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Benefits Of Batch Traceability in Pharmaceutical Manufacturing
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Benefits Of Batch Traceability in Pharmaceutical Manufacturing Company
Benefits Of Batch Traceability in Pharmaceutical Manufacturing Company 700 500 Xcelpros Team

Introduction

In a previous article: Batch traceability in pharmaceutical manufacturing, we talked about GS1 traceability standards, the DSCSA, and why the pharmaceutical industry has to be prepared for item-level traceability by the end of 2023. Now let’s go over the benefits of traceability that the industry should not ignore.

Benefits of Pharmaceutical Track and Trace

The pharmaceutical industry relies on several workflows, and the ability to track and trace batches are one of the most important. With traceability slated to be mandatory by the end of 2023, it will help to understand the benefits that will come along with this change.

  • Reduced counterfeits Counterfeits are still a significant challenge for the industry, accounting for nearly 7% of all medicines globally. These fakes can replace high-quality treatment anywhere in the supply chain.

    With real-time lot tracking and tracing, it’s easy to fully follow the journey of a batch to ensure it hasn’t been misplaced or replaced at any point in the supply chain. This is a crucial step in reducing the number of counterfeit medicines.

  • Streamlined recall processes Despite paying mandatory diligence, specific errors are bound to happen. There are as many as 1200 recalls on medicine every year. But remembrance can be difficult when the manufacturer isn’t aware of the exact position of finished goods and raw materials in their supply chain.

    After implementing a traceability solution, manufacturers have much more control over finished goods and raw materials as they move through their supply chain. This means more opportunities to recall or even stop defective medicines from reaching the public.

  • Increased quality throughout production To ensure continual production, and an adequate supply of raw materials is essential. By adopting the practice of advanced track and trace for pharmaceuticals, these companies can maintain quality tracking at every production stage.

    The right pharmaceutical tracking system can record critical data like quantities in pounds or gallons, products consumed, remaining stock, quality throughout production, finished goods quality, and more. This data ensures only the best products are produced and quality requirements are upheld.

  • Maintaining supply chain integrity Another benefit of a system offering traceability is maintaining a higher level of supply chain integrity.

    Traceability solutions like D365 let manufacturers closely track the quality and pedigree of every batch from raw materials to finished goods.

  • Increased compliances As a pharma industry player, adherence to certain compliances and regulations is fully necessary. Achieving full compliance is one of the most important benefits of having item-level traceability.

    Full traceability helps you track the journey of a lot from manufacturing units to the pharmacies which is crucial for things like the Automation of Reports and Consolidated Orders System (ARCOS), GS1 traceability standards, and more.

Figure 1:Benefits of Pharmaceutical Track and Trace

Benefits of Pharmaceutical Track and Trace

  • Easy lot number tracking Traceability solutions like Microsoft D365 help departments assign specifics like a package, serial, and lot numbers to any outbound or inbound finished medicines. This makes tracking whole batches quick, easy, and accurate.

    Traceability solutions also help post tracking details as ledger entries – where there is a dedicated page for managing the workflow. This dedicated page even shows the total sums of traced items throughout production.

  • Item availability Lot traceability with Microsoft Dynamics 365 Finance and Operations helps calculate and report an item availability in real-time.

    It’s not just about tracking, though; D365 also helps by providing a wide range of accurate item information on the tracking page so that it’s easy to find out how much of the product is consumed and what remains.

    You can check the lot availability per lot number and serial number. It also prevents the double allocation of items in a lot or batch.

    Some of the critical metrics D365 offers visibility on include things like:

    • Total Quantity
    • Current Requested Quantity
    • Total Requested Quantity
    • Current Pending Quantity and
    • Total Available Quantity
  • Lot or serial number allocation for inbound transactions Not likely to change anytime soon, seamless purchase order management is essential for inbound transactions, and D365 F&O makes it possible. D365 helps manufacturers process real-time lot code tracking from the moment they are part of the organization.

    This tool can automatically transfer the lot/serial number in the transaction documents and keep the warehouse team updated.

  • Lot/batch sales Whether you want to block a lot in the sales lines or control its entire journey, D365 F&O makes it possible.

    This solution enables manufacturers to freeze or partially dispatch specific lots before they’re sold. This plays a crucial role when it comes to managing recalls, especially important when you’re dealing with expired or defective lots.

