and pose risks to patient safety while also leading to financial loss.

CCMS supports the management of products under controlled storage, preventing temperature excursions and deviations throughout the supply chain. Typically, manufacturing and supply processes track time out of refrigeration (TOR) and time In refrigeration (TIR), both of which accumulate the time a product spends within different temperature zones — cold, ambient, or frozen, for example — on the journey from the production line to the patient at the end of the supply chain.

Before Fusion CCMS, tracking TOR and TIR relied on a combination of custom-built in-house legacy systems, as well as error-prone manual paper-based processes. This led to complicated, time-consuming workloads, high error rates, re-work, and bureaucracy — all of which ultimately risks patient safety, product efficacy, and regulatory compliance.

CCMS digitalizes TOR and TIR tracking, offering full visibility of temperature conditions across the supply chain to proactively prevent anomalies. With automated workflows and smart alerts, it minimizes spoilage and patient risk, integrating with 麻豆原创 systems to enhance efficiency and safety through automated data from RFID and IoT devices.

鈥淭he Fusion Cold Chain Management Solution exemplifies the power of collaboration and innovation on 麻豆原创 BTP,” said Andreas Krummlauf, vice president of Life Sciences and Healthcare Product Management at 麻豆原创. “By addressing critical challenges in temperature-sensitive product management, it enhances patient safety, regulatory compliance, and reduces environmental impact. This solution perfectly extends our 麻豆原创 for Life Sciences solution portfolio, aligning with our strategy to offer comprehensive capabilities to our customers. We’re proud to support partners like Fusion in developing cutting-edge solutions that drive meaningful change in life sciences delivery.鈥�

鈥淭he collaboration with 麻豆原创 is a prime example of how innovative strength and expertise can lead to literally life-saving solutions that transform the industry, such as the CCMS,鈥� said Fares Zaier, chief revenue officer of Fusion Consulting.

Critical Link with Quality Management and Batch Release

The described TOR information is one of the crucial attributes that need to be checked by the Quality department. This is relevant throughout the whole supply chain process, whenever a batch decision needs to be taken. Throughout the entire value chain, sharing this information is of utmost importance.

Having the 麻豆原创 Batch Release Hub for Life Sciences solution and Fusion CCMS both built on the 麻豆原创 BTP Platform enables seamless integration into the process flow. This in turn enables seamless integration of systems, helping ensure data consistency and optimizing processes.

By combining these powerful solutions, companies in the life sciences industry lay the foundation for future innovations. Ultimately, the close cooperation between Fusion Consulting and 麻豆原创 has enabled the development of solutions that not only meet current requirements, but also those of the future.

Looking to the future, Fusion plans to set up its industry consortium working with top life sciences customers to continuously taking their feedback and requirement into the product design and development.

Aladdin Mandishah is director of Product Marketing for Life Sciences at 麻豆原创
Marco De Lorenzo is vice president of Product Marketing for Life Sciences at 麻豆原创.

The has mandated manufacturers to improve traceability, which is essential for ensuring that medicines reach patients safely. 麻豆原创 Information Collaboration Hub for Life Sciences is designed to help meet these demands by streamlining the tracking process. However, as the network of users has grown, support challenges have surfaced. To address these issues, 麻豆原创 introduced Built-In Support into the hub to help provide direct, seamless assistance to life sciences companies and their partners.

I had the opportunity to interview Tarun Luthra, head of Support 鈥� Industries & CX, and Andreas Krummlauf, vice president and head of Product Management Life Sciences, Health and Ecosystem, about the project鈥檚 impact. Here’s how Built-In Support is helping to enhance operational efficiency for network users in the life sciences industry.

Q: How did this project come about?

Krummlauf: , manufacturers of medicine needed to develop the ability to uniquely identify every pack of medicine they sell in those countries. This is to avoid counterfeiting in the legitimate supply chain. To support this requirement, 麻豆原创’s serialization portfolio was initiated in 2015 with the 麻豆原创 Advanced Track and Trace for Pharmaceuticals application, a corporate serialization repository.

麻豆原创 Information Collaboration Hub for Life Sciences started in 2016 with a focused goal: to manage traceability and serialization data exchange for our customers and a couple of hundred of their business partners. In 2021, the hub won the Hasso Plattner Founders鈥� Award.

As the network expanded to tens of thousands of partners, a key limitation emerged: we did not have a simple way for business partners, acting as network end users, to directly interact with 麻豆原创 support in case of critical issues, even without having a support contract with 麻豆原创 in place.

Q: What support challenges were network end users facing?

Luthra: The challenge arose from supporting an increasing number of network end users that were not direct 麻豆原创 customers. Without access to 麻豆原创鈥檚 support system, the network end users had to rely on their customers to resolve issues, adding unnecessary steps and risked communication gaps. This presented an opportunity to implement Built-In Support to support our customers鈥� business partners as network end users when they use 麻豆原创 Information Collaboration Hub for Life Sciences.

Q: How does Built-In Support make a difference for network end users?

Luthra: We are now providing network end users with a direct entry point from within 麻豆原创 Information Collaboration Hub for Life Sciences, enabling them to easily contact the support team. Built-In Support is seamlessly integrated into the hub. The network end user can find help by searching 麻豆原创 Knowledge Base Articles or submitting a case.

Krummlauf: This streamlined process can enhance the support experience and helps ensure users can quickly find the help they need. Network end users can now resolve issues independently or submit a case without involving customers in the resolution process. This improvement leads to faster response times. Users can efficiently search for relevant product information and potentially resolve issues on their own. This autonomy helps enhance the overall support experience and empowers users to find solutions quickly and effectively.

Built-In Support Enhances User Experience and Support Efficiency

In conclusion, marks a significant advancement in enhancing user experience and support efficiency. When network end users are empowered to directly access support resources and resolve issues independently, we not only help to streamline the support process but also reinforce 麻豆原创’s commitment to improving lives through better life sciences solutions. As regulatory demands evolve, our innovative approaches will continue to drive progress and collaboration in the life sciences sector. For more insights, stay connected with 麻豆原创’s ongoing developments.

With the integration of cutting-edge technologies, organizations can leverage data-driven insights to make informed decisions, accelerate time-to-market for new treatments, and ultimately improve patient care. Life sciences and healthcare companies are at the forefront of innovation and competitive advantage by embracing changing industry trends and harnessing technology’s power.

The 麻豆原创 Industry Heroes program was launched in 2023 to celebrate companies that leverage technology to transform their business in innovative ways. Healthcare and life sciences heroes have harnessed the power of technology to transform the traditional patient paradigm into an adaptive, customer-centric frontier.

Astellas

Astellas Pharma Inc. is a leading pharmaceutical company dedicated to advancing healthcare through innovative therapies and cutting-edge research. Focusing on addressing unmet medical needs, Astellas develops and markets a wide range of healthcare solutions across various therapeutic areas, striving to improve the health and well-being of patients globally. With RISE with 麻豆原创 and 麻豆原创 SuccessFactors solutions, Astellas is building an internal environment that will leverage globally integrated data to unlock the organization’s full potential.

DXC Technology

DXC Technology is a global IT services and solutions company known for its expertise in digital transformation, enterprise applications, cloud computing, and cybersecurity. With a focus on enabling clients to thrive in the digital era, DXC offers a wide range of technology and advisory services tailored to meet the diverse needs of businesses across industries. A mobile app built on the 麻豆原创 Business Technology Platform (麻豆原创 BTP) and 麻豆原创 Business AI is enabling individuals with Parkinson’s disease to keep clinicians informed about their symptoms, accompanied by a clinician dashboard 鈥� and generative AI query extensions are also in development. The innovative solution aims to improve the quality of life for these patients and their caregivers and marks a huge step forward in using AI to support clinical decisions.

Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Gilead鈥檚 digital transformation journey includes a bold migration to 麻豆原创 S/4HANA with segmentation and 麻豆原创 Ariba and continues to expand its reach with 麻豆原创 BTP and cutting-edge solutions such as 麻豆原创 Intelligent Clinical Supply Management, 麻豆原创 Cell and Gene Therapy Orchestration, and 麻豆原创 Batch Release Hub for Life Sciences.

Most notably, Gilead and 麻豆原创 are co-innovating on 麻豆原创 Batch Release Hub for Life Sciences. This groundbreaking add-on will support continued compliance with regulatory standards across regions and jurisdictions with emphasis on highest quality and safety standards for Gilead’s products, further safeguarding patient wellbeing across the globe. Integrating 麻豆原创 Ariba solutions, including 麻豆原创 Business Network, Gilead aims to create a globally interconnected platform, enhancing collaboration between suppliers and buyers while optimizing its global procurement operations.

Additionally, 麻豆原创 and Gilead are collaborating on co-innovating jurisdiction control checks using 麻豆原创 Batch Release Hub for Life Sciences. The add-on will perform control checks on manufactured batches of pharmaceutical products, helping life science organizations to maintain compliance with regulatory standards across multiple regions and jurisdictions. This safeguard checklist will further support the quality and safety of products.

麻豆原创 celebrates these organizations’ outstanding efforts, collaboration, and dedication to driving successful business outcomes with technology. The innovations streamline research processes, enhance efficiency, and improve patient care, ultimately revolutionizing how healthcare and life sciences companies operate.

麻豆原创 Innovation Days for Life Sciences & Healthcare are taking place in Palo Alto, California, from April 24- 25, 2024, and Newton Square, Pennsylvania, from April 29-30, 2024, celebrating industry heroes and bringing attendees together to discuss leveraging technology to drive business outcomes. Get more information on the events .

One example is Technologies, Canada鈥檚 leading life sciences research company that sees itself as a company of scientists helping scientists. Based in Vancouver, STEMCELL has a 30-year history of growth in developing and manufacturing products and services that help other industrial and academic scientists innovate in the areas of stem cell, immunology, cancer, regenerative medicine, and cellular therapy research. STEMCELL has staff in 20 countries and sells a constantly expanding portfolio of over 2,500 products, including cell culture media, cell separation technologies, instruments, and accessories, as well as education and services. Reducing the time to market for new products is crucial to the company鈥檚 mission of pursuing life sciences discoveries leading to the next generation of healthcare treatments.

鈥淲e鈥檙e always looking for ways to accelerate time to market for new products and adapt our technology environment to meet the evolving needs of our internal stakeholders and external customers,鈥� said John Lilleyman, CIO at STEMCELL. 鈥淎dvanced discoveries in areas like precision medicine are bringing new hope to patients and their families. At the same time, we have to comply with increasingly stringent global mandates for sustainable packaging and product safety.鈥�

Faster Innovation with 麻豆原创 S/4HANA

Since STEMCELL went live with , the biotech leader has been intent on using the latest innovations from 麻豆原创 to help speed up product testing. Speaking during a session held at this year鈥檚 , Lilleyman shared the company鈥檚 strategy for effective and fully automated software with 麻豆原创.

鈥淲e鈥檙e particularly excited about the cloud-first innovations from , which will help us deliver a more sustainable solution, continuously meet security and compliance requirements, and set us up for success with future upgrades,鈥� he said. 鈥淲ith a new test-automation strategy, we can make sure that testing is an accelerator and not a bottleneck to change.鈥�

Automation Expedites Rigorous Product Testing

STEMCELL doesn鈥檛 create end-user patient therapies. Rather, the company develops the products and solutions that help other life sciences researchers innovate for new therapeutic discoveries. To develop these solutions for other scientists, STEMCELL performs rigorous product quality testing to comply with the and other global regulatory frameworks and guidelines.

