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. This course will describe the whole process, focusing on the clinical aspects of drug development. Multiple exercises will allow participants to gain an appreciation for team responsibilities and how people with different priorities work together for the common good. Following preparation of a development strategy, participants will prepare individual study designs that implement the strategy. The logistics of the process will be examined to optimize time and cost. The dynamic tension between a pharmaceutical company and regulatory agency will be examined in the context of optimizing development.
- Summarize the process of transforming a drug candidate into a drug product
- Discern the decision-making process that efficiently moves a drug through development
- Describe how pharmacokinetic principles are applied in the decision-making process
- Describe how individual departments work together to reduce the project timeline and cost
- Prepare a clinical development plan and resulting clinical study designs
- Describe the strategy and logistics of a meeting between the company project team and regulatory agency
- Clinical investigators and clinical research organization (CRO) personnel
- Sponsor personnel (e.g., scintists, CRAs, project managers, statisticians) who are new to clinical drug development
The course will be led by one of the following instructors:
Robert L. Kunka, Ph.D.
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Day 1: 8:30 a.m. – 5:00 p.m.
- Pharmaceutical Company Structure and Function: Key groups within R & D; Understanding the structure and dynamics of teams; Stages of drug development
- FDA Structure and Function: Overall FDA organization with focus on CDER; dynamics of interactions with regulatory agencies; stages of clinical development: Phases 0-4; key regulatory documents: IND, NDA, sNDA, and aNDA; milestone meetings with the agency; role of advisory committees
- 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 dose vs. multiple dose, blinded vs. unblinded; regualated product submission (RPS)
Day 2: 8:30 a.m. – 5:00 p.m.
- 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
- Pediatric Drug Development: Key FDA and EMEA initiatives; utilization of adult
data; bridging studies; utilization of pharmacokinetic and pharmacodynamic
data; strategies for overcoming inherent limitations of working in children
- Applications for Drug Delivery Systems: Geeric; immediate and modified-release oral products; inhalation; product extensions
- Craft a clinical development plan and transform the plan into specific clinical studies
- Role play individuals on a clinical development team as they respond to a regulatory question
- Work towards consensus on a team
- Respond to a medical need
- Present a development plan to the FDA and defend it
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-12-088-L01-P. Released: 10/12.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.