The opening ceremony of the "Development and Production of National Biosimilar Cancer Drug - BİOSİM" and "National Pandemic Influenza Vaccine - GRİPA" projects of TÜBİTAK MAM Institute of Gene Engineering and Biotechnology, initiated by TÜBİTAK and its project partners, was held on October 02, 2015 at TÜBİTAK Gebze Campus.

With the launch of the National BİOSİM and GRIPA Projects, our country's dependence on foreign countries for biotechnological products in the field of health will decrease, and a major step will be taken in line with the policies of bringing the necessary technological know-how and experience for domestic production to our country.

Ata ŞENLİKÇİ, Gebze District Governor Mehmet ARSLAN, Darıca District Governor Ömer KARAMAN and other protocol guests, as well as project partners NOBEL Pharmaceutical Company Chairman Hasan ULUSOY, SENTEGEN Company Founder Burak YILMAZ, Public Health Institution of Turkey, MEDİPOL University, ISTANBUL University officials and many other guests.

In the opening speech of the program, which started with the project introduction film, TÜBİTAK MAM President Assoc. Prof. Dr. Bahadır TUNABOYLU said, "With the start of BİOSİM and GRIPA projects, our country's dependence on foreign biotechnological products in the field of health will decrease thanks to these technologies to be realized nationally."

In his speech at the opening ceremony, Minister MÜEZZİNOĞLU said that the developed countries of the world want people in Turkey to have an understanding that is more oriented towards labor and physical strength.

Stating that the people of this country have a history of shaping the world with their discoveries in the field of science, Müezzinoğlu said, "What is more sacred than the sweat of the brow is the sweat of the brain, the sweat of the mind. We need to realize that we are the addressee of 'Don't you ever think' and that if someone can succeed, so can I. In this sense, Turkey has been trying to build the infrastructure of that process in the last 10 years. How successful it has been, we are starting to see the first nuclei of our successful steps today. Inshallah, we will reach those points we desire in 2018 and on the 100th anniversary of the founding of our Republic."

Stating that the world of science, academic studies, entrepreneurship and the private sector are very important, Müezzinoğlu mentioned the importance of the state standing behind these structures.

Explaining that Turkey has reached a level where it can carry out macro and micro level studies, Müezzinoğlu said that the country has the necessary infrastructure and people with entrepreneurial spirit.

Müezzinoğlu said that during their journey to the program, Fikri Işık, Minister of Science, Industry and Technology, told a story that ended with the words "you will die in accordance with the legislation":

"We will not kill this country in accordance with the legislation. We need to take this country to a different point without getting stuck in the legislation and by making the legislation suitable for the vision of this country. If we are to be in the race at the level of contemporary civilization, legislation should not be an obstacle to this, on the contrary, it should be at a point that supports this and paves the way for it. As the Ministry of Health, we have come to an important point. We are currently building 216 hospitals with a capacity of 36 thousand beds. Our hospitals with a round figure of 70 thousand bed capacity will be put into service in the next 1, 2 and 3 years, i.e. one third in 1 year, one third in 2017 and the rest in 2018 at the latest."

Stating that the medical technology device, medical and medical product and the consumption product in the following process are called "kit", Müezzinoğlu said, "We consume millions of kits every day. As Turkey, will we boast of being a country that can offer health services that can compete with the world or will we be a member of an understanding that can produce what we consume at the same time and present what we produce to the world? If we can take this business with both feet, we can be at a sustainable and executable point."

- "The pharmaceutical industry has a well-established structure"

Stating that the historical importance of these two projects will be better seen in 2017-2018, Müezzinoğlu said: "Our pharmaceutical industry has a deep-rooted infrastructure that can almost be called historical. We have a strong infrastructure that can compete with the world when our academicians trained in this sense in our universities are well coordinated, motivated and integrated. Some politicians in Turkey say, 'independent Turkey'. If you cannot produce your own products here, if we are not here, independence will remain in words."