    The job is done by clicking on the Items and selecting the Sales Blocked options.

  • Complete control of the track and trace items The real-time lot control and traceability abilities of Microsoft D365 Finance and Operations enable manufacturers to find out where a tracked item is used and how. This makes it easy to follow the present instances of a specific lot/batch.

    Regarding quality control, these features are significant as they help you understand which customer received which item. In case of defective product delivery, immediate actions can be taken to minimize damages.

Final thoughts

Regarding the pharmaceutical industry, we know accurate items and batch-level tracking will soon be a requirement – not just a nice to have. With advanced lot control and traceability capabilities, Microsoft D365 F&O is here to make everything more accessible than ever.

With that in mind, the effective implementation of solutions like D365 F&O will deliver the promised outcomes. The task is often a massive challenge as it is a comprehensive tool with multiple modules and features.

A seasoned Dynamics expert that understands your industry is the best way to keep the hassles to a minimum while extracting the maximum potential of a system like Microsoft Dynamics.

For more information or to find out how we can help, schedule a call today.

The Importance of Supply Chain Visibility for Pharmaceutical Companies
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The Importance of Supply Chain Visibility for Pharmaceutical Companies
The Importance of Supply Chain Visibility for Pharmaceutical Companies 1449 1036 Xcelpros Team

Introduction

Today, many businesses rely on the supply chain to fill their shelves with products ready to sell, and pharmaceutical companies are no exception. To provide the fastest response time possible, pharmaceutical companies must have full visibility of the products in their supply chain, from when they are manufactured until they reach the store shelf. This can be a challenge, especially as many products come from outside sources and other countries. How can supply chain visibility help your business? Read on to find out!

The Modern Supply Chain

The supply chain has become more complicated and sophisticated with pharmaceuticals being regulated. Using an efficient, reliable supply chain directly impacts customer satisfaction, cost containment, and competitive differentiation. This is because customers want consistent quality drugs that work every time they are administered to patients. Pharmacists want to give their customers the cheapest possible medication while meeting their needs.

Pharmaceutical supply chains have changed in recent times to make this happen. For example, products go through various manufacturing phases, including research and development, before becoming end products. There are also numerous checkpoints along the way that include inspections by regulators.

Manufacturers need an accurate grasp of current production costs to accurately predict new drug pricing and minimize any additional expenses associated with these phases. The supply chain needs to be flexible enough to accommodate sudden changes in demand, raw material prices, and regulatory requirements. They also need to monitor operational metrics such as fill and inventory turnover rates so that all stakeholders know what is going on.

3 of the key features that define the modern supply chain are proximity, visibility, and sustainability.

  1. 1.Proximity – Proximity means cutting out middlemen who add cost and complexity to transactions.
  2. 2.Visibility – Visibility means being able to know where every product is at any given time.
  3. 3.Sustainability – Sustainability means paying attention not only to the natural environment but also how our supply chains interact with other industries (e.g., manufacturing) as well as social issues (e.g., food security).

One of the most important aspects of a modern pharmaceutical supply chain is visibility. If it was difficult or impossible to see where products were and how fast they were moving, there would be too much room for error. That is why good tracking systems are necessary for companies in this industry. One common solution includes scanning barcodes to keep track of items, but there are other ways as well depending on each company’s needs. Some solutions allow for locating materials anywhere in a warehouse using a radio frequency identification system (RFID). An RFID reader sends out radio waves from its antennae which causes tags attached to objects within range to reflect certain frequencies, causing them to stand out against other objects not tagged with an RFID tag.

Benefits of Supply Chain Visibility

Pharmaceutical organizations have found that supply chain visibility provides several important benefits, including greater data accuracy, lower inventory costs, reduced compliance risk, and increased business agility. With the help of insights from better visibility, they can identify potential problems before they happen. With this information, pharmaceutical industries can proactively solve problems before they cause severe damage to their organization. It has even been shown that well-managed supply chains lead to higher customer satisfaction scores and product reliability.

Increasing supply chain visibility offers a wide range of benefits for organizations today, including:

  • Increased data accuracy.
  • Improved process efficiency.
  • Lower inventory costs.
  • Reduced risks associated with compliance.
  • Enhanced agility to meet the needs of changing markets quickly.

