PHARMACEUTICAL

How Pharmaceutical Companies Get New Products to Market during Covid-19

How Pharmaceutical Companies Get New Products to Market during Covid-19 700 500 Xcelpros Team

Introduction

As the world continues to deal with one of the deadliest pandemics in modern history, governments are working overtime to protect their citizens from the deadly disease known as Covid-19.

With the potential impact of Covid-19 on pharmaceutical sales estimated to be huge, two types of drugs are being sought after:

  • Vaccines to keep humans from catching the disease
  • Therapies to treat people with the disease and help them recover

At the end of 2020, the U.S. Food and Drug Administration (FDA) modified its approval process for vaccines, issuing an emergency use authorization (EUA) to Pfizer-BioNTech for a vaccine to prevent coronavirus disease 2019 (COVID-19). The initial EUA applied to vaccines for people 16 and older. It was further modified on May 10, 2021 to include adolescents ages 12-15. The EUA lets the vaccine be distributed in the US. Similar documents were issued to Moderna, Inc. and Johnson & Johnson / Janssen. On July 9, 2021, Pfizer said it would seek approval for a booster shot to target the newer variants of the disease. The FDA and other regulators have, at this time, disagreed with the need for it. This could result in Pfizer share price climbing by as much as 66% in 2021, as suggested by analysts from investors.com

Companies might want to rethink their pharmaceutical product launch strategies. This change in the FDA approval process may require changes in pharmaceutical new product launch plans, prioritizing Covid-19 treatments over other medicines. These plans affect not only products sold in the U.S. but also in the Indian pharma market with its 1.4 billion residents (four times that of the U.S.).

Using enterprise resource planning (ERP) software can help pharmaceutical companies gain regulatory approval of their drugs and treatment plans.

By the Numbers

Expected 2021 sales from Covid-19 vaccine makers:

  • $15 billion-$30 billion: Pfizer/BioNTech (share price +1.8% for Pfizer, +156% for BioNTech)
  • $18 billion – $20 billion: Moderna (share price +372%)
  • $10 billion: Johnson & Johnson (share price +7.7%)

Five other companies are also making Covid-19 vaccines but none have been approved by the FDA yet. (Source: The Guardian)

Normal Drug Development Process

The normal pharma go to market strategy requires a clear long-term view since most medications take 10-12 years to go from the laboratory to the medicine cabinet. Full FDA approval requires six months of data plus another six months for review before official approval is given. These additional steps then come at the end of the drug creation journey:

  1. 1.Research and laboratory work begins.
  2. 2.Preclinical research and animal testing looks into the drug’s safety for human beings.
  3. 3.Clinical research begins on humans, typically comparing test results from patients getting the therapy to those receiving a placebo.
  4. 4.The FDA reviews the data and then decides to approve or disallow the medicine.
  5. 5.The FDA monitors the drug for safety once it becomes publicly available.

The Covid-19 vaccines are examples of drugs required to combat a crisis, one that has already killed more than 606,000 U.S. citizens and 4 million people worldwide. They present different pharmaceutical marketing challenges than existing medications.

“An EUA can be given if there are no adequate or approved alternatives,” WKYC of Cleveland, Ohio states. Pharmaceutical manufacturing companies still need to prove the drug is safe by thoroughly testing against thousands of study participants.

“The only difference really between the emergency use and the licensure is that volunteers are observed for a longer period of time to see the duration of protection and if there might be rare adverse events that occurred down the road,” WKYC quotes Dr. William Schaffner of Vanderbilt University as saying.

Figure:

 Normal Drug Development Process

Difference Between EUA and Standard Approval

Drugs with full FDA approval have several major advantages over those with just an EUA, including:

  • The medications stay on the market after the pandemic is no longer an emergency
  • EUA-approved therapies must be pulled from the market
  • Medicines still in the development pipeline may be tested against newer, more drug-resistant, variants
  • The pharmaceutical manufacturer can market directly to consumers
  • After full approval, businesses can require all employees to be vaccinated, WKYC states

The FDA Requires Records

According to the FDA’s Code of Federal Regulations (CFR), Section 312.57

“Recordkeeping and Retention,” a drug sponsor (i.e., manufacturer), “shall maintain adequate records showing the receipt, shipment or other disposition of the investigational drug. These records are required to include, as appropriate, the name of the investigator to whom the drug is shipped and the date, quantity and batch or code mark of each shipment.”

Records must be kept for two years after the marketing application is approved or for two years after shipment and delivery of the drug for investigational use is discontinued and the FDA notified.

Traditional Recordkeeping is Cumbersome

Many pharmaceutical companies still use spreadsheets to keep track of records. However, they often get data from a single source or department. Multiple sources may mean mixed-up or missing records, slowing the approval process.

Typically, companies using older software tend to silo their data. Inventory has its records. Finance has its own. Sales and marketing have theirs.

The problem in terms of regulatory compliance is that none of this information is shared across departments.

Enterprise resource planning software (ERP) such as Microsoft Dynamics 365 Finance and Operations lets pharmaceutical manufacturers gather information from all of these different sources. The data is combined into one unified whole.

Dynamics 365 can then automatically generate labels. It allows companies to track everything from large batches to individual doses, making FDA compliance simple and easy.

Data comes into the ERP network from sources scattered literally all over the globe. Real-time information is available with the click of a mouse or typing a few keystrokes.

Dynamics 365 data is securely stored on Microsoft Cloud servers. It’s available any time, anywhere. Executives can obtain any record in the system quickly and easily, ensuring compliance with FDA regulations. This lets executives provide accurate data to regulators quickly and easily.

Summary

Covid-19’s death toll led the FDA to accelerate its approval process from 10-12 years to a mere matter of months. Moving forward, agile pharma go to market strategies that can adapt to these changing requirements will undoubtedly be more profitable. An effective ERP software solution such as Dynamics 365 helps pharma companies adapt, and be able to quickly provide any required regulatory documents in order to remain compliant.

Get a free consultation on pharmaceutical go to market strategy during challenging times.

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About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

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How ERP Solutions Benefit Pharmaceutical Manufacturers

How ERP Solutions Benefit Pharmaceutical Manufacturers 700 500 Xcelpros Team

Introduction

Speed and accuracy are fundamental for any business, including the pharmaceutical industry. Microsoft Dynamics 365 for Finance and Operations (F&O) offers an intelligent cloud-based solution tailored to meet the pharmaceutical industry’s needs.

