BIO Professional Development
Through a curated network of education alliance partners, BIO offers industry professionals executive training and development resources for accelerating career growth
06/15/2025 - 06/15/2025 | 9:00 AM - 3:30 PM EDT
Commercialization Readiness from Preclinical to 1st Launch
Commercialization Readiness from Preclinical to 1st Launch will equip early-stage biotechnology leaders with the commercialization knowledge they need to strategically position their organizations for financing success and meeting critical commercial milestones.
The drug development process is complex and multifaceted, and understanding the commercialization considerations at each phase is vital. From preclinical to first product launch, this one-day course will help biotech executives make informed strategic choices for long-term success.
This interactive course will cover phase-specific market analysis, including a competitive landscape assessment, regulatory considerations, the Commercialization Roadmap development, FTEs and dollar spend, market access pricing and reimbursement, value proposition development, and go-to-market preparation.
Developed by Biotech Primer, BIO’s official education partner, Commercialization Readiness: From Phase 1 to 1st Launch will empower first time CEOs to navigate the commercialization journey effectively.
This one-day course will be held in-person on Sunday, June 15, 2025, in Boston, Mass. Registration opens on January 27, 2025.
Interested in only registering for an in-person course in Boston? For course-only registration instructions, email: courseshelp@bio.org
Takeaways
Commercial imperatives that impact value: Preclinical -- Phase I
Commercial and medical affairs imperatives: Phase II -- Phase III
Commercial and medical affairs imperatives: Positive data readout to launch
Medical affairs imperatives
Life cycle management
Certificate Requirements
Attend the entire in-person course
Complete course evaluation within two weeks of the course end date
A good regulatory strategy is essential to a good business strategy.
Do we correct information about our drug in a company’s sponsored chat room? What types of websites shouldn’t we link to? Learn the FDA regs and more.
Under what conditions can companies find a safe harbor for communicating investigational data? How and why is scientific exchange codified in the Code of Federal Regulations (CFR). Learn the FDA regs and more.