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Pharmaceutical

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Key Role of ERP Systems in the Pharmaceutical Industry
Key Role of ERP Systems in the Pharmaceutical Industry 700 500 Xcelpros Team

At a Glance

  • Disruptions brought by Industry 4.0 and digitization in the pharmaceutical sector are undeniable. Thus, pharma companies must arm themselves with state-of-the-art software solutions and tools to stay ahead in the game.
  • Tracking, tracing, and serialization need the support of automated tools that can reduce manual efforts and mitigate the errors leading to stock-outs, delivery issues, and callbacks.
  • Pharma companies need to be sure they comply at all times. An ERP with Pharmaceutical and Biotech centric solutions help companies meet all the regulatory requirements.

Technology has taken over our way of life and way of work. All major and minor sectors are undergoing massive changes to adapt to these changing times; the same goes for the pharmaceutical industry. Pharma companies worldwide face various challenges, such as increasing process complexities, changing consumer dynamics, healthcare reforms, a growing abundance of data without the infrastructure to leverage it, and more. These changing tides caused pharma companies to look at ERP as a panacea to solidify their IT framework and use the latest technologies (Cloud, Big Data, Automation, Artificial Intelligence, Machine Learning, Data Analytics, etc.).

However, merely adapting an ERP system will not give pharma companies value for their money.

In fact, according to a report by Gartner, by 2021, ERP cloud enterprise application implementation labor rates will increase by 60 percent due to high demand and a lack of skilled resources.

This realization indicates that, like other sectors, the pharma industry would need to invest in skill upgrading of their employees and get expert ERP consultants on board for a smooth implementation.

Now, let’s talk about the need for an ERP software system in the pharmaceutical industry in today’s time (especially as it needs an ERP that is tailor-made for the industry’s regulations and norms). Below are some of the key reasons for pharma companies to move to ERP

Manufacturing formulation and preformulation management

The drug manufacturing process comprises strict formulation and monitoring raw material ingredients and finished product yields to produce a batch. The pre-formulation stage includes defining drug production procedures, steps, quantities, etc. With a robust ERP system, such as the Microsoft Dynamics 365 ERP, pharma companies can ensure automated management of these formulations without constantly monitoring productions and worrying about manual errors.

Effective product costing

The costing of drugs involves various factors such as raw material master management, procurement cost, supply chain tracking, vendor cost management, and so forth. In a legacy system, these departments work in silos, and changes in data or any variable take time to communicate to other branches. There’s centralized access to data with an ERP system, and an interconnected network is established between various functions to develop concurrency. Well-captured data helps in efficiently defining product costs, and any changes can reflect in the system, enabling finance to accommodate those changes appropriately.

Figure 1:Benefits of ERP for Pharmaceutical Companies

Benefits of ERP for Pharmaceutical Companies

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Meeting Regulatory Compliance

Regulatory compliance is a big one for all pharma companies. These regulations affect the brand name and consumer’s trust, but there is a factor of safety involved. Regulations and norms also differ regionally. It is essential to stay on top of safety and healthcare protocols to maintain global standards, and this is where a comprehensive system like Microsoft Dynamics 365 ERP can serve as a game-changer. Its flexible interface, centralized networking features, and automation solutions allow pharma companies to keep up with the changing rules and regulations and helps drug manufacturers to track these measures and stay compliant.

Pharmaceutical companies are also mandated to maintain CFR 21 Part 11 where it’s a statutory requirement to record (or document- either in print form or electronically) the steps and procedures that comprise complies with this FDA-regulated electronic signature and the production of a medicinal product. Microsoft Dynamics 365 Finance and Operations is compliant with this FDA-regulated electronic signature and electronic record.

Systematic and Efficient Inventory Management with Real-time Tracking

Effective inventory management for a smooth supply chain and avoiding stock-outs or bottlenecks are always concerns for pharmaceutical companies. This concern has reached the global level as governments worldwide are looking to manufacture or procure enough potential Covid vaccines and manage inventories so that the doses go to their population smoothly. An ERP system can help with a real-time track, trace, and serialization to manage inventory and avoid plausible glitches. An ERP system can also help accelerate product recall with its high-end traceability solutions.

Managing Variability and Predicting Scalability

Manufacturing of drugs involves managing supply chain variability, understanding its sources, and gaining a hand over release failures. Another aspect is predicting the scalability of product demand to alter manufacturing capabilities/capacities effectively. Both these involve strong communication between different functions and the use of data to preempt change. With a robust ERP for the pharmaceutical industry, companies can achieve these goals through predictive analysis, data crunching, and supply chain visibility.

Final Thoughts

Pharmaceutical companies can benefit a great deal from an effective ERP implementation. This transition leads not just to accelerated production but is a massive plus in streamlining operations and managing costs.

  • A cost-effective and flexible ERP system such as Microsoft Dynamics 365 Finance and Operations enables pharmaceutical companies to take the proper steps in digitization, automation, and artificial intelligence.
  • ERP system is the need of the hour, and getting expert consultants on board can help pharma companies meet their customized financial, operational, and regulatory requirements.
  • Industrial dynamics are changing at lightning speed, and the pharmaceutical industry needs to keep up with these changes to stand the test of time.

References:

Part 11, Electronic Records; Electronic Signatures – Scope and Application

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Protecting pharmaceutical data with Azure
Protecting pharmaceutical data with Azure 700 500 Xcelpros Team

At a Glance

  • $985 million: The median cost of getting a new drug into the market
  • $1.3 billion: The newer, lower average cost of getting a new drug to market
  • $2.8 billion: The previous average cost of getting a new drug to market
  • $200 billion: The estimated size of the counterfeit drug market
  • 13: the number of new drugs not brought to market each year because of revenue losses from counterfeit drugs

Sources: Wikipedia and Statista.com

Introduction

On average, the cost of bringing a new medicine from idea to market – aka the drug development process – has dropped significantly, from $2.8 billion per drug to $1.3 billion each, according to an online encyclopedia. Counterfeits still have a measurable effect on the number of drugs being brought to market. Recent studies published on Wikipedia and Statista.com show that prescription drug makers continue to get hammered by counterfeit competition.

Statista’s 2022 study provided interesting data on different scenarios showing changes based on market size. The number of new medicines not brought to market ranged from six at $100 billion to 28 at $431 billion

So, what does all this mean? The short version is big pharma and even smaller companies have a considerable investment in intellectual property (IP) they must protect.

IP and Drug Manufacturers

“IP rights, if sufficiently limited, are typically justified as necessary to allow pharmaceutical manufacturers the ability to recoup substantial costs in research and development, including clinical trials and other tests necessary to obtain regulatory approval from the Food and Drug Administration (FDA),” the Congressional Research Service states (CRS).

Pharmaceutical companies are protected by two types of intellectual property (IP): patents, which give exclusive rights to the holder for 20 years, and regulatory exclusivities. According to CRS, these exclusivities range from six months to 12 years, depending on the specific type of drug or biologic.

These companies have a substantial financial investment in their research, development, and testing data. The only way to recover their vast assets is by making and selling products.

It can cost millions of dollars and over ten years of dedication to developing a single drug. With the money levels involved, thieves have a solid incentive to capture this research for themselves.

Protecting Your IP Investment

Take a look at another statistic: $590 million. That’s the amount the U.S. Treasury Department estimates was paid by victims of 450 ransomware attacks in the first half of 2021 alone.

Using that short time frame alone, the Treasury’s Financial Crimes Enforcement Network (FinCEN) stated that “ransomware is an increasing threat to the U.S. financial sector, businesses, and the public.”

Ransomware is one of many cyber-attacks that share a common goal: stealing money. This attack works by infiltrating a company’s computer network and taking control of it. Companies face a difficult decision: pay the ransom, have their data destroyed, or worse, share it worldwide.

Distributed denial of service (DDoS) attacks is another standard weapon in a hacker’s arsenal. “In computing, a denial-of-service attack is a cyber-attack in which the perpetrator seeks to make a machine or network resource unavailable to its intended users by temporarily or indefinitely disrupting services of a host connected to a network,” a Wikipedia article states.

