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New approaches, and new skill sets are necessary for meeting the challenges of global drug reimbursement policies

The convergence of international and US pricing controls

Small changes in contract terms can have large consequences in net revenue

Getting a Better Business Picture Through Gross-to-Net Analytics

Effective integration of a company’s contract strategy with operations can have a big impact on financial performance

Challenges in Contract Strategy and Operations for Pharmaceutical Manufacturers

Sensitech, a supply chain visibility company and part of Carrier Global Corporation, has purchased the Monitoring Solutions business of Berlinger & Co. AG, a company that specializes in innovative and customized solutions for monitoring temperature-sensitive goods in the pharma and life science, global health, and clinical sectors.

 The deal is expected to close in Q3 2024.

“The acquisition of Berlinger’s monitoring business is an exciting opportunity for Sensitech to expand our portfolio of monitoring solutions for pharma supply chains and accelerate growth in strategically important adjacencies,” said Bhasker Kaushal, VP & general manager, Sensitech and refrigeration aftermarket. “Digitization, sustainability, and automation are transforming pharma supply chains and driving adoption of real-time monitoring and cloud-based solutions. Sensitech and Berlinger share a common vision and focus on innovation, and through this combination, we will deliver comprehensive and differentiated monitoring solutions that deliver patient safety, supply chain efficiency, and sustainability outcomes for our customers. We look forward to welcoming the Berlinger team to Carrier and Sensitech.”

According to the involved parties, the merger works well as the companies complement each other: Berlinger provides software and hardware solutions that will have the capability of widening Sensitech’s cold chain monitoring product portfolio. One piece of that portfolio is its branded SmartSystem platform that provides modular, real-time, end-to-end monitoring with the help of cloud-based software platform and temperature-monitoring devices; software and analytics that can automate the end-to-end stability and validation process for clinical trials; software and analytics to automate the end-to-end stability and validation process for clinical trials; and fridge-tags for vaccine fridges and refrigerated site-monitoring.

“We are absolutely convinced that Sensitech can successfully further develop our Berlinger & Co. AG business together with its skilled and dedicated employees,” commented Andrea Berlinger, Chairwoman of the Board of Directors of the Berlinger Group.

Earlier this year, Sensitech unveiled TempTale GEO X, a state-of-the-art internet of things (IoT) temperature monitoring solution that reportedly fits the need of both the life sciences sector and logistics organizations.

 The service provides a validated, GxP-compliant solution to monitor temperature-sensitive medicines and vaccines transported globally across different modes, such as air, ocean, rail and road.

It offers real-time location visibility, monitoring temperatures from -95°C to 55°C, global connectivity flight compliance, a screen to display live product quality information, and built-in battery management. When combined with its branded SensiWatch platform and Lynx Logix digital solution, TempTale GEO X has the capability of providing real-time data and analytics for automation of product accept-reject decisions shipment visibility and alerting.

“The TempTale GEO X solution will help transform the pharmaceutical supply chain through real-time data, intelligent workflow automation and advanced analytics,” said Bhasker Kaushal, VP & general manager, Sensitech. “We are constantly innovating to provide real-time monitoring and analytics solutions that make pharma supply chains more connected, automated, resilient and sustainable. This new solution will provide the data, insights and automation to help deliver next-level supply chain efficiency, cold chain compliance and sustainability outcomes.”

1. Sensitech to Strengthen Life Sciences Cold Chain Solutions with Acquisition of Berlinger & Co. Monitoring Solutions. 

https://www.sensitech.com/en/resources/news/news-article/2024-06-17-berlinger-acquisition.html

2. Sensitech Launches TempTale GEO X Solution for Real-Time Pharma Cold Chain Visibility and Logistics Management. 

February 20, 2024. Accessed June 18, 2024. 

https://www.sensitech.com/en/resources/news/news-article/2024-02-20-temptale-geo-x.html

The deal also adds a spread of supply chain efficiency, sustainability, and patient safety outcomes to the mix.

Sensitech Bolsters Its Cold Chain Offerings, Acquires Berlinger & Co. Monitoring Solutions 

In order for biologics and specialty pharmaceuticals to reach their full potential, it is imperative that the cold-chain logistics process allows products to arrive at the desired temperature and also on time. The importance of this process is brought to light with the fact that 80% of pharmaceutical products in Europe are in need of temperature-controlled transportation.

