Is there a magic pill? Ozempic and 9 other potential weight loss innovations

With obesity a growing concern worldwide, clinicians and health officials are scratching their heads as to what appropriate and sustainable lines of treatment there are. Obesity, along with other non-communicable diseases like diabetes and hypertension, has major implications for healthcare systems. 

Apart from expensive and hazardous surgery, the other option is weight-loss drugs. These have understandably hit the market with huge aplomb. Losing weight through the so-called “traditional” means of diet and exercise has failed miserably for millions of people.

Weight loss drugs Wegovy and Ozempic are self-administered weekly injectables. They mimic a human hormone called GLP-1. This hormone is released in the gut in response to eating and signals fullness much quicker. Generally, semaglutide has been used in treating Type 2 diabetes, but is effective in addressing obesity. 

The drugs are quite complex to use, and come with a hefty price tag. Indeed, the lowest price for a month’s supply of semaglutide at the maximum dose for weight loss is $804 in the US. 

This is why the field is ripe for new and improved ways to treat obesity 

Introducing startups like Fracty, Health. This biotech company aims to simplify treatment, reduce cost, and ensure the longevity of results. Indeed, with weight loss drugs like Ozempic, once someone stops taking the ‘dose’, the weight piles back, and usually with interest. 

Fractyl Health has developed a treatment for Type 2 diabetes with uses for weight control. It is hoped that this could be a ‘one-and-done’ treatment that lasts for years. Essentially, the company aims to use gene therapy to deliver an artificial gene to the pancreas to continuously produce the GLP-1 hormone. 

Gene therapy is a fascinating and exciting field for biotech companies and lifescience entrepreneurs. In this instance, the treatment usesinactivated viruses to carry a therapeutic gene to pancreatic cells. Viruses are used because of their natural ability to deliver genetic material to cells. 

What opportunities exist for biotech in sustainable weightloss interventions?

The bottom line is that innovative treatment is needed to tackle obesity. Many things cause this disease; biotech can consider numerous ways to contribute to treatment. Broadly, biotech can leverage advancements in genetics, microbiome research, pharmaceuticals and personalized medicine. Possibilities include: 

  1. Precision medicine and genetic testing

Biotech can use genetic testing to identify individuals’ genetic predispositions to weight gain and obesity. There’s an opportunity to develop personalized weight loss plans and interventions based on genetic profiles to optimize outcomes.

  1. Microbiome modulation

Research and development interventions that target the gut microbiome to influence metabolism and weight regulation look promising. This could involve probiotics, prebiotics or microbiome-based therapies. 

  1. Pharmaceutical innovations

Drug discovery that targets specific biological pathways involved in appetite regulation, fat metabolism and energy expenditure should be invested in. These drugs, combined with lifestyle changes to enhance weight loss efforts, may be effective in the long term. 

  1. Nutrigenomics

Biotech companies can study the interaction between nutrients and genes to tailor dietary recommendations based on a person’s genetic makeup. Personalized nutrition plans could be designed. 

  1. Neuroscience and brain-machine interfaces

Lifescience innovators could investigate how the brain processes hunger and satiety signals. Interventions could, for example, use brain-machine interfaces or neurostimulation to regulate appetite and promote healthier eating behaviors. 

  1. Cellular and gene therapies

Cellular therapies, which include adipose-derived stem cells, could target fat tissue and promote healthy weight loss. Gene therapies that modify genes related to metabolism and fat storage present significant opportunities for biotech entrepreneurs. 

  1. Bariatric surgery innovations

There is great potential for scientists to develop minimally invasive and safer bariatric surgery techniques. These could have fewer complications and be less expensive, making weight loss surgery a more accessible and sustainable option.

  1. Metabolic engineering

It is possible to engineer metabolic pathways to enhance energy expenditure and reduce fat storage. Biotech entrepreneurs could develop therapies that target specific metabolic processes to promote weight loss. 

  1. Combination therapies

Investigating the synergistic effects of combining different biotechnological approaches, such as drugs, genetic interventions and behavioral strategies to create sustainable weight loss interventions is a critical gap. 

No need to tighten your belts with Similari

There are a myriad of weight loss innovations with potential. They also come with ethical, safety and regulatory considerations. Rigorous research, clinical trials and collaboration between researchers and healthcare professionals are essential. 

With Similari’s AI-enabled intelligence platform, you can gauge the weightloss drug discovery and innovation landscape in granular detail. You’ll be able to forge ahead knowing what your competitors are up to, who has secured patents and who has concluded a trial. Similari trains itself over time and delivers top insights relevant to your industry. 

Book a demo today to find out how you can offload 90% of your research time with Similari. 