Many of these attacks start with simple phishing schemes. If they get one employee out of thousands to open an infected email, they have a doorway into your data. Microsoft does everything it can to block these attacks and protect its investment and yours.

As with ransomware and other attacks through stealth or brute force, the goal of DDoS attacks is money. The thinking is, “Hit a company badly often enough, and it will pay you to leave them alone.

Figure 1:Key Strategies to avoid cyber security attacks

Key Strategies to avoid cyber security attacks

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Protection in the Cloud

Every company has another option, though: investing in its security.

One method of stealing data involves capturing it as it moves from place to place. Microsoft has invested millions of dollars to continuously protect its customers’ data through its Azure cloud computing platform. The company stated in a recent blog post that they detect 1.5 million attempts per day to compromise its systems, spending about $1 billion a year on computer infrastructure security.

With the ongoing need to invest in protecting their on-premise equipment from attacks, more firms are migrating to the cloud, with platforms like Azure gaining importance with each thwarted attack. Moving data from on-premise network servers to widely spread cloud data centers means attackers have to hit moving targets if they want to control a company’s data.

“The cloud has some built-in advantages. Unlike the internet, it was built from the ground up with modern security and privacy in mind. It’s also a controlled ecosystem protected by people who spend all day thinking about data security and privacy,” according to a recent Microsoft online store.

Traditionally, internet and computer security safeguards were bolted onto a tool rather than built into it. “With cloud infrastructure, security considerations are part of the development process,” Microsoft states. “The cloud is an opportunity to do security better,” security analyst Doug Cahill added.

Azure’s status as a cloud platform means that all of the money, and the 3,500 security engineers Microsoft devotes to making it secure, also benefit the software running on top of it. For example, Microsoft Dynamics 365’s Supply Chain Management, which helps companies track raw materials and finished products from the warehouse to the customer, runs on top of Azure.

Companies using this software get the bonus of automatic protection for their cloud data. While these updates can’t directly help prevent thieves from making a physical attack on their buildings, it can make it harder for them to steal data on the move.

“If we detect a set of attacks on one tenant or a handful of tenants, we can synthesize that and start using the things we learn to protect all the other tenants out there,” Bharat Shah, Microsoft’s vice-president of Security for Azure platform, said. “That’s the cloud effect. We learn. We react. We turn something on, and we protect everybody else.”

Azure benefits from Microsoft’s investment in machine learning – a branch of artificial intelligence – to track attempted attacks. Microsoft takes what it learns and uses it to benefit not just Azure but all the companies who’s multi-million-dollar intellectual property investment rides on top of it.

The Bottom Line

Citing the NETSCOUT Threat Intelligence report, Forbes.com estimated 26,000 cyber-attacks per day, or 18 per minute, in 2020 alone. The report indicated that security threats against industrial control systems and operational technology tripled in 2020, while DDoS attacks will grow to 15.4 million by 2023.

These numbers should make any executive who doesn’t have a significant cyber security team on their staff nervous. Thankfully, companies who use Microsoft Azure’s cloud computing platform have the security of more than 3,500 security engineers devoted to protecting it and the data running through it.

With the livelihood of pharmaceutical companies depending on keeping their data safe, secure, and private, you don’t risk your company’s data with poor security. Investing in Azure services today can make a huge difference in your bottom line.

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Manufacturing Metrics and KPIs That Matter the Most
Manufacturing Metrics and KPIs That Matter the Most 700 500 Xcelpros Team

At a Glance

  • The manufacturing industry operates best by integrating people, tools, processes, and information.
  • The data generated from each of these facets needs to be quantified and analyzed.
  • In the manufacturing world, organizations that know their metrics tend to understand the tricks of the game.
  • It’s critical to focus on the metrics that matter the most; the ones that help your entire organization gain essential insights regarding different functionalities and business areas to continuously improve the manufacturing process.
  • One key that comes from knowing and managing your manufacturing metrics is the ability to systematically optimize your operations based on results.

In any industry, it’s essential to know exactly what your numbers are and what they mean to your business. While this sounds like it should be simple enough, we all know how difficult this can be in practice. When you’re able to gather numbers and metrics they still need to be collated, classified, quantified, and analyzed to add value to the business, especially for a multi-pronged industry like manufacturing. Manufacturing metrics can be diverse, and each metric has a different value throughout the manufacturing value chain. A cumulative study of a group of these metrics is a good way for manufacturing companies to gauge their performance and form strategies for continuous improvements.

Figure 1:Cycle of Continuous Improvement Methodology

Cycle of Continuous Improvement Methodology

As a manufacturing company, you always want to aim for a higher ROI which can mean a thorough analysis of manufacturing metrics and alignment of short-term and long-term business goals. Each of these metrics serves as a source of truth, representing a precise measurement of your manufacturing processes either in terms of quality or quantity (and sometimes, both). Let’s take a look at the manufacturing metrics that matter the most and how you can fortify your IT infrastructure to study and derive insights from these metrics.

1.Demand Forecasting Market research helps companies gain ideas to make estimates about demand forecasting. A manufacturer’s objective is to gauge the amount and type of raw material they will need for their upcoming business cycle. Planning, supply chain management, and operational alignment can benefit significantly from this metric’s help. It’s essential to remember that demand foreshadowing is dependent on external factors and, as such, subject to sudden changes. Take, for example, the ongoing Covid-19 pandemic. Many manufacturers found that much of their yearly estimates had taken a hit (especially sectors like automotive and luxury consumer goods). On the other hand, the demand for things like medical equipment and hygiene products increased by several fold, the world over. In this scenario, manufacturing companies can benefit from a robust enterprise resource planning system such as the Microsoft Dynamics 365 Finance and Operations that seamlessly enables change management, demand analysis, and order management.

2.Throughput & Yield of Units Produced A manufacturing company’s operational efficiency is directly proportional to its yield. Throughput is a metric that measures the average number of units produced in a particular amount of time (other coefficients being per machine, per production line, or facility). Access to the correct yield information helps manufacturers gauge their performances accurately, address bottlenecks, and develop plans for improvements.

63%

of manufacturing executives plan to get more out of what they already have invested within their manufacturing and supply chain network.

Source: Accenture

3.Inventory Turnover Properly managed inventory is a strong indicator of a manufacturing companies’ performance- after all, knowing how often inventory is sold or used in a particular timeframe is the measure of knowing its success in the market. This is precisely why decision-makers in the manufacturing industry focus on analyzing the turnover data of their inventories. To expedite the analysis and avoid data mismanagement, manufacturers still using legacy systems need to strongly consider investing in an automated ERP system that can track inventory data in real-time and facilitate seamless coordination between multiple stakeholders.

4.Quality Analysis The final quality of your product is one of the best indicators of production performance. A successful product is the best way to build your customer base, making it essential to understand applicable quality metrics- including monitoring and documenting raw material quality, incoming supplier quality, random quality checks at manufacturing plants, packaging quality, and more.

5.Overall Equipment Effectiveness (OEE) Whether it’s a single piece of equipment or an entire production line, knowing how effective every piece of equipment is, has become essential to a timely yield that matches quality and quantity requirements. This metric is recognized by the manufacturing industry worldwide as one the most important to assess agility, downtime, and overall production quality.

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The metrics above are just a few in manufacturing that often generate mountains of data through multiple sources that are constantly subject to changes. The answer to managing all this information is a data pool – a single source of truth for multiple manufacturing metrics that can help companies track, manage, and analyze the data against their KPIs.

Figure 2:Role of Sophisticated ERP in Managing Manufacturing

Role of Sophisticated ERP in Managing Manufacturing

Implementing Microsoft Dynamics 365 ERP and Power BI lets you optimize your IT infrastructure to systematically allow real-time data access, multi-level visibility, and artificial intelligence-backed insight generation. This allows you to visualize and track the progress of your manufacturing metrics, along with a cumulative awareness of your production line.

Final Thoughts

For every manufacturing company operating today, metrics and KPIs have become among some of the most important things to understand and track. How you view these metrics moving forward, how accurate the information is, and how you’re able to leverage it will be the deciding factor in your success.

