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:
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.