With the help of Dynamics F&O, pharma companies can reduce regulatory burdens, introduce automation, boost productivity and build a secure environment focused on achieving high-value work.

Pharmaceutical companies often prepare medicines with diverse formulas. Much of the focus is placed on raw material quantities, yields with constant and variable scrap percentages, and operations within production. Pharmaceutical companies need an enterprise resource planning (ERP) system that monitors functions such as procurement, production and supply chain operations.

Microsoft Dynamics F&O Features for Pharma

Feature Function
Product quality and safety Manage:

  • Multi-stage tests of raw materials
  • Lot expiration, stock aging and re-testing requirements
  • Supplier information such as vendor batch details/ expiration dates on raw material batches
  • Integration of quality management to inspect incoming raw materials
Sales and promotion management Manage:

  • Leads, prospects and customers
  • Delivery orders, sales contracts and export invoices
  • Discounts and price lists, including competitor analysis
Processing and packaging
  • Trace inventory including lots, batches and serial numbers
  • Generate bar code labels for packaging and shipping
  • Integrate with real-time data collection systems like PLC and SCADA
Financial control
  • Provide insights on intercompany purchases and sales
  • Track batch costing for planned vs. actual

1.CRF 21 PART 11 Compliance

Pharmaceutical companies are constantly searching for ERP systems that offer 21 CFR part 11 compliance. This FDA rule requires companies treat electronic records and signatures like paper records and handwritten signatures. Companies keeping any electronic records are required to comply with the regulation.

Pharmaceutical manufacturers require software that’s able to meet changing regulations. Integrated Pharma ERP systems track document revisions. They provide an audit trail of comments stating how members or groups interact with the documents. Effective software also boosts data security and includes intelligent document control.

Pharma manufacturers are using digital documents instead of paper for daily operations. CFR 21 Part 11 requires a legally bound signature to ensure its integrity. Microsoft Dynamics F&O includes this function. ERP software lets company owners relax in terms of digital document authenticity and validity. When an ERP system checks for electronic signatures, it looks for notarization, non-repudiation and integrity.

2.Inventory Management

Pharma companies constantly face inventory management challenges, including temperature control, inaccurate counts, poor warehouse management, imbalances in inventory supply, and even failure to shed excess inventory. A powerful ERP program helps eliminate these common problems.

Tracking expiration dates is another part of inventory management. When done incorrectly this can quickly add up to big costs for pharma companies.

An effective ERP inventory program such as Microsoft Dynamics 365 Supply Chain Management not only tracks inventory shelf-life, it can also track and trace lots, batches and individual products. This solution from Microsoft is also able to verify batch potency, generating notifications to the business owner about their products’ quality.

Dynamics Supply Chain Management also goes well beyond visual inventory counts. Using barcodes or QR codes, employees with handheld scanners or cell phones can use its mobile supply chain management features. These include recording real-time inventory counts during operations. Chief executive officers can verify inventory at any time, including pick and put away or when raw materials are consumed.

Figure: 1ERP for Pharma

ERP for Pharma

Another part of keeping accurate inventories is generating reports, like those dealing with aging. Reports provide a breakdown of inventory quantities and values by various dimensions such as batch, serial number, site, warehouse, location and license plate number. Dynamics Supply Chain Management includes many reporting features.

3.Transparency and Traceability

In the pharmaceutical industry, transparency and traceability is a complex issue. Companies need to keep track of product families, dosages, lot numbers, schedules, strengths, global trade item numbers (GTIN) and National Drug Code numbers. The Supply Chain Management module tracks product code, NDC number, brand strength and dosage.

Pharma firms also need end-to-end lot traceability. This comes in handy for recalls. Dynamics Supply Chain Management can notify all customers who receive the recalled batches without forcing employees to struggle through mountains of paperwork.

4.Quality Control

Quality control in an integrated ERP manages testing on raw materials, intermediates and finished products. Using an ERP to compare data ensures that raw materials meet agreed-upon standards.

For example, an ERP can quickly identify and provide the list of affected or remaining lots, and can even provide supplier details. Every pharma manufacturer wants to know their products are in compliance with FDA requirements to avoid penalties and fines.

5.Shipping

Dynamics 365 Supply Chain Management includes powerful lot and batch tracking functionality. It lets department leads monitor batches from the start to in-process quality control (IPQC). Executives have a program that reports delivery status as soon as items are scanned into the system.

Final Thoughts

Moving forward, the Pharmaceutical industry will continue to face increasingly stringent regulations. Companies seeking to keep up with ever-growing innovations in market trends, changes in the health care sector and rising global competition will need all the help they can get. An enterprise resource planning solution like Microsoft Dynamics 365 helps companies overcome these challenges everyday, while simultaneously reducing costs, streamlining operations and most importantly, helping businesses remain compliant.

Book a free assessment to get started with tailored ERP solutions for pharmaceutical manufacturing.

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About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

Managing Pharmaceutical Discounts, Rebates Chargebacks

Managing Pharmaceutical Discounts, Rebates and Chargebacks

Managing Pharmaceutical Discounts, Rebates and Chargebacks 700 500 Xcelpros Team

Introduction

The way pharmaceutical firms price their drugs and administer rebates and discounts, has put the industry in a potential governmental spotlight.

Key topics likely to be investigated include:

  • How discounts are set
  • How drug makers establish and monitor rebates
  • How pharma firms report their pricing details

Background

Around the world, pharmaceutical manufacturers are under increased pressure from governments and the public to reduce consumer drug prices. In some cases, the amount consumers pay for medicines has skyrocketed. One example cited by Endocrine.org is the cost of an insulin dose rising from $170 in 1987 to more than $1,400.

A 2019 Time magazine article attributes rising consumer drug costs to a complex drug supply chain. Pricing is set by a combination of pharmaceutical manufacturers, pharmacy benefit managers (PBMs) who serve as middlemen, and insurers.

Typically pharmaceutical companies set a non-discounted “list” or base price for each product. Many pharmaceutical companies offer discount coupons and rebates. Depending on a consumer’s health insurance coverage though, some patients may be forced to pay the undiscounted list price for specific medications.