How synthetic biology could change therapeutics

Life sciences is, frankly, an awe-inspiring space. Enter something that can sustainably and ethically engineer and redesign biological systems that don’t yet exist in nature: synthetic biology. Synthetic biology can enable the biosynthesis of drugs that are too complicated and expensive to produce with chemical engineering or drugs that rely on rare plants. There is, thus, enormous scope for the biotech industry to apply this to a range of therapeutic applications. Let’s explore more.

Synthetic biology will reshape our relationship with nature via bio-based products

As climate change threatens human life on Earth, people are reconsidering their relationship with the living world. Synthesis is a powerful approach to learning about and building in step with natural processes. 

In a briefing paper, the World Economic Forum noted that synthetic biology uses science and engineering expertise to design biologically-based parts, novel devices and systems, and redesign existing, natural, biological systems. 

The paper says that the broadest impact area is manufacturing bio-based products and the numerous applications of these products in health and well-being. It doesn’t end there – entrepreneurs are looking at opportunities in the food and feed, industrial chemicals and biofuel industries. 

Synthetic biology will drastically improve healthcare

Synthetic biology has tremendous potential to improve healthcare. Related devices can provide diagnostic tools and enable the design of novel strategies for treating cancer, immune diseases, metabolic disorders,  and infectious diseases, as well as the production of cheap drugs. It presents a significant opportunity for biotech entrepreneurs to develop new treatments and therapies that can improve patient outcomes. 

Synthetic biology is good for the environment

Synthetic biology enables circular manufacturing processes, transforming waste materials into valuable products. Using synthetic biology techniques, biotech entrepreneurs can develop innovative ways to convert carbon-rich waste materials into valuable products. This reduces the need for new raw materials. 

Synthetic biology can be used to improve drug discovery

Synthetic biology improves drug discovery by reorienting all steps of the drug discovery process, speeding up drug target discovery, enabling biosynthesis of drugs, and using synthetic gene circuits for drug target functional screening. Here’s how: 

Target discovery

It can speed up drug target discovery by using genetically-engineered cells to control the localization, timing, and dosage of therapeutic activities in response to specific disease biomarkers. Biotech entrepreneurs can therefore develop new tools and methods for studying disease mechanisms at a molecular level.

Biosynthesis

Synthetic biology can enable the biosynthesis of drugs that are too complicated and expensive to produce with chemical engineering or drugs that rely on rare, sometimes endangered plants. Biotech entrepreneurs could develop new methods for synthesizing lead compounds and drugs to treat diseases. 

Phenotypic screening

An exciting component of this novel process is that it can be used for drug target functional screening. It uses screening by using synthetic gene circuits capable of biological sensing and computation of signals derived from intracellular or extracellular biomarkers. By using synthetic biology techniques, biotech entrepreneurs can develop new methods for identifying drug targets and designing new treatment strategies for diseases. 

Synthetic biology strategies are investment ready

They are a rapidly emerging interdisciplinary research field built on the foundations of molecular biology and genetic engineering. We’re at a critical juncture.

This is where Similari adds value

Similari can equip you with the tools to take informed risks in the ever-growing field of synthetic biology. Similari’s deep data points meaningfully inform your R&D decision-making. Get in touch for a demo today to find out how Similari can help you identify true white spaces in the synthetic biology landscape. 

3 reasons why biotech is booming

Scientific discovery and innovation are no longer relegated to the margins. Indeed scientists are no longer mad megalomaniacs creating Frankenstein’s monster.  

Biotechnology is hip, happening, and certainly the cool kid on the block. Biotech was behind the speed and adeptness with which scientists could understand COVID-19. Within a few short months, scientists mapped the virus’s genome and translated novel technology – mRNA – into a groundbreaking vaccine. Millions of lives were saved. Investment grew manifold. 

A McKinsey report reveals that biotech companies raised more than $34 billion in 2021, which doubled the 2020 total of $16 billion. Venture capital companies invested in 2200 biotech startups in 2016 (globally). In 2021, this had grown to 3100. 

Here are three reasons why biotech is booming. 

Technological advancement

Biotechnology has witnessed rapid technological growth. These advancements include gene editing tools like CRISPR-Cas9, next-generation sequencing techniques, and high throughput screening methods. Such groundbreaking discovery has accelerated drug development and enabled researchers to identify potential therapies more efficiently and effectively.

Increased investment and funding opportunities

The biotech sector has attracted significant investment from both private and public sources. Venture capitalists, big pharma and governments have shown strong interest in biotech startups and research initiatives. This increased funding has allowed biotech companies to pursue ambitious projects and take more calculated risks in their research and development endeavors. 