  • Every company needs to reinvent its best practices with the help of manufacturing metrics for a profitable business.
  • Investing in a fortified IT infrastructure to track and manage manufacturing metrics is the need of the hour for manufacturing companies.

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Gen-Next Serialization in the Pharmaceutical Supply Chain: Improving Track & Trace
Gen-Next Serialization in the Pharmaceutical Supply Chain: Improving Track & Trace 700 500 Xcelpros Team

At a Glance

  • Worldwide pharmaceutical companies are dealing with drug counterfeiting, adulterations, supply chain thefts and packaging glitches.
  • Serialization is much more than just applying barcodes to personalized medicines.
  • This modern age of fast-paced digitization calls for modifications and improvements in serialization techniques.
  • To better strengthen the supply chain, loopholes need to be identified and closed.
  • Transparency needs to be maintained for every drug dose.
  • Pharmaceutical companies and their supply chain vendors should use of advanced analytics, cloud computing and the Internet of Things (IoT) to get a grip on modern serialization techniques.

Introduction

Traceability in pharmaceuticals is now very much seen as a global mandate. With laws differing from country to country, major pharmaceutical companies are looking for ways to improve how they track and trace their products in the supply chain to always remain in compliance.

Struggling to meet those requirements continuously is causing pharmaceutical companies to develop and implement new serialization techniques. Supply chain security, battling counterfeit and altered drugs, better product traceability, and overall cost-savings are chief among the motivations.

Reports suggest that by 2023, more than 90% of the global drug supply will be scrutinized under track and trace regulations. The program will enhance patient safety measures by combating drug counterfeiting.

Serialization is no longer restricted to global compliance mandates either. It’s helping more and more pharmaceutical companies add transparency, accountability and integrity to their supply chains.

Serialization is proving to be more effective at reducing shrinkage (i.e., errors and theft) than other solutions such as sturdy packaging and traceable 3D hologram models.

Figure: 1Common Loopholes in the Pharmaceutical Supply Chain

Common Loopholes in the Pharmaceutical Supply Chain

Innovation is the key to improving trace and track in any supply chain model, including the frequently complex pharmaceutical supply chain.

Companies worldwide are investing millions of dollars in maintaining product integrity.

Assigning unique identification numbers or barcodes to individual items (such as a strip of tablets or a bottle of medicine) for computerized serialization and tracking is becoming among the best ways to maintain product integrity.

Among newer innovations and latest trends in serialization in the pharmaceutical supply chain.

Data Encryption and Data Security

The ultimate aim of pharmaceutical supply chain serialization is to ensure consumers get the right drugs at the right price and quality. At the same time, companies that trace and track their products end up knowing where each shipment is at any given moment.

Verification for this requires very strict data management and security. One way to get it done is through computerized encryption that lets only designated people read the data.

The pharmaceutical industry loses on average 4.5% of its potential revenue because of supply chain inefficiencies.Source: Interactive Data Corporation

Recalling Individual Products

The pharmaceutical industry is highly susceptible to recalls caused by poor packaging, leading to contaminated products that could harm patients.

Previously, these recalls were made at batch-levels, causing massive revenue loss as well as disrupting the supply chain. Narrowing defective medicines to individual units makes it possible for companies to limit recalls to specific products. The same serialization can then be used to determine when and where the product was altered or contaminated.

Figure: 2 Serialization to Improve Track and Trace

Serialization to Improve Track and Trace

Use of Advanced Analytics

By studying buying trends, life sciences organizations and their research groups constantly work to understand what consumers need and want. Using advanced analytics applications like Microsoft Power BI to create in-depth business intelligence reports is becoming the best way to help realize and act on these patterns. Power BI’s dashboards take advantage of interactive visualizations to help users make informed decisions about if and when they need to alter their production schedules to keep up with market demand.

Enhanced Visibility at Every Level of Supply Chain

Serialization is a good way for companies to provide accountability regarding compliance with government regulations. It’s also an excellent way to enhance visibility and improve monitoring at every level of the pharmaceutical supply chain. Knowing how much you have and where to reduce stock-outs improves the overall distribution and ensures your products are available when and where the consumers want them.

Barcoding and Labeling

Barcodes can provide a lot more information than just a serial number alone. You can include electronic links to product information sheets, safety data sheets, ingredients, storage requirements, shipping requirements, dosage levels, and other information. All a worker needs to scan a code made with advanced label-making capabilities using a barcode reader or cellphone to access this data on the spot.

$200 billion (10%): that is the global monetary cost of counterfeit drugs according to the World Health Organization.
One million: That is the annual cost in human lives each year from fake and altered medicines according to Interpol.

Serialization’s Impact on Companies

In the United States, the serialization of all drugs at the sealable unit and case level became a requirement with the passage of the Drug Supply Chain Security Act (DSCSA) in November, 2017. This requirement had an impact on pharmaceutical companies and their supply chain vendors that had to ensure serialization of all drugs at an individual container or dose level with barcodes for better tracking and tracing.

Ultimately however, this has led to a number of benefits including:

  • Better market visibility down to individual drug demand. This helps by allowing for more efficient drug distribution.
  • Warehouses and inventories need to be equipped with a fortified drug distribution plan.
  • Better understanding and communication among cross-functional teams. Since serialization provides an inflow and outflow of different information, life sciences researchers, packaging personnel, IT experts, and distributors alike can share any data available for a particular drug.

Challenges in Serialization

Like any other change across the supply chain, serialization has its own set of challenges, including:

  • Hardware Setup and Updates
    Companies need to ensure they have the right equipment and supplies on hand at all times to print the labels, barcodes and seals required for serialization.
  • Steady Flow of the Production Line
    Introducing serialization and the training required to understand the process might have an impact on the production line early on as labeling each and every product may initially slow down the process.
  • Higher Costs
    Adding serialization to an existing process often means adding costs in terms of hardware, software, and people. These costs can be reduced by using pooled investments and sustainable hardware and software applications.
  • Skilled Personnel Shortage
    Newer, digital methods of serialization require a workforce that understands what needs to be done. Companies are facing a lack of a skilled, technically sound employee base to implement their serialization strategies.
  • Technical Glitches
    Serialization should ultimately require minimal human intervention, aiming to significantly reduce manual errors. With anything else so integrated, you will need to make sure any technical issues can be identified and addressed in a timely manner to avoid any major disruptions to production.

XcelPros’ Microsoft Dynamics 365 solutions enable pharmaceutical companies to seamlessly implement serialization for better compliance and enhanced track and trace.

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Key Benefits of Serialization in Operations

Pharmaceutical companies able to take advantage of advanced digital serialization processes for their supply chain operations often realize a number of benefits, including

  • Easy end-to-end implementation across the supply chain
  • Efficient sealing of supply chain loopholes to combat drug counterfeiting and packaging mistakes
  • Minimal human intervention required, making serialization a fool-proof, effective way to ensure brand authenticity and reduce batch recalls
  • Full compliance with government traceability regulations
  • Reduction of counterfeit drugs and compromised quality.

Final Thoughts

Overall, serialization in the pharmaceutical supply chain plays a significant role in avoiding drug theft, counterfeiting, batch recalls, and other potential hazards. Every pharmaceutical company needs to have a unique serialization process to meet its requirements. Newer serialization software uses advanced analytics for better drug distribution and fewer stock-outs.

With government mandates requiring pharmaceutical companies and their supply chain vendors to understand and master the technical details of implementing serialization at batch and case levels in an effort to fortify their supply chain and enhance visibility, these companies need to be prepared to overcome any challenges that arise. Is your track and trace solution ready?

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The Importance of Pharmacovigilance During a Pandemic
The Importance of Pharmacovigilance During a Pandemic 700 500 Xcelpros Team

At a Glance

  • The World Health Organization (WHO) emphasizes providing the most effective drugs that do not cause severe adverse effects.
  • Understand adverse effects and how to prevent them by assessing the right chemicals, quantities and processes in medical vaccine manufacturing.
  • Digital solutions and services are designed to help scientists and pharmaceutical company decision-makers detect, assess, understand and prevent adverse effects from their medicines.
  • Starting now, pharmaceutical companies are placing a greater emphasis on drug quality checks to avoid mistakes caused by rushing the production process.

