Pharma

Challenges in Pharmaceutical Supply Chain due to Covid-19

Pharmaceutical Supply Chain Challenges due to Covid-19

Pharmaceutical Supply Chain Challenges due to Covid-19 2035 764 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

Book a free consultation to learn more about building resilience in the pharmaceutical supply chain.

Book Now

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.

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

ERP in developing the operational efficiencies in Pharma

Impact of ERP Software in Boosting Operational Efficiencies for Pharma

Impact of ERP Software in Boosting Operational Efficiencies for Pharma 1200 600 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.

Organize your operations today, to lead your company to success tomorrow.

Amplify the power of digital at your company. Get a free consultation today.

Get Started

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