VC investors appear focused on emerging technologies that can precisely tailor treatments to individual patients and deliver them to the target site. 

Five platforms, in particular, are creating buzz:

  1. Cell therapy

This can pinpoint and treat diseased tissues or cells and other diseases (for example, solid tumors). 

  1. Next-generation gene therapies

These can edit and modulate DNA and RNA and could cure genetic diseases.

  1. Precision medicine

Precision medicine has the potential to diagnose conditions earlier than other diagnostic tools. Therapies can thus be tailored to a patient’s specific needs and genetic profile. 

  1. Treatment of resistant illnesses

Strategies are being developed to target previously drug-resistant or complex targets, such as hard-to-hit proteins and hard-to-treat diseases. 

  1. Novel delivery mechanisms

New delivery methods can send novel therapies to an affected tissue, precisely and safely. 

Growing demand for innovative healthcare solutions

The rapid rise of non-communicable diseases like hypertension and type 2 diabetes, an aging population, and other emerging health concerns, means that the healthcare industry has to respond meaningfully and efficiently. 

Biotech companies are well-positioned to develop cutting-edge therapies, personalized medicine, and other novel treatments for several medical conditions. 

Healthcare costs have also increased globally

Healthcare costs have left many bankrupt. This has pressurized the healthcare sector to find more efficient and cost-effective solutions. Innovative healthcare technologies have the potential to streamline processes, reduce operational expenses and improve patient outcomes. 

Enhanced data analytics will improve healthcare

The ability to collect, process and analyze vast amounts of healthcare data has significantly improved. Now we can harness this data to identify trends, patterns and potential health risks, leading to better-informed decision-making and targeted interventions. 

This is where Similari comes in

With Similari, your data monitoring needs are taken care of to drive data-driven business decision-making. Deep data points are mined and presented in a user-friendly and intuitive dashboard. Reach out today for a free demo, and find out how Similari can help you offload up to 90% of your data monitoring time while delivering valuable insights in real time.

Data monitoring for life science R&D: why reading widely is critical and how you can get it done

While intensive research and development time is critical in the life sciences industry, keeping on top of news, insights and research is essential for data-driven decision making. A discovery is only as good as its broader context. Questions to consider include whether there are competitors playing in the arena, and what patents exist, if any, in your area of development. It’s possible to make rapid breakthroughs if all your (information) ducks are in a row. 

Covid-19 proved how rapidly the biotech sector evolves. Companies like Moderna and BioNTech were newbies in the mRNA space before the pandemic, and with significant leaps in income and status, are now household names.

But as the industry is in constant flux and fast paced, staying on top of reading material can be tricky. Indeed, information overload and time constraints are real concerns for busy biotech entrepreneurs. We’ll look at why you need to read widely, and how to carve out precious time and resources to do so. 

Why staying on top of developments, insights, data, news and research is important

Comprehensive knowledge

Reading widely opens the door to a broad range of studies, research papers, reports and expert opinions. Because the world of biotech can be complex, reading widely on the subject matter can also uncover several perspectives and nuances. 

Identify trends and patterns

Analyzing different data sources helps to identify trends and patterns. This leads to informed decision-making and more accurate predictions based on the collective knowledge from various sources. 

Validation and cross-checking

Reading widely allows you to cross-check information and validate findings. Reproducibility and verification are essential in the scientific community to ensure the credibility and reliability of data. 

Sparking new R&D ideas

There’s no doubt that exposure to diverse ideas and research can spark creativity and lead to innovative approaches in data monitoring and analysis. 

You may be thinking that this is all well and good, but how do I find the time?

Here are a few ways to prioritize your knowledge sessions.

Set specific time slots

Allocate specific time slots during your day dedicated to reading news and insights in the life sciences space. It could be during your morning coffee, lunch break, or after work. 

Use commuting time

If you have a daily commute via public transport, perhaps use the time to catch up on news. If you have a car trip, consider podcasts or recorded readings. 

Prioritize reading

It may seem pithy, but prioritizing your reading time is key. If you consider it essential for your professional development, you’ll be more motivated to find the time for it. 

Participate in webinars

Many organizations, media publications and research institutions host webinars and online seminars on a huge variety of life science topics. These can provide valuable insights without needing to read vast swathes of information. You’ll also likely hear from experts in the field and indeed, get to ask any burning question you may have.

Automating data monitoring

There’s no doubt that the sheer volume of data generated by the life sciences industry is too large for humans to monitor effectively. AI-driven insights management solutions like Similari are able to do it in real-time, collating key findings into an easy-to-read format, and helping researchers offload 90% of data monitoring time from their daily work. 

