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"Why Make Luxury Sports Cars We Can't Sell Overseas? We Need Strong Bioregulations"Korea's Bio Industry: Voices of the field ① James Jungkue Lee, CEO of Bridge Biotherapeutics
  • By Nam Doo-hyun
  • Published 2016.12.29 08:04
  • Updated 2017.06.19 14:56
  • comments 0

The only thing domestic pharmaceutical companies know is medicine?

Recently, domestic pharmaceutical companies have been jumping into the global competition by increasing their investment in the development of new drugs, but some in the industry call for the need to improve the environment, such as related policies and regulations.

Jung-kue Lee, who founded Bridge Biotherapeutics, a “No Research, Development Only (NRDO)” firm last year, pointed out that the domestic pharmaceutical industry lacked expertise in diseases compared to other countries.

Lee is an expert in pharmaceutical biotechnology, who has worked in overseas projects and project development at LG Life Sciences and who has served as an advisor for a number of biotechnology companies.

In particular, he is one of the rare people in the pharmaceutical industry who argues for stronger regulations in the field of biotechnology. We asked him for his opinion on and outlook for the domestic biotechnology industry in general.

- Bridge Biotherapeutics was founded in September 2015. What is the role of the company as an NRDO firm?

James Jungkue Lee, CEO of Bridge Biotherapeutics

We will only focus on preclinical and clinical trials. Usually, R&D refers to the research and development of new drugs, but overseas, research is clearly divided from development. If research is the search for new compounds by basic researchers, development refers to clinical trials or toxicological testing. Once preclinical or clinical trials are launched with a candidate compound, we are likely to experience trial and error since it is expensive and we can't change the compound being tested. For pharmaceutical companies, they (the material researched) are their babies, so they can be biased. But a company focused on development can select good research from outside, so they are less likely to be biased.

The company has a primary goal to select a candidate compound before the preclinical stage and carry out tests until phase two of clinical trials. Then we plan to pass that compound on to a larger multinational pharmaceutical company or biotechnology company. I look to license the products (in the future). Right now, since we are restricted in our resources to independently develop new drugs in the U.S., we will out-license, but we aim to receive a license and sell our products centered on diseases that do not require many sales personnel in some regions including South Korea. If we focus on specialties that are supplied to general hospitals and not primary products supplied to a wider range of hospitals including clinics, we don't need to have a big sales division.

- What candidate compounds are you currently developing?

There is a drug, code-named BBT401 (Pellino-1 inhibitor), currently in the preclinical preparation stage. Sungkyunkwan University Professor Park Seok-hee found a new function in proteins. He found that a protein was involved in inflammatory diseases and immune responses, and the name of that protein is Pellino-1. The Korea Research Institute of Chemical Technology developed a compound that binds to Pellino-1. So we obtained the rights from these two sources.

- What are the criteria for judging the possibility of a new drug?

No drug is perfect. Anticancer drugs may be toxic, but for terminally ill patients, the benefits can be regarded as great, if they can extend their lives by a few months. Thus it may be okay if the patient's hair falls out when she takes the drug, but if a patient's hair fell out for taking antibiotics, the risk would be considered bigger than the benefit. In other words, when it comes to drugs, we have to look at both the risks and the benefits. For patients with severe diseases or whose lives are at stake, it will be considered a positive drug if it has benefits despite the toxicity. It is important to find the indications for the characteristics of the drug. We are focusing on finding the indications for BBT401 as well. We are testing for the possibility of multiple diseases such as ulcerative colitis, multiple sclerosis, etc.

- In Korea, many point out that commercialization should be strengthened along with research.

It is important to find indications for a drug, but in Korea, pharmaceutical companies are pharmacist-oriented. The situation is changing, but compared to other countries, pharmacists still have significant weight. So these companies may know a lot about drugs, but they don't know much about diseases. On the other hand, there are a lot of doctors with experience in research and clinical trials in multinational pharmaceutical companies. That is why they excel in finding indications for drugs considering their risks and benefits compared to domestic pharmaceutical companies.

For example, (in some domestic pharmaceutical companies) they often try to develop oral drugs, because they believe oral drugs are convenient to take. However, oral drugs must pass through the digestive system and be absorbed in the intestines to the liver, passing through the blood to get to the organ where the disease is located. So it must not be toxic in any part of the body. There are also more factors to consider during synthesis. But if the drug is administered to a cancer patient already admitted in a hospital receiving IV fluids, there is no need for a pill. It can be more effective to make the drug into an injection. If you know the disease, it is not necessary to make the drug for oral administration. Then it becomes much easier to produce a drug with characteristics that fit the disease. Domestic pharmaceutical companies need to strengthen their expertise on such unmet medical needs.

- Should domestic pharmaceutical companies hire more doctors?

After all, things are not as easy as in the past in the medical profession. In the past, qualified specialists were given executive positions, but these days there are a lot of doctors who would be satisfied as a director. I think both sides have a need for the other. Also, more and more young doctors are enthusiastic with the belief that concentrating on basic research and developing new treatments or therapies helps the patient more than opening a medical practice.

