The AI wrote about itself in pharma sector

Artificial intelligence (AI) is changing the pharmaceutical sector, offering new opportunities for research, development and production of drugs. Thanks to AI, it is possible to analyze large amounts of data, identify promising molecules, accelerate clinical trials and optimize production processes. In this article, we will see how AI is used in the pharmaceutical sector and what are its main applications.

AI is a technology that allows machines to imitate human cognitive abilities, such as pattern recognition, learning, reasoning and decision making. AI can help researchers identify new molecular targets, design optimal molecules, predict side effects and pharmacological interactions, and reduce the costs and time of clinical trials. AI can also support drug production and distribution processes, optimizing quality, efficiency and safety. Finally, AI can help personalize therapies based on a patient's genetic profile, microbiome and preferences, increasing effectiveness and satisfaction. In conclusion, AI offers significant opportunities for the pharmaceutical sector, but also requires addressing ethical, legal and social challenges.

As mentioned, artificial intelligence (AI) can have practical applications in the pharmaceutical sector beyond researching and developing new drugs. AI can, in fact, help improve the efficiency and quality of drug production, distribution and monitoring, leveraging the potential of technologies such as the Internet of Things (IoT) and blockchain.

Pharmaceutical production is a complex and delicate process that requires high standards of safety, quality and traceability. AI can help optimize production phases by reducing time, cost and waste through the analysis of data from sensors and intelligent machines. AI can also predict and prevent any anomalies, failures or contamination, ensuring the greater reliability of the final product.

The distribution of drugs is another critical aspect of the pharmaceutical sector, which must ensure the timely and safe delivery of medicines to patients. AI can support the management of the supply chain by improving planning, optimization and control of stocks, transport and logistics flows. AI can also integrate with blockchain, a technology that allows for securely and transparently recording and sharing information about drugs along the entire supply chain, ensuring product serialization and traceability.

Drug monitoring is, finally, a fundamental aspect to evaluate the effectiveness, safety and quality of medicines over time. AI can facilitate drug monitoring through the use of IoT devices that collect and transmit data on patients' vital parameters, health status and adherence to therapy. AI can also process these data to provide feedback to doctors and patients, to customize drug doses and methods of administration, and to report any side effects or interactions with other medicines.

In conclusion, AI plays a key role in the pharmaceutical sector, not only in researching and developing new drugs, but also in the production, distribution and monitoring of medicines. AI can, in fact, bring benefits in terms of efficiency, quality, safety and personalization, leveraging the potential of technologies such as IoT and blockchain.

Text and image were elaborated by the BING AI.

What does sustainable (or eco-friendly) beauty mean?

In a world where everyone is trying to go more "green", it seems like we are hearing more and more about “sustainable” beauty products. However, many of us do not really understand what it means.

A product does not have to fulfil any official requirements to be classified as sustainable, at least not from a legal point of view.

Actually, “eco-friendly” can mean a lot of things. For example, it can mean that a company uses packaging made from recycled materials, or that a company makes a specific effort to reduce waste and pollution during their manufacturing activities.

Anyway, an eco-friendly company is making an effort, in some way, to produce their goods in a manner that does not hurt the environment. In this regards, “sustainability” could be referred to:

Sourcing of raw materials: recently simple components and non-invasive procedures has been popular in the cosmetics industry. It is why there is still an increasing interest in raw materials obtained directly from nature or produced in a eco-friendly way.
Sustainable vs natural: a sustainably harvested ingredient won’t be disruptive to its surrounding ecosystems and will be harvested in a way that will ultimately help serve the communities that are doing the harvesting. So, sustainable is the synonym of “green” and refers to manufacturing processing. Natural and Organic ingredients are harvested by agriculture with the lack of synthetic ingredients.
A natural cosmetic product should not contain synthetic substances; although some certifying organizations consider the product to be natural if it contains a very low percentage of synthetic substances. For the production of natural cosmetics, companies shall not use, for example, mineral oils, paraffins, petrolatum, synthetic dyes, synthetic fragrances, synthetic preservatives, i.e. parabens or formaldehydes, as well as propylene glycol (PPG), silicones, BHT, SLS and SLES.

Production: Cosmetics manufacturers are striving to minimise any negative impact on the environment, economy and society in general caused by the manufacturing processes. Transforming materials into products requires, in fact, complex manufacturing systems and uses resources such as energy, water and materials (generates carbon dioxide emissions, uses water and land, produces waste products).

Eco-frienldy Packaging: In the last years, many natural and organic brands have redesigned traditional cosmetic products to drastically reduce or completely avoid plastic packaging, for example, prohibiting the use of halogenated plastics and promoting recyclable and renewable materials for primary and secondary packaging, as well as supporting the reduction of packaging whenever possible.