Introduction

Today, most people are familiar with terms like “clinical trials,” “safety assessment tests for vaccines” and “FDA approvals” because of COVID-19 media coverage over the last few years. While these terms have always been a part of any pharma and biotech manufacturing companies’ quality assurance program, the ongoing pandemic has made them part of everyday conversation.

People often wonder why it takes so long for a drug or vaccine to get approved for mass use, and rightfully so. The answer however, lies in the principles of pharmacovigilance, also known as drug quality control.

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. Source: The World Health Organization

The Primary Goals of Pharmacovigilance Guidelines

The goals of a typical pharmaceutical quality control program include:

  • Assessing a drug’s short-term and long-term adverse effects and any harm the drug might cause a patient.
  • Continuously collating and monitoring a particular drug’s safety data.
  • Assessing the risks and rewards of the drug to make a guided decision on the administration of the drug.
  • Communicating adverse drug reactions (ADRs) data between health professionals and clinical researchers while maintaining transparency at all levels.
  • Preventing the distribution and administration of unsafe drugs by medical bodies and drug companies.

All pharmaceutical companies require a team of professionals to carry on this constant quality check of their drugs. This team can include scientists, clinicians, biochemists, physicians and medical writers. The team’s job is to collect, collate, analyze and assess the safety profile of every drug.

This task requires constant alertness and unprecedented agility for an accurate and quick response. In today’s market, manual data reviews are no longer adequate. Combining finely tuned digital tools and well-trained employees is the best way to protect patients from severe injury or death.

A drug maker’s automated quality control program should be smart enough to help collect, analyze and check data. The software equipped with artificial intelligence can check a drug’s composition, verify safety profile mapping and perform other crucial steps required for necessary quality checks.

Pharmaceutical companies need to follow a wide range of procedures to ensure their pharmacovigilance is up to government and industry standards in order to remain compliant.

“The scope of the problem of poor-quality drugs transcends national borders because the manufacturing and supply chain of medical products thrives in an international market.” Elizabeth Ndichu, MD, and Kevin Schulman, MD

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To comply with new quality standards and still meet today’s demands for fast-track drug development and clinical trials, pharmaceutical and biotechnology firms need to strictly adhere to the process of end-to-end pharmacovigilance.

  • Carrying out detailed patient surveys for different age groups, countries and health conditions
  • Using consultants and experts to manage its quality control program
  • Using software such as Microsoft Dynamics 365 for the pharmaceutical industry to help ensure error-free data maintenance, analysis and report generation
  • Keeping all stakeholders in loop at all times to avoid any errors
  • Maintaining records of their quality control policies and procedures. These records are required for medicines plus other products such as cosmetics, nutritional supplements and dietary products
  • Formulating a plan for intervention, mitigation, assessment and resolution in the event of drug quality issues

Figure 1:Digital Ecosystem: Pharmacovigilance

Digital Ecosystem: Pharmacovigilance

Pharmaceutical companies need to take an agile approach toward pharmacovigilance. Leveraging technology for streamlining safety procedures and quality checks is no longer a matter of convenience but a necessity.

Solutions like Microsoft Dynamics 365 Finance and Supply Chain Management provide Quality Control functionality. Each of these computer programs has methods to collect, track and report quality test results. This software is a comprehensive solution that makes it easy to leverage technology to streamline quality check operations.

These solutions can pave the way towards regulatory compliance, stringent component mapping and monitoring of a drug’s safety profile. It reduces manual intervention by employees, allowing individual case safety reports (ICSRs) to be performed easily.

Microsoft Dynamics modules can be used by different departments by the likes of clinical researchers, scientists, medical writers, physicians, medical representatives and government drug governing bodies. These solutions for monitoring drug safety are considered one of the best investments a company can make today.

Key Takeaways

  • Technologically-enhanced pharmacovigilance is the need of the hour for today’s pharmaceutical companies.
  • The pharmaceutical sector continues to evolve on a large scale. This change requires gathering medicinal data at a global level to map drug safety.
  • Forming a blueprint to follow the pharmacological journey is a critical step for any pharma and biotech company.

References: Pharmacovigilance: Regulation and Prequalification

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How a Pharma CDMO can manage the Serialization Challenge
How a Pharma CDMO can manage the Serialization Challenge 700 500 Xcelpros Team

At a Glance

  • Today, serialization has moved from being a luxury option to a necessity.
  • Pharmaceutical companies are hiring contract development and manufacturing organizations (CDMOs) to develop solutions that maintain drug quality while avoiding supply chain problems.
  • Pharmaceutical serialization lets manufacturers keep accurate track of their inventory wherever it may be.

As more pharmaceutical and chemical companies move to digitize their operations, they’re looking for ways to track raw materials and finished products through the manufacturing cycle. One way to track these products is through serialization.

“Serialization is the assigning of a predetermined coding type to each product item, assigning it a distinct identity” for tracking and tracing its location in the supply chain,” RFXcel.com states. A simple definition calls serialization, “the process of assigning a unique identity to each saleable product item,” according to Neurotags.com.

Pharmaceutical companies that have gone digital are starting to use serialization to track and trace their products throughout the supply chain. The industry is constantly looking to improve its tracking systems to combat counterfeiting, theft, packaging and storage errors. Companies are also worried about their products being altered after leaving their plants.

Pharmaceutical companies often hire contract development and manufacturing organizations (CDMOs). Using digital labeling methods such as barcodes and QR codes (a type of barcode) helps serialize the supply chain, making tracking raw materials and finished goods easier.

30-40% of all medicines circulated in the developing countries are counterfeit.
5-7% of all medicines circulated in the developed countries are fake. Source: WHO Report

Counterfeit drugs pose a serious threat to the public’s health. They also damage the reputations of legitimate companies and the pharmaceutical industry globally.

CDMOs worldwide face challenges when implementing a robust pharma serialization solution. Streamlining manufacturing and distribution processes while understanding their client’s unique requirements is challenging.

Serialization Challenges Faced by CDMO

Some of the challenges a CDMO faces while implementing pharmaceutical serialization for track and trace functionality include:

Seamless Serialization for Multiple Clients

CDMOs typically prefer to operate globally, providing comprehensive drug manufacturing and supply services to many pharmaceutical companies. Catering to a diverse client base has its unique set of challenges, especially when it comes to the serialization of individual drugs.

CDMOs need to equip themselves with the right technology to be able to modify their production or manufacturing lines and seamlessly label multiple drugs for different clients.

Regional Compliance

Every country around the world can have different regulations for exporting drugs. Labeling—or serialization—is part of that compliance. CDMOs are expected to take responsibility in terms of drug quality of drugs and compliance with various government rules. Being in compliance is challenging for CDMOs, especially considering the volume of information required to achieve it.

Figure: 1Key Serialization Challenges Faced by CDMOs

Key Serialization Challenges Faced by CDMOs

Picking the Right Labelling Solution

When it comes to drug serialization, a “one size fits all” approach to labeling solutions doesn’t always work. Assuming a CDMO has a preferred labeling software, there’s still the important decision of choosing:

  • Printer types such as thermal inkjet, thermal transfer, lasers
  • Printing materials such as paper, film or holograms
  • Special formulas to make counterfeiting harder

In terms of label design, everything must meet government codes and regulations. This applies to label layout, orientation, barcode configuration and other design elements. Every label must be printed in time to avoid delaying shipments. CDMOs are pressured to make the right choices for coding and labeling products.

Understanding Market Requirements

While larger pharmaceutical manufacturing companies use an in-house team of analysts and marketing specialists, smaller firms often rely on CDMOs for market intelligence.

When it comes to labelling client drugs, CDMOs need to understand the different markets and their requirements. Using market analysis, CDMOs must decide how many drugs need to be labelled for a particular market, including whether they’re choosing to label randomly or with a centralized approach.

