Discovery and Research

  • Identifying Unmet Needs: Conduct thorough research to understand the medical needs that are currently unmet, focusing on life-threatening and life-altering diseases such as cancer and neurological disorders.

  • Target Identification: Utilize cutting-edge scientific methods to identify potential biological targets that can be modulated to treat these diseases.

  • Compound Screening: Screen thousands of compounds to identify those that can interact with the identified targets effectively.

Preclinical Development

  • In Vitro Studies: Conduct laboratory experiments to test the biological activity of the compounds on cell cultures.

  • In Vivo Studies: Perform animal studies to assess the safety, efficacy, and pharmacokinetics of the promising compounds.

  • Toxicology Studies: Evaluate the potential toxic effects of the compounds to ensure they are safe for human trials.

Clinical Development

  • Phase I Trials: Conduct first-in-human studies to assess the safety, tolerability, and pharmacokinetics of the drug in a small group of healthy volunteers or patients.

  • Phase II Trials: Test the efficacy and side effects of the drug in a larger group of patients with the targeted condition, further evaluating its safety.

  • Phase III Trials: Conduct large-scale studies to confirm the drug’s efficacy, monitor side effects, and collect information that will allow the drug to be used safely. These trials often involve thousands of patients across multiple sites.

Regulatory Review and Approval

  • Submission of NDA/BLA: Compile and submit a New Drug Application (NDA) or Biologics License Application (BLA) to regulatory authorities, including all data from preclinical and clinical trials.

  • Regulatory Review: Engage in a detailed review process with regulatory agencies, addressing any questions or concerns they may have.

  • Approval: Once the drug is deemed safe and effective, receive approval from regulatory bodies to market the drug.

Community Engagement and Education

  • Patient Advocacy: Work closely with patient advocacy groups to ensure that patient perspectives are integrated into ongoing research and development.

  • Education Programs: Develop educational programs for patients, caregivers, and healthcare providers to ensure they are well-informed about the new treatments.

  • Public Awareness Campaigns: Run campaigns to raise awareness about the new drug and its benefits, focusing on its potential impact on public health.