Replacing manual testing with a highly automated process has generated significant results for the company. To date, STEMCELL has reduced the time required to complete 麻豆原创 system validation for GxP 鈥済ood practice鈥� guidelines and regulations by 86%, test quote-to-cash scenarios by 97%, and execute a full regression cycle by 98%.

鈥淚nstead of taking the better part of a month or more, most of the testing is now completed in a handful of days or less,鈥� said Lilleyman. 鈥淭his is a tremendous accelerator for our business and our teams. We鈥檒l be able to take advantage of enhancements in 麻豆原创 solutions faster. It will continue to pay dividends every day, week, month, and year as we move forward, expanding our footprint in new product markets and locations.鈥�

Digital Helps Fast-Track Global Expansion

Averaging 20% annual growth, STEMCELL has made digitalization central to its strategy for bringing products to market faster and more sustainably. Lilleyman said that speeding up testing in compliance with global mandates will help the company as it expands worldwide.

鈥淐loud-based automation at all stages of testing helps move us towards continuous compliance in a continuously changing market,鈥� he said. 鈥淎s we continue to expand our inventory for testing, we鈥檒l be able to accelerate upcoming projects as we open up in different environments. We can have a library with a simple checklist to set up a new entity where we can test end-to-end. We can shift the testing burden away from business users to release innovations faster with completed testing.鈥�

He looked ahead to greater benefits from further automation, including on-demand validation reports for updated system testing and quality controls. Speedier testing from STEMCELL is making the lives of researchers easier by accelerating the release of the tools they need to in turn deliver advanced, patient-centric therapeutic discoveries for a healthier world.

Susan Galer is a communications director. Follow me @smgaler.

鈥淲e are driven by our mission to make a meaningful difference for people worldwide who are impacted by difficult-to-treat cancers and other serious diseases,鈥� said Chris Astle, chief financial officer at Zymeworks. 鈥淲e chose because it鈥檚 a trusted solution for the biotech and pharmaceutical industries, proven to manage the complexities we face around pricing, manufacturing, supply chain logistics, and more. We鈥檙e building the bedrock for our growth in a dynamic industry with ever-changing market conditions.鈥�

A 2023 , Zymeworks went live with a broad range of solutions through RISE with 麻豆原创. I sat down with Astle during this year鈥檚 , where he filled me in on how 麻豆原创 solutions are essential to the company鈥檚 expansion plans. He told me that Zymeworks expects significant resource savings from replacing manual, multi-step processes with self-service automation, gaining efficiency improvements from 50% up to 90% respectively across operational planning, HR, and invoicing.

Digital Platform Creates Automation Efficiencies

Working on new drug development and clinical trials for oncology treatments, Zymeworks is tackling one of the most challenging healthcare markets given the numerous kinds of cancers, sub-types of cancers, and patient populations. Headquartered in Vancouver, Canada, with operations in the U.S., Zymeworks is expanding to Europe and Asia. Astle was well aware of what the company鈥檚 finance, manufacturing, research and development (R&D), supply chain, procurement, and HR teams are up against as the volume of transactions, currencies, and compliance mandates increase with geographical build-out.

鈥淲e鈥檙e constantly exploring therapeutics for patients where there鈥檚 a high unmet need with few treatment options to date,鈥� said Astle. 鈥淎s we grow, we鈥檒l need to manage greater transactional volume, risk, and complexity. Having end-to-end, integrated data company-wide will automate processes and provide the digital foundation of the company. Once the systems are fully operational and everyone is trained, we expect a significant reduction in time to prepare budgets, close the books, and manage HR onboarding and reporting. This will free people up to focus on more strategic, value-added activities.鈥�

Data Transparency Supports Financial and Healthcare Governance听

Although currently in the clinical development phase, Zymeworks went live with 麻豆原创 solutions to be better prepared to meet global industry mandates, including external audits as products are launched.

鈥淓mbedding compliance within our processes reduces risk and gives us more flexibility and agility,鈥� said Astle. 鈥淲e interact with healthcare leaders, as well as government policymakers and auditors. With , we can accurately track and report our spend with partners like physicians, grant writers, and advisory boards. are our primary source for travel and expense data, helping monitor compliance with industry regulations.鈥�

Integrated Data Has Company-Wide Business Results

People are at the heart of Zymework鈥檚 innovation and using for the company鈥檚 self-service HR will help bring extended benefits throughout the company.

鈥淲e鈥檝e developed an organizational hierarchy matrix with well-defined roles for promotions and career planning,鈥� said Astle. 鈥淲e鈥檝e set up workflow automation based on someone鈥檚 role, assigning tasks accordingly, whether it involves onboarding new hires, regulatory sign-offs, or purchase order approvals. Automation from integrated data helps people make better decisions faster, increasing efficiencies from standardized processes as we grow.鈥�

Working with 麻豆原创 Bolsters Continuous Journey to Best Practices

Zymework鈥檚 relatively small size compared to industry behemoths in no way detracts from the value of the company鈥檚 relationship with 麻豆原创. In fact, the organization has the best of both worlds 鈥� best practices with less customization.

鈥淚mplementing a tier 1 solution like 麻豆原创 was a big training opportunity for our finance team and the wider organization,鈥� said Astle. 鈥淲e鈥檝e acquired best practices from the largest industry leaders and can go with a more out-of-the-box solution that鈥檚 already standardized and fit for purpose, requiring almost no customization.鈥�

Future-Proofing the Business with Adaptability

Despite the daunting task ahead developing advanced treatments, Zymeworks is well-positioned for growth, committed to ongoing investments for innovation.

鈥淚t鈥檚 strategically important to be diverse to reduce company risk, and we are looking at other therapeutic areas, too. We have some really innovative science and fantastic scientists, and we鈥檙e not afraid of the challenge,鈥� said Astle. 鈥淲ith our move to 麻豆原创, we鈥檝e laid the foundation for the future growth of our company. We can focus on achieving our vision, innovating to bring new medicines to market for patients in need.鈥�

To hear more from customers on their digital transformation journey with 麻豆原创,听.

Susan Galer is a communications director at 麻豆原创. Follow me @smgaler.

The reactive, ad-hoc approach that companies have taken to tackle disruption has resulted in mismatched supply chain processes that offer little visibility and don鈥檛 keep up with the speed of change. Companies rely on convoluted, manual communication methods between suppliers and buyers. E-mails and calls get lost in the shuffle of vacations and holidays, making critical collaboration untraceable and delayed.

麻豆原创 Business Network Is an Industry-Ready Digital Network of Suppliers and Buyers

Businesses need a collaborative, many-to-many platform to drive transparent, resilient, and sustainable supply chains. That鈥檚 where 麻豆原创 Business Network comes in: a multi-enterprise collaboration network, built for industry, that helps companies execute their vision and meet growth targets by connecting with trading partners seamlessly.

Only 麻豆原创 Business Network provides collaboration across a broad range of processes, including indirect and direct procurement, supply chain, logistics, asset collaboration, finance, and talent.

But each industry faces unique challenges that can鈥檛 always be addressed with a one-size-fits-all approach. For this reason, we are introducing 麻豆原创 Business Network for Industry with an initial focus on the consumer products, life sciences, high tech, and industrial manufacturing industries. This includes:

• A portfolio of 麻豆原创 Business Network capabilities that address industry needs
• A new 麻豆原创 Business Network Industry Advisory Board to guide our product and road map strategy
• New 麻豆原创 Business Network for Supply Chain industry services accelerators for select industries to help customers fast-track their implementation and post go-live success

With 麻豆原创鈥檚 more than 50 years of industry expertise and industry process excellence embedded in our technology, we know better than anyone how to help customers tackle their specific challenges.

Capabilities Designed to Meet Industry Needs听

As we work to help companies tackle challenges with supply chain transparency, resiliency, and sustainability, we鈥檝e engaged directly with customers to improve existing functionalities and develop new capabilities for 麻豆原创 Business Network.

We developed capabilities including contract manufacturing, planning and forecasting, quality collaboration, stock transfers, support for supplier-managed inventory, material traceability, and track and trace. Several of these capabilities were developed alongside customers to answer unique industry challenges in a variety of industries, including consumer products, high tech, industrial manufacturing, and life sciences. While these and other innovations were originally created to address a specific industry need, many of them can be applied cross-industry to help businesses increase visibility, mitigate risks, and operate more efficiently.

Working with our customers has helped evolve 麻豆原创 Business Network into the well-rounded, comprehensive solution it is today. It has been amazing to see the innovations that have come out of these relationships with customers, and their stories and successes have truly inspired me. To build on what we鈥檝e accomplished so far, we鈥檙e strengthening the way we collaborate with customers and helping accelerate implementation with new industry-specific use cases.

Continuing the Tradition of Customer Collaboration

To continue the tradition of working with our customers to enhance and extend our product capabilities, we鈥檙e introducing the 麻豆原创 Business Network Industry Advisory Board. This select group of industry leaders will provide strategic direction for our product and road map, making sure we鈥檙e meeting the needs of our customers and helping their businesses grow. I鈥檓 eager to see the exciting new ideas and developments that will come out of this collaborative forum of industry experts.

Expedite Time to Value with Industry Services Accelerators for 麻豆原创 Business Network for Supply Chain

For customers beginning their journey with 麻豆原创 Business Network for Supply Chain in particular, we鈥檙e introducing new industry services accelerators from our 麻豆原创 Business Network Services team to help expedite time to value and achieve success.

These industry services accelerators support critical supply chain business processes in the consumer products, high tech, industrial manufacturing, and life sciences industries. With prepackaged industry use cases and capabilities, implementation best practices, and dedicated post go-live support, industry services accelerators are based on 麻豆原创鈥檚 knowledge and expertise with 麻豆原创 Business Network for Supply Chain. Industry services accelerators can be delivered in collaboration with partners.

Stay Tuned for More

Other additions to 麻豆原创 Business Network include new supplier innovations that will help support supplier adoption, focusing on creating an easier integration process to reduce friction and help grow your business to achieve maximum value.

To learn more, visit . Here, we鈥檒l keep you up-to-date on all of the exciting innovations happening and share resources to help you tailor your 麻豆原创 Business Network experience.

And, don鈥檛 miss learning more about 麻豆原创 Business Network and how 麻豆原创 can help solve the unique business challenges of your industry at .

Val Blatt is global head for 麻豆原创 Business Network Customer Success & Go-to-Market at 麻豆原创.

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Q: What are some of the industry challenges today that life sciences companies are facing when it comes to the supply chains for clinical trials?

A: Life sciences companies are facing three types of challenges 鈥� business, IT, and regulatory.

When it comes to business challenges, life sciences companies today are conducting an increasing number of clinical trials, often hundreds at any given time, and navigating greater complexity. COVID-19 led to an increase in direct-to-patient trials and greater pressure to deliver quick results and put products into the market faster. With the shift to more personalized medicines, clinical trial planning and execution needs to be adapted to account for manufacturing and delivery for batch sizes of one.

