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Balancing Innovation and Safety: The Tepezza Lawsuit’s Implications for the Pharmaceutical Industry

StrategyDriven Innovation Article | Balancing Innovation and Safety: The Tepezza Lawsuit's Implications for the Pharmaceutical Industry

In today’s time, scientific and technological breakthroughs have helped mankind combat the deadliest of diseases and bring relief. The mere onset of an unknown medical condition has the pharmaceutical giants leaving no stone unturned to deliver the antidotes as fast as they can.

However, more often than not, in an attempt to stay ahead of the competition and increase their profits, these pharma companies put human health at risk. 

Take Tepezza as an example. In its initial years, this drug was hailed as a game-changer for patients suffering from a critical condition known as Thyroid Eye Disease or TED.

In recent years, however, several patients have complained about severe hearing issues after using Tepezza. This has raised serious concerns associated with this drug. 

In this blog post, we will shed light on the concerns surrounding Tepezza and what it means for the ever-growing pharmaceutical industry. 

A Detailed Background on Tepezza

Tepezza is a medication developed by Horizon Therapeutics. In January 2020, the FDA approved Tepezza as the inaugural solitary medication tailored to address Thyroid Eye Disease (TED). This condition, a rare autoimmune disorder, triggers inflammation and harm to the muscles and tissues surrounding the eyes.

How Does It Work?

Tepezza is a human monoclonal antibody that targets and inhibits the Insulin-like Growth Factor-1 Receptor (IGF-1R). By inhibiting IGF-1R, Tepezza reduces inflammation and prevents the production of proteins that can cause eye muscle swelling and tissue damage in TED patients. 

This drug is administered via injection, with healthcare providers conducting infusions once every three weeks. Individuals with Thyroid Eye Disease receive a total of eight Tepezza infusions as part of their prescribed treatment regimen. 

Initial Reception and Success

Following its FDA approval, Tepezza gained recognition for its ability to improve the lives of TED patients. Numerous patients experienced swift and substantial enhancements in their symptoms, enabling them to restore their quality of life and resume regular activities.

The success of Tepezza in treating TED led to its swift adoption by eye care professionals and endocrinologists, who praised the drug’s efficacy and its potential to transform the standard of care for TED patients.

Despite its initial success and positive impact on patient outcomes, the emergence of the Tepezza hearing loss lawsuit has raised concerns about the drug’s safety profile and the potential risks associated with its use.

Tepezza Lawsuits: The Legal Landscape 

Tepezza litigation asserts that Horizon Therapeutics neglected to apprise patients of the potential hazards and adverse reactions associated with the medication. This resulted in serious complications, such as hearing impairment and tinnitus.

One of the first Tepezza lawsuits was filed by Daniel Weibel in August 2022. As per his statement, the pharmaceutical manufacturer was aware or should have been aware that Tepezza, when utilized as directed and intended, induces detrimental hearing impairment and other manifestations, notably tinnitus. 

According to TorHoerman Law, the Tepezza Litigation is currently advancing, with 74 lawsuits consolidated under MDL 3079. These legal proceedings center on marketing, sales practices, and product liability matters concerning the drug. 

However, the number of plaintiffs is expected to grow as more patients become aware of the potential link between Tepezza and hearing loss. Horizon Therapeutics has denied the allegations made in the Tepezza hearing loss lawsuit. 

The company maintains that Tepezza is a safe and effective treatment for Thyroid Eye Disease. It was only in July 2023 that Horizon updated the drug label for Tepezza with a new warning regarding potential hearing impairment, including hearing loss. 

Balancing Innovation and Safety

The pharmaceutical sector is vital for creating innovative therapies that meet medical gaps and enhance patient well-being. However, the pursuit of innovation must be balanced with the equally important responsibility of ensuring patient safety. 

The Importance of Pharmaceutical Innovation

Pharmaceutical innovation is essential for addressing unmet medical needs and improving patient outcomes and quality of life. Researchers and drug developers work tirelessly to identify new therapeutic targets, design novel compounds, and develop groundbreaking treatments that can alleviate suffering and extend lives. 

The Need for Robust Safety Measures

While innovation is crucial, it must be accompanied by robust safety measures to protect patients from potential harm. Rigorous clinical trials and post-market surveillance are essential for identifying and characterizing the risks and side effects associated with new drugs. 