Biodegradability of the final product is a key factor increasingly improved in the last few years in cosmetics to contribute to the protection of the environment. Innovation and new formulation processes have made it possible to find alternatives to the use of certain substances traditionally used. For example microplastics, water-insoluble plastic particles (smaller than 5 mm) can easily pass through the filters of water treatment plants and end up in the sea.

So, from the final consumer point of view, sure of buying a product safe for the environment, people often feel attracted by the wrong label, the one that actually defines only one aspect of a huge matter: some ingredient used to prepare the cosmetic. And that is not enough. What makes the difference is the entire product life. Everything revolves around two terms that are often wrongly given as synonyms: naturalness and sustainability.

Digital therapies: the new horizon of modern medicine

We are experiencing a digital revolution in healthcare that has never been experienced before and Digital Therapeutics (DTx) are the symbol of this radical change. In fact, it is an example of connected assitance where the patient becomes an actor and manages his data with awareness.

DTx are expanding what is globally achievable in healthcare through advanced technologies that offer increased therapy accessibility and personalization. By definition, DTx products deliver therapeutic interventions to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of disorders.

As PPHC wrote in an interesting article, in addition to the technological side, attention must be paid to clinical and scientific aspects of these medical devices because those apps are subjected to randomized clinical trials, just like drugs.
But they are software with the aim of changing the paradigm of healthcare and, maybe for this reason, they are not so easily defined.

So, after the introduction of synthetic active ingredients, biotechnologies and advanced therapies, here comes a new way of treating pathologies, which is based in some cases on a combination of software and drug.

DTx are already proving useful for treating numerous diseases, especially those related to or caused by behavioral and psychological factors, because they act precisely on the behavior of the individual: from gastrointestinal problems to diabetes, from ADHD attention deficit through Alzheimer's disease, insomnia, depression and respiratory diseases such as COPD.

Globally, the reference for DTx is currently represented by the Digital Therapeutics Alliance which brings together the leading manufacturers of clinically validated digital therapeutic solutions in the healthcare sector. The group's mission is to transform global healthcare by advancing digital therapeutics to improve clinical and health economic outcomes.

The alliance works to broaden the understanding, adoption, and integration of clinically evaluated digital therapeutics with patients, clinicians, payors, policymakers through education, advocacy, and cross-industry collaboration.

DTx are devices certified by notified bodies and must be subjected to clinical trials comparable to those carried out for drugs, but with the new regulation, the DM will also have a post-marketing follow-up that will accompany their use.

According to specialized reports, the Digital Therapeutics Market size is projected to reach USD 8.91 Bn by 2027, from USD 2.1 Bn in 2020 growing at a CAGR of 22.93% during 2021-2027.

The growth of the digital therapeutics market is driven by factors such as government initiatives for preventive healthcare, technological advancements in mobile healthcare, a significant increase in venture capital investments, and the benefits of digital therapeutics, such as the ability to induce behavioral change (an important challenge in healthcare), user-friendliness, patient convenience, and improved drug compliance. On the other hand, a lack of awareness and access to digital therapeutics programs in developing countries, patient data privacy concerns, unstable payment models, and resistance from traditional healthcare providers are challenging the growth of this market to a certain extent.

The reference legislation, in Europe, is mainly represented by the European Regulation on Medical Devices 2017/745 (MDR) even if the EU text does not explicitly mention digital therapies, perhaps because when it was written the concept of digital therapy was, precisely, just a concept.

One of the latest digital therapies approved by the US Food & Drug Administration is a video game, called Endeavor, which has been shown to be effective in managing ADHD diseases in children. It is in effect a therapy, has a package insert, the dose is 25 minutes a day, for 5 days a week, for 4 consecutive weeks. It is exactly the scheme that has been implemented in randomized clinical trials, in analogy with drugs.

In Europe, Germany is leading the way. Berlin has already approved 15 digital therapies, while another 21 are in the process of being approved. Germany is also the first country in the world to prescribe digital health apps, called DiGA (Digital Health applications), and reimburse them through the national health system. The country has introduced a "Fast Track" system for the introduction into clinical practice, with testing, experimentation and evaluation of these apps, and is open to all companies in the European Union.

The tools through which to deliver the DTx are many: apps, video games, virtual or augmented reality systems and wearables.

Patients will provide data in real time and the information gathered can be used also to assess the progress of treatment from a real world evidence perspective: to support coverage decisions, to develop guidelines and decision support tools for use in clinical practice, to support clinical trial designs and observational studies and to generate innovative treatment approaches.
The patient can be now an active part in improving the therapy.

It must be specified that DTx not entirely without risk. While they aren't molecules and therefore may not cause toxicity, DTx can have side effects, such as migraine, dizziness, nausea, dependence on the instrument, all symptoms associated with the prolonged use of electronic devices of any kind.