In terms of IT challenges, companies use multiple IT systems to manage the clinical trial execution process. As the digital landscape grows and transforms, increased collaboration among a growing number of upstream and downstream supply chain partners is driving companies to develop more integrated, interoperable, and scalable systems.

And lastly, clinicians face mounting regulatory challenges. Countries are developing their own unique regulations, making it challenging to plan, execute, and launch clinical drug products into country-specific markets. Furthermore, depending on unique government regulations, any delays in supplies or quality batch approvals can cause trials to go on hold or delay the availability of critical, lifesaving drugs.

How is 麻豆原创 helping address these challenges?

麻豆原创 recently launched the solution, closing a significant process gap in the life sciences industry. Traditionally, companies managed clinical trials via a paper format, tracking trials on lab books, Excel spreadsheets, and custom, siloed applications. With 麻豆原创 Intelligent Clinical Supply Management, 麻豆原创 offers customers an integrated solution to help track a clinical trial all the way from study initiation to the shipment of the final drug product. Using 麻豆原创 standard solutions, together with our extended partner ecosystem, life sciences companies can streamline their clinical trial supply chain processes 鈥� readily facilitating forecasting, manufacturing of drug substance and drug products packaging, labeling, and shipping of clinical finished goods.

How have clinical trials evolved over the past decade and how did regulations and technology impact the change?

Until recently, clinical trials were conducted in silos. (ICH) brings together regulatory authorities and the pharmaceutical industry to 鈥渁chieve greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed, registered, and maintained in the most resource efficient manner whilst meeting high standards.鈥� Furthermore, the adoption of GS1 standards that instill trust and enhance transparency in the clinical supply chain are garnering attention. Finally, organizations like the European Medicines Agency and other standard guidelines are addressing the need for greater diversity and representation in clinical trials, reinforcing the need for technology and resilient supply chains that can support cross-border trials.

With the evolution of direct-to-patient trials, there is an increasing need to integrate the sponsor, contract manufacturing organization, clinical sites, and patient sites across multiple and varied technical landscapes without compromising on quality and delivery of the final drug product.

How can improving batch release processes help with the supply chain for clinical trials and benefit patients at the same time?

For pharmaceutical companies, the smoother the clinical batch execution process, the quicker they can release drugs to the market. Improving the clinical batch release process and gaining greater visibility into drug substances and products with a solution like 麻豆原创 Intelligent Clinical Supply Management enables clinicians to efficiently track and release clinical batches while considering country-specific, site-specific, and regulatory releases.

During the clinical trial process, delays in the release of a batch can completely derail the execution of a trial. And in treatments like cell and gene therapies, it can cost patient lives. 麻豆原创 Intelligent Clinical Supply Management optimally integrates with the quality batch release processes, so companies can monitor all the releases in one place with minimal reliance on information transfer from multiple siloed systems. In turn, they can deliver products to market with lesser data hops and quality checks between the systems, thereby improving the lives of the patients who stand to benefit from the drugs.

Why does this matter?

Improving the execution of clinical supply chains matter. Reduced complexity and greater accuracy during clinical trials reduces waste and lowers the cost of execution, ultimately impacting the cost of drugs for the end patient. More effective and efficient clinical trials allow life sciences companies to allocate more resources to solving other challenges in patient health.

Is there anything else you want to add?

The future of clinical supply chains will focus on improving the patient experience, delivering drugs to patient-specific locations, and effectively bringing together dispersed data points as clinical trials become even more decentralized. The efficiency of supply chains will become increasingly dependent on the technology and digital maturity of life sciences companies. At 麻豆原创, we are constantly innovating in the clinical space and reimagining the clinical trial supply management processes and its integration into the larger ecosystem of tech-transfer and commercial manufacturing processes.

What excites you about the work you do at 麻豆原创?

Every day, I am inspired by the opportunity to make a positive impact on the future of 麻豆原创 and the life sciences industry. I am surrounded by highly motivated and talented individuals 鈥� some of the best brains in technology. Together, we are solving complex challenges facing pharmaceutical companies, advancing progress in clinical trials, and improving patient health.

Explore our infographic showcasing four industry cloud solutions by 麻豆原创 that , so you can bring medicines and medical devices to market faster.

Kelly Cannon is part of Content Creation & Strategy for the Content Lab at 麻豆原创.

While 麻豆原创 develops its own industry cloud solutions, we rely on our partners鈥� deep domain of expertise to satisfy highly specialized, continually evolving customer needs. Our job boils down to maximizing the value our customers derive from doing business with 麻豆原创 and our many partners. That value now depends on the shared successes that emerge from innovating and collaborating with our 麻豆原创 partner community that increasingly revolves around industry cloud.

Life Sciences Anchors

In life sciences, we aim to harness and industry cloud solutions to bring customers tailored, end-to-end suites built from components cultivated in the industry鈥檚 finest ecosystem. 麻豆原创鈥檚 deep expertise in life sciences has positioned us to deliver anchor solutions in four areas: clinical trials, manufacturing supply chain, batch release, and cell and gene therapy. But we鈥檙e not doing it alone.

We鈥檙e working closely with software and service partners in developing these core solutions and, more importantly, with consortia of customers whose needs, insights, and best practices become embedded in what we believe will become industry-standard products.

Even in areas in which 麻豆原创 develops its own solutions, white spaces remain and those can represent golden opportunities for partners and customers alike. Here are three examples: Raumedic p36鈥檚 UDI platform to ensure compliance with European Medical Device Regulation; Roche worked with Tenthpin and 麻豆原创 to clinical trial supply chain operations; and Klosterfau implemented Gramont鈥檚 Product Information Management to achieve Identification of Medicinal Products () compliance.

While solutions addressing specific industry pain points like these are an industry cloud staple, our partners are delivering value to our customers in other ways, too, as Merck did in BlueBoot accelerators to quickly implement and upgrade its plant maintenance user experience.

continue to proliferate by the day. We are dedicated to offering the best of what 麻豆原创 and its partners can bring to bear for our customers.

Open Healthcare Ecosystem

麻豆原创 is working to build a similar ecosystem for healthcare providers, delivering a modular healthcare system landscape of the future. The focus is to bring new, innovative healthcare business process capabilities in the areas of patient management, accounting, analytics, digital supply chain, and sourcing and procurement. This is a nascent effort, and one that鈥檚 advancing behind the of providing an open ecosystem and then giving partners the opportunity to lead in their areas of expertise.

To achieve this, working with hospital information system (HIS) providers is key. This is to foster integration between HIS and enterprise resource planning (ERP) solutions in accordance with healthcare-specific electronic medical record (EMR) regulations. The reality is EMR regulatory requirements and functional demands differ by local market. It just makes sense to give a diversity of EMR and other healthcare solution providers the keys to an open platform 麻豆原创 Business Technology Platform and the healthcare data interoperability standards. This approach helps ensure the needed flexibility to give healthcare providers business process capabilities tailored to their individual and local market needs.

Our healthcare partners have embraced this approach. Several partners already did announcements to leverage this open ecosystem to benefit their 鈥� our 鈥� healthcare customers.

Life sciences and healthcare are very different industries with shared goals: preserving and improving human health. In both industries, our partners are essential to the success of our shared offerings and I鈥檓 thrilled by the enthusiasm I鈥檓 seeing from our partners. There鈥檚 no doubt that the combination of their industry-specific cloud offerings and the robustness and flexibility of 麻豆原创 Business Technology Platform can provide extraordinary value to our life sciences and healthcare customers for many years to come.

Markus von Quast is global head of Life Sciences Ecosystem at 麻豆原创.

Increasing regulations are also sparking digital innovation across life sciences. For example, organizations are required to share updated supply chain data with trusted partners for compliance with the final phased-in regulations of the . Initially passed in 2013, the latest batch of requirements from this act will require pharmacies, wholesalers, and manufacturers to track and report drug shipments for legitimacy between authorized trading partners. That鈥檚 where Spherity Credentialing Service CARO comes in, an app that provides updated information proving a dispenser鈥檚 trading partner status.

鈥淲hen a pharmacist in a tiny dispensary in North Dakota has suspicions about a received drug shipment, they send a verification request to a global pharmaceutical manufacturer that has numerous wholesalers in between them and the pharmacy,鈥� said Dr. Oliver Nuernberg, chief product owner of Life Sciences at 麻豆原创. 鈥淎utomating the credentialing process builds transparency and trust between indirect partners, immediately surfacing the pharmacy鈥檚 credentials as an authorized trading partner. This saves time and costs with greater information accuracy and fewer delays, strengthening an organization鈥檚 ability to meet DSCSA regulations.鈥�

Available on , Spherity Credentialing Service CARO is integrated with听, a cloud-based network solution that helps organizations comply with other provisions of the U.S.听DSCSA. For example, drug traceability is another U.S. DSCSA mandate. Pharmaceutical manufacturers can also use the information hub to help law enforcement trace drug shipments by serial numbers, supporting audits that help keep counterfeit medications out of the supply chain.

Intelligent Automation Strengthens Health of Drug Supply Chain

Spherity functions as a digitally encrypted wallet that captures and stores a dispenser鈥檚, or any other trading partner鈥檚, verified identity data, including address, notarized documents such as articles of incorporation, as well as updated U.S. state and DEA license information. By digitizing previously manual data collection and distribution tasks between systems, the app eliminates historical time lags that often resulted in outdated information.

鈥淚n the past, information about trading partner status was manually imported on a monthly basis from spreadsheets provided by third parties. An order might come from a wholesaler or dispenser whose license expired or was revoked weeks or even months ago,鈥� said Nuernberg. 鈥淓lectronic credentialing surfaces accurate information much faster, helping organizations automatically prove compliance with regulations, including license type as required to dispense various drugs.鈥�

Once a pharmacy鈥檚 identity is verified in their digital wallet, pharmaceutical companies would also be informed on an ongoing basis if the state or federal agency didn鈥檛 renew that license or revoked it for any reason.

Verified Partner Identity for Supply Chain Safety

Verifying a dispenser鈥檚 identity isn鈥檛 as easy as it sounds. Drug supply chains are complex, involving manufacturers, wholesale distributors, re-packagers, and logistics companies long before the goods reach pharmacies for dispensing. Having an app that automatically verifies a dispenser鈥檚 identity in real or near real time is designed to support regulatory compliance and help make drug supply chains more secure. Anticipating the 2023 regulations, some global pharmaceutical manufacturers and wholesalers have been testing the app with measurable results.

鈥淯sing the app, organizations have told us that they can securely and more easily verify trading partners and generate audit-ready records,鈥� said Georg J眉rgens, manager of Industry Solutions at Spherity. 鈥淲ith electronic interactions, they can trust that a trading partner is legitimate because due diligence has been conducted that proves identity. The app is easy to get up and running and has already increased efficiencies.鈥�

J眉rgens added that the app鈥檚 interoperability with different systems is designed to help meet regulatory mandates around electronic data sharing, easing collaboration between trusted partners along the clinical supply chain.

Digitalized Business Innovation

Eliminating counterfeit drugs in the legitimate supply chain is just the beginning of what鈥檚 possible in a fully digitalized life sciences supply chain. Pharmaceutical companies will be able to bring in and ramp up new, trusted suppliers faster. Intelligence will only grow with greater automation for business and patient value.