According to Time, manufacturers provide discounts based on the drug and the buyer. Typically these discounts are in the form of rebates negotiated with individual PBMs. The PBM gets paid for its efforts to reduce the amount the manufacturer charges. The final price—which may or may not include any rebates or discounts—is then passed to the insurance companies, who in turn pass the pricing on to consumers.

In addition to negotiating pharma rebates, PBMs also wield power by determining where a particular drug appears on an insurance company’s hierarchy, Time states. These middlemen can make a given drug the most discounted, and therefore most prescribed, medication. They can also exclude it, forcing patients who want or need it to pay more.

Prescription drug price negotiations often happen behind closed doors, leaving patients and physicians out of the discussion despite the impact drug pricing has on the health and treatment of patients,” The American Medical Association (AMA) stated in a 2019 online article on how prescription drug prices are determined.

Raising the price of prescription medicines forces patients with limited funds to skip doses, split pills or abandon treatment, the AMA states. All of these actions, plus growing demands for prescription drug price reforms, are causing the U.S. government to further examine medicine prices.

Figure: 1Percentage of Revenue Spent on R &D

Importance of change management in erp implementation

Governmental Scrutiny

Federal government agencies such as the Department of Health and Human Services (DHHS) are paying extremely close attention to how much consumers actually pay. Agencies want to know if the actual prices reflect the research and development (R&D) and other costs of creating and manufacturing new products. Or are consumer prices a way for an unscrupulous company to use its hot new medication as a way to boost profits and stock prices?

The Biden Administration froze drug price reforms started by the previous administration pending further review. One reason for reviewing these proposals is the fear of higher insurance premiums, an online article by Joshua Cohen in Forbes states.

Cohen suggests that the Biden Administration may require health insurers “disclose current list prices and historical net prices for prescription drugs and provide patients with personalized estimates of cost sharing.

Figure: 2Amount of Revenue Spent on R &D

Amount of Revenue Spent on R &D

Setting Discounts

One way pharma companies can protect their integrity is by using Enterprise Resource Planning (ERP) software such as Microsoft’s Dynamics 365. ERP software allows pharmaceutical manufacturers to set various discounts and rules for each price break. For example, one rule in Dynamics 365 Commerce asks, “is a coupon required to obtain a discount?” A slider lets authorized users select Yes or No. When this feature is active, the discount only appears when a coupon or bar code is provided. This section also has “All discounts” and “Pricing and discounts management” workspaces, letting companies create customized discounts.

ERP software works by creating a series of properties for simple pharmaceutical discounts and quantity price breaks. For example quantity tiers must be reached independently for each line or product.

Microsoft Dynamics 365 Commerce lets companies select between four types of discounts: “Discount,” “Quantity,” “Mix and match” and “Threshold.”

Users also have the option to determine which discounts compete on a transaction. Values are “Exclusive,” “Best price” and “Compound” with “Exclusive” always being calculated first.

Individual products or product variants can be selected along with categories, units of measure and many other variables. Other options include setting up sales lines and invoice discounts.

When there are issues with drug quality, the “Quality management” section establishes rules for pharmaceutical chargebacks.

Managing Rebates

Microsoft’s Dynamics 365 Supply Chain includes a “Rebate management module” with an important feature for pharmaceutical companies. “The setup on this page is shared across all legal entities and can be modified by users who have the appropriate security permissions,” Microsoft states.

This module makes it easy to create contracts, deals and agreements with customers and vendors. It lets firms calculate and keep track of rebates, deductions and royalties. The information is stored in a central location for easy review.

Rebates can be created for customers or vendors. The function also allows inputting notes about a specific deal. For example, a pharmaceutical rebate may be given to one company instead of another. A note can explain the reason like a long-standing business relationship.

Since pharmaceutical rebates appear to be a likely focus of government action, documenting a firm’s rebates makes it easier to show what is taking place.

Reporting

With transparency being a likely focus of governmental action on drug pricing, investigators may ask to see pricing reports. ERP programs like Dynamics 365 have a number of powerful reporting features. A Report Wizard lets users select from a series of previously created reports and update them. Tables and charts can be included.

A big part of Dynamics 365 Supply Chain is tracking the status of each rebate for reporting and inquiry purposes. Reports can be linked to web pages, static files and dynamic Office-based files that read data from a Dynamics 365 database. Reports are filtered using SQL or FetchXML queries depending on the software in use.

Summary

Consumer drug pricing is becoming a hot topic in Washington, D.C. Pharma manufacturers are likely to face increased scrutiny on how they set pricing. ERP programs like Microsoft’s Dynamics 365 let firms set and track rules for discounts and rebates, as well as generate all necessary reports.

Get a free consultation on how to manage pharmaceutical discounts in dynamics 365 supply chain management.

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About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

Strategies to Implement Digital Processes in the Pharmaceutical industry

Strategies to Implement Digital Processes in the Pharmaceutical industry 700 500 Xcelpros Team

ERP software provides a cradle to the grave system of tracing an entire supply chain.

Digitizing the pharmaceutical industry supply chain pays benefits to the companies, executives and employees. How? By allowing companies to be more efficient, resilient and responsive to rapidly changing customer requests and regulatory demands. This digitization allows for:

  • Near real-time tracking of raw materials.
  • Accurate raw materials inventory tracking.
  • Updated details quality control.
  • Batch tracking from production to final delivery.

Companies benefit from greater efficiency and better resource allocation. Better resource allocations means employees can be performing more meaningful work.

Key Advantages

Accountability is one of the key advantages of using enterprise resource planning (ERP) software. When a company inputs data for supply chain topics such as inventories of raw materials, quality control test results, warehouse storage temperatures and government recall notices, it has the company’s core data at its fingertips. Chief financial officers (CFOs) and chief technical officers (CTOs) can track any product from its raw materials source through development, testing, production and distribution.

When a company implements a fully digital solution, it has the ability to track any single item anywhere under company control. This permits more efficient use of raw materials—they go where they are needed now—and accurate planning for the future.

Raw Materials Purchase Order Workflows

Digitization dramatically speeds the ordering and delivery of purchase orders. With the click of a mouse, a company in the U.S. can send a PO to a supplier in India. The supplier can review the request and compare the materials and quantities requested to what is on hand. If the supplier lacks any of the requested items, it can either order it from a different firm or notify the requesting pharmaceutical plant. Either way, the production facility quickly knows what is coming and when.

