Depok, August 3rd 2023. Rector of Universitas Indonesia (UI), Prof. Ari Kuncoro, S.E., M.A., Ph.D., inaugurated Prof. Dr. apt. Fadlina Chany Saputri, M.Si. as Permanent Professor in the Field of Cardiovascular Pharmacology, UI Faculty of Pharmacy. At the inauguration which took place on Wednesday (2/8), at the UI Convention Hall, Depok Campus, Prof. Fadlina delivered a scientific oration entitled “Disease Modeling in Experimental Animals: Challenges in Drug Discovery and Development, and Translational Research as Strengthening Resilience in the Health Sector”.
In her speech, Prof. Fadlina said that currently, knowledge about the mechanisms and pathways for the occurrence of a disease is increasingly complex and comprehensive. This encourages the process of discovery and development of new drugs through different mechanisms and pathways. One of the important stages in the discovery and development of new drugs is the preclinical testing stage, which aims to clarify how the drug candidate works, investigate potential toxicity, evaluate safety, validate efficacy in various in vitro and in vivo models, and evaluate the formulation.
According to Prof. Fadlina, every new drug developed must go through preclinical testing on experimental animals before clinical trials on humans. Unfortunately, nine out of ten drug candidates that have passed preclinical testing fail in Phase I, II and III clinical trials. This high failure rate in clinical trials causes investment in drug development to be very high. Therefore, efforts are needed to select drug candidates with strict criteria during the preclinical stage of drug development.
The existence of a drug that has been proven to be efficacious and safe in experimental animals, but which turns out not to be efficacious and safe in humans/patients can occur due to complex factors. One of them is the genetic differences between experimental animals and humans which allows for differences in mechanisms, pathways, and course of disease in experimental animals and humans. These differences pose a challenge to translational research because they can cause differences in the results obtained in research on experimental animals and research on humans.
A number of techniques have been used to develop disease modeling in experimental animals so that it more closely resembles disease modeling in humans. This development is carried out in three ways, namely inducing disease pharmacologically using chemicals/pharmacological agents as inducing agents; inducing disease with surgery through invasive intervention in certain organs so that disease models can develop; or genetically modified animals by applying gene editing to the desired target genes in animal embryo cells, so that model animals can form spontaneously when the animal is born.
The three induction models have advantages and disadvantages which will be adjusted to each research objective. Therefore, validation down to the molecular level is important to ensure that the desired model is created according to human conditions.
“Testing using animals is the final stage before a drug candidate is tested on humans. Therefore, the model formed must be valid and have high reproducibility. Selecting and using an appropriate preclinical model is very important to ensure that the selected experimental animal model is appropriate for the desired objectives. Furthermore, the use of appropriate animal models will improve and deepen the fundamental understanding of the disease process, so that it will contribute very significantly to the discovery and development of drugs, vaccines and antibiotics,” said Prof. Fadlina.
She added that selecting the right animal model for testing cardiovascular drugs is crucial, considering that this disease can be caused by other diseases, such as hyperlipidemia, obesity, diabetes mellitus, and hypertension. The use of certain animal models may be less suitable for evaluating drug candidates that work through other pathways. For example, animal models used to evaluate antihypertensive drug candidates cannot be used to evaluate drug candidates for myocardial infarction.
Therefore, Prof. Fadlina emphasized the importance of developing appropriate animal models in drug discovery and development studies as well as translational research. The use of appropriate animal models can accelerate the process of developing and discovering new drugs, as well as exploring drug candidates from Indonesian natural ingredients. In this way, the drugs that will be produced can be used optimally to answer health challenges on a national and global scale.
Prof. Fadlina’s inauguration procession was also attended by the Rector of Bhakti Kencana University, Dr. apt. Entris Sutrisno; Vice Rector of Nurtanio University Bandung, Marsma TNI (Ret.) Dr. apt. Yuli Subiakto, M.Si.; Main Director of UI Hospital, Dr. dr. Astuti Giantini, Sp.PK(K), MPH; Chairman of the Food and Drug Administration for the 2010–2011 period, Dra. apt. Kustantinah, M.App.Sc .; Director of Business Development and Portfolio Management PT Pos Indonesia, Dr. Prasabri Pesti; and Senior Principle Expert PT Telkom Indonesia, Dr. (cand) Endang Susilowati, MT
Prof. Dr. apt. Fadlina Chany Saputri, M.Si. completed Bachelor of Science education in 2000 and Pharmacist education in 2001 at the Department of Pharmacy, FMIPA UI; Master of Science education at the Faculty of Pharmacy, Bandung Institute of Technology in 2004; and Doctor in Medical Science education at the Faculty of Pharmacy, Universiti Kebangsaan Malaysia in 2012. Prof. Fadlina has also published many scientific papers, some of which are entitled Platelet Glycoprotein-Ib (GPIb) May Serve as a Bridge between Type 2 Diabetes Mellitus (T2DM) and Atherosclerosis, Making It a Potential Target for Antiplatelet Agents in T2DM Patients (2023); PCSK9 Promotes Cardiovascular Diseases: Recent Evidence about Its Association with Platelet Activation-Induced Myocardial Infarction (2023); And Recent Update on PCSK9 and Platelet Activation Experimental Research Methods: In Vitro and In Vivo Studies (2022).