CT Pharma aims to be the best partner for you with a global perspective while acting with local values and goals.
W- Mrs. Semra can you briefly introduce you and CT Pharma Research?
S.A.-Hello, I graduated from Istanbul Technical University, Department of Chemical Engineering in 1998. After working in various positions in the field of Quality Control, R&D analytical method development and validation in the pharmaceutical industry and licensing in the last 6 years, in 2012, we established CT Pharma Research with my husband, Dr. Şerhan Şimşek, who has worked in the field of R&D formulation in the pharmaceutical industry for more than 20 years.
W-What are the services you provide for the sector, do you provide product portfolio consultancy?
S.A.-We carry out turnkey projects in generic drug R&D in the pharmaceutical industry. This process starts from the molecule selection and after the formulation development, analytical method development and method validation is completed, the transfer of both the production method and analytical methods to the GMP production areas and the delivery of the documentation of all these studies in CTD format, including the pharmaceutical development report.
W- What are the standards you refer to?
S.A.- We refer to the regulations published by the Ministry of Health in our work. We also work in accordance with Turkish, EP, BP and USP pharmacopoeias and GMP, GLP and ISO 17025 standards.
W- Can we get information about CT Pharma hardware?
S.A.-In our laboratory, we have the infrastructure for formulation and analytical development of oral, topical and parenteral dosage forms for equivalent small molecules. However, we also have infrastructure for large molecules such as proteins and peptides.
W- Can you explain the importance of hardware?
S.A.-We transfer the products we have developed to the production facilities of the largest manufacturers of the sector, so we have chosen our equipment among the most used and highest quality equipment in the sector from the very beginning in order to avoid problems during transfer to production and quality control laboratories.
W- Do you have domestic-foreign business partners? In which areas do you cooperate?
S.A.-We have developed R&D projects for 14 different companies in the country. In addition, CT Farma carries out drug development studies on its own behalf in areas that will not cause conflict with our customers. Until now, we have completed 2 projects within the scope of TEYDEP 1507 projects. In addition, we have product development studies in the fields of food supplements and dermocosmetic.
We carry out the licensing and sales activities of pharmaceuticals, food supplements and dermocosmetic products, which we plan to launch in 2018, as a separate company under the name of TFLL Pharma.
In addition, there are pharmaceutical companies that we work with abroad. In order to strengthen our communication with foreign companies and to make investments in Europe, we established a Belgian company called TFLL Pharma BVBA independently of our Turkish company in Belgium in 2017 and started our activities.
W- Do you also participate in clinical trials? Another issue I am curious about is: Do you cooperate with academic institutions and do you support incubation centers?
S.A.-We have some activities that we carry out within the scope of clinical research, we carry out these studies together with TÜBİTAK MARTEK technology transfer office. We are trying to support the incubation companies operating in the field of medicine and health within TÜBİTAK MARTEK with our experience.
W- Do you think there is an R&D climate in our country?
S.A.-I think that there is an R&D climate in Turkey, but still, in the field of generic R&D, not in innovative products R&D. In order to develop innovative products, it is necessary not only to provide R&D support, but also to differentiate in the mentality. It is necessary to instill self-confidence, the awareness of experimenting and making mistakes in the educational infrastructure of Turkish children. For this reason, I think we still have a long way to go in the field of innovative R&D.
W- Continuing on the same subject, when we evaluate the innovation issue for our pharmaceutical industry, which has been declared a strategic sector, we make "Incremental Innovation", but we could not make "Breaktrough Innovation" and in this case, do you think the "National Pharmaceuticals" 2023 target is possible? In your opinion, what steps should be taken in this vital issue?
S.A.- I believe that setting the 2023 target is an important step, so that awareness on many issues has been raised and accordingly, both the state support and the work in the private sector increasingly continue. However, in the basic sciences of physics, chemistry and biology, and of course, robot technology, which has been on the agenda recently, unfortunately, we still have a way to go. A strong infrastructure must be established in these areas for a breakthrough innovation.
W- Advanced technology drugs with high added value; biosimilars, low molecular weight drugs, etc. Do you also provide services in this field?
S.A.- We, as a company, see our sector and field of activity as a field with high added value. That's why we don't want to limit it to just high-tech drugs or biosimilars. We believe that they have very high added value in their small molecules. As development on biosimilars is a different discipline and our client is subject to various clinical studies, we do not have any activity today. However, as CT Pharma, we are developing a project on behalf of our company on peptides.
W- Do you provide services to pharmaceutical companies abroad? Is it through the representatives of the companies here or independently?
S.A.-We serve the pharmaceutical companies abroad independently, not through representation, and since 2017, we aim to further strengthen our communication network through TFLL Pharma BVBA located in Belgium.
W- Are there any points that need to be improved in the regulations of the government regarding R&D?
S.A.- This issue has been one of the issues that the industry has brought up the most for many years. Although we think that the current system (TEYDEP or KOSGEP ETC) is close to the best possible system, shortening the evaluation and review times of the applied projects seems to be the most important improvement for us.
W- At the beginning of 2017, the modified-developed Patent law came into effect, how did it affect you?
S.A.-As CT Pharma Research we always attaches importance to the value of information, patents have always been important to us. One of our patents, which we applied for in 2013, has completed the preliminary examination and the evaluation process continues as a patent with examination. Again, in 2018, we aim to apply for patents on 2 different subjects that we have completed.
W- Why should I choose CT Pharma as a strategic partner?
S.A.- Because CT Pharma is a company that aims to be the best partner for you with a global perspective while acting with local values and goals. We are already in a different position in the sector with our ethical values. The rapid progress of our operations abroad is a result in parallel with this vision. If you become our customer, you will not only receive an R&D service, but also gain a strategic partner.
W- What are the responsibilities you have taken and can you tell us your understanding of confidentiality?
S.A.- The time and cost spent on a project is very high and we value it as a company. We attach great importance to the confidentiality of information since the first day we established CT Pharma Research, we have confidentiality agreements with both our customers and our employees. By making an exclusivity base agreement with our demanding customers, we only work for one customer until the project is licensed.
W- Can you share your future investments and projects?
S.A.- As I mentioned above, in line with the investments we made in Belgium in 2017, we aim to obtain a pharmaceutical license in Belgium and to be on the market with the brand of TFLL Pharma. In addition, we are planning to complete the R&D studies of some of our projects that require high production technology here, and to obtain licenses for these products both in Turkey and in Europe.
W- We thank you for sharing your valuable opinions and wish you continued success.
