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Pharmaceutical operations management
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Digital Evolution of Pharmaceutical Operations Management
Digital Evolution of Pharmaceutical Operations Management 700 500 Xcelpros Team

At a Glance

  • The healthcare and pharmaceutical sector is changing rapidly with the integration of latest technologies.
  • Digitization is on the agenda of major (and even most of the small-scale) pharma companies to enhance end-to-end operations management.
  • Pharma companies face challenges pertaining to manufacturing, quality control, serialization, supply chain management, process automation and more. Businesses can address these challenges with the help of cutting-edge tools and technologies.

The year 2020 has been particularly demanding for the healthcare and pharmaceutical industry. The increased need for newer or existing therapeutics and demand for a vaccine to curb the ongoing Covid-19 pandemic has put pharmaceutical manufacturers at the frontline. The challenges and pain areas that the pharma sector was dealing with became all the more prominent in 2020.

Pharmaceutical operations management has seen many changes in the past decade and these changes have accelerated because of rapid digitization. Top executives and decision-makers are looking for transformation technologies that can streamline operations, fortify quality control and optimize supply chain management. The manufacturers are looking at ways to transition from batch to continuous manufacturing. To say that the pharmaceutical and biotechnology sector is navigating through times of transformation would not be an exaggeration.

According to Mckinsey and Company, more than 65 percent reduction in deviations and over 90 percent faster closure times have been recorded in first real-life use cases of pharma manufacturing labs (that adapted emerging technologies such as automation and advanced analytics amongst others).

This period of transformation and disruptions is particularly testing for operations management in the pharmaceutical manufacturing sector. Here is a look at some of the challenges in pharmaceutical industry in this area:

1.The Shortcomings of Batch Manufacturing:This rather conventional method of manufacturing comes with its set of problems such as increased efforts and costs. Production in batches also entails batch-wise quality control increasing employees’ downtime. Batch manufacturing is also cumbersome to manage as it requires multiple storage facilities, multiple process reports, various checkpoints and overall increased chances for errors. Pharmaceutical Operations require agility and customized production and the batch manufacturing process falls short by being a rather ‘set’ process.

2.Quality Control and Quality Assurance Challenges:Quality is very obviously a non-negotiable aspect in the pharma industry. In Pharmaceutical operational management, regular quality checks and observing all deviations are a must. However, maintaining quality comes with its set of challenges. Many manufacturers often struggle with clearing quality control checks for raw materials as well as manufactured batches. There is a need to test every batch for generic and customer-specific potency requirements thoroughly, ensure proper storage conditions at every facility, report and record observations, perform in-process quality testing, etc.

Figure 1:Major Challenge Areas: Pharma End-to-end Operations Management

Major Challenge Areas: Pharma End-to-end Operations Management

3.Inventory Management Issues:If the current pandemic has disrupted a branch of pharmaceuticals completely, it would be supply chain and inventory management. Unpredictable demand patterns, over or under stocking, false forecasting have been some major challenges of pharmaceutical manufacturers and vendors. Major and small-scale pharmaceutical companies face issues with quantification and replenishment decisions.

4.Challenges with Digital Transformation in the Pharmaceutical Industry:Pharmaceutical, life sciences and biotech companies are going the digital way to expedite processes, integrate automation and streamline their operations. This journey of digitization in the pharmaceutical industry can be a daunting one for companies as they struggle with moving to newer systems. Top executives need to factor in the cost of digital transformation, expenditure to upgrade their IT infrastructure and budget to upskill their workforce.

To overcome these challenges, pharmaceutical companies need to rethink their operational management strategies. With the help of advanced systems such as the Microsoft Dynamics 365 Finance and Operations, biopharmaceutical manufacturers can make strides in their digitization journey while systematically managing their end-to-end operations. The strength is in the Microsoft cloud-based ecosystem that integrates the enterprise ERP with process automation, analytics, AI, etc.

Figure 2:All Microsoft apps under one umbrella

All Microsoft apps under one umbrella

Figure 3:Microsoft Dynamics 365 Finance and Operations quick glimpse

Microsoft Dynamics 365 Finance and Operations quick glimpse

Here are some of the prominent ways that Dynamics 365 is helping pharmaceutical companies build efficiency in operations management:

  • Automation of processes leading to reduced manual efforts, better time management, decreased operational costs and an overall reduction in time-to-market.
  • In-system generation of reports, invoices, and labels for quality checks, drug batches and related processes.
  • Efficient quality control and assurance with the help of customized processes.
  • Efficient monitoring of inventories to avoid wastage or stock-outs.
  • Real-time tracking of supply chain and centralized connectivity between various stockholder, creating a harmonized system that can run smoothly.
  • Effective raw material planning and in-system purchase order generation with timely reminders and customization options.

These and many such features make a high-end ERP system the must-have addition to pharmaceutical companies’ operational management strategy. Pharma companies need to chalk down their unique challenges and requirements and then invest in a comprehensive ERP tool to fulfill those needs.

In a complex and dynamic digital canvas, pharmaceutical companies are navigating their way towards efficient end-to-end operations management with the latest tools and technologies.

Key Takeaways

  • The challenges in end-to-end operations management are not new to the pharma sector, however, the recent Covid-19 pandemic has made these matters even more pressing.
  • Integration of tools and technologies that can optimize and aid in enhancing process efficiencies are must-haves for the pharma manufacturers.
  • A comprehensive and systematic ERP tool can prove to be the game-changer in pharma and life sciences operations management.

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New technology in pharmaceutical industry
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Maximize Profit with New Technology in the Pharmaceutical Industry
Maximize Profit with New Technology in the Pharmaceutical Industry 700 500 Xcelpros Team

At a Glance

  • Pharma industry is moving from conventional methods of research, manufacturing and distribution towards more technologically adept ways for better output.
  • The globalized nature of the pharma supply chain calls for technological transformation at macro and micro levels of every player in the industry.
  • The need for newer technologies, the cost of their adaption and the overall ROI are factors that pharmaceutical companies should consider to bring about a technology-driven reformation of their processes.

