To ensure that patients globally receive required medications and treatment on time, the management of manufacturing and distribution must be ultra-efficient, agile, and responsive.

With patient safety on the line and high-quality expectations, there is no room for error. 

One company that has mastered this balancing act is Ireland-based , a high-growth, diversified healthcare services company that provides distribution services for pharmaceutical products. The company works closely with manufacturers to offer third-party logistics (3PL) and fourth-party logistics (4PL) services to remain true to its mission of securing patient access to pharmaceutical products.

In the last decade, UniPhar has witnessed unprecedented growth and today delivers pharmaceutical products to more than 160 countries.

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麻豆原创 and UniPhar: A 15-Year Partnership

UniPhar has grown organically and through acquisitions, and during this time its 麻豆原创 enterprise resource planning (ERP) landscape had become highly customized.

Two years ago, UniPhar鈥檚 board gave its Chief Enterprise Architect Piotr Wojdowski a mandate 鈥渢o rework the company鈥檚 digital core鈥� and deliver a digital transformation to unlock future growth while still safeguarding the highest of standards in the manufacturing and distribution chain.

In the quest to find a software partner for its digital transformation, Wojdowski says UniPhar needed 鈥渁 partner and a software that is reliable and best in class鈥� to strengthen and future-proof the company鈥檚 ability to deliver on its mission of securing patient access to pharmaceutical products.

Wojdowski explains that there is an element of social responsibility to UniPhar鈥檚 mission. The patient requiring the pharmaceutical products or services 鈥渃ould be somebody鈥檚 relatives, it could be somebody鈥檚 mother, or it could be somebody鈥檚 son,鈥� making it even more important that the selected digital transformation software and partner was not only best in class but also reliable and trustworthy. 

鈥淣ot only had 麻豆原创 proved itself to be a trusted and reliable partner for UniPhar for 15 years,鈥� Wojdowski explains, but 麻豆原创 鈥渋s a standard in the health services sector, making integration of other services easier.鈥�

麻豆原创 Advances UniPhar鈥檚 Technology and Talent

UniPhar’s goals are to grow horizontally, expand, and scale on demand. , , and play a pivotal part by, on the one hand, standardizing IT processes across the group and, on the other, managing distribution and inventories across different warehouses with 麻豆原创 EWM state-of-the-art warehouse management software, while using 麻豆原创 Datasphere for data management.

In a nutshell, says Wojdowski, 鈥渢he 麻豆原创 technology stack allows us to effectively advance our program quickly,鈥� using to build applications and extend 麻豆原创 solutions. 麻豆原创 Business Technology Platform (麻豆原创 BTP) acts as an accelerator to move to 麻豆原创 S/4HANA Cloud Private Edition, helping UniPhar transform with confidence and speed using proven migration tools and enabling integration across applications.

麻豆原创, and especially 麻豆原创 BTP, is not only a technology enabler but also allows UniPhar 鈥渢o innovate and attract the top talent as an organization because people want to come to work in an environment that is innovative, that allows you to try things, and that allows you to experiment,鈥� Wojdowski says.

Laying Foundations with 麻豆原创 Today for Tomorrow鈥檚 AI

UniPhar is currently in the implementation process and Wojdowski has a keen eye on the future, noting that 鈥渆venting, observability, and telemetry鈥� will form the basis of future artificial intelligence (AI) enhancements.

Data is critical in the pharmaceutical industry, he explains, and UniPhar 鈥渉as terabytes and terabytes of data that we are not physically able to analyze because it’s complex and massive.鈥� The plan is to migrate the data to a central repository and in the future 鈥減lug into an AI system to track patterns, track customer behaviors, track market trends, and react accordingly.鈥�

Make a Challenge a Proof-of-Concept

麻豆原创 solutions are enabling UniPhar to innovate and step into the future on its own terms, with standardized processes, best practices, and foundations for AI technology that can scale and strengthen UniPhar鈥檚 mission to improve patient access to pharmaceutical services and products across the globe.

Wojdowski says 麻豆原创 seems to have a solution for every business requirement, but even though 鈥測ou may have to customize and change things that 麻豆原创 provides out of the box, at the end of the day it’s a full enterprise suite and you can run 麻豆原创 end-to-end if you wish.鈥�

And Wojdowski鈥檚 advice for other companies planning a digital transformation? Challenges can become proofs of concept 鈥� there is no need to accept that something cannot be done. 鈥淏e brave, be daring, and ask questions. Challenge your partners and challenge yourself,鈥� he concludes.

