Unleashing the Power of Innovation in CDMOs through Customer-Centricity and Culture of Service ()
1. Introduction
In the rapidly evolving pharmaceutical sector, innovation is essential for maintaining a competitive edge and addressing patient needs. Grand View Research predicts that the CDMO market will experience significant growth, reaching a value of 157.7 billion in 2025, up from 98.7 billion. This represents a compound annual growth rate of 6.9%, faster than the pharmaceutical industry. Several reasons for this growth include the increasing global population, better insurance coverage in developing countries, and aging societies in developed countries, all of which contribute to a higher demand for pharmaceuticals. Additionally, pharmaceutical companies are increasingly outsourcing services to CDMOs to reduce time to market, save costs, simplify operations, and allocate resources more efficiently. Therefore, the CDMO market’s rapid expansion is due to external factors and companies’ strategic outsourcing decisions (Grand View Research, 2017) . Development and Manufacturing Organizations (CDMOs) play a pivotal role in fostering innovation by offering services in research and development, manufacturing, and the final product to market through client ideology and expectations. To establish a sustainable culture of innovation, CDMOs need to embrace a customer-centric mentality, focusing on the requirements and expectations of their pharmaceutical collaborators. This encompasses adopting novel contracting models, goal alignment, and forming strong alliances with pharma companies. Nevertheless, more than a service-oriented culture is needed to spur innovation in CDMOs (Rauhut, 2020) . They must also nurture a mindset of transformation and advancement of the current regulations and digital era. This necessitates a readiness to experiment, undertake measured risks, and draw lessons from setbacks. The culture of transparent communication and collaboration within their organization and with their pharma partners is vital for success. This article aims to provide a comprehensive understanding of the culture of service and customer centricity in business, along with the critical role played by CDMOs in driving innovation in the field of advanced research. Through this exploration, it provides to adopt effective leadership strategies that prioritize customer satisfaction while leveraging the expertise of CDMOs to achieve breakthrough results.
1.1. The Importance of a Culture of Service in Driving Innovation
A culture of service prioritizes delivering exceptional customer service through a complex set of attitudes, values, and behaviors ingrained in every aspect of an organization. It encourages employees to exceed expectations, take ownership, use customer feedback to improve, and value internal customers. A culture of service is critical to success in today’s competitive business environment, as it fosters loyalty and generates a key competitive advantage. CDMOs can ignite innovation by promoting a service culture. This requires building strong customer relationships, prioritizing continuous improvement, fostering teamwork and collaboration, ensuring transparency and accountability, and committing to excellence. CDMOs can drive innovation and lead the pharmaceutical industry forward by cultivating this culture. This approach entails comprehending the customer’s needs and priorities, devising strategies to save time and reduce costs, and navigating customers through the regulatory process (Rauhut, 2020) , demonstrate agility in adopting technological advancements to spearhead process innovation and boost operational efficiency. They can embrace emerging technologies such as Hi-Potency handling, regulations for new drug deliveries, automation, flow chemistry, electronic lab notebooks, and robust training in the inner circle to impact the clients positively (Rondinelli & Berry, 2019) .
1.2. Customer-Centric Approach-Flexibility Is the Key
A Contract Development and Manufacturing Organization (CDMO) that adheres to the dictum “this is our standard approach” fails to prioritize customer satisfaction. It is incumbent upon CDMOs to foster a customer-centric culture, nurture employees who embody exemplary behavior, and proactively eliminate instances of clients encountering internal bureaucratic hurdles. CDMOs must take responsibility for erasing such expressions and ideologies from their organization through increased awareness and education and creating a work environment where employees are incentivized to prioritize customer well-being (Wysocki & Kime, 2013) . By adopting these practices, CDMOs can demonstrate their commitment to customer satisfaction and create a culture of continuous improvement.