For years now, the pharmaceutical sector has been slow to adopt technologies, especially when it comes to their business models. While the past decade has seen positive changes in the way technological advancements have made their presence felt in this industry, there is still a lot to be desired. Technology can be leveraged by pharmaceutical companies (start-ups and the giants) to transform their operations, the pace of research, and manufacturing processes. Even the pharmaceutical supply chain is on the verge of going through a digital overhaul, changing how medicine/ raw material distribution will be handled locally and globally.

Pharmaceutical Facets Being Transformed by Cutting-Edge Technologies

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Application of Newer Technologies

01

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Expedited Process, Optimized Operation, Reduced Manual Labour and Error Mitigation

02

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Better Understanding of the Market and End-User Dynamics

03

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Formation of a data-driven and Technologically-Enabled Business Strategy for Enhanced ROI and Profitability

04

The impact of adopting newer technologies on the business front is going to be positive. However, the pharma companies’ key decision-makers would need to align their business models with the current market needs and then choose the right mix of technologies to drive growth and maximize pharmaceutical profits.

Let us look at how technology in the pharmaceutical industry can prove to be integral in accelerating business growth for pharma companies.

01.Going Big with Big Data – Anchoring Business Decisions Based on Data Generated Insights

Big Data has made its way in almost all the major industries and healthcare-pharmaceutical integration can benefit from this technology to store, organize and leverage the humongous amount of data generated. The pharmaceutical industry can gain insights from the patient data stored on various applications. It can also leverage the data generated at hospitals to gain foresight into the current medicine demands and the c-suite level executives can drive their decisions based on these insights. The global pharmaceutical supply chain can benefit from historical and real-time data sources available on Big Data platforms. This will help mitigate supply errors, prevent bottlenecks, and ensure smooth distribution of medicines and raw material. To make best use of Big-Data learn more about pharmaceutical data analytics and business intelligence here.

02.Artificial Intelligence (AI) is the Way Forward- Expediting Processes and Enhancing Profitability

The past few months are abuzz with the news of AI being used to fasten vaccine development using computerized programs. AI is imperative to complete genome sequencing of the Covid-19 virus, running humongous data through machine learning tools to shortlist plausible drugs and vaccine candidates and systematically design massive-scale clinical trials. The pharmaceutical industry has been using AI and related technologies to fine-tune operations, fasten the drug discovery processes, and minimize human efforts. Speaking of its impact on business, the pharma executives see the positive transformation of accelerated processes. The increase in profit margins caused by AI tools and techniques has encouraged pharmaceutical companies to expand AI use.

According to Gartner’s 2020 CIO Survey, AI is the healthcare industry’s top game-changing technology. These analysts predicted 75 percent of healthcare delivery organizations will invest in an AI capability to explicitly improve either operational performance or clinical outcomes by 2021.

03.Going Virtual – Catering to the Need of the Hour to Make Better Business Choices

The past few years have seen a shift in the way the healthcare sector has been operating. Patients are moving towards online consulting and self-medication via various forums and apps. The partial shift of the healthcare sector to virtual platforms has created a ripple effect on its related sectors. The pharmaceutical companies can use this transformation to their benefit and enhance customer engagement by going digital. Digital customer engagement and experience will help them in understanding the demands and expectations of their end-users. Pharma companies can align Business strategies for manufacturing and distributing generic and over the counter (OTC) drugs with insights generated from capturing the consumer behavior on these virtual platforms. A well-researched business strategy can become the blueprint that the pharmaceutical companies can replicate in other geographies to grow their business.

How Technology is Crucial in Enhancing the Pharma Business

01

Research and Development – Cloud Computing, Big Data, AI, and Machine Learning are Expediting R&D in the Pharma Sector

02

Drug Manufacturing – Automation is Proving to be a Game Changer in Continuous Manufacturing

03

Pharmaceutical Supply Chain – The Pharmaceutical Supply Chain is Getting Digitized and Optimized with Latest Technologies

04.Opting Automation – Moving from Batch to Continuous Manufacturing to Meet the Demands

There is an ever-growing demand for medicines and vaccines worldwide, and pharmaceutical companies are on the lookout to enhance their manufacturing capacity without inflating costs to the extent that it will disrupt their business models. Technology experts are touting automation in the pharmaceutical industry as the next big thing for them. Automating the manufacturing processes and facilities will enable pharma companies to move from batch production to continuous manufacturing. Business process automation will help meet customer demands and enhance their operational efficiency.

To summarize, adapting new technologies in the pharmaceutical industry during these rapidly changing times will favor these companies. The key decision-makers who are ready to think out of the box and take bolder steps by trusting the endless possibilities of technology will be remembered as pioneers in transforming the pharmaceutical sector.

Key Takeaways:

  • Adapting new technologies and up-scaling entire infrastructure as needed might be a cost-intensive process, but in the long run, it will help pharma companies cater to the needs of changing times.
  • Business executives in pharmaceutical companies have started looking at newer technologies as imperative factors in not just R&D optimization but as catalysts in the overall transformation of the sector.

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Pharmaceutical industry challenges
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Top 5 Challenges in the Pharmaceutical Industry: The COVID-19 Effect
Top 5 Challenges in the Pharmaceutical Industry: The COVID-19 Effect 700 500 Xcelpros Team

At a Glance

  • The economic upheaval caused by the shutdowns to prevent the spread of coronavirus is raging globally, and many industries, including the pharmaceutical sector is facing uncertainties.
  • The pharma companies, however, have another significant role in the pandemic, and that around managing Pharma operations during the pandemic.
  • The unprecedented demand and expectation from the pharma sector in terms of R&D, production, supply chain management, and cost optimization is presenting many issues across the industry.
  • Top executives and decision-makers will need to maneuver their pharma companies in a calculated manner to rise to humanity’s occasion and make their businesses steady again.

The rapid spread of the coronavirus across the globe halted air travel, crumbling healthcare systems, countries going under lockdowns, thousands losing their jobs, and a looming prospect of the economic crisis are all the events that we as a world have seen in 2020. Industries across the board face the brunt of disrupted supply chains, skeletal workforce, and dwindling investments. However, one industry to which everybody is looking with bated breaths is the pharmaceutical industry- for it can provide an answer to this pandemic in the form of a drug or a vaccine.