Pharmaceutical companies need to conduct extensive testing and monitoring to confirm that the advantages of their products outweigh any potential risks.

Implications of the Tepezza Lawsuit for the Pharmaceutical Industry

The lawsuit regarding Tepezza’s association with hearing loss carries substantial consequences for the pharmaceutical sector. It has heightened public awareness and concern about drug safety, potentially leading to increased scrutiny from regulators, healthcare providers, and patients. This may result in more extensive safety testing requirements and longer drug development and approval timelines.

The lawsuit underscores the significance of obtaining informed consent. Patients need to be fully informed about the possible risks and benefits of medication to make educated choices regarding their treatment.

Pharmaceutical companies may need to work more closely with healthcare providers to develop effective communication strategies and patient education materials.

Additionally, such a scenario may lead to changes in drug labeling and marketing practices. Companies may need to provide clearer disclosures of potential side effects and risks and adopt a more conservative approach to efficacy and safety claims.

By increasing scrutiny of drug safety, emphasizing informed consent, and promoting transparent labeling and marketing practices, the industry can work to balance the need for innovation with the imperative of patient safety.

Why Adaptability is the Key to Business Success

StrategyDriven Innovation Article | Why Adaptability is the Key to Business Success

If 2020 has taught us anything, it’s how quickly things can change. Almost overnight, the world was plunged into a new era of lockdown restrictions and social distancing as the COVID-19 spread from one country to another. As well as causing a global health crisis, the on-going pandemic has caused economic instability and turmoil for businesses. However, organizations that have been able and willing to adapt to the necessary changes have been the ones to thrive.

While the COVID-19 pandemic may be an extreme example, it highlights just how important it is for businesses to be adaptable. When you can modify your operations or accommodate changes to your industry, you’re far more likely to survive. To learn more, take a look at these three reasons why adaptability is the key to business success:

Evolution

Industries change over time, which means your business needs to evolve too. With continuous improvement tools, you can ensure that your business continues to evolve in a way that facilitates on-going success. The introduction of technology revolutionized the workplace, for example, but businesses who failed to embrace the changes soon fell by the wayside. Conversely, the organizations that used tech to enhance their processes triumphed.

No business remains static, so changing in positive ways is always going to be better than the alternative. As your business evolves, you have the opportunity to expand your operations and increase your profitability. Without being adaptable, you’ll never grow your business successfully, which means evolution is critical to long-term commercial success.

Fast Responses

Being able to respond to things quickly means you can minimize losses, protect your enterprise, and capitalize on new areas of profit. Similarly, a sudden surge in demand for products or services won’t throw you off your stride. Instead, you can adapt your operations to respond to the demand and enjoy the unexpected increase in your profits.

There are numerous factors that can affect business performance, such as environmental disasters and economic downturns. Often, you’ll need to make strategic decisions swiftly, if you want to avoid unnecessary financial losses. When you can scale your business swiftly in response to external factors, you can ensure that you’re operating efficiently, productivity, and with minimal waste.

Effective Teams

An adaptable business recognizes the need for varied skills and talents. As such, you’ll be eager to hire personnel who can drive your business forward and facilitate growth. Similarly, you won’t be afraid to make changes to the workforce when the need arises. Currently, we’re seeing a shift away from static work environments to remote, distributed teams. Unsurprisingly, it’s the businesses that can adapt to this way of working that will benefit the most from the global talent pool and the reduced cost of maintaining a distributed staff.

Being More Adaptable

With so much of your success depending on your adaptability, it’s vital to incorporate this attribute into as many areas of your business as possible. By making adaptability a core tenant of every business decision, you can create an enterprise that’s inherently adaptable and primed for commercial success.

A Fast – and Brutally Effective – Way to Make Your Organization More Innovative

StrategyDriven Innovation Article | A Fast – and Brutally Effective – Way to Make Your Organization More InnovativeStartups are good at innovation for many reasons, but the two most important ones are people and culture.

They attract people who are looking for a challenge and opt into taking risk in the pursuit of a potential, yet uncertain, upside. The successful ones create a culture that embraces problems as an opportunity to break the rules and find a better way. There are clear incentives to succeed and significant repercussions if you don’t – like losing your job. These organizations are often resource-limited, which creates an incredible focus on only doing what really matters.

