Life is the main value on earth
Every day, every second of a patient’s life, free of disease, are important. Every disease of every patient is a unique, complicated and complex phenomenon, which requires deep fundamental understanding of the biological process itself and the most suitable intervention way to cure it.
Advances in biotechnology and biomedical sciences allow us, as never before, to develop and provide truly personalized, precision therapeutics to every patient in need. Taking advantage of it, scientists and engineers our R&D Science Center are working on the most advanced R&D and manufacturing technologies, preclinical and clinical development strategies. They are identifying, screening and developing the most promising candidates to bring every patient the cure they need.
Being the key element in realization of the YURiA-PHARM’s mission, our R&D-strategy is focused on strengthening our potential as a developer of generic drugs and therapeutic solutions in spectra of different modalities. At the same time, we are proactively investigating and developing innovative therapeutic solutions and modalities, cutting-edge R&D-technologies and solutions to cure the most complex and important diseases.
Our strategy is based on a few key principles:
1. Science first
At YURiA-PHARM we strongly believe: it’s the breakthrough science that stands at the origins of breakthrough therapeutics, the ones that save and improve lives, and help people look and feel better and younger.
We leverage and develop cutting-edge technologies (proteomics, metabolomics, high-content imaging, mRNA, CRISPR and synthetic libraries etc.) and leading chemo- and bioinformatics solutions. They are crucial for building deep understanding of the biology behind pathological processes (autoimmunity, fibrotic diseases etc.) and aging, at all stages of drug development – from target selection and preclinical pharmacodynamics characterization to human immunogenicity profiling. All of that allows us not only to develop effective and safe medicines but guides us on pathologies we can efficiently target next.
2. Focus on the development of platform solutions
Development of a new drug is always a time-consuming and costly process. Every modality and dosage form often requires establishment or, even, creation of the R&D-infrastructure from scratch in order to develop safe and effective drugs efficiently and compliantly. Different molecule classes require different expertise for time- and cost-effective development. Regulatory framework is different for different modalities. All of this makes patients wait more for the therapeutic they need right now.
That is why our R&D is focused on the development of the R&D and therapeutic platforms – sets of technologies, knowledgebase and manufacturing solutions, aimed at the development of therapeutics of the same or similar molecular or structural classes, that can be predictably designed/reprogrammed/repurposed to provide different pharmacodynamic effect.
Development of therapeutic platforms allows us:
- to leverage the knowledge accumulated in the process of development of previous drugs on the platform, to develop more effective and safer drugs faster;
- to establish and have access to the focused network of the best experts in the field;
- to use the same or similar manufacturing infrastructure, multiproduct facilities and production lines;
- to understand structure-quality and structure-manufacturability relationships at every stage of research and development process more deeply thanks to the possibility to generalize on the data, generated during R&D campaigns for multiple similar drugs;
- to considerably reduce risks, associated with any step of drug development process.
All of this allows us to provide patients with more effective, safer and more affordable drugs faster.
3. Advanced manufacturing technologies
Manufacturing process efficacy is one of the key factors that determine global affordability and availability of important therapeutics for patients in need. Its effect is even more pronounced for developing economies. Also, the gradual shift of pharmaceutical industry towards low-volume, personalized drugs manufacturing puts additional constrains on traditional manufacturing technology.
At YF R&D we are actively investigating, developing, and implementing advanced manufacturing technologies to optimize manufacturing processes, with a particular focus on:
- scalability and flexibility;
- control state maintenance and automation;
- suitability to manufacture difficult-to-produce or unstable products on the same platform;
- reduced CAPEX and OPEX for process implementation and operation.
4. Maximization of the R&D processes efficacy
Maximization of R&D process efficacy is the key determinant of the «time-to-patient» and «cost of development» parameters. Thus, it is one of our main strategic imperatives, priorities, and even a part of our R&D culture. We focus maximization efforts on multiple domains:
- Development of innovative R&D-technologies, which allow us to make the development process faster and more efficient, to increase quality/level of drug candidate characterization, creating access to previously undruggable therapeutic spaces for us or for the industry as a whole.
- Utilization of the most advanced analytical instrumentation and data processing solutions to improve candidate characterization, confidence in the results and to allow researchers to focus on the most important – the understanding of the system under study.
- Internalization of “critical chain” activities and core competences allows to flexibly adapt protocols, technologies, and instruments to the required tasks, efficiently schedule activities between projects, eliminate delays associated with material and technology transfer, reduce risks associated with the supply chain and logistics.
- R&D process digitalization and automation at every step possible – LIMS introduction, ELN for research records, automated inventory tracking, service ordering systems and many more.
5. Data-rich development
Product and process characterization level highly correlate with the quality and robustness of the manufacturing process. The quality of our products is our top priority, thus our strategic focus is to maximize the level of product and process characterization in the process of drug development, while maintaining the project schedule and budget. Modern analytical technologies (high-content imaging, multi-detector sample analysis, automatic microextraction and low-flow assays etc.), orthogonal analytical characterization (LC/CE etc.) and systematic approach to DoE (Design of Experiments) (multifactorial experiments, hierarchical experiments etc.) enable us to effectively accomplish that.
All of the active product and process development campaigns are performed with the broadest possible implementation of Quality-by-Design (QbD) principles.
6. Partnerships are the key strength
We realize that complex and difficult-to-treat diseases, problems of antibiotic resistance and aging can be solved only in collaboration of the brightest minds in science and healthcare. We are open and actively engaging in collaborations at every stage of R&D process – from idea to clinical development. Collaborations in fundamental research are of particular importance for us, as we believe, this is the only way to discover and open completely new possibilities to cure the most complex diseases.
As a holder of unique and proprietary technologies and having established a diverse and the most advanced R&D infrastructure in Ukraine, we strategically aim to transform our corporate R&D Center into an R&D hub, providing opportunities to researchers from over the Globe to conduct research and development of groundbreaking therapies and solutions for patients, who need it most.
Professional development as the moving force of research
High-quality science can only be performed by high-quality professionals. Thus, when opening a new job position, we seek out for the brightest minds in the relevant fields of medicine, biology, chemistry and engineering.
However, we realize, that proficiency takes time and effort to be achieved. And we are proud that our R&D Science Center has long become a platform for professional development for early career researchers and engineers. Having access to a broad spectrum of laboratory equipment and being able to train their skills in a variety of projects, they become unique professionals in their fields. Moreover, we readily provide support with any training needed to enhance knowledge and get access to the cutting-edge technologies through participation in international conferences, seminars and consultations.
We understand that only a creative atmosphere, openness to alternative views/solutions, a team approach to evaluation/decision-making, an “open door” culture that encourages the exchange of ideas, openness to the introduction of ideas from new technological and therapeutic areas, continuous professional development of our scientists ensure the highest possible level of implementation of extremely complex tasks.
Human life is at the center of the corporate philosophy of YURіA-PHARM, and therefore it inspires us to create vital drugs, making them available to patients all over the world.