Alain Bernard, general manager of consulting firm BPAC, spoke today: Bioprocess International Europe In Vienna, Austria, I spoke about important considerations for biotech startups to form and maintain successful partnerships with contract development and manufacturing organizations (CDMOs).
He said the number of first-time biotech launches is increasing globally, with startups rivaling the efficiency of large pharmaceutical companies, with 16 new product launches from 2020 to 2021.
But founding a startup can be physically draining, mentally taxing, and endlessly nerve-wracking. Start-up companies often lack the resources needed to develop, test, and manufacture therapeutics. Most facilities have limited equipment, few assets, and no laboratories. Some people are limited to working in small spaces with a laptop, cell phone, and sometimes a desk and office chair. You can’t rely on internal structures to develop your product.
These companies rely on strong network strategies and greater agility to secure funding from public and private investors and get projects off the ground. A company’s survival often depends on the launch and success of a single product, with major restructuring being the best-case scenario in the face of failure. Therefore, choosing the right CDMO partner is of paramount importance.
Bernard highlighted important factors that startups should consider before investing in a CDMO partnership. He said cost is a concern for new organizations with fewer resources, but it is wise to avoid risk and work with an experienced CDMO, even if it requires additional financial investment.
The best CDMO partners have strong portfolios and track records that speak to reliability, timeliness, and skill in navigating regulatory issues. Nevertheless, working with a CDMO can be daunting due to the loss of autonomy. “Your product is in the hands of very talented people, but they’re thousands of miles away,” Bernard said. Therefore, it is important for sponsors to find a trusted partner who is open to consistent communication and collaboration.
Sponsors can reduce risk by researching the CDMO and avoiding assumptions about the organization’s specific capabilities, but it is impossible to completely eliminate risk. Sponsors must anticipate problems and be prepared to adapt to unexpected shortcomings. Stakeholders must be convinced to invest in future activities and maintain contingency plans in case schedules are compromised or a do-over is required. Relationships built on patience, humility and honest communication will help you overcome contentious situations.
But by preparing for the future and building trust, startups and CDMOs can both succeed.