They also fail at an incredibly high rate. According to the Startup Genome Project, more than 90 percent of startups fail. If you tried to do something with that failure rate at most established companies, you’d be fired. So what can you do?

One of the solutions that some larger companies have tried is to create an innovative startup within an existing business. This approach hasn’t had much success, as it’s far more complicated to implement than people think. These internal startups strive to be innovative, but tend to become more incremental. They’re limited by the people available to them and the culture of the parent organization.

The good news is that there’s a faster way to get innovation going: Eliminate all the jobs in your company with the title of vice president. This probably seems like a drastic step. But, if you want to innovate, you need to find the right people and create a culture that’s willing to embrace unconventional ideas and is unafraid of change. Keep in mind, culture isn’t defined by words; it’s the embodiment of your actions.

You can’t get serious about innovation until you’ve put these foundational pieces in place.

Substance over form

To get started, take your current organization chart and delete the vice president positions. You’ll still need some people to lead teams and organize work, but call these jobs what they really are: managers. If there’s an overlap between jobs with all the titles removed, it’s a great time to simplify things and get rid of any role that isn’t critical to achieving the goal. Fewer people results in a secondary benefit of smaller teams, which research has shown are much more innovative.

When you tell someone you’re eliminating their title, you’re forcing them to choose to derive their value from the work they do instead of what they’re called. You’re making them choose substance over form. If the title is so important that they can’t or won’t do their job without it, then they’ll get in the way of innovation. If they’re willing to quit over their job title, it’s highly unlikely they’ll embrace the culture required to pursue innovation and drive change. Innovation requires people that care more about what they do than what they’re called and can deal with the brutal truth.

Why target the VPs?

The VP title is a symbol of bureaucracy, which is the enemy of innovation.

According to the Merriam-Webster dictionary, a vice president is: “an officer next in rank to a president and usually empowered to serve as president in that officer’s absence or disability.”

That seems like an important role if something happens to the president, but if the U.S. government only needs one, why do companies need so many? They don’t, that’s the point.

It seems illogical that anyone would want the vice president title to begin with. You’re explicitly acknowledging that you’re not trusted to be in charge unless there’s an emergency. If you literally described the title on a business card it would read something like: “John Doe, Not really empowered.”

If someone wants that job, they’re not the right person to be on a team focused on innovation. You can’t have people waiting around to be empowered; they need to be motivated enough to empower themselves. In fact, if you’re going to pursue something that’s never been done before, you need people who are willing to hold themselves accountable for things outside their direct control.

As organizations evolve over time, you’ll likely be recruiting people from larger companies who feel they need titles to do their job. This is a warning sign that they’re not aligned with the innovation culture. You will hear the argument that titles are cheap; they don’t cost anything. But titles are more expensive than you can imagine; they can cost an organization its soul.

Beware of C-level fever

A new enemy in the title game is potentially more problematic than having too many vice presidents. In Russell Fleischer’s article for Fast Company, he talks about a “C-level fever” that’s not only affecting big companies, but startups as well. He points out that if everyone is a chief, no one really is.

Unlike vice presidents, the chief of something implies that someone is in charge, and when it comes to innovation, this can lead to two significant issues. Chiefs tend to like to make decisions, or at least to be consulted on decisions, which slow people down. They also tend to make themselves the focus of their team, when the focus needs to be on solving the next problem and finding the next idea. One of the keys to innovation is optimizing the people doing the work, not those sitting around talking about it. Limit the number of chief titles to those who need to be legally responsible (and potentially liable) for the actions of the company. When people understand that personal liability comes with the title, it tends to be an effective deterrent.

Innovation is hard, but only because we allow ourselves to make it complicated. Simplify your organization chart, find people who don’t need titles to feel empowered, and create a culture that insists on substance over form. You will be much more successful creating solutions to problems that other people believe can’t be solved.


About the Author

StrategyDriven Expert Contributor | Chuck SwobodaChuck Swoboda is Innovator-in-Residence at Marquette University, President of Cape Point Advisors and retired Chairman and CEO of Cree, Inc. He is co-inventor on more than 25 patents covering LEDs and lighting technology, and has over 30 years of experience in the technology business. Additionally, he is an author, speaker and host of the “Innovators on Tap” podcast. His new book is The Innovator’s Spirit: Discover the Mindset to Pursue the Impossible (Fast Company, May 5, 2020). Learn more at www.chuckswoboda.com.