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Uniphar is a leading healthcare and pharmaceutical services company based in Ireland. Piotr Wojdowski, chief enterprise architect at Uniphar Group, shares how 麻豆原创 cloud technology allows the company to innovate, attract top talent, and reduce complexity. Learn more.

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.

is one of the world鈥檚 largest biotech companies, a leading provider of in-vitro diagnostics and a global supplier of transformative, innovative solutions across major disease areas.

Cost as a Main Driver for Asset-Intensive Organizations

鈥淎s a pharmaceutical company, Roche was founded more than 100 years ago in Basel, Switzerland, with both pharma and diagnostics divisions. We are in the middle of an journey with the goal to harmonize business processes on all sites and divisions around the world,鈥� said Accioli.

To manage assets under volatile conditions effectively, just like other asset-intensive organizations, Roche focuses on reducing maintenance cost and increasing asset reliability, which are key to its customers and patients.

The challenge is 鈥渢he handover from original manufacturer to engineering to maintenance and how to interact with each other,鈥� explained Accioli. 鈥淲e resolve this with these business process harmonization initiatives.鈥�

Risk Resilience as an Investment for the Future

麻豆原创 suggests three strategies to help companies manage their business holistically, including cost, speed, profit, customer service, and risk:

• Connecting supply chains to the entire business so that information insight flows go quickly from operations to manufacturing, design, and into the business to respond to disruptions
• Contextualizing information during the work process to equip users with technology to get real-time insights and make decisions during the business process to increase impact
• Collaborating externally with suppliers, asset operators, OEMs, and logistics providers to ensure that information is flowing beyond the internal network to set up a risk-resilient business while mitigating risk

Closing the Loop Between Strategy and Execution

Managing costs and increasing equipment reliability is a major factor and closing the loop between asset strategy and maintenance execution, such as to make assets more reliable and connected to maintenance execution considering different asset type, is a big opportunity.

鈥淔ive to 10 years ago, reliability engineering became a shining topic at Roche, and we discussed where to start, how much we spend on maintenance, what our most important assets were, and where we should spend more energy and money. We standardized processes to classify our equipment into different asset criticalities 鈥� high, medium, and low – and, based on each category, we established a maintenance strategy,鈥� explained Accioli.

鈥淎fterwards, we looked for a tool that would best suit Roche given the amount of data. Now we have an asset and maintenance strategy in place that is reflected in our system. In 2019, we started harmonizing our processes and were pleased that 麻豆原创 solutions could support us,鈥� he continued.

In particular, Roche looked to:

• , which helps with performing criticality evaluations directly in the 麻豆原创 system instead of spreadsheets. With criticality results reflected in the system, the maintenance strategy can result in preventive maintenance plans. 鈥淩oche is in the middle of the journey. No sites are live yet,鈥� said Accioli. Roche is also enabling access to its service providers to get design insights and improve collaboration.
• , which enables maintenance plans and work orders to be accessible to maintenance technicians so that they can make instant material reservations and get access to maintenance manuals on mobile devices.

鈥淚 expect a significant decrease of maintenance execution as we can plan our work better thanks to a mobile-supported solution,鈥� said Accioli. 鈥淭he experience with the solution is quite good.鈥�

Roche was already using 麻豆原创 at different sites with its own work order types and data model, but it was not automated and connected.

鈥淲e also intend to migrate to , a successor cloud-based application, where Roche鈥檚 enhancement ideas have been incorporated,鈥� explained the manager.

Connected Asset Data Helps Contextualize Business Decisions

For contextualizing every business process through the eyes of maintenance, it is necessary to converge enterprise IT data with equipment and sensor data to run analyses based on algorithms and machine learning technology. Accioli explained: 鈥淏eing able to schedule maintenance activities is a substantial improvement for maintenance organizations. To monitor both targets and results, we are using , which has many good capabilities. We are developing maintenance KPIs with the insights we get from聽 artificial intelligence (AI) and rolling these back into the asset strategy and reliability process. These are particularly good tools.鈥�

Effective Collaboration Across the Ecosystem to Build a Collaborative Supply Chain

鈥淔or Roche, sharing information and effective collaboration with asset providers and across our ecosystem is particularly important. Vendors and different equipment suppliers must exchange and collaborate on asset data. Operators and service providers should be able to use the network but also manage the work order process,” said Accioli.