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According to researchers at , precision medicine therapeutics have accounted for 25% to 40% of all FDA approvals in the past seven years. They believe precision medicine has 鈥減roven its worth with mounting evidence of improved patient outcomes in oncology, cardiology, endocrinology, and other disease areas.鈥� From the patient鈥檚 perspective, analysts suggested a digital-first 鈥渉ealth journey鈥� vision that prioritizes digital engagement and the use of digital interactions, products, and services throughout an individual鈥檚 journey through health, wellness, and illness.

Data Makes Life Sciences Supply Chains More Intelligent

Michael Townsend, research director of Life Sciences Commercial Strategies at IDC, saw the industry in the early stages of digitalization, focusing on the value of technology that brings intelligence across life sciences supply chains.

鈥淐ompanies are beginning to make processes more digital, applying intelligence from technologies to make better decisions,鈥� said Townsend. 鈥淔or instance, there鈥檚 significant investment in supply chain solutions like digital twins, where you construct a digital model to experiment with what-if scenarios in performance at various points along the chain such as assembly, shipment, or geography. You can stress test alternate choices without actually having to make any changes.鈥�

Townsend said that segmentation was another intelligent node across supply chains, allowing companies to identify and store medicines and packaging based on country-specific regulations, improving lead times, reducing unused inventory, and simplifying shipping. Some organizations are also using control towers to track demand patterns against materials and component availability, avoiding overstocks and shortages. For example, if COVID-19 cases rise in a certain region, a vaccine manufacturer can act faster to stock up and start shipping prevention and treatment products to that location. Connecting data across supply chains for quick response times applies to any unexpected disruption, including natural disasters and political conflicts.

Ecosystems Surface Expert Wisdom

Mandar Paralkar, head of Life Sciences Industry at 麻豆原创, agreed that organizations are moving from historical emphasis on addressing disease with bulk manufacturing of medications to personalized therapies that improve individual patient outcomes and involve more ecosystem collaboration. In an industry with longer product development cycles, he said that collaborative consortiums like are a way to share intelligence for expedited success.

鈥淲hether startups or established leaders, life sciences companies are using technology to improve patient outcomes and company profitability while reducing costs and risk,鈥� said Paralkar. 鈥淭hey鈥檝e realized the imperative to compete as an ecosystem across connected digital supply chains and smart factories. One example of this is 麻豆原创 Intelligent Clinical Supply Management, a solution we innovated with a consortium of customers and partners. This collaborative effort exemplifies how innovation in the cloud can potentially help life sciences organizations create, manufacture, and deliver effective solutions faster, allowing the partner ecosystem to compliment value-added services.鈥�

Cloud-Based Technology Disrupts Life Sciences

The pandemic has irrevocably disrupted life sciences, revealing a new vision for innovation from cloud-based collaboration. Almost overnight, companies invested in technology to work from home, and that bled over into new ways of thinking about the use of technology in areas like process automation and decentralized clinical trials, along with working together in trusted relationships.

鈥淐ollaboration hubs where multiple, trusted entities can exchange information, collaborating to learn from each other and solve problems is part of the life sciences vision,鈥� said Townsend. 鈥淓xperts involved with clinical supply chains and other aspects of life sciences are motivated to streamline processes, make suggestions to software providers, and share information between systems. Cloud-based software is critical. If you鈥檙e on subscription-based software, updates are almost in real time and it鈥檚 much easier to collaborate and access different sources of data when it鈥檚 available in the cloud.鈥�

Achieving a Healthier and Profitable Vision

As costs and regulatory pressures rise and educated patients clamor for personalized treatment, digital innovations will inexorably alter the life sciences landscape. Within a few years, researchers predicted 75% of trials will be “patient-centric” decentralized clinical trials, 90% will be hybrid, and at least 10% will be virtual, driven by a 30% growth in connected health technologies.鈥� They said that by 2025 the market for prescription digital therapeutics will more than triple, focusing on mental health and chronic conditions, blurring the boundaries between healthcare and life sciences. It鈥檚 no wonder that analysts advised life sciences manufacturers to prioritize 鈥渃linical solutions that include interoperability as a core feature, including easier connectivity of content and data between clinical sites, sponsors, clinical research organizations, and other ecosystem participants.鈥� Trusted intelligent data is the must-have for a healthier future.

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These were among the innovations that Michael Schmidt, cofounder and executive board member of , shared when he spoke at a recent 麻豆原创-sponsored event with customers and other partners about the transformational opportunities facing the life sciences industry.

鈥淢oving manufacturing to the point-of-care will disrupt the traditional pharmaceutical supply chain with the patient on the first floor and the manufacturing facility in the basement,鈥� said Schmidt. 鈥淲ith production downstairs, you鈥檝e reduced your physical supply chain to an elevator, limiting costly risks from transportation delays or patient no-shows and disrupting packaging norms. Self-contained production facilities for vaccines are another innovation, supporting the fundamental right to people鈥檚 health in developing countries.鈥�

Headquartered in Switzerland, Tenthpin is a global management consulting firm focused on life sciences companies worldwide. Drawing from his firm鈥檚 experience working with pharmaceutical and biotech organizations, medical device manufacturers, clinical researchers, and other clients, Schmidt shared an intriguing look into what happens when life sciences ecosystems are driven by health outcomes and market demands shift from patient treatment to prevention, diagnostics, and cure.

Cloud-Based Collaboration Is Central to Outcome-Driven Healthcare

disruptions 鈥� with positive results 鈥� are a symptom of the transformational journey that every life sciences organization is undergoing. In an environment where health outcomes matter most, life sciences companies are moving business models towards value-based care, conducting research and evaluating drugs and treatments based on comparative effectiveness and risk-based pricing. In this context, California鈥檚 decision to make its own insulin shows the dramatic impact across healthcare value chains as power shifts to governments and payers intent on reducing costs.

Talking during the 麻豆原创 life sciences event, Schmidt saw cloud-based platforms as critical to bringing experts together for faster innovation and mentioned COVID-19 vaccine development as an example of competitors working together towards a shared objective to save lives.

鈥淟ife sciences organizations are collaborating to connect data across a patient-centric value chain for early engagement of partners in areas like research and manufacturing,鈥� he said. 鈥淲e believe there will be more opportunity-driven collaborations in the future. For example, the supply chain changes fundamentally with compressed timeframes between research, production, and delivery. You want to be set up from an organizational perspective to allow for more strategic ad hoc and cross-industry collaborations such as ramping up new facilities to adapt your manufacturing footprint in response to ongoing disruptions.鈥�

Data Sharing for Human-Centered Healthcare

As the healthcare industry explores advanced therapies, personalized treatments, and services, there鈥檚 a shift from traditional batch to continuous manufacturing. New technologies provide greater access to real-time patient data for developing more effective drugs with improvements in the patient experience and health results. However, these market ramp-ups stress existing business and treatment models.

鈥淧ersonalized treatments mean that organizations suddenly get much closer to patients,鈥� said Schmidt. 鈥淭he human health experience is all about connecting a tremendous amount data 鈥� which room of the house you were in when you took the medication and what you had for breakfast. Technology allows us to collect, analyze, and reuse detailed data.鈥�

Schmidt urged companies to consider the next evolution of systems, investing in data governance and data quality now for automation and other innovations built on cloud-based platforms.

鈥淭he life sciences value chain of tomorrow is data-driven and patient-centric, putting technology at the heart of industry transformation,鈥� said Schmidt. 鈥淥nce you have a stable system core, you鈥檒l be well-positioned for the future growth of markets such as cell and gene therapies for personalized treatment regimens.鈥�

The Next Treatment Innovation Is One Elevator Ride Away

Organizations in the life sciences industry face numerous other challenges such as imminent patent expirations and increasingly complex regulations, including waste reduction. But technology has a major role in all areas, for instance, speeding up the development of advanced treatments and regulatory approvals so innovations reach patients faster. Schmidt advised companies to connect digital transformation plans to high-end strategic innovations expected years down the road, as well as tomorrow.

鈥淭he life sciences industry is at a crossroads, and we need to reimagine its future,鈥� he said. 鈥淭he next disruptors are companies that may have a portfolio of investments, or are partnering with different networks, using external manufacturing and other innovations, creating competitive IP in new ways. There鈥檚 a significant opportunity for established and startup entrants that are collaborating with connected data to better understand how human body works and prevent and cure disease.鈥�

California鈥檚 trailblazing efforts to manufacture a drug is just one way that the life sciences industry is getting a healthy makeover. Let鈥檚 hope industry leaders heed the call to collaborate in new ways for more life-saving innovations.

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Industry innovation has been a fascinating topic over the last few years. It鈥檚 impossible to ignore how companies create new offerings and experiences that dramatically shift how an industry 鈥� or in some cases, multiple industries 鈥� operates and how people live. Such groundbreaking changes are usually built with an appreciation of existing data and technologies and through a desire to do things better in terms of product safety, supply chain optimization, and business finances.

I鈥檝e been very fortunate to experience the power of such industry innovation through the Customer Innovation & Maintenance team as part of the Customer Solution Support & Innovation organization at 麻豆原创. For years, we have worked with various organizations to navigate existing crises, address emerging challenges, and deliver new opportunities for the world. In this article, I will discuss three of our latest projects.

Saving People鈥檚 Lives by Reducing Counterfeit Drugs

One prime example of our efforts is tackling a global menace that impacts the entire world: counterfeit pharmaceuticals. Many falsified or substandard medicines contain dangerous ingredients, such as heavy metals, highway paint, and rat poison, that worsen people鈥檚 health conditions and create new diseases. As a result, the World Health Organization (WHO) estimates that more than yearly from these snake oil cures.

For years, governments have initiated legislation and regulations to criminalize and control the production and distribution of counterfeit drugs. However, my team discovered that the lack of a rigorous, universal network makes it difficult to curtail the problem often hidden within complex supply chains and sophisticated packaging.

Based on input from 麻豆原创 customers in the life sciences industry and working with 麻豆原创 industry experts on this international challenge, we developed . The industry network hub enables pharmaceutical firms to share product information for traceability and verification across the supply network and with government regulators. Running on and leveraging 麻豆原创 Blockchain Business Services, it is the first public-cloud, industry-specific business network used by more than 45 pharmaceutical firms, over 1,500 trading partners, and 80% of COVID-19 vaccine manufacturers.

But our contribution to the fight against counterfeit drugs is far from over. We are working toward adding aid workers from organizations 鈥� such as the Red Cross and Doctors Without Borders 鈥� to the hub so they can verify critical medicines and vaccines on the fly in low- to middle-income countries. This innovation is accomplished by integrating the hub into the application.

Accelerating the Development of Lifesaving Therapies

Another barrier to delivering large quantities of medical therapies quickly, efficiently, and safely is the structure of the traditional clinical supply chain. During the COVID-19 pandemic, supply chain resilience was highlighted as a critical requirement for providing lifesaving vaccines, prophylactics, and therapies created through industry-wide collaboration and a patient-centric focus.

To accelerate clinical R&D and time to value, my team worked with Roche, Tenthpin, and more than 25 additional customers and vendors connected to the pharmaceutical sector. Together, we reimagined clinical supply operations and brought to life a digital transformation of the entire life sciences ecosystem by developing the solution.

