Clinical Development Track

For students interested in the interplay between biotechnology and clinical research and development, specifically pertaining to safety and effectiveness of medications, devices, diagnostic products, and treatment regimens intended for human subjects: 

Core topics for this track include--

  • New product development
  • Legal and regulatory affairs
  • Project management
  • Principles of clinical research
  • Principles of toxicology
  •  Statistical principles of epidemiology

The recommended plan of work for the Clinical Development track (42 credit hours):

Fall Semester 1:

MB 585 - Industry Case Studies in Microbial Biotechnology (required; 3 credits)

MB 714 - Microbial Metabolic Regulation (core course; 3 credits)

BIT 510 - Core Techniques in Molecular and Cellular Biology (required; 4 credits; offered fall and spring) OR BEC 540 - Expression Systems in Biomanufacturing I (3 credits)**

**IN-COMING STUDENTS MAY BE ABLE TO OPT OUT OF THIS REQUIREMENT if sufficient evidence is provided and indicates, at least, basic experience and understanding of technologies including recombinant DNA procedures, gene expression, isolation and identification of nucleic acids and proteins. Sufficient evidence may include a letter from current or former supervisors and/or professors attesting that the applicant possesses at least basic understanding of and experience with the aforementioned technologies. Applicants with doctoral training in a related area may opt out of BIT 510 OR BEC 540, with MMB Director or Coordinator approval. 

Spring Semester 1:

MB 585 (required; 3 credits)

MBA 585 - Current Topics in Biosciences Management (required; 3 credits)

MB 751 - Immunology (core course; 3 credits)

Summer semester 1:

Summer internship (students will register credits for the internship during the second fall semester)

Fall Semester 2:

MB 585 (required; 3 credits)

MB 620 (summer internship; 3 credits)

MBA 586 - Legal and Marketing Dynamics in Pharmaceutical and Biotechnology (3 credits; offered fall only)

ST 511 - Experimental Statistics for Biological Sciences I (recommended; 3 credits)

Spring Semester 2:

MB 590 - Topical Problems (required; 3 credits)

MBA 554 - Project Management (recommended; 3 credits)

One of the following: TOX 501 - Principles of Toxicology (4 credits; offered spring only); BEC 575 - Global Regulatory Affairs (3 credits); ST 512 - Experimental Statistics for Biological Sciences II (3 credits)   


Recommended elective courses* (click on the link for each section to see individual course descriptions)

*Courses listed in the sample plan of work above are highly recommended

Biochemistry (BCH) courses:

BCH 553 - Biochemistry of Gene Expression (3 credits; offered fall and spring)

BCH 555 - Proteins and Molecular Mechanisms (3 credits; offered spring only)

BCH 571 - Regulation of Metabolism (3 credits; offered fall only - alternate ODD years)


Biotechnology (BIT) courses:

BIT 501 - Ethical Issues in Biotechnology (1 credit; offered spring only)


Comparative Biological Sciences (CBS) courses:

CBS 565 - Fundamentals of Biomedical Sciences (3 credits; offered in fall only; instructor permission required for enrollment)


Genetics (GN) courses:

GN 513 - Advanced Genetics (3 credits; offered fall and spring)

GN 521 - Molecular Genetics (3 credits; offered fall and spring)

GN 701 - Molecular Genetics (3 credits; offered fall only)

GN 730 - Functional Genetics and Physiology (3 credits; offered spring only - alternate years)

GN 735 - Functional Genomics (3 credits; offered spring only; prerequisite: GN 701)


Master of Business Administration (MBA) courses:

MBA 554 - Project Management (3 credit hours; offered fall and spring)

MBA 563 - Product and Brand Management (3 credits; offered in spring only)

MBA 570 - Managing the Growth Venture (4 credits; offered spring only)

MBA 576 - Technology Evaluation and Commercialization Concepts (4 credits; offered fall only)

MBA 577 - Technology Evaluation and Strategy (4 credits; offered spring only; MBA 576 is a pre-requisite)

MBA 586 - Legal and Marketing Dynamics in Pharmaceuticals and Biotechnology (3 credits; offered in fall only)

MBA 590 - Special Topics in Business Management (3 credits)


Statistics (ST) courses:

ST 513 - Statistics for Management I (3 credits; offered fall only)