COVID-19

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

Jump-starting resilient and reimagined operations

Jump-starting resilient and reimagined operations

Jump-starting resilient and reimagined operations 2400 900 Xcelpros Team

Jump-starting resilient and reimagined operations

Based on a wonderful piece from our friends at McKinsey, describing the effort needed by businesses moving forward after COVID disruptions. A reminder that businesses able to maintain a certain level of speed during the transition can create a significant long-term advantage.

Get a free consultation to learn more about building resilient operations for your company.

Get Started

how manufacturing companies are pivoting operations

The new world reality post Covid 19 – How manufacturing companies are pivoting operations?

The new world reality post Covid 19 – How manufacturing companies are pivoting operations? 1920 1080 Xcelpros Team

Introduction

Process Manufacturing companies are adapting to the sudden changes in the economic landscape due to COVID-19. Dependency on China for raw material and supplies has hindered the local US market forcing manufacturing companies to pivot operations and meet consumer needs. Starting late January, China’s industrial production came to a standstill as companies suspended their operations completely amid the lockdown. Though China is getting back on its feet now, the whole world had to take its heat as the event disrupted the global supply chain massively. In 2020, China contributes nearly 20% to the global GDP. You can now imagine the losses businesses will suffer all over the world and how long it will take to recover and ramp up operations fully.

A survey by the German company Kloepfel Consulting states that every third company has Chinese customers in a higher number, and on top of it nearly 81% of them are dependent on Chinese suppliers to run their operations.

From the above facts it can be anticipated that a major supply chain restructuring is coming on your way. Now, more than ever, integrated technology is imperative to streamline and automate the lines of business, people and processes.

FIGURE 1 Industry-wise Projected Covid-19 Impact from Minor to Severe


Loading…

1=Minor impact

2=Moderate

3=Significant

4=Major

5=Severe

Source : Statista

What is the new world reality in manufacturing?

The World Health Organization (WHO) has declared COVID-19 a public health emergency which led to a seismic shift in the life of manufacturing and distribution companies. The industry is now experiencing a new reality in running operations while they continue to produce finished goods to meet customer demand. Of course, remote tools and collaboration softwares are helping certain departments within these companies to manage work remotely. However, full quarantine is not a viable alternative for certain sections of the industry that require an actively engaged workforce in manufacturing and supply chain operations.

Honeywell now plans to start making over 20 million face masks a month to help healthcare workers battle the coronavirus.

Honeywell’s move of ‘coming to aid’ at this time is commendable and is paving the path to other enterprises from the same industry. Current day consumers’ needs have shifted to safety and hygiene which in turn has become one of their business objectives.

Companies that have always been historically change-averse are now forced into a new way of working.

Conventional manufacturing and distribution organizations have always been apprehensive in making any process or technology advancements. With the sudden change in market dynamics, these businesses are realizing the need for an enhanced technology they wished they had adapted earlier. This thought process has created a forced awareness which is now their ‘new reality’ and there is no going back after that.

So, how are companies pivoting operations?

Manufacturing facilities that are already suitable to create products requiring batch processing, are taking a leap into newer areas of production in an agile mode. These companies have the facilities to accommodate materials and processes. They are familiar with proper quality testing standards and potency detection methods for batches. Quite a few companies have already pivoted to help out in every way possible. But only companies that are well automated, are the ones that can move quickly in such emergencies.

Corona Virus Pandemic is hurting the bottom line of Manufacturing Industry globally. You need to find an effective alternative sourcing strategy to survive through this massive supply-chain disruption.

FIGURE 2 Supply chain within manufacturing with the ability to pivot operations

In this ‘new normal’, companies that can pivot quickly to accommodate consumer needs will become the front runners and market leaders of the future.

Business users adapt quickly ‘only’ if they are ahead in process automation and optimization. The benefit is leveraged by using the right kind of technology that can effectively handle various processes and procedures. New-age technology is instrumental in simplifying work and transforming business users into advanced users, especially to streamline HR processes that enable users to be ready for any changes. With newer skills, users can easily adapt to sudden changes and disruptions caused due to a pandemic like COVID-19.