With Similari, you can do your essential reading in a smart way

It’s important to read trustworthy and robust news and research. With the right data monitoring approach, readers can expand their knowledge in an evolving and dynamic field. With Similari, you have all the information at your fingertips presented on one dashboard. Yep, no need to compile a reading list from multiple sites.  What’s more, Similari’s AI-enabled insights management platform monitors millions of deep data points in your chosen arena of inquiry. Reach out today for a free demo, and find out how Similari can help you offload up to 90% of your data monitoring time, while delivering deeper, more relevant insights in real-time.

Interested in starting a biotech company? Here’s what you need to know

It’s no surprise that more academics and researchers are looking to start their own life science startups. Since COVID-19, the biotech market has had an unprecedented amount of funding to meet huge local and global demand for lifesaving biotechnology. Indeed, 2022 was probably the best year on record for health startup funding.  What’s more, the USA boasts a robust biotech ecosystem, creating a supportive environment for collaboration and access to resources.

Knowledge of the industry’s scientific, business and regulatory aspects is critical

Birthing a biotech company has many unforeseen obstacles. Aside from the typical entrepreneurial headaches, there are a plethora of information obstacles. Knowing your patents from your property law, what R&D exists, and who’s who in the industry is critical to your success. 

We’ve set out a few guidelines, essential to build your knowledge and expertise in the exciting biotech startup space. 

Have your biotech fundamentals down pat

Develop a strong foundation in biotechnology principles, including molecular biology, genetics, cell biology, biochemistry, and microbiology. Familiarize yourself with cutting-edge technologies and emerging trends in the biotech industry.

Do your market due diligence

Understand the current market trends, potential competitors, and opportunities in the biotech sector. Analyze the demand for specific biotech products or services and identify the target market.

Know your trademarks from your copyright

Familiarize yourself with intellectual property laws, including patents, trademarks, and copyrights. Learn how to protect your innovations and navigate the patent application process effectively.

Play it safe

Biotech companies must adhere to various regulations, especially those related to product development, clinical trials, and commercialization. Research the requirements of regulatory agencies, such as the FDA. 

Business management skills are crucial

Acquire knowledge of business management principles, including market strategy, financial planning, funding options, and risk assessment. Develop a clear business plan outlining your company’s goals, objectives, and strategies.

Follow the money

Research funding options are available to biotech startups, such as venture capital, angel investors, government grants, and partnerships. Understand the expectations of investors and how to pitch your business effectively.

It’s also wise to research the legal requirements and taxation policies applicable to biotech companies in your jurisdiction.

Drug discovery and product development essentials

Gain insights into the process of developing biotech products, conducting preclinical studies, and designing and executing clinical trials. Understanding the regulatory requirements and safety standards in this area is crucial.

First, do no harm

Understand the ethical implications of biotechnology, especially when dealing with sensitive areas such as genetic engineering or human clinical trials. Ethical practices are essential for building trust with stakeholders. Familiarize yourself with business ethics and compliance standards. Ensure that your company follows ethical guidelines in research, development, and commercialization processes.

For extensive and personalized biotech startup tips and insights, choose Similari

Getting to grips with business, competitors, existing patents and legal implications of biotech can seem overwhelming. 

With Similari, you are able to stay abreast of such topics in structured, intuitive and meaningful ways, helping you succeed on this journey riddled with challenges. 

Similari’s AI-enabled insights management platform brings you a live feed of all the latest biotech news and developments as they happen by monitoring millions of data points in your chosen arena of inquiry.

Reach out today.

Navigating life sciences M&A in 2023

There’s unprecedented firepower on the table

It’s an interesting year for M&A in the life sciences. The industry is emerging from a period of unprecedented turbulence, and there is currently approximately $1.4 trillion in firepower on the table – the highest amount of available capital for acquisitions recorded in the last decade. Analysts predict large-scale transformative dealmaking, and as life sciences organizations look to grow and future-proof their operations, strategic M&A will play an increasingly important role. 

Here’s a quick guide to navigating life sciences M&A in 2023.

M&A activity is on the rise in 2023

2022 saw a fairly muted year for M&A activity in the pharmaceutical industry. According to Bain & Company, strategic healthcare deals declined by over 30%, with average deal size dropping 15% despite some mega-deals in the fourth quarter. But so far, 2023 has delivered some key indicators that M&A is set to rebound. M&A activity increased by 43% in value terms in Q1 compared to the previous quarter’s total, a rise of 196% compared to Q1 2022. 