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Overcoming Serialization Challenges

No two CDMO clients are the same and neither are the challenges each CDMO faces. In terms of how each company deals with its serialization issues, they should consider:

  • Equipping their workforce with the technical knowledge and details of serialization hardware and software
  • Making use of advanced technological applications like Big Data, cloud computing, the Internet of Things (IoT and advanced analytics)
  • Understanding how enterprise resource planning (ERP) software, like the Microsoft Dynamics 365 line of modular product, can help them maintain and monitor client data

With the right software and people skilled in its use, a CDMO can manage multiple production lines while meeting drug production requirements for different clients.

Investing in the right partner with experts that understand global pharmaceutical regulations will help CDMOs label and locate their products no matter where they are in the world.

Since CDMOs are not only vendors but also producers, they need to be in constant contact with their clients and suppliers. This includes dealers, wholesalers, packagers and transporters. Using the right ERP will help them maintain transparency at every level while avoiding recalls or stock-outs.

CDMOs benefit by developing flexible templates for their serialization solutions. These templates serve as a blueprint for any pharmaceutical client. Making them flexible lets a CDMO adjust a process to meet the client’s requirements, saving time, effort and money.

Final Thoughts

Drug serialization and labelling pose several challenges for CDMOs around the world. However, managing these challenges is an excellent opportunity for an organization to show its technological skills. When a CDMO has the right team and solution, it can overcome any challenge.

Taking advantage of products like Microsoft’s Dynamics 365 suite of solutions gives pharmaceutical companies access to powerful tools. Included is a way to track serialization, such as customer onboarding and lot traceability to toll manufacturing, from start to finish.

Using a powerful and effective ERP to enhance serialization will help a CDMO combat counterfeiting and theft while ensuring government compliance. At the same time, good software can also help a CDMO establish a more efficient supply chain.

Meeting serialization requirements for pharmaceuticals pose many technical and skill-based challenges. CDMOs worldwide are constantly looking for more efficient ways to handle these challenges. Investing in the right partner can make a big difference.

With the help of cutting-edge applications, a skilled team and a systematic approach toward serialization, CDMOs can establish themselves as leading end-to-end manufacturing and distribution partners.

References: What Is a CDMO (and Why Do You Need One)

Cros move from conventional project management to strategic partnership banner
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How Life Sciences CROs Are Changing To Strategic Partners: The Covid-19 Effect
How Life Sciences CROs Are Changing To Strategic Partners: The Covid-19 Effect 700 500 Xcelpros Team

At a Glance

  • The biotechnology and life sciences industry is at a cusp of significant changes due to COVID-19. A lot of fluidity is built up due to the pandemic and a significant dependency on government rules, FDA regulations, intricate drug production and overall research and development.
  • These firms are looking for Contract Research Organizations (CROs) who can take the role of strategic partners that can manage their life sciences research & development. The preference of CROs has already shifted from traditional to technologically adaption that can handle the rapid pace needed due to the existing COVID-19 emergency.
  • The call for innovation and increased collaboration among CROs has led to a new, more comprehensive project management era. It is improving customer engagement and experience.

The Role of a Contract Research Organization

Project management is the backbone of any contract research organization. Regardless of its specialty–biopharmaceutical development, commercialization, preclinical research, clinical research, clinical trial management or pharmacovigilance-all require project management. Pharmaceutical and life sciences companies outsource research and development work to CROs for better time management, test data maintenance and focus on concrete results.

While the role of CROs was not very well defined in the early 2000s, they have evolved from being mere project management vendors to strategic partners for life science organizations. Contract work is now common in various steps of the research life cycle. Adding contractors is now a necessity for the R&D wings of any biotechnology or pharmaceutical company.

Active engagement with CROs helps accelerate the drug development process. In the Covid-19 era, these CROs must be prepared to streamline their project work without a process breakdown.

CROs have evolved from a target-based model to become more a strategic partner to life sciences and biotechnology companies.

Pharmaceutical companies conduct sponsored trials, driving their products safely and quickly to the market. Initially, these projects were outsourced to CROs with a limited scope of time and budget management. Now the CROs are expected to manage risks and maintain transparency throughout the clinical trials. The rapidly expanding biochemical industry demands that CROs keep up with market conditions.

According to contract research organizations global market report, The global market for clinical trial services to biopharmaceutical, biotechnology and medical device companies is forecast to grow at 12% year on year up to 2021.

This stat is already obsolete. The need for contract research and development services is increasing as life science companies seek to find effective treatments and possible cures for the SARS Covid virus.

Figure: 1 Steps for Right Partner Selection

Steps for Right Partner Selection

Growth and general technological disruptions in project management are leading to a progressive change in the roles of CROs while managing sponsored clinical trials.

Situations affecting CRO evolution

  • End-to-End Strategic Partnerships: CROs are no longer just outsourced vendors for life sciences companies to carry out Pharma research or conduct clinical trials. CROs are now expected to become pharma companies’ strategic partners, helping make their clients successful. End-to-end coordination with pharmaceutical companies gives these organizations the time and stability they need to focus on core research. Coordinating from the start helps the CROs capture the right kind of clinical data required to make each drug commercially viable.
  • Bringing Innovation to the Table: CRO project management is not just about completing given tasks while meeting their client’s deadlines. Working closely with their customers means changing how they work. That, in turn, requires newer project management approaches that take research from start to finish. Pharmaceutical companies expect innovative, out-of-the-box solutions to manage risks, cut costs and push the boundaries of paramedical science while complying with the government’s rules and regulations. An important change is that CRO project management has moved from being reactive and solving problems to becoming proactive, anticipating problems and providing solutions.

Figure: 2 Key Parameters CROs are Assessed on

Key Parameters CROs are Assessed on

  • Being Technologically Ahead: Companies can start with three main technology initiatives: transitioning to cloud computing; creating strong workflows to move processes and procedures forward; using online collaboration tools.
  • Each of these above points leads to faster results, fewer errors, better team management and improved communication between the client and the CRO during the project life cycle.

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Customer Experience and Engagement

A crucial part of project management is actively engaging clients when a project requires collaboration. Customer experience and engagement can no longer be ignored. Making a strategic partnership work requires communication between everyone involved.

An effective customer experience approach requires knowing what to do, how to do it and using every available tool to create acceptable results.

Connect your processes, customer data and tools with Dynamics 365 and the Microsoft Cloud

Customer Experience (CX) and Customer Engagement (CE) can be made better for a CRO

01.Process and Procedures

Some ways to improve the customer experience and boost customer engagement are:

  • Improving team management
  • Quick onboarding of clinical trial experts
  • Using effective cost management techniques
  • Proactively managing clinical trial risks
  • Mitigating probable risks strategies
  • Using detailed analytics to monitor, report and understand research data
  • Using resource planning tools to optimize resources for multiple projects
  • Simplifying milestone-based billing
  • Improving deviation-tracking methods to remove unknowns early in the project lifecycle.

Life science CROs should consider using a next-generation customer experience platform to accelerate development and drive demand. Microsoft Dynamics 365 is one such system that offers the essential tools and capabilities in one comprehensive ecosystem.

The seamless integration between Dynamics 365, robust cloud computing, artificial intelligence and tools such as Office 365 can help. Dynamics 365 is a class-leading life science customer engagement platform that functions across mobile devices, which is a large market need.

02.Digital Advancement

To enhance their customer experience and engagement, companies should:

  • Move from legacy systems to the cloud
  • Use advanced analytics for risk prediction and mitigation
  • Systematically manage their R&D database with digital applications
  • Use software tools to Improve collaboration with clients
  • Reduce human intervention and automate project management workflows
  • Create customer and supplier self-service portals to engage both
  • Use in-line reporting through key project milestones to build trust and visibility with customers

03.The Inevitable Evolution

The changing role of CROs is leading to greater expectations from life sciences clients. Pharmaceutical companies are looking for CROs that are not afraid to push boundaries and are adept at using the latest tools and techniques.

Companies aiming for greater customer satisfaction can use cutting-edge technologies to engage with CRO’s at an integral level. As a result, CROs are becoming be more innovative and agile in their project management approach.

An interdependent relationship helps with clinical trials while improving the client company’s overall research and development. A well-managed and organized workflow-based environment helps contractors and clients.