The Right Way To Disrupt Markets (Hint: You Might Be Doing it Wrong)

StrategyDriven Entrepreneurship Article | The Right Way To Disrupt Markets (Hint: You Might Be Doing it Wrong)For the past five years, I’ve established a highly successful manufacturing company that actually supports the little guy. Lots of people said it couldn’t (or even shouldn’t) be done – that manufacturing simply didn’t work that way. I’m happy to say we are growing at an incredible rate, and helping other business owners see amazing growth in the process. But it didn’t happen overnight, and there are many ways that this new style of manufacturing could have gone wrong, instead of becoming the market disrupter that it is today.

Market disruption has become something of a buzzword over the last decade or so. It’s the ultimate goal of most entrepreneurs: find a new, better way of doing things that will become the new normal. Because there’s a rush to find the unique, disruptive, unheard of technology before somebody else does, some innovators dive headfirst into an idea, planning to take on the large corporations in their marketplace without a clear path to success. The right way to disrupt the market is a more calculated, step-by-step planning process.

It goes something like this:

  1. Know the market, inside and out. Before launching our own brand, my business partner and I worked for years inside the industry. We understood the nuances of profit margins, process, and market saturation. We also knew from this experience that there was room for something more. We saw too many smaller brands shut out of a process that could have been much more accessible, and we knew there was an opportunity to change the marketplace.
  2. Secure financing. You simply can’t launch a large-scale, market disrupting company without some capital. If you are independently wealthy, great – but odds are you’ll need to go looking for investors. Investors want to know exactly how you’re different from anyone who has come before you, and they want to see that you have a thought-through plan to get there. Most of all, they want to see your passion for your disruptive business and a dedication to making it happen. Be ready with your insider knowledge and a solid plan, and you’ll get there.
  3. Have a laser focus on your customer. One of the reasons market disruption becomes possible, even in well-established industries such as manufacturing, is because huge corporations lose focus on who made them successful in the first place: their customers. Constantly put yourself in the shoes of the type of person or company you are hoping will come to you. Revaluate their needs on an ongoing basis. For example, our company not only fulfills an initial manufacturing need – we help on the back end with marketing and brand development. If your customer is successful, they’ll have the means to invest. If you’re the reason they’re successful, they’ll have the incentive to invest in your brand. In short, when your customers succeed, so do you.
  4. Always be ready for the future. As your brand truly is able to disrupt your marketplace, you’ll grow with your customer base. But always remember: there are other disruptors right behind you. Always be planning for the next big thing for your consumers. We are continuously looking for ways to bring prices down, so we can reach an even wider base of clients looking for a small-scale manufacturing solution. We always follow market trends, so we know that our facility has to keep up with the demand for cleaner, sustainable formulas for our products. Our commitment to progress and to find innovative solutions will never rest.

Market disruption comes down to the right idea, with the right team, at the right time. Make sure you’ve put in the preparation – and then you’ll be ready to take advantage of your moment.


About the Author

StrategyDriven Expert Contributor | Jordan ErskineJordan Erskine has used his motivation and entrepreneurial skills to advance the personal care products industry for more than 17 years. He currently serves as the President of Dynamic Blending Specialists, a global cosmetics manufacturing company committed to delivering innovative solutions to businesses of all sizes. Jordan has contributed to the technical formulations of a variety of products, including those of Fortune 500 companies, and has facilitated the launch of several successful businesses. Jordan holds an MBA in International Business from Northeastern University.

The Value of the Human Mind – How Machine Learning is Helping Humans Win

StrategyDriven Innovation Article | The Value of the Human Mind - How Machine Learning is Helping Humans Win

Overview

There is no doubt that we are living in the AI era. Artificial intelligence is at work all around us today. Even if we do not realize it, our thoughts and actions are training the technology to respond in the way we desire. Machine learning is one of the fundamental tasks of AI. Just as the name implies, the machines and platforms we use daily are learning from the consistent input we provide. Let’s look into ways that machine learning is helping to make our lives much easier.

What is Machine Learning?