Enterprise resource software such as Microsoft Dynamics 365 for Finance gathers information from multiple sources. It combines individual data points—a customer’s request for a new shipment, a salesperson’s request to have the order fulfilled, a stock check to determine if sufficient raw materials are on hand, an order to one or more suppliers for the active pharmaceutical ingredients (APIs)—in one place.

The end result is that instead of making numerous phone calls trying to locate everything, a chief financial officer can ask the question, “Can we fill this customer’s order now? If not, when?”.

Figure: 1Raw material purchase order process

Raw material purchase order process

Digitizing Quality Control Testing

Tracking products is important. So is tracking product quality. When the quality control testing process is digitized, CFOs:

  • Have access to standardized recording and reporting processes
  • Can act proactively instead of reactively
  • Have open lines of communication with different departments
  • See when a process is working and can discontinues those that are not

Digitizing these processes lets companies recognize and resolve quality control issues early in the process. They save money by not producing large quantities of inferior products.

It allows firms to recognize problems on the factory floor, saving the time and expense of shipping defective or poor quality materials—such as medicine stored at the wrong temperature—only to then pay for shipping it back.

Through digitization, quality control inspectors increase the speed of their inspections when they upload information into a centralized database.

Digitization also makes it easier for companies to comply with regulatory requirements. Required records and standards are a few keystrokes or mouse clicks away.

Data collected anywhere from cell phones, tablets and hand-held scanners allows workers to input inventory information. This can include creation dates, batch numbers, temperatures and anything required by company standards or to meet regulatory requirements.

Having digital records makes it easy for company quality assurance teams to create certificates of analysis (COAs). “A COA typically contains the actual results obtained from testing performed as part of quality control of an individual batch,” a report by InSource Solutions states.

When connected to an ERP system such as Microsoft Dynamics 365 Supply Chain Management, companies can:

  • Create quality orders based on trigger points
  • Document test results and then determine if they meet established criteria
  • Maintain nonconforming products to track down the original cause
  • Schedule error correction processes
  • Print a COA showing the test results

Figure: 2Quality control analysis from System Dynamics Supply Chain

Quality control analysis from System Dynamics Supply Chain

Batch and Lot Tracking

ERP programs such as Microsoft System Dynamics 365 Supply Chain Management allows companies to create and track specific production quantities.

For example, if an individual batch is created, the ERP program creates a label with a barcode or QR code on it. The label allows scanners to immediately access information such as the creation location, date and other relevant data. After the production batch is created, individual lot numbers are assigned. Serial numbers are then assigned to individual items.

Workers scan each batch and add its warehouse and location details, such as section, row and bin number. When batches are broken into lots, each scan updates the tracking information providing a clear path from the current location to its creation.

Using these codes, warehouse workers can locate any given batch, lot or individual item from the time of creation through storage and transportation until final delivery.

Lot Traceability

The ability to trace production lots is important not just to ensure that every item goes to the correct destination but to ensure when problems occur, they can be addressed quickly.

For example, a batch of Covid-19 vaccines is given an expiration date. New data arrives indicating that the original expiration is incorrect, prompting a safety recall.

Having digital barcodes on each lot and individual product allows pharmaceutical companies to track the batch and every lot from it. Requests to pull specific lot numbers are sent directly to affected customers only. Those receiving unaffected batches are not notified. Impacted customers can then be given instructions on what to do if they encounter a bad batch.

Digital Signatures

The days of requiring a person to manually sign a form acknowledging receipt of a delivery are long gone. The U.S. Electronic Signatures in Global and National Commerce Act (ESIGN) of 2000 ensures that electronic signatures are legal wherever federal laws apply. When federal law is not applicable, most U.S. states follow the Uniform Electronic Transactions Act (UEFA).

Now considered valid in terms of regulatory compliance are electronic signatures, such as using a stylus and tablet when making or receiving a delivery, and digital signatures. Digital signatures do not require a handwritten acknowledgement but are still considered legal, according to Adobe.

One of the benefits of using electronic signatures in the pharmaceutical industry more than paper versions is providing the proof of delivery. This authorization is readily available to authorized executives anywhere in the world within seconds. When questioned about a delivery, the electronic signatures provide proof of receipt.

Summary

Going digital saves companies time, money and unneeded expenses. Information can be organized more efficiently and is available on demand. ERP programs allow for accurate product tracking of raw materials and finished products, along with the added benefit of things like digital signatures and barcode scanning.

For more information on implementing digital processes in your pharmaceutical company, book a free consultation with our team of experts.

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About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

Embracing Digital Technologies to Transform Life Sciences R&D

Embracing Digital Technologies to Transform Life Sciences R&D 700 500 Xcelpros Team

At a Glance

  • Biotech companies are now more dependent on the latest technologies for innovation and pace. Mid-size and larger life sciences companies are looking to invest in tools that offer precision and efficiency in R&D.
  • 2020 brought a spotlight to pharmaceutical and biotechnology R&D as the world sought ways to curb the Covid-19 pandemic. Pharma companies adapted and implemented high-end technologies for faster results.
  • Cost-efficiency is also a major concern for pharma companies’ R&D. Newer tools enhance efficiency while reducing costs.

The year 2020 was unprecedented in many ways. It engulfed the world in an unheard of disease, locking everyone inside and putting a serious strain on the global healthcare system.

The entire world is now hoping for an effective vaccine to slow the spread of the Covid-19 virus. A vaccine or an effective treatment is at the top of every nation’s agenda. This focus puts tremendous pressure on pharmaceutical and biotech companies to fortify and speed their R&D. The ability to produce these products has direct impacts on our lives and businesses.

Even before the coronavirus pandemic, pharma companies were struggling to keep up with the demands for newer drugs, expiring patents, developing innovative formulations, etc. Compared to many other industries, the biotech and pharma sector was slow in terms of updating technology in business operations and labs. Times are changing and bringing R&D along.