Two tools that can help build this interdependency are Microsoft Dynamics 365 Finance combined with D365’s Supply Chain Management. The two modules can help create a comprehensive system to aid a CRO in becoming better strategic partners with Pharma and Biotech companies.

Figure: 3How to Create Successful Sourcing Partnerships?

How to Create Successful Sourcing Partnerships

Increase your speed of business with unified processes and predictive analytics

The speed of doing business is increasing. As companies seek to stay competitive, they must rely on technology to provide agility and the capabilities needed to excel. However, many organizations are still running on ERP systems that are complex, inflexible and impede their ability to innovate and grow.

Microsoft Dynamics 365 helps you to

  • Elevate your company’s financial performance and streamline its supply chain management
  • Innovate with connected operations in an extensible platform
  • Drive HR operational excellence through organizational agility and centralized data
  • Unify the processes listed above with predictive analytics and intelligence
  • Track and trace inventory management
  • End-to-end customer project management

Key Takeaways

CROs are transforming from time-bound project management consultants into performance and results-oriented firms.

  • As technology evolves, so do project management tools. CROs are equipping themselves with these tools for better time management, budget management and risk mitigation.
  • Technology allowing smoother customer and supplier onboarding for clinical trials is needed today.
  • Pharmaceutical companies are looking for CROs to manage R&D projects end-to-end while providing innovative solutions.
  • While time management and cost management will always be top priorities for CROs in any project, they must also offer greater returns to their clients.

References: Overview of CROs

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Using AI & ML in the Pharmaceutical Industry – Key Considerations
Using AI & ML in the Pharmaceutical Industry – Key Considerations 700 500 Xcelpros Team

Introduction

Artificial intelligence is one of those science-fiction-sounding phrases, but what does it mean to people in the pharmaceutical industry? What is the difference between AI and its cousin, ML, which means machine learning? How can the two types of computer software make pharmaceutical companies more efficient and profitable?

The answers are in what they do and how AI and ML work together.

AI can be defined as using computer algorithms—math—to perform tasks requiring human intelligence. IBM defines AI as “leveraging computers and machines to mimic problem-solving and decision-making capabilities of the human mind.”

“It is the science and engineering of making intelligent machines, especially intelligent computer programs. It is related to the similar task of using computers to understand human intelligence, but AI does not have to confine itself to methods that are biologically observable,” John McCarthy was quoted as saying in a 2004 paper.

So if AI acts like somewhat like a human mind to solve problems, how is machine learning different?

“Machine learning is the study of computer algorithms that can improve automatically through experience and by the use of data. It is seen as a part of artificial intelligence,” Wikipedia states.

In essence, the two types of programs work together to analyze information.

For example, say the first 100 production runs of product XYZ1000 have a 70 percent success rate in terms of meeting basic quality standards. Analysis shows the difference between success and failure is one step. Every run where the temperature was kept within a 0.2-degree range succeeded. Every run where the temperature exceeded 0.5 degrees failed. Logic says that keeping the temperature within that narrow range boosts success which, in turn, improves productivity.

Machine learning tells operators, “keep the temperature within 0.2 degrees for this one step.” Artificial intelligence builds on machine learning. It says, “by keeping everything else the same and keeping the temperature in this single step within 0.2 degrees,” the company will see:

  • More efficient use of raw materials
  • Less waste
  • Greater profits
  • A host of other benefits

So how does a pharmaceutical manufacturing company benefit by using AI and ML? Let’s look at the numbers.

By the Numbers

  • $100 billion: The amount of money AI and ML can generate in the US health care industry alone.
  • $161 million – $2 billion: The estimated cost of getting a new drug through clinical trials and obtaining FDA approval.
  • 72 percent: The percentage of healthcare companies believing that AI will be crucial to how they do business in the future.
  • 62 percent: The percentage of healthcare companies considering investing in AI soon.
  • 61 percent: The percentage of companies believing that AI will help them identify opportunities they will otherwise miss.
  • 13.8 percent: A study from the Massachusetts Institute of Technology estimates the number of drugs successfully passing clinical trials.
  • 11 percent: The percentage of businesses who have not considered investing in AI.

Sources: Digital Authority Partners and PharmaNews Intel.

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How AI Helps the Pharmaceutical Industry

Add in a third element—large data sets created by Internet of Things (IoT) sensors wired into a company’s network—and the result is a technology-savvy, company that can see ways to improve efficiency. AI runs computations that estimate probabilities based on known numbers.

Going back to our earlier example, 30 percent of the production runs failed quality standards. That’s the new baseline. Having computers that can finely tune machines reduces tolerances.

Another way pharmaceutical companies are using AI is to speed up drug discovery. It sifts through large datasets from clinical studies and other sources to detect hidden patterns, performing tasks in seconds that once took months. Learning every time they perform a task, AIs run through millions of tasks.

“Drug discovery is being transformed through the use of AI, which is reducing the time it takes to mine the vast amounts of scientific data to enable a better understanding of disease mechanisms and identify new potential drug candidates,” says Karen Taylor, director of the Centre for Health Solutions at accounting and consultancy group Deloitte. “Traditional drug discovery has been very fragmentary, very hit and miss,” she adds in The Guardian article.

The rapid creation of effective Covid-19 vaccines is a direct result of AI and ML in the pharmaceutical industry, Taylor states.

Figure: 1 Funding in Artificial Intelligence in the Pharmaceutical Industry

Funding in Artificial Intelligence in the Pharmaceutical Industry

How valuable is AI to big pharma? Britain’s two largest drug makers—AstraZeneca and GSK—recently funded the Cambridge Center for AI in Medicine at the prestigious university. GSK already opened a £10 million (roughly $13.5 million) in central London. This lab is near Google’s DeepMind AI lab.

DeepMind founder Demis Hassabis recently unveiled Isomorphic Labs, which intends to use an AI-first approach to discovering new drugs. DeepMind’s AlphaFold2 AI system solved the 50-year-old challenge of protein folding. AlphaFold is capable of predicting the 3D structure of protein directly from its amino acid sequence to atomic-level accuracy, Hassabis said in a recent Isomorphic blog post.

“One of the most important applications of AI that I can think of is in the field of biological and medical research, and it is an area I have been passionate about addressing for many years,” he said.

Hassabis considers biology an extremely complex and dynamic information processing system, making it a perfect match for AI.

“But just as mathematics turned out to be the right description language for physics, biology may turn out to be the perfect type of regime for the application of AI,” he said.

The Guardian article also looks at the money: Using older methods, nine of every 10 drugs in development will fail. The average drug development time is 10-12 years. With AI, the success rate is expected to at least double and possibly boost success from 1:10 to as high as 1:2.

How Can SMBs Benefit from AI?

While having $13 million in labs devoted to research is a great idea, many companies don’t have that large of an R&D budget. At least one well-known company has enterprise resource planning modules that integrate AI: Microsoft.

Figure: 2 AI Powered Insights by Microsoft

AI Powered Insights by Microsoft

AI Powered Insights by Microsoft

One example is Microsoft Dynamics 365’s Customer Insights is one of several modules that has AI built in. When pharmaceutical companies combine Dynamics’ Business Intelligence module with its Integrated Chemical Management (iCM), the two work together to mine your pharmaceutical data.

iCM is specifically designed to handle tasks like System of Record (SOR) for chemical and regulatory data plus compliance with cGMP regulations.

Add in Dynamics’ Supply Chain Management module and pharmaceutical manufacturers and suppliers can know to the second how much of any given product they have. Using AI and other information mined from a thorough inventory review, companies can accurately predict how much of any given precursor chemical they need to meet forecast demands. With this information, companies can place orders when costs are low or keep just enough on hand.

The Bottom Line

Pharmaceutical companies already create mountains of data. Instead of losing valuable nuggets of information such as trends and insights, artificial intelligence can sort through it. AI can:

  • Perform comparatively mundane tasks extremely fast
  • Provide your company with ways to create new products at lower costs
  • Produce new drugs much faster than before
  • Reduce the number of new drug failures

Using Microsoft Dynamics 365 modules equipped with the power of AI will ultimately help boost your bottom line.