Figure 1:Adverse Effects of the Covid-19 Pandemic Globally

Adverse Effects of the Covid-19 Pandemic Globally

To say that major and minor pharma companies have sprung into action would be an understatement! The leaders and decision-makers from different pharma companies have responded reasonably quickly and are guiding the world towards a better tomorrow. However, the ‘new normal’ that we live in currently presents many pharmaceutical industry challenges (from financial to operational).

According to a report by Global Data, 23 percent from the pharmaceutical sector are concerned about supply and demand gaps tied to the COVID-19 outbreak.

Let us take a look at some of the top concerns that the pharmaceutical sector will be facing in the current times and the post-covid-19 world:

1.Disrupted Supply ChainOver the globe, supply chains have been broken, disrupted, and some have even come to a grinding halt because of the nation-wide lockdowns, closed borders, and halted air travel. The coronavirus pandemic has created a disorder of the kind that we have never witnessed before. The pharma sector drives its operations through the smooth running of the supply chain to deliver drugs and vaccines across the globe by:

  • rapid procurement of raw material and chemicals for drug manufacturing
  • managing equipment for research & production
  • optimized warehouse management
  • inventory management through track and trace
  • on time in full shipments to customers

The industry executives will need to reduce their pharmaceutical supply chain challenges by changing strategies and using available resources to their fullest. A robust supply chain management (SCM) tool with interconnectivity and interoperability can work wonders to realign the supply chain and provide extensive visibility to stakeholders that sequentially bring processes back on track for pharma companies.

2.Need for Highly Skilled Workforce Almost all the developed and many developing companies are involved in research, development, and clinical trials for the potential coronavirus vaccine. This research requires scientists with immense knowledge, experience, and skills. The pharma sector will need to boost its investment in the high-skill workforce to continue making progress in the current and future times.

3.Humongous Data Collation and AnalysisThe research and clinical trials for potential drug treatments and vaccines for coronavirus worldwide generate unprecedented amounts of data and information. Paramedical experts and scientists in the pharma industry look at agile tools to collate and manage data while generating insights. After all, the clinical trial data insights will help pharma companies guide the world towards a better tomorrow.

4.Need for Agility and TransparencyWith the Covid-19 pandemic, there has been immense interest in the pharma sector’s workings by almost all social hierarchies. There is an increased need for faster, accurate, and transparent operations across the board.

5.Workforce optimization and ControlsDuring COVID-19, Pharma manufacturing companies made many adjustments to modus operandi. That includes accommodating remote workforce, social distancing when in person, wearing masks and gloves, and avoiding any possibility of spreading the coronavirus. Mainly while dealing with organic material within the raw material ingredients, additional testing is needed before the drug passes Quality and is deemed ‘in spec’. The extra impetus has led to newer Standard Operating Procedures in operations and quality when it involves batch production through batch records.

While these changes and concerns are bound to affect the pharmaceutical industry’s workings, proper management, technology, and software to navigate these challenging times will enable the pharmaceutical sector to rise to the occasion.

The Covid-19 pandemic has brought forward existing and new challenges for the pharma sector. However, it has given a chance to create opportunities and get transformations that can have a positive impact on the pharmaceutical industry.

Key Takeaways

  • Pharmaceutical companies need to change their business strategies to suit the current environment and to navigate smoothly through the times of the Covid-19 pandemic.
  • There is a need for pharma companies to invest in robust software and tools that can optimize supply chains, facilitate automation, reduce manual labor, and systematically manage the enterprise to maximize their output.

For more information on our Microsoft offerings for the Pharmaceutical industry, Contact us today!

pharmaceutical supply chain best practices
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How technology helps in optimizing the Pharmaceutical supply chain
How technology helps in optimizing the Pharmaceutical supply chain 700 500 Xcelpros Team

At a Glance

  • The Pharmaceutical industry has witnessed exponential growth during the past decade, and pharma revenues worldwide totaled 1.25 trillion U.S. dollars in 2019 – Per Statista.
  • This growth rate automatically created a need to boost supply chain visibility and inventory traceability.
  • Regulatory measures put forth by the government or agencies such as the FDA can create unforeseen challenges for Pharma companies.
  • Leveraging technology’s power and identifying solutions for Pharma to streamline operations can effectively boost your bottom-line and help in better quality control while meeting both regulations and market demands together.

Understanding the Pain Points

The inability to adapt to technological advancements and rapidly changing regulatory landscape makes managing pharmaceutical supply chains quite a tough pill to swallow. Successful pharmaceutical companies leverage the power of IT to streamline their supply chain operations.

Figure 1: Pain Points in Pharmaceutical Industry

Pain Points in Pharmaceutical Industry

The pharma industry has established itself as one of the fastest-growing industries in the past few decades, with a significant share of its investments in research, marketing, manufacturing, and development of its products.

In the present scenario, the table seems to be turning. The industry is struggling to keep pace with rapidly changing regulations and dealing with challenges such as:

  • Keeping up with the growing competition due to faster technological advances
  • The rapid development of new products to handle growing health concerns.
  • Healthcare providers and government reforms putting downward pressure on product prices of the industry.
  • Full traceability of the product pipeline to be on par with requirements like quality compliance, serialization mandate, and the rise of counterfeited drugs.
  • Issues related to delivering products to the market.

The above challenges highlight the importance of comprehensive solutions that help Pharma companies progress and overcome various hurdles in shipping products to customers.

Collaboration Within the Pharma Value Chain

To keep up with the growing list of challenges, Pharma companies are increasingly relying on third parties like CROs, CMOs, 3PLs to manage the following:

  • outsource research & development.
  • manufacturing of intermediates.
  • 3rd party logistics for warehouse and inventory management.
  • quality control testing.
  • shipping and distribution of products.

While this is beneficial for Pharmaceutical companies, it comes with its complexities, including the remote location of different departments, inventory, and testers. How do you run a pharmaceutical supply chain effectively when all the departments are functioning from other locations? How would you effectively manage workflows that involve the exchange of information with outsourced parties on multiple tiers of your supply?