As the industry acclimatizes to macroeconomic uncertainties, analysts predict a number of factors will drive growth in this arena. The first is the surplus of cash on hand. The top 25 US firms had approximately $30 billion in cash on hand at the beginning of this year – enough to see some significant movement as the year progresses. To add to this, there are approximately $100 billion in patents set to expire by 2030, meaning pharma M&A activity is expected to rebound significantly in the immediate future as companies move to plug the gaps in their portfolios brought on by approaching patent cliffs. The looming patent cliff is estimated to put around $258 billion at risk as revenues are eroded by the introduction of lower-priced generics and biosimilars. 

The biggest deals of 2023 (so far)

There’s already been some significant M&A activity in the sector this year. 

In April, Merck acquired Prometheus Biosciences for $11 billion, adding an exciting experimental treatment for ulcerative colitis and Crohn’s disease to its portfolio.

In March, Pfizer bought Seagen for $43 billion in what analysts predict will be the biggest deal of the year. The Seattle-based biotech startup is set to broaden the pharmaceutical giant’s oncology capabilities significantly.

Lastly, AstraZeneca is set to acquire American clinical-stage biopharmaceutical company CinCor for $2 billion, looking to boost its cardiorenal pipeline. 

Three steps to successful M&A dealmaking in 2023

In a guest column for Life Science Leader, Arda Ural lays out three strategies for successful M&A dealmaking in 2023. 

  1. Attempt to de-risk deals as far as possible

50% of M&A deals targeted pre-Phase 3 assets in 2022, suggesting that companies are moving towards earlier-stage assets, as opposed to de-risking by targeting late-stage, well-validated clinical assets. Assets that are earlier in the R&D lifecycle come at a lower price, which offsets the higher risk of failure. 

  1. Assess which deals have worked historically, and why

Ural suggests analyzing historical trends to isolate the highest areas of return. For example, bolt-on transactions have higher yields when the target company is in an adjacent therapeutic arena to the primary portfolio of the purchasing company. This suggests that depth and specialization are more lucrative than breadth. 

  1. Ensure the right processes are in place to integrate new acquisitions

According to Ural, M&A doesn’t end when the funds have cleared. A robust change management infrastructure must be in place to ensure the success of the deal in the long term. This includes measures for facilitating cultural collaboration, change management, integration and new workflows.

For the latest in M&A news and insights, choose Similari

The M&A landscape changes by the minute, and to keep abreast of the latest developments, researchers need a tool that analyzes the bigger picture, while customizing granular, relevant insights to their area of immediate interest. 

Similari’s AI-enabled insights management platform brings you a live feed of all the latest M&A news and developments as they happen by monitoring millions of data points in your chosen arena of inquiry.

Reach out today to find out how Similari can help you spot trends as they’re shaped, sharpen your forecasting and keep absolutely up to date on competitor activity, minute by minute. 

Drug repurposing: an emerging approach to lifesaving care

What is drug repurposing?

Drug repurposing, also known as drug repositioning, is emerging as a low-cost, low-risk, highly efficient means of capturing value in the drug discovery process. It involves finding new pharmacological or therapeutic indications for existing drugs that have already been approved by regulatory agencies. Not only does this circumvent the exorbitant costs and resources required to develop a new drug from scratch, it also means that, in an instance when an existing drug is found to have useful applications for other diseases, patients are able to access the benefits of effective care much faster than with traditional drug discovery processes. 

Over the last five years, drug repurposing has gained significant momentum, with the drug repurposing market estimated to grow to a value of $46 851.5 million by 2028, expanding at a CAGR of 5.4% year on year. There are approximately 10 000 known diseases, but only 2500 are paired with FDA-approved drugs. This presents a major opportunity for pharmaceutical organizations, particularly in the realm of rare diseases, diseases in children and pregnant women, and neglected tropical diseases – many of which could be addressed by existing drugs.

In this article, we’ll take a closer look at drug repurposing, and how it has the potential to deliver lifesaving care to patients across the globe, while delivering major returns to the pharmaceutical industry.

A doctor saves his own life

In the early 2010s, Dr. David Fajgenbaum, at the time a medical student at the University of Pennsylvania, became gravely ill with idiopathic multicentric Castleman disease. The disease is characterized by deadly cytokine storms – flares of immune-signaling cells which cause the immune system to attack the body. Determined to save his own life, Falgenbaum set out to find a new treatment approach, examining his own medical records. He noticed that a protein called vascular endothelial growth factor (VEGF) was spiking at 10 times the normal level. He consulted with his doctor and request a prescription for Sirolimus, an approved immunosuppressant usually prescribed to transplant patients. Years later, he remains relapse-free.