Keeping this in mind, UPS Healthcare has decided to invest more than $21.6 million (€20 million) in over 200 state-of-the-art, temperature-controlled vehicles in order to boost its comprehensive cold-chain capabilities in the Netherlands, France Italy, and Hungary.

“Whether it's small parcels or large pallets, our pan-European end-to-end cold chain ground network is equipped to manage the most complex healthcare products,” commented Felipe Morgulis, president of UPS Healthcare, Europe and LATAM. “From transporting active ingredients or last-mile deliveries to hospitals, laboratories, pharmacies, and patients, we provide control, adaptability, and real-time monitoring to simplify the most time and temperature-sensitive supply chains.”

The new vehicles add to the already existing cold chain fleet that contains more than 1,100 vehicles. They are expected to help meet the European healthcare industry demand across the entire region by supporting last-mile and long-haul deliveries. They also have dual-temperature capabilities, meaning that they can provide deliveries to various members of the pharma supply chain—between 2°C to 8°C and 15°C to 25°C. In fact, this good distribution practice (GDP)-compliant service features digital quality management systems alongside vendor management that can help must customers’ client requirements.

UPS Healthcare has been in the news over the past few months, after opening a healthcare logistics facility in Dublin, Ireland, which covers over 64,500 square feet and has created 30 new jobs thus far.

 The company also decided to further grow its European hub facility in Roermond, Netherlands

 by 235,299 square feet, and will be using that additional space for in-demand freezer farms, which serve as a collection of ultra-low cold storage units that preserve biological samples for long periods, a necessity for a bulk of biopharma products.

“Society’s healthcare needs are changing, and thanks to next generation treatments, practitioners can provide patient care like never before. These complex treatments are time-and-temperature-sensitive and require the highest level of precision end-to-end logistics solutions, from the lab to the patient,” said Anouk Hesen, operations director, UPS Healthcare West Europe. “By expanding this facility, we’re extending our cold chain capabilities to support a rapidly growing and innovating market.”

1. UPS Healthcare Invests More Than 20 Million EUR to Boost Temperature-Controlled Fleet in Europe. 

. July 3, 2024. Accessed July 4, 2024. Press release delivered via email.

2. Europe Pharmaceutical Cold Chain Logistics Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029). 

https://www.mordorintelligence.com/industry-reports/europe-pharmaceutical-cold-chain-logistics-market

3. Saraceno N. UPS Healthcare Opens Logistics Facility in Dublin. 

. May 16, 2024. Accessed July 4, 2024. 

https://www.pharmaceuticalcommerce.com/view/ups-healthcare-opens-healthcare-logistics-facility-in-dublin

4. Saraceno N. UPS Healthcare Grows Its Netherlands Plant. 

. June 13, 2024. Accessed July 4, 2024. 

https://www.pharmaceuticalcommerce.com/view/ups-healthcare-grows-its-netherlands-plant

The investment is expected to help enhance the company temperature-controlled services in the Netherlands, France, Italy, and Hungary.

UPS Healthcare Financially Commits Over $21.6 Million Toward Cold Chain Fleet

Veranova, a manufacturer and developer of specialist and complex active pharmaceutical ingredients (APIs) for the pharmaceutical and biotech sectors, has begun to expand its antibody-drug conjugate (ADC) and highly potent compound development and manufacturing capabilities at its Devens, MA facility.

 The FDA-approved site has over a decade of experience in the development, scale-up, and clinical and commercial production of ADC linker-payloads and other highly potent APIs.

The financial commitment—valued at an estimated $30 million—is expected to add to the plant’s current development and manufacturing services; it’ll also help meet the demand for US-based capacity for ADCs along with other potent small molecules; the FDA-approved site already has over a decade of experience in the development, scale-up, and clinical and commercial production of ADC linker-payloads and other highly potent APIs.

The project features a new high-potent process development laboratory and two new current good manufacturing process (cGMP) suites designed to handle potent compounds with occupational exposure limits (OEL) of less than 0.01 µg/m³. The facilities are prepared to handle high-potency compounds, ADC linker-payloads, and other complex molecules, while featuring air handling systems, airlocks for clean-in-place operations, isolator technology, and a wide range of processing capabilities, such as chromatography, synthesis reactors, lyophilization, and thin film evaporators.