That last point may be especially critical for pharmaceutical companies given the fact they stand to incur substantial penalties if violations occur during the supply chain process. All these factors make visibility an essential component not only to reducing risks but also to success overall.

With so many benefits, improving supply chain visibility should be a top priority for any company, regardless of its size or industry. The initial investment in implementing these changes will pay off handsomely in terms of financial benefits, brand protection, and positive impacts on both customers and employees.

Improving Visibility

Companies that maintain a high level of visibility throughout their supply chain will benefit from increased safety, lower risk of errors, reduced cost, and improved customer satisfaction.

In today’s digital world, there are many ways to implement visibility measures into your business practices. This can be done through computerized systems that track inventory and orders, barcodes, radio frequency identification (RFID) tags on products, or other innovative modern technologies. These systems can not only keep you informed on the location of your products but also allow you to detect theft, tampering, or defects in packaging before they get shipped out.

A proactive approach such as this is necessary to reduce the risk of having issues with faulty goods or health and safety hazards that could affect customers. It is crucial for businesses in the pharmaceutical industry where an error may result in death, injury, or permanent disability because it is important to ensure every step has been taken to provide quality assurance along the way.

Figure 1:Steps to be taken to ensure quality in the supply chain

Steps to be taken to ensure quality in the supply chain

  1. 1.Identify customer supply chain activities – Track customer shipments as soon as they are picked up and shipped in real time. Always have visibility on what has been delivered, where it is currently located, and any delays.
  2. 2.Utilize location-based technologies – Utilize the latest in GPS technology to monitor transportation so you can track deliveries from start to finish with ease. This will give you full control of your supply chain and alert you to any discrepancies immediately instead of having to search through multiple records manually later.
  3. 3.Use big data analytics tools – Leverage automated tools that provide a complete view of all activity across every part of your supply chain.
  4. 4.Share accountability with everyone involved – Make sure that everyone who handles or touches the product throughout its life cycle knows their responsibility at every step and is held accountable if there’s a problem somewhere along the way.
  5. 5.Understand global dynamics – Achieving visibility means understanding what is happening locally and globally and how international events may affect local ones (and vice versa).
  6. 6.Keep customers informed – Be transparent about what is happening throughout the entire process by keeping customers informed about shipping schedules and any issues that arise during shipment.

Finding the Right Solution

One of the biggest challenges in managing supply chain visibility is coordinating all parties involved. Creating and executing a plan can often be complicated with multiple stakeholders, especially when crossing borders or distributing products from different geographic locations.

Various software solutions and cloud-based platforms are available to help with these challenges, but companies must choose the right technology for their needs.

The following benefits should be considered before choosing a solution:

  1. 1.A single solution that integrates data across the entire supply chain.
  2. 2.An accurate view of each vendor’s location and inventory levels.
  3. 3.Work seamlessly with one another regardless of location or platform.

When considering which solution is best for you, it is important to evaluate your company’s goals and make sure that your decision will support them.

Your business may have specific needs related to planning and forecasting, inventory management, asset tracking or other capabilities. By determining what you want to achieve through supply chain visibility, you will be better equipped to decide about which product or service fits your company’s unique situation best. In some cases, implementing an ERP (Enterprise Resource Planning) system is ideal for connecting diverse systems, tracking assets on a global scale, and organizing all activities from sales orders to invoices.

Microsoft Dynamics 365, through its a combination of big data and analytics that are continuously updated, can provide valuable insights to help pharmaceutical companies achieve more supply chain visibility by assisting with inventory tracking, forecasting, customer insights and trade spend. By having these features readily available, a business can get the real-time visibility they need to gain insight into market fluctuations and improve their order fulfillment rate.

Microsoft Dynamics 365 offers benefits in automating complex processes such as invoicing, accounting, and sales analysis.

Some of the software’s inventory management capabilities make it an efficient way to manage many aspects of supply chain visibility. It is also good for tracking inventory distribution across multiple warehouses or stores in order to gain greater supply chain visibility. Plus, Microsoft Dynamics 365 offers deep insights into customer behavior which helps track competitive offerings and measure performance success by channel. Finally, Dynamic’s manufacturing features provide details critical to maintaining safe working conditions while reducing manufacturing costs.

In addition to providing information on order fulfillment rates and logistics processes, this type of system also improves control over manufacturing process timescales and provides alerts if any disruptions occur in any part of the system.