Since then, Fajgenbaum has founded a number of organizations dedicated to finding treatments for the 7000 rare diseases affecting over 400 million people around the world, using repurposed drugs.

Blockbusters-in-waiting

A number of repurposed drugs have gone on to become blockbusters in the pharmaceutical market. Most famously, Sildenafil, originally developed to treat angina pectoris and hypertension, was repurposed into Viagra, one of Pfizer’s most successful drugs of all time. Other examples include Minoxidil, which led to Rogaine, and Wellbutrin, which delivered the smoking cessation drug Zyban. 

The advantages of drug repurposing

Repurposing a drug has two main advantages over the traditional drug development process: faster time to market and significantly lower cost of development. The average drug development process takes approximately 10-16 years on average, as opposed to 3-12 years for a repurposed drug – a saving of about 5-7 years of average R&D time. It only costs about $1.6 billion to develop a new drug using a drug repositioning strategy, as opposed to the average $12 billion it costs to develop a new drug from scratch. Chances of success and approval are also much higher – 45% of the failure rate of traditional new drug discovery processes can be attributed to safety and toxicity concerns, a factor not relevant in already-approved drugs targeted for repurposing. Overall, about 30% of repurposed drugs make it through to patients – 20% more than new drugs. 

How AI is accelerating drug repurposing efforts

Researchers are increasingly deploying AI’s ability to process immense data sets and discover and examine complex relationships between data to identify and predict the success of repurposing candidates. In one recent example, researchers used AI to try and identify existing medications that may be effective for the treatment of COVID-19. In just 48 hours, the system had identified baricitinib, a rheumatoid arthritis drug, as the most likely candidate. The drug went on to gain FDA approval for the treatment of adult COVID-19.

Accelerating R&D through AI-enabled insights management

Drug repurposing is one example of how researchers use existing data to create major value in the drug discovery process. 

For R&D teams throughout the pharmaceutical industry, the need to monitor the ever-increasing volume of data emerging across the industry every day is mission-critical to research success. 

By monitoring millions of data points in real-time, many of which are invisible to traditional search methods, Similari’s AI-enabled insights management platform allows you to offload up to 90% of your manual data monitoring time, keeping you absolutely up to date with all the latest developments in your specific arena of inquiry, and allowing you to optimize decision-making, resource allocation and research efforts across the board. 

Find out how Similari will change the way you work by trying a free demo today.

The impact of patent thickets on R&D innovation

Patent thickets – good, bad or simply ugly?

Patent thickets have long been a point of controversy in the life sciences industry. By design, patents are intended to incentivize the R&D innovation and capital investment needed to bring new drugs to market with the promise of exclusive rewards downstream. But a wave of patent legislation passed in the US in the 80s broadened the scope of patentable subject matter and strengthened patent rights significantly, opening the door for a new, arguably anticompetitive practice often employed by bigger pharmaceutical companies to protect their R&D investments by preventing generics or biosimilars from entering the market for years beyond the original drugs’ initial patent coverage period. 

Ethicists claim that patent thickets drive up drug prices, slow down research and ultimately impact patients’ ability to access care. IP advocates assert that patent thickets are simply a natural product of the competition required to drive the innovation that makes treatments available in the first place. But how do patent thickets really impact R&D in the life sciences?

What is a patent thicket?

A patent thicket is a dense knot of often overlapping patents carefully constructed to protect a particular product or technology by inhibiting or preventing generics or biosimilars produced by competitors from entering the market. Patent thickets often include patents which cover similar or the same subject matter. To quote one patent researchers, branded pharmaceutical companies’ patent portfolios often look like the “many-headed hydra from Greek mythology”. 

In order to develop generic or biosimilar drugs, competitor pharmaceutical companies need to either wait for the patents which cover the original drug to expire, or they need to challenge each patent by arguing that the subject matter they cover is not novel or obvious.

The denser the patent thicket surrounding a drug, the more difficult and costly it is to break through it. As a result, patent thickets are an effective deterrent against the development of competitor generics or biosimilars.

Humira approaches the patent cliff

Patent thickets have re-entered the conversation this year as one of the most famous patent thicket cases – the blockbuster drug Humira – approaches key patent expiration in 2023. Humira, made by AbbVie, is the world’s top drug by sales, and it has long been surrounded by controversy due to the sheer number of overlapping patents that protect it – 257 in total, with protections that will run into the next decade, including a patent that covers the “firing button” of the Humira pen device.

To give you an idea of the density of the patent thickets which surround America’s top drugs, 584 additional patent applications were filed for the top five drugs in the US (Humira, Enbrel, Keytruda, Revlimid and Imbruvica) after initial FDA approval, gaining in one case, an additional 28 years of patent protection beyond the key patent expiration.