This next-generation cloud solution enables faster clinical supply cycle times, fewer inventory overages, and better-informed decision-making by providing accurate insights into forecasted demand and clinical site stock levels. It is also a milestone in the industry鈥檚 adoption of the cloud, facilitating end-to-end process operations and visibility to plan, source, manufacture, distribute, and reconcile supplies for clinical R&D. In addition, the solution helps address the blinding and randomization needs of clinical trials during the manufacturing, packaging, labeling, and shipment of clinical supplies to hospitals and clinics.

Meeting Financing Needs to Boost Growth

In addition to counterfeit drugs and the need for resilience, supply chain volatility and turbulence is providing the impetus for innovation. This reality is prompting capital investments including end-to-end due diligence and product tracing services; machines and plant setups that improve environmental impacts; and networks for finding, vetting, and onboarding new suppliers quickly.

Incorporating all these innovations into business operations 鈥� regardless of ecosystem size and geographic reach 鈥� requires money that many companies may not have immediately on hand. But to meet those finance needs, businesses and banks need to connect with each other smoothly, quickly, and securely without introducing more work and complexity to finance and treasury processes.

By delivering the solution, we play a key role in increasing the reliability of relationships between companies and their banks. Built on top of 麻豆原创 Business Technology Platform, the solution creates a multi-bank, digital channel between each party鈥檚 enterprise resource planning (ERP) systems to embed Electronic Banking Internet Communication Standard (EBICS) and SWIFT connectivity into the remote data transfer of payment transactions.

In return, treasury operations can be refined and simplified by updating payment status and cash positions in real time across business and bank ERP systems. 麻豆原创 Multi-Bank Connectivity can automate manual, error-prone steps associated with the execution and reconciliation of payments, order-to-cash applications, and order entry documents 鈥� helping to increase control, efficiency, and transparency.

Helping the World Run Better 鈥� One Innovation at a Time

The news headlines running across our screens every day prove that industry innovation is far from done. Unfortunately, no person, organization, or business carries the ultimate wisdom to solve every problem single-handedly. But if industry practitioners, business and technology experts, thought leaders, and inspired problem-solvers collaborate toward a common goal, a better future can be possible for everyone.

It is this vision that guides my leadership of Customer Solution Support & Innovation. My team of experts continuously looks for opportunities to do better for our customers, business, and global neighbors. And with the feedback and knowledge shared during every interaction, we look forward to working side by side with our customers and partners to provide the digital capabilities they need to make the world a better place 鈥� today and in the future.

Andreas Heckmann is executive vice president of Product Engineering and head of Customer Solution Support and Innovation at 麻豆原创. Follow him on and .

The batch release process is one such process 鈥� a necessary stopgap to ensure life sciences products were produced according to manufacturing requirements and meet the closely controlled regulations around distribution. During batch release, quality assurance and operations teams can identify deviations before the product is released to the market.

A non-compliant batch can have an irreversible and unforgiving impact on valuable human lives and the environment. A faulty product can cause physical harm or even death. Because people’s lives are at stake, the life sciences industry needs to be strictly regulated.

In 2021, there were 78 product recalls reported to the Food and Drug Administration (FDA). Failure to effectively manage this process is not only critical to protecting lives but can introduce a potential health hazard to patients, requiring a batch recall. According to , a single warranty or recall process can cost the manufacturer up to US$600 million. This does not include other recall-related costs like lawsuits.

A product recall can cause consumer and investor confidence to fall, resulting in a decline in revenue and stock prices. For example, the same study estimated a 13% drop in stock prices听across the industry, triggered by product听recalls. In fact, the total annual cost for the life听sciences industry can exceed $5 billion. That听doesn’t even consider the credibility costs.鈥�

Such recalls can have huge costs to a life sciences company and its brand reputation, in addition to inflicting harm to patients and damage to the environment due to waste.

Based on 麻豆原创 working with leading pharmaceutical companies, it takes a working group of quality control professionals around 40 hours to determine the release decision for one single batch. While vital to protect consumers, this process requires a significant amount of time, can impact a business鈥� overall supply chain, and requires consistent manual collection and evaluation of cumbersome data from different siloed systems. This slows down the overall supply chain performance and order fulfillment lead time, resulting in higher levels of inventory carrying costs.

With growing market trends demanding faster supply chains, highly personalized batch-size-one types of products, and more tightened regulations, it is critical to take steps to de-risk, speed up, and scale up the batch release process and do so without compromising quality or safety.

麻豆原创 has undertaken the development of an industry standard together with two leading global pharmaceutical companies. 麻豆原创 realized that the process deserves not only closer scrutiny, but an end-to-end re-engineering to replace the inefficient, legacy, labor-intensive manual process with a digital platform, eliminating manually pooling information from non-integrated systems.

In this context, 麻豆原创 has launched the 麻豆原创 Batch Release Hub for Life Sciences solution, which helps address life sciences organizations鈥� unmet market need for transparent, flexible, integrated, and efficient batch release management.

麻豆原创 Batch Release Hub for Life Sciences is an听innovative cloud solution developed on听. It听is听designed to semantically integrate with听existing heterogeneous 麻豆原创 and third-party solutions 鈥� both听on premise and in the cloud 鈥� with a unique听integration data model听that can听help make faster听and more secure batch release decisions.

It receives the release check data required to release a batch from various source systems, automatically evaluates it against predefined criteria, and visualizes the results into a cockpit to enable a faster and more intuitive decision-making process.

Based on 麻豆原创鈥檚 leading technology, the solution is a digital hub that helps provide qualified persons and release-responsible persons with the intelligent tools to streamline and simplify the full batch release procedure to make fast and accurate batch usage decisions. The reduction of review cycle times enables scalability through data collection and evaluation automation while retaining compliance. Digital batch release supports preventive actions to enable a life sciences company to produce the right product the first time, minimizing the CO2 footprint associated with replenishment and recall of a non-compliant batch.

With the solution, organizations can:

• Reduce the risk of quality non-compliance by standardizing and simplifying the batch release process, reducing the risk of human errors.
• Reduce compliance and risk management costs by automating and simplifying the time-consuming and labor-intensive legacy batch release activities.
• Reduce order fulfillment lead time by enabling a faster batch release cycle time, thanks to automation and standardization.
• Reduce inventory carrying costs and the environmental impact of excessive inventory by reducing the required level of inventory with lower order fulfillment lead times.

The 麻豆原创 Batch Release Hub for Life Sciences solution is the latest life sciences innovation from 麻豆原创 and serves as an important pillar in the 麻豆原创 for Life Sciences solution portfolio. 麻豆原创 Batch Release Hub for Life Sciences helps extend the enablement of the Intelligent Enterprise by bringing software intelligence to the core process of batch release for life sciences products.

Learn more about 麻豆原创 Batch Release Hub for Life Sciences in the听 and this .

Aladdin Mandishah is global industry solutions manager for Life Sciences at 麻豆原创.

According to a McKinsey report, the median , with poor forecasting and planning attributed as the primary reasons. Using a data-driven approach to improve demand forecast accuracy and reduce overage could optimize costs, leading to annual savings of more than $100 million.

This highlights a significant opportunity to reimagine the current clinical trial supply management (CTSM) processes and adopt emerging technologies.

Currently available CTSM solutions are either highly customer-specific consulting solutions or highly fragmented; they do not offer end-to-end or out-of-box integration to clinical supply processes and core supply chain 麻豆原创 S/4HANA modules. In addition, the 麻豆原创 portfolio extends to include partner solutions the address industry-specific needs.

In this context, 麻豆原创 has launched 麻豆原创 Intelligent Clinical Supply Management, which addresses life sciences organizations’ unmet market need for transparent, flexible, integrated, and efficient clinical trial supply management.

麻豆原创, as well as Roche, Tenthpin, and a consortium of more than 25 life sciences organizations, contributed by providing regular feedback into the design and development of the solution. This customer engagement initiative is defining the industry standard for tracking clinical studies 鈥� all the way from drug forecasting till delivery and distribution.

“The execution of clinical trials has become very expensive, due to the lack of oversight into drug product visibility across multiple partners and IT systems,鈥� said David Volk, executive director of Clinical Supply at Roche. 鈥淭his is an industry-wide challenge that we must all address together. The model of a consortium to solve this issue is not only beneficial to our industry, but to society. Setting standards will help greatly improve clinical trial success rates, to ensure time and money spent will push more clinical trials through to completion.鈥�

麻豆原创 Intelligent Clinical Supply Management helps life sciences companies gain end-to-end visibility of clinical supplies, from planning to production to patient.

With the solution, life sciences organizations can:

• Optimize clinical trial processes and eliminate manual interfaces
• Gain end-to-end visibility into the clinical supplies process from source to clinical site with unified master 听data
• Support advanced and dynamic study designs with flexible and configurable clinical study set up
• Reduce inventory overage/wastage听and clinical supply cycle times with more accurate demand forecasting and planning
• Establish a network of clinical supply chain stakeholders such as interactive response technology providers, contract manufacturing organizations, contract research organizations, logistics providers, etc.
• Innovate an industry standard to determine best practices, develop the future standard solution from which to learn, and co-innovate with other life sciences stakeholders
• Enable end-to-end process operations to plan, source, manufacture, distribute, and reconcile supplies for clinical research and development (R&D)
• Lower total cost of ownership (TCO) by leveraging existing 麻豆原创 business capabilities through 麻豆原创 S/4HANA extensions, such as material management, production process, logistics, sales, global label management, warehouse management, advanced track and trace for pharmaceuticals, global trade services, etc.

Based on the success of the clinical trial solution consortium, 麻豆原创 has launched another consortium to address the needs for life sciences organizations cell and gene therapy processes.听 This consortium will support the development of the planned 麻豆原创 Cell and Gene Therapy Orchestration solution.

Learn more about 麻豆原创 Intelligent Clinical Supply Management:

• Read the
• View the infographic:

Gayatri Gopal is director of Product Management for Life Sciences at 麻豆原创.

While CGTs offer a potentially promising new option for patients, they are complex to develop, manufacture, and deliver. In contrast to traditional therapies, individualized therapies often involve extracting cells or tissue from the patient or a donor, processing the sample, manufacturing a personalized therapy, and administering the final product to the patient.

There are already many companies working to deliver CGTs to patients, ranging from small startups to large biopharmaceutical companies that are aiming to realize a full portfolio of cell and gene therapies.

There are also specialized IT solutions available that are supporting some CGT business processes and addressing some CGT-specific challenges.

Most life sciences companies are moving away from single-tenant portals and looking for a standardized platform that will allow the GCT industry to scale. Organizations offering cell and gene therapies need a time-sensitive and fault-tolerant orchestration engine to manage the flow of samples from treatment centers to manufacturing locations and then the return of the personalized therapies for administration at treatment centers.

Based on intensive market research and collaboration, 麻豆原创 realized that there is a significant technology gap that needs to be filled to support the safe and efficient delivery of these specialized products to patients. Therefore, 麻豆原创 has undertaken the development of an industry-standard CGT orchestration solution. To complement and support the development of this solution, we have initiated an industry consortium to ensure the solution supports emerging industry standards.

