This hands-on course offers a modern, AI-integrated, and project-driven overview of drug development, from discovery to delivery. With a focus on regulatory strategy, translational science, and real-world biotech case studies, students will gain the tools to design, analyze, and manage therapeutic innovation pipelines.

- Navigate the full drug development pipeline, from discovery to regulatory approval.

- Apply AI and machine learning tools in drug discovery and trial design.

- Understand FDA regulatory pathways including 505(b)(2), EUA, and fast-track designations.

- Develop go-to-market strategies, pricing, reimbursement, and health economics plans.

- Evaluate manufacturing models including small-batch, GMP, and biologics production.

· Module 1: History and Economics of Drug Development

· Module 2: Target Discovery and AI Integration

· Module 3: Preclinical Development and IND Preparation

· Module 4: Clinical Trials – Phases I-III and Trial Design

· Module 5: Regulatory Strategy – FDA, EMA, Global Access

· Module 6: Manufacturing – Biologics, Small Molecules, GMP

· Module 7: Commercialization, IP, and Reimbursement

· Module 8: Global Health Applications – Cancer, TB, HIV, Tropical Diseases

Project 1: Develop a regulatory plan for a CRISPR-based therapeutic entering Phase I trials.

Project 2: Use an AI platform to analyze a target-pathogen pair and propose lead candidates.

Project 3: Design a go-to-market strategy including payer engagement for a biologic drug.

Project 4: Model cost of manufacturing and design a GMP scale-up strategy.

- Pharmacogenomics and personalized medicine

- Off-label use and safety surveillance

- Vioxx case study and post-market drug risks

- Drug repurposing and AI-guided phenotypic screens

FDA Drug Approval Process: https://www.fda.gov/drugs/development-approval-process-drugs

ClinicalTrials.gov: https://clinicaltrials.gov/

NIH All of Us: https://allofus.nih.gov/

MIT OCW Original Course: https://ocw.mit.edu/courses/15-136j-principles-and-practice-of-drug-development-fall-2013/

Insilico Medicine: https://insilico.com/

Atomwise: https://www.atomwise.com/

Deep Genomics: https://www.deepgenomics.com/

- Dr. Sergey Sikora – CEO and CMO, biotech veteran with experience in Phase III biologics

- Dr. George Poste – Precision medicine thought leader, former GSK CSO

- Dr. Maria Zuber – VP of Research, MIT (systems innovation in pharma)

- Dr. Wayne Harris – Co-founder of Cer Tek Bio, CRISPR-based vaccine innovator

To enroll click  "SIGN UP" or request more information, please email us at: info@ion5institute.org