Thickets like these have come under increasing scrutiny, particularly in the US, where the public pays higher prices for drugs than anywhere else in the world. Last year, a bipartisan group of US Senators formally requested that the US Patent and Trademark Office make decisive moves to clear out patent thickets they believe inflate drug prices and stifle healthy competition, and combating high drug prices has been firmly on the agenda for the Biden administration. In 2021, the President passed an Executive Order that clearly pointed to the misuse of patents to “inhibit or delay generic drugs and biosimilars” as a key driver of drug price inflation. 

The problem with upstream patents

One of the primary concerns around patent thickets is that many are constructed around basic upstream research technologies, making it increasingly difficult to conduct effective biomedical research without risking patent infringement. 

One famous case of upstream patents restricting research was the “golden rice” development process. Scientists developing the vitamin A-elevated genetically modified crop apparenetly came up against over 70 different patents hindering their ability to conduct the foundational research required to take the project to completion. In this case, the relevant patent holders agreed to license the technology needed for free (primarily because the project was in aid of a humanitarian cause, not for-profit). 

However, while upstream patents covering basic research technologies are troubling in principle, there is no clear evidence to suggest that upstream patents have any major impact on biomedical R&D efforts, specifically in academia. 

Avoiding patent thickets with Similari

For researchers and R&D teams, patent thickets present an expensive dead end to R&D efforts. But due to their complexity, they can be difficult to avoid without a clear overview of the patent landscape for the field of research you’re working in. As a result, many researchers spend hours every week manually monitoring data for patent news and competitor intelligence to ensure that resources aren’t being directed toward protected targets. 

The AI-enabled Similari insights management platform allows researchers and R&D teams to offload up to 90% of this manual data monitoring time, providing you with a moment-by-moment crystal-clear picture of your defined arena of inquiry. By monitoring millions of deep data points across your field, Similari is able to deliver actionable insights and the latest patent and clinical trial news, much of which is invisible to traditional search methods. 

Find out how Similari can help you navigate and avoid patent thickets by trying a free demo today.

6 tech trends advancing biotech and pharma

Unlocking the power of big data 

The life science sector, a historically slow adopter of digital transformation, has taken enormous strides toward digital maturity over the last few years, primarily in response to the unprecedented demands of the COVID-19 pandemic. 2023 sees a host of exciting technologies, and the enormous potential for progress they represent, rolling out into common usage across the industry. Some of these technologies are not new, but rather newly useful, due to new data analytics technologies which help turn the data they provide into actionable insights and efficiencies. Others have been in the pipeline for years, finally reaching the inflection point where they’re fit for purpose to effect real change. 

In this article, we take a closer look at 6 tech trends currently advancing biotech and pharma, and the ways in which they’re set to change drug discovery and patient care forever. 

Wearable tech

The increasing accuracy and capabilities of wearable technologies for collecting health data have them playing a growing role in clinical trials going forward. It’s estimated that 70% of clinical trials will include some kind of wearable tech data collection by 2025. Not only does wearable tech allow closer monitoring and automated collection of patient health data, it also allows for offsite or remote trials, cutting the costs associated with administering trial sites, which can range from 35-65% of the total cost of a trial, and lowering the rates of patient attrition. The use of wearable tech in collecting invaluable Real-world Evidence for post-trial studies is also becoming increasingly important, helping life sciences organizations optimize their processes and more accurately analyze their products’ efficacy and safety once it goes to market. 

Blockchain

Blockchain technology is being deployed to increase visibility across the pharmaceutical supply chain and secure its fidelity by improving privacy and security at critical touchpoints. This includes secure tracking and tracing of products, more efficient product recall capabilities, combating drug counterfeiting and securing patient and trial data. Blockchain is also helpful in the R&D process, by facilitating robust IP and data-sharing protection, particularly for dispersed research teams. 

Artificial Intelligence (AI)

Analysts predict that 2023 will mark an inflection point for the use of AI and ML in the biopharma industry, as the products available have reached a point where they are finally fit for purpose. AI can cut down both the time and the significant cost it takes to bring a new molecule to market as it’s deployed throughout the drug discovery lifecycle, from identifying the most viable targets and predicting small molecule structures to analyzing the increasingly large amount of data generated throughout the clinical trial process. According to one report, the AI healthcare market will be worth at least $31.3 billion by 2025, growing an astonishing 41.5% per year until then. 

