Table of contents
Supply chain digital transformation is critical for clinical-phase companies, but competing priorities and limited resources often delay its adoption.
In this Orchestrating Outcomes for External Manufacturing podcast, Colby Wolfe, Executive Director, Head of Global Supply Chain at Dyne Therapeutics, shares his insights on how smaller teams can enable agility in early digitalization efforts, while the transition to commercialization introduces new complexities.
He discusses the challenges of moving from manual processes like Excel to more advanced digital tools, the evolving role of supply chain functions in clinical organizations, and why successful digitalization must create value for both brand owners and CMOs.
Key topics:
- Smaller Teams, Fewer Barriers: The Clinical-Phase Digitalization Advantage
- From Excel to ERP: How Clinical-Phase Companies Navigate Digitalization
- Making Supply Chain Digitalization a Win-Win for CMOs and Brand Owners
- The Stages of Supply Chain Digitalization for Clinical-Phase Companies
- Digital Challenges and Opportunities for Clinical Phase Companies: The Complete Interview with Colby Wolfe
Explore some video highlights below and then watch the full interview for more insights.
Smaller Teams, Fewer Barriers: The Clinical-Phase Digitalization Advantage 
Smaller teams and fewer barriers can make digitalization more attainable for clinical-phase companies—but competing priorities still present challenges. In this interview highlight, Colby Wolfe, Executive Director, Head of Global Supply Chain at Dyne Therapeutics, explains that while early digital adoption can be an advantage, regulatory demands and the realities of scaling operations can still slow progress.
From Excel to ERP: How Clinical-Phase Companies Navigate Digitalization 
Clinical-phase companies often start with Excel to manage supply chain operations, but as complexity grows, they must transition to more robust digital solutions. Without an ERP system in place, teams rely on manual processes until increasing product volume and regulatory requirements force a shift. Colby Wolfe describes how companies navigate this transition, balancing cost, compliance, and functionality while seeking digital tools that fit their evolving needs.
Making Supply Chain Digitalization a Win-Win for CMOs and Brand Owners 
For digitalization to succeed between brand owners and CMOs, it must create value for both parties. If the benefits are one-sided, CMOs may hesitate to invest in change, especially when managing multiple customers with different demands. Colby Wolfe explains why a collaborative approach—where digital tools help streamline operations, improve forecasting, and reduce inefficiencies—can strengthen partnerships and make supply chain digitalization a win-win.
The Stages of Supply Chain Digitalization for Clinical-Phase Companies 
Supply chain digitalization in clinical-phase companies evolves alongside their growth, starting with internal alignment before expanding to external collaboration. Early stages focus on structuring processes and integrating basic digital tools, while later phases require binding forecasts, financial commitments, and more sophisticated data exchange with CMOs. As operations mature, companies must formalize processes, define key metrics, and ensure digital solutions align with business needs.
Digital Supply Chain Challenges and Opportunities for Clinical Phase Companies: The Complete Interview with Colby Wolfe 
The path to supply chain digitalization for clinical-phase companies is both promising and complex, shaped by agility, resource constraints, and evolving priorities. Colby Wolfe explores the stages of digitalization for clinical organizations, from early internal alignment to managing supplier relationships and scaling operations. He highlights the importance of balancing digital investment with other business priorities, the difficulty of integrating systems in a highly regulated environment, and how collaboration with CMOs can drive greater efficiency—if approached as a win-win partnership. Watch the full interview now.
- Chapter 1: Colby Wolfe’s Career Journey in Supply Chain (01:54)
- Chapter 2: Defining Supply Chain Digitalization (07:30)
- Chapter 3: Why Pharma Lags Behind in Digitalization (08:25)
- Chapter 4: Balancing Digitalization with Competing Priorities in Clinical-Stage Companies (13:51)
- Chapter 5: Creating a Win-Win Digital Strategy for Brand Owners and CMOs (21:00)
- Chapter 6: Strengthening CMO Partnerships Through Digitalization (25:30)
- Chapter 7: How Digitalization Evolves Along the Clinical Supply Chain Lifecycle (31:52)
- Chapter 8: The Top Three Benefits of Supply Chain Digitalization (38:15)
