CMBB Training

PSM Program The CMBB, in conjunction with the College of Business, has also initiated a Professional Science Masters (PSM) degree program in biotechnology. This 2-year program is primarily for students with an undergraduate degree in the biological sciences who would like to obtain further training in both the scientific and business aspects of the biotechnology field. The program will include 2 internships in biotechnology companies that will provide students with exposure to this exciting field. Additional information can be found here or contact Dr. David Binninger (561-297-3323, binninge@fau.edu)

Certificate

The Center for Molecular Biology and Biotechnology (CMBB) offers a Biotechnology Certificate Program. The purpose of the program is to encourage and recognize students who are planning for a career in a biotechnology-oriented field. The program is open to all students in the departments of Biological Sciences and Chemistry & Biochemistry at Florida Atlantic. Individuals with a baccalaureate degree in biology or chemistry from another institution may also participate. A Biotechnology Certificate will be awarded to students who completed the following courses: 

A Biotechnology Certificate will be awarded to students with an overall GPA of at least 2.5 and the minimum grade indicated for each of the following courses:

Course Number	Course Title	Credits
Biochemistry Laboratory	BCHL3103	3
General Microbiology	MCB 3023	3
General Microbiology Laboratory	MCBL3023	1
Genetics	PCB 3063	4
BSCL4403	Biotechnology I Laborator	2
BSCL4405	Biotechnology II Laboratory	2

 

Successful completion of the Biotechnology Certificate progr   am will be indicated on the student’s transcript and a certificate will be awarded by the Center of Exce   llence in Molecular Biology and Biotechnology (CMBB).
 
The application form can be downloaded as either a    MS Word    or    PDF    document. The completed form should be returned to the CMBB office in room 223 in the RF Building of the Jupiter Campus. Completed applications may also be sent by e-mail to Ms. Marjorie Cazeau (   mcazeau@fau.edu   ).
 
If you have additional questions, please feel free to contact Dr. David Binninger by phone (561.297.3323) or email (   binninge@fau.edu   ).

Drug Development Training Courses

Introduction to Drug Development

Drug Development

CHM 4274C/CHM6277C

3

This course provides the basics in US FDA drug regulations, facilities and process qualification and the processes involved in drug discovery and development.  Students will learn how specific activities fit into the overall scheme of drug development and evaluate the impact of each activity on the overall progression of a new drug candidate.  The principles of current good manufacturing practices (cGMPs), quality control and quality assurance are introduced. The basics of regulatory compliance, the global nature of regulations and their importance of validation in the Pharmaceutical and Biotechnology Industries will be presented.

Topics include:

• Drug Discovery and Non-clinical Development
• Early Phase Formulation and Analytical Development
• Requirements for Investigation New Drug (IND) Approval
• Quality and Regulatory Requirements in GMP Development
• Phase I Clinical Development
• Phase II Clinical Development
• Phase III Clinical Development
• Chemistry Manufacturing and Controls (CMC) required for NDA Filing
• Process and Analytical Validation
• FDA Pre-Approval Inspection (PAI)

Drug Discovery and Formulations:

Introduction to Drug Formulation

CHM 4276C/CHM6279C

3

This course provides an in depth coverage of the early phase of drug development.  Students will learn about drug discovery, pharmacology, toxicology and pharmaceutics.  These functions are required to move a drug from discovery through to the point of first in man clinical evaluation.  A laboratory portion will cover routine formulation development and testing techniques for tablets, capsules, emulsions and injectable dosage forms.

Topics include:

• Drug Discovery
• Medicinal Chemistry
• Pharmacology
• Toxicology
• Pre-Formulation
• Formulation

Requirements: Instructor permission.  Students who took “Drug Development and Regulation” course are preferred.

For additional information, please contact  Dr. Shailaja Allani.