Embracing novel approaches and flexibly grasping the client’s vantage point can foster a mutually beneficial partnership. At times, clients may develop a passionate connection to their products and timelines, leading to unreasonable requests or demands that fall beyond the scope of the initial proposal, thereby requiring additional resources. In such situations, Contract Development and Manufacturing Organizations (CDMOs) must display flexibility, patience, and understanding, recognizing that these scenarios are vital to sustaining the business and helping the patients. By adopting a client-centric approach with flexibility, establishing clear lines of communication, and developing effective strategies to meet clients’ needs and expectations, CDMOs can demonstrate a steadfast commitment to excellence and engender a culture of continuous improvement (Zhang, Chen, & Guo, 2019) .
In customer-centricity, establishing a connection with customers is only the initial step. A critical aspect of this approach involves recognizing and catering to the needs and demands of a select group of customers who serve as trendsetters and influencers for others in the market. By aligning with these trailblazers, companies can lead the more extensive base of their core customers toward new and improved directions through innovative solutions. The ability to adapt and address evolving customer requirements not only strengthens existing relationships but also enhances the potential for future partnerships.
A customer-centric approach entails a concerted effort by leaders to cultivate a collaborative atmosphere that promotes collective efforts toward mutual objectives and customer contentment. Committed leaders are expected to model a customer-centric mindset by proactively engaging with clients, comprehending their requirements, and harmonizing the organization’s efforts to provide exceptional service. Implementing a Culture of Service requires leaders to establish a coherent vision and mission, aligning team members and motivating them to deliver excellent service (Crumpacker & Crumpacker, 2015) .
2. Winning Hearts and Minds: Winning Customers—Not Projects
2.1. Traditional vs. Customer-Centric Approach
As the trend towards outsourcing continues to grow, winning projects for execution and ensuring sustainability is becoming increasingly challenging for Contract Development and Manufacturing Organizations (CDMOs). In today’s competitive landscape, CDMOs must shift their traditional approach and embrace a customer-centric mindset to win and retain customers. The conventional process to winning projects in the CDMO business involves showcasing capabilities, capacity, and technical expertise, sharing success stories and rich heritage. While this approach can provide an excellent first impression for initial discussions, more is needed in today’s world of transparency and intense competition. CDMOs must adopt a customer-centric approach, prioritizing trust, transparency, and integrity to win customers and projects in the advanced digital era. Fostering a positive environment from the initial discussions, providing technical ideas, acknowledging and addressing client concerns, and responding promptly with honesty and transparency are critical steps to building a successful partnership.
2.2. Collaborative Innovation: Transparent Proposal Discussion
To win over clients and secure business, it’s essential to adopt a collaborative partnering approach rather than showcasing and educating them with our technical capabilities. This approach involves paying attention to detail to build a complete project scope and proposal that addresses the client’s needs and requirements. Crafting a steel-cased proposal for the client is an initial step for any successful project discussion. It is a time-consuming and challenging process that requires a customer-centric mindset and treating the client as the top priority. The proposal-building process demands technical expertise, attention to detail, and effective communication. By prioritizing the client’s needs and preferences, one can tailor the proposal to meet their unique needs and establish a long-term partnership based on mutual respect and understanding. Having an open mindset is also crucial to be receptive to their feedback and suggestions and being willing to adjust the project scope and approach to meet their needs.
2.3. Know Customers and Projects—Rapport Is the Key
However, other qualities such as flexibility, transparency, and communication can also play a vital role in ensuring project success and customer satisfaction. While often overlooked, these qualities can significantly impact execution and overall customer experience. Know each client personally, irrespective of their project size or scope. Each project is unique and warrants an equal level of diligence and consideration. To establish a favorable rapport with prospective clients, gaining insight into their interests and engaging in amiable discourse that centers on their personal experiences is imperative. Employing a robust inquiry technique that encourages information sharing can be efficacious in cultivating a sense of familiarity and intimacy. One can pinpoint salient aspects that resonate with their priorities by gauging their previous encounters with other companies. The incorporation of visual aids such as imagery and videos can enhance the degree of engagement and rapport. Capitalizing on human cognitive biases and accentuating potential losses rather than gains can be a potent persuading tool. Creating value and ease is pivotal in engendering a favorable impression. Dismissing the ego and portraying oneself as a scientific and business partner helps one understand the client in a better way. Delivering outstanding service and presenting a robust proposal with a peerless team and facilities are quintessential in clinching the deal. Acquiring internal support is highly beneficial, as it enables passionate team members to become influential allies who can help persuade potential customers to favor the company.