To summarize, the key benefits of 麻豆原创 Asset Strategy and Performance Management and 麻豆原创 Service and Asset Manager Accioli sees are:

麻豆原创 Asset Strategy and Performance Management:

• Defining which maintenance strategy applies to which classification of equipment
• Maintaining assessments in the system
• Generating criticality based on assessments
• Reflecting reliability-centered maintenance in the system, including decision trees and supportive templates

麻豆原创 Service and Asset Manager:

• Being a digitized, automated, paperless solution
• Being able to work offline
• Having all maintenance data at hand in one place

Listen to the webinar recording . In addition, watch this to learn how to maximize asset health and performance with 麻豆原创 Intelligent Asset Management solutions and read what . To know more about the role of service and asset management in your industry, .

Karin Fent is senior director of Global Customer Success Digital Supply Chain at 麻豆原创.
Top photo credit: Roche

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聽

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,聽.

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

To further expand its global business, GC Biopharma selected 麻豆原创 SuccessFactors solutions for its human resources (HR) transformation.聽Its legacy HR portal was developed long ago, and its IT team encountered many challenges in responding rapidly to employees鈥� change requests. Employees did not access the legacy HR portal often due to its inferior user experience and limited access to the PC environment.

To improve the situation, GC Biopharma leveraged to design and implement its new HR portal, which serves as the main entry point for all employees to access the corporate HR systems through both PCs and mobile devices.

New HR Portal Designed along 麻豆原创鈥檚 Human-Centered Approach to Innovation

The 麻豆原创 AppHaus team worked with customer representatives by first listening to the end users and accurately defining the as-is situation. The joint project team investigated the HR business scenarios for several personas, including employees, managers, and executives, and discovered their needs and pain points. As a result, the team defined a set of essential HR tasks, such as time and attendance management, talent recruitment, and employee training, and validated the end users鈥� expectations for the new HR portal.

麻豆原创 AppHaus designed various cards on 麻豆原创 SuccessFactors Work Zone tailored to the customer’s needs and developed user interface (UI) integrated cards with the 麻豆原创 T&I Platform Adoption and Advisory team. Through this journey, the customer team was able to get various ideas for configuring their own HR portal.

鈥淲e鈥檙e delighted that 麻豆原创 SuccessFactors Work Zone now serves as the main entry point to our whole HR system. Mobile access is now available and the system is more responsive to the needs of our employees,鈥� says Youngwoon Kim, corporate human resources officer at GC Biopharma.

Based on 麻豆原创 SuccessFactors Work Zone and (麻豆原创 BTP), the solution enables a personalized employee experience when using the HR portal as well as a rapid response to users’ change requests.

Easy Maintenance Thanks to 麻豆原创 BTP

麻豆原创 BTP supports easy maintenance without code development by utilizing the appropriate application with 麻豆原创 SuccessFactors Work Zone based on employee requirements. Also, flexible portal configurations for HR personas 鈥� that is employees, managers, and executives 鈥� for individual HR tasks are available.

Moreover, 麻豆原创 SuccessFactors Work Zone allows IT users to develop in the PC environment and seamlessly adapt to the mobile app without any further development. Therefore, end users can easily access HR-related information on both PC and mobile devices, which increases its accessibility and utilization.

The new HR portal went live in October 2022, ushering in both improved functionality and user experiences for more than 2,300 GC Biopharma employees.

Euree Hawer is a senior UX designer for 麻豆原创 AppHaus Korea.

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聽, a cloud-based network solution that helps organizations comply with other provisions of the U.S.聽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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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聽across the industry, triggered by product聽recalls. In fact, the total annual cost for the life聽sciences industry can exceed $5 billion. That聽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聽innovative cloud solution developed on聽. It聽is聽designed to semantically integrate with聽existing heterogeneous 麻豆原创 and third-party solutions 鈥� both聽on premise and in the cloud 鈥� with a unique聽integration data model聽that can聽help make faster聽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聽 and this .

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