What’s Next?

The next step for most companies should be meeting with your partner to discuss supply chain visibility. At this point, an organized and ongoing audit process must be in place so you know what needs improving and where to go next. Once a plan has been created, it should be revisited at least once a year or when processes change, or the latest information becomes available.

A third party can play a role in this continuous improvement by bringing impartiality and objectivity. Continuous improvement will keep your company ahead of evolving regulations such as GDPR (General Data Protection Regulation), which means maintaining compliance and staying ahead of potential requirements by gaining valuable insights through accurate supply chain visibility.

Better supply chain visibility will also help you identify trends that lead to additional revenue opportunities, such as inventory obsolescence or potential overproduction. For example, if your sales team told you about reduced demand for certain products and gave feedback on how to address the problem, these insights could come from supply chain visibility. Ultimately, working with the right partner to achieve greater supply chain visibility will enable your company to thrive despite external pressures or changes to industry standards. Contact us today for more information to see how we can help your business grow.

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Pharmaceutical Analytics and Business Intelligence using Power BI
Pharmaceutical Analytics and Business Intelligence using Power BI 700 500 Xcelpros Team

Introduction

Modern pharmaceutical companies are undergoing a significant transformation with new opportunities from digitization, big data, and analytics. In response to COVID-19, businesses are seeing an increased need for an agile enterprise Business Intelligence (BI) architecture to leverage these opportunities in order to grow. Successful Pharmaceutical companies are looking beyond standard operational and statutory reports to implement more powerful Analytics and AI-driven solutions. These new solutions provide actionable insights and useful KPIs to help make better decisions. This leads to more empowered teams and new engagement that drives additional revenue.

Pharmaceutical companies generate massive information every day through their day to day operations. But the data is not always being put to the right use. Some companies tend to look at reports with a traditional eye that doesn’t drive a ‘call to action’ to grow the business.

The strength of any analytics software lies in its ability to help users easily create quick insights, especially for an agile business like pharmaceutical manufacturing. Creating reports in days instead of months frees up hundreds of hours in unnecessary spend to gather these hidden insights. This allows business leaders to repurpose cost savings towards other operational improvements and growth.

There is a right and wrong way of reporting – one provides overwhelming numbers, while the other means to understand those numbers and make them actionable.

As the pharmaceutical industry continues to undergo significant adjustments to new opportunities presented by digitization, big data, and analytics, more enterprises continue to see the need for an agile enterprise Business Intelligence (BI) architecture to leverage these opportunities & seamlessly deliver business-critical insights to executives.

The Strength of PowerBI

Power BI, Microsoft’s business analytics solution, lets you visualize your data and make it accessible to your Organization. Insights can be easily shared through various platforms of your Organization by embedding them in your app, portals, or website, collaborating on Teams, and integrating them into your ERP or CRM applications. Microsoft’s Power BI makes it easy to combine these numbers from different sources, streamline analytics onto a single dashboard, act on newfound insights, and enhance visibility to other teams in your organization.

Leveraging PowerBI interactive reports in a few quick and easy steps

  • Onboard
    • Access PowerBI either from powerbi.com or any of the Microsoft ERP/ CRM applications.
    • Connect to your data wherever it lives.
    • Explore your data with interactive visuals.
  • Collaborate & Share
    • Publish reports and dashboards.
    • Collaborate with your team.
    • Share insights inside and outside of your Organization.
  • Access insights from anywhere
    • Act with seamless access to data insights from your desk or home.
    • Access on the go with Power BI visual reports built rapidly.

Book a demo to learn how Power BI can boost your pharmaceutical analytics.

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Turning Industry Data into Smart Decisions

Leading Pharmaceutical companies who are transforming into agile organizations need 360-degree insights for business-critical functions such as manufacturing execution, sales productivity, financial management, purchasing raw materials from approved suppliers, quality assurance & quality control.

Today’s pharmaceutical organizations collaborate, monitor, and communicate on available live data to achieve operational excellence. Pharmaceutical business intelligence enables these organizations to monitor real-time data from multiple sources and combine them into one pharmaceutical dashboard with the ability to drill-down into the report to identify issues, as necessary.

