Pharma R&D Trends

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

Introduction

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

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

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

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

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

The Strength of PowerBI

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

Leveraging PowerBI interactive reports in a few quick and easy steps

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

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Turning Industry Data into Smart Decisions

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

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

Figure 1: Pharmaceutical Analysis using Power BI

Pharmaceutical Analysis using Power BI

Usage in the Pharmaceutical Industry

01.Interactive Reports

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

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

02. KPI Reporting

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

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

03.Real-Time Analytics

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

Figure 2:Real-Time Data Tracking with Power BI

Real-Time Data Tracking with Power BI

Benefits of PowerBI enabling business improvements

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

Basic analytics used by the Pharmaceutical Industry

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

Final Thoughts

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

References: Advantages of Using Power Bi

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Using AI & ML in the Pharmaceutical Industry – Key Considerations
Using AI & ML in the Pharmaceutical Industry – Key Considerations 700 500 Xcelpros Team

Introduction

Artificial intelligence is one of those science-fiction-sounding phrases, but what does it mean to people in the pharmaceutical industry? What is the difference between AI and its cousin, ML, which means machine learning? How can the two types of computer software make pharmaceutical companies more efficient and profitable?

The answers are in what they do and how AI and ML work together.

AI can be defined as using computer algorithms—math—to perform tasks requiring human intelligence. IBM defines AI as “leveraging computers and machines to mimic problem-solving and decision-making capabilities of the human mind.”

“It is the science and engineering of making intelligent machines, especially intelligent computer programs. It is related to the similar task of using computers to understand human intelligence, but AI does not have to confine itself to methods that are biologically observable,” John McCarthy was quoted as saying in a 2004 paper.

So if AI acts like somewhat like a human mind to solve problems, how is machine learning different?

“Machine learning is the study of computer algorithms that can improve automatically through experience and by the use of data. It is seen as a part of artificial intelligence,” Wikipedia states.

In essence, the two types of programs work together to analyze information.

For example, say the first 100 production runs of product XYZ1000 have a 70 percent success rate in terms of meeting basic quality standards. Analysis shows the difference between success and failure is one step. Every run where the temperature was kept within a 0.2-degree range succeeded. Every run where the temperature exceeded 0.5 degrees failed. Logic says that keeping the temperature within that narrow range boosts success which, in turn, improves productivity.

Machine learning tells operators, “keep the temperature within 0.2 degrees for this one step.” Artificial intelligence builds on machine learning. It says, “by keeping everything else the same and keeping the temperature in this single step within 0.2 degrees,” the company will see:

  • More efficient use of raw materials
  • Less waste
  • Greater profits
  • A host of other benefits

So how does a pharmaceutical manufacturing company benefit by using AI and ML? Let’s look at the numbers.

By the Numbers

  • $100 billion: The amount of money AI and ML can generate in the US health care industry alone.
  • $161 million – $2 billion: The estimated cost of getting a new drug through clinical trials and obtaining FDA approval.
  • 72 percent: The percentage of healthcare companies believing that AI will be crucial to how they do business in the future.
  • 62 percent: The percentage of healthcare companies considering investing in AI soon.
  • 61 percent: The percentage of companies believing that AI will help them identify opportunities they will otherwise miss.
  • 13.8 percent: A study from the Massachusetts Institute of Technology estimates the number of drugs successfully passing clinical trials.
  • 11 percent: The percentage of businesses who have not considered investing in AI.

Sources: Digital Authority Partners and PharmaNews Intel.

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How AI Helps the Pharmaceutical Industry

Add in a third element—large data sets created by Internet of Things (IoT) sensors wired into a company’s network—and the result is a technology-savvy, company that can see ways to improve efficiency. AI runs computations that estimate probabilities based on known numbers.

Going back to our earlier example, 30 percent of the production runs failed quality standards. That’s the new baseline. Having computers that can finely tune machines reduces tolerances.

Another way pharmaceutical companies are using AI is to speed up drug discovery. It sifts through large datasets from clinical studies and other sources to detect hidden patterns, performing tasks in seconds that once took months. Learning every time they perform a task, AIs run through millions of tasks.

“Drug discovery is being transformed through the use of AI, which is reducing the time it takes to mine the vast amounts of scientific data to enable a better understanding of disease mechanisms and identify new potential drug candidates,” says Karen Taylor, director of the Centre for Health Solutions at accounting and consultancy group Deloitte. “Traditional drug discovery has been very fragmentary, very hit and miss,” she adds in The Guardian article.

The rapid creation of effective Covid-19 vaccines is a direct result of AI and ML in the pharmaceutical industry, Taylor states.

Figure: 1 Funding in Artificial Intelligence in the Pharmaceutical Industry

Funding in Artificial Intelligence in the Pharmaceutical Industry

How valuable is AI to big pharma? Britain’s two largest drug makers—AstraZeneca and GSK—recently funded the Cambridge Center for AI in Medicine at the prestigious university. GSK already opened a £10 million (roughly $13.5 million) in central London. This lab is near Google’s DeepMind AI lab.