The solution will be built on and will be delivered as part of 麻豆原创鈥檚 industry cloud. The CGT solution will integrate with treatment center platforms using open APIs to support the broadest ecosystem possible. It will be pre-integrated with 麻豆原创 S/4HANA for manufacturing and other processes but will use open APIs to enable interoperability with other manufacturing platforms and contract manufacturing organizations.

The objective of the new cell and gene therapy solution from 麻豆原创 will be to help ensure that the right patient is treated with the right medicine at the right time without error in the value chain. In order to achieve this result, the planned capabilities include:

• End-to-end chain of identity, chain of custody, and supply orchestration to track CGT products to ensure that patients get the right medicine and can be treated safely as planned
• Facilitating critical value stream management activities and business processes — such as logistics, slot scheduling, labeling, batch release, and invoicing — to reduce overall process lead time and support the short shelf life typical of CGTs
• Ability to manage high order and process variability as well as unpredictability, with exceptions being the standard, and to reduce operational cost due to optimized supply chain execution and fewer manual activities
• Streamlined processes and real-time data to help leaders make informed decisions on every aspect of the CGT supply chain
• Better collaboration and increased satisfaction among all CGT stakeholders, from healthcare providers to life sciences companies, cell labs, contract manufacturers, and logistics providers with real-time, event-driven data exchange based on stable and published APIs
• Supporting post-marketing commitments, such as tracking of outcomes and outcome-based pricing
• Enabling compliance with applicable regulations like HIPAA and GXP

鈥淟ife sciences biopharmaceutical companies are working to bring cell and gene therapies to patients and have gained or are about to gain market approval by the regulatory agencies,” said Matt Laukaitis, general manager of Consumer Industries at 麻豆原创. “So now they need an industry-standard solution suitable to orchestrate brand new processes required by these therapies. 麻豆原创’s industry cloud aims to deliver these capabilities with limited disruption to the current landscape, open integrations to support a broad ecosystem, and with a very short time to value for our customers.鈥�

If you are interested in joining the consortium to shape the future of 麻豆原创’s cell and gene therapy solution, please contact the solution management team:

• Mazahir Valikarimwala, Solution Owner, 麻豆原创 Cell and Gene Therapy
  mazahir.valikarimwala@sap.com
• Tim Hood, Cell Gene Therapy Consortium Lead
  tim.hood@sap.com

麻豆原创 today also announced the availability of the 麻豆原创 Intelligent Clinical Supply Chain Management solution, for which development was also based on an industry consortium of almost 30 life sciences organizations.

Tim Hood is chief technology officer for Consumer Industries at 麻豆原创.

Counterfeit versions of biopharmaceutical company Gilead Sciences鈥� HIV medicines ended up on pharmacy shelves and in patients鈥� hands, according to court documents recently released.

Gilead pointed to a network of small drug suppliers and distributors that tampered with packaging and falsified the medications鈥� pedigree — the documentation that comes with drugs and is meant to authenticate them. The network ultimately sold 85,247 counterfeit bottles of branded medications worth more than $250 million.

麻豆原创’s Take

In the U.S., once a drug is sold to a wholesaler, the pharmaceutical maker does not know where it goes. European regulations led to the creation of a system to store and share such information, but the U.S. Drug Supply Chain Security Act of 2013 doesn鈥檛 require the pharmaceutical industry to implement one until 2023.

鈥淚n Europe, they’re set up today where pharmacies could do a verification,鈥� said Kevin Brophy, 麻豆原创 life sciences industry advisor at 麻豆原创. 鈥淵ou can’t do verification here.鈥�

What the U.S. does have right now, Brophy says, is a 鈥渢rack and trace鈥� system for drug returns. By borrowing some tactics and technology from that approach, the pharmaceutical industry could create a system could prevent counterfeits from entering the system in the first place, Brophy said.

In fact, it鈥檚 likely that by next year, the pedigree documentation system will be improved. 鈥淭echnology has a big play here to help with the holes we just saw in the system, and information holes will be improved,鈥� Brophy said.

On deck is the use of an information collaboration hub, where crucial information can be accessed to trace drug shipments. Beyond that, technology is being developed that would create a passive system, which would not require a suspicious pharmacist to act to verify the product authenticity. Instead, that data would be standard with other product-specific information

Further innovation could come with the use of blockchain technology, which today is used to track and trace drug returns. Among other things, blockchain allows all parties to enter and see exactly where a product is at any given time in the returns process. 听That can be used to enhance a tracking system for sales.

鈥淵ou can embed things into a blockchain to provide 100% verification on a scan of something,鈥� Brophy said.

Contact:
Joellen Perry, Head of Global Public Relations, 麻豆原创
+1 (626) 265-0370, joellen.perry@sap.com, PST

The smart app will allow U.S. law enforcement officials across the country to scan the 2D barcode on Boehringer Ingelheim-manufactured life-enhancing medications and authenticate them before the medicines reach patients.

鈥淭he law enforcement smart app utilizes 麻豆原创鈥檚 scalable and secure blockchain solution for manufacturers to drastically improve the pharmaceutical supply chain from start to finish,鈥� said 麻豆原创鈥檚 global GM for Consumer Industries, Matt Laukaitis. 鈥淎s this app demonstrates, vertical industry expertise is a critical success factor in delivering innovations to protect patients and ensure access to authentic, life-enhancing medicines.鈥�

Passed into law in 2013, the U.S. Drug Supply Chain Security Act (DSCSA) aimed to boost the FDA鈥檚 ability to protect U.S. patients by developing a connected, digital system to trace prescription drugs throughout the country and identify counterfeit, stolen or contaminated medicine before it reached the hands of consumers.

麻豆原创鈥檚 smart app is a major step in achieving the vision of the DSCSA and is vital to protecting communities and patient safety. When counterfeit drugs are released into the supply chain, vulnerable patients and marginalized populations with limited access to safe, authentic and affordable medicines bear the brunt of the impact.

鈥淧atient safety is our top priority at our family-owned company, and unverified pharmaceuticals, especially amid a global pandemic, pose a significant threat to the safety and security of both patients and healthcare providers,鈥� said Aaron Graham, Executive Director, Brand Safety & Security, Boehringer Ingelheim. 鈥溌槎乖粹�檚 blockchain-based solution allows our team to safeguard against illicit and unsafe medicines reaching the hands of those who need medicine the most.鈥�

This technology builds on 麻豆原创鈥檚 previous efforts to eliminate counterfeit products with 麻豆原创 Information Collaboration Hub for Life Sciences, a blockchain-technology tool that allows users to authenticate pharmaceutical packaging as it moves between manufacturers, U.S. wholesalers and U.S. hospitals and pharmacies.

To learn more, watch a .

Visit the . Follow 麻豆原创 on Twitter at .

Media Contact:
Stacy Ries, +1 (484) 619-0411, stacy.ries@sap.com, ET
麻豆原创 麻豆原创 Room; press@sap.com

Any statements contained in this document that are not historical facts are forward-looking statements as defined in the U.S. Private Securities Litigation Reform Act of 1995. Words such as 鈥渁nticipate,鈥� 鈥渂elieve,鈥� 鈥渆stimate,鈥� 鈥渆xpect,鈥� 鈥渇orecast,鈥� 鈥渋ntend,鈥� 鈥渕ay,鈥� 鈥減lan,鈥� 鈥減roject,鈥� 鈥減redict,鈥� 鈥渟hould鈥� and 鈥渨ill鈥� and similar expressions as they relate to 麻豆原创 are intended to identify such forward-looking statements. 麻豆原创 undertakes no obligation to publicly update or revise any forward-looking statements. All forward-looking statements are subject to various risks and uncertainties that could cause actual results to differ materially from expectations. The factors that could affect 麻豆原创’s future financial results are discussed more fully in 麻豆原创’s filings with the U.S. Securities and Exchange Commission (“SEC”), including 麻豆原创’s most recent Annual Report on Form 20-F filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates.
漏 2021 麻豆原创 SE. All rights reserved.
麻豆原创 and other 麻豆原创 products and services mentioned herein as well as their respective logos are trademarks or registered trademarks of 麻豆原创 SE in Germany and other countries. Please see for additional trademark information and notices.

In response, hospitals, insurers, and other healthcare organizations are linking drug therapy and medical device usage and payment to performance guarantees while trying to own more services to reduce costs. Enter business networks, where healthcare professionals can work together for greater transparency across the entire .

鈥淪uppose someone gets lab work completed for their tumor. The hospital lab ships the blood to experts at the biopharmaceutical company who create a drug for individualized treatment,鈥� said John Murray, strategic director for Life Sciences at 麻豆原创. 鈥淭he business network securely manages the chain of identity and custody between patient and healthcare provider to manufacturer and back. Transparency can help organizations better meet drug therapy performance guarantees.鈥�

Life Science Business Network Provides Supply Chain Visibility

When drug manufacturers know where their shipments are and need to be in real time, they can monitor progress against performance guarantees and make decisions to prevent problems. For example, during the initial COVID-19 vaccine distribution, bad weather grounded some airplanes, delaying shipments and the rollout of inoculations. With no transparency between flight updates and local vaccine sites, patients, healthcare providers, and government leaders had no way to quickly understand the roadblocks and make alternate plans. Healthcare workers turned away frustrated people who had shown up for scheduled appointments, while policy leaders had no answers.

鈥淎 life science business network would create an end-to-end process beginning with individual patients, involving researchers, manufacturers, as well as transportation and distribution to healthcare practitioners and patients, all the way through someone鈥檚 medical outcomes, which is the measure for everyone on the supply chain,鈥� said Murray. 鈥淭his is central to 麻豆原创鈥檚 vision. Our solutions are already the backbone running many life science organizations, and we now have the opportunity to bring partners together in one connected business network.鈥�

One example is that can track medical and other supplies and business processes, comparing planned against actual milestones across business partners and multiple disparate systems. Leading pharmaceutical companies worldwide are using the hub. But that鈥檚 just the beginning.

鈥淭he long-term vision is to harmonize all of these separate business networks into one life science network so that it becomes a set of services for partners who can also interface with data across enterprise systems,鈥� said Murray. 鈥淲inning businesses will have clear supply chain visibility from maker to user, meaning patients whose medical results and lives improve.鈥�

Making Personalized Medicine Affordable

While bespoke anything automatically drives up the price tag, personalized medicine can become more affordable when organizations along the life science supply chain share the risk. It鈥檚 the only way to manage costs and make these highest quality treatments affordable for more people. Partnerships are certain to change business models across the life science industry.

鈥淎s organizations increasingly compete not on price, but patient outcomes, healthcare practitioners and manufacturers are adapting to performance guarantees,鈥� said Murray. 鈥淗ospitals know they won鈥檛 get reimbursed by Medicare in the U.S. if patients return with the same health conditions after being treated within certain time frames. One medical device manufacturer guarantees treatment prices that meet national health service billing caps if practitioners meet certain usage conditions.鈥�

Advancements in science, technology, and biopharma, including genome sequencing, are making tremendous improvements in individualized treatment plans. Personalized oncology drugs, wireless programmed pacemakers, 3D printing of specialized prosthetics, and other innovations have the potential to improve healthcare results for millions of people worldwide. Unlike some other industries, life sciences and healthcare are not just about business. In transforming to securely share data and knowledge more transparently through specialized business networks, the life science industry can fulfill the patient-centric promise of personalized medicine, improving the quality of life that鈥檚 deeply personal to each of us and our loved ones.

