Description
This advanced course explores the critical intersection of biotechnology, business, and regulatory frameworks, equipping participants with the knowledge and strategies needed to successfully bring biotech innovations to market. Covering key areas such as regulatory approval pathways, pricing and reimbursement dynamics, market access, and commercialization strategies, this course provides a comprehensive roadmap for navigating the complexities of biotech product launch and market adoption. Through interactive lectures, case studies, and a hands-on capstone project, participants will gain practical insights into market assessment, go-to market planning, strategic partnerships, and financial feasibility.
Date & Time
Tuesday, October 14th, 2025, 9:00 AM – 5:00 PM EST
Wednesday, October 15th, 2025, 9:00 AM – 1:00 PM EST
Please plan to arrive at least 15 minutes before class starts. Class will start at 9:00 AM. We will have breaks in between.
This course will be held in-person. Breakfast and lunch will be provided at this all day workshop.
Agenda
Regulatory Pathways & Market Assessment
- Overview of global regulatory frameworks (FDA, EMA, PMDA, etc.)
- Role of Health Technology Assessment (HTA) bodies in market access
- Market opportunity analysis: TAM, SAM, SOM, and competitive landscape
- Understanding customer needs and decision-making processes
Commercialization & Go-to-Market Strategy
- Developing a commercialization roadmap
- Sales and distribution models for biotech innovations
- Key partnerships, licensing, and business development strategies
- Marketing, branding, and customer engagement for biotech products
Pricing, Reimbursement & Financial Strategy
- Pricing models, reimbursement mechanisms, and value-based agreements
- Clinical indication sequencing and long-term pricing strategy
- Funding mechanisms: venture capital, grants, and partnerships
- Financial feasibility and ROI evaluation for commercialization
Capstone Project: Commercialization Plan & Presentation
- Team-based development of a commercialization plan for a biotech product
- Presentation of strategy, including regulatory approach, financial model, and market entry plan
- Group feedback and expert insights