“At Veranova, we recognize the growing demand for development and manufacturing of ADCs and other highly potent compounds,” said Mike Riley, CEO of Veranova. “This investment signals our commitment to providing state of the art capacity and capabilities to enable these next generation therapies to reach patients, and is a key milestone as we advance our broader growth strategy for Veranova.”

In other Veranova news, the company unveiled that it was collaborating with Phorum.AI

 on augmenting pharmaceutical manufacturing processes with the help of artificial intelligence (AI); Phorum.AI’s work revolves around the implementation of generative AI systems to help biopharma companies rapidly design manufacturing processes that can lower costs and speed development timelines, while decreasing one’s environmental footprint.

The involved parties plan on utilizing Veranova’s empirical manufacturing dataset—in conjunction with Phorum.AI’s generative AI know-how—to create a tool that will facilitate the development of manufacturing processes at a quicker rate.

“Phorum.AI and Veranova have the potential to create a step change in the quality and development efficiency of pharmaceutical processing,” added Riley. “We are delighted to partner with a leading AI technology innovator to be able to offer our clients a new capability that has the potential to develop optimized manufacturing processes at an accelerated pace.”

Phorum.AI executives were also ecstatic about the collaboration.

“By partnering with Veranova, a worldwide leader in developing and manufacturing APIs, we are able to more rapidly scale our market footprint and create greater impact sooner,” commented Dan Chinnapen, CEO of Phorum.AI. “We are excited to reduce time to market and mitigate costs for much-needed therapeutics.”

1. Veranova Announces New Investment to Expand ADC and Highly Potent API Capabilities at Devens, MA, Facility. 

. June 27, 2024. Accessed July 1, 2024. 

https://veranova.com/news/veranova-announces-new-investment-to-expand-adc-and-highly-potent-api-capabilities-at-devens-ma-facility/

2. Veranova and Phorum.AI Partner to Deliver Generative AI Chemistry Optimization to the Pharmaceutical and Biotech Industry. 

. May 16, 2024. Accessed July 1, 2024. 

https://veranova.com/news/veranova-and-phorum-ai-partner-to-deliver-generative-ai-chemistry-optimization-to-the-pharmaceutical-and-biotech-industry/

The company’s latest investment—featuring new cGMP suites at its Devens, MA plant—is valued at $30 million.

Veranova Expands Its Financial Commitment Toward Growing Highly Potent API Services

 Novo Nordisk plans to invest $4.1 billion toward the construction of a second fill-finish manufacturing plant in Clayton, NC, which will expand the company’s efforts in to creating injectable treatments for individuals with obesity and other chronic diseases.

The 56-acre project is expected to add 1.4 million square feet of production space for aseptic manufacturing and finished production processes, thereby doubling the combined square footage of all three of the company’s current North Carolina facilities. The company is calling this manufacturing investment one of the largest manufacturing investments in Novo Nordisk’s history.

Such a financial commitment will also open up 1,000 new jobs, combined with the nearly 2,500 Novo Nordisk employees already working in the region.

“It took us a century to reach 40 million patients, but through this expansion and continued investment in our global production, we’re building Novo Nordisk’s ability to serve millions more people living with serious chronic diseases in the future,” said Lars Fruergaard Jørgensen, president and CEO of Novo Nordisk. “This is yet another real signal of our efforts to scale up our production to meet the growing global need for our life-changing medicines and the patients of tomorrow.”

With a combination of water strategies, roof-top solar panels and other technology, the facility merges sustainability and efficiency in order to deliver high-quality products to patients. Ultimately, Novo is looking to obtain LEED Gold certification, often known as a “standard of excellence” in designing carbon and cost-saving green buildings.

“Clayton was the first manufacturing site for Novo Nordisk in the US, and this new, large-scale investment confirms the continued importance of our production facilities there as cornerstones of our company’s growth,” commented Henrik Wulff, EVP, product supply, quality & IT, Novo Nordisk. “For decades, we have partnered to foster a well-trained, dedicated and diverse local workforce in North Carolina. In Clayton and across our global manufacturing sites, we are driven by one purpose: to deliver more for the millions of people living with chronic diseases – and this facility will help us achieve just that.”

Construction is anticipated to be finalized between 2027 and 2029. Managed by BE&K Building Group. Around 2,000 external contractors will be involved in the project.