The Tufts Center for the Study of Drug Development states the average cost to produce a new medicine is $868 million. -PwC

Updating R&D

Pharma and biotech companies want to make more efficient R&D choices. One goal is to ensure that more molecules from the initial phases become the part of the final product. New tools and tech are helping achieve these goals by:

1.Leveraging Data Analytics for Effective Insight Generation in the Lab: Scientists deal with numerous molecules, formulations and data-points while developing a drug. Manually keeping tab of all these data-points is cumbersome and time-consuming. It can lead to missing crucial data and other human errors, unintentional or not. Using “Big Data” and the latest data analytics tools, pharma companies are enabling their scientists to automatically collect, collate and manage large volumes of data.

2.Digitizing Labs with IoT: Labs become faster and more efficient by connecting every machine, enabling real-time information flow. This method generates quicker insights and results in faster decisions. Using internet of things (IoT) connected devices, the lab lets machines communicate with each other. The system becomes agile and proactive as compared to traditional responsive operations of the past. Digitizing labs helps predict and then eliminate bottlenecks. It removes ineffective molecules and formulations, strengthening the entire R&D workflow.

3.Digital Pathology with Virtual Staining: Virtual staining lets scientists highlight and study non-labeled sections of a single tissue for enhanced microscopic clarity. With the help of artificial intelligence-based tools, scientists can effectively digitize the entire process. These tools help automatically analyze radio images, pathological images and related medical data. Not only does this speed the entire process, it saves time and increases overall accuracy.

4.Creating a Shared Ecosystem between R&D Functions: R&D in pharma includes labs plus pre-clinical and clinical trials. Each function generates data points and massive amounts of information. With the help of digitally-enabled platforms, pharma companies can create a shared ecosystem that collects, classifies and provides centralized access to this data.

Example: Pfizer’s Precision Medicine Analytics Ecosystem provides shared access to information about genomics, formulations, clinical trials and other recorded data. Pfizer’s system allows scientists and researchers to simultaneously study possible outcomes and narrow down the best possible treatments.

Figure: 1Biotechnology R&D: Conventional vs. Digitally-enabled Processes

Biotech R&D: Conventional vs. Digitally-enabled Processes

The Covid-19 pandemic taught the world that leveraging technology for biotech and pharma R&D is not a choice but a necessity. Using the latest digital advancements, pharma companies are making a seemingly impossible feat possible by getting several vaccines approved for emergency use. Developing a vaccine for a novel pathogen in a year is truly a victory for science and technology. It also shows that the biotech and pharma sectors can create many new products by embracing the latest tools and technologies.

Key Takeaways:

  • Pharma/ biotech labs can be simplified and streamlined using newer tools powered by the latest technologies.
  • Pharma companies need to look into technologies to enhance efficiency and manage the financial aspects of R&D.
  • Adapting and implementing the latest technologies requires major changes and investments. In the long term, these investments will pay for themselves.
  • Digital trends are making R&D faster and more efficient, helping scientists narrow treatments and speeding clinical trials.

For more information on implementing digital technologies in your life sciences R&D, book a free consultation with our expert.

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About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

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Trends Influencing the Future of Pharmaceutical Supply Chain Management

Trends Influencing the Future of Pharmaceutical Supply Chain Management 700 500 Xcelpros Team

Introduction

Pharmaceutical supply chains continue to evolve even as the worldwide Covid-19 pandemic shows signs of improvement in some countries (the U.S.) and worsening in others (India). Key trends include:

  • Geographically diverse suppliers
  • Sustainable sources of raw and packaging materials
  • Increasing use of computer technology to help manage companies

How chief financial officers (CFOs) and chief operating officers (COOs) of pharmaceutical companies respond to growing demands while facing labor shortages in areas hard hit by the pandemic largely depends on their ability to obtain raw materials and then manufacture and ship finished products.

Reports in SupplyChain Brain, EazyStock and Manufacturing.Net state that supply chain management trends likely to influence the pharmaceutical supply chains near term include increased use of:

  • Diverse (i.e., multiple) suppliers for improved resilience
  • Sustainable supply chain sources
  • Enterprise Resource Planning (ERP) and pharmaceutical warehouse management software (WMS) to improve management of the overall business, including the supply chain
  • Artificial intelligence (AI) to boost productivity and decrease errors
  • Cloud-based technology to permit scaling small and medium businesses as they grow using mutable
  • Industrial Internet of Things (IIoT) to track products ranging from individual batches to complete orders
  • Robots and other forms of automation to perform labor-intensive tasks
  • Flexible supply and delivery sources permitting personalized shipments
  • Layering technologies to eliminate data silos and create actionable data across technology platforms
  • Blockchain to improve transparency in data sharing using immutable databases Smart contracts that automatically execute when a set of conditions is met

Geographically Diverse Suppliers and the PSC

Having a geographically diverse source of raw materials such as active pharmaceutical ingredients (APIs) becomes important in a world proven so susceptible to pandemics. Companies whose primary suppliers are in India (currently suffering an uptick in coronavirus cases), for example, may find their suppliers are short-handed and unable to fulfill orders. CRB Group states supply chain challenges from rare events also include:

  • Transportation issues and disruptions
  • Adding counterfeit material into the supply chain
  • Site closures
  • Lack of coordination and traceability causing inventory build-ups or shortages

According to GoMarketWise, having a diverse supply chain also provides:

  • Access to innovation outside your organization
  • Flexibility to respond when market conditions change
  • Competitive pricing at local levels
  • Specialization many small to medium businesses (SMBs)

Sustainability in the Pharma Supply Chain

Many organizations across all business sectors are looking at climate-smart supply chain planning because of the effect of climate change on the availability of resources and materials, a report in All Things Supply Chain cites a Harvard Business Review study claiming companies advocating for sustainability grow 5.6 times faster than brands that don’t.

One area impacted by sustainability is product packaging. A study by Pelican BioThermal quoted in The LoadStar states that 48% of respondents claim to be looking for packaging that is recyclable or can easily enter the waste stream. Larry St. Onge, president of DHL’s global sector, life sciences and healthcare is quoted as saying his customers’ packaging would become a strategic priority in the near future. “This is of utmost priority because 25% of the global 8.3 billion tons of plastic produced originates from packaging and more than 90 countries have imposed bans on single-use plastic.”

“A more sustainable pharmaceutical supply chain (PSC) should be implemented to match future operations and management of the pharmaceutical products across the entire life cycle,” a look at Pharma Industry 4.0 on ScienceDirect states.

