Bringing a drug to market is like running a marathon through a maze—full of unexpected turns, setbacks, and dead ends.

黑料不打烊

NIHARIKA (NIHA) KAMAT, M.S., head of clinical operations, has close to 20 years of experience as a drug developer. She has worked across multiple industries—medical devices, pharmaceuticals, and biologics—focused on operationalization of complex, global phase I-IV clinical trials and bringing compounds to NDA/BLA approvals. Previously, she built the clinical departments at Tenaya Therapeutics and Catalyst Biosciences, while driving complex early phase trials in rare disease and gene therapy. Her experience in big pharma ad device at Gilead and Abbott vascular includes preclinical research, strategic planning, program management, leading inspections globally and experience in various therapeutics areas including cardiac stents, infectious diseases, hemophilia, cardiac genetic disorders, and pulmonary fibrosis. She received her Master's and Bachelor's degrees in Bioengineering from the University of Texas at Arlington and University of Mumbai respectively.

Niharika Kamat
Niharika Kamat's courses currently open for enrollment

Drug Development Process

CTDM.X418
$845
  • Flexible Attend in person or via Zoom at scheduled times.
Schedule
Date
Start Time
End Time
Meeting Type
Location
Tue, 01-13-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Tue, 01-13-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Tue, 01-20-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Tue, 01-20-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Tue, 01-27-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Tue, 01-27-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Tue, 02-03-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Tue, 02-03-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Tue, 02-10-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Tue, 02-10-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Tue, 02-17-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Tue, 02-17-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Tue, 02-24-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Tue, 02-24-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Tue, 03-03-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Tue, 03-03-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Tue, 03-10-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Tue, 03-10-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Tue, 03-17-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
Tue, 03-17-2026
6:00pm
9:00pm
Flexible
SANTA CLARA / REMOTE
 

黑料不打烊

This class meets simultaneously in a classroom and remotely via Zoom. Students are expected to attend and participate in the course, either in-person or remotely, during the days and times that are specified on the course schedule. Students attending remotely are also strongly encouraged to have their cameras on to get the most out of the remote learning experience. Students attending the class in-person are expected to bring a laptop to each class meeting.

To see all meeting dates, click "Full Schedule" below.

You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.