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Overview: Drug development is the process of incorporating data from multiple disciplines into a logical and coherent argument for the efficacy and safety of a drug product resulting in regulatory approval. The course will focus on the clinical aspect. The primary goal of the course will provide students with the basic principles and process for taking a chemical and developing it into a drug product. Medical, pharmaceutical, pharmacokinetics, and statistical principles will be reviewed and utilized in the course. Examples will be provided by my experience, experiences in the literature, and approvals from the Food and Drug Administration (FDA) website. The outline for the class will include organization of a pharmaceutical company including preclinical, pharmaceutical development, clinical pharmacology, clinical, and regulatory. Several therapeutic areas will be used in examples. The valuable use of teams will be described by membership and responsibilities. Interactions with different drug company teams will be examined along with interaction with FDA teams. The stages of development (Phases 1 - 4) along with formal meetings with the FDA along with important regulatory submissions (IND, Phase I, II, III, NDA) will be described and discussed. Importance of regulatory interaction will be described and discussed along with strategies for providing a successful outcome for both parties. While dynamic tension between the regulatory authority and the pharmaceutical company will occur, it can be used to provide the energy for generating a successful outcome. While the company develops the clinical strategy, the FDA often provides changes that improve it. Reviews of real life drugs will be used as examples along with developing the prescribing information. Pharmacokinetic approaches will be described without the need for understanding the math. The use of pharmacokinetic information will be described. Why should you attend: This seminar provides you with an understanding of the process. People often use the term, "Well, it's not rocket science!", to indicate that something is not complicated. They could also use the term "Well, it's not drug development!" The process of clinical drug development utilizes pharmacokinetics, medical, statistics, and other clinically relevant principles to turn a chemical compound into a safe and effective drug. These key areas will be examined and the process that utilizes them will be examined in a way that draws from real examples. Who Will Benefit: This two-day seminar will provide overview and guidance to scientists who want to develop drugs for a pharmaceutical company or a clinical research organization (CRO) at any management level. Regulatory Clinical Pharmacology Clinical Product development Regulatory Consultants Agenda Day One Lecture 1: Pharmaceutical company structure and function: Key groups within pharmaceutical R and D Understanding? the structure and dynamics of teams Stages of drug development Lecture 2: FDA structure and function Overall FDA organization with focus on Center for Drug Evaluation and Research (CDER) Dynamics of interactions with regulatory agencies Stages of clinical development: Phases 0 - 4 Key regulatory documents: Investigational New Drug application (IND),New Drug Application ( NDA), Supplemental NDA (sNDA), and abbreviated NDA (aNDA) Milestone meetings with FDA Role of advisory committee Lecture 3: Stages of clinical development Phase 0 - first time in man Phase I - pharmacokinetic, pharmacodynamic, safety Phase IIa and IIb - efficacy and safety Phase III - pivotal efficacy and safety Phase IV - post-approval Design questions: healthy subjects vs. patients, objective vs. subjective endpoints, single vs. multiple dose, blinded vs. unblended Regulated product submission (RPS) Day Two Lecture 1: Developing a clinical plan Review relevant package inserts to identify key questions Develop study designs to address questions Strengths and weaknesses of using a clinical research organization Role of pharmacokinetics in drug development Lecture 2: Pediatric drug development Key FDA and Europe, Middle East, and Africa (EMEA) initiatives Utilization of adult data Bridging studies Utilization of pharmacokinetic and pharmacodynamics data Strategies for overcoming inherent limitations of working in children Lecture 3: Drug delivery systems Immediate and modified-release oral products Inhalation Product extensions Speaker: Robert L. Kunka, Ph.D., is an accomplished and respected scientist who contributed to the development of 28 pharmaceutical products in eight therapeutic areas. His expertise on international product development teams produced submissions with successful clinical strategies, sound matrix management of individual study teams, and effective interactions with regulatory agencies leading to successful IND, aNDA, and NDA approvals. Quick Contact: GlobalCompliancePanel USA Phone:800-447-9407 Fax: 302-288-6884 support@globalcompliancepanel.com http://www.globalcompliancepanel.com
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