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Purpose-built by 麻豆原创 in conjunction with partners, these open-platform solutions are interoperable with the intelligent suite and 麻豆原创 Business Network. Several partners have recently announced breakthroughs that are helping them accelerate business operations, balance cost efficiencies, and simplify the provisioning of high-value vertical solutions. Here are their stories.

Managing Medical Device Compliance Worldwide

Germany鈥檚 p36 GmbH was recently recognized as a 2021 麻豆原创 Pinnacle Award finalist in the Partner Application of the Year, Industry Cloud category. The company worked closely with 麻豆原创 to develop a best-in-class solution to help businesses in life sciences respond to unique device identification (UDI) requirements for medical devices.

Built on 麻豆原创 Business Technology Platform (麻豆原创 BTP), p36鈥檚 new UDI solution fits into existing IT landscapes with 麻豆原创 and third-party applications. It provides a holistic, managed UDI service supporting both business and IT operations with active market monitoring and process best practices for different countries 鈥� exactly what customers demand from a modern software-as-a-service (SaaS) solution. By doing so, the platform helps p36 customers achieve UDI compliance in order to become and remain competitive globally.

The annual 麻豆原创 Pinnacle Awards acknowledge the contributions of 麻豆原创 partners that have excelled in growing their partnership with 麻豆原创 and helping their customers meet their goals. 鈥淏eing nominated as a finalist from more than 20,000 麻豆原创 partners worldwide is an incredible recognition of the way we have provided best-in-class cloud solutions for the life science industry. Our continued partnership with 麻豆原创 has been a major factor in our success, and being a part of 麻豆原创’s industry cloud portfolio is the perfect way to support our business strategy of industry-focused SaaS solutions,鈥� said Robin Wennemuth, CEO and co-founder of p36.

New Standard for Life Sciences Clinical Trial Supply Operations

To better address the specific needs of the clinical supplies practice, 麻豆原创, Roche, and Tenthpin recently initiated an industry consortium consisting of numerous life science stakeholders, including clinical trial and interactive response technology system vendors. The consortium is focused on defining and orchestrating optimally aligned supply processes in order to harmonize clinical and commercial supply chain management systems. The next-generation 麻豆原创 Intelligent Clinical Supply Management solution aims to shape the future of clinical supplies operations.

To further strengthen its strategic partnership with 麻豆原创, Tenthpin opened a that is focused on fostering innovative clinical trial solutions designed on 麻豆原创鈥檚 industry cloud.

鈥淭he life science industry is at a crossroads and our clients need to reimagine their future,鈥� said Michael Schmidt, Tenthpin partner and co-founder. 鈥淭here is a strong need for innovation and the opportunity for the industry is significant. The future of the value chain for the life science industry will be data-driven and patient-centric. With the blurring of lines between pharmaceuticals and medical technology, and with the emergence of bioelectronics, the industry will provide integrated healthcare solutions and treatment that go beyond the pill. Innovation capabilities from Tenthpin in support of 麻豆原创鈥檚 industry cloud will be at the heart of this transformation.鈥�

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Cloud-Based Clinical Trial Analytics Solution Built on 麻豆原创 BTP

In May, Achiral Systems Pvt., Ltd. launched its solution and made it available on 麻豆原创鈥檚 digital marketplace for partner offerings. The new solution provides a harmonized approach to clinical trial analytics, working to deliver increased transparency into performance, more accurate planning for future studies, greater trust in data, and ultimately higher success rates.

Life science organizations conduct clinical trials worldwide through multiple contract research organizations (CRO). The success of trials depends on study planning and the performance of various sites, CROs, and the experience of researchers. Performance can vary considerably depending on the therapeutic area, the country where research is conducted, and the phase of the study. In most of these organizations, core data is scattered across departments and across multiple spreadsheets. This solution consolidates and aggregates data to bring clarity to analytics.

鈥淲e are working exclusively to provide comprehensive solutions for clinical trials,鈥� commented Uma Janapareddy, managing director of SyMetric. “Through our 麻豆原创 partnership, we are able to leverage 麻豆原创 Business Technology Platform to deliver flexible, cloud-based solutions to our customers. We are pleased to announce the launch of SyMetric Trial Analytics on 麻豆原创 Store as part of 麻豆原创鈥檚 industry cloud.鈥�

To further the spirit of collaboration, Tenthpin and Symetic 听their strategic partnership to build clinical trial solutions. Bringing the industry expertise of Tenthpin with 厂测惭别迟谤颈肠鈥檚 clinical trial solution know-how, on top of 麻豆原创 technology, is a winning match to help improve clinical trial processes.

Vertical Solutions Drive Cost-Effective Transformation and Sustainable Growth

For life science companies, 麻豆原创鈥檚 industry cloud can provide resilience, efficiency, and flexibility while supporting strategic transformation. Its wide selection of specialized, cutting-edge solutions can be used to enhance and extend business capabilities while maintaining process integrity and compliance.

Innovators can respond to changing business requirements with applications they can trust while minimizing integration and support costs. They can enable continuous innovation while protecting the security and integrity of business processes. Industry cloud solutions from 麻豆原创 help increase automation and support business transformation in a safe, controlled way.

Mandar Paralkar is global head of Life Sciences at 麻豆原创.

鈥淲e are providing a holistic solution for clinical trials management, what we call ERP for clinical research,鈥� said Uma Janapareddy, founder and managing director at SyMetric. 鈥淗aving easily accessible data on one unified platform helps researchers develop more effective drugs with stronger study results so they can bring pioneering medicines faster to people.鈥�

People-Driven Clinical Trials

Physicians, researchers, project managers, investigators, and biostatisticians are using SyMetric Trial Analytics to conduct studies at global pharmaceutical companies and clinical research organizations in a variety of therapeutic areas such as neurology, respiratory illness, oncology, and dermatology.

Running on , the solution captures and analyzes historical and updated clinical trial data in one system. This includes patient information indicating initial eligibility to participate in a clinical trial and progress monitoring through rigorous statistical analyses at trial completion for regulatory submission. The tool captures and analyzes electronic data from anywhere, such as a patient鈥檚 activities tracked on a mobile device or artificial intelligence (AI)-based imaging that shows medical progress.

鈥淚f you鈥檙e starting a lung cancer study, you can easily find out disease prevalence rates and research histories by geography, experience of the investigators, availability of skilled coordinators or pharmacists, and other factors. Our solution brings this data together for informed planning that leads to more efficient execution,鈥� said Janapareddy. 鈥淥nce the trial is underway, our easy-to-use solutions help researchers accurately track patient recruitment, study progress, make necessary amendments to the clinical study on the fly, and conduct any other activities.鈥�

Time-Saving Clinical Data Analytics

According to Janapareddy, the solution gives clinicians cost-savings foresight and flexibility. Built-in algorithms automatically monitor data, for example, rejecting potential patients who don鈥檛 fit certain parameters based on gender, age, or certain health and lifestyle conditions. Real-time data saves time in data clean up at the project completion stage.

Customers have reduced clinical trial setup and completion timelines by 20%. Some have saved up to 30% wastage of drug supplies during the trial manufacturing phase. One customer saved thousands of dollars using the solution to calculate the number of patient volunteers, as well as the number of drugs and testing kits required to meet randomization objectives with greater precision.

鈥淲ith real-time data and built-in algorithms, companies can quickly adapt protocols in response to continuous patient recruitment,鈥� she said. 鈥淩esearchers can conduct interim analyses at any time before study completion, adjusting drug dosages, delivery mechanisms, and packaging quantities. The system automatically incorporates protocol adjustments and amendments, sans any downtime and without jeopardizing overall study timelines.鈥�

Working with 麻豆原创 Labs India

While most of 厂测惭别迟谤颈肠鈥檚 customers are based in the United States and India, Janapareddy has set her sights on Europe, inspired by the strength of 麻豆原创鈥檚 innovation ecosystem. An alumni of 麻豆原创 Startup Studio at , Janapareddy appreciated the design thinking workshops her team used to develop use cases from their collective experiences. She also valued the co-innovation relationships her startup has forged with other members of the program. These include biopharmaceutical companies, medical device manufacturers, and cosmeceutical and nutraceutical manufacturers.

鈥淲e have a shared passion with 麻豆原创 for the power of life sciences and integrated enterprise resource planning (ERP) data on a single platform 鈥� where every company becomes an ,鈥� said Janapareddy. 鈥溌槎乖� is a global leader in life sciences including pharmaceuticals, manufacturing, and ERP, and its leaders generously share their expertise with us. We also appreciate the significant exposure to 麻豆原创 customers from this partnership.鈥�

SyMetric Trial Analytics and the SyMetric Clinical Trial Platform are available on .

Connected Clinical Trial Supply Chain

Before she founded SyMetric, Janapareddy held leadership positions at an international non-profit organization that provided funding, education, and other opportunities for underprivileged women. She developed the concept for SyMetric with input from her family and friends at 麻豆原创 and in the life sciences industry.

鈥淚 wanted to do something big in life, contributing to the community in a way that would have lasting impact,鈥� she said. 鈥淭here was no integrated system for clinical trials anywhere in the life science industry, so I founded SyMetric to help manage the entire supply chain for people-centric research.鈥�

From Data-Centric to Patient-Centric Trials

Janapareddy envisioned a fully interconnected data platform for everyone involved in life sciences clinical research and manufacturing.

鈥淭he industry is looking ahead to patient-centricity, where people can control their data using the latest technologies to share information and act on it on secure, compliant cloud-based platforms,鈥� she said. 鈥淚t began with informed consent and now connected data brings researchers and patients even closer together.鈥�

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When the COVID-19 pandemic broke out, CureVac immediately applied the its founder, Ingmar Hoerr, had , to develop a vaccine candidate. Currently in the process of completing its late-stage clinical trials, the company expects approval to produce and distribute its vaccine in the second quarter of this year. are already in circulation.

Ramping Up Operations in All Areas

CureVac therefore needs to rapidly transition from research and lab-scale producer to large-scale manufacturer. CEO Dr. Franz-Werner Haas the goal of producing 300 million doses by the end of this year and 600 million in 2022.

Pierre Kemula, chief financial officer of CureVac, described the challenge ahead: 鈥淭o get ready, we have to ramp up our operations in all areas, including manufacturing, procurement and supply chain, quality management, business planning, and analytics 鈥� but also administrative functions like human resources and finance.鈥�

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To scale up rapidly, CureVac is working with partners. In January, the company entered a German multinational pharmaceutical group Bayer to draw on its expertise and infrastructure. Then in February, CureVac announced a , building on their existing relationship to jointly develop next-generation mRNA vaccines to address multiple emerging variants.

By with experienced contract development and manufacturing organizations (CDMOs), CureVac will tap into expertise and capacity across Germany, France, the Netherlands, Belgium, Spain, and Austria, as well as potentially Sweden, Poland, Italy, and Ireland. CureVac is also building a at its headquarters in T眉bingen, to go into operation in 2022.

