Register for Event

Member Registration

Members of LabOps Unite: please register here.
Members of BioCT: please register here.
Members of MassBio: please register on this page.

Want your organization to gain access to member rates?  Email courses@massbioed.org for more information.

Rates & Funding

Please view the discount options for courses before registering here.

Member Rate: $850
Non-Member Rate: $1,025

Deadline to apply to the WTFP Express Program: February 11, 2026.
Course ID: C-13314

Single Company Offerings

Interested in offering this training exclusively to your team?
Email courses@massbioed.org to learn more.

Description

Drug Development Pathways provides a comprehensive, end-to-end overview of how a drug progresses from an initial idea to an approved product. Participants explore the full drug development lifecycle, beginning with target and indication identification in the discovery phase and moving through de-risking activities, manufacturing considerations, and regulatory requirements.

The course covers pre-clinical and clinical development, the role of regulatory agencies, and the importance of mitigating risk to control costs and enable successful progression through each stage. Participants will also examine the network of vendors, functional roles, and interdependent teams involved throughout the process, as well as post-approval considerations such as study design, regulations, partnerships, and commercialization. Historical context on U.S. FDA regulations is included to provide a framework for understanding why current guidance and requirements exist.

Who should attend? This course is designed for a broad audience, including individuals who want to understand the bigger picture of how drugs are developed from concept to market. It is well suited for professionals currently working in the life sciences who want to better understand how their role fits into the larger drug development ecosystem, as well as those who are new to—or exploring—careers in the biotechnology and pharmaceutical industries and would benefit from a high-level overview of development processes, regulations, and their underlying rationale.

For participants interested in deepening their understanding of the business, financial, and commercialization aspects of drug development, this course pairs well with Intro to Biotech, Business & Science, Finance of Biotechnology, and Biotech Commercialization.

Schedule

Thursday, March 5, 2026 | 9:00–11:30 AM EST
Thursday, March 12, 2026 | 9:00–11:30 AM EST
Thursday, March 19, 2026 | 9:00–11:30 AM EST

Meet the Instructor

Catherine Mesner
Bio-Pharma Advisor

Catherine brings over 30 years of experience leading drug development programs across biotech and pharma, with senior roles at Eli Lilly, Pfizer, and Checkmate Pharmaceuticals. She has overseen clinical strategies from discovery through Phase 2 trials, managed $250M+ R&D budgets, and guided multiple products to regulatory approval. Now a strategic advisor to emerging biotech start-ups, Catherine offers practical insights shaped by decades of hands-on experience.