Sergey Avdeychik, Director of Healthcare Technologies at Andersen.
According to data by Statista, the revenue of the worldwide pharmaceutical market at the end of 2020 was $1.27 trillion. The growth of this market is largely associated with information technologies. More and more pharmaceutical companies are entrusting their manufacturing and logistics processes to outsourcing companies in order to reduce costs and increase overall efficiency. Let's review how pharmaceutical manufacturers apply technologies throughout drug discovery and development and what opportunities this brings for technology companies.
Significance Of Partnerships Between IT And Pharmaceutical Companies
According to Journal Biostatistics, only 13%-14% of more than 20,000 drug candidates from all disease areas entering the development process from the year 2000 to 2015 will ultimately be approved. In oncology, the success rate dropped to a devastating 3.4%. AI/ML technologies can help select several of the most promising compounds out of tens of thousands of candidates for the role of a drug. This selection process is carried out in silico, with no lab tests or human participation, which can accelerate drug discovery from 4-5 years to several months and therefore help drive down the costs.
I’d like to highlight the growing trend of digital health — cooperation between AI companies and big pharma. According to Nature, the total external investments in 14 leading AI companies of this segment amounted to around $3.5 billion in 2020 and 2021.
An example of AI's potential in drug discovery is the identification of baricitinib as a potentially effective drug against coronavirus in just a few days, and now, this medication has been approved by the FDA for emergency use against Covid-19.
For state-funded scientific institutions, I would like to single out such an area of interest as in silico drug discovery. In this area, the ATOM Modeling PipeLine stands out. This open-source modular and extensible software pipeline exists to build and share models which help advance silico drug discovery. The National Cancer Institute oversees this project as part of the Cancer Moonshot initiative.
Another area of interest for the IT business in the pharma industry that I’d like to mention is the development and implementation of clinical trial management systems (CTMS). These solutions make it possible to find trial subjects, including remote enrollment capabilities, manage their data, streamline data transfer, achieve greater transparency of the trial conduction, improve research documentation and make trial audits clearer.
Applications that automate the process of data exchange between an electronic health record (EHR) and electronic data capture (EDC) and solve the current interoperability problem are also worth paying attention to. An example of such a solution is one company's cloud-based SaaS, capable of remotely accessing patient records in EHRs of different vendors and providing fast automated delivery of accurate, traceable and verified data to research applications.
Special attention should be paid to the advancement of decentralized clinical trials (DCT), where many stages, including patient registration, clinical data collection and patient monitoring in real-world settings, are carried out remotely with the help of remote patient monitoring (RPM) solutions and TeleMedicine. Some scientists consider this a new era of high-performance and inclusive clinical research tuned to the diversity and unique needs of individual patients.
Digital Supply Chain And Manufacturing Management
McKinsey has estimated that, in terms of investment volume, supply chain management and manufacturing is the second-largest sector after marketing and sales, reaching $88.9 billion globally.
The manufacturing stage of drug development requires processes to be organized in accordance with the industry standards, such as good manufacturing processes (GMP) and process analytical technology (PAT) framework. Pharmaceutical manufacturers must comply with the requirements for the procurement of raw materials, organization of pharmaceutical production, supply chain and pharma distribution management, as well as disposal of waste and unclaimed products. Dedicated software – including enterprise resource planning, batch management software and more – can be used for procurement management, production and quality control.
Intelligent tools make supply chains faster and cheaper, improve end-to-end supply chain visibility, adjust needed inventory levels on time and accurately, optimize predictive maintenance, protect the integrity of the supply chain and help monitor compliance with the transportation technical standards.
As a technology that is gaining momentum, I’d like to highlight blockchain, which can be used to track the path of raw materials, ingredients and components. An example of such a solution is a temperature-monitoring system developed in order to maintain the required temperature regime during the transportation and storage of shots.
Blockchain is likely to be part of the future of supply chain management. There are also signs pointing to the onset of pharma Industry 4.0, which is characterized by the integration of connectivity, AI and robotics to enable systems that operate with little or no human involvement for an efficient, safe and cost-effective pharma business.
You can see how the tightening of standards for control over pharmaceutical products at the level of state regulators increases the demand for solutions to detect, assess, report, understand and prevent adverse effects of medicines. This demand impacts the growth of the market — with one calculation noting the CAGR stands at 7%.
Pharmacovigilance software has evolved from a “system of records” to a “system of intelligence” that integrates various databases, services and systems for working with various types of databases and structured and unstructured datasets.
Drug adverse effect reporting and analyzing is pharma companies’ obligation that is enshrined in the laws of many countries. This obligation can be effectively observed by using mobile apps, such as Yellow Card (UK), LAREB (the Netherlands) and HALMED (Croatia). These programs enable patients, caregivers and healthcare professionals to report adverse drug reactions (ADR) and receive the latest information and news alerts.
The pharmaceutical market offers a vast number of opportunities for using IT solutions. The partnership between IT businesses and pharmaceutical companies contributes to the effective organization of processes at all levels of drug discovery — from identifying drug candidates to managing production and supply chain. The advantages of integrating software solutions, blockchain tools, cloud technologies and AI/ML in the pharmaceutical industry include automated production and distribution cycles, lower production and logistics costs, increased efficiency and quality of production and management processes, and enhanced data security.
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