Figure 1: Pharmaceutical Analysis using Power BI

Pharmaceutical Analysis using Power BI

Usage in the Pharmaceutical Industry

01.Interactive Reports

Power BI is an analytics software that brings to the table a strong background in delivering end-to-end BI analytics to modern Pharmaceutical companies such as

  • Efficiency Reports On Lot Production
  • Trending And Analysis Of Quality Control Data
  • Recommendations Based Clinical Trial Reporting
  • And Financials Per Batch Produced For Each Product
  • Product Go to market assessments (how much spend and types of activity is involved, expected and actual results)

02. KPI Reporting

Accurate decision making occurs when reporting provides clarity on both good and bad data points on prime KPIs. With business analytics in the pharmaceutical industry, companies can acquire intelligence in real time and can track key performance indicators like:

  • Machine utilization
  • Process efficiency
  • Cost of Sales
  • Inventory levels
  • Batch Losses and cycle times
  • Quality standards of a product line
  • Customer engagement and customer experience

03.Real-Time Analytics

One of the essential requirements for agile Pharmaceutical companies is to have real-time analytics of overall operations, and to be able to make quick corrections and proactively handle situations before they turn into risks. Especially for manufacturing execution and pharmaceutical inventory management, knowing the work is progressing and inventory is turning around helps production supervisors to manage batch production processes much faster and make on the fly corrections. This real-time reporting on screens throughout a production plant gives needed visibility to both the managers and operators who can be alerted and fully aware of any issues.

Figure 2:Real-Time Data Tracking with Power BI

Real-Time Data Tracking with Power BI

Benefits of PowerBI enabling business improvements

  1. 1. This information gives the ability to make changes to processes based on how well resources are functioning to increase productivity, and how each product lot produced is performing in the market.
  2. 2. Getting real-time alerts with Power BI mobile apps makes your operations more efficient, allowing you to achieve a higher level of organizational agility and minimize response times.
  3. 3. Power BI enables monitoring of your supply chain end-to-end, letting you identify problems and potential bottlenecks before they can affect critical processes.
  4. 4. Monitoring quality inputs and outputs from all sources, including your customers, allows you to make quick and meaningful decisions that will improve the quality of batches that are manufactured.
  5. 5. The ability to share your dashboards with suppliers and partners is a plus and accommodates adjustments to the latest information available to work towards making your processes leaner and smarter.
  6. 6. Microsoft’s Power BI is a full-featured BI solution that offers a number of benefits to many different organizations on their path to success such as –
    • Global Scale – Local Speed
    • Agile Business Processes
    • Predictive Analytics
    • Machine-to-Machine
    • Employee Onboarding

Basic analytics used by the Pharmaceutical Industry

  • Products & Inventory
    • Full Track & Trace Functionality
    • Enhanced Global Marketability
    • Customer Requirements
    • Product Quality
    • Product Recalls
  • Sales
    • Quotes & Order analysis
    • Pricing and Cost reporting
    • Available-to-Promise reporting
    • Order Profitability
  • Supply Chain Management
    • Match demand and supply
    • Improved Supply Chain Responsiveness
    • Updated and efficient Logistic analysis
  • Financial
    • Product Profitability reports
    • Batch costs
    • A full audit of transactions
  • Manufacturing
    • Safety and sustainability analysis
    • Realtime production data reports
    • Equipment failure predictions
    • Production rescheduling

Final Thoughts

A big step towards change today comes from enhancing visibility across all operations including manufacturing execution, sales force productivity, procurement, and financials. Power BI brings to the table a strong background in end-to-end BI services for modern pharmaceutical companies – covering BI strategy, managed services, implementation & support, and even more. From the moment you start considering a BI solution for your growing Pharmaceutical company, the benefits of Microsoft’s Power BI become evident very quickly. Microsoft’s Power BI will continue to be a must-have product for leading Pharmaceutical companies by delivering a 360-degree insight of operations.

References: Advantages of Using Power Bi

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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.

Challenges in Pharmaceutical Supply Chain due to Covid-19
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Pharmaceutical Supply Chain Challenges due to Covid-19
Pharmaceutical Supply Chain Challenges due to Covid-19 700 500 Xcelpros Team

Introduction

Even while the United States and much of the world continues to vaccinate and protect its citizens from COVID-19, new variants of the disease continue to pop up around the world. Since its arrival, not only have millions of lives been lost and affected, problems caused by the disease continue to wreak havoc on the pharmaceutical supply chain.

