Drug Discovery Development to Commercialization

• Orientation to job related practical aspects of the drug regulatory managers, is covered in this course extensively.
• Simulation to real life working in regulatory affairs department. It help to enhance the regulatory strategic decision making.
• Advance training on drug registration requirements for various regulatory bodies.
• Access to Case Studies to learn about the drug registration steps.

Who should attend this course? 

• Those who are in working in drug discovery and development.
• Drug Discovery R&D personnel who want advance understanding on drug approval process.
• Professionals from drug discovery development.
• Anyone requiring an overview of drug regulatory affairs.
• Fresher or beginners, Those who want to make a career in drug regulatory department.

Few of the similar courses

• Pharma Global Management
• Market Access and Pricing
• US Pharmaceutical and Biopharmaceutical Regulatory Affairs
• Drug Registration and Regulation in China
• Drug Discovery and Development to Commercialization
• European Drug Regulatory Affairs
• Drug Registration and Regulation in GCC countries
• UAE Drug Regulation and Registration

Course Timeline

The online drug development process course is broken down into four modules:

• The Drug Development Process Regulatory Environment. 
• Training on Stages in the Drug Development Process – the second module provides a detailed overview of the drug development process, taking a look at the life cycle, history, timelines and phases critical to the process. The module covers the product discovery and clinical testing steps essential to the early stages of the drug development process. After that, course provides detailed understanding on the activities needed for regulatory approval, manufacturing scale-up and post-market issues such as adverse event monitoring or reporting and patent exclusivity.
• Preclinical Steps in Drug Development -Training on the preclinical studies (studies in animal subjects). Topic includes preclinical pharmacology, pharmacokinetic, GLP compliance and more.
• Clinical Steps in Drug Development –This covers what happens after discovering an NCE, conducting preclinical trials and completing the IND/CTA application. Attendees will learn the different phases of these clinical studies and about the NDA/MAA application.
• Launching and marketing of Innovative Branded Drug – marketing planning, strategic initiative, usage of clinical trial in marketing, Product Life cycle Management, forward and backward integration for the branded pharmaceuticals for managing high ROI.

Drug Discovery Development to Commercialization Pathway

The Drug Discovery Development to Commercialization Pathway is a complex, multi-phase process that transforms a new scientific discovery into a marketable therapeutic product. Here is an overview of the major stages:

1. Drug Discovery

• Target Identification and Validation: Identify and validate biological targets (e.g., proteins, genes) associated with a disease.
• Hit Identification: Screen thousands to millions of compounds to identify potential candidates (“hits”) that interact with the target.
• Hit to Lead: Optimize these hits to improve their potency, selectivity, and pharmacokinetic properties, creating “lead” compounds.

2. Preclinical Development

• Lead Optimization: Further refine lead compounds for improved efficacy, safety, and drug-like properties.
• In Vitro Studies: Conduct laboratory tests on cell cultures to evaluate the biological activity and toxicity of the leads.
• In Vivo Studies: Perform animal studies to assess the pharmacodynamics (PD), pharmacokinetics (PK), and toxicology of the drug candidates.

3. Clinical Development

• Phase I Clinical Trials: Conduct initial trials on a small group of healthy volunteers or patients to assess safety, dosage, and side effects (20-100 participants).
• Phase II Clinical Trials: Test the drug’s efficacy and side effects on a larger group of patients (100-300 participants). This phase also determines the optimal dose.
• Phase III Clinical Trials: Perform large-scale testing on a diverse population (1,000-3,000 participants) to confirm efficacy, monitor side effects, and compare with standard treatments.

4. Regulatory Submission and Approval

• New Drug Application (NDA) or Biologics License Application (BLA): Compile and submit detailed documentation of preclinical and clinical data to regulatory agencies (e.g., FDA, EMA) for review.
• Regulatory Review: Regulatory authorities review the application, may request additional data, and conduct inspections of manufacturing facilities.
• Approval: If the drug meets safety and efficacy standards, it receives approval for marketing.

5. Commercialization

• Manufacturing Scale-Up: Transition from small-scale to large-scale production, ensuring quality control and compliance with Good Manufacturing Practices (GMP).
• Marketing and Sales: Develop marketing strategies, conduct market access and pricing assessments, and begin product launch and distribution.
• Post-Market Surveillance: Monitor the drug’s safety and effectiveness in the general population, manage adverse events, and conduct post-marketing studies if required.

6. Lifecycle Management

• Label Expansion: Seek approval for additional indications or patient populations.
• Product Improvements: Develop new formulations, delivery methods, or combination therapies.
• Generic Entry Management: Plan strategies to extend the product’s lifecycle and manage competition from generic drugs.

Key Considerations

• Intellectual Property (IP): Secure patents and exclusivity rights to protect the drug.
• Regulatory Compliance: Adhere to regulatory requirements at each stage.
• Stakeholder Engagement: Collaborate with healthcare providers, payers, and patient advocacy groups.
• Market Access and Pricing: Navigate reimbursement policies and set appropriate pricing strategies.

This pathway is highly iterative, with feedback loops between stages to refine and optimize the drug candidate. Successful navigation of this process requires collaboration among scientists, clinicians, regulatory experts, and business professionals.