Clinical Drug Development and Approval Process - 2-day In-person Seminar

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
Understandingý 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
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