As of May 2021, Google states nearly 3.4 million dead in 220 countries and territories worldwide, including over 587,000 in the US alone

Some of the more prominent short-term effects cited in a July, 2020 article on Springer include

  • Demand changes leading to shortages caused by panic-buying oral home-care medications
  • Supply shortages of active pharmaceutical ingredients (APIs) and finished products, especially those coming from China and India
  • Shifting communications and promotions to telecommunication and tele-health, resulting in a 70 – 80 percent drop in visits to physician offices and clinics
  • Change in the focus of research and development programs to dealing with COVID-19

More Long-lasting effects include:

  • Delayed approvals for non COVID-related pharmaceutical products, partially caused by the closure or semi-closure of regulatory agencies
  • Self-sufficiency and lower demand for APIs and finished products made in China and India caused by delays in manufacturing and disruption to shipping and logistics
  • Organization growth impacted by economic slow-downs around the globe
  • Ethical issues from poorly researched clinical therapies and products
  • Drastic change in consumer use of cleaning and health products

By the Numbers

  • 2x increase in investigational treatments in the U.S.
  • 100% – 700% increase in the use of medicines to treat COVID-19 in U.S. hospitals (January-July 2020)
  • Upwards of 24 million excess prescriptions have been written in the U.S. alone, for things like hypertension, mental health issues, respiratory problems, diabetes, and anxiety.
  • 156 clinical trials for COVID-19 in the Middle East and 140 in the EU
  • 70%-80% reduction in patient visits to doctors’ offices in the EU
  • 23% of patient interactions in the EU are now being done online

Source: Springer.com

Supply Chain Effects

A recent report by Deloitte about the impact of COVID on the pharmaceutical industry includes a look at Supply Chain Management. The report cites a number of key risks to be aware of in different functional areas, including the following

Procurement

  • Quality checks of received materials. Mitigation measures include increasing warehouse space for quarantining shipments from China.
  • Shortages of raw materials, APIs and solvents due to dependency, inadequate materials to complete BOMS/batch size processing. Prevented by boosting stocks of critical inventory, evaluating alternate sourcing of impacted materials and using government support policies when looking at investments in production plants.
  • Shutdowns of vendor plants. Solved only by identifying shutdowns from remote (i.e., Asian) sources and pressure testing supply chains for various scenarios.

Planning

  • Expiration of materials and monitoring for reassessments and quality certificates where the solution is submitting studies to the FDA with the longest agreeable expiration date.
  • Shutdowns from contract manufacturers, requiring sufficient communication regarding their ability to deliver products.
  • Additional quality control checks for contamination issues. This can be mitigated by having quality control personnel on-site and thorough sanitizing of all in-bound products, employees and equipment.
  • Contamination after final packaging. Requiring the disinfecting of shipments before delivery, possibly with photographic proof.

Transportation and logistics

  • Non-availability of local transportation to move raw materials and finished goods. Can be solved by locating alternate partners and getting approval to move essential drugs should a lockdown occur.
  • Contamination issues related to transportation or vehicles. Requires the disinfecting of all vehicles, plans for properly storing temperature-sensitive products in assigned warehouse space.

Export

  • Contractual compliance. This can be mitigated by ensuring the person collecting the order is aware of any regulatory restrictions.
  • Contractual terms with domestic and export customers. Preventing this requires seeking advice from insurance brokers and engaging early with clients to determine what could work if supply chain or personnel issues occur.

Figure: 1Pharmaceutical Supply Chain Areas Affected by Covid-19

Supply Chain Effects

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Lasting Effects

The effects from COVID have caused businesses to do whatever necessary to stay competitive, such as the repurposing of disposable components from single use systems to use in COVID-specific programs at the expense of other critical efforts. This is just one of the continuing effects on the supply chain cited by Contract Pharma in a recent COVID-19 Impact Report, as well as the following pointed out by other executives in the industry.

