Drug Development Overview
Drug Development Overview explores the regulatory landscape for small molecule and biologic drugs, highlighting their differences in complexity, manufacturing, stability, and mechanisms of action. It details the role of regulatory agencies like the FDA, with centers like CDER and CBER managing small molecules and biologics, respectively. The overview covers regulatory statutes, guidance, and harmonization efforts that shape drug development. It walks through the drug development lifecycle—from preclinical research and clinical trials to post-marketing surveillance—and examines expedited programs like fast track and priority review for drugs addressing unmet needs. Challenges in rare disease development and the complexities of biosimilars versus generics are also discussed.
Non-CPE Credit
CPE Credit
Section 1
Learn about the key differences between small molecule drugs and biologic drugs, and how these impact their development, regulation, and applications in modern medicine.
Section 2
Learn about the complex regulatory landscape of the pharmaceutical industry, including the roles of the FDA, product exclusivity, and the drug development life cycle.
Section 3
Learn about the complex process of drug development, from preclinical studies to clinical trials, regulatory approvals, and post-approval life cycle management.
Five Takeaways
- Discover the fundamental differences between small molecule drugs and biologics in complexity, manufacturing, stability, and mechanism of action, which significantly impact their development and regulation.
- Understand the role of specialized FDA centers (CDER and CBER) in reviewing and approving drugs based on their unique characteristics, not just on whether they are small molecules or biologics.
- Explore the drug development lifecycle, from preclinical research to clinical trials in humans, with critical regulatory interactions and meetings at key milestones to guide development plans.
- Identify the benefits of expedited development programs like fast track, breakthrough, priority review, and accelerated approval, which offer flexibility and enhanced regulatory support for drugs addressing serious or unmet medical needs.
- Recognize the complexities of developing biosimilars compared to generic small molecules, as biosimilars require additional clinical and non-clinical studies to address the unique challenges of biologics characterization.
Features
- Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Course materials
- Real-time tracking
- Progress reporting
- Accessibility features
- Corporate account upgrades
- LinkedIn certificate attachment
- Verified certificates
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