Minister Müezzinoğlu emphasized that one can talk about independence if one is strong in the field of science and scientific knowledge, and noted the following:

"Otherwise, if today we have to buy even a very simple medicine and spare parts for an MRI tomography device from somewhere... We experienced this during the Cyprus landings, they didn't give us our airplane tires. Independence is not in words, if we can be strong and assertive in production in the race with the world, if we can motivate the mind and heart dynamics of our people in this sense, we are a rich country in this sense and we are a country with 1 million 200-250 thousand young people of all ages. If we can reflect to our young people the sanctity and meaning of the sweat of the minds of both the administrators, educators and those who guide them, the future of Turkey will be much different."

In his speech at the opening ceremony, Minister IŞIK said that they are happy and proud to start these projects after a long and intensive preparation process.

Explaining that the two projects will improve the infrastructure for biotechnological drug production, Işık said that the accumulated knowledge will open the door to new projects and reduce dependence on foreign pharmaceuticals.

Işık explained that BİOSİM and GRIPA projects are located in the intersection cluster with the programs on Reducing Dependence on Imports, Commercialization in Priority Technology Areas, Technology Development and Domestic Production through Public Procurement and Structural Transformation in Health Industries.

- "We must take serious steps in new-generation sectors"

Emphasizing that the 25 Priority Transformation Program was one of the most important things they did during their previous government, Işık continued as follows:

"With these reform packages based on structural transformation, we have pro-actively determined the steps that our country will need in the next 10, 20 and 30 years. Since 2002, Turkey has gained a very serious momentum, achieving great successes and records. We cannot be content with preserving our current achievements; on the contrary, we must continue on our way with new and bigger goals. This is why we emphasize that we need to start a second breakthrough period, and we are already formulating the formulas required for this new era. As a country aiming for high income, we must seek and find competitiveness in R&D, innovation, scale-up, design and branding."

Stating that the share of high-tech products in Turkey's exports hovers around 3-4 percent, Minister Işık said, "We need to increase this rate to 15 percent. For this purpose, we should both focus on efforts to increase added value in classical sectors and take serious steps in new generation sectors. In particular, biotechnology has become one of the most talked about and discussed areas in terms of its processes and results all over the world today."

- Domestic production targets in pharmaceuticals

Emphasizing that the 21st century can be defined as a "biotechnology century" with the point reached in gene technology, Işık said

"This sector has the potential to produce solutions to the problems faced by humanity in many areas such as food, water, medicine and health. Today, the fact that the share of bio-technological products in the world pharmaceutical market is approaching 20 percent reveals how sensitive the issue is. In Turkey, the total market size of biotechnological products reached TL 2.6 billion in 2014. Domestic production accounts for 73.5 percent of the medicines consumed in Turkey on a box basis. However, the high value-added of imported products led to a trade deficit of approximately USD 4 billion in the pharmaceutical sector last year. This example clearly shows how sensitive domestic production is in the pharmaceutical sector in general and in biotechnological drug production in particular."

Işık reminded that the ministry had prepared the Turkish Pharmaceutical Industry Strategy and the Turkish Biotechnology Strategy Document and said that with these roadmaps, they planned to develop and produce products such as bioactive molecules, drugs, systems, tissues and organs for the prevention, diagnosis and treatment of diseases.

Noting that valuable projects such as the production of biotechnological drugs and gene mapping are being carried out within TÜBİTAK, and that they have also initiated efforts to establish the infrastructure of the "Medical Biotechnology Center of Excellence" through TÜBİTAK, Işık said, "What makes us most happy and hopeful is that our universities and the real sector are now taking very valuable steps in the pharmaceutical and biotechnology sector."

- "Biosimilar cancer drug to be developed domestically"

Pointing out that they attach importance to the R&D activities carried out in the pharmaceutical sector, Minister Işık said that as of yesterday, the number of R&D centers in Turkey has reached 210 and the number of R&D centers in the pharmaceutical sector has reached 13.

Stating that he believes that new and large investments will be made in the sector, especially since R&D investments will benefit from the 5th region supports regardless of where they are made, Minister Işık continued his speech as follows:

"We aim to develop Turkey's first national biotechnological biosimilar cancer drug with domestic facilities. More importantly, we aim to produce this drug in cooperation with the private sector in accordance with international standards. With the GRIPA project, we will bring cell-based vaccine production technology to our country by using reverse genetics, reverse vaccine and virus-like particles and synthetic biology techniques. Thus, we will provide our country with the mechanism that will enable rapid vaccine production against influenza epidemics."

