Emerging Biotech companies undergo many grievances during the process of drug development. But, the potential risks and challenges can be prevented and mitigated if specific rules and regulations are followed
Fremont, CA: Any new biotech company is put under test while developing life-enhancing drug therapies to market quickly and efficiently. The challenges that the company has to endure comprise of complex and competitive industry hiccups that need to be navigated skillfully. The most common of these concerns are high levels of uncertainty, overcoming manufacturing limitations, and resources constraint. Some steps that can be employed to overcome these risks and achieve success are:
Determine a Fixed Goal and Assess Team
Emerging biotech companies must define their destination or a goal and determine if the necessary resources and team members to reach that goal are in hand. The companies should assess the team with great care and attention and hire suitable experts to guide the team through various developmental stages.
Weigh Risks vs. Rewards
After the teams are ready, the biotech companies need to select the level of risks they are willing to endure during the progression towards the next milestone. One end of the risk scale is to reach the investigational new drug (IND) stage slowly at a measured pace and minimal risk. The other end is to get to IND as soon as possible but equip to face an increased risk of failure. By assessing these risks, the company's strategy and actions can be focused on.
Select the Right Partner
Most emerging biotech companies need help while taking their molecule to commercialization, especially when they lack having expertise in all of their processes to help navigate between the steps. In this case, a partnership needs to be built and that too with the right company, usually a CDMO or CRO industry. It is critical to choose the right partner as they should encourage the work done by the biotech company and understand the acumen. Some important qualities to look for in a potential partner:
• Communication Efficiency
• Flexibility or adaptability
Develop a Step-by-Step Strategy – and Stay Aligned to It
It is advantageous to develop the strategy in the initial steps of the development process as the emerging biotech companies can foresee the potential risks and challenges before it arises. Help can be sought, or measures can be defined in place to decide the course of action towards mitigating these risks. It is essential for the biotech companies to continually question their methods and the process on how to achieve the goal and what they want to accomplish. The steps that need to be taken to arrive at the target can be figured out quickly. The strategy should align perfectly with the end goal of the company, regardless of it being an IND filing or beyond into a long term commercial success.
While developing the action plan, it is essential to have a clear step-by-step progression adhering to the plan, along with descriptions. Even if it is easier by skipping some steps to save time and money, adhering to strategy will help better and lower the risk of failure, ultimately saving time and money.