A report by FDA showed that over 60% of the shortages in 2019 were attributed to supply disruptions due to manufacturing or quality issues.

Following are a few benefits for Pharma companies to be technology-centric:

  • Real-time & end-to-end supply chain visibility.
  • Collaboration with the Pharma value chain.
  • Optimized inventories with least stock out situations.
  • Higher margins through smarter channel allocations for an increasing share in the market.
  • Improved customer experience.
  • Visual analytics and reporting.

Digitize the Pharma Supply Chain

Companies require well-streamlined processes and collaboration using agile software solutions for Pharma that provide significant cost savings and flexibility. Technology for Pharmaceutical industry can be a helping hand to optimize the supply chains. Advanced Solutions for Pharma increase inventory visibility and lot traceability across your supply chain, ultimately improving the overall product quality. Post COVID-19, embracing technology as a growth enabler has become the need of the hour for the pharma industry.

Following the path of other industries like hi-tech and consumer goods, the Pharma companies also need to focus on these five initiatives:

01.Connecting and collaborating using a working business network

A digital business network sets the foundation of a multi-enterprise supply chain, where all departments are interconnected on the cloud, ensuring seamless information flow and collaboration. Unlike the outdated model based on point-to-point connections, this multi-tier network is much advanced and helps end-users stay in sync with counterparts and move quickly through the process. The ability to collaborate enables end-to-end visibility and collaboration – the two critical factors that support smooth business interactions among different business partners involved in the value chain. Seamless integration helps you get real-time visibility and coordination in your entire extended supply chain, including multiple partners.

Figure 2: Process of Temperature Control

Process of Temperature Control

For example, there can be immense damage caused to vaccines due to the drop in temperature in the storage areas while being transported from one place to another. Real-time data tracking can help with adequate temperature controls by notifying when the temperatures are above or below the desired levels.

02.Estimating true demand

Demand predictions are just well-painted guesses of how much percentage of the population would require a particular product in the future. Most innovative pharmaceutical companies are now following demand forecasting as per consumer product companies for their OTC products. They do this by capturing massive volumes of demand related data and feeding it into sophisticated demand planning software, which helps them predict demand effectively. The data or demand forecasts captured are shared with all supply chain partners, ensuring the pharma companies, suppliers, and CMOs align with the arrangement. Estimating actual demand helps them to bring significantly higher on-shelf availability and lowers the inventory.

03.Control quality for CMOs

Pharmaceutical companies need to ensure end-to-end traceability. How do they keep track of their pharmaceutical manufacturing supply chain when a CMO is involved? Having visibility into partner’s manufacturing operations and tracking product quality across the multi-tier system is essential for pharma companies. The real-time visibility can be done by connecting CMOs to your Manufacturing Execution Systems. A manufacturing execution system helps capture relevant data at all production stages, providing granular visibility into plant operations. Pharma companies will effectively track material flows, lot genealogy, processing steps, and associated parameters, such as yields or test results – critical information to ensure traceability. Quality control is of optimal importance for any serialization initiative within Pharmaceutical companies.

04.Faster planning across the network

Another essential requirement for companies is to detect and respond to changes in supply and demand faster. With largely connected systems and expanding business networks, companies have a clear, end-to-end visibility of the supply chain in the Pharma company and not just in-house operations; this includes expected lead times on inventory from a contract manufacturer or raw material supplier. However, traditional planning systems can impact your decision-making capabilities required to manage inventory shortages and suggest alternative purchase/ manufacturing scenarios. Advanced planning tools allow rapid evaluation of new buy-sell signals and easily recommend purchases from secondary vendors or alternate manufacturing routes. This new plan can then be shared with all the supply chain partners within the value chain through collaboration portals, tools, so forth.

05.Manage distribution

Pharma companies are increasingly relying on third parties for transportation, warehousing, and other value-added services. Ensuring product availability implies proper management of distribution partners. For downstream visibility, inventory management coupled with sophisticated stock strategies are needed. Proactive pharma supply chain management helps all products be delivered to the right customers to increase your sell-metric, which is critical when competing in the market.

Pharma companies will customize supply chains to suit the product types being transported – data will play a key role in enabling this vision.-PWC Pharma 2020: Supplying the future

Key Takeaways

  • The expectation of better customer experience is the same across all industries and progressive Lifesciences companies understand the need to embrace digital for Pharma.
  • More Pharma companies are continually evaluating ways to address supply chain challenges to meet customer’s needs ultimately.
  • A cloud-based agile technology network to increase visibility in the supply chain and keep all functions connected for better collaboration can boost your profits and increase growth potential.

As Dynamics 365 ERP experts, we recommend taking a test drive of the solution. Email us at contact@xcelpros.com for a demo. For our product list, please Click here.

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Value based healthcare implementation - Key Benefits
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Rapid Implementation of Value Based Healthcare – Key Benefits
Rapid Implementation of Value Based Healthcare – Key Benefits 700 500 Xcelpros Team

At a Glance

  • The word value implies the most important outcome in a healthcare setting, measuring improvement in a patient’s condition. Value-based healthcare keeps this measure at its core.
  • While many hospitals and healthcare facilities (both private and government-funded) are looking to move away from the free-form structure, taking the right steps is crucial while implementing a value-based framework.
  • There are many factors to be considered while thinking about value-based healthcare and its future improvement in a patient’s health. The impetus is on the cost of actual effort, healthcare professionals involved, provision of better healthcare facilities, continuous research by independent bodies to measure the value-based healthcare system’s efficacy, and newer tools and technologies to help in this implementation.

Healthcare has been at the focal point of every nation, every county, and every region in 2020 with the ongoing coronavirus pandemic. Now more than ever, there is a need for reform, a qualitatively superior healthcare infrastructure. This need has been felt for decades now, which is where the concept of value-based healthcare caught experts’ eyes.

Newer, exciting technologies and governments’ interest in bringing about transformation in the care system is what got things moving in the value-based format’s direction. While the world is making great strides in this direction, stakeholders are still looking at various challenges in accelerating value-based systems’ implementation while getting its benefits.

