Course Description:
Participants will be introduced to major clinical steps and considerations in the new drug development process. Starting with the selection of medically promising molecules, through the execution of major I-IV phases of clinical trials, and ending in clinical profiling for marketing.
The course will address:
- Standard procedures;
- New strategies implemented in clinical trials;
- Selection of clinical investigators, consultants and opinion leaders;
- Interactions with regulatory agencies in various countries;
- Impact of regulations on the programs; as well as other common challenges.
Participants will learn about similarities and differences in clinical strategies for standard vs unique molecules, for domestic vs global programs, and for large pharma projects vs small biotech companies.
Learning Objectives:
- To understand the role of medical input in the selection of potentially therapeutic molecules and their subsequent clinical profiling.
- To understand and be able to design the most appropriate strategy for a clinical program, including all clinical developmental phases, from IND to NDA/PLA.
- To understand basic trial methodologies, study execution, monitoring and evaluation processes.
- To understand the selection of the investigators and consultants in various countries; the criteria for study placement and their cost, as well as the concept of “go no go” clinical decision for the molecule.
- To become familiar with common challenges and key issues effecting trial designs and their execution in different countries and difficult investigators.
- To understand how to work with multifunctional and often multicultural teams.
- To discuss the clinical part of FDA and ICH guidelines and their impact on clinical programs.
Seminar Fee Includes:
Who will Benefit:
- Junior or new staff of clinical pharmacology and clinical research departments.
- Pre-clinical, business, legal and marketing professionals who wish to become familiar with the clinical drug development process and the interpretation of clinical data.
- Investment or licensing community members who are interested in clinical programs, particularly in the process of planning, costs, timing and issues of clinical evolutions and/or profiling of new molecule.
- Clinical research associates, project managers, research scientists, medical writers, clinical statisticians, junior regulatory personnel, licensing and acquisition staff.
- Any college graduates who are contemplating careers in clinical research involving the bio-pharma industry.
Course Outline:
| Day 1 (8:30 AM – 4:30 PM) | Day 2 (8:30 AM – 5:00 PM) | ||
Morning Session A, 9:00 AM - 12:30 PM Clinical considerations during preparation and conduct of first clinical trials in humans. Major goals are safety, early activity, and dose finding.
Afternoon Session B, 1:00 PM - 4:30 PM Phases I and/or I/II and II A or B. Early activity and efficacy. Early safety profile.
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Morning Session C, 8:30 AM - 12:30 PM Providing definitive evidence of efficacy and safety.
Afternoon Session D, 1:00 PM to 5:00 PM Final regulatory submissions. Secondary indications. Marketing support. Special issues.
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Meet Your Instructor
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Zofia Dziewanowska MD, PhD Pharmaceutical Executive /Clinical Research & Regulatory For over 30 years, Zofia E Dziewanowska MD, PhD, has been in charge of new drug development, including all Phases(I to IV, domestic and international) for big pharma like Merck and Hoffman la Roche, and smaller biotech start-ups like Genta and Ligand. Early in her career, she personally designed and conducted multiple clinical trials. Subsequently, she became the senior Clinical R&D Executive responsible for medical strategies, execution and management of programs which spanned multiple therapeutic areas. Dr. Dziewanowska submitted many successful NDAs. She has also participated in the selection of molecules for clinical development, including their profiling and post approval programs. She presented to regulatory agencies in US and Europe. Her academic affiliations included medical schools and institutes in the US and Europe. She organized numerous professional meetings and educational programs. Presently, she is a senior consultant to the biopharmaceutical industry as a founder and medical director of New Drug Associates. |
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