Time to Explore Pharmerging markets
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It’s Time to Explore Pharmerging Markets
It’s Time to Explore Pharmerging Markets 700 500 Xcelpros Team

Introduction

A relatively new term making waves in business is “pharmerging markets.” What does the term mean and why should pharmaceutical manufacturers care? The short version is these markets are expected to grow at a faster rate than the rest of the world.

Add in potentially catastrophic supply chain issues and it’s now a great time to invest in markets closer to where active pharmaceutical ingredients are produced. This includes China, India and those in Southeast Asia.

One definition is, “a group of countries having a low position on the pharmaceutical market, but having a fast pace of growth. Those are China and India and to a lesser extent, Brazil, South Africa and other countries,” IGI Global states.

Imarc adds Russia, Mexico, Indonesia, Turkey and others, placing them into three tiers. China is the lone Tier 1 entry.

Tier II contains:

  • India
  • Brazil
  • Russia
  • South Africa

Tier III pharmerging countries include:

  • Argentina
  • Mexico
  • Poland
  • Ukraine
  • Turkey
  • Saudi Arabia
  • Egypt
  • Algeria
  • Nigeria
  • Thailand
  • Indonesia
  • Pakistan

All of these countries share two important characteristics:

  • They have a per capita gross domestic product (GDP) threshold of $25,000.
  • They saw a spending increase of at least $1 billion from 2012 – 2016, though only part of that was in medicines.

Growth Rates

Figure: 1 Expected Growth Rate of Pharmerging Markets by 2025

Integrating the Purchase Order Process

Key Changes in the Outlook

  1. 1.2020: -1.8% (-$23Billion)
  2. 2.2021: +0.6% above pre-COVID-19 growth; +2.3% above 2020 growth
  3. 3.Current outlook including vaccines +4% over outlook that excludes vaccines due to ~$50-55billion vaccine spending in both 2021 and 2022, later reduced as volume shifts to biennial boosters and price drops over time
  4. 4.Expected budget pressures will emerge from longer-term pressures of sustained pandemic
  5. 5.Vaccine spending declines as biennial boosters and costs decline in endemic phase, followed by overall growth returning to expected levels

The 6-year cumulative delta on 2020-2025 spending excluding Covid-19 vaccines is -$4 billion globally.

Sources: IQVIA Market Prognosis, Sep 2020; IQVIA Institute, Mar 2021

Pharmerging markets are expected to have a combined annual growth rate (CAGR) from 6% -9% through 2025, reaching $1.4 billion by 2024. By comparison:

  • Developed nations will grow at no more than 3%
  • The rest of the world will grow 2% to 5%
  • The overall global growth rate is anticipated to be 3% – 6%
  • The U.S. market will grow no more than 3%, possibly less

Pushing the need for prescription drugs and targeted medical therapies in these countries are aging populations, more public hospitals and a heavier burden caused by chronic disease, Pharmaceutical Processing World states. The result is increased pharmaceutical spending since 2016.

A key note, industry research firm IQVIA states, is this growth excludes spending on Covid-19 vaccines. The cumulative spending on Covid-related vaccines, treatments and related products should hit $154 billion.

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Fueling Pharmerging Growth

Access to healthcare has historically been a driving force in the use of medicines within the Tier II and Tier III countries. However, IQVIA sees a slowing trend with volume decline across many markets.

However, China’s use of non-Covid pharmaceuticals is expected to accelerate, especially once the pandemic dies down. Changes in the use of medicines, with demands for new vaccines plus shifts in demand for existing therapies and patient behaviors, will also have an impact on the global pharmaceutical market.

These same countries with lower incomes also have dramatically lower access to medicines. The result is an increased demand, especially in those countries where access to quality healthcare is improving.

Highlights of IQVIA’s report include:

  • The largest aggregate contributors to growth in the next five years are immunology, oncology and neurology.
  • Oncology and immunology are forecast to grow at 9-12% CAGR through 2025.
  • Oncology is expected to add 100 new therapies for migraines and possibly Alzheimer’s and Parkinson’s along with other, rare neurological diseases.

Selling in pharmerging markets may sound like a “no brainer” to some corporations but it comes with a critical catch right now: Covid-related issues have the world’s supply chains on the brink of collapse.

Supply Chain Failure?

In areas that pre-Covid rarely saw more than one or two ships waiting to dock, the Ports of Los Angeles and Long Beach had 72 ships at sea on Oct. 4, 2021, an Oct. 6, 2021 story on CNN.com states.

Before Covid, most ships went straight to a berth. Now? There’s an average 10-day wait to get in, unload and reload.

“It’s like taking 10 lanes of freeway traffic and moving them into five when the cargo gets here to the port,” Gene Seroka, executive director of the Port of Los Angeles, told CNN International on Oct. 5. “We’re having difficulty absorbing all of that cargo into the American supply chain,” CNN states.

Adding to port woes are a lack of truck drivers to move containers along the supply chain into warehouses. Delays in unloading also cause problems with getting empty containers where they are needed. Manufacturer’s can’t send large volumes of goods overseas when they don’t have containers to ship them. It’s either not enough empties or having empties in one port when they are desperately needed in another.

The effects of these supply chain issues are quickly reverberating back to consumers.

“Say hello to your pandemic price increase,” the headline of an Aug. 12, 201 column in SupplyChainDive states.

Gaps in the supply chain cause buyers to look at smaller suppliers to meet raw and unfinished materials demands. The result is procurement professionals are finding new suppliers, sometimes at a better price than their old standbys, the article states.

Now comes the question many pharmaceutical companies need to ask: Can they keep production on schedule even with a uncertain supply chain?

Technology is Part of the Solution

Enterprise Resource Planning products like Microsoft Dynamics 365 and its Supply Chain Management module can help. It makes tracking essential precursor materials pharmaceutical companies much easier. It can track APIs from the time they leave a factory in India to the moment they land in a production warehouse. From there, accurate labeling using barcodes and QR codes lets these companies know where every item, batch, lot and pallet goes.

Other software equipped with artificial intelligence can quickly produce usable supply chain information. When did we order this? Was it delivered in time to meet our needs? Is there someone else closer, either to our production facilities or our customers, that can ensure we meet our contractual obligations?

ERP software can also help forecast not only supply but demand and where that demand might be the greatest. If demand is in a pharmerging market close to where a company gets its raw materials, there might be a justification to build a new facility. Not having to cross oceans will reduce shipping costs and extensive delays.

Final Thoughts

Businesses don’t run in a vacuum. Supply chains that affect cars and consumer goods also impact pharmaceutical companies. Keeping very close track of where raw materials are produced, how long it takes for them to arrive are just as important as the time spent producing finished goods and then shipping them to the customers.

Implementing a solution like Microsoft Dynamics 365 Supply Chain Management goes a long way to removing the guesswork.

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Reshaping Procurement within Pharmaceutical Supply Chain
Reshaping Procurement within Pharmaceutical Supply Chain 700 500 Xcelpros Team

Procurement in the Pharmaceutical Industry

The procurement of raw materials in any pharmaceutical company is a source of inventory. An established method to improve visibility, track, and trace product quality is a must-have, regardless if it’s a manual, electronic, or a hybrid purchase-to-pay process. Procurement in the pharmaceutical industry is thoroughly scrutinized, and businesses have become more cautious of raw material and service spending. Many companies are evaluating different suppliers, who can fulfill their requirements at a lower cost, with attention to overall spending and quality requirements.

A robust supply chain management system is needed to:

  • manage on hand inventory, and
  • build a more reliable end-to-end pharmaceutical supply chain.

What are some considerations when revisiting purchasing functions?

This question shines a light on companies’ need to organize their purchasing process, include more visibility for senior management, and increase traceability of purchasing transactions for streamlining the procurement process. A comprehensive supply chain management solution with low-code and customizable workflows to modernize the pharmaceutical procurement process will be an incredibly valuable asset.

Figure: 1Checklists to Turn Your Supply Chain More Efficient

Checklists to Turn Your Supply Chain More Efficient

Businesses can benefit through a supply chain management system with advanced procurement processes to help accomplish the following objectives.