According to a recent poll conducted by Definitive Healthcare (A USA-based Data Analytics firm), lack of resources (short-staffed, insufficient healthcare IT software, etc.) ranks as the most significant barrier (25 percent) to implementing value-based care.

Some of the other challenges in this direction are:

  • Rigid or unclear governmental policies
  • Financial risks involved
  • Lack of guidance for health organizations to move from conventional payroll software to newer, more sophisticated tools
  • Data management and analysis (pertaining to patient information)
  • Tools to accurately calculate health outcome in terms of value to the patient instead of volume
  • Lack of skills to leverage the latest care management tools to gain maximum benefits

This article discusses ways to accelerate the implementation of value-based healthcare and how the future looks for this transformative system.

How can Organizations Implement Value-based Healthcare?

1.Determine the medical facets for a value-based healthcare system implementation:In the beginning, health organizations are advised to categorize and prioritize the areas of medical care where they wish to go for a value-based format. Based on your goals, you can either implement this system for state-insured healthcare or high-burden medical areas or the ones where professionals have to deal with high volume frequently. This type of categorization will help you set intermediate goals and systematically implement and assess the benefits of a value-based healthcare format. It will also encourage the employees to adapt to the change in a gradual, phased, and systematic manner.

2.Make use of technology to expedite the implementation process:We live in the age of digital advancements and an abundance of data. By leveraging these two strategically, you can take leaps ahead in terms of not only implementing but accurately running a value-based healthcare system. Tools and software of the digitized era allow hospitals to maintain each patient’s data and to calculate health benefits for them with ease. Take Microsoft Dynamics 365 ERP for an example. This tool facilitates data collation, analysis, automated report generation, and across the board rollout of the latest health plans for medical care facilities.

3.Think of healthcare as an integrated stream with multidisciplinary bodies:In a conventional, free-form healthcare system, medical personnel worked in silos. This creates a barrier amongst different faculties- medical, paramedical, and operational. To successfully implement a value-based healthcare system, organizations need to think of healthcare as a cumulative system where all the disciplines should have access to a centralized data pool to input their findings and generate insights pertaining to patient output.

Future of Value-based Healthcare: What Lies Ahead

Figure 1:Value-based Healthcare: The Multi-pronged Approach

Value-based Healthcare

The Covid-19 pandemic has compelled governments worldwide to inspect their healthcare infrastructure. As the world navigates through these tricky times, it is a given that there will be significant reformations in the medical care system globally. Speaking specifically about the value-based healthcare format, here are some of the upcoming value based care trends that organizations need to keep a tab on:

  • Encouraging movement towards the value-based healthcare system because of the implementation of risk-sharing models.
  • The emergence of cloud-based, one-stop-solution IT infrastructure to facilitate the value-based medical care system.
  • Need for motivating factors and incentives for the medical staff to keep on working in a value-based ecosystem.
  • Increased mergers and acquisitions, giving rise to corporate investments in the healthcare system.

To sum it up, any organization or a healthcare facility looking to implement and sustain a value-based healthcare system will need to internalize a behavior change. This behavior will be driven by the need to enhance patient outcomes. Similarly, technology will play a significant role in this type of implementation. Professionals in the medical domain will need to upgrade their technological know-how to effectively leverage a value-based care system’s benefits.

Key Takeaways

  • The world is looking at value-based healthcare as the next big thing in the medical domain, and thus there is a need for more advancements to facilitate accelerated implementations.
  • Medical professionals, technology consultants, business experts, and investors will play a key role in sustaining this type of transformative healthcare format.

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Customer Journey VP of Quality Control
Customer Journey VP of Quality Control 1440 810 Xcelpros Team
Top concerns of biotechnology industry current issues banner
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Top Concerns of Biotechnology Industry Current Issues
Top Concerns of Biotechnology Industry Current Issues 700 500 Xcelpros Team

At a Glance

  • The world has turned its hopes towards biotech companies to reduce the spread and impact of the Covid-19 pandemic.
  • The biotech industry is working continuously towards fortifying healthcare systems, enabling serosurveillance to gauge the spread of disease in a community and to aid in the development of a vaccine.
  • With governments across the globe funding research and production costs to enable biotech companies to win this battle against time, there are various operational, technological, and workforce concerns that these companies face that need to be addressed with strategic maneuvering from the apex.

Introduction

The Biotech and Life Sciences industry is one of the most sought after sectors this year in conjunction with the pharmaceutical industry as a solution to the current Covid-19 pandemic. Health experts across the globe have agreed that highly effective treatments, including the development of a vaccine, would be needed to reduce and eventually stop the spread of novel coronavirus, allowing cultures around the world to get back to normal activity. While some countries have fared better than others in handling the Covid-19 health crisis, there are still looming fears of new waves. Current Biotechnology issues are expected to normalize with an effective antidote or vaccine.

While the biotech industry sprung into action to begin developing a solution almost immediately, there’s still a long way to go. Challenges faced by biotechnology have been as real as the crisis itself. While the biotech and life sciences industry has a primary role in addressing pandemics like that of COVID-19, it’s not immune to economic downturns, supply chain disruptions, workforce shortage, or any other challenges.

Below are some of the pain points that the Biotech and Life Sciences industry are facing:

01.Roadblocks and Hurdles

All over the world, various biopharma companies, both privately and through government-funded efforts, are performing clinical trials for different potential vaccines and drugs. In 63 days after the genome sequence of the novel coronavirus was shared with the world, USA’s Moderna Biotech Inc. had developed its mRNA candidate to battle the pandemic. Being able to move at a pace never seen before requires immense talent, robust AI-enabled software setup to perform bioinformatics processes, and exceptional R&D infrastructure.

The journey from vaccine development to approval and administration on a global scale is wrought with numerous additional steps and hurdles, requiring mobilization of assets and task forces, recruitment of volunteers, conducting clinical trials, collation, and analysis of humongous amounts of data, smoothly operating supply chains, enormous monetary investments, and a well-equipped production and distribution infrastructure.