DeepMind founder Demis Hassabis recently unveiled Isomorphic Labs, which intends to use an AI-first approach to discovering new drugs. DeepMind’s AlphaFold2 AI system solved the 50-year-old challenge of protein folding. AlphaFold is capable of predicting the 3D structure of protein directly from its amino acid sequence to atomic-level accuracy, Hassabis said in a recent Isomorphic blog post.

“One of the most important applications of AI that I can think of is in the field of biological and medical research, and it is an area I have been passionate about addressing for many years,” he said.

Hassabis considers biology an extremely complex and dynamic information processing system, making it a perfect match for AI.

“But just as mathematics turned out to be the right description language for physics, biology may turn out to be the perfect type of regime for the application of AI,” he said.

The Guardian article also looks at the money: Using older methods, nine of every 10 drugs in development will fail. The average drug development time is 10-12 years. With AI, the success rate is expected to at least double and possibly boost success from 1:10 to as high as 1:2.

How Can SMBs Benefit from AI?

While having $13 million in labs devoted to research is a great idea, many companies don’t have that large of an R&D budget. At least one well-known company has enterprise resource planning modules that integrate AI: Microsoft.

Figure: 2 AI Powered Insights by Microsoft

AI Powered Insights by Microsoft

AI Powered Insights by Microsoft

One example is Microsoft Dynamics 365’s Customer Insights is one of several modules that has AI built in. When pharmaceutical companies combine Dynamics’ Business Intelligence module with its Integrated Chemical Management (iCM), the two work together to mine your pharmaceutical data.

iCM is specifically designed to handle tasks like System of Record (SOR) for chemical and regulatory data plus compliance with cGMP regulations.

Add in Dynamics’ Supply Chain Management module and pharmaceutical manufacturers and suppliers can know to the second how much of any given product they have. Using AI and other information mined from a thorough inventory review, companies can accurately predict how much of any given precursor chemical they need to meet forecast demands. With this information, companies can place orders when costs are low or keep just enough on hand.

The Bottom Line

Pharmaceutical companies already create mountains of data. Instead of losing valuable nuggets of information such as trends and insights, artificial intelligence can sort through it. AI can:

  • Perform comparatively mundane tasks extremely fast
  • Provide your company with ways to create new products at lower costs
  • Produce new drugs much faster than before
  • Reduce the number of new drug failures

Using Microsoft Dynamics 365 modules equipped with the power of AI will ultimately help boost your bottom line.

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

Introduction

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

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

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

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

More Long-lasting effects include:

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

By the Numbers

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

Source: Springer.com

Supply Chain Effects

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

Procurement

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

Planning

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

Transportation and logistics

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

Export

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

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

Supply Chain Effects

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Lasting Effects

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

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

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

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

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

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

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

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Latest Trends in Pharmaceutical Manufacturing Industry 2021
Latest Trends in Pharmaceutical Manufacturing Industry 2021 700 500 Xcelpros Team

By the Numbers

In a July 2021 report, Grand View Research estimated the 2020 global pharmaceutical manufacturing market value at $405.52 billion. Key metrics include:

  • 11.34%: The industry’s expected compound annual growth rate (CAGR) from 2021 – 2028
  • $957.59 billion: The revenue forecast for 2028
  • 77.95%: The retail segment market share in 2020

The IQVIA Institute for Human Data Science used a five-year estimate from 2018-2023 in its 2019 report. This report estimated spending on medicine to top $1.4 trillion by the end of 2021. Looking ahead to anticipated global medicine spending and growth in 2023 shows the top individual regions in terms of spending and 5-year CAGR as being:

  • United States: $625 – $655 billion, + 4% – 7%
  • Pharmerging: $355 – $385 billion, + 5% – 8%
  • Top 5 Europe: $195 – $225 billion, + 1% – 4%
  • Japan: $89 – $93 billion, – 3% – 0%

“Pharmerging” is a term given to emerging nations in areas such as Africa and parts of Asia.

Figure: 1Estimated medicine spending by companies in 2023

Estimated medicine spending by companies in 2023

Figure: 2Estimated growth rate of medicines by 2023

Estimated growth rate of medicines by 2023

5 Topics to Ponder

Despite all the problems and deaths caused by Covid-19, along with its impact on pharmaceutical manufacturing and the U.S. trade war with China, the market for medicines and related products is staying strong.

Looking several years out, one question CEOs and CFOs must ponder is what changes can we make now to prepare for a profitable future?

