Culture Fit
Two companies with different cultures can work together, but this is analogous to employees who don’t share the same values as their companies. When that’s the case, employees rarely put in the extra effort and don’t end up staying with the company very long. The same concept applies to pharmaceutical companies and outsourced manufacturers. To form lasting relationships and bring multiple projects to market, partnering organizations must share similar values.
Separating the “good” partners from the “great” involves the ability to balance growth with agility. Cultural characteristics of CDMOs that are likely to make “great” partners include:
- Long tenured employees who contribute to the strength of relationships and minimize risk. In a world where any miscue or mishap is amplified by exorbitant financial consequences and intolerable health hazards, familiarity is a welcomed benefit. Working with the same people is a perk of smaller outsourced manufacturers and builds trust, which translates into peace of mind. When managing large, complex batches or technology transfers in early phases of development, this is a priceless asset.
- Candid communication, which provides honest feedback while leaving space for constructive criticism.Few aspects of a collaboration are more refreshing than clear and consistent communication, and favorable partners prioritize forthright dialogue. They have organized project teams, inclusive of senior leadership, and set communication plans along with detailed project schedules early. Open lines of communication encourage and facilitate deeper understanding and greater compatibility between partners.
- Attention to detail, which is vital to customer service in a rapidly growing, highly regulated industry. As outsourced manufacturing continues to expand, CDMOs looking to meet demand will need to invest in additional resources to maintain the quality of their service offerings. A careful look at CDMOs’ regulatory history with the U.S. Food and Drug Administration (FDA) and other agencies offers an accurate glimpse of their ability to keep executing with precision in the future.
Quality
With U.S. regulators poised to implement tougher manufacturing standards both domestically and abroad in the next few years, it’s even more pressing for pharmaceutical companies to keep quality top of mind and think long-term.
This means putting less weight on pricing and more emphasis on factors that contribute to outstanding quality, such as:
- Capacity: In recent years, variations to the one-stop-shop model (generally formed through mergers and acquisitions) have created ambiguity around the capacity issue. It is important to do your homework and “not judge a book by its cover.” For example, small-to-medium sized CDMOs are now capable of moving products from clinical trials through commercialization by managing their own outsourced partners. These CDMOs are capitalizing on a competitive advantage developed through years of experience in the industry while their partners reap the benefits of a collective expertise.
- Experience: There is no substitute for a long-standing track record of service and quality. One of its greatest benefits to outsourced manufacturers, and subsequently their pharmaceutical clients, is self-awareness. Too many companies try to be everything for everybody and quickly lose sight of what they do best. Time affords the opportunity to examine service offerings, determine an expertise, and particularly key in our industry, build a strong reputation.
- Reputation: The hidden gem of the outsourced manufacturing industry is the CDMO that doesn’t overpromise and consistently delivers a high-quality product on schedule. This should be a no-brainer, but a surprising number of organizations can’t deliver on a timeline, costing partners both time and money. Reliable indicators for reputable, long-term outsourced manufacturing partners are expansions and investments in cutting-edge technology. Successful relationships result in the need to grow and CDMOs increase technical competency to support longstanding, mutually beneficial arrangements as they prepare for future demand.
- Technical Competency: This comes with capacity and experience, and it is part of an outsourced manufacturing partner’s reputation. But forward-thinking partners will want to further differentiate themselves by not relying on equipment to be the sole differentiator. A deeper dive will reveal another difference maker: outsourced manufacturing partners that recruit nationally secure a more diverse and highly skilled employee base, adding critical elements to both the culture of the company and quality of its product.
As with many sectors, especially in the health care space, the outsourced manufacturing landscape continues to evolve. The needs of pharmaceutical clients are changing, and more efficient delivery models are taking precedence. With this constant flux, the dependable partner who prioritizes culture and quality — and understands the intricacies that define a brand — is an indispensable component to success.
