Alternative ways to accelerate drug development

Drug development is an essential process in the pharmaceutical industry, but it is also time-consuming and expensive, including pre-clinical, clinical and after-sales markets
.
It’s important to find new ways to develop and speed up the process, and one of the solutions that have gained widespread attention in the past few years involves quantitative methods and modeling ( QMM ), which cover a variety of methods that can be commonly used in the modernization of generic drugs.

QMM is related to many methods used in modern drug development and product lifecycle management

Modeling and simulation are increasingly used in drug development because they provide opportunities to synthesize information and make inferences beyond existing research
.
This has led to the creation of Model-Directed Drug Development (MIDD), a method that can be used for generic drugs and branded drugs

MIDD can use large data sets and support the work of agencies like the FDA
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This model can be used for scientific and regulatory purposes at all stages of drug development, from the start of new drug application to NDA, ANDA, and post-approval evaluation

Quantitative systems are proving to be more and more important, and their potential impact is also great
.
These methods are being more recognized and utilized, especially when a faster drug development process is required

The empirical model used by QMM has obvious advantages
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First, it can be used for interpolation and prediction based on existing data

In addition, QMM is particularly useful for the development of generic drugs, and this use is often discussed
.
Since data from branded projects is usually available, it becomes a way to cut costs and time when developing generic drugs, and provides an empirically reasonable method that can simplify the process and increase speed when the drug is unsafe

Generic drugs usually have a smaller market, which requires more effective development methods to maintain a competitive advantage, while also having a positive impact, because generic drugs are more easily accepted by the public

In addition, QMM is not only related to drug development
.
It can be used for other purposes, for example, to track the natural history of rare diseases, such as Quantitative Retrospective Natural History Modeling (QUARNAM), which can be used to better understand very rare diseases, to develop interventions, to provide consultation and understanding Disease
.
This method can also be used in case studies, just as meta-analysis can be used to understand published research, because it provides a modern way of analyzing cases
.

The advantage of QUARNAM is that it is fast and requires less effort.
It can answer the time required for diagnosis, the patient's survival, which factors can predict the severity of the disease, and where to recruit patients for research
.
By understanding rare diseases, this method can also provide a way to develop new solutions and treatments
.

On the other hand, the pharmaceutical industry in general is increasingly using digital technology, and this trend shows no signs of stopping
.
In particular, the tasks that really promote outsourcing take too much time and require complex data analysis and pattern recognition
.
Another important driving force is to make drug development faster and more effective, which means quick results and better use of existing data
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In particular, the COVID-19 pandemic indicates the need for faster solutions, but beyond that, the generic drug market and other markets need better solutions to help safely launch the necessary drugs, from the beginning of the development process until End after listing
.

       In the future, QMM may continue to develop and become a more widely used method in the drug development process
.
As artificial intelligence (AI) and other digital tools become more accessible, methods for drug development are becoming more and more important
.
However, COVID-19 and the resulting push for digitalization provide an opportunity to see that digital solutions are effective
.

       Today, more organizations will be able to adopt QMM , and agencies such as WHO or FDA are currently promoting QMM, so it is becoming more recognized in modern generic drug development and review
.

       Reference source:

       1.
Clinical Pharmacology & Therapeutics (February 2019), Volume 105, Number 2

       2.
FDA.
(2020).
https://       3.
FDA.
(2017).
https:// public

       4.
Pharmacometrics & Systems Pharmacology (2015), 4(2), 91-97.

       5.
FDA (2017).
https://       6.
J Inherit Metab Dis.
(Aug 26.
2020) Online ahead of print.

       About the author: Zhang Yulin, Ph.
D.
, senior director of a health care industry company in the United States
.
He has experience in clinical medicine, biotechnology, health care industry and other fields, and is responsible for the research and development of botanicals, functional foods and health products
.
He was a clinician and worked for the National Cancer Institute, the FDA and the National Cancer Center of Japan for many years
.