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Four steps emerging biotech companies can take to achieve success
June 4, 2020
By: Thierry Cournez
Head of End-to-End Solutions, MilliporeSigma
Emerging biotech companies face unique challenges in bringing life-enhancing drug therapies to market quickly and efficiently, particularly in the early stages of development. These challenges include navigating a complex and competitive industry, facing a high level of uncertainty, and overcoming manufacturing and resource constraints. Although emerging biotech companies face many challenges, there are several steps they can take to help mitigate risks, overcome challenges, and achieve success in advancing their molecules from laboratory to clinic. 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:
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