Clinicians & Researchers

• Establishing clinical development strategy – Designing a new medical device or working on a new active ingredient or therapeutic technology is challenging and requires extensive experience at all stages of clinical development. Deciding on regulatory strategy and optimal clinical indications are among the many crucial steps in clinical development of new products.
• Pre-clinical design by expert professionals – A complete pre-clinical package is mandatory to enter first-in-man trials. Our clinicians and scientists will assist you in designing preclinical work that will provide an optimal package for regulatory authorities.
• Protocol and clinical program design – Clinical protocols can make the difference between the success and failure of a new therapeutic to reach the market. As such, clinical protocols require careful planning of eligibility criteria, proper controls, relevant endpoints, etc.
• Support with ethical committee submissions – In many cases, the submission of applications to ethical committees can be a long process involving several rounds of correspondence and discussions.

CGMP Manufacturing Facilities

Our cGMP facilities are designed for production of biological, medicinal and chemical products such as cell cultures, tissues, viruses, bacteria, molecules, etc. State-of-the-art facilities contain four operational class 10,000 laboratories and other equipment that operates under a strict QC and QA program. Environmental cleaning and monitoring are addressed in a range of standard operating procedures. All facilities comply with FDA and European Medicines Agency standards.

• Consultation about regulatory strategy – Determining appropriate regulatory strategy is critical for successful commercialization of new or repurposed products in the healthcare industry.
• Potency assays – Measurement therapeutic activity and surrogate end-points are important assays for in-process and product release of drug products. Potency assays conform to appropriate laboratory testability criteria in a relevant biological system. These assays are also useful in drug discovery for ranking therapeutic candidates. Cost-efficient, accurate potency assays can be developed by our leading researchers according to their expertise and based on customer needs, for example, cell-based assay, ELISA assay, flow cytometry-based assay, in vivo assay, etc.
• Mode of action – Mode of action and mechanism of action studies are important elements in drug discovery and regulatory development which may require a combination of biochemistry, genetics and computation.
• Identity of cell products – Regulatory agency guidelines require that the final cell-based product be identified and distinguished from other products being processed at the same facility. Testing includes an assay that measures the presence of vector and an assay that enables identification of a specific cellular component of the final product.
• Impurities of cell products – Product testing includes purity tests to measure the relative freedom from extraneous material, and whether it is harmful to the recipient or deleterious to the product. Purity tests include multiple assays for detecting residual proteins, cellular populations, and cell debris.

Bioassays determine the concentration, purity, or biological activity of an active substance by measuring its effect on a test organism or its part (cells, enzyme, receptor). Bioassays are used for testing pharmacological effects, side-effects, toxicity, specificity, concentrations, pollutions, etc.

These are just some of the bioassays that can be performed at Hadassah and customized for you:

• Immune functions
• Immune regulation
• Surrogate clinical end points
• Flow cytometry-based assays
• Next generation sequencing
• Mutational analysis
• Biomarkers
• Human tissue analysis – molecular/histochemical/ex-vivo cultures/primary cells with specific mutations
• Unique patient derived cancer cell lines

Hadassah researchers employ diverse animal models for pre-clinical research and for proof-of-concept. Our researchers can also customize animal models according to your needs. Available animal models include:

• Neurodegeneration, oncology, autoimmune, epilepsy, metabolic disease, obesity, hepatic diseases, diabetes, behavior & cognitive, ophthalmology, gastroenterology, nephrology, cell-therapy, hematology, coagulation, dermatology, and dental
• Imaging: PET-CT
• State-of-the-art operating theatres for animal surgical and interventional procedures
• Expert collaborative services (e.g., minimally invasive surgery, gastroenterology, neurosurgery, orthopedic surgery, cardiology)
• Surgical training and workshops in laparoscopy and endoscopy
• Ethical Review Committee for animal studies