The transition from promising scientific discovery to successful clinical trial represents one of the most central challenges in the biotechnology industry. biotechfarm leads in this field thanks to a research team with years of experience and deep knowledge in all phases of medical development, from the moment an innovative idea is born in the laboratory to conducting successful clinical trials in humans.
How Was the Unique Experience in Translation Processes Acquired?
Biotech Farm Ltd. was established by Adir Korah and Rinat Bornstein-Korah after more than 25 years of experience leading and managing research. The extensive experience was acquired through work with a wide range of projects in various biotechnology fields, from basic research to advanced clinical development. The team underwent advanced training at leading research institutions worldwide and gained experience in international projects.
Extensive experience in drug development includes work on projects that successfully reached market, as well as learning from failures and challenges in the process. The company works with large and small companies in Israel and abroad for the benefit of humans and animals, providing the team with exposure to a wide range of technological and regulatory challenges.
What Special Skills Characterize the Research Team?
The facility's professional team is dedicated to advancing drug and medical device research and development for Israel's bio-medical and biotech industries. Skills include expertise in fields such as biochemistry, pharmacology, toxicology, biomedical statistics, and international regulation. Biotech Farm Ltd. is an advanced, well-equipped, managed, and scientifically supported service provider.
Multidisciplinary expertise enables the team to evaluate projects from different angles and identify early-stage success potential or expected challenges. The team includes experts with advanced academic backgrounds, extensive industry experience, and deep knowledge of regulatory requirements in various markets worldwide.
How Are Projects with High Clinical Potential Identified?
The identification process is based on advanced scientific and technological criteria enabling early assessment of success chances. The research and development phases designated at BIOTECH FARM Ltd. are pre-regulatory studies in large animals, as well as GLP validation studies. Potential assessment includes examination of mechanism of action, potential market size, existence of alternative therapeutic solutions, and technological feasibility.
The team performs comprehensive feasibility analysis including examination of preclinical data, assessment of expected safety profile, and analysis of regulatory requirements. The process also includes economic evaluation of expected development costs and financing strategy for subsequent phases.
Why Do Failures Occur in Transition to Clinical Phase?
The team has gained extensive experience in identifying common failure factors and developing strategies to prevent them. Common causes of failure include insufficient preclinical testing, incorrect assessment of safety profile, problems in active ingredient production and supply, and issues in clinical trial design. Common failure causes are carefully analyzed to prevent recurrence in future projects.
The proactive approach includes conducting more comprehensive testing in the preclinical phase, designing more clinically relevant experimental models, and early preparation of manufacturing and supply strategies. The team emphasizes early planning of clinical trials during preclinical research phases.
How Is Professional Guidance Provided Throughout the Translation Process?
Professional guidance includes preparing a detailed work plan for each phase in the process, from preclinical research phase to planning the first clinical trial. The process includes ongoing assessment of project progress, early identification of potential problems, and strategy adjustment according to accumulated results.
The facility provides advanced consulting services including IND document preparation, clinical trial protocol planning, selection of appropriate research centers, and coordination with regulatory authorities. Guidance also includes assistance in raising financing for clinical phases and connections with potential investors.
How Is Strategic Planning for Clinical Trials Conducted?
Clinical trial planning begins in the preclinical phase, considering expected regulation, market size, and future marketing strategy. Planning includes selecting primary indications, determining primary and secondary endpoints, and planning strategy for different trial phases.
The team specializes in planning efficient development strategies enabling faster transition between different phases while maintaining scientific quality and regulatory compliance. Planning also includes preparation for more advanced development phases, including collaborations with major pharmaceutical companies.
What Characterizes the Innovative Approach to Development?
The innovative approach includes integration of advanced technologies such as artificial intelligence, machine learning, and advanced data analysis to predict drug and medical device behavior. The team uses advanced computational models for experimental design optimization and outcome prediction.
Innovation also includes developing new methods for monitoring safety and efficacy, using advanced biomarkers, and implementing personalized medicine approaches. This approach enables faster development, lower costs, and higher success rates in clinical trials.
In summary, the research team's extensive experience and deep expertise form the foundation for success in translating scientific discoveries from laboratory to clinical trials. The combination of advanced scientific knowledge, extensive industry experience, and deep understanding of regulatory requirements enables the company to provide clients with efficient and professional solutions to the most complex medical development challenges.