  • Kay Schmidt of Catalent said finding vaccines and target therapies for Covid-19 has boosted demand for their services. The increased demand, “has led to greater collaboration and innovation between partners, regulators and throughout supply chains to meet key milestones”. This boost to business requires additional planning and communication to ensure resource allocation for multiple programs.
  • James Rogers of Sterling said, “The impact of the global pandemic has exposed the fragility of the pharmaceutical supply chain.” He predicts that supply chain resilience and reliability will be given the same importance as price when developing future supply strategies.
  • Danita Broyles of U.S. Pharmacopeia is quoted by Contract Pharma as saying, “the decrease in on-site inspections has the potential to increase quality risks to the global supply chain,” adding pressure to manufacturers and suppliers to ensure the quality of their products.
  • Ben Wylie of ChargePoint Technology said that, “many governments are now pushing the industry to rethink its model to safeguard drug production.” He cited a program in India to reduce reliance on China for critical drugs and APIs.

Final Thoughts: The Impact of COVID-19 on Regulatory Practices

COVID-19 will continue to have an ongoing impact on regulations in the areas of clinical study trial design, clinical trial study development and post-clinical trial regulatory submissions, Dr. Ronan Brown of IQVIA wrote in an article on European Pharmaceutical Review.

Among the changes forced on drug manufacturers includes a more decentralized approach to collecting patient information and rapid access to regulators, Dr. Brown said. This includes pre-investigational new drug meetings with the FDA now granted in less than 30 days. The FDA has also taken steps to accelerate the review and start of new studies.

Flagging potential obstacles and safety concerns during these early meetings lets pharmaceutical companies move faster into human trials, he explained.

Decentralized clinical trials, which he expects will ultimately cost about the same as the traditional versions, will offer greater diversity in terms of patient cohorts along with increased mobility and convenience.

ERP in developing the operational efficiencies in Pharma
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Impact of ERP Software in Boosting Operational Efficiencies for Pharma
Impact of ERP Software in Boosting Operational Efficiencies for Pharma 700 500 Xcelpros Team

Introduction

Increased efficiency is an ongoing goal for any organization looking to stay ahead in today’s market, especially those in the Pharmaceutical industry. There’s often a lot of focus placed on things like increasing productivity, lowering operating costs, enhancing operational efficiency and improving product-based profitability, to name a few.

On top of that, pharmaceutical organizations need to devote a considerable amount of time towards operational planning, drug commercialization, go-to-market strategy and more.

While today’s best-in-class companies conduct these operations using automated tools, smaller pharma and biotech companies end up handling these operations with manual processes. Especially for these companies, a modern Enterprise Resource Planning(ERP) system that can handle end-to-end business processes and be used to collect, track, manage, and distribute critical information across all departments is invaluable.

A few high-level benefits of a modern ERP System include the ability to

  • Standardize business processes and enable automation across different departments.
  • Monitor business processes across departments to accelerate operations.
  • Allow visibility and transparency by data sharing.
  • Establish strong collaboration across multiple departments.
  • Provide a multitude of flexibility and customization options to meet specific business requirements.

Modern ERP systems

Today’s ERP systems have evolved into powerful, agile platforms designed to integrate core and incremental business functions into one unified system. These modern ERP applications automate the flow of real-time information across departments, allowing easier collaboration and actionable insights to help drive important business decisions.

Based on experience, here are some of the differences seen in higher-end ERPs.

ERP SYSTEM ORACLE SAP MICROSOFT
ATTRIBUTE      
COLLABORATION MEDIUM MEDIUM HIGH
LOW CODE INTEGRATION MEDIUM MEDIUM HIGH
USER ADOPTION MEDIUM LOW HIGH
UPGRADE COSTS HIGH HIGH LOW-MEDIUM
CHANGE MANAGEMENT MEDIUM MEDIUM MEDIUM
ENHANCEMENT COSTS MEDIUM HIGH MEDIUM
EASE OF INTEGRATION LOW LOW MEDIUM
SCALABILITY TO BUSINESS GROWTH HIGH HIGH HIGH

Different Types of ERP Deployment

01. Cloud

A cloud-based solution delivered over the internet using Software as a Service (SaaS).

Benefits

  • No upfront cost for hardware and software
  • Remote access to critical business applications
  • The cloud vendor manages costs related to updating and upgrading.
  • Datacenter takes care of IT support services.
  • The company server is secured against the threat as the data is stored in the cloud.
  • Cloud services are scalable and can be consumed as per the requirement of the business.

02. On-Premise

The ERP system is installed locally in the client environment, and data is stored on internal servers.

Benefits

  • More customization options are available and with greater ability.
  • The organization holds control over the implementation process.
  • Data security control remains in the hands of the organization.