2.4. Rejection to Reflection: The Value of Handling “Turn-Down” with Grace
The biotechnology industry is experiencing an unprecedented pace of innovation, which presents unique challenges for Contract Development and Manufacturing Organizations (CDMOs). Clients may work with multiple providers for various reasons, such as one-stop service offerings, time constraints, technical capabilities, regional considerations, and cost criteria. On the other side, for some projects, CDMOs may only sometimes be able to accommodate a client’s desired delivery timing due to prior commitments to other clients. Despite these challenges, it is vital for CDMOs to establish and maintain positive relationships with their clients and to communicate effectively, especially in situations where project outcomes fall short of expectations.
Conducting a postmortem analysis using experimental data can be an invaluable tool for CDMOs to comprehend project outcomes and evaluate alternative approaches. It is crucial to effectively communicate these findings to clients and discuss potential avenues for future collaboration. This approach can help to sustain relationships with clients, even in challenging situations, and demonstrate the CDMO’s value as a reliable partner for future endeavors. Ultimately, maintaining positive relationships with clients is a critical factor for success in the highly competitive landscape of CDMOs.
2.5. Customer-Centric Project Management
The success of a project largely depends on its execution after winning. Effective project management is crucial for Contract Development and Manufacturing Organizations (CDMOs) in today’s competitive environment. Identifying key project deliverables, and responsible departments, understanding client perspectives, and comprehending proposals and statements of agreements is essential to initiate the project successfully. It involves understanding project requirements, timelines, and expectations. The project manager must communicate clearly among all team members and define their roles and responsibilities. This includes identifying the departments and stakeholders involved and establishing communication protocols.
Crafting a Team: The project team should include personnel with expertise across all development and manufacturing stages of delivery systems. The biopharmaceutical partner should establish its group of similar members, and a steering committee of senior managers from each team should facilitate communication and enable prompt decisions on critical issues.
Communication Transparency: Effective communication minimizes risks and fosters productive team relationships. Regular project manager meetings, conference calls, and reports ensuring transparent communication and information flow. A predetermined communications tree can streamline decision-making by quickly assembling the appropriate individuals.
Executing the Plan: Key Steps for effectiveness: Once a complete team and project plan are in place, the project can proceed with project managers continuously monitoring needs, addressing emerging issues, and enforcing timelines. Specific milestones and decision points at critical junctures ensure that objectives, resources, costs, and deadlines align with the plan. Drug development is a high-risk venture, and partnering with a CMO that employs robust project management processes can reduce risk and costs while accelerating market readiness. Effective risk management is crucial in project management to avoid chaos and turbulence that can become uncontrollable. Techniques such as Program Evaluation and Review Technique (PERT) and Gantt charts can help identify risks and develop a mitigation and contingency plan to manage known or foreseeable risks.
From Crisis to Control: Dealing Project Delays: The most prominent challenge is dealing with unprecedented delays and out-of-scope proposal work. As the CDMOs work high pace with multiple projects handling batch failures, dealing with release delays, out-of-scope work adjustments, and change order approvals are the critical aspects project management should take care of with the relevant stakeholders. Understanding the client’s urgency, transparent communication from the failures, and timeline challenges should be handled with continuous learning and effective training programs. Project management excellence is vital in managing several projects for biotech companies from preclinical to commercialization. Implementing the RACI model and training project managers from subject matter experts in their respective fields can enhance technical communication and facilitate effective meeting management. Measuring project success is more than just delivering on time and within budget. Discontinued projects can provide valuable lessons that lead to more significant opportunities and long-term business profitability. Therefore, when developing metrics for project success, both technical and business components should be evaluated
3. A Shared Set of Values
3.1. R3 (Recognize, Relate, and Resolve) Approach
CDMOs should foster a shared set of values among their employees. Culture is a shared set of values, beliefs, and norms of behavior that can profoundly impact an organization’s success. When employees are aligned on a shared set of values, they are more likely to work towards the same goals and objectives. CDMOs should identify and communicate their values, such as quality, customer service, and innovation, to their employees to help create a culture of service (Dagher & Itani, 2016) . This will help make a customer-centric approach that will drive innovation and enable the organization to adapt to changing customer needs.
