Unlocking CDMO Insights with Annette Boland

Pharmaceutical companies increasingly rely on Contract Development and Manufacturing Organizations (CDMOs) to bring efficiency, flexibility, and innovation to their operations. As partnerships with CDMOs become critical to achieving business objectives, it is imperative for pharma companies to choose the right partners and manage these relationships effectively. To shed light on how pharma companies can optimize CDMO collaborations, we spoke with Annette Boland, a seasoned Quality & Compliance Executive at PharmaLex, a Cencora Company.

Annette brings over 30 years of experience in quality assurance within the pharmaceutical, biologics, and medical devices sectors. She has worked extensively with both generic and branded multinational companies. With a BSc (Hons) in Analytical Science and a Post Graduate Diploma in Pharmaceutical Manufacturing Technology, Annette is a Qualified Person (QP) with a wealth of insights into quality operations, remediation, continuous improvement, and audit management.

In this exclusive interview, Annette shares her expert views on choosing the right CDMO, aligning goals, ensuring compliance, and navigating industry trends.

When it comes to choosing the right CDMO, what do you think are the three most important things pharma companies should look for?

1. Cultural Fit: The CDMO should be an extension of your business. Core operating principles and company values must align to ensure seamless collaboration.
2. Proven Track Record: A history of success in niche manufacturing technologies and regulatory compliance is essential. You want a partner who knows the intricacies of the industry.
3. Continuous Improvement Mindset: Look for a CDMO with a collaborative approach to continuous improvement. They should be proactive in providing reliable supply, compliant solutions, and minimizing cost burdens.

Quality and compliance are non-negotiable in pharma—how can companies really tell if a CDMO meets the highest standards?

• Regulatory Inspection Outcomes: A clear indicator is how well a CDMO has fared in past regulatory inspections. If there are observations, assess how the CDMO responded and addressed them.
• Embedded Quality Culture: Day-to-day indicators of a high-quality culture include active reporting of issues, timely investigations, real-time data monitoring, and the use of risk management principles. When a CDMO demonstrates these practices, you can trust that they are committed to maintaining high standards.

How can pharma companies make sure they’re on the same page with a CDMO when it comes to goals and expectations?

• Establish Clear Expectations: Never assume that a CDMO fully understands your goals without explicit communication. Clearly outline project deliverables, risks, dependencies, timelines, and KPIs. Ensure that roles and responsibilities are agreed upon by both parties. Regular check-in meetings are crucial for tracking progress, identifying issues, and creating contingency plans. Quality and Technical Agreements serve as essential tools to formalize these expectations and align discussions.
• Prioritize Consistent Communication: Continuous communication is the backbone of a successful partnership. Frequent updates and reviews help in keeping both parties on the same page and proactively managing any emerging risks. Avoid assuming mutual understanding—clarity must be maintained at every stage of the project.
• Access to Technical Experts: While client relationship managers play a key role in project management, they may not possess the technical depth required for critical discussions. Ensure that the CDMO provides access to their technical leaders, who can offer detailed insights and solutions. The relationship manager should facilitate these interactions to guarantee accurate and complete information transfer.

In your experience, how much of a difference does a CDMO’s technical know-how and ability to innovate make in a successful partnership?

Most effective supply chains operate in a bimodal state:

Balancing Reliability and Agility in Supply Chain Partnerships

1. Mode 1: Reliability Through Operational Excellence: Mode 1 focuses on maintaining high standards of quality, managing costs, and ensuring operational efficiency. This is the foundation of any successful supply chain, where technical expertise and experience are essential to consistently meet customer demands.
2. Mode 2: Agility Through Innovation: Mode 2 emphasizes innovation and rapid adaptation. This approach allows for creative problem-solving and swift adoption of new technologies to address unforeseen challenges. A CDMO with a forward-thinking mindset can help maintain market supply by providing compliant solutions without compromising quality.
3. The Dual Approach for Success: Effective partnerships require a balance between Mode 1 and Mode 2. While reliability ensures consistency, agility drives growth by enabling quick responses to new opportunities and challenges. A successful partnership leverages both modes to push boundaries while maintaining compliance and operational excellence.

Working with a CDMO can be risky at times—what are the common pitfalls, and how can companies avoid them?