02.Collateral Delays

The spread of the coronavirus pandemic brought most of the world to a screeching halt, with many businesses having been forced to close. A result of this is disruptions to major clinical trials and research work on medicines and vaccines for other life-threatening diseases like cancer, HIV, autoimmune diseases, etc. These are collateral delays, and the biotech industry is now challenged with not ignoring existing health issues while still focusing on developing a solution for the ongoing pandemic.

03.Global Distribution

Health experts and top executives at significant biotech companies agree that even if we succeed in making an effective vaccine for Covid-19, there would be a need for immense strategic and operational changes in the current global and local supply chains to ensure that it’s produced and distributed to everyone around the world. With disruptions to most supply chains, only adding to challenges faced by the Biotechnology industry, it will be interesting to see how these organizations address these issues.

Figure 1Covid-19 Vaccine Development in Phases: The Role of Biotech and Pharma

Covid-19 Vaccine Development in Phases: The Role of Biotech and Pharma artwork

04.ROI

A global health crisis of this scale requires a humanitarian approach to ensuring treatment is available to all. This is why most pharmaceutical and biotech companies have agreed that the first or even second batches of any drugs or vaccines they produce(should they prove to be valid) will be distributed at non-profitable rates. We shouldn’t, however, neglect the current biotechnology issues who are investing millions of dollars in rising to the occasion. These organizations will need a blueprint for steady business growth and monetary returns in the post-COVID era.

05.Remote Solutions

Now more than ever, biotech companies need highly skilled and experienced scientists, health experts, and paramedical personnel who can make this journey towards vaccine development smooth. With most businesses still not fully operational to support new workplace requirements, more remote access solutions will have to be developed and embraced to keep operations moving forward.

Role of Microsoft Dynamics 365 Supply Chain in Biotech Companies

We have spoken about some ongoing challenges faced by the biotechnology industry in the war against Covid-19. It is important to note that current biotechnology issues are handled with strategic realignment and robust Enterprise Resource Planning tools. An ERP system such as Microsoft Dynamics 365 Supply Chain enables biotech companies of all sizes to optimize their supply chains, mitigate costs on manual labor, avoid redundant efforts, automate billing cycles, and other enterprise-level processes.

Key Takeaways

These are challenging times for organizations in the Biotech and Life Sciences industry. They now, more than any other sector, continue to work at unprecedented speeds to help the world end this global crisis. Billions of lives are at stake, waiting anxiously for a solution to the ongoing pandemic. There are many challenges that the biotech sector needs to address from disrupted supply chains to the need for multi-layered coordination for clinical trials. With strategic intervention by strong leadership and the use of modern robust tools, these challenges and more, can all be overcome.

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Predictive Analytics in the Pharmaceutical Industry: Key Use Cases
Predictive Analytics in the Pharmaceutical Industry: Key Use Cases 700 500 Xcelpros Team

At a Glance

  • The digital era has given companies various tools and techniques to help pharmaceutical manufacturers optimize and streamline their operations, and predictive analysis is one such highly advanced method.
  • There are different ways with which predictive analytics can integrate with existing software setup and forecast plausible technical glitches and predict future trends, thus helping in enhancing operational efficiency.
  • Predictive analysis can help planning to execution, aftermarket services level to develop better products/ services, improve their response time, and stay ahead of the curve for delivering better customer experience.

The Role of Robust Infrastructure

Database management has become one of the topmost priorities for companies across the globe. This database is used to fabricate trends and patterns for a particular time-frame or a process or a product. Data historians have been around for quite some time now, but manufacturers have recently started to look at them as more than software that stores and retrieves data. Application of predictive analytics is turning out to be a game-changer in terms of predicting the future with maximum accuracy and helping manufacturers make the right calls across various functions- purchase, operations, consumer demands, marketing, and more.

Any business operates with the ultimate motive – to enhance productivity and profits. Optimizing operations thus becomes a must for manufacturers. Companies are riding the digital wave with cutting-edge technologies and tools such as Cloud, Internet of Things (IoT), Machine Learning, and Digital Analytics. By making the most of this digital disruption and using predictive analysis to their advantage, companies can achieve better operational efficiency and higher productivity.

Increased and better predictability for both structured and unstructured data helps companies in planning their operations accordingly for enhanced productivity and a faster pace of work.

Predictive Analytics in Pharmaceutical Operations

Predictive analytics is creating a buzz in the Pharma industry for quite some time now. Different pharmaceutical manufacturing companies are looking to model their business processes by gauging the future requirements. The predictive analysis makes use of data historians to accurately make predictions about future trends, possible glitches, and diversions along the road. While technology has come a long way when it comes to predictive analysis, at an enterprise level, there are many things you can do to make the most of this technique.

93%

of healthcare executives stated that predictive analytics is important to their business’ future.

Source: CIO.com

As major companies are competing to stay ahead, product sales and consumer acceptance of a specific drug are a few contributing factors that help decide on advancing to Predictive analytics.

Here are a few ways that predictive analytics helps Pharmaceutical operations become more streamlined and agile:

01.Predictive analytics assets help in understanding patient needs ahead of time

For years Pharma companies have invested heavily in market research and insight experts to understand various geographies and patient domains. This included research to understand and forecast patient needs and medicine usage compliance to help both R&D and manufacturing teams prepare them ahead, thus catering to the requirements of the patient base. Predictive analysis plays a vital role in this domain by taking historian data and mining it to populate trends and patterns that can be used by Pharma companies to decide upon the demand for their product. Advanced digital analytics is also capable of generating models based on consumption density for a particular geography, demographic, and health index of the patient base. A pharmaceutical company, thus, would automatically be empowered by knowing its end customer base better and learn the composition of drugs and approximate quantities to produce. You can, therefore, produce the medicines as per the forecast and restructure your supply chain as per the demand. All this will optimize your operations by streamlining both the production department and your supply chain. This will result in enhanced productivity and reduced risks of stock-outs or inventory influxes.