Further restricting the adoption of sustainable processes in the PSC are high costs and time consumption, enforcement of regulations, a lack of business incentives, lack of objective benchmarks, poor end-customer awareness and other issues.

Increasing Use of ERP and WMS in Pharma

Pharmaceutical companies are increasing their use of enterprise resource planning (ERP) and warehouse management software (WMS) from companies like Microsoft to improve management of the overall business, including the supply chain. Software add-ons automate many previously manual tasks, such as inventory optimization and shipping solutions, EazyStock states.

A report by Grand View Research states the market size for WMS programs is expected to grow from $3 billion in 2021 to $8.1 billion with a compound annual growth rate (CAGR) of 15.3% from 2021-2028 with a CAGR of more than 17% in WMS software alone. The WMS market was $348.6 million in 2016.

Grand View Research cites healthcare as one of the biggest growth sectors as companies seek to increase product output and meet rising customer demand. “A WMS helps reduce lead time, increase product delivery speed and minimize distribution costs,” Grand View states.

Much of the increased demand for pharmaceutical WMS software is expected to come from small- and mid-sized businesses using it on a cloud-based computing system. WMS software, “is widely used as a tactical tool by businesses to meet the unique customer requirements of their supply chain and distribution channel,” the report indicates.

Figure: 1 Recent Trends in Pharmaceutical Supply Chain

Pharmaceutical Supply Chain Management Trends

Using Robots in Pharma Factories

Robots offer several advantages over human workers in select conditions, a report by TweakYourBiz states. including:

  • Increasing worker safety when assembling implants and drugs containing radioactive or biohazardous compounds
  • Reducing contamination by having robot-only areas
  • Performing repetitive tasks to perfect efficiency, increase productivity and eliminate human error
  • Retooling and refitting a robotic ensemble to perform different tasks
  • Automating high-throughput screening (HTS) for chemical or biological compounds
  • Scanning products to identify potential counterfeits

“Robots provide improved reliability and result in fewer rejects and material waste,” the TWB report concludes.

Smart Contracts and the PSC

Administrative expenses are a significant part of PSC expenses, which add 7% – 8% to the final cost of a pharmaceutical product, a report by Exyte claims. Administrative staff is required to handle invoices and send payments. These processes are automated when using smart contracts that automatically execute using a transactional computing protocol when stated conditions are met.

However, these contracts use blockchain technology to, “verify, validate, capture and enforce agreed-upon terms between multiple parties,” Finextra states.

Summary

As businesses strive to increase their efficiency and performance, increasing diversity in terms of raw materials sources, APIs, using software to help manage operations with robots and other forms of automation on both factory and warehouse floors continue to rank high among emerging pharmaceutical supply chain trends.

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About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

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Covid-19 Impacts on the Pharmaceutical Supply Chain

Covid-19 Impacts on the Pharmaceutical Supply Chain

Covid-19 Impacts on the Pharmaceutical Supply Chain 700 500 Xcelpros Team

Introduction

While the United States continues to vaccinate and protect its citizens from Covid-19, new variants of the disease continue to pop up around the world. In addition to costing millions of lives (Google states nearly 3.3 million in 220 countries and territories worldwide as of May 7, 2021, which includes 579,000 in the US alone), problems caused by the disease are wreaking havoc with the pharmaceutical supply chain.

Figure: 1Covid-19 Impacts on the companies

Covid-19 Impacts on the companies

Among the short-term effects cited in a July 3, 2020 article on Springer are:

  • 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, such as 70 – 80 percent drop in visits to physician offices and clinics.
  • Changes in the focus of research and development programs to dealing with Covid-19.

Long-term effects on the pharmaceutical industry cited in the Springer article include:

  • Delayed approvals for non-Covid-related pharmaceutical product, partly 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 individual countries and organizations such as the European Union looking at the health needs of its citizens.
  • Slowed growth resulting from economic slow-downs in economies around the globe.
  • Ethical issues caused by poorly researched clinical therapies.
  • Consumption changes of health products by consumers.

By the Numbers

  • A 2-fold 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).
  • 7 million excess prescriptions for hypertension, 6 million for mental health, 5 million for respiratory problems, 4 million for diabetes and 2 million for anxiety in the U.S. alone.
  • 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 done online.

Supply Chain Effects

Deloitte produced its “Covid-19 Response for Pharma companies: Respond. Recover. Thrive” report. Among the report’s sections is a look at Supply Chain Management.

Key risks in procurement cited by Deloitte are:

  • 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. Mitigate 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. Mitigate by identifying shutdowns from remote (i.e., Asian) sources and pressure test supply chains for various scenarios.

Key risks for planning include:

  • Expiration of materials and monitoring for reassessments and quality certificates. Mitigate by submitting studies to the FDA with the longest agreeable expiration date.
  • Shutdowns of contract manufacturers. Mitigate though communication regarding their ability to deliver products.
  • Quality control checks at contract manufacturers or traded goods for contamination issues. Mitigate by having quality control personnel on-site and thoroughly sanitizing all in-bound products, employees and equipment.
  • Contamination after final packaging. Mitigate by disinfecting shipments before delivery and providing photographic proof.

Logistics and transportation risks cited by Deloitte include:

  • Non-availability of local transportation to move raw materials and finished goods. Mitigate by locating alternate partners and getting approval to move essential drugs should a lockdown occur.
  • Contamination issues from transport vehicles. Mitigate by disinfecting all vehicles, planning to store temperature-sensitive products and arranging warehouse space.

Export risks are:

  • Contractual compliance. Mitigate by ensuring the person(s) collecting the order is aware of any regulatory restrictions.
  • Contractual terms with domestic and export customers. Mitigate by seeking advice from insurance brokers and engaging early with clients to determine what could work if supply chain challenges or personnel issues occur.

Continuing Effects

Disposable components for single use systems are being shunted to Covid programs at the expense of other critical programs. This is one of the continuing effects on the supply chain cited by Contract Pharma in its Covid-19 Impact Report.

Kay Schmidt of Catalent said finding vaccines and target therapies for Covid-19 has boosted demand for its services. The increased demand “has led to greater collaboration and innovation between partners, regulators and throughout supply chains to meet key milestones” plus internal and external management, 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.

Covid-19’s Impact on Regulatory Practices

Covid-19 will 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 makers is 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.