Understanding the customer’s needs and goals is essential for a culture of service to thrive. CDMOs must work with their clients to understand their requirements, expectations, and challenges to deliver tailored solutions. This approach fosters a collaborative partnership, promotes trust, and drives innovation through shared insights and knowledge.
Recognize, Relate, and Resolve (R3) approach is a customer-centric approach used by CDMOs to engage with their clients effectively. It involves recognizing the customer’s needs, building a solid relationship, and resolving any issues arising during the project. This approach helps to develop long-term relationships with clients by prioritizing their needs and delivering high-quality services (Beladi & Bala, 2017) .
3.2. Balancing Pace and Patience
Genuine transformations demand holistic solutions that balance exercising patience and maintaining a sense of urgency. While the former is necessary to realize long-term objectives, the latter is crucial to sustain momentum and avoid unnecessary delays. Successfully navigating this tension between pace and patience is vital for achieving sustainable and meaningful change that can endure in the face of evolving challenges and opportunities (Groysberg et al., 2013) .
CDMOs are often required to work at an unprecedented pace to support biopharma companies in bringing innovations to market while maintaining regulatory compliance. This balancing act requires both speed and patience, and CDMOs are continuously adapting to meet the needs of the industry (Mankins & Garton, 2021) .
Moreover, CDMOs must be aware of the latest trends and innovations in the industry and adapt accordingly. For instance, the emergence of ADC linkers and biologics and the complexities of developing and manufacturing them have increased the need to simplify manufacturing operations and reduce operating expenditure, leading to the growth of the CDMO.
For a company to achieve its desired outcomes, it is crucial to identify the necessary decisions, tasks, and knowledge required for individuals to make progress and sustain success. Each stage of the process demands timely and effective execution, with a positive outcome being the goal. To gain a deeper understanding of the journey, companies can ask critical questions about each stage, including how to accelerate progress, what issues or inconsistencies to avoid, and what success would look like.
After determining what success means for the customer, the next step is to identify the potential barriers that impede progress and develop strategies for overcoming them. Obstacles can arise in three primary domains: resources, customer readiness, and context. Conversations with customers can be an effective way to identify these barriers. Customers can be asked questions such as how current offerings fall short, what areas require additional knowledge or motivation, and what factors prevent desired progress.
3.3. Agility and Flexibility
The ability to adapt to our customer’s needs quickly and seamlessly transition from research to first-in-man research to clinical batch production is critical for Biotech companies and CDMOs. Flexibility is the cornerstone of our success in meeting these demands. The pharmaceutical industry constantly evolves, and CDMOs must adapt quickly to changing market trends and customer demands. Organizations that implement agile strategies are viewed as high-priority initiatives. Therefore, for CDMOs to remain at the forefront of process innovation and operational efficiency, they must be flexible in adopting technological advancements. Furthermore, prioritizing patient safety and health is critical for biotechs and CDMOs (Voigt & Wang, 2016) .
3.4. Continuous improvement: Perform-Transform Approach
Leadership teams at CDMOs are responsible for two distinct but equally vital tasks: managing day-to-day business operations and building a future that aligns with their commitments. In essence, they must balance the demands of both performing and transforming. The absence of either of these aspects can impede a company’s success, as a failure to perform hinders the present, while a lack of transformation undermines prospects. Consequently, scorecards should measure performance and transformation, reflecting the equal importance of both responsibilities (Wadhwa, 2020) . To advance companies and adopt new technologies, it is crucial to identify critical leadership roles, assemble the right people, and focus on leadership that drives innovation and transformation. These essential steps are integral to the success of any CDMOs towards progress and growth.
To demonstrate their abilities successfully, Contract Development and Manufacturing Organizations (CDMOs) must fully grasp their clients’ requirements and deliver innovative solutions within the agreed-upon timeframe. This necessitates expertise in continuous manufacturing, flow chemistry techniques, quality by design concepts, advanced chromatographic methods, regulatory compliance, and high potency handling. Additionally, CDMOs must prioritize maintaining their performance for the current projects and adopting new practices to stay competitive in the market (Simon & Trottier, 2019) .