02.Digital analytics plays an imperative role in predicting plausible manufacturing equipment glitches

Anyone working on a production line can vouch for the fact that faulty equipment can cost fortunes by becoming the reason for slowed down or altogether stopped production for days. What predictive analysis does is that it uses the stored equipment data and runs the algorithms to understand the working patterns of any equipment. This, in turn, helps in generating reports for plausible scenarios of equipment malfunction. The production team can get forewarned and can work on the said equipment beforehand to prevent any glitches. Apart from helping in enhancing the operational efficacy, this can also help in preventing loss due to stalled production.

One can take the predictive analysis a step further and use the trends generated to get into a proactive maintenance mode, rather than a more cumbersome and costlier reactive maintenance option.

9%

uptime improvement can be achieved by ensuring predictive maintenance in factories.

Source: A Report by PWC

03.Predictive analytics enhances operational efficiency by enabling risk assessment

Predicting the actions and production outcome of a batch record has become integral to measuring the performance of a Pharma product line. Predictive analytics helps in this assessment with maximum accuracy. It also helps in proactively foretelling issues risks related to product line performance, which allows Production Managers to mitigate these risks to raise product quality standards, and hence become a key driver in increasing product performance in the market. This could apply to both software and hardware in a production line. The cumulative phenomenon results in better risk assessment. This helps the operations team to proactively plan the course of their actions for a better outcome. The advanced predictive analytics tools integrate with different software used by the manufacturers to recognize patterns, share information with other machines and apply the principles of machine learning to automatically gauge risks and alert the users on a timely basis. For optimized operations, risk aversion plays an important role.

Figure 1Use Cases of Predictive Analytics in Pharma

01

Deriving 360 degree patient journey insightsDeriving 360 degree patient journey insights

02

Influencing patient adherenceInfluencing patient adherence

03

Capturing genomics data to accelerate discovery of precision medicineCapturing genomics data to accelerate discovery of precision medicine

04

Speeding up drug discovery and developmentSpeeding up drug discovery and development

05

Improving the efficiency in clinical trialsImproving the efficiency in clinical trials

06

Identifying gaps in compliance to streamline regulationsIdentifying gaps in compliance to streamline regulations

07

Reducing cost and speeding up time-to-marketReducing cost and speeding up time-to-market

08

Improving safety and risk managementImproving safety and risk management

09

Managing operations and employee trainingManaging operations and employee training

10

Taking effective sales and marketing initiativesTaking effective sales and marketing initiatives

04.Advanced analytics is essential in accelerating operations

The ways mentioned above with which advanced predictive analysis helps in operational efficiency have all resulted in more agility in the overall operations. Rapidly delivering medicines to the end customer, is becoming a primary responsibility for Pharma companies within the Pharma Value Chain. Companies see a rapid generation of patterns, demands met with more ease, lower risks in manufacturing processes – advancing production lines, and related functions to be more agile.

Business Scenario

Meridian Medical Technologies, a Pfizer company, continues to experience manufacturing challenges in the production of EpiPen® (epinephrine injection, USP) 0.3 mg and EpiPen Jr® (epinephrine injection, USP) 0.15 mg Auto-Injectors, and the authorized generic versions of these strengths. These challenges are expected to result in tighter supplies and greater variability in pharmacy-level access at this time.

Added to the shortage of EpiPens due to tighter supplies, the U.S. Food and Drug Administration provided additional information on lots that are about to expire creating further risk in Epipen availability for the patient base.

A good model of predictive analytics in the Pharma supply chain that provides a gauge of stock requirements based on patient demand, in-store inventory, and expiration dates would have mitigated this risk of Epipen outage before it is too late. Time to market is an essential factor in deciding the success of a product. Accelerating pharma manufacturing processes will thus help companies stay ahead in the competition.

Key Takeaways

  • Predictive analytics is highly effective in risk assessment, equipment analysis, trend forecasting, and data mining.
  • Every industry has their specific criterion to make use of predictive analysis to boost sales and with better use of such tools, enterprises will be better prepared to serve their customer base.
  • Manufacturers can benefit highly from this advanced digital technology by optimizing their operations and enhancing the speed of production.
  • Speeding up the medicine to the market process by predicting demand based on patient demographic enables Pharma companies to be prepared for the increase in end-customer demand and manage stock outages without compromising patient needs.

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Enhance Supply Chain Planning within Pharmaceutical operations
Enhance Supply Chain Planning within Pharmaceutical operations 700 500 Xcelpros Team

Introduction

The COVID-19 pandemic has created significant changes in market dynamics, forever changing the face of the global economy. Along with the pandemic’s impact on our daily lives, there has been a ripple effect in the day-to-day operations of Pharmaceutical manufacturing. As industries around the world continue to adjust to changes, Pharmaceutical manufacturers in specific, are noticing technology, process, and infrastructure gaps that are impeding growth and sustainability. Additionally, businesses that were forced to slowdown production during the initial stages of COVID-19 and are now getting back to full momentum, are finding it difficult to manage end-to-end operations.

Pharmaceutical companies cater to a customer base that is dependent on their products to manage patient health. This requires additional efficiency in everything they do, especially for planning supply-demand. The primary objective is to not halt manufacturing, as the dependencies can impact the entire Pharma value chain. Since pharma companies are quality controlled, there is an additional time factor that comes into the picture while determining the right deadlines to produce finished product and deliver to end customers. The entire process from drug discovery to packaging for delivery is a series of collaborations within the supply chain before the final product reaches the end customer.

Roughly 66% of the surveyed were concerned that COVID-19 could result in a possible supply chain disruption for pharmaceutical products. The statistic illustrates concern levels on possible drug supply chain disruptions due to the COVID-19 pandemic as of April 7, 2020. Matej Mikulic | Statista

The Planner’s Panorama

Due to the rapid changes in the global supply chains, production planners at pharmaceutical manufacturing are now tasked with surveying inventory and operations with a new set of eyes. Organizations need to be more watchful of new safety standards related to inventory storage, retrieval, usage of material, and equipment maintenance. Tools like Visual Gantt Charts are becoming invaluable for planning and managing inventory. The ability to depict a weekly schedule of operations for different production jobs and a clear picture of resource capacity is a core requirement for any good production planner. The production planner’s prime focus is to ensure there are enough raw materials and resources (equipment or human resources) to ensure a near-to-perfect supply-demand ratio. An additional element that supports a planner is to have inventory visibility within their current warehouse and plan transfers of inventory from overflow warehouses.