Avoiding Common Pitfalls in CDMO Partnerships

1. Thorough Qualification Over Reputation: Skipping qualification steps or relying solely on the CDMO’s reputation can lead to mismatches in capabilities. Ensure that the CDMO’s expertise aligns with your specific requirements, including timelines and flexibility. Formal agreements outlining expectations at the start of the relationship are essential to mitigate potential issues later.
2. Maintaining Active Communication: Complacency in communication can undermine the partnership. Regular business-review forums and active engagement are crucial. Always ask the right questions to distinguish between realistic deliverables and aspirational goals. Effective dialogue is key, whether during the technology transfer phase or routine operations. Understand how the CDMO handles unexpected delays, deviations, and timeline adjustments, and ensure clear communication channels for changes in priorities or supply forecasts.
3. Two-Way Dialogue: Successful partnerships require both parties to remain proactive and transparent. Regular check-ins and open discussions about risks and progress help maintain alignment and avoid miscommunication.

Cost is always a factor, but so is quality. How can companies find the sweet spot between affordability and top-notch service?

• Risk-Based Control Application: Effective decision-making starts with understanding regulatory risk elements. By focusing on these elements, companies can apply appropriate controls that balance quality and cost. Quality Risk Management (QRM) ensures that risks are controlled at a tolerable level while minimizing unnecessary expenses. The ideal control mechanism should be simple to implement and cost-effective for the organization.
• Customer-Centric Lean Approach: Achieving the right balance between quality and cost isn’t a one-size-fits-all solution. By adopting a demand-driven mindset rather than a cost-focused one, organizations can naturally evolve toward a lean, compliant supply model. This approach ensures the right product is delivered in the right quantity at the right time.
• Evaluating the CDMO’s Approach: When seeking the sweet spot between affordability and top-notch service, consider whether the CDMO:
  • Views compliance as a strategic advantage and integrates quality goals with business objectives (e.g., preventive CAPAs, risk management tools).
  • Demonstrates a continuous improvement mindset by identifying and eliminating bottlenecks and redundancies, and by openly communicating and celebrating improvements.

What are the key signs companies should look for to know if their CDMO partnership is working well?

• Reliable Product Supply: The ability to proactively manage risks and maintain supply chain resilience.
• Consistent Compliance: A favorable regulatory compliance record.
• Adaptable Culture: Agility to adapt to changing priorities and a spirit of celebrating shared successes.
• Performance Metrics: Consistently meeting pre-agreed KPIs and metrics is a strong indicator of a successful partnership.

The CDMO industry is changing fast—what trends do you see shaping its future, and how can companies stay ahead of the curve?

• Digitization and Automation Enhancements: With technology advancing at an exponential pace, digitization and automation are becoming central to operational efficiency. Companies should explore these advancements to identify opportunities for value-added improvements in their business models.
• Increasing Adoption of Flexible Isolator Technology: The growing use of flexible isolators enables quick line modifications tailored to client needs without disrupting the cleanroom environment. This innovation enhances time management and ensures compliance with modern aseptic manufacturing standards.
• Heightened Regulatory Oversight: Given the highly regulated nature of the pharmaceutical industry, health authorities emphasize that CDMOs are extensions of the manufacturer. It remains the manufacturer’s responsibility to ensure product quality aligns with current Good Manufacturing Practices (cGMP). There is no delegation of accountability when it comes to compliance.

To stay ahead of the curve, it’s important to forge strategic partnerships where both parties share the common goal of staying updated on current industry regulations, guidance documents, and developing proactive risk management strategies to implement or adopt new technologies as needed based on business requirements.

Guest Bio

Annette Boland is a highly experienced Quality & Compliance Executive at PharmaLex, a Cencora Company, focusing on quality operations, remediation, continuous improvement, and audit management. With over 30 years of experience across pharmaceuticals, biologics, and medical devices, she has worked with both generic and branded multinational companies. Annette holds a BSc (Hons) in Analytical Science and a Post Graduate Diploma in Pharmaceutical Manufacturing Technology, with Qualified Person (QP) status.

Disclaimer

The contents of this article are solely the opinion of the author and do not represent the opinions of PharmaLex GmbH or its parent Cencora. PharmaLex and Cencora strongly encourage readers to review the references provided with this article and all available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions related thereto.

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