“It’s a historic day for Johnston County,” noted Butch Lawter, chair of the Johnston County Board of Commissioners, who recently announced county grants to support the expansion project. “Thirty-one years ago, Novo Nordisk decided to make a new home here in Clayton. Then, in 2016, they announced a new facility right across the street - the single largest life sciences investment on state record at the time. Today, they’re breaking that record again… with a third facility, 1,000 new jobs and a vote of confidence in the partnerships we have forged in the community over the decades.”

By year’s end, in order to boost supply, Novo Nordisk is anticipated to raise its production investments, as it plans to invest approximately $6.8 billion in production, compared to last year’s actual investment of $3.9 billion.

1. Schmalfuhs M. Pharma pulse 6/25/24: Novo Nordisk Invests $4.1 billion to Expand US Manufacturing, Improving the Efficacy of Genetic Medicines & more. 

. June 25, 2024. Accessed June 28, 2024. 

https://www.pharmaceuticalcommerce.com/view/pharma-pulse-6-25-24-

2. Novo Nordisk announces 4.1 billion USD investment to expand US manufacturing capacity. 

. June 24, 2024. Accessed June 28, 2024. 

https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=168528

The North Carolina project adds 1.4 million square feet of dedicated production space for aseptic manufacturing and finished production processes.

Novo Nordisk Financially Commits $4.1 Billion Toward Growing US Manufacturing Capabilities

Interview with Blake Powers, Part 1

: You recently penned your first byline, which has appeared in the June issue of 

 What I'm doing here in the first write up is really contemplating digital platforms and dynamic pricing models, and what they've accomplished in other sectors. And really having an objective look about what it might appear if these technologies are applied to the pharma supply chain—taking a bit of a contrarian approach to some of the status quo models, and kind of looking at it from another angle and seeing what have other sectors accomplished from this kind of innovation and this dexterity with pricing, and how might it be applied to the pharma supply chain?

 Why do you believe the pharma sector is stuck in its ways, in terms of depending on older models that rely on long-term price negotiations that lock in prices?

 I think a major reason is that fragmentation in this sector is naturally creating an uphill battle for any change agent that's entering the space. In terms of looking at what other commodities and services have accomplished with dynamic pricing in these digital platforms, I think it is important to take a closer look at medications and how they're distributed. There's a certain degree of scrutiny that certainly needs to be applied, because these are life-sustaining and life-saving medications. However, in the piece, I take the stance that the status quo models have their shortcomings, and I try to highlight the benefits, and take that position of, what would digital models taking a free-market type of approach, what kind of benefits would they have for pharmacies, sites of care, and drug manufacturers?

In this Pharmaceutical Commerce video interview, Blake Powers, CEO of Medigi,  discusses his first byline with the publication, along with why the industry may be stuck in its ways in certain aspects.

Exploring the Concept of Dynamic Pricing 

Today's global marketplace demands robust measures for maintaining both product integrity and adherence to strict regulatory frameworks. Serialization technology is at the forefront of these efforts. This evolving technology—through its sophisticated mechanisms—is enhancing the safety and reliability of products throughout their journey from production to consumer.

Below, we’ll explore how advancements in serialization technology are reshaping processes across different industries, reinforcing the global supply chain, and fostering trust among consumers and stakeholders.

The role of unique identifiers in supply chain security

First, it’s important to understand that the cornerstone of serialization technology is the embedding of unique identifiers on product packaging. This strategy facilitates a comprehensive system of precise tracking and authentication throughout the supply chain. By marking each product with a distinct serial number, it becomes feasible to monitor its path from the manufacturer to the end user.

This process is instrumental in mitigating the risks associated with counterfeit products while also streamlining operations. Put simply, by making sure every item can be verified as genuine, these unique identifiers protect consumer interests and corporate reputation.

Importance of serialization in the pharmaceutical industry

Serialization plays a pivotal role in the pharmaceutical sector in particular. It’s utilized for several key aspects of product management and safety including:

: Serialization significantly contributes to the efficacy of 

. By providing a traceable history of each medication, serialization helps in verifying and analyzing the effectiveness of drugs, both during trials and after their release into the market. When every unit of medication is serialized, it becomes simpler to track its distribution and use in clinical trials, which can lead to more accurate data collection and analysis. This capability is key in situations where understanding the impact of a medication requires precise data on its usage and results.