As per drugs, to be truly accessible to all, reimbursement is a key element.
The implementation of policies and regulations to allow access to and reimbursement of digital health applications has been underway in some regions for some time, particularly in certain European countries. Germany is the first country to provide a dedicated route to national reimbursement for these applications. And the use of DiGAs has increased since they were approved for reimbursement.

From a pricing perspective, DTxs cost 1/5 less than drug therapies. There are no studies comparing the two approaches, but generally the costs required for clinical trials are very high for drugs and very low for digital therapies.

It will be interesting to assess the cost-effective potential of DTx for National Healthcare Services. These therapies are expected to enhance health outcomes and optimize healthcare expenditure (e.g. reduction in hospital readmissions) leading to a reduction of costs associated with diseases/condition.
The generation of real-world evidence will surely have a pivotal role in the measurement of patient-centered and value-based outcomes in economic evaluations.

With a view to the management of chronic diseases, and considering prevention for risk reduction by changing lifestyles, digital therapies can mark a turning point in the management of these patients.

In Italy?

As pmlive has recently reported, a plan has already been developed in Italy, and as of early 2021, it is levelling up the score with other countries in the digital therapeutics realm. The white paper ‘Digital Therapeutics, an Opportunity for Italy’, published on 13 January 2021 in "Tendenze Nuove" journal, contains recommendations for the Italian ecosystem to advance in DTx.
Co-promoted by daVinci Digital Therapeutics, FADOI, FSK (Smith Kline Foundation) and Healthware Group, the publication is the outcome of ongoing collaborative efforts by over 40 of Italy’s leading experts in the field.

To summarize, the regulatory management elements of DTx currently exist (although multiple regulatory issues remain partially or even completely unresolved) and there is no document that puts everything together. Further it is probably necessary to set up the structure for the prescription, data gathering, supply chain, and maybe, thanks to the health emergency, we could see an acceleration that in other times we would not have seen.

Given the acceleration of "tele-health", the adoption of remote and other digital health tools as a result of the pandemic, as well as the increasing investment opportunities pouring in to the digital therapeutics space, a comprehensive plan involving all ecosystem stakeholders is required for digital therapeutics to overcome the mentioned and other barriers to patient access.

We believe that digital therapies will help build a more efficient, digital, sustainable health system.

Sources: ; ;; DiGA

How blockchain is shaping Pharma 4.0

Blockchain and trust.  

The key word in the world of commerce is "trust." Without trust in the brand, consumers would never buy the product, nor would companies finalize a supply agreement. Globalization and e-commerce on the one hand have greatly expanded the commercial horizons of companies, but on the other they have not immediately been able to provide a substitute for the personal relationship between seller and buyer, between supplier and principal, capable of generating the trust that is essential to business. This is precisely where blockchain comes in.

What is blockchain  

The blockchain in fact, is nothing more than a "decentralized" database or distributed on hundreds of computers (nodes) that communicate with each other through peer-to-peer technology. Each computer has an exact copy of the entire database, synchronized in real time with the one present on all other nodes of the network.

Each proposed change to the database must be approved by all computers in the network, and only when the continuity and integrity of the previous changes has been verified, the new one is entered into the database. This creates a continuous and verified sequence of information, chained to each other, that is able to prevent any alteration of data.

Another feature of the blockchain is that it is completely decentralized, therefore devoid of a central authority that can turn the tables and decide what to change or not. The data chain recorded in this way is immutable, shared between the parties of the blockchain so that everyone can verify it and, precisely because of this, it is able to offer each party the trust we were talking about without the need for intermediaries and additional costs.

To give you an image of how a blockchain works, imagine a group of people, each with a huge ledger that is the same as everyone else's, and who agree from time to time on what can or cannot be written on this ledger.

The principle of operation just described also has another enormous advantage: data redundancy. If even one of these books were lost or altered, the copy held by all the others could easily solve the problem by locating the missing or altered data. If realizing controls of this type with traditional tools is unthinkable if not with a huge expenditure of time and energy, not so in the computer world, where information travels at the speed of light.

The strengths of blockchain, therefore, are:  

Together these elements provide a perfect and secure traceability of every transaction or agreement recorded in the database, so that none of this data can be modified, deleted, altered or considered invalid.

Traceability and storage two essential elements  

Anything of value, whether tangible or intangible, can be tracked and exchanged on a Blockchain network, thereby reducing risk and cutting costs for all involved parts, and there is no doubt that it is precisely in the pharmaceutical sector, where product and process certification plays an essential role, that it can play a disruptive role.

In most developed countries, there are agencies in place to verify that the drug being marketed does exactly what it is intended to do.  However, in low- and middle-income countries (but worrying figures are also being reported in advanced countries due to the ease with which medicines can be purchased online), trade in counterfeit medicines, which escape the scrutiny of qualified agencies, is on the rise.