Operations gantt in batch manufacturing

Simple visual planning methods are no longer adequate to correctly manage all inventory-supply-demand processes and ensure proper movement of transactions across the company’s supply chain.

What planners need is a robust system that can track supply – demand by including a complex set of parameters such as lead times, working calendars, the capacity of equipment and capability of vendors to ship materials on a timely manner. Planners also need the ability to alert different departments of the next steps based on plans made for upcoming weeks or months. Any modern system should be able to offer required insights including the current state of batches manufactured and available equipment for future work orders.

A production planner often prefers handling the supply chain proactively rather than reactively by responding to the demands. The planner needs visibility of when the finished product will be ready, tested, and released for shipment. This type of planning helps overcome downtime and shortages in raw materials, which is a common issue in most companies. Responding quickly to changing inventory is one way for planners to be more proactive.

Process manufacturing operational efficiency

Even today, many small and medium-sized pharmaceutical companies continue to use a combination of excel sheets, inventory reports, and some old school methods when managing their supply chain. As industries continue to face changes related to the COVID-19 pandemic, only companies that have thought ahead and have invested in an automated AI-based planning system that can assess and predict future demand as well projected resource plans will be best equipped to handle their product delivery on time and in full. Companies now need a quicker and more streamlined process to take their products to market.

The Role of a Master Planning and Scheduling System

01. MPS Driven by Demand

The goal of a Master Planning and Scheduling (MPS) system is to provide suggestions to meet material requirements. If set up correctly, MPS systems respond to demand and plan supply accordingly. Demand usually comes from sales orders recorded in the Order Management system. Master planning ties Planned orders for Production or Procurement to corresponding sales orders. The supply requirements are then calculated based on settings for each item that is included in the Finished Goods Bill Of Material(BOM). The coverage settings of an item show precisely how and when to send feedback with a view of current stock levels or foreseen changes in stock levels from existing planned orders in place.

02. Planned Supply

MPS systems use algorithms for tracking the demand from sales orders, customer forecasts, safety stock levels, and calculating net-requirements for purchase and manufacturing. MPS also pulls together independent or groups of demands that trace back to the production of intermediate and raw materials to be consumed in different Manufacturing and Packout processes.

Determining the quantities required would depend on the inventory quantity setup of any single item. The requirement could be specific for a static batch size or dynamic quantities based on the demand needs. MPS systems provide planners the capability to either consolidate supplies across multiple demand orders, offering a comprehensive supply and demand management experience, or consider only the net change from the start of a full production run.

03. Lead Times

The ability to define lead times is critical to a master scheduling system. For instance, if a user enters a purchase lead time the system should account for the time it takes to receive raw materials after placing a purchase order.

I. Purchase Lead Times

Purchase lead times for a supplier can be set up based on different factors including

  • Pricing agreements
  • Time in days that a supplier can accommodate
  • Transportation time, and
  • Any other unforeseen coverage settings

Within Dynamics 365 Finance and Supply Chain, a purchase lead time found for a specific supplier and item combinations takes precedence over general settings of an item. This applies when (1) no vendor is assigned to the item, and (2) the Find trade agreements checkbox is selected via Master planning parameters form > Planned orders tab.

II. Production Lead Times

Production lead times are the details that can be configured in coverage settings; however, these values are disregarded when items are produced via routes. Routes, defined in the modern Production control modules, consider available resources (people or equipment) and their working schedule. In this situation, production lead times needed to create finished goods do not have to be specified by a user, as they are calculated automatically.

Planning for the Unknown

There are still unknowns within pharmaceutical production and operations. Without the right system, planners will struggle to retrieve the data needed to better streamline the manufacturing process. To help with this, Production Planners can benefit from valuable information like –

  • Batch production history and patterns of user behavior that show actual production lead times
  • Quality standards of work-in-process production run based on raw materials that are procured from specific suppliers
  • Quantity yields of past batches, actual scrap percentages based on changes in production routes and resources
  • Accurate actual batch costings in comparison with estimates

These additional details provide supplementary insights to help improve production, downtime planning, maintenance, and most importantly, promise dates to customers. Production planners need to be equipped with a system that presents elaborate sets of insights and actionable suggestions on how to plan/schedule production operations. A well reliable tool empowers a company to drive efficiency and growth.

An AI-ML & Analytics Centric Approach

Eventually, and soon, a standard planning system will no longer be capable for the Pharmaceutical supply chain to operate efficiently. Systems that reduce human effort, learn from history, and improve daily operations will become necessary to overcome inefficiencies. At the same time reporting possible issues and roadblocks that impact orders as well as deliveries, improves the overall plan vs actual picture. Production planners are proving to be more efficient when they have real-time and historical analytics available during the planning process to make better decisions while managing inventory and orders. A guided method of operating and reporting through actionable data can make your company a powerhouse within the industry. An intelligent and optimized planning system can help eliminate guesswork for the production planners in build a competitive edge in the market.

Final Thoughts

The supply chain within a pharmaceutical company is only as efficient as the ability of a planner to proactively coordinate supply, demand, and inventory. A robust planning system with an emphasis on analytics and guided user behavior can play a key role in building efficiency and moving shipments out the door, along with meeting the required quality standards.

Xcelpros has designed Microsoft’s offerings to enhance planning for Pharmaceutical, Chemical, or Biotech industries. For more information on Production planning and Scheduling tools within Microsoft – Schedule Demo

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IT manager customer journey
IT manager customer journey 700 500 Xcelpros Team

Steve an IT Manager, in his job function is a subject matter expert for technology-related processes and systems. He needs to develop strategic roadmaps that align with both business and technology requirements. In regulated industries, like Pharmaceutical and Chemical, he is accountable for all IT activities and ensuring cGMP and 21 CFR Part 11 compliance. He is responsible to develop and implement corporate data compliance and governance initiatives across systems while maintaining IT Best Practices and creating secure, scalable, reliable, flexible, and compliant services.

Customer Journey : IT Manager

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