AI-enabled Insights Management Platforms

Researchers, R&D teams and other key stakeholders in the life sciences sector are using AI-enabled insights management platforms to carry out key data monitoring tasks. With AI-enabled insights management, researchers are able to offload up to 90% of manual data monitoring time, while accessing deeper insights, as they emerge. These platforms monitor millions of data points across the industry, including the latest trial data, press releases, patent news, emerging startups, competitor activity and more. This information is then used to identify true white spaces for R&D efforts, inform strategic decision-making and avoid research duplication.

Data Analytics

Forbes projects that the life sciences industry will increase the amount spent on data analytics by 27%, to $1.2 billion by 2030. According to Forbes, digital analytics technologies are set to deliver more effective clinical trials, better risk assessments, improved forecasting and optimized R&D processes, reducing drug development costs by at least 15%.

Digital Health

Many of the biggest players in the pharmaceutical industry have made significant investments in digital health this year, including giants like Merck, Pfizer and Novartis. Digital health involves using digital tools to monitor and improve patient care, including wearable medical devices, mobile apps, software as a medical device (SaMD) and health informatics. The digital health market is set to hit $42 billion by 2027.

For AI-enabled insights management, choose Similari

The powerful AI-enabled Similari platform allows you to put your data monitoring functions on autopilot. By constantly monitoring millions of deep data points across your chosen arena of inquiry, Similari equips you with a comprehensive, moment-by-moment snapshot of your field, as it develops day to day. Spot potential partnerships, identify white spaces, streamline research processes and avoid costly R&D dead ends with the right insights, delivered to your feed as they happen.

Find out how Similari can advance your R&D efforts by trying a free demo today.

AI-enabled business intelligence

An insurance policy for the life sciences sector

Mitigating risk in the R&D lifecycle

With over 450 000 clinical trials currently in process, the volume of data in play is far too large for error-free human monitoring. In a sector that shifts at a phenomenal rate, without the correct business, competitor and innovation intelligence solution, life science organizations open themselves up to significant risk in a number of critical areas.

Patent thickets, research waste, sunk costs, IP risk, dead ends, trial redundancy, reputational and financial risk, as well as the risk of unnecessarily compromising the health of duplicative trial participants are all immediate dangers without a clear, moment-to-moment view of emerging data within the field.

To avoid throwing precious resources at a dead-end and to retain ethical fidelity, many life sciences organizations are investing in AI-enabled business intelligence solutions as a type of insurance policy to help mitigate these risks. 

Here’s why the right AI-enabled business intelligence solution is critical for R&D teams in the life sciences sector, protecting both organizations and patients from major risk.  

The Ethics of duplicative trials

A 2021 cross-sectional study of clinical trials in mainland China evaluating statins in patients with coronary artery disease investigated the effects of redundant trials on patients. The study revealed that, among 2577 eligible trials conducted, 79.4% of them were considered redundant. In these redundant trials, over 100 000 patients were treated in control groups without statins, resulting in an extra 3000 Major Adverse Cardiovascular Events (MACEs), and nearly 600 deaths.

Avoiding redundancy in clinical trials is a question of ethics, and while most pharmaceutical R&D organizations make sincere efforts to get this right, sufficient monitoring of all ongoing trials is next to impossible without the assistance of an AI-enabled business intelligence solution.

Staying ahead when competition is fierce

Setting up and executing a clinical trial is enormously resource- and time-intensive, and R&D teams face a constant threat of being beaten to the punch by a competitor muscling in on their targets. To mitigate these risks, extensive, granular competitive intelligence is crucial. With an AI-enabled BI solution, researchers have access to moment-to-moment updates on all news, publications, press releases and other relevant information to help them keep tabs on competitor activity, identify viable opportunities before others do, identify threats and risks before they become a problem, and forecast expenses more accurately for better planning and budgeting.

Avoiding IP risk

AI-enabled business intelligence solutions provide insurance against IP risk by providing a comprehensive view of existing patents and prior art findings – a mammoth and high-stakes task with traditional manual search methods alone.

By expediting the FTO analysis and allowing for comprehensive proactive data monitoring, AI-enabled business intelligence solutions keep R&D organizations ahead of both existing and emerging IP risks.

Mitigate risk with the right BI solution

In order to mitigate risk in every step of the R&D process, life sciences organizations need to invest in a comprehensive BI solution for competitor, innovation and business intelligence. An AI-enabled BI solution like Similari allows you to monitor millions of existing and emerging data points in your chosen arena, delivering critical insights which will help you protect your operation from dire financial, innovation and reputational risk, while streamlining your research processes and offloading up to 80% of manual data monitoring time. 

Get in touch with our team today to find out how Similari stands as the insurance you need against redundancy, dead ends, sunk costs, IP risks and more.