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About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

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Moving from Batch to Continuous Manufacturing in the Pharmaceutical industry

Moving from Batch to Continuous Manufacturing in the Pharmaceutical industry 700 500 Xcelpros Team

At a Glance

  • The pharmaceutical and life sciences sectors have relied on conventional batch manufacturing methods as a trusted model for production requirements. For faster, more dynamic manufacturing, pharma companies like CDMOs are turning to continuous manufacturing.
  • While continuous manufacturing offers more flexibility and agility, there are a number of practical and financial aspects that pharma companies need to take into consideration while making the partial or complete transition.
  • Transitioning from batch manufacturing to continuous manufacturing requires pharma companies to be equipped with the right tools and technologies. For many, partnering with experts to seamlessly drive the transition and ensure employees are well-trained is essential.

For years, CDMOs have made do with solutions focused on batch manufacturing. Fast forward to today, however, and the world is changing rapidly, with newer more efficient technologies being introduced for more dynamic process management. While the pharma sector might seem hesitant to let go of batch manufacturing, more and more companies are slowly transitioning to continuous manufacturing.

The global pharmaceutical continuous manufacturing market is predicted to grow with a CAGR of 8.2% over the forecast period of 2018-2024.– Researchandmarkets.com

With a growing number of benefits, including shorter production cycles, no equipment-stop requirements, and reduced risk for things like manual errors; continuous manufacturing is being viewed as the next big step in pharmaceutical manufacturing. In addition to the benefits, however, businesses need to expect any financial, practical, and behavioral hurdles that might arise.

This article aims to highlight these hurdles for organizations comparing batch vs. continuous manufacturing in order to gauge respective pros and cons.

Continuous Manufacturing and Its Impact on the Pharma industry

Continuous manufacturing is a highly streamlined ecosystem where multiple stages and discreet testing across various facilities are not required. For pharma companies, this can mean avoiding excessive downtime or closures of production units in the event of a faulty batch, saving manufacturers thousands of dollars previously dedicated to these types of tasks.

Figure: 1Batch Manufacturing vs. Continuous Manufacturing

continuous manufacturing vs batch production

Continuous manufacturing is more flexible and dynamic in nature, allowing manufacturers to introduce changes with ease and efficiency. In comparison, batch manufacturing in the pharmaceutical industry has always been highly restrictive in nature. Continuous manufacturing enables pharma companies to lower their carbon footprint, reducing any harmful emissions released into the environment and does not require the longer ‘hold times’ familiar to batch manufacturing, where between every stage materials need to be tested for quality. The transportation and storage of these samples (which are often in bulk) require both high costs and a planned holding time. These hold-ups and more can be mostly mitigated with continuous manufacturing. Companies can also significantly reduce the manufacturing lifecycle, including time to market for a drug. The single production line model found in continuous manufacturing works well to save time, leverage process flexibility, and enhance resource utilization.

3 Hurdles Implementing Continuous Manufacturing

With so many apparent benefits, it’s still a question of why the pharma industry hasn’t gone all out when it comes to continuous manufacturing. The answer lies in understanding the hurdles involved in implementing continuous manufacturing. Listed below are 3 common hurdles to consider when moving to continuous manufacturing.

1.InfrastructureContinuous manufacturing is typically considered a more advanced business model, often requiring changes in infrastructure across different functional areas. The IT framework of pharma companies and CDMO’s needs to be able to support an agile, flexible manufacturing model. Many pharmaceutical companies are still apprehensive to transition to continuous production as it usually entails a major infrastructure overhaul.

2.Regulatory IssuesPharma manufacturing is highly sensitive in terms of quality checks and regulatory approvals. After working with batch manufacturing for decades, a transition to continuous manufacturing means applying for newer approvals and altering quality check-points. For current product lines, pharma companies already have all their approvals in place for the production lines and quality check methods. Getting approvals for newer methods and production lines, like those found in continuous manufacturing, can be a costly and intimidating process.

3.Behavioural ResistanceCompared to other industries such as automotive or even chemical, the pharma sector has always been rather conventional in its approach towards newer methods and technologies. Implementing drastic changes has always been met with resistance as it can lead to numerous major shifts in processes, work methods, and operations. Employees need to be properly trained and made aware of possible hurdles when it comes to adopting a new process. For Pharma companies, this is best handled by letting change cascade from upper management, on down.

The Right Path for the Pharma Industry

With so much impact and so many possible benefits, the application of continuous manufacturing will continue to rise for businesses in the pharma sector. Going forward, precision medicine, personalized care, and agile transformation will continue to be of utmost importance for CDMOs and pharma giants. While these goals and more can be met by embracing continuous manufacturing, in order to achieve these targets, pharma companies will need to be willing to make necessary changes to their infrastructure in order to make a smoother transition to continuous production.

Key Takeaways

  • The pharmaceutical industry can take advantage of numerous benefits and opportunities with continuous manufacturing vs older batch manufacturing processes.
  • While continuous manufacturing is on the rise in the pharma sector, companies need to plan appropriately to ensure a smooth implementation/ transition.
  • Pharma companies need to be open to changes in infrastructure and mindset to take full advantage of a continuous manufacturing model.

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About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

Pharmaceutical Inventory Management: Challenges and Solutions

Pharmaceutical Inventory Management: Challenges and Solutions 700 500 Xcelpros Team

Introduction

In the pharmaceutical industry, the task of keeping track of inventory is a critical process where large investments can either make or break a company. There are so many different things to consider that have a significant impact on an organization’s bottom line.

When it comes to pharmaceutical inventory management there are a certain questions that need to be answered for full accountability, including

  • What products or raw materials do we have in inventory?
  • Where is it being stored – both physical location and in the production process
  • Does the physical inventory on hand match what each department is supposed to have?
  • Are there any discrepancies?
  • Are any raw materials or products either approaching, at, or past their expiration dates?

If just a few of these questions are left unanswered, the damages to a company can quickly begin to pile up. This can result in a loss of revenue, fines, or worse, risk to human life. Understanding exactly what issues could arise, and how, is the best first step to approaching inventory management in the pharmaceutical industry.

Understanding common causes

With rapidly rising costs for things like materials, transportation, and fines associated with non-compliance, understanding the most common causes of the issues plaguing the industry, and more, is critical to the operations and success of organizations in the pharmaceutical industry.