Pointing out that they have increased the localization rate in the defense industry from 25 to 60 percent, Işık said, "We have clearly seen in the recent terrorist operations how valuable the use of our national satellite and national unmanned aerial vehicles is, not only in terms of quantity. We believe that the nationalization of the pharmaceutical sector is also very important and we are taking steps in this direction. Such a country needs to produce the technologies, devices, medicines and medical equipment used in the health sector with its own national resources."

"A major step will be taken in line with the policies of bringing the necessary technological know-how and experience for domestic production to our country and Turkey will start production in health. We know how important it is to nationalize the pharmaceutical industry. We have world-class hospitals and doctors. Turkey is becoming a center of attraction in the field of health. We must produce with our own national means. I would like to thank those who contributed to the formation of the project."

After the opening ceremony, which attracted great interest, laboratory visits were made to the TÜBİTAK MAM Institute of Genetic Engineering and Biotechnology.

"National Biosimilar Cancer Drug Development and Production Project - BİOSİM"

Every year, 8 million people worldwide die from cancer. Intensive efforts are being made to fight cancer and new cancer drugs are being introduced to the market. However, it takes many years to develop a new cancer drug. The cancer drugs on the market are both expensive and time-consuming to obtain due to their high cost and importation from abroad.

The global market size of antibody-based biotechnological drugs is around USD 40 billion. Turkey spent 1.64 billion Turkish Liras on biotechnological cancer drugs in 2014 alone. In order to reduce foreign dependence on cancer drugs and to establish domestic production, Turkey has made a new breakthrough in the field of biotechnological drugs.

The BİOSİM project is designed to develop and produce a biosimilar anti-cancer drug to be used in cancer treatment at world standards, in partnership with public R&D and the domestic pharmaceutical industry, using domestic resources in line with TÜBİTAK's objectives. In this context, the necessary infrastructure for biotechnological drug production technology will be prepared and biosimilar antibodies will be developed and produced in living cells on a small scale. After the properties of the produced drug are checked and approved in our laboratories in accordance with international standards, it will be produced in large quantities within Nobel Pharmaceuticals and used in animals and clinical studies.

With the completion of the BİOSİM project, which is supported by TÜBİTAK with a budget of 21 million Turkish Liras, significant contributions will be made to the national economy and scientific knowledge, and a biotechnological pharmaceutical infrastructure with high standards that can compete in the international arena will be brought to our country.

With the BİOSİM project and the infrastructure to be established within this scope, the TÜBİTAK MAM Institute of Gene Engineering and Biotechnology aims to be a pioneer in the creation of new projects for the development of new biosimilar molecules and biotechnological original drugs, and to have a say in the development of biotechnological cancer drugs in Turkey.

"National Pandemic Influenza Vaccine - GRIPA"

Vaccines are the most effective means of protection against global influenza pandemics, which can have devastating effects on public health and the economy. The vaccine is a strategic product in terms of both providing protection before the onset of flu symptoms and preventing the spread of the flu. Turkey is completely dependent on foreign countries for the supply of flu vaccine and is under a serious threat in the event of a pandemic. Turkey's ability to produce its own pandemic flu vaccine is critical for public health as well as for socioeconomic impacts. In the event of a pandemic, the influenza virus required for the vaccine needs to be rapidly obtained, propagated and replaced, if needed, for an effective vaccine. Moreover, since pandemics are a global threat, enough vaccine needs to be produced for a very large population. The recent influenza pandemic has highlighted the need to re-examine current vaccine technologies in terms of the quantity and speed of vaccine production.

Today, the budget allocated to prepare for potential pandemic influenza outbreaks has reached USD 10 billion worldwide. As recommended by the World Health Organization, each country should be able to produce its own vaccine to ensure national security and prevent socioeconomic losses in the event of a pandemic.

The National GRIPA project will provide Turkey with an advanced technology that will enable the production of fast, safe, highly efficient and effective vaccines during a pandemic. At the end of the project, it is aimed to create and produce the synthetic virus required for the vaccine as soon as possible at the beginning stages of the pandemic and to develop the process to create the vaccine. With this national technology, Turkey will take its place among the world countries producing pandemic vaccines.