What do operators need to adjust to the change?

54%

of respondents believe that coronavirus could have a significant impact on their business operations.

-A PWC Survey of CFOs

A well-streamlined workflow can help the workforce fall into the rhythm. Especially workforce with native knowledge of their regular operations, need to rapidly adapt to the change in functioning. It is not always easy to handle the new set of production lines that are abruptly put in place. Operators would require a detailed understanding of the new product batch records in order to adapt to the change.

Workflow for warehouse operators should be streamlined to –

  • Guide them while using mobile devices
  • Help them progress through each step
  • Hand hold them during unknown situations
  • Allow them to record inline deviations

If companies are unprepared, they may go through a chaos during manufacturing execution. Production managers and supervisors who have also been used to familiar batch records with specific yield expectations, are now adapting to the ‘new thing’ that they need to produce. Alerts on each operation would immensely help them be aware of how the overall production job is progressing.

FIGURE 3 Supply chain within manufacturing with the ability to pivot operations

When it comes to the regular production operations, Production supervisors or Plant managers are used to seeing both the norms and deviations in the process. Without an internal view of the new product history, they will need to be extra aware of test results and yield quantities of each production job to quickly analyze and extrapolate how to adjust batch formulas, and rapidly incorporate the learnings of each production run. A rule-based algorithm that can look at the last ‘n’ batch runs and automatically suggest changes for ‘approval and instant adoption’ will be crucial to keep the process optimized in an agile manufacturing environment.

Companies that are taking up these initiatives are also required to understand how the end consumer is reacting to the new products released in the market. An easy way would be to label their products with proper QR codes that can be scanned to quickly send an end-user survey back to the manufacturer about their new product. These quick surveys help the manufacturers understand consumer feedback about the product. The feedback can be incorporated into their testing methods to make on-the-fly decisions and corrections of their manufacturing execution.

What are the few technological elements companies wished they had within operations during the Covid19 pandemic?

A question that every manufacturing company is asking to understand is how they can simplify and streamline their processes further to keep the momentum in the operations going. A few technical elements are depicted in the picture below.

Companies have asked me how all of this is different from what was recommended in the past year? It isn’t, but the need is more real now and is no more a nice-to-have. These technological advancements have become an ‘essential-to-must-have’ if businesses want to survive the current condition.

How do we get the required automation?

Unless we see what the business is at its core, it may not be possible to provide a specific view of what all changes would be needed. However, going by some assumptions there are a few business solutions that can be drawn out to help businesses to become more agile in their operations.

FIGURE 4 Batch Manufacturing Facility Agile And Optimized

All of the different ways to speed up, simplify and automate overall operations can propel companies to function a lot more efficiently and be agile to changes that are thrown at them while they are still dealing with a limited workforce.

Key Takeaways

  • There is never an individual contribution that can move a huge ship forward during difficult times. It is always the collaboration and synchrony of an entire workforce that really pushes the throttle. The trick is in how well you are able to keep your people aligned with all the technologies you invest in.
  • Technology centric Manufacturing organizations are already ahead of the market curve and when sudden changes occur, a well defined HR department of a company that has agile training plans in place helps with the changes that are thrown at them.
  • Finally, it is important to understand that even though temporarily it may feel as though companies need to bear the cost of advancement and changes, in a bigger schema a good technology stack like Microsoft is essential for the overall success of any organization.

Recommendation to the reader: Evaluate Microsoft suite of tools to help your business and stay agile in this volatile market.

Xcelpros is a direct Microsoft Cloud Solutions Provider and can help you with your business continuity and make you nimble during these times. We are currently offering various discounts on multiple Microsoft products and Transformation packages. Contact us right away!

Get Free Consultation For all Your Business Needs

Get Started Now

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