Machine learning is an AI component that uses algorithms to find and apply data patterns. The process involves the input of data into a model that is used to predict an outcome. The more data that is input into the model, the “smarter” the machine application seems to get.

The data used can take on many forms, such as text numbers, images, videos, clicks, etc. If there is a way that the item can be stored, it can be applied to a machine-learning model. There are a variety of ways that machine-learning algorithms are incorporated. These various algorithms fit under three specific types of machine learning.

StrategyDriven Innovation Article | The Value of the Human Mind - How Machine Learning is Helping Humans Win

Types of Machine Learning

The three types of machine learning are supervised learning, unsupervised learning, and reinforcement learning. Deep learning is the refined form of machine learning we see used daily. Deep learning uses an algorithm to create what are called neural networks. Neural networks are loosely based on the neural networks of the human brain. Each of these types of neural networks fits in one of the three categories.

Supervised Learning

Supervised learning involves machine learning, where variables—called features—and labels are assigned to the model used. These features and labels are utilized to properly classify the data received. The algorithm can identify patterns based on predetermined features and labels.

An example of machine learning using the supervised model is a machine that can count coins of different denominations. If the weights (features) of nickels, dimes, and quarters (labels) are input into an algorithm, the model can predict the denominations of the coins based on knowing the weight (feature) of each. Another example of this is with a music streaming service that predicts the best choices of music to play based on the genre you routinely choose.

Unsupervised Learning

Unsupervised learning does not use predetermined features and labels. The model is set up to search for any patterns it can recognize. The process is much like a person collecting shells at the beach and later categorizing them based on their shapes. Since there are no labels in this process, there is a greater ability for the machine to analyze the data to locate hidden structures contained within it. Unsupervised learning has become popular among those in the cybersecurity community.

Reinforcement Learning

Behavior modification involves the use of reward and penalty to encourage or discourage specific activities. For instance, if a dog is being house trained, it will be rewarded when it does its business outside and scolded when it does so inside. Reinforcement learning uses these same feedback responses to train machines to learn.

The algorithm for reinforcement learning is based on a trial and error model. Large amounts of data are input into the model, and the machine is rewarded or penalized subsequent to whether the selections help or hinder the objective of the application. Reinforcement learning is seen with the training of robots for industrial automation.

StrategyDriven Innovation Article | The Value of the Human Mind - How Machine Learning is Helping Humans WinHow Machine Learning Helps Humans

We see machine learning at work in our everyday lives. From our search engine results to our ride-sharing apps, machine learning is front and center in the process.  What he have seen is that augmented intelligence enhances human’s intelligence. Let’s focus on some of the applications that use machine learning.

GPS has become a staple in the lives of all travelers. GPS uses machine learning to assist us in reaching our destination by using other users’ input and recognized patterns. Picture recognition used by Facebook is another form of machine learning that uses a supervised model. Ride-sharing apps use various machine learning models to predict destinations, estimate times, and determine pricing.

StrategyDriven Innovation Article | The Value of the Human Mind - How Machine Learning is Helping Humans Win

Conclusion

Once merely an element in sci-fi movies, AI has become a part of our daily experience. Whether we notice the presence of machine learning or not, our lives have been made notably simpler due to its role in developing applications designed to give humans the advantage. Hopefully, you can now recognize the ways that AI continues to benefit you every day.

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StrategyDriven Innovation Forum

Today’s fast moving market demands that businesses large and small continually innovate in order to remain relevant. Such innovation includes customer offerings and the methods supporting ongoing business operations.

Market

The shape, size, color, and texture of the market is continually changing. To be successful, leaders must understand the market, anticipate its changes, and respond accordingly.
 
 
Market ForumsBut the market is complex, comprised of multiple overlapping environments. Shaping this aggregated external environment are the economic, technological, political, and sociocultural forces exerted by shareholders, customers, competitors, government entities, suppliers, employees and labor unions, trade associations, creditors, and special interest groups. The highly interrelated nature of these environments means that a change in one will have a rippling impact across all of the others. Successful leaders remain ever vigilant to these changes and exert the flexibility necessary to bend these changes into opportunities while remaining faithful to their organization’s overall vision, mission, values, and goals.

Materials in the Market forum are dedicated to discussing the principles of successful marketplace interactions within the following topical areas:

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