Abstract
The drug development phase is one of the most time-consuming and expensive stages in the lifecycle of a drug. Marred by patent expirations, price regulations, complexities in disease conditions, life sciences companies are facing a daunting task to bring new molecular entities into the market. Digital health technologies are playing a critical role in addressing some of the challenges faced during drug development. In this chapter, the author talks about the challenges and key trends in the world of drug development, use of new digital health technologies, and the future of drug development. As an example, the author dives into a specific case study on the use of virtual assistants in clinical trials and the benefits of its usage on patients, healthcare professionals, and life sciences companies.
TopDrug Research And Development Overview
It takes 10-15 years for a single drug to reach the market. The overall cost for this process increases every few years and currently stands at around $1.4 billion. It is not just the time and cost involved but also the success rate of the compound that makes development of a drug one of the most complex and risky process in the whole pharma value chain. If one starts to screen 10,000 compounds during the initial discovery phase, there is a chance of just 1 compound to get a market approval from a regulatory authority. Hence, both from a social and economic perspective, it is quite natural that drug research and development phase is a key focus area to implement process and operational efficiencies, automation and risk reduction techniques.
Drug research and development comprises of four major stages namely, discovery, pre-clinical, clinical development and pharmacovigilance. As the drug passes through these phases in the development life cycle, there are important regulatory milestones that defines the progress of the compounds till market approval. Figure 1 depicts the various R&D phases and regulatory milestones.
Figure 1. Drug research and development process
During the drug discovery phase, the scientists get involved in understanding the mechanisms of the disease, identifying the disease targets, screening the potential compounds that can bind with the target and selecting the most promising compounds that exhibit good potency with minimal toxicity. Most of the work is done in the laboratory through in silico (using computer simulation and modelling) and in-vivo (in test tubes) methods.
The high potential compounds enter the pre-clinical phase where they are tested on animals whose animal models are analogous to humans and appropriate for the tests being conducted. The main objectives of the pre-clinical testing are to arrive at the right dosages of the compound that are safe for human consumption, evaluate the pharmacokinetics properties measured by ADME (Absorption, Distribution, Metabolism, Excretion) tests and determine the toxicity profile of the compound. Once the compound is found to achieve the objectives, the trial sponsor files an Investigational New Drug (IND) application to FDA. This application is to seek approval for conducting clinical trials on humans.
Key Terms in this Chapter
Investigator: Investigator is a person practicing medicine and is responsible for all clinical trial activities in the hospital site.
IND: Investigational new drug is a formal application requesting the Food and Drug Administration (FDA) to approve the conduct of clinical trials with the drug under investigation.
FDA: Food and Drug Administration is the regulatory body of United States that regulates the use of any food and medicinal products in the United States.
Clinical Trial: It is a scientific study where new investigational medicinal product is tested on human beings for efficacy and safety. Only products passing clinical trials can be launched to the market for use by wider patient population.
R&D: Research and development is the first phase in the life cycle of a drug. It is further divided into discovery, pre-clinical, clinical, and pharmacovigilance.
SMAC: It is an acronym for four digital technologies, namely social media, mobility, analytics, and cloud computing.
Subject: Trial subject is a person participating in a clinical trial. He/she could be a healthy patient or a patient with a disease condition.
NDA: New drug application is a formal process of requesting the Food and Drug Administration (FDA) to approve the use of a medicinal drug in the United States.