01.Ensure Compliance:

Failure in quality compliance can result in hefty penalties and may jeopardize customer trust, especially when activities, such as buying from approved vendors or segregation of duties between the buyer and invoicer, are compromised. Your procurement management system should provide the ability to perform required audits with controls, and enable only authorized users to perform their appropriate functions. Preferably, a pharmaceutical supply chain management system needs to be in full compliance with 21 CFR part 11.

02.Support Strategic Vision:

Successful life science companies focus on strategic planning and development to boost their bottom line. Any modern supply chain management system should help an organization achieve its strategic goals. Functions like a streamlined buying process are possible with spend analytics, derived from multiple dimensions of purchase transactions. Factors, such as the success rate of higher quality materials from approved suppliers, competitive pricing details, and gauging on time and in full payments from preferred suppliers, are a few key analytics that can help improve decision-making within the purchasing department of the organization to meet their goals.

03.Effective Supplier Relationship Management:

Long-lasting supplier relationships are crucial to procuring higher quality products at the lowest prices. Building a strong relationship with a familiar supplier is far more effective than continually switching vendors to lower costs. Frequently changing suppliers places an additional burden on the entire procurement ecosystem. Suppliers put a lot of effort into understanding your business’ needs over time, including feedback on the quality of raw materials purchased and the speed of shipments delivered, allowing them to make any necessary corrections to their processes. A supply chain management system that supports collaboration in such cases, helps integrate suppliers as partners to add value to the overall supply chain process.

Figure: 2Supplier Relationship Management

Supplier Relationship Management

04.Reduce Operational Costs:

Buyers or purchasing managers should be able to quickly analyze products offered by various suppliers spread across multiple geographical locations in order to secure the best pricing and reduce expenses.

The right kind of solution should eliminate wasteful spending—a critical factor in calculating the performance of any organization.

A detailed view of supplier insights can help make decisions while identifying the best supplier for various materials. Identifying solutions to balance the cost and quality of purchased materials, can help significantly reduce operational overhead without compromising on any KPIs of pharmaceutical procurement. Result-oriented companies in the life science industry should have a well-thought-out method in place to manage procurement functions, allowing them to maintain highly competitive prices without compromising the quality of a lot.

Figure: 3Better tools for modern supply chain management

Better tools for modern supply chain management

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Improving Organizational Efficiency is Your Key Metric:

Streamlining procurement in the supply chain, as well as identifying all possible failure points in your workflows, can significantly improve your organizational efficiency and increase the overall performance of the business. Every organization requires the ability to identify areas of their business that need improvement. Enhancing procurement in the supply chain, directly affects the utilization of materials and labor appropriately without compromising quality or cost. Optimizing resource time and inventory management together, increases efficiency. A well-planned purchasing procedure will make it easier to show incremental results on crucial analytics, such as vendor performance and spending analysis.

The Ideal System

  • helps organizations streamline their pharmaceutical procurement process and get deep visibility into product inventory.
  • easily and quickly identifies product and service needs, and procure products, post receipts, invoices, and payments through included procurement and sourcing management modules.
  • defines purchasing policies and workflows to configure procurement processes that meet your business needs.
  • manages product catalogs and procurement channels based on demand and vendor pricing and capabilities.
  • defines spending limits to constrain requisition spending and the purchasing workflow.
  • protects the privacy of the business and its customers.

Procurement management 2.0—Revamping technology

Any advancement in market dynamics has a direct impact on the buyer’s journey. Because of this, the need for procurement department heads to play a more strategic and tech-enabled role increases significantly. Early life science procurement departments had only two primary objectives: cost reduction and risk mitigation. Now, digital technologies have revolutionized procurement in the supply chain in companies to expand focus into different areas, like efficiency, accessibility, sustainability, and metrics for generating better purchasing decisions.

In the five years immediately following the 2008 global financial crisis (GFC), total return to shareholders (TRS) for companies with top-quartile procurement capabilities was 42 percent higher than for companies whose procurement operations were in the bottom quartile.
Source: Mckinsey

To stay on top, companies must move past the traditional buyer mindset, and deliver value to businesses by keeping their procurement teams collaborative with their suppliers by internally driving productivity and increasing savings, and externally maintaining better supplier relationships, and reducing unnecessary supply chain risks.

As technology continues to advance, we will continue to see new applications giving new life to the pharmaceutical supply chain in order to promote business functions.

01.Cloud-Based Platforms:

Moving procurement to the Cloud enables life science organizations to operate with more agility and with benefits, including enhanced collaboration, security, and data privacy. A growing number of traditional enterprises are already embracing the Cloud’s capabilities to accelerate their businesses. Buyers can be a lot more agile at moving materials through the supply chain if they’re managing procurement functions on the Cloud. Embracing portals and well-defined workflows, allows better engagement with suppliers, allowing the acceleration of tasks like request for quotations (RfQs).

Gartner reports that the procurement industry has an anticipated growth of up to 3.2 billion dollars by the end of 2020, fueling the Cloud procurement sector.

02.Data Analytics:

Adopting an analytically driven approach might not be revolutionary, but it’s certainly an evolution for the pharmaceutical procurement management that we know today. The significant challenges that organizations face today are primarily related to a lack of visibility.

A survey by Deloitte Global CPO showed that analytics would play a significant part in shaping procurement in the supply chain over the next two years. According to the study, the respondents use analytics in different ways:

50%for Cost optimization

45% for Management reporting

48%for process improvement

As procurement departments’ spend vs quality goal is often to exceed expectations for their businesses, turning to integrated analytics can offer innovative solutions to enable efficient resolution of ongoing buyer challenges. For best results, these teams need analytics as a core function in their decision-making process instead of treating it like a checklist submission to management. With the right reporting and analytics, life science companies should have an easy preview of the quality of raw materials per supplier. Categorizing suppliers into the proper buckets, based on supplier evaluation criteria or consuming specific lots based on customer potency/quality requirements, helps make better purchasing decisions.

03.Enhancing Collaboration:

The previous decade has seen a relatively large shift in procurement-based technology, with solutions moving from on premises to completely collaborative Cloud platforms. The initial extension of legacy ERP software systems, which included purchasing modules in the 1990s, has now evolved to easily accessible systems with enhanced collaboration and procure-to-pay solutions.

As businesspeople start exploring the pharmaceutical procurement process further, the focus is moving to niche functions, like strategic sourcing, asset acquisition, and others. These standalone technological products did nothing to solve a significant challenge: collaboration. Integrated tools, such as Microsoft Flow integrated with Microsoft Teams, are providing seamless collaboration between buyers and suppliers.

04. Mobility

With the increasing population of millennials entering the workforce, the demand for mobile devices continues to steadily rise. Deloitte predicts that nearly 42 percent of companies invest in mobile phone technologies to support their procurement strategies, meaning mobile devices should now be considered an integral part of every procurement strategy going forward. With the help of the Cloud and mobile enabled services, companies can better manage their operations and analyze real-time functions and processes, leading to more proactive decision-making.

The Role of Microsoft Dynamics 365 Supply Chain Management

Microsoft Dynamics 365 Supply Chain Management helps organizations streamline their procurement process and get deep visibility into product inventory by:

  • easily and quickly identifying product and service needs and procure products, post receipts, invoices, and payments through included procurement and sourcing management modules.
  • defining purchasing policies and workflows to configure procurement processes that meet your business needs.
  • managing product catalogs and procurement channels based on demand and vendor pricing and capabilities.
  • defining spending limits to constrain requisition spending and the purchasing workflow.

Figure 4 Optimize your supply chain with Dynamics 365

Optimize your supply chain with Dynamics 365

Key Takeaways

  • Modern pharmaceutical and life science companies have digitized their operations and processes within the procurement department to help streamline the buying process.
  • Advanced digital approaches, such as using Microsoft Dynamics 365 Supply Chain Management or automating the pharmaceutical procurement process, can help accomplish the goal of well-stabilized procure-to-pay cycles.
  • A revamp in the Microsoft ecosystem’s overall procurement process enables life science companies to identify and eliminate inefficient, time-intensive aspects.

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