 Serialization also maintains compliance with pharmaceutical regulations by enabling detailed tracking and verification across the supply chain. This process is critical in verifying that each product adheres to established manufacturing and patient safety standards. In-depth tracking and authentication of products is especially important in adhering to rigorous regulatory frameworks, such as the Drug Supply Chain Security Act (DSCSA) in the United States. These systems are integral in preventing drug counterfeiting, thereby ensuring that only verified and reliable medications reach consumers.

 Furthermore, serialization directly contributes to maintaining the integrity of pharmaceutical products. It allows companies to continuously verify the origin and authenticity of their products, a process essential for preserving the quality and consistency of pharmaceuticals. This constant verification sustains consumer and regulator trust, highlighting serialization's role in safeguarding the actual composition and quality of medications, distinct from compliance, which focuses more on adhering to legal standards.

The expanding spectrum of serialization technology

Nowadays, organizations utilizing serialization technology have a variety of cutting-edge tools at their disposal to further enhance product integrity and regulatory compliance:

: These platforms provide scalable and flexible options for managing serialization and data storage effectively. They allow for rapid adjustments to serialization strategies in response to changing market demands or regulations.

: Utilizing RFID tags, QR codes, or NFC technology, this system enables the real-time tracking of product locations and movements. This technology is vital for logistics optimization and instant verification of goods throughout the supply chain.

: This technology offers a decentralized, tamper-proof ledger, which is ideal for creating immutable records of product data at each step of the supply chain. By improving transparency and security, blockchain makes it harder for counterfeit products to penetrate the market.

: This involves creating a digital replica of the physical supply chain. Digital twins use real-time data to simulate, predict, and optimize the product life cycle, providing insights that can improve serialization strategies.

: IoT-enabled devices can be connected to individual products, packaging, or pallets to gather and transmit data continuously throughout the supply chain. This data enhances traceability and helps maintain the integrity of serialized data by providing live feedback from the field.

These technologies collectively enhance the reliability of serialization processes by improving visibility, accountability, and efficiency across the supply chain. All this comes together to maintain compliance with regulatory requirements and safeguard against the risks of counterfeit products.

Artificial intelligence in serialization systems

Another technology making headway in this area is artificial intelligence (AI). There are various ways in which AI is being put to use in serialization:

: AI algorithms efficiently manage and interpret the vast data generated during serialization, detecting anomalies, and identifying patterns that may indicate issues like counterfeiting.

: By analyzing historical and current data, AI predicts disruptions in the supply chain—such as potential stock shortages—allowing companies to take proactive measures.

: AI systems continuously learn from operations, enhancing their predictions and operational efficiency over time. This optimizes serialization processes, such as printing accuracy and anomaly detection.

: AI automates compliance monitoring within serialization so that data aligns with regulatory standards, thereby reducing human error and speeding up compliance checks.

Integrating AI into serialization not only enhances compliance and anti-counterfeiting efforts but also drives deeper insights into supply chains, improves operational efficiencies, and fosters innovation in product distribution and management.

Harnessing the power of serialization technology for future growth

Through our exploration, it's evident that advancements in serialization technology are crucial for protecting product integrity and maintaining regulatory compliance in the pharmaceutical sector, as well as across various other industries. By embedding unique identifiers on products, serialization strengthens the supply chain, boosts transparency, and enables companies to adhere to stringent quality and safety standards.

Looking forward, the integration of cutting-edge technologies with serialization systems equips businesses with powerful tools to combat challenges, such as counterfeiting, logistical inefficiencies, and beyond. These innovations are enhancing trust among consumers and regulators, setting the stage for a more secure and efficient global marketplace.

As we move ahead, serialization technology is set to continue as a key driver in augmenting the security, efficiency, and innovation of global industries. Its evolving role is integral to enabling businesses to flourish in an increasingly interconnected and dynamic economic landscape, promising a future where market trust and product reliability are paramount.

Liz Cornish is the senior digital marketing & brand manager for BA

Sciences, a cGMP-compliant, FDA/DEA-registered, ISO/IEC-17025:2017-certified analytical laboratory in Salem, NH.

These advancements continue to act as a key driver in helping to boost the security, efficiency, and innovation of global industries, include pharma.

Robert Matsuk, HighPoint Solutions

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