RECORDED Drug Development Immersion
Drug Development Immersion explores the commercial, regulatory, and scientific factors that pave the way for a successful drug launch. It begins by comparing the characteristics of small and large molecule drugs, agonist and antagonist drugs, and their desirable qualities. A high-level overview of the nuanced go/no-go decision-making process, where management carefully assesses each drug candidate, is provided. This course unveils the intricacies of regulatory compliance, expedited programs, and special designations. It details the dynamic process of drug development, including trial design options, endpoint choices, and experimental/control group concepts. This class culminates with real-world evidence initiatives, drug launch best practices, pharmacovigilance expectations, and lifecycle management strategies. Register today and up your drug development acumen!Â
Week 1: Setting the Stage
Learn about the characteristics of small and large molecule drugs, desirable drug qualities, and the distinctions between agonist and antagonist drugs. Explore the choice of drug administration routes based on drug types and delve into traditional and gene/cell therapy development pathways. Understand drug development metrics, success probabilities, timelines, and costs.
Week 2: The Business of Drug Development
Dive into the Business of Drug Development. Discover the integrated drug development process, key stage gates for making ‘go/no go’ decisions, and the significance of target product profiles. Explore the creation of draft labels, the role of US patents, and market exclusivity considerations in the drug development landscape.
Week 3: The Players: Who is involved
Learn about the essential roles of subjects, sponsors, and investigators. Understand the importance of ethics committees and informed consent. Explore the contributions of contract research organizations, patient advocacy groups, and data monitoring committees, and discover how DMCs impact clinical trials.
Week 4: General Principles: Ethics and Risk
Explore the principles of risk assessment and management, as well as the importance of maintaining data integrity and addressing bias through blinding and randomization.
Week 5: The Regulatory Process
Dive into the global regulatory agencies, FDA and EMA expedited programs, and compliance. Understand approval pathways for generics and biosimilars, as well as FDA and EMA orphan drug designations.
Week 6: Preclinical Development
Discover the safety testing, nonclinical studies, and the transition to clinical trials with IND/CTA filings. Learn about essential preclinical data objectives and terminology.
Week 7: Conduct of Clinical Trials
Get to know study design, endpoints, inclusion/exclusion criteria, safety reporting, and clinical trial documentation. Understand the purpose and elements of clinical research.
Week 8: Clinical Development Phase I
Explore Drug Development Phase I Clinical Trials. Discover their purpose, design, dose selection methods, and different types of Phase I trials, including bioequivalence and combined Phase I/II studies.
Week 9: Clinical Development Phase II
Dive into Drug Development Phase II Clinical Trials. Uncover their objectives, phases, and key concepts like randomized control trials, statistical considerations, null hypothesis, P values, and type 1 and 2 errors.
Week 10: Clinical Development Phase III
Explore Drug Development Phase III Clinical Trials and their purpose, Phase IIIB, trial designs (parallel, crossover, adaptive), and the critical stages of database cleaning, lock, and regulatory application submittal.
Week 11: Clinical Development Phase IV
Dive into Drug Development Phase IV Clinical Trials, where real-world evidence initiatives, launch, lifecycle management, drug safety, and pharmacovigilance take center stage.
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Five Takeaways
- Become proficient in the terminology and acronyms used in preclinical and clinical development.
- State the roles of regulatory agencies worldwide and list the tools they use to ensure approved drugs are safe and efficacious.
- Cite the testing criteria in preclinical development that ensure a candidate drug is safe and supports first-in-human clinical trials.
- Explore the rationale, study design, and special considerations for both traditional and non-traditional clinical trial phases.
- Discuss the launch process and post-approval drug safety monitoring to ensure continued safety and efficacy for patients.
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