Drug Discovery Process

At Crasenim Pharma, our drug discovery process is a rigorous and systematic approach to developing new, effective medications that meet the needs of patients worldwide. This process involves several key stages that ensure the safety, efficacy, and quality of our products. Here’s an overview of our drug discovery process:

1. Target Identification

Objective: The first step is to identify a biological target (such as a gene or protein) that plays a key role in a disease.
Process: Through advanced research and understanding of disease mechanisms, we identify specific targets that could be modulated to treat conditions effectively.

2. Hit Identification

Objective: Find compounds or molecules that interact with the identified target.
Process: High-throughput screening of large compound libraries helps identify “hits,” which are potential drug candidates that can affect the target of interest.

3. Hit-to-Lead Development

Objective: Refine and optimize the hits to develop a viable lead compound.
Process: Chemists and biologists work together to modify the hits, improving their potency, selectivity, and stability, while also minimizing toxicity.

4. Preclinical Testing

Objective: Test the lead compound in laboratory settings to evaluate its safety, toxicity, and effectiveness.
Process: In vitro (test tube) and in vivo (animal) studies are conducted to assess the compound’s pharmacokinetics, pharmacodynamics, and safety profile.

5. Clinical Trials (Phase I, II, III)

Objective: Test the safety, dosage, efficacy, and potential side effects of the drug in humans.
Phase I: Small groups of healthy volunteers are given the drug to determine safety, side effects, and optimal dosage.
Phase II: The drug is tested in a larger group of patients with the disease to assess effectiveness and further monitor safety.
Phase III: Extensive trials in diverse patient populations to confirm efficacy, monitor side effects, and compare the drug with existing treatments.

6. Regulatory Review and Approval

Objective: Submit all clinical data to regulatory authorities (such as the FDA, EMA) for review and approval.
Process: Regulatory bodies assess the safety and efficacy data, and if the drug meets the required standards, approval is granted for commercial production.

7. Post-Market Surveillance

Objective: Monitor the drug’s performance after it is released to the market.
Process: Ongoing studies and reporting systems are put in place to detect any long-term side effects or issues that arise once the drug is widely used by patients.

Key Considerations in Our Drug Discovery Process

Patient-Centered Approach: At every stage, we prioritize the needs of patients, ensuring our drugs improve their health outcomes and quality of life.
Collaboration with Experts: We collaborate with leading research institutions and healthcare providers to enhance the discovery process and ensure access to the latest scientific advancements.
Innovation and Technology: Crasenim Pharma leverages cutting-edge technologies like artificial intelligence, machine learning, and biotechnology to accelerate the discovery process and ensure the development of effective treatments.
Global Compliance: Throughout the entire process, we adhere to stringent international regulatory standards, ensuring our drugs meet the highest safety and quality standards.