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Learn Drug Development from Discovery to Commercialization
Developing a new pharmaceutical product from initial discovery to market approval is a complex, multidisciplinary process involving scientific research, preclinical evaluation, clinical trials, regulatory strategy, quality compliance and commercial planning. Decisions made at each stage can significantly influence development timelines, investment requirements, product safety, efficacy and commercial success.
This comprehensive 3-day training program provides an integrated understanding of the pharmaceutical drug development lifecycle, exploring the scientific, regulatory, clinical, operational and commercial considerations involved in transforming a promising drug candidate into an approved and market-ready pharmaceutical product.
The program examines the major stages of drug discovery and development, from target identification, lead optimization and preclinical testing through clinical development, regulatory submissions, FDA review and commercialization. Participants will understand how nonclinical data supports clinical investigations, how clinical trials are designed and evaluated across Phases I–IV, and how sponsors establish the evidence required to demonstrate product safety, efficacy and quality.
Particular emphasis is placed on the FDA regulatory framework and the requirements governing Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologics License Applications (BLA), regulatory interactions and marketing authorization. The program also explores the application of GLP, GCP, GMP and relevant ICH guidelines throughout the development lifecycle.
Beyond regulatory and scientific requirements, participants will examine the business and strategic dimensions of drug development, including development economics, cost-benefit considerations, intellectual property protection, patent exclusivity, critical development milestones, pharmacoeconomics and commercialization planning.
Through practical examples, development scenarios and regulatory perspectives, participants will gain insight into how cross-functional teams coordinate scientific, clinical, regulatory, quality, manufacturing and commercial activities to navigate development challenges and advance pharmaceutical products toward successful market approval.
Learning Objectives
By the end of this training program, participants will be able to:
- Understand the complete pharmaceutical drug discovery and development lifecycle.
- Explain the scientific principles underlying drug discovery, target identification and lead optimization.
- Identify preclinical testing requirements and understand their role in supporting human clinical studies.
- Understand the objectives, design considerations and regulatory expectations of Phase I, II, III and IV clinical trials.
- Navigate FDA regulatory requirements for IND, NDA and BLA applications.
- Understand FDA interactions, application review procedures and drug approval pathways.
- Apply GLP, GCP, GMP and relevant ICH guidelines within the drug development framework.
- Evaluate clinical trial design, safety considerations and regulatory compliance requirements.
- Understand development economics, investment considerations and cost-benefit assessments.
- Examine intellectual property protection, patents and market exclusivity.
- Understand drug labeling, pharmacoeconomic studies and commercialization considerations.
- Recognize the importance of cross-functional project management in successful drug development.
Who Should Attend
- Drug Discovery, Research & Development (R&D) Scientists
- Clinical Research and Medical Professionals
- Regulatory Affairs Professionals
- Quality Assurance (QA) and Quality Control (QC) Professionals
- CMC and Pharmaceutical Development Professionals
- Manufacturing and Production Personnel
- Pharmacovigilance and Drug Safety Professionals
- Project Managers and Auditors
- Biostatistics and Data Management Professionals
- Sales, Marketing, Brand and Commercial Teams
- New Employees and Non-Scientific Professionals seeking an understanding of the drug development process
- Anyone looking to build or enhance their knowledge of pharmaceutical drug development
Course Agenda
The Drug Development Process from Concept to Market
Day 1: Drug Discovery, Preclinical Development & Regulatory Foundations
Understand how a drug candidate progresses from discovery to clinical development.
Session 1: Drug Development Landscape (2026 Perspective)
- End-to-end drug development lifecycle
- Small molecules, biologics, biosimilars, gene & cell therapies
- Routes of administration and formulation considerations
- Emerging trends: AI-driven drug discovery, precision medicine & digital health
Session 2: Drug Discovery & Preclinical Development
- Target identification and validation
- Hit identification, lead optimization and candidate selection
- In vitro and in vivo studies
- ADME (Absorption, Distribution, Metabolism & Excretion)
- Toxicology studies and bioavailability
Session 3: CMC & Pharmaceutical Development
- Chemistry, Manufacturing & Controls (CMC)
- API and formulation development
- Dosage forms and drug delivery systems
- Stability studies
- Scale-up and technology transfer
Session 4: Regulatory Strategy & IND Submission
- FDA, EMA and global regulatory agencies
- Investigational New Drug (IND) application
- CTD/eCTD overview
- Expedited regulatory pathways (Fast Track, Breakthrough Therapy, Accelerated Approval)
Day 2: Clinical Development, GCP & Digital Clinical Trials
Learn how drugs are evaluated for safety, efficacy and regulatory compliance.
Session 1: Clinical Trial Development
- Clinical trial phases (Phase I-IV)
- Study design and protocol development
- Clinical endpoints
- Patient recruitment and retention
- Adaptive clinical trials
Session 2: Good Clinical Practice (ICH E6(R3))
- GCP principles
- Sponsor, CRO and investigator responsibilities
- Clinical quality management
- Inspection readiness
- Data integrity in clinical research
Session 3: Digital Transformation in Clinical Research
- Decentralized Clinical Trials (DCT)
- Electronic Data Capture (EDC)
- Remote monitoring
- AI in clinical development
- Wearables and Real-World Data (RWD)
Session 4: Clinical Safety & Pharmacovigilance
- Adverse event reporting
- Serious adverse events (SAEs)
- Signal detection
- Benefit-risk assessment
- Risk management during clinical development
Day 3: Regulatory Approval, Commercialization & Lifecycle Management
Successfully bring pharmaceutical products to market and maintain regulatory compliance.
Session 1: Marketing Authorization & Regulatory Approval
- NDA and BLA submissions
- FDA and EMA review process
- Regulatory approval timelines
- Advisory committee meetings
Session 2: Commercial Manufacturing & GMP
- GMP requirements for commercialization
- Process validation
- Continued Process Verification (CPV)
- Technology transfer
- Supply chain readiness
Session 3: Post-Approval Changes & Lifecycle Management
- ICH Q8, Q9, Q10 and Q12 overview
- Quality by Design (QbD)
- Quality Risk Management
- Post-approval changes and variations
- Product lifecycle management
Session 4: Post-Marketing Surveillance & Future Trends
- Phase IV studies
- Global pharmacovigilance systems
- Risk Management Plans (RMPs)
- Product recalls and compliance
- AI and the future of pharmaceutical development
Know Your Faculty
Kelly Thomas, Head Of Quality Assurance (USA)
Kelly Thomas is a seasoned Quality Assurance and Regulatory Compliance expert with over 20 years of experience in the pharmaceutical, biotechnology, API, and medical device industries. Her expertise includes FDA cGMP compliance, Quality Management Systems (QMS), process validation, technology transfer, supplier quality management, regulatory inspections, and global quality systems.
Kelly has successfully led FDA, EMA, Health Canada, ANVISA, and other international regulatory inspections, supporting API, biologics, sterile injectable, oral solid dosage (OSD), medical device, and combination product manufacturing. She is recognized for strengthening quality systems, driving inspection readiness, implementing Lean Six Sigma initiatives, and helping organizations achieve regulatory compliance while ensuring product quality and patient safety.