This lets businesses plan more carefully to be able to successfully manage their inventories down to the smallest detail. Some of the most widely seen causes of pharmaceutical inventory management errors include

  1. 1.Human error resulting in misinformation being entered into an organization’s enterprise resource planning (ERP) system.
  2. 2. Improper or incorrect storage of finished goods or raw materials.
  3. 3. Waste and/or shrinkage (i.e., theft) resulting in incorrect inventory counts and undocumented loss of revenue.
  4. 4. Errors caused by incorrect measurements or from using inaccurate equipment.
  5. 5. Discrepancies between ordered, shipped and the received quantities.
  6. 6. Failures to properly account for expired, damaged or destroyed items including raw materials and finished goods.

Inventory Management Systems

Efficient, accurate inventory management is critical because it controls the amounts of raw materials, work in progress and finished products available at any given time. More companies are taking advantage of today’s modern solutions to achieve a number of functional benefits along with enhanced visibility of their inventory levels. These new systems all support three major goals, including

  1. 1.Making sure there are enough raw materials to meet current and anticipated demand.
  2. 2.Using working capital on other needs, such as replacing outdated equipment, opposed to buying or storing additional inventory.
  3. 3.Balancing the above goals while allowing the company to make a profit.

Along with achieving these goals, these systems let business perform much of the following

Tracking Production Lots

Unlike other industries that track raw materials and finished products by part numbers, many existing pharmaceutical factories tend to produce medicines and other drugs in lots.

The lot method uses various machines to create various lot and batch sizes of a particular drug or product in common increments such as gallons or pounds. Each lot should then be marked with a pedigree serial number as required by the US FDA Safety and Innovation Act (FDASIA). All drugs distributed by wholesalers, repackagers or distributors must have a pedigree serial number for tracking purposes.

The manual and electronic (ePedigree) versions allow for tracking individual drug production lots from start to sale. Lot numbers let healthcare providers know if a particular batch of product:

  • Is ready for sale
  • Is expired
  • Is part of a recall

Lots have codes unique to each batch, making it easy to learn when problems occur. For example, if Batch A is perfect but Batch B has a problem, the manufacturer can use lot codes to narrow down where the problem occurred and correct it.

Pharmaceutical Lot tracking and the Supply Chain

Lot tracking increases supply chain integrity by tracing the pedigree of each batch of drugs manufactured.-2014 article by Lowry

Figure: 1Pharmaceutical Drugs Management Life Cycle

Banner: Pharmaceutical Drug Management Life Cycle

Specific to pharmaceuticals, lot tracking ensures tracing of each ingredient, dosage units, product family, national drug code (NDC) number, strength, schedules and other information for each batch. Lot numbers permit tracing throughout the production, processing and distribution processes.

Each lot is given an expiration date that determines its shelf life. This lot can be tracked through the supply chain to determine:

  • When it was made
  • Where the lot is at any given moment such as production shipping or a storage warehouse
  • Which customers received it
  • When the customers received their shipment of a specific lot

Typically, batches nearing their expiration date undergo a quality control test. The quality control lab either extends the expiration date or scraps the batch.

The Drug Supply Chain Security Act (DSCSA) plus the FDA and Drug Enforcement Agency (DEA) are constantly updating regulations related to lot and batch labeling.

Enhanced Tracking Methods

A stand-alone inventory management system, or the more robust ERP offerings in products such as Microsoft Dynamics 365 – Supply Chain, uses lot or batch numbers in the pharmaceutical industry, and/or product codes for internal tracking. Many wholesalers use the FDA-assigned NDC number, which is unique to a specific product. These systems can also track products by brand, brand description, strength and dosage as required by the DSCSA and for suspicious order monitoring.

The Global Trade Item Number (GTIN) is a 12-digit number used with a barcode for tracking purposes in the US and Canada. It is also known as a universal product code (UPC). The first 6-9 digits are the company prefix. The next digits reflect the product while the last digit is a check digit based on a calculation of the first 11 digits. An European Article Number (EAN) is similar to a GTN except it has 13 digits. EANs are used everywhere in the world except in the US and Canada.

Modern Inventory Management Systems

An pharmaceutical inventory management system that works with accounting, such as Microsoft System Dynamics 365 – Supply Chain, allows pharmaceutical companies to track, manage and organize inventory levels plus order, sales and deliveries.

The purpose of inventory management software is to maintain an optimal inventory level, track goods during transport between locations, receive new items, manage pharmaceutical warehouse processes such as picking, packing, and shipping, prevent product obsolescence and spoilage, and ensure your products are never out of stock.-Microsoft

Other advantages of using an inventory management system include

  • Inventory optimization
  • Product identification and tracking
  • Asset tracking
  • Reorder point determination

Inventory Management in ERP Systems

When included from the beginning as part of an ERP system, Inventory Management provides a number of additional benefits, such as

  • Direct integration into a company’s Supply Chain Management operations
  • Tracking of individual lots and batches using barcodes
  • Insights from real-time tracking using a cloud-based system, visible on mobile devices at any time
  • Artificial Intelligence (AI) recommendations for determining optimal inventory levels
  • Quicker, easier software updates for cloud-based systems compared to standard on-premise programs

Final Thoughts

The adoption of modern inventory management systems helps businesses reduce the likelihood of having either too little or too much in terms of raw materials or finished goods. For the pharmaceutical industry, inventory management is critical, offering accurate, continuous tracking of batches and lots. This ensures the company meets stringent federal and state regulations and helps ensure that only current—not expired—products are available to customers. To achieve the best results, businesses need to understand the issues and perform enough research to determine how beneficial adopting a modern inventory management system would be.

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About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

Role of Technology in Optimizing the Pharmaceutical Supply Chain

Role of Technology in Optimizing the Pharmaceutical Supply Chain 700 500 Xcelpros Team

Introduction

The pharmaceutical industry is a rapidly growing industry with strict regulatory requirements. The COVID-19 pandemic has put immense pressure on these companies to meet the changing demands of the market. Meeting these high demands while adhering to requirements can be one of the biggest challenges for these firms. With more and more industries going fully digital, technology is helping these companies overcome challenges as they arise to stay in business. Let’s find out how!

Leverage the power of technology to optimize your supply chain and boost your profits. Start your digital transformation!

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About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com