-The government seems determined to develop the biotechnology and pharmaceutical industry and is busy easing regulations.

Regulations should be further tightened. It is true that the pharmaceutical industry is a severely regulated sector. But tight regulations are not necessarily bad. Since they (drugs) can be poisonous to a patient, there are many regulations. In Korea, even if a company makes drugs at low cost, it still costs them more than 10 billion won to receive approval for a new drug. But what is the use of creating data that will only be approved in Korea and not overseas with the same amount of money? This would be like regulating Hyundai so that they can receive approval for a luxurious sports car only in Korea and telling them to sell it overseas.

The bio-pharmaceutical industry has to go overseas. It wouldn't be a problem if companies could get easy approval in South Korea and easily sell their products abroad, but no country is going to recognize the product just because South Korea gave easy approval. The government should tighten regulations, and if that requires more money, then the pharmaceutical industry will have to ponder over this and work harder. The domestic pharmaceutical industry cannot grow if we have weak regulations.

- Many argue that stem cell treatments are safe because there are few reports of deviant cases.

I oppose (the argument) that they (autologous stem cell therapy) are safe because you take it out from your own tissue and reinject it. After all, there is no evidence that it is safe. Cells are different from other substances. Once you extract and process them, their nature keeps changing. Whether the changed cell is safe has not been scientifically proven.

Nevertheless, some cell therapy firms demand that they be allowed to sell their products with a conditional approval based on only the results of phase two clinical trials. This means that the government has to permit a treatment, the efficacy of which has yet to be confirmed, and also set a price for such treatment. Let's say that the government may be able to approve the safety of the treatment, but putting a price on a drug with its effectiveness yet to be proven, well, that's a problem even when we consider the patient. Even if the drug is approved in Korea like this, it will never be able to enter the overseas market this way. If it does, it will only be in developing countries.

- In which areas do we need approval first, regulation later?

In the U.S. they only give approval when it is absolutely urgent and when there is no other alternative. In this case, they are more lenient in giving approval than South Korea. They sometimes even allow the drug to be administered on patients while in the phase one clinical trial, not to mention phase two. This is possible, because there are grounds for such flexibility. Good regulations should be top-down, with established general principles at the top flowing to the bottom according to rational thinking.

In South Korea, however, regulations do not follow a top-down system under a larger principle. Instead, they tend to go into great detail. An example is how South Korea only approves gene therapy for diseases A, B, and C. Due to advances in technology, the therapy can be applied to more diseases, but this is blocked by the regulations. Therefore the government should install a general fence claiming that new treatments should rationally prove their efficacy and safety and modify specific guidelines in step with scientific developments.

- What should South Korea do to be flexible and establish effective regulations?

To establish good regulations, we need to be familiar with the characteristics of the drugs and science. If not, we are bound to import overseas products or accept what they (foreign firms) suggest. Overall, the regulations tend to be inconsistent and shredded. First, South Korea's Ministry of Food and Drug Safety must have its own research function. It needs to identify the newest trends and regulate accordingly. The government needs to establish regulations based on rationality, but the current bio-pharmaceutical regulations tend to be a collection of pieces.

- What needs to be improved the most at the Ministry of Food and Drug Safety?

They need to hire more workers. Reviewers and researchers need to carry out sufficient examinations and research to be confident, but they are busy reviewing applications for the approval of new drugs. The number of staff remain the same, but they are pressed to quickly give approval. They can't allow for accidents, and they are expected to absorb foreign trends well. But their number is far too small compared to the number of cases they must handle. Eventually, the companies will suffer damages. If proper regulations are in place, the results can be predicted, and firms can enter overseas markets according to such expectations, but not in the current situation.

In the U.S., they drastically increased the fee for the approval of a new drug, which the company must pay when applying for approval, in order to hire more workers. With that money, they hired more people and solved the problem of a lack of reviewers. This way, pharmaceutical companies may have to pay more for the review, but since the regulating authority is scientifically more competent, they can get approval more easily as long as they focus on the scientific aspect. Even if the companies have to shoulder higher costs for now, eventually, this is a win-win situation for everyone. This is all the more necessary because biotechnology is a field with a strong emphasis on expertise.

- You gathered a Board of Directors solely with outside directors, who are experts in a variety of fields. Why?

Biotechnology requires expertise in terms of the specific diseases as well as management. So when outside directors with experience all in different fields attend a meeting and share diverse opinions regarding a big decision, those inside focus on decision making within a large boundary. Most biotech companies in the U.S. take this form.

But in Korea, the founder is the major shareholder, and the major shareholder is the CEO and the CEO is the president, so there isn't much external input. Assessments cannot be properly conducted when a decision goes wrong. It's the same with venture capital firms, so I hired experts in their own fields as outside directors. Just because one is good in science, does not mean he is good in business management and vice versa.

- How do you plan to manage your company?

I plan to concentrate on scientific research. My ultimate goal is to develop good treatments by utilizing a new science created by South Korea in a field with many unmet medical needs.

hwz@docdocdoc.co.kr

<© Korea Biomedical Review, All rights reserved.>

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