WHO estimates that one in ten medical products in low- and middle-income countries is substandard or counterfeit, and that 1% of medicinal products in circulation on Western markets are fake.

But this is not just a problem in less developed countries. In an increasingly globalized economy, pharmaceutical supply chains are increasingly complex, involving countries from all over the world.  Drugs manufactured in one country may be packaged in a second country and distributed and marketed in yet another country, making it more difficult to conduct proper controls on the supply chain.

Although the pharmaceutical industry has invested billions in defensive measures, so far the efforts have only slowed rather than stopped counterfeiters. According to PwC, a network that provides strategic business and legal advice, the most common anti-counterfeiting tactics only stop half of the counterfeit drugs at great harm to public health and the economy.

This is compounded by another, sometimes even more insidious problem. The raw materials used in the preparation of medicines, but also supplements and cosmetic products, very often come from non-EU countries where there are no reliable control agencies that can certify the absolute quality of the raw material purchased.

This forces pharmaceutical companies to carry out additional checks once the raw material is imported or, in the best case, to always turn to the same trusted non-EU supplier who has proven reliability and safety not only on the economic side but also, and above all, on the technical and scientific side.

It goes without saying that a tool that is able to certify the quality of the raw materials used and the preparation techniques, but also the path of the product in the supply chain, is able not only to improve the efficiency of the supply chain but also to reduce costs by promoting competition.

How blockchain can help  

The implications of blockchain in the pharma supply chain are many. The most immediate concerns the possibility of combating counterfeiting by ensuring continuity between drug production and delivery.

A drug, for example, through the use of RFID or NFC devices integrated in the primary packaging, can be followed step by step in its path from the manufacturing company to its destination, and each step would be recorded in an immutable way in the blockchain so that no counterfeit is possible, even if the secondary packaging, should be replicated.

The steps, thanks to the use of RFID and NFC standards could also be easily verified by anyone, even by the end user, who through modern smartphones that are, almost all, equipped with an NFC reader, would be able to reconstruct the entire supply chain.

As mentioned, combating counterfeiting of drugs in addition to having important implications for public health, also has important direct and indirect economic implications.

Pharmaceutical companies in fact periodically have to deal with a high number of returned drugs. This happens because of overstocking by wholesalers that can reach up to 2-3% of the drugs marketed globally, with a value of between 7 and 10 billion dollars.

Many of these drugs are then, after the appropriate controls, put back on the market, but not before having verified and eliminated the presence of counterfeit products.

In the EU, this is the job of the European Medicines Agency, but when it is necessary to work with other countries, where a centralized regulatory body is lacking, it can become extremely complicated for companies.

Through blockchain, pharmaceutical manufacturers can easily record the serial number of the packaging on blockchain in a fully automated manner and verify the return of that particular product.

Another interesting use case involves product storage. Modern RFID and NFC chips are able to evaluate any physical stress suffered by the product during transport, such as high temperature, humidity, etc. and record this data at any time and in an immutable way in a blockchain. Operators would then only have to verify, downstream, the correct preservation of the product, deciding on its eventual disposal if the recorded data should prove negative.

These are just some of the applications of blockchain in the Pharma industry, but there are many others such as inventory and overstock management, drug compliance, clinical trials etc.. In short, we are at the beginning of a real revolution in the industry and some of the horizons that this new technology is opening remain to be discovered.

Five main issues related to overstock

Overstock can lead to an increase in logistics costs and other unsafe consequences for the company. Here the five main didvantages related to excess inventory:

1) Inefficient handling and flows of goods: the need to keep more goods in the warehouse limits the possibilities of carrying out an efficient slotting. The greater the volume of items to be stocked, the more difficult it will be to manage the warehouse.

2) Deterioration of stocks: a bad management of warehouse inputs and outputs can compromise shelf-life or product traceability, two crucial aspects in sectors where you work with perishable goods (the pharmaceutical or food industry, for example).

3) Increase in storage costs: an excess of inventory leads to greater investments in areas to be used for logistics. In addition, the expenses to be made in equipment and workforce for warehouse management increase.

4) Bad business reputation: mistakes in any warehouse operation impact on the quality of service offered. Excess stock increases the error rates in orders preparation , causing dissatisfaction and complaints from customers.

5) In addition, overstock reduces profit margins both due to the decrease in demand and because, in case of increase in supply, the company will have to invest in larger logistics facilities to increase its storage capacity. It could be also necessary to buy automatic storage systems capable of managing logistical flows.

In this regards, The Mesh represents a valid channel to sell your excess materials.  
You can use the “Manufacturing & Supply” area to place ads to sell your excess inventory and start discussing with interested users. The Mesh will explore any possible business opportunity for your products also outside the platform, leveraging on a growing professional network.