Determine End-Goal and Assess Team
It is important for emerging biotech companies to define their end-goal and determine whether they have the appropriate resources and team members to reach that goal. During this process, emerging biotech companies should assess their team and determine whether they have the appropriate experts to take them through the various stages of process development, chemistry, manufacturing and controls (CMC), filing and regulatory affairs.
Weigh Risks vs. Rewards
Emerging biotech companies need to determine what level of risk they are willing to take in their progression to the next milestone. One extreme is to reach the investigational new drug (IND) stage at a slow and measured pace, with minimal risk; the other extreme is to get to IND as quickly as possible but face an increased risk of failure. Assessing risk comfort will help guide an emerging biotech company’s strategy and actions.
Select the Right Partner
Many emerging biotech companies that need to take their molecule to commercialization do not have all the expertise in-house that they need to navigate the entire process, so they may decide to outsource parts of their work and will start looking for a suitable partner, generally a CDMO or CRO. Selecting the right partner can be a very difficult decision to make, as there are many factors that need to be taken into account. Here are some important qualities to look for when choosing a potential partner:
- Proven expertise – Choose a CDMO that has the most expertise in-house in order to avoid managing multiple vendors. When evaluating a potential partner, an emerging biotech company should ask itself: how many molecules has the CDMO carried successfully through product development, manufacturing and filing?
- Excellent communicator – An excellent partner should also be an excellent communicator. This includes enabling access to its experts when urgent matters come up, as they will. Small biotech companies will need to work with several partners throughout their projects, and the more experts one partner has in-house, the easier the organization and communication of the project will be.
- Flexible and adaptable – A small biotech company should consider whether their partner is flexible enough to adapt to their project needs. This means that the partner should have one project manager making sure that the process is centralized and coordinated. But it is essential that the project manager has the ability to reach out to all of the experts in the organization, so if there is a specialized discussion the expert can be at the table explaining the decision or the data to the client directly. A good partner must be able to adapt to an emerging biotech’s needs and be flexible enough to adjust the process if there is an urgent request, such as finding a different target or accelerating the project.
By defining a strategy early on in the development process, emerging biotech companies can foresee any potential risks and challenges before they arise and help determine the best course of action to help mitigate these risks. When building a strategy, it is important for biotech companies to ask themselves what they hope to accomplish and what steps will need to be taken in order to get there. The strategy should directly align with the company’s end goal, whether that be IND filing or beyond to long-term commercial success.
While developing a clear step-by-step plan is important, adhering to the plan is even more critical. Although it may be tempting to skip certain stages of a project to save time and money, adhering to the strategy will help lower the risk of failure, thus ultimately saving you time and money in the long-run.