03. Hybrid

Splitting ERP functions between on-premise systems and the cloud server to receive the best outputs.

Benefits

  • Increased flexibility allows loose coupling among modules.
  • An intermediate cost between cloud and on-premise solutions.
  • Lesser training expenditure involved compared to cloud ERP.

93%

percent of organizations apply cloud-based software or system architecture. Also, the application of hybrid cloud systems has escalated from 19% to 57% in 2017, a three times rise in a year.

Source: Mcafee

The role of ERP in the Pharmaceutical industry

At present, the pharmaceutical industry faces numerous business challenges including

  • Major healthcare reforms
  • Rigorous regulatory requirements
  • Incalculable market trends
  • A discerning and demanding customer base
  • Increasing global competition
  • Lower drug prices demanded by consumers

The growing consumer demand for superior-quality healthcare products at compelling costs and the competitive market makes it essential for pharmaceutical companies to streamline operations, reduce cost, and maximize efficiency.

From planning and purchasing to things like inventory, supply chain management, sales, marketing, and human resources, a modern ERP technology solution can enhance operational transparency with better collaboration across all departments.

Why do companies choose ERP?

When current systems become the reason for slowed business growth most companies start looking for other options. Some companies just want to positively change the way they function and switching to an agile ERP system can help trigger a major change.

Some additional reasons a company may choose to implement an ERP solution include

  • Improving business performance
  • Making employee jobs easier
  • Satisfying regulatory compliance
  • Improving system integration

Reasons for Budget Overrun

One of the big detractors of new ERP implementations is budget, as it can be easy to underestimate the complexity involved. There are numerous reasons for a budget overrun during an ERP implementation, including

23%of budget overruns take place due to unexpected technical issues.

22% for the additional technical necessity

20%for increased scope

17% for underrated project staffing

The benefit of ERP for Pharma companies

In an industry that is so highly regulated, implementing an ERP can help streamline your organization’s ability to operate efficiently. Below are a few major benefits that pharma companies can gain from a modern ERP

  • Streamline production floor processes leading to a higher production rate
  • Manage sales & purchases in a few simple steps
  • Closely monitor and control inventory, including raw materials
  • Minimize operational work by sending real-time data alerts across departments
  • Increase operational performance accuracy
  • Ability to perform WIP and yield quality testing for an item or group of items
  • Save time and operational expense
  • Limit material wastage with pre-expiry alerts
  • Help maintain and manage compliance
  • Track the distribution of manufactured goods
  • Enhanced customer support
  • Maintain records of all business transactions through extensive reporting
  • Allow remote access to data to help make better business decisions 24/7
  • Handle all payments including customers and vendors

Challenges implementing an ERP in the Pharmaceutical Industry

Despite widespread ERP usage, there are still companies that face difficulty moving to a modern solution. Can the same ERP implementation strategy and formula work for every business? Unfortunately not, as each organization follows a distinct process, and has unique needs and expectations.

Here are a few challenges that companies usually encounter:

  • Selecting the ERP software that best meets their companies requirements
  • Attempting to complete the implementation in one step leading to numerous unforeseen problems
  • Crossing the budget limit because of project schedule overruns due to poor planning
  • Encountering compatibility issues with different ERP modules

Don’t forget

Finally, here are some things to consider when you begin the task of finding the right solution

  1. 1.Conduct in-depth research before selecting any ERP software. It’s wise not to make a decision based on a high-level feature list alone. Rather, go by detailed research that includes an understanding of the entire project.
  2. 2.Analyze your specific business requirements. Before choosing any ERP application, define a clear vision of what you plan to achieve from the ERP Solution.
  3. 3.Work with a partner that provides a free assessment. This process gives you the ability to break down the project into easy to manage pieces.
  4. 4.Evaluate the Return on Investment (ROI). The initial investment cost in an ERP solution may seem high, but the long-term benefits more than outweigh the initial cost. Understand from what specific solutions you need, and you can more accurately determine cost.
  5. 5.Ensure appropriate personnel training. Your team needs to hold a clear overview of how to use the ERP application. Initiating a mandatory training program for all users should help solve any such issues that may arise.

Key Takeaways

The right ERP solution, along with proper planning can improve your business processes and catapult your business to the top of it’s game.

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