Continuous improvement is a mindset that encourages organizations to be proactive and responsive to changing customer needs and market trends. This mindset fosters innovation by encouraging employees to think creatively and seek new ways to meet customer needs. CDMOs can improve continuously by learning from successful and unsuccessful past projects and using them as training tools to maintain technical expertise and equipment proficiency. These initiatives can help reduce the risks and challenges associated with upcoming projects and demonstrate a solid commitment to quality and improvement for biotech companies. A CDMO with a working knowledge of process characterization, method development, and phase-appropriate quality management systems will be more vigilant in managing common commercial variability challenges. CDMOs can implement initiatives such as Six Sigma methodology, 5S tracking system, and metrological advancements to enhance their capabilities further. Additionally, they should prioritize qualification and training on manufacturing equipment to minimize delays and optimize production processes. To monitor their performance and ensure quality, CDMOs can utilize visual data concepts to track and analyze data related to delay times. By employing these practices, CDMOs can demonstrate their commitment to quality, performance, and efficiency to their clients (Brunk, 2019) .
Investing in the right talent and developing technical professionalism is crucial for CDMOs to leverage their core competency. This enables them to offer valuable insight, oversight, and innovation to biotech companies supporting their innovation goals. To ensure successful customer projects, Contract Development and Manufacturing Organizations (CDMOs) must prioritize effective collaboration across multiple teams to accomplish various project tasks. It is essential to promptly address client concerns and arrange technical reviews outside regular meetings to foster continuous improvement. To oversee a project from start to end, CDMOs must integrate prioritization across different functions and gain a thorough understanding of each department’s priorities as the project progresses. The recruitment and training of highly efficient personnel are critical for achieving optimal project outcomes. By adopting these practices, CDMOs can commit to operational excellence and ultimately achieve success in meeting their clients’ evolving demands. This commitment to continuous improvement allows CDMOs to stay ahead of the curve and offer their customers the most innovative and effective solutions.
3.5. Understanding Needs through Shared Expertise
Setting clear expectations and standards for customer service is also essential. This encompasses outlining service benchmarks, monitoring performance, and offering consistent feedback and guidance to employees. To align towards a common goal, it is crucial to prioritize several vital areas, including identifying technical complexity, fostering interactions among subject matter experts, sharing information effectively, complying with relevant regulations, and establishing a robust proposal review system. By focusing on these areas, teams can work together more efficiently and effectively, ultimately achieving their objectives more successfully.
4. Service Culture: The Power of Employee Empowerment
Empowering employees is another crucial aspect of leadership in fostering a Culture of Service. Providing the necessary tools and resources, such as training, information access, and decision-making authority, enables employees to take ownership of their work and make customer-centric decisions. Acknowledging and rewarding employees who excel in customer service is vital. This reinforcement of the importance of customer service motivates employees to maintain high-quality performance. Organizations prioritizing service make it a part of their DNA and build a sense of ownership among their employees. Empowered employees can take calculated risks and innovate, improving customer satisfaction and innovation (Lee, Lee, & Park, 2021) .
Adapting to evolving trends and external education is vital for employees participating in innovative projects to satisfy client expectations. Sustaining a solid foundation in technical expertise is imperative, and training them in client communication, project leadership, and a compassionate grasp of the client’s viewpoint is required. Leadership is critical in nurturing technical talent to handle the complex relationship between scientific business and customers. Staying abreast of current regulatory trends and digital advancements and conducting regular technical expertise assessments are essential in meeting client expectations concerning technical and leadership domains.
