As corporations and other large pharmaceutical clients streamline their lists of working relationships, there is growing pressure for contract development and manufacturing organizations (CDMOs) to distinguish themselves in a highly fragmented market.

To be top-of-mind for pharmaceutical companies, CDMOs should focus on acquiring significant assets, establishing the right relationships and making their case for the lion’s share of available business.

Earning your spot
Strategic alliances with big pharma companies are passports to the future, and to get one, CDMOs will need to land on big pharma’s “short list.” It starts with finding a niche, developing an expertise and building an irrefutable reputation.

Finding a niche. This involves self-discipline and patience. Many companies start out trying to handle small molecules and highly potent active pharmaceutical ingredients (HPAPIs) before they have the experience and technical competency to support such complex tasks. This overreach is driven largely by excitement over current demand for these services, and the large profits that await CDMOs capable of delivering them. The temptation of profit is great, especially in the oncology field, but so is the financial risk—and more importantly, the public health hazard. It is wiser to start by concentrating on what you do well and become an expert in a specific sector of the marketplace. For example, Grand River Aseptic Manufacturing (GRAM) is cornering the sterile injectable space using high-quality processes, which is expected to grow exponentially in the coming years.

Developing an expertise. This is a testament to an organization’s employees and their pursuit of excellence. To secure a diverse and highly skilled workforce, CDMOs should not limit their pool of applicants to a specific region or background. Different mindsets and skill sets are needed in the evolving landscape of the outsourced manufacturing industry. Individuals capable of processing information from numerous inputs and reorganizing it to develop executable strategies will be the leaders of tomorrow. As the one-stop-shop model gains popularity and more is expected of CDMOs, these leaders will want to surround themselves with people willing to challenge norms and put in the time it takes to devise more efficient ways to consistently deliver quality.

Reputation building. Building an irrefutable reputation not only demonstrates a CDMO’s ability to execute with precision, but also serves as an indicator of its likelihood to continue doing so while adapting to change. As CDMOs grow in both size and influence, their projects inevitably become larger as do their employee bases and responsibilities. To manage this variability and set achievable expectations, clear communication and process validation must be a focus.

Keeping your spot
Once a strong reputation is established, the key is to not become complacent. An organization is never more vulnerable than at the moment it thinks it has succeeded. This moment is a pivotal juncture for leadership, and a time when CDMOs must transform by adjusting resources, modifying approach and redefining their perception of success.

Adjusting resources. CDMOs will not only need to invest in their workforce through new hires, but also state-of-the-art facilities and more sophisticated technology. These additional assets contribute to the bedrock of a company’s future and demonstrate long-term aim. Preparing for this moment well in advance will help CDMOs outpace the competition as foresight provides the agility to make wise decisions in a rapidly changing environment. Another way for organizations to optimize their timelines during an expansion is to utilize a design-build concept. Under this arrangement, the CDMO and construction company work together, providing recommendations to fit a particular schedule and budget while construction is underway. Any changes are also addressed by the entire team, leading to collaborative problem-solving and innovation.

Modifying approach. As expectations rise with increased demand, CDMOs will want to build capabilities within their organizations, and more broadly through relationships in the industry. Processes need to be developed to support a range of services, from clinical trials through commercialization, and deliver on expedited timelines. Smaller CDMOs should consider establishing working relationships with their own outsourced partners, adopting a variation of the popular one-stop-shop model. The unique combination of these two adaptations greatly benefits clients, safeguarding reliability and quality while tapping into the collective wisdom of the industry—a recipe for continued success.

Redefining perception of success. It is important to understand that the goal has never been to just participate in the conversation. Achieving the status of an active participant is a step along the way to forming long-term, mutually beneficial and strategic partnerships. The responsibility now is to support these partners by prioritizing their needs and protecting their reputation. Customer service and quality – are indispensable components to prosperity in the outsourced manufacturing industry, followed closely by transparency through open communication.  There is nothing more reassuring than knowing all parties are on the same page.

The transition from sought-after CDMO to strategic partner requires efficient collaboration and a willingness to continually evolve. Keeping these guidelines in mind, CDMOs will pave their own pathways to the forefront of the industry, equipped with the tools to secure their positions when they get there. 

---

Judy Meyers began her tenure at Grand River Aseptic Manufacturing (GRAM) as a senior business development manager in 2014. With nearly two decades of pharmaceutical business management experience, Meyers is an integral member of the business development team, where she successfully builds and maintains positive client relationships. Prior to her career at GRAM, Meyers held business development and project management positions at Cook Pharmica, Covance Central Laboratory and Baxter Pharmaceutical Solutions.