The key to drug development is not just safety and efficacy

[Interview] Young-Joon Park, Ajou Univ. of pharmacy (a representative of IMDpharm)

"Overseas Sale Permit, more Quality Control Submissions"

"The final goal is to establish a foundation for domestic new drug development"

박영준 대표

“In short, it is an area that is easy to miss even though it is important enough to be the core of new drug development.

 

Most of the domestic companies that have applied for a permit with the US FDA or the European EMA are asked to submit additional data.

 

As more and more pharmaceutical companies are attempting to penetrate overseas, Korean companies are also beginning to recognize the importance of quality data”.

 

The reporter met with Park Young-jun, Ph.D.

 

(55, Seoul National University) who is a professor of Ajou University, to hear about CosmaxIMD, IMDpharm joins a venture founded by CosmaxPharma.

 

However, Professor Park emphasized the importance of Chemistry, Manufacturing and Controls (CMC) in the new drug development process.

 

Professor Park has been developing medicine at pharmaceutical companies since graduating from pharmacy.

 

After 17 years as head of product development at Yuhan Research Institute, he worked as research director at Samil Pharmaceuticals and CJ Healthcare.

 

Korea's No.

 

30 new drug 'K-Cap' is a product that he developed as a CJ research director.Professor Park then set up a new drug research institute.

 

IMDfarm stands for 'Innovative Medicine & Drug Delivery'.

 

◆Overlooking the importance of CMC to ensure 'quality of material' IMDpharm is a company researching new innovative new drugs, ▲At the same time as developing new innovative medicine for intractable diseases, ▲Improving absorption of poorly soluble drug solubilization, a pharmaceutical formulation technology ▲Sustained Release Drugs ▲Persistent Injectable Technology ▲Disease Targeted Nanoparticle Technology ▲ It is a company that develops convergent new drugs by holding technologies in various formulations such as eye drops and external preparation technologies and applying them to new drugs.

 

However, at present, IMDpharm's cash cow is quality management, or CMC, which is an essential element in the process of leading clinical trials.

 

Venture companies that are engaged in new drug development are the main customers of IMD Pharm CMC service.

 

According to Professor Park, there is no company in Korea that offers a full range of CMC services from nonclinical to clinical.

 

Most of the nation's top pharmaceutical and venture companies, which spend ₩billions on new drug development, use CMC companies in China or India.

 

This is the result of the CMC not receiving attention in the domestic pharmaceutical industry.

 

But the mood has changed recently.

 

This is because CMC, the quality control of the substance, is considered as important as the efficacy and safety of the drug.

 

"The first thing to notice when developing a new drug is the effectiveness, because any substance has a 'pharmacological effect' to get started.

 

The next thing to notice is safety.

 

It is marketable as a drug, 'Quality Control' covers the whole process, from the beginning to the end, demonstrating that all experiments and tests are made of the same substance and keeping this process as records and data".

 

A typical case is 'Rolontis' by Hanmi Pharmaceuticals, .

 

In March, the US FDA requested additional data from Hanmi Pharmaceuticals for marketing approval, which is CMC data.

 

Overseas, the quality control of substances has already been considered important, and more quality control data are required for companies attempting to obtain a marketing license.

 

Professor Park said, "The reason we have to conduct CMC thoroughly from the beginning of new drug development is that we can't do the same clinical trial again." "Even if you already have finished the clinical trial and submitted the results, if you should prove that you have tested all the animals and humans with the same substances and without impurities, can companies that haven't left their data back in time?"

"CMC is important for finished products as well as new drugs, increased impurity risk " "Controversial impurity management is also an important part of CMC.

 

With the development of analytical techniques and tightening impurity regulations, this poses a greater risk for pharmaceutical companies.

 

CMC will become even more important throughout the production and distribution of finished products, and Valsartan, Ranitidine, and Nizatidine are all about this.

 

" In this atmosphere, IMDpharm has recently expanded its business.

 

Established in 2016 and started full-fledged business from 2017, the company expanded non-clinical CMC to clinical CMC from August.

 

In September, the company established a joint venture with CosmaxPharma.

 

Cosmax Pharma, which has a finished mass production facility, produces the formulation developed by IMDpharm.

 

“CosmaxPharma and IMDpharm have combined to provide full-service services for CMC, and this year, non-clinical and clinical CRO, Dt & CRO (DTI & CRO), will join us to ensure the safety of materials at all stages of drug development, from non-clinical and clinical.

 

The ultimate goal is to increase the success rate of new drug development for domestic companies”.

 

Professor Park would like to help create a new drug development foundation so that all the processes and technologies necessary for drug development can be solved in Korea".