Building a Culture of Continuous Learning
Training and competency skills are crucial elements of a robust GMP framework and play a significant role in fostering a culture of service and quality. As CDMOs expand their customer base, they must continuously adapt to new processes and programs, making effective training programs indispensable. To ensure high quality, CDMOs must have good training programs that lower systemic excursions and reduce the cost of poor quality. This requires clearly defined job skill matrices, competency assessments, and structured on-the-job training (OJT) frameworks. The learnings captured during the drug development can provide significant dividends when the program expands to commercial manufacturing. Organizations also focus on devising strategies to implement and assess employee empowerment beyond formal on-the-job training. While regular on-the-job training is crucial for scientists, it is equally essential for CDMOs to establish a system to foster scientific business leadership skills in conjunction with emerging trends (Suresh & Sharma, 2019) .
5. Fostering a Culture of Safety and Compliance
5.1. Prioritizing Quality and Safety
Leaders must emphasize the importance of maintaining the highest quality and safety standards in all aspects of the CDMO’s operations, reinforcing that these factors are crucial to delivering exceptional service. By embodying these qualities, leadership in a CDMO can successfully establish a Culture of Service and drive long-term success. A collaborative partnership with companies showcases the importance of solid leadership commitment in fostering a service-oriented CDMO environment.
The deviation system, data integrity, quality culture, and change management all play crucial roles in creating a culture of service in CDMOs. A robust deviation system captures non-conformances and excursions, which helps maintain quality standards and prevent future issues. At the same time, a mature data integrity program generates high-quality data that strengthens the CDMO’s reputation as a trusted partner. Prioritizing quality and instilling a culture of excellence in every aspect of their operations can help CDMOs create a culture of service that prioritizes the customer’s needs. Clear change management frameworks also ensure that changes are managed effectively, minimizing potential disruptions to the drug development program and building customer trust and confidence. By prioritizing these critical components and working collaboratively with drug sponsors, CDMOs can establish themselves as reliable partners committed to delivering high-quality services (Lee, Lee, & Park, 2021) .
5.2. Patient-Centric Approach
Ensuring patient safety and health is paramount to biotech’s and CDMOs. It’s essential to adopt a patient-centric approach that prioritizes the well-being of patients. The primary and utmost focus should be delivering high-quality drug products while ensuring the manufacturing processes are safe and efficient. Additionally, biotech’s and CDMOs must establish strong client partnerships based on mutual trust and aligned goals. Overall, a patient-centric approach is critical for the success of biotechs and CDMOs in the pharmaceutical industry (Poels & van der Heijden, 2019) .
6. Conclusion
Transitioning from traditional methods to innovative ways of working, redefining and modernizing customary training practices with cutting-edge technical education and cultivating technical expertise to manage the enthusiasm and momentum of clients is essential for CDMOs to facilitate innovation through a client-centric approach. The role of Contract Development and Manufacturing Organizations (CDMOs) in supporting biotech innovation is critical and adopting a customer-centric service culture is paramount for their continued success. By leveraging their expertise and resources, CDMOs can streamline drug development, reduce lead times, improve cost-effectiveness, and drive process innovation and operational efficiency. To maintain a competitive edge in a rapidly evolving industry, CDMOs must prioritize customer-centricity, patient safety and cultivate a culture of service that emphasizes compliance, safety, and continuous improvement. This requires active listening, timely communication, and a focus on quality while empowering employees to drive innovation and anticipate shifts in the market. Ultimately, a culture of service that drives innovation and prioritizes customer satisfaction will enable CDMOs to differentiate themselves and provide exceptional value to biotech companies, patients contributing to the advancement of the biopharmaceutical industry.
This article presented various leadership strategies and working mechanisms that can help CDMOs drive innovation in the biotech industry. However, leadership engagement and customer-centricity through a culture of service are continuous processes that require ongoing attention and adaptation to meet customer and project requirements. To improve performance, it may be beneficial for organizations to explore new research methodologies, provide advanced training, and address any gaps or biases in their approach. By doing so, the industry can work towards continuous improvement and innovation in leadership strategies.
Acknowledgements
I would like to express my heartfelt gratitude to the Veranova Leadership Team (VLT) for their invaluable support and insightful suggestions in preparing this article. I also wish to acknowledge the support and contributions of my colleagues from Business Development, Project Management, and functional heads, whose input was instrumental in the development of this article. Lastly, I would like to extend my appreciation to my colleagues from Analytical Research & Development for their support and encouragement throughout this process.