Although mRNA vaccines are not a new concept, the pandemic marks the first time they have been authorized for use outside of clinical trials. The resulting surge in demand has been the source of some hiccups in the supply chain. A shortage of messenger RNA is not expected, but there is , according to Scientific American.

One of the limiting factors in vaccine production currently are lipid nanoparticles (LNP), the material needed to encapsulate and protect the messenger RNA, which are very sensitive and require rare special expertise to produce, explained Dr. Oliver N眉rnberg, chief product owner for 麻豆原创 Life Sciences at 麻豆原创.

Moving the Needle: CureVac Entrusts 麻豆原创 with its Business Transformation

A business transformation of this magnitude with peak demand and supply chain challenges from the outset requires a highly adaptable, integrated, and intelligent enterprise resource planning (ERP) system. To achieve the desired scale quickly, CureVac will focus on developing and producing vaccines, while relying on for its business and operations.

鈥淲e need a partner like 麻豆原创 to define and implement the business processes to tackle this incredible growth,鈥� Kemula confirmed. CureVac leaders have teamed up with 麻豆原创 to introduce cloud-based solutions for procurement, manufacturing, quality management, and supply chain processes to a global scale.

Since most of CureVac鈥檚 partners, suppliers, and customers already run 麻豆原创, CureVac鈥檚 CFO is convinced the collaboration, sharing of digitized data or interoperability of manufacturing and supply chain systems will be much easier. 鈥溌槎乖� solutions also support CureVac鈥檚 GxP compliance, which is a key requirement for all biopharmaceutical companies. This a must-have for us,鈥� he said.

Top image via video.

麻豆原创 solutions are designed to help governments, healthcare organizations, life sciences companies, medical device manufacturers, and distributors manage the delivery network for safe and efficient vaccine delivery to the communities.

These stakeholders are working hard to simultaneously mitigate public health risks, stabilize economies, and support life-saving vaccine approval. Being able to rely on 麻豆原创 solutions to manage resources and have transparency into a fully connected supply chain will be a key to success for national and global organizations. 麻豆原创 tools better position stakeholders to overcome potential resource and supply constraints, quickly adapt to changes, drive accountability, monitor vaccine access equity, and increase constituent trust.

The VCH also includes the , which helps governments — from state and local to the largest nationally — prioritize who gets vaccinated, gauge sentiment about being vaccinated to encourage greater adoption, schedule vaccinations, and track patients after vaccination for any potential side effects and follow-ups. It also creates a digital “vaccine passport” that could be shared as necessary with schools, employers, etc., depending on local policies.

麻豆原创 solutions address the following areas of vaccine distribution and tracking:

Frontline Healthcare
麻豆原创 allows medical staff to stay better informed and enable timely and efficient decision-making, thus helping improve hospital wait times, hospital throughput, and access to quality care for vulnerable populations. 听麻豆原创 also provides the tools and apps for governments to more effectively conduct tracing of known and, anonymously, of unknown contacts to interrupt the chain of COVID-19 infections.

Vaccine Manufacturing
麻豆原创 helps with solutions to protect against counterfeit vaccines, provides vaccine manufacturers the capability to comply with serialization regulations across multiple jurisdictions, and supports vaccine production tracking.

Vaccine Distribution
麻豆原创 provides a seamless experience for governments worldwide to publicly fund and order vaccines for their constituents. 麻豆原创 solutions provide a comprehensive view of vaccine program management, allowing governments to manage inventory, model supply chain network constraints, assess risks, and intervene when necessary. Supply chain network planning will enable governments and industry partners to more easily pivot and scale efforts as new vaccines emerge, and government requirements and guidelines change. 麻豆原创 solutions provide full transparency into the transport, storage, and dispensing of vaccines to support ensuring their safety and effectiveness.

Vaccine Administration
麻豆原创 provides the tools for governments to manage provider enrollment by jurisdiction, monitor resident trust and perception of the vaccine, manage patient assessment and scheduling based on public health guidelines and vaccine availability, and analyze constituent sentiment via the user-friendly dashboarding for monitoring, decision-making, and provider accountability.

Public Awareness
麻豆原创 provides the tools to gauge resident perception and sentiment by demographic groups, including marginalized communities, and align those insights with strategy and policy to address concerns and deliver a better experience quickly. This helps governments understand the resident sentiment around the vaccine and what actions they can take to help people feel more confident and safe about distributing, administering, and protecting the vaccine.

Managing the Workforce
麻豆原创 helps organizations support their team members as they adapt to working at home through rapid sentiment analysis. This will support organizations鈥� efforts to close experience gaps while maintaining business continuity. Additionally, 麻豆原创 provides the tools for businesses and governments to complete workforce planning and quickly staff up with full-time and contingent workforce to meet mission-critical, time-sensitive demands.

麻豆原创 solutions bring together vertical industry expertise to help governments and organizations address the challenges created by the COVID-19 pandemic from clinical support, vaccine supply chain, regulatory compliance, and how businesses respond and manage their workforces effectively.

Learn More

Maria Mizell works in Industry Executive Advisory at 麻豆原创.
John Murray is senior director of Strategic Initiatives for Life Sciences at 麻豆原创.

麻豆原创鈥檚 VCH is built on the industry-award-winning 麻豆原创 Information Collaboration Hub for Life Sciences. It covers the end-to-end process from manufacturing to controlled distribution to听administration and听postvaccine monitoring.

鈥淐OVID-19 has put a lot of pressure on the life sciences industry where they have realized a large gap in their supply chain strategy,鈥� said Michael Townsend, industry analyst at IDC.听鈥淎 one-stop place for the life sciences industry to manage their vaccination procedures and tap into a source of suppliers, even those across industries, will help to fill this gap, to ensure patients obtain lifesaving drugs and devices.鈥�

Businesses that are part of the vaccine production process, from manufacturers, logistics service providers and pharma companies to wholesalers and dispensers, can run their critical vaccine processes on 麻豆原创 software. Building on its听deep expertise in the industry, 麻豆原创 has designed the VCH as an extension to its business network鈥揺nabled drug supply chain, to help make collaboration among the network partners easy and monitor the order fulfillment of vaccines, all the way from vaccine suppliers to the dispensing units.

The VCH provides the critical network and technology capabilities required to effectively support large-scale vaccination programs and drug distribution while creating the backbone to better mitigate future emergencies.

To learn more, read “Shortening the Road to Recovery.”

Visit the . Follow 麻豆原创 on Twitter at .

Media Contact:
Stacy Ries, +1 (484) 619-0411, stacy.ries@sap.com, ET
麻豆原创 麻豆原创 Room; press@sap.com

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The so-called 鈥渂lockchain winter鈥� of 2018, which brought the hype surrounding the technology to an end, turned out to be very much to 麻豆原创鈥檚 advantage.

Read part one of this story here.

鈥淲e were able to spend 2019 consolidating our collective expertise and focusing much more closely on specific use cases in the enterprise environment,鈥� Torsten Zube, former head of the 麻豆原创 Innovation Center Network and current head of 麻豆原创 Cloud Platform Business Services, says. 鈥淲e saw that more and more businesses were looking seriously at blockchain and gaining a better understanding of the technology.鈥�

鈥淭he challenge for us is to ask the right questions at an early stage,鈥� says Thomas Uhde, head of the blockchain team at the 麻豆原创 Innovation Center Network in Potsdam. 鈥淚t often happens that customers come to us with a business problem and assume that the solution must lie in blockchain. We then have to look together at whether the problem we want to solve is in fact a case for blockchain or not.鈥�

One such case emerged from the need to verify the authenticity of returned drug products.

鈥淐ounterfeit, stolen, and contaminated pharmaceuticals products are a massive issue all over the world,鈥� says Oliver Nuernberg, chief product owner for 麻豆原创 Life Sciences. 鈥淲hich is why the United States introduced an act in 2013 requiring pharmaceuticals companies that trade on the U.S. market to perform strict checks on returned products prior to resale. A pharmaceuticals customer of ours, Merck Sharp and Dohme, wanted to invest in blockchain, and the blockchain use case was a perfect fit for them in this context.鈥�

The result was .

鈥淓very pharmaceutical product package delivered to the United States is registered on our solution鈥檚 blockchain,鈥� explains Nuernberg. 鈥淐ustomers no longer have to authenticate a returned product themselves; instead, they simply use an app that accesses the blockchain.鈥�

Alongside verification, traceability is one of the major benefits that when properly used, blockchain technology can deliver. The , a blockchain extension of the 麻豆原创 Logistics Business Network, provides an end-to-end picture of the supply chain in industries such as foods and pharmaceuticals.

鈥淚ncreasingly, people want to know where their food comes from,鈥� says Product Owner Christoph Huber. 鈥淲e proposed a cloud solution to customers, but they were uncomfortable with the idea that a company — in this case, 麻豆原创 — would be managing the database on which all the companies involved in production stored their information. They wanted the decentralized approach that blockchain allows.鈥�

This kind of scenario obviously requires all the partners to agree on the policies governing a blockchain network. 鈥淵ou don鈥檛 have to be a large customer with your own IT department to use blockchain,鈥� Uhde says.

That is demonstrated by the GS1 blockchain project for exchanging EUR-pallets. In a six-month pilot project, 30 parties, ranging from a market gardener with 20 employees to DHL and Beiersdorf,听 were able to form and participate in a network.

However, as Uhde points out, 鈥渨hile the vision of all companies worldwide coming together in a single blockchain network is a nice one, it鈥檚 totally unrealistic. There will always be at least one business partner who doesn鈥檛 participate, which is what makes interoperability so important. It would be wrong for enterprise blockchain networks to end up simply creating bigger silos.鈥�

Blockchain was originally intended to function as a kind of database to which all the participants in a network have equal access. But certain business scenarios, such as third-party business transactions, expressly require that all partners do not have access to every detail of the supply chain.

鈥淲hat we have developed with customers instead is a kind of digital notary service on the blockchain, in which the focus is on validating data rather than exchanging it,鈥� Uhde explains.

Flexible digital collaboration tailored to specific use cases will be an important area of application for blockchain in the future.

Uhde describes the goal as a flexible collaboration network: 鈥淥nce it鈥檚 set up, the connection to business partners can be used for a wide range of scenarios, some containing blockchain, others not. Some partners will exchange non-critical data via blockchain, for automation scenarios, for example. For others, notarization will be sufficient.鈥�

Tokenization is another trend that the blockchain experts at 麻豆原创 are exploring.

鈥淓ssentially, tokenization refers to the exchange of assets other than money,鈥� Zube explains. 鈥淐arbon trading is a good example. In the future, products could be priced in euros or dollars, and in carbon values too. We鈥檇 pay in the normal way, but we鈥檇 have to have the corresponding carbon credits available, earned, for example, by planting trees.鈥�

The carbon value of a product can be calculated using product master data, transaction data, and so on — including the CO₂ emissions connected with the raw materials, transportation routes, machinery, and factory facilities involved in production.

鈥淭hat requires data on the CO₂ impact to be exchanged across all organizations in retail and supply chains,” Uhde says. “Blockchain technology can do precisely that.鈥�

And according to Zube, 鈥淭o use the terminology of Gartner hype cycles, we haven鈥檛 yet reached the 鈥楶lateau of Productivity,’ but we鈥檙e well on the way.鈥