As I prepare for BIO this week in San Francisco, I’m excited by the tremendous opportunities for emerging biopharma companies to deliver much-needed new drugs to patients. These firms are lean, agile and typically led by forward-thinking entrepreneurs with the ambition to change the status quo to develop medicines that otherwise might not make it to market. While this combination of business creativity and innovative applications of biotechnology can certainly lead to success, few emerging biopharma companies have the breadth and depth of experience, infrastructure and expertise needed to execute a complete development and commercialization strategy on their own. But if they partner with an experienced strategic provider, they can reduce risk and gain access to the requisite tools and expertise to help deliver that innovative new drug to market.
How to choose
To best choose a service provider, emerging biopharma companies must be thoughtful in the way they vet and select their partners. When making this choice, they should look for the following:
- A company that has experience in the specific therapy area and market. Emerging biopharma companies should look for a company that has established relationships with payers, providers, regulators, and patient communities in the targeted markets, and that it has experience in developing similar trials and addressing the related regulatory processes. The provider also should be willing to immediately leverage those assets in support of molecule development, and to use its experience to help navigate clinical, regulatory and payer hurdles.
- State-of-the-art data management technologies. Emerging biopharma companies need a partner who can provide access to advanced analytics tools as well as modeling and simulation technology that will help speed progress and eliminate risk throughout the project lifecycle. Such tools can be game-changing for emerging biopharma companies with limited assets because they can help clinical teams predict trial results and inform planning and design decisions. This increases the likelihood that companies will meet the safety and efficacy goals needed to secure regulatory approval and win payer support, all of which is critical for market access.
- Financial guidance. One of the biggest challenges emerging biopharma companies face is understanding the financial issues associated with bringing a molecule to market. It is difficult to estimate how much money a development project will require, the trajectory of these costs, and how to rein in spending without impacting outcomes — all significant impediments to maximizing success. Having a provider that understands these financial issues and who can help proactively plan and manage costs will decrease risk, streamline progress, and improve the company’s probability of success.
- A record of success supporting similar projects and partners. Ultimately, if the service provider is passionate about the company’s innovations, and it has the capabilities and experience to accelerate the company’s clinical development programs, the company will act as a thought partner helping the team make the best decisions possible.
To read more on this topic, please see: Partnering solutions for emerging biopharma: Alternative outsourcing strategies to improve probability of success