According to The Medical Futurist, the Top 5 trends for leaders to consider in the coming years include:

  1. 1.Using artificial intelligence to speed research & development. Spending on AI in healthcare alone is expected to hit $31.3 billion by 2025.
  2. 2.Empowering patients to aid in drug design and advisory boards. TMF notes the Food and Drug Administration has its own patient engagement advisory committee. The FDA states the committee considers different topics including the design of clinical investigations, communicating device benefits and risks, digital health technology and more.
  3. 3.Conducting experiments using computer simulations or “in silico,”. This is another digital trend in pharmaceutical manufacturing. This method eliminates animal testing and side effects on humans and animals. So far, this technology is less than halfway to becoming a reality, though.
  4. 4.Boosting the supply chain with technology such as blockchain to enhance security and improve inventory tracking. “Counterfeit drugs might make a cheaper alternative but are the cause of tens of thousands of deaths worldwide while the fake drug trade continues to be a profitable multi-billion dollar business,” according to TMF.
  5. 5.Using technology to appeal to more providers and payers. TMF mentions a wearable monitoring device and an app for feedback from doctors plus the app itself. Another technology is 3D printed pills such as Spritam that gained FDA approval in 2015.

Another topic mentioned in a different report is using real-world-evidence (RWE). A 2018 report by Deloitte defines RWE as, “clinical evidence about a product’s usage, potential benefits and risks derived from real-world data.”

However, Deloitte’s survey also highlighted three potential barriers to RWE adoption by pharmaceutical companies:

  • 75 percent: Major lack of receptivity by external stakeholders
  • 70 percent: Lack of understanding by internal stakeholders
  • 65 percent: Lack of access to necessary external data

AI and ERPs

Enterprise Resource Planning (ERP) software such as Microsoft Dynamics 365 Finance can support different AI modules, as needed. Depending on a business’ requirements, AI can help conduct research more efficiently, automate manual processes and perform other repetitive tasks.

AI benefits researchers through natural language processing and reasoning, learning from data and optimization addressing problems. One example cited by the Royal Society is using “deep” neural networks to identify features required to solve problems. Another uses reinforcement learning to examine many scenarios and assigning credit to different moves—such as chemical combinations—based on performance.

When it comes to research and manufacturing of pharmaceutical products, AI helps researchers use genomic data to predict protein structures, improving diagnosis and developing new treatments. Using machine learning—one part of AI—to predict the three-dimensional structure of proteins from DNA sequences is another example. This is quickly becoming one of the biggest trends in the pharmaceutical industry in 2021.

By creating a highly-detailed computer model that replicates a human organ, pharma companies can see the effectiveness of different drug therapies on specific diseases.

When it comes to pharmaceutical manufacturing technology, which versions work? What are the side effects? What changes can we make to reduce the side effect’s severity? These are some of the questions AI can help answer quickly and efficiently without experimenting on humans or animals.

In terms of business, “artificial intelligence technology allows businesses to automate a variety of processes, frees up employees’ time and helps improve productivity.” The result is greater output in less time at lower cost, according to Intellspot.

AI also helps capture competitive research and analysis. One tool with that capability is Microsoft Power Bi. This software has three types of AI transformations:

  • Text analytics tags images and extracts key phrases
  • Vision analyzes images
  • Azure ML helps generate insights and predictions

ERPs and Regulatory Compliance

A major obstacle unique to technology in pharmaceutical manufacturing is dealing with FDA regulations. Many of these rules require strict recordkeeping. Modern ERPs, which share data between departments, allow companies to keep more accurate documentation and inventory. ERPs allow executives to review data for accuracy, ensuring that information from Inventory Control matches what Finance says it should report.

A key feature of sharing information between different departments such as Inventory Control and Finance, companies can spot areas for improvement. Are FDA documentation requirements being met? A simple query can give a CEO the answer for any department anywhere in the world.

ERPs can also ensure that product communications meet the FDA’s stringent requirements for truth under the Federal Food, Drug and Cosmetic Act (FD&C Act). These laws can result in severe fines for conveying important information the FDA considers misleading.

Labelling is another major part of FDA rules, one where D365’s Inventory Control Module for Dynamics Supply Chain Management stands out. This lets businesses generate barcodes and other labels, tracking products and batches from the moment they arrive through production to their delivery to customers.

Summary

Pharmaceutical manufacturing technology, like the use of AI or ML in research & development, are quickly becoming leading pharmaceutical industry trends since 2020, helping make pharmaceutical companies leaner and more efficient. Modern software like tier 1 ERPs lets them gather, sort and analyze information obtained from the continuous manufacturing of pharmaceuticals much more rapidly than ever before.

Keep up with the Pharmaceutical Manufacturing trends. Get an obligation trial of Microsoft ERP tailored for the Pharma Industry.

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

Introduction

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

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

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

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

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

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

By the Numbers

Expected 2021 sales from Covid-19 vaccine makers:

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

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

Normal Drug Development Process

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

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

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

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

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

Figure:

Normal Drug Development Process

Difference Between EUA and Standard Approval

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

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

The FDA Requires Records

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

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

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

Traditional Recordkeeping is Cumbersome

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

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

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

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

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

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

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

Summary

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

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

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

At a Glance

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

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

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

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

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

Updating R&D

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

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

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

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

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

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

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

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

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

Key Takeaways:

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

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

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