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  1. Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders
  2. 257: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 1
257: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 1

257: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 1

Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders · Jun 2, 2026

Biotech vet Milan Tomic shares 30 years of CMC lessons: integrate regulatory early, let curiosity guide your career, and design for manufacturing.

Integrate Regulatory Affairs into Early Drug Design for Strategic Advantage

Instead of viewing regulatory affairs as a final compliance hurdle, involve them at the earliest stages. Their input on market needs and application can strategically shape the drug's design and development process, distinguishing a mere "drug" from a viable "product."

257: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 1 thumbnail

257: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 1

Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders·2 months ago

Drive Biotech Career Growth by Connecting Dots Across Disparate Functions

Career advancement isn't always about deepening expertise in one narrow field. It can be driven by a curiosity to understand how different functions connect. This cross-functional perspective reveals process inefficiencies, and solving them leads to recognition, growth, and new opportunities.

257: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 1 thumbnail

257: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 1

Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders·2 months ago

Scientist-Founders Must Master Salesmanship, a Skill Antithetical to Deep Analysis

For scientists becoming entrepreneurs, the biggest shock isn't the business logistics, but the need for salesmanship. This requires shifting from deep, analytical 'how' conversations to a broader, persuasive style that feels unnatural for those accustomed to letting data speak for itself.

257: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 1 thumbnail

257: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 1

Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders·2 months ago

Leverage Quality Control Insights to Drive Manufacturing and Facility Redesign

Quality Control is more than a compliance function; it's a vantage point for understanding systemic process inefficiencies. By mastering QC workflows—from raw materials to product release—one can gain the deep operational insights needed to lead large-scale process improvements and even redesign entire manufacturing facilities.

257: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 1 thumbnail

257: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 1

Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders·2 months ago

Secure Biotech Investment by Integrating Manufacturing Viability into Early Drug Design

A great molecule isn't enough to attract investment. Scientists must demonstrate they've considered manufacturing from day one. Designing a robust process that fits a consistent GMP facility shows investors that the project is not just a scientific curiosity but a viable path to a scalable product.

257: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 1 thumbnail

257: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 1

Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders·2 months ago