Today, our lives are filled with choices. Should I buy or lease a new car? Should I purchase the generic or the name-brand
product? Is it better to rehab an existing structure or build new? In most situations, the choices we make can be changed
even in mid-stream with few long-term consequences. But the realities of business are more complex, particularly for a small
or startup biotechnology company with limited resources and equipment. The decisions that are made can often determine the
success or failure of the company. Smaller biotech companies cannot do everything alone. They often lack the knowledge and
resources to independently follow the path from clinic to market. The solution: a collaboration with a CMO or contract development
and manufacturing organization (CDMO). In fact, perhaps no choice is more important to get right the first time than the selection
of an outsourcing partner.
A well-chosen CMO with development expertise can be of vital support to smaller organizations by helping them to set up and
manage processes and to facilitate creative decision-making during the early drug-development period. However, finding the
right CDMO can be a challenging, time-intensive process. The following answers to common questions, based on the author's
experience, are meant to provide guidance in making a suitable choice.
ONE PARTNER OR SEVERAL?
The first choice to be made is whether to partner with several companies or with one full-service CDMO that can help bring
a compound from early clinical development through to commercial manufacturing and market supply. Developing and manufacturing
an innovative drug involves considerable risks, particularly financial ones. Finding a single suitable partner can free up
limited company resources, enabling the sponsor company to concentrate on core competencies such as R&D. Such a partnership
can add perceived value to both the compound(s) and company, and help attract future investors and licensing opportunities.
HOW DO I FIND THE RIGHT PARTNER?
Generally speaking, the more experienced the CDMO, the greater the likelihood of success and the smoother the collaboration.
Some questions to ask:
- How long has the CDMO been in business, and what kinds of work has it done? If relevant to the project, does the CDMO have
experience with complex compounds?
- Is its work history consistent with your current and future project(s)?
- Does it have experience in supporting your company's drug-development requirements, including clinical filling as well as
commercial manufacturing and market supply?
- Does it have relationships with regulators? How extensive is their knowledge of regulatory rules and international regulations?
- Does the CDMO have well-trained teams of scientists and engineers?
DOES THE CDMO HAVE A TEAM MENTALITY?
The core of any partnership is trust. Because small biotechnology companies often have less experience and resources in assembling
their own project-management teams, knowing how and by whom your business will be handled is essential. The partner organization's
level of experience and its designated project managers are crucial for realizing project-specific needs. The sponsor